From d7c5e9f77558422ee0ecbb9fe3a602afb2a97046 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Wed, 10 Jun 2026 12:07:32 -0400 Subject: [PATCH 01/18] merge main --- Published/CORE-000084/negative/02/results/results.csv | 8 -------- 1 file changed, 8 deletions(-) diff --git a/Published/CORE-000084/negative/02/results/results.csv b/Published/CORE-000084/negative/02/results/results.csv index ac0a344f7..daf1aa5b6 100644 --- a/Published/CORE-000084/negative/02/results/results.csv +++ b/Published/CORE-000084/negative/02/results/results.csv @@ -1,14 +1,6 @@ Dataset,Record,Variable,Value -<<<<<<< HEAD -AE,0,AEENTPT,2013-05-20 -AE,1,AEENTPT,2013-05-20 -AE,2,AEENTPT,2013-01-14 -AE,3,AEENTPT,2013-01-14 -AE,4,AEENTPT, -======= AE.csv,1,AEENTPT,2013-05-20 AE.csv,2,AEENTPT,2013-05-20 AE.csv,3,AEENTPT,2013-01-14 AE.csv,4,AEENTPT,2013-01-14 AE.csv,5,AEENTPT, ->>>>>>> main From 63e258583b9db040aa7f3ce2e8f66b5929c9351c Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Wed, 15 Jul 2026 15:15:16 -0400 Subject: [PATCH 02/18] fixes --- Published/CORE-000865/negative/01/data/lb.csv | 2 +- .../positive/01/data/_datasets.csv | 3 ++ .../positive/01/data/_variables.csv | 42 +++++++++++++++++++ Published/CORE-000865/positive/01/data/lb.csv | 5 +++ Published/CORE-000865/positive/01/data/pp.csv | 5 +++ Published/CORE-000866/rule.yml | 32 +++++++++----- 6 files changed, 77 insertions(+), 12 deletions(-) create mode 100644 Published/CORE-000865/positive/01/data/_datasets.csv create mode 100644 Published/CORE-000865/positive/01/data/_variables.csv create mode 100644 Published/CORE-000865/positive/01/data/lb.csv create mode 100644 Published/CORE-000865/positive/01/data/pp.csv diff --git a/Published/CORE-000865/negative/01/data/lb.csv b/Published/CORE-000865/negative/01/data/lb.csv index 51b9f0808..804ba04c2 100644 --- a/Published/CORE-000865/negative/01/data/lb.csv +++ b/Published/CORE-000865/negative/01/data/lb.csv @@ -2,4 +2,4 @@ STUDYID,DOMAIN,USUBJID,LBSEQ,LBTESTCD,LBTEST,LBCAT,LBORRES,LBORRESU,LBORNRLO,LBO CDISCPILOT01,LB,CDISC001,1,ALB,Albumin,CHEMISTRY,3.9,g/dL,3.5,4.6,39,39,g/L,35,46,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,3,TP1,1,PT05M,PT08M,Day 1 dose,PT05M CDISCPILOT01,LB,CDISC001,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,2,TP2,2,PT05M,PT08M,,PT05M CDISCPILOT01,LB,CDISC002,3,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,Grade II,TP3,3,PT05M,PT08M,Day 1 dose,PT05M -CDISCPILOT01,LB,CDISC002,4,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,Day 1 dose, +CDISCPILOT01,LB,CDISC002,4,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,, diff --git a/Published/CORE-000865/positive/01/data/_datasets.csv b/Published/CORE-000865/positive/01/data/_datasets.csv new file mode 100644 index 000000000..f54881356 --- /dev/null +++ b/Published/CORE-000865/positive/01/data/_datasets.csv @@ -0,0 +1,3 @@ +Filename,Label +lb,Laboratory Test Results +pp,Pharmacokinetics Parameters diff --git a/Published/CORE-000865/positive/01/data/_variables.csv b/Published/CORE-000865/positive/01/data/_variables.csv new file mode 100644 index 000000000..39379eec4 --- /dev/null +++ b/Published/CORE-000865/positive/01/data/_variables.csv @@ -0,0 +1,42 @@ +dataset,variable,label,type,length +lb,STUDYID,Study Identifier,Char,12 +lb,DOMAIN,Domain Abbreviation,Char,2 +lb,USUBJID,Unique Subject Identifier,Char,8 +lb,LBSEQ,Sequence Number,Num,8 +lb,LBTESTCD,Lab Test or Examination Short Name,Char,7 +lb,LBTEST,Lab Test or Examination Name,Char,39 +lb,LBCAT,Category for Lab Test,Char,10 +lb,LBORRES,Result or Finding in Original Units,Char,6 +lb,LBORRESU,Original Units,Char,7 +lb,LBORNRLO,Reference Range Lower Limit in Orig Unit,Char,200 +lb,LBORNRHI,Reference Range Upper Limit in Orig Unit,Char,200 +lb,LBSTRESC,Character Result/Finding in Std Format,Char,8 +lb,LBSTRESN,Numeric Result/Finding in Standard Units,Num,8 +lb,LBSTRESU,Standard Units,Char,7 +lb,LBSTNRLO,Reference Range Lower Limit-Std Units,Num,8 +lb,LBSTNRHI,Reference Range Upper Limit-Std Units,Num,8 +lb,LBNRIND,Reference Range Indicator,Char,8 +lb,LBSTAT,Completion Status,Char,8 +lb,LBREASND,Reason Not Done,Char,50 +lb,LBLOBXFL,Last Observation Before Exposure Flag,Char,1 +lb,VISITNUM,Visit Number,Num,8 +lb,VISIT,Visit Name,Char,200 +lb,EPOCH,Epoch,Char,9 +lb,LBDTC,Date/Time of Specimen Collection,Char,19 +lb,LBDY,Study Day of Specimen Collection,Num,8 +lb,LBTOX,Toxicity,Char,50 +lb,LBTOXGR,Standard Toxicity Grade,Char,50 +lb,LBTPT,Planned Time Point Name ,Char,50 +lb,LBTPTNUM,Planned Time Point Number,Num,8 +lb,LBSTINT,Planned Start of Assessment Interval ,Char,20 +lb,LBENINT,Planned End of Assessment Interval ,Char,20 +lb,LBTPTREF,Time Point Reference,Char,100 +lb,LBELTM,Planned Elapsed Time from Time Point Ref,char,30 +pp,STUDYID,Study Identifier,Char,12 +pp,DOMAIN,Domain Abbreviation,Char,2 +pp,USUBJID,Unique Subject Identifier,Char,8 +pp,PPSEQ,Sequence Number,Num,8 +pp,PPTESTCD,Parameter Short Name ,Char,7 +pp,PPTEST,Parameter Name ,Char,39 +pp,PPSPEC,Specimen Material Type ,Char,200 +pp,PPTPTREF,Time Point Reference,Char,20 diff --git a/Published/CORE-000865/positive/01/data/lb.csv b/Published/CORE-000865/positive/01/data/lb.csv new file mode 100644 index 000000000..3045afe3d --- /dev/null +++ b/Published/CORE-000865/positive/01/data/lb.csv @@ -0,0 +1,5 @@ +STUDYID,DOMAIN,USUBJID,LBSEQ,LBTESTCD,LBTEST,LBCAT,LBORRES,LBORRESU,LBORNRLO,LBORNRHI,LBSTRESC,LBSTRESN,LBSTRESU,LBSTNRLO,LBSTNRHI,LBNRIND,LBSTAT,LBREASND,LBLOBXFL,VISITNUM,VISIT,EPOCH,LBDTC,LBDY,LBTOX,LBTOXGR,LBTPT,LBTPTNUM,LBSTINT,LBENINT,LBTPTREF,LBELTM +CDISCPILOT01,LB,CDISC001,1,ALB,Albumin,CHEMISTRY,3.9,g/dL,3.5,4.6,39,39,g/L,35,46,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,3,TP1,1,PT05M,PT08M,Day 1 dose,PT05M +CDISCPILOT01,LB,CDISC001,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,2,TP2,2,PT05M,PT08M,Day 1 dose,PT05M +CDISCPILOT01,LB,CDISC002,2,ALP,Alkaline Phosphatase,CHEMISTRY,93,U/L,35,115,93,93,U/L,35,115,NORMAL,,,Y,1,SCREENING 1,SCREENING,2012-11-23T11:20,-7,,Grade II,TP3,3,PT05M,PT08M,Day 1 dose,PT05M +CDISCPILOT01,LB,CDISC002,2,ALP,Alkaline Phosphatase,CHEMISTRY,,,,,,,,,,,NOT DONE,sample broken,,1,SCREENING 1,SCREENING,2012-11-23T17:21,-7,,,TP1,1,PT05M,PT08M,Day 1 dose,PT05M diff --git a/Published/CORE-000865/positive/01/data/pp.csv b/Published/CORE-000865/positive/01/data/pp.csv new file mode 100644 index 000000000..974413e30 --- /dev/null +++ b/Published/CORE-000865/positive/01/data/pp.csv @@ -0,0 +1,5 @@ +STUDYID,DOMAIN,USUBJID,PPSEQ,PPTESTCD,PPTEST,PPSPEC,PPTPTREF +CDISCPILOT01,PP,CDISC001,1,TMAX,Time of CMAX ,ABDOMINAL WALL,Day 1 dose +CDISCPILOT01,PP,CDISC001,2,,,"ADIPOSE TISSUE, BROWN",Day 1 dose +CDISCPILOT01,PP,CDISC001,3,,,"ABDOMINAL WALL;ADIPOSE TISSUE, BROWN",Day 1 dose +CDISCPILOT01,PP,CDISC001,4,,,"ABDOMINAL WALL;ADIPOSE TISSUE, BROWN;AIR SAC",Day 1 dose diff --git a/Published/CORE-000866/rule.yml b/Published/CORE-000866/rule.yml index afcbf7c01..783743a43 100644 --- a/Published/CORE-000866/rule.yml +++ b/Published/CORE-000866/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -21,7 +22,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -35,7 +37,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -49,7 +52,8 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -63,7 +67,8 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -77,7 +82,8 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -91,7 +97,8 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -105,7 +112,8 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -119,7 +127,8 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -133,7 +142,8 @@ Authorities: - Name: SENDIG-AR References: - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, and study day of observation (--DY) should be submitted. Document: FDA @@ -155,7 +165,7 @@ Check: - name: --ENDTC operator: non_empty - name: --DTC - operator: date_greater_than + operator: date_greater_than_or_equal_to value: --ENDTC Core: Id: CORE-000866 From 0979ea72e6d2aeb23176551208c5b40386d6bf92 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Wed, 15 Jul 2026 16:46:21 -0400 Subject: [PATCH 03/18] fixes through 833 --- Published/CORE-000837/negative/01/data/Activity.csv | 1 - Published/CORE-000852/positive/01/data/se.csv | 4 ++-- 2 files changed, 2 insertions(+), 3 deletions(-) diff --git a/Published/CORE-000837/negative/01/data/Activity.csv b/Published/CORE-000837/negative/01/data/Activity.csv index 2195e58ec..6cfd625e9 100644 --- a/Published/CORE-000837/negative/01/data/Activity.csv +++ b/Published/CORE-000837/negative/01/data/Activity.csv @@ -1,5 +1,4 @@ parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,instanceType,definedProcedures,biomedicalConceptIds,nextId,timelineId,previousId,bcSurrogateIds,bcCategoryIds -parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,instanceType,definedProcedures,biomedicalConceptIds,nextId,timelineId,previousId,bcSurrogateIds,bcCategoryIds StudyDesign,StudyDesign_1,activities,definition,Activity_1,Informed consent,,Informed consent,Activity,False,False,Activity_2,,,False,False StudyDesign,StudyDesign_1,activities,definition,Activity_2,Inclusion/exclusion criteria,,Inclusion and exclusion criteria,Activity,False,False,Activity_3,,Activity_1,False,False StudyDesign,StudyDesign_2,activities,definition,Activity_3,Patient number assigned,,Patient number assigned,Activity,False,False,,,Activity_2,False,False diff --git a/Published/CORE-000852/positive/01/data/se.csv b/Published/CORE-000852/positive/01/data/se.csv index 20f436457..0be00fd50 100644 --- a/Published/CORE-000852/positive/01/data/se.csv +++ b/Published/CORE-000852/positive/01/data/se.csv @@ -1,2 +1,2 @@ -,STUDYID,DOMAIN,USUBJID,SESEQ,ETCD,ELEMENT,EPOCH,SESTDTC,SEENDTC,SESTDY,SEENDY -,CDISCPILOT01,SE,CDISC001,1,SCREEN,Screening,SCREENING,2012-11-23,2012-11-30,-7,1 +STUDYID,DOMAIN,USUBJID,SESEQ,ETCD,ELEMENT,EPOCH,SESTDTC,SEENDTC,SESTDY,SEENDY +CDISCPILOT01,SE,CDISC001,1,SCREEN,Screening,SCREENING,2012-11-23,2012-11-30,-7,1 From 545d07375ae4815dac998a67d8b0c3ae9d97e3da Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Wed, 15 Jul 2026 17:14:22 -0400 Subject: [PATCH 04/18] 832 --- Published/CORE-000832/negative/01/data/StudyIntervention.csv | 1 - 1 file changed, 1 deletion(-) diff --git a/Published/CORE-000832/negative/01/data/StudyIntervention.csv b/Published/CORE-000832/negative/01/data/StudyIntervention.csv index a7385c2d1..eeccd371b 100644 --- a/Published/CORE-000832/negative/01/data/StudyIntervention.csv +++ b/Published/CORE-000832/negative/01/data/StudyIntervention.csv @@ -1,3 +1,2 @@ parent_entity,parent_id,parent_rel,rel_type,id,description,name,label,instanceType,administrations,type,type.id,type.code,type.codeSystem,type.codeSystemVersion,type.decode,role,role.id,role.code,role.codeSystem,role.codeSystemVersion,role.decode,productDesignation,productDesignation.id,productDesignation.code,productDesignation.codeSystem,productDesignation.codeSystemVersion,productDesignation.decode,pharmacologicClass,pharmacologicClass.id,pharmacologicClass.code,pharmacologicClass.codeSystem,pharmacologicClass.codeSystemVersion,pharmacologicClass.decode,codes,minimumResponseDuration,minimumResponseDuration.id,minimumResponseDuration.value,minimumResponseDuration.unit,minimumResponseDuration.unit.id,minimumResponseDuration.unit.standardCode,minimumResponseDuration.unit.standardCode.id,minimumResponseDuration.unit.standardCode.code,minimumResponseDuration.unit.standardCode.codeSystem,minimumResponseDuration.unit.standardCode.codeSystemVersion,minimumResponseDuration.unit.standardCode.decode,minimumResponseDuration.unit.standardCodeAliases -parent_entity,parent_id,parent_rel,rel_type,id,description,name,label,instanceType,administrations,type,type.id,type.code,type.codeSystem,type.codeSystemVersion,type.decode,role,role.id,role.code,role.codeSystem,role.codeSystemVersion,role.decode,productDesignation,productDesignation.id,productDesignation.code,productDesignation.codeSystem,productDesignation.codeSystemVersion,productDesignation.decode,pharmacologicClass,pharmacologicClass.id,pharmacologicClass.code,pharmacologicClass.codeSystem,pharmacologicClass.codeSystemVersion,pharmacologicClass.decode,codes,minimumResponseDuration,minimumResponseDuration.id,minimumResponseDuration.value,minimumResponseDuration.unit,minimumResponseDuration.unit.id,minimumResponseDuration.unit.standardCode,minimumResponseDuration.unit.standardCode.id,minimumResponseDuration.unit.standardCode.code,minimumResponseDuration.unit.standardCode.codeSystem,minimumResponseDuration.unit.standardCode.codeSystemVersion,minimumResponseDuration.unit.standardCode.decode,minimumResponseDuration.unit.standardCodeAliases StudyDesign,StudyDesign_1,studyInterventions,definition,StudyIntervention_1,LY900018,LY,LY900018,StudyIntervention,True,True,Code_478,C1909,http://www.cdisc.org,2023-12-15,Pharmacologic Substance,True,Code_477,C41161,http://www.cdisc.org,2023-12-15,Experimental Intervention,True,Code_480,C99909x1,http://www.cdisc.org,2023-12-15,IMP,True,Code_479,A,FDA,None set,B,True,True,Quantity_4,1,True,AliasCode_209,True,Code_481,C25301,http://www.cdisc.org,2023-12-15,Day,False From c43ec3aab83dfe03d7405ffcb456f213aeb8e2f4 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Wed, 15 Jul 2026 17:14:54 -0400 Subject: [PATCH 05/18] sort yaml --- Published/CORE-000001/rule.yml | 143 +- Published/CORE-000004/rule.yml | 218 ++- Published/CORE-000006/rule.yml | 124 +- Published/CORE-000007/rule.yml | 221 ++- Published/CORE-000009/rule.yml | 372 ++-- Published/CORE-000010/rule.yml | 131 +- Published/CORE-000011/rule.yml | 149 +- Published/CORE-000012/rule.yml | 147 +- Published/CORE-000013/rule.yml | 151 +- Published/CORE-000014/rule.yml | 260 ++- Published/CORE-000015/rule.yml | 208 ++- Published/CORE-000016/rule.yml | 204 ++- Published/CORE-000017/rule.yml | 148 +- Published/CORE-000018/rule.yml | 242 ++- Published/CORE-000019/rule.yml | 312 ++-- Published/CORE-000020/rule.yml | 186 +- Published/CORE-000021/rule.yml | 209 ++- Published/CORE-000022/rule.yml | 254 ++- Published/CORE-000023/rule.yml | 188 +-- Published/CORE-000024/rule.yml | 118 +- Published/CORE-000025/rule.yml | 128 +- Published/CORE-000026/rule.yml | 147 +- Published/CORE-000027/rule.yml | 499 +++--- Published/CORE-000028/rule.yml | 149 +- Published/CORE-000029/rule.yml | 78 +- Published/CORE-000030/rule.yml | 160 +- Published/CORE-000033/rule.yml | 134 +- Published/CORE-000034/rule.yml | 153 +- Published/CORE-000035/rule.yml | 76 +- Published/CORE-000036/rule.yml | 117 +- Published/CORE-000037/rule.yml | 70 +- Published/CORE-000038/rule.yml | 94 +- Published/CORE-000039/rule.yml | 109 +- Published/CORE-000040/rule.yml | 107 +- Published/CORE-000041/rule.yml | 190 +-- Published/CORE-000042/rule.yml | 62 +- Published/CORE-000043/rule.yml | 62 +- Published/CORE-000044/rule.yml | 62 +- Published/CORE-000045/rule.yml | 117 +- Published/CORE-000046/rule.yml | 118 +- Published/CORE-000047/rule.yml | 144 +- Published/CORE-000048/rule.yml | 66 +- Published/CORE-000049/rule.yml | 172 +- Published/CORE-000050/rule.yml | 68 +- Published/CORE-000051/rule.yml | 68 +- Published/CORE-000052/rule.yml | 64 +- Published/CORE-000054/rule.yml | 64 +- Published/CORE-000055/rule.yml | 64 +- Published/CORE-000056/rule.yml | 64 +- Published/CORE-000057/rule.yml | 167 +- Published/CORE-000058/rule.yml | 64 +- Published/CORE-000059/rule.yml | 64 +- Published/CORE-000060/rule.yml | 64 +- Published/CORE-000061/rule.yml | 64 +- Published/CORE-000064/rule.yml | 64 +- Published/CORE-000065/rule.yml | 64 +- Published/CORE-000066/rule.yml | 64 +- Published/CORE-000067/rule.yml | 64 +- Published/CORE-000068/rule.yml | 64 +- Published/CORE-000069/rule.yml | 64 +- Published/CORE-000070/rule.yml | 64 +- Published/CORE-000071/rule.yml | 64 +- Published/CORE-000074/rule.yml | 117 +- Published/CORE-000075/rule.yml | 144 +- Published/CORE-000080/rule.yml | 158 +- Published/CORE-000081/rule.yml | 327 ++-- Published/CORE-000083/rule.yml | 130 +- Published/CORE-000084/rule.yml | 136 +- Published/CORE-000085/rule.yml | 138 +- Published/CORE-000086/rule.yml | 165 +- Published/CORE-000087/rule.yml | 130 +- Published/CORE-000088/rule.yml | 338 ++-- Published/CORE-000090/rule.yml | 146 +- Published/CORE-000092/rule.yml | 234 ++- Published/CORE-000093/rule.yml | 146 +- Published/CORE-000094/rule.yml | 132 +- Published/CORE-000095/rule.yml | 161 +- Published/CORE-000096/rule.yml | 157 +- Published/CORE-000097/rule.yml | 167 +- Published/CORE-000098/rule.yml | 164 +- Published/CORE-000099/rule.yml | 148 +- Published/CORE-000100/rule.yml | 153 +- Published/CORE-000101/rule.yml | 134 +- Published/CORE-000102/rule.yml | 152 +- Published/CORE-000103/rule.yml | 171 +- Published/CORE-000104/rule.yml | 178 +- Published/CORE-000105/rule.yml | 170 +- Published/CORE-000106/rule.yml | 142 +- Published/CORE-000107/rule.yml | 182 +- Published/CORE-000108/rule.yml | 252 ++- Published/CORE-000110/rule.yml | 116 +- Published/CORE-000111/rule.yml | 99 +- Published/CORE-000112/rule.yml | 99 +- Published/CORE-000113/rule.yml | 99 +- Published/CORE-000114/rule.yml | 99 +- Published/CORE-000116/rule.yml | 78 +- Published/CORE-000117/rule.yml | 265 ++- Published/CORE-000118/rule.yml | 274 ++- Published/CORE-000119/rule.yml | 106 +- Published/CORE-000120/rule.yml | 117 +- Published/CORE-000121/rule.yml | 126 +- Published/CORE-000122/rule.yml | 147 +- Published/CORE-000123/rule.yml | 132 +- Published/CORE-000124/rule.yml | 132 +- Published/CORE-000125/rule.yml | 132 +- Published/CORE-000126/rule.yml | 130 +- Published/CORE-000127/rule.yml | 132 +- Published/CORE-000128/rule.yml | 132 +- Published/CORE-000129/rule.yml | 131 +- Published/CORE-000130/rule.yml | 132 +- Published/CORE-000131/rule.yml | 134 +- Published/CORE-000132/rule.yml | 586 ++++--- Published/CORE-000133/rule.yml | 133 +- Published/CORE-000134/rule.yml | 167 +- Published/CORE-000135/rule.yml | 160 +- Published/CORE-000136/rule.yml | 160 +- Published/CORE-000137/rule.yml | 318 ++-- Published/CORE-000138/rule.yml | 223 ++- Published/CORE-000139/rule.yml | 220 ++- Published/CORE-000140/rule.yml | 150 +- Published/CORE-000141/rule.yml | 260 ++- Published/CORE-000142/rule.yml | 212 ++- Published/CORE-000143/rule.yml | 369 ++-- Published/CORE-000144/rule.yml | 126 +- Published/CORE-000147/rule.yml | 346 ++-- Published/CORE-000148/rule.yml | 124 +- Published/CORE-000151/rule.yml | 271 ++- Published/CORE-000152/rule.yml | 136 +- Published/CORE-000154/rule.yml | 363 ++-- Published/CORE-000155/rule.yml | 142 +- Published/CORE-000156/rule.yml | 145 +- Published/CORE-000157/rule.yml | 130 +- Published/CORE-000158/rule.yml | 156 +- Published/CORE-000159/rule.yml | 152 +- Published/CORE-000160/rule.yml | 128 +- Published/CORE-000161/rule.yml | 136 +- Published/CORE-000162/rule.yml | 140 +- Published/CORE-000163/rule.yml | 152 +- Published/CORE-000164/rule.yml | 152 +- Published/CORE-000165/rule.yml | 397 +++-- Published/CORE-000166/rule.yml | 78 +- Published/CORE-000167/rule.yml | 171 +- Published/CORE-000168/rule.yml | 152 +- Published/CORE-000169/rule.yml | 140 +- Published/CORE-000170/rule.yml | 106 +- Published/CORE-000171/rule.yml | 148 +- Published/CORE-000172/rule.yml | 293 ++-- Published/CORE-000173/rule.yml | 183 +- Published/CORE-000177/rule.yml | 158 +- Published/CORE-000179/rule.yml | 418 +++-- Published/CORE-000180/rule.yml | 122 +- Published/CORE-000182/rule.yml | 306 ++-- Published/CORE-000183/rule.yml | 160 +- Published/CORE-000184/rule.yml | 219 ++- Published/CORE-000185/rule.yml | 133 +- Published/CORE-000186/rule.yml | 124 +- Published/CORE-000187/rule.yml | 207 ++- Published/CORE-000189/rule.yml | 76 +- Published/CORE-000190/rule.yml | 76 +- Published/CORE-000191/rule.yml | 106 +- Published/CORE-000192/rule.yml | 106 +- Published/CORE-000195/rule.yml | 129 +- Published/CORE-000196/rule.yml | 129 +- Published/CORE-000197/rule.yml | 131 +- Published/CORE-000198/rule.yml | 131 +- Published/CORE-000199/rule.yml | 315 ++-- Published/CORE-000200/rule.yml | 197 ++- Published/CORE-000201/rule.yml | 361 ++-- Published/CORE-000202/rule.yml | 175 +- Published/CORE-000203/rule.yml | 180 +- Published/CORE-000204/rule.yml | 179 +- Published/CORE-000206/rule.yml | 465 +++-- Published/CORE-000207/rule.yml | 454 +++-- Published/CORE-000208/rule.yml | 133 +- Published/CORE-000209/rule.yml | 145 +- Published/CORE-000210/rule.yml | 132 +- Published/CORE-000212/rule.yml | 160 +- Published/CORE-000213/rule.yml | 160 +- Published/CORE-000214/rule.yml | 153 +- Published/CORE-000217/rule.yml | 278 ++- Published/CORE-000218/rule.yml | 350 ++-- Published/CORE-000219/rule.yml | 293 ++-- Published/CORE-000220/rule.yml | 160 +- Published/CORE-000221/rule.yml | 178 +- Published/CORE-000222/rule.yml | 138 +- Published/CORE-000223/rule.yml | 121 +- Published/CORE-000224/rule.yml | 121 +- Published/CORE-000225/rule.yml | 167 +- Published/CORE-000227/rule.yml | 145 +- Published/CORE-000228/rule.yml | 147 +- Published/CORE-000236/rule.yml | 218 ++- Published/CORE-000237/rule.yml | 296 ++-- Published/CORE-000238/rule.yml | 184 +- Published/CORE-000239/rule.yml | 162 +- Published/CORE-000240/rule.yml | 154 +- Published/CORE-000241/rule.yml | 154 +- Published/CORE-000242/rule.yml | 139 +- Published/CORE-000243/rule.yml | 139 +- Published/CORE-000244/rule.yml | 139 +- Published/CORE-000245/rule.yml | 167 +- Published/CORE-000246/rule.yml | 167 +- Published/CORE-000247/rule.yml | 146 +- Published/CORE-000248/rule.yml | 592 ++++--- Published/CORE-000249/rule.yml | 177 +- Published/CORE-000250/rule.yml | 475 +++--- Published/CORE-000252/rule.yml | 231 ++- Published/CORE-000253/rule.yml | 231 ++- Published/CORE-000254/rule.yml | 235 ++- Published/CORE-000255/rule.yml | 182 +- Published/CORE-000256/rule.yml | 371 ++-- Published/CORE-000257/rule.yml | 421 +++-- Published/CORE-000258/rule.yml | 146 +- Published/CORE-000260/rule.yml | 153 +- Published/CORE-000261/rule.yml | 140 +- Published/CORE-000262/rule.yml | 158 +- Published/CORE-000265/rule.yml | 415 +++-- Published/CORE-000266/rule.yml | 288 ++-- Published/CORE-000267/rule.yml | 133 +- Published/CORE-000268/rule.yml | 265 ++- Published/CORE-000269/rule.yml | 187 +- Published/CORE-000270/rule.yml | 176 +- Published/CORE-000271/rule.yml | 154 +- Published/CORE-000272/rule.yml | 293 ++-- Published/CORE-000273/rule.yml | 243 ++- Published/CORE-000274/rule.yml | 237 ++- Published/CORE-000289/rule.yml | 145 +- Published/CORE-000290/rule.yml | 145 +- Published/CORE-000291/rule.yml | 156 +- Published/CORE-000293/rule.yml | 159 +- Published/CORE-000294/rule.yml | 149 +- Published/CORE-000295/rule.yml | 105 +- Published/CORE-000296/rule.yml | 136 +- Published/CORE-000298/rule.yml | 145 +- Published/CORE-000299/rule.yml | 145 +- Published/CORE-000302/rule.yml | 308 ++-- Published/CORE-000303/rule.yml | 310 ++-- Published/CORE-000305/rule.yml | 298 ++-- Published/CORE-000308/rule.yml | 298 ++-- Published/CORE-000310/rule.yml | 294 ++-- Published/CORE-000318/rule.yml | 314 ++-- Published/CORE-000321/rule.yml | 295 ++-- Published/CORE-000324/rule.yml | 220 ++- Published/CORE-000325/rule.yml | 192 +-- Published/CORE-000328/rule.yml | 302 ++-- Published/CORE-000334/rule.yml | 382 ++--- Published/CORE-000337/rule.yml | 169 +- Published/CORE-000341/rule.yml | 207 ++- Published/CORE-000342/rule.yml | 412 +++-- Published/CORE-000351/rule.yml | 323 ++-- Published/CORE-000352/rule.yml | 173 +- Published/CORE-000353/rule.yml | 351 ++-- Published/CORE-000354/rule.yml | 171 +- Published/CORE-000355/rule.yml | 329 ++-- Published/CORE-000356/rule.yml | 328 ++-- Published/CORE-000357/rule.yml | 145 +- Published/CORE-000358/rule.yml | 166 +- Published/CORE-000359/rule.yml | 148 +- Published/CORE-000361/rule.yml | 245 ++- Published/CORE-000363/rule.yml | 188 +-- Published/CORE-000370/rule.yml | 219 ++- Published/CORE-000374/rule.yml | 162 +- Published/CORE-000376/rule.yml | 251 ++- Published/CORE-000381/rule.yml | 190 +-- Published/CORE-000382/rule.yml | 184 +- Published/CORE-000383/rule.yml | 157 +- Published/CORE-000384/rule.yml | 129 +- Published/CORE-000385/rule.yml | 206 ++- Published/CORE-000386/rule.yml | 102 +- Published/CORE-000387/rule.yml | 158 +- Published/CORE-000388/rule.yml | 226 +-- Published/CORE-000389/rule.yml | 158 +- Published/CORE-000390/rule.yml | 166 +- Published/CORE-000391/rule.yml | 41 +- Published/CORE-000392/rule.yml | 40 +- Published/CORE-000393/rule.yml | 260 ++- Published/CORE-000394/rule.yml | 162 +- Published/CORE-000395/rule.yml | 152 +- Published/CORE-000396/rule.yml | 152 +- Published/CORE-000397/rule.yml | 142 +- Published/CORE-000398/rule.yml | 214 +-- Published/CORE-000400/rule.yml | 87 +- Published/CORE-000401/rule.yml | 102 +- Published/CORE-000402/rule.yml | 124 +- Published/CORE-000403/rule.yml | 120 +- Published/CORE-000404/rule.yml | 109 +- Published/CORE-000407/rule.yml | 68 +- Published/CORE-000408/rule.yml | 114 +- Published/CORE-000413/rule.yml | 90 +- Published/CORE-000414/rule.yml | 80 +- Published/CORE-000416/rule.yml | 130 +- Published/CORE-000417/rule.yml | 106 +- Published/CORE-000419/rule.yml | 120 +- Published/CORE-000423/rule.yml | 124 +- Published/CORE-000424/rule.yml | 113 +- Published/CORE-000427/rule.yml | 136 +- Published/CORE-000428/rule.yml | 107 +- Published/CORE-000429/rule.yml | 49 +- Published/CORE-000430/rule.yml | 225 ++- Published/CORE-000431/rule.yml | 172 +- Published/CORE-000432/rule.yml | 216 +-- Published/CORE-000433/rule.yml | 219 ++- Published/CORE-000436/rule.yml | 249 ++- Published/CORE-000438/rule.yml | 203 ++- Published/CORE-000440/rule.yml | 213 ++- Published/CORE-000441/rule.yml | 50 +- Published/CORE-000442/rule.yml | 46 +- Published/CORE-000444/rule.yml | 116 +- Published/CORE-000445/rule.yml | 100 +- Published/CORE-000446/rule.yml | 200 +-- Published/CORE-000447/rule.yml | 186 +- Published/CORE-000449/rule.yml | 100 +- Published/CORE-000451/rule.yml | 424 +++-- Published/CORE-000454/rule.yml | 227 ++- Published/CORE-000455/rule.yml | 188 +-- Published/CORE-000456/rule.yml | 198 +-- Published/CORE-000457/rule.yml | 162 +- Published/CORE-000458/rule.yml | 243 ++- Published/CORE-000459/rule.yml | 201 ++- Published/CORE-000460/rule.yml | 198 +-- Published/CORE-000461/rule.yml | 46 +- Published/CORE-000462/rule.yml | 154 +- Published/CORE-000463/rule.yml | 197 ++- Published/CORE-000465/rule.yml | 118 +- Published/CORE-000466/rule.yml | 145 +- Published/CORE-000471/rule.yml | 164 +- Published/CORE-000472/rule.yml | 177 +- Published/CORE-000474/rule.yml | 172 +- 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Published/CORE-000505/rule.yml | 376 ++--- Published/CORE-000507/rule.yml | 183 +- Published/CORE-000508/rule.yml | 190 +-- Published/CORE-000509/rule.yml | 208 +-- Published/CORE-000511/rule.yml | 187 +- Published/CORE-000513/rule.yml | 46 +- Published/CORE-000514/rule.yml | 46 +- Published/CORE-000516/rule.yml | 279 ++- Published/CORE-000517/rule.yml | 298 ++-- Published/CORE-000518/rule.yml | 298 ++-- Published/CORE-000519/rule.yml | 176 +- Published/CORE-000520/rule.yml | 200 +-- Published/CORE-000521/rule.yml | 211 ++- Published/CORE-000523/rule.yml | 180 +- Published/CORE-000524/rule.yml | 214 ++- Published/CORE-000526/rule.yml | 215 ++- Published/CORE-000527/rule.yml | 216 ++- Published/CORE-000529/rule.yml | 884 +++++----- Published/CORE-000534/rule.yml | 294 ++-- Published/CORE-000535/rule.yml | 363 ++-- Published/CORE-000537/rule.yml | 152 +- Published/CORE-000538/rule.yml | 167 +- Published/CORE-000539/rule.yml | 195 +-- Published/CORE-000540/rule.yml | 188 +-- Published/CORE-000541/rule.yml | 160 +- Published/CORE-000542/rule.yml | 493 +++--- Published/CORE-000545/rule.yml | 211 ++- Published/CORE-000546/rule.yml | 212 ++- Published/CORE-000547/rule.yml | 679 ++++---- Published/CORE-000548/rule.yml | 332 ++-- Published/CORE-000549/rule.yml | 72 +- Published/CORE-000550/rule.yml | 187 +- Published/CORE-000551/rule.yml | 273 ++- Published/CORE-000552/rule.yml | 214 ++- Published/CORE-000553/rule.yml | 214 ++- Published/CORE-000554/rule.yml | 66 +- Published/CORE-000555/rule.yml | 189 +-- Published/CORE-000556/rule.yml | 173 +- Published/CORE-000557/rule.yml | 275 ++- Published/CORE-000558/rule.yml | 212 +-- Published/CORE-000559/rule.yml | 231 ++- Published/CORE-000560/rule.yml | 164 +- Published/CORE-000561/rule.yml | 200 +-- Published/CORE-000567/rule.yml | 194 +-- Published/CORE-000568/rule.yml | 202 +-- Published/CORE-000569/rule.yml | 186 +- Published/CORE-000570/rule.yml | 186 +- Published/CORE-000571/rule.yml | 158 +- Published/CORE-000572/rule.yml | 204 ++- Published/CORE-000573/rule.yml | 186 +- Published/CORE-000575/rule.yml | 431 +++-- Published/CORE-000576/rule.yml | 240 ++- Published/CORE-000577/rule.yml | 64 +- Published/CORE-000578/rule.yml | 123 +- Published/CORE-000580/rule.yml | 211 ++- Published/CORE-000581/rule.yml | 411 +++-- Published/CORE-000583/rule.yml | 208 ++- Published/CORE-000584/rule.yml | 266 ++- Published/CORE-000590/rule.yml | 53 +- Published/CORE-000591/rule.yml | 73 +- Published/CORE-000592/rule.yml | 57 +- Published/CORE-000593/rule.yml | 98 +- Published/CORE-000594/rule.yml | 322 ++-- Published/CORE-000595/rule.yml | 120 +- Published/CORE-000596/rule.yml | 76 +- Published/CORE-000597/rule.yml | 158 +- Published/CORE-000598/rule.yml | 357 ++-- Published/CORE-000599/rule.yml | 170 +- Published/CORE-000600/rule.yml | 91 +- Published/CORE-000601/rule.yml | 90 +- Published/CORE-000602/rule.yml | 60 +- Published/CORE-000603/rule.yml | 48 +- Published/CORE-000604/rule.yml | 89 +- Published/CORE-000605/rule.yml | 110 +- Published/CORE-000606/rule.yml | 88 +- Published/CORE-000607/rule.yml | 65 +- Published/CORE-000608/rule.yml | 172 +- Published/CORE-000609/rule.yml | 60 +- Published/CORE-000610/rule.yml | 61 +- Published/CORE-000611/rule.yml | 61 +- Published/CORE-000612/rule.yml | 289 ++-- Published/CORE-000613/rule.yml | 194 +-- Published/CORE-000614/rule.yml | 194 +-- Published/CORE-000615/rule.yml | 194 +-- Published/CORE-000616/rule.yml | 236 +-- Published/CORE-000617/rule.yml | 194 +-- Published/CORE-000618/rule.yml | 235 ++- Published/CORE-000619/rule.yml | 174 +- Published/CORE-000620/rule.yml | 281 ++- Published/CORE-000621/rule.yml | 200 ++- Published/CORE-000622/rule.yml | 194 +-- Published/CORE-000623/rule.yml | 194 +-- Published/CORE-000624/rule.yml | 194 +-- Published/CORE-000625/rule.yml | 194 +-- Published/CORE-000626/rule.yml | 197 ++- Published/CORE-000627/rule.yml | 197 ++- Published/CORE-000628/rule.yml | 194 +-- 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Published/CORE-000744/rule.yml | 169 +- Published/CORE-000749/rule.yml | 216 +-- Published/CORE-000750/rule.yml | 99 +- Published/CORE-000751/rule.yml | 119 +- Published/CORE-000752/rule.yml | 65 +- Published/CORE-000753/rule.yml | 65 +- Published/CORE-000754/rule.yml | 65 +- Published/CORE-000755/rule.yml | 63 +- Published/CORE-000756/rule.yml | 271 ++- Published/CORE-000757/rule.yml | 104 +- Published/CORE-000758/rule.yml | 224 ++- Published/CORE-000760/rule.yml | 80 +- Published/CORE-000762/rule.yml | 194 +-- Published/CORE-000763/rule.yml | 199 +-- Published/CORE-000764/rule.yml | 101 +- Published/CORE-000765/rule.yml | 282 ++-- Published/CORE-000768/rule.yml | 190 +-- Published/CORE-000769/rule.yml | 170 +- Published/CORE-000770/rule.yml | 374 ++-- Published/CORE-000771/rule.yml | 210 ++- Published/CORE-000772/rule.yml | 218 ++- Published/CORE-000773/rule.yml | 168 +- Published/CORE-000774/rule.yml | 308 ++-- Published/CORE-000775/rule.yml | 239 ++- Published/CORE-000776/rule.yml | 303 ++-- Published/CORE-000780/rule.yml | 197 ++- Published/CORE-000781/rule.yml | 169 +- Published/CORE-000782/rule.yml | 169 +- Published/CORE-000783/rule.yml | 294 ++-- Published/CORE-000784/rule.yml | 178 +- Published/CORE-000785/rule.yml | 171 +- Published/CORE-000786/rule.yml | 178 +- Published/CORE-000788/rule.yml | 199 ++- Published/CORE-000789/rule.yml | 199 ++- Published/CORE-000791/rule.yml | 308 ++-- Published/CORE-000793/rule.yml | 286 ++-- Published/CORE-000794/rule.yml | 196 +-- Published/CORE-000796/rule.yml | 71 +- Published/CORE-000797/rule.yml | 120 +- Published/CORE-000798/rule.yml | 108 +- Published/CORE-000799/rule.yml | 113 +- Published/CORE-000800/rule.yml | 118 +- Published/CORE-000801/rule.yml | 149 +- Published/CORE-000802/rule.yml | 114 +- Published/CORE-000803/rule.yml | 87 +- Published/CORE-000804/rule.yml | 156 +- Published/CORE-000805/rule.yml | 88 +- Published/CORE-000806/rule.yml | 140 +- Published/CORE-000807/rule.yml | 105 +- 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| 77 +- .../ADAMIG/CDISC.ADaMIG.AD0864/rule.yml | 66 +- .../ADAMIG/CDISC.ADaMIG.AD0865/rule.yml | 71 +- .../ADAMIG/CDISC.ADaMIG.AD0866/rule.yml | 71 +- .../ADAMIG/CDISC.ADaMIG.AD0867/rule.yml | 79 +- .../ADAMIG/CDISC.ADaMIG.AD0868/rule.yml | 79 +- .../ADAMIG/CDISC.ADaMIG.AD0872/rule.yml | 75 +- .../ADAMIG/CDISC.ADaMIG.AD0873/rule.yml | 75 +- .../ADAMIG/CDISC.ADaMIG.AD0874/rule.yml | 66 +- .../ADAMIG/CDISC.ADaMIG.AD0875/rule.yml | 64 +- .../ADAMIG/CDISC.ADaMIG.AD0876/rule.yml | 64 +- .../ADAMIG/CDISC.ADaMIG.AD0877/rule.yml | 72 +- .../FDA Business Rules/CORE-000734/rule.yml | 129 +- .../FDA Business Rules/CORE-000737/rule.yml | 188 +-- .../FDA Business Rules/CORE-000738/rule.yml | 118 +- .../FDA Business Rules/CORE-000748/rule.yml | 89 +- .../FDA Business Rules/FB0804/rule.yml | 232 +-- .../FDA Business Rules/FB1113/rule.yml | 166 +- .../FDA Business Rules/FB1901/rule.yml | 301 ++-- .../FDA Business Rules/FB6501/rule.yml | 203 ++- .../FDA Business Rules/FB6502/rule.yml | 203 ++- .../FDA 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.../SDTMIG/CDISC.SDTMIG.CG0253/rule.yml | 106 +- .../SDTMIG/CDISC.SDTMIG.CG0254/rule.yml | 107 +- .../SDTMIG/CDISC.SDTMIG.CG0267/rule.yml | 86 +- .../SDTMIG/CDISC.SDTMIG.CG0295/rule.yml | 108 +- .../SDTMIG/CDISC.SDTMIG.CG0296/rule.yml | 104 +- .../SDTMIG/CDISC.SDTMIG.CG0298/rule.yml | 90 +- .../SDTMIG/CDISC.SDTMIG.CG0312/rule.yml | 355 ++-- .../SDTMIG/CDISC.SDTMIG.CG0320/rule.yml | 139 +- .../SDTMIG/CDISC.SDTMIG.CG0321/rule.yml | 149 +- .../SDTMIG/CDISC.SDTMIG.CG0322/rule.yml | 117 +- .../SDTMIG/CDISC.SDTMIG.CG0323/rule.yml | 138 +- .../SDTMIG/CDISC.SDTMIG.CG0324/rule.yml | 113 +- .../SDTMIG/CDISC.SDTMIG.CG0347/rule.yml | 128 +- .../SDTMIG/CDISC.SDTMIG.CG0375/rule.yml | 122 +- .../SDTMIG/CDISC.SDTMIG.CG0377/rule.yml | 106 +- .../SDTMIG/CDISC.SDTMIG.CG0378/rule.yml | 119 +- .../SDTMIG/CDISC.SDTMIG.CG0380/rule.yml | 95 +- .../SDTMIG/CDISC.SDTMIG.CG0381/rule.yml | 96 +- .../SDTMIG/CDISC.SDTMIG.CG0382/rule.yml | 96 +- .../SDTMIG/CDISC.SDTMIG.CG0383/rule.yml | 96 +- .../SDTMIG/CDISC.SDTMIG.CG0384/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0385/rule.yml | 105 +- .../SDTMIG/CDISC.SDTMIG.CG0386/rule.yml | 109 +- .../SDTMIG/CDISC.SDTMIG.CG0400/rule.yml | 106 +- .../SDTMIG/CDISC.SDTMIG.CG0418/rule.yml | 105 +- .../SDTMIG/CDISC.SDTMIG.CG0425/rule.yml | 96 +- .../SDTMIG/CDISC.SDTMIG.CG0431/rule.yml | 132 +- .../SDTMIG/CDISC.SDTMIG.CG0436/rule.yml | 96 +- .../SDTMIG/CDISC.SDTMIG.CG0437/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0442/rule.yml | 73 +- .../SDTMIG/CDISC.SDTMIG.CG0443/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0445/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0446/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0448/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0449/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0450/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0451/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0453/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0454/rule.yml | 66 +- .../SDTMIG/CDISC.SDTMIG.CG0460/rule.yml | 99 +- .../SDTMIG/CDISC.SDTMIG.CG0461/rule.yml | 99 +- .../SDTMIG/CDISC.SDTMIG.CG0463/rule.yml | 126 +- .../SDTMIG/CDISC.SDTMIG.CG0464/rule.yml | 128 +- .../SDTMIG/CDISC.SDTMIG.CG0466/rule.yml | 94 +- .../SDTMIG/CDISC.SDTMIG.CG0523/rule.yml | 76 +- .../SDTMIG/CDISC.SDTMIG.CG0524/rule.yml | 77 +- .../SDTMIG/CDISC.SDTMIG.CG0525/rule.yml | 84 +- .../SDTMIG/CDISC.SDTMIG.CG0526/rule.yml | 77 +- .../SDTMIG/CDISC.SDTMIG.CG0527/rule.yml | 84 +- .../SDTMIG/CDISC.SDTMIG.CG0532/rule.yml | 128 +- .../SDTMIG/CDISC.SDTMIG.CG0546/rule.yml | 138 +- .../SDTMIG/CDISC.SDTMIG.CG0548/rule.yml | 64 +- .../SDTMIG/CDISC.SDTMIG.CG0551/rule.yml | 70 +- .../SDTMIG/CDISC.SDTMIG.CG0555/rule.yml | 133 +- .../SDTMIG/CDISC.SDTMIG.CG0556/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0557/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0558/rule.yml | 133 +- .../SDTMIG/CDISC.SDTMIG.CG0559/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0560/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0563/rule.yml | 94 +- .../SDTMIG/CDISC.SDTMIG.CG0604/rule.yml | 41 +- .../SDTMIG/CDISC.SDTMIG.CG0605/rule.yml | 41 +- .../SDTMIG/CDISC.SDTMIG.CG0607/rule.yml | 52 +- .../SDTMIG/CDISC.SDTMIG.CG0608/rule.yml | 52 +- .../SDTMIG/CDISC.SDTMIG.CG0609/rule.yml | 52 +- .../SDTMIG/CDISC.SDTMIG.CG0610/rule.yml | 53 +- .../SDTMIG/CDISC.SDTMIG.CG0614/rule.yml | 38 +- .../SDTMIG/CDISC.SDTMIG.CG0615/rule.yml | 39 +- .../SDTMIG/CDISC.SDTMIG.CG0616/rule.yml | 42 +- .../SDTMIG/CDISC.SDTMIG.CG0617/rule.yml | 39 +- .../SDTMIG/CDISC.SDTMIG.CG0651/rule.yml | 106 +- .../SDTMIG/CDISC.SDTMIG.CG0663/rule.yml | 104 +- .../SDTMIG/CDISC.SDTMIG.CG0998/rule.yml | 67 +- .../SDTMIG/CDISC.SDTMIG.CG0999/rule.yml | 77 +- Unpublished/SDTMIG/CG0011/rule.yml | 104 +- Unpublished/SDTMIG/CG0011A1/rule.yml | 96 +- Unpublished/SDTMIG/CG0011A2/rule.yml | 92 +- Unpublished/SDTMIG/CG0011B1/rule.yml | 208 +-- Unpublished/SDTMIG/CG0011C2/rule.yml | 105 +- Unpublished/SDTMIG/CORE-000205/rule.yml | 86 +- Unpublished/SDTMIG/CORE-000343/rule.yml | 94 +- Unpublished/SDTMIG/CORE-000344/rule.yml | 128 +- Unpublished/SDTMIG/CORE-000345/rule.yml | 116 +- Unpublished/SDTMIG/CORE-000346/rule.yml | 92 +- Unpublished/SDTMIG/CORE-000347/rule.yml | 138 +- Unpublished/SDTMIG/CORE-000348/rule.yml | 99 +- Unpublished/SDTMIG/CORE-000349/rule.yml | 95 +- Unpublished/SDTMIG/CORE-000350/rule.yml | 94 +- Unpublished/SDTMIG/CORE-000536/rule.yml | 113 +- Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml | 74 +- Unpublished/SDTMIG/NicTest/rule.yml | 48 +- Unpublished/SDTMIG/WHODrug/rule.yml | 72 +- Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml | 186 +- Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml | 166 +- Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml | 76 +- Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml | 164 +- Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml | 202 +-- Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml | 49 +- Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml | 57 +- Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml | 165 +- Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml | 181 +- Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml | 141 +- Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml | 144 +- .../SENDIG/CDISC.SENDIG.190.1B/rule.yml | 199 ++- Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml | 283 ++-- Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml | 236 ++- Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml | 300 ++-- Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml | 234 ++- Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml | 206 +-- Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml | 209 ++- Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml | 209 ++- Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml | 445 +++-- .../SENDIG/CDISC.SENDIG.265.1/rule.yml | 115 +- Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml | 162 +- Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml | 116 +- Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml | 182 +- Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml | 233 ++- Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml | 214 +-- Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml | 138 +- Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml | 61 +- Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml | 102 +- Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml | 92 +- Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml | 177 +- Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml | 134 +- Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml | 74 +- Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml | 108 +- Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml | 95 +- Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml | 185 +- Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml | 94 +- Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml | 52 +- Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml | 42 +- Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml | 189 ++- Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml | 213 ++- Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml | 59 +- .../SENDIG/CDISC.SENDIG.SEND1/rule.yml | 41 +- .../SENDIG/CDISC.SENDIG.SEND142/rule.yml | 168 +- .../SENDIG/CDISC.SENDIG.SEND157/rule.yml | 243 ++- .../SENDIG/CDISC.SENDIG.SEND293/rule.yml | 201 +-- .../SENDIG/CDISC.SENDIG.SEND411/rule.yml | 36 +- Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml | 387 ++--- Unpublished/SENDIG/SEND100/rule.yml | 185 +- Unpublished/SENDIG/SEND106.1/rule.yml | 234 ++- Unpublished/SENDIG/SEND238/rule.yml | 238 ++- Unpublished/SENDIG/SEND239/rule.yml | 312 ++-- Unpublished/SENDIG/SEND261/rule.yml | 188 +-- Unpublished/SENDIG/SEND283/rule.yml | 207 ++- Unpublished/SENDIG/SEND298/rule.yml | 197 +-- Unpublished/SENDIG/SEND300/rule.yml | 57 +- Unpublished/SENDIG/SEND310/rule.yml | 172 +- Unpublished/SENDIG/SEND313/rule.yml | 74 +- Unpublished/SENDIG/SEND321/rule.yml | 79 +- Unpublished/SENDIG/SEND327/rule.yml | 130 +- Unpublished/SENDIG/SEND328-1/rule.yml | 218 ++- Unpublished/SENDIG/SEND328-2/rule.yml | 216 ++- Unpublished/SENDIG/SEND333/rule.yml | 155 +- Unpublished/SENDIG/SEND340/rule.yml | 53 +- Unpublished/SENDIG/SEND348/rule.yml | 183 +- Unpublished/SENDIG/SEND362/rule.yml | 80 +- Unpublished/SENDIG/SEND399/rule.yml | 119 +- Unpublished/SENDIG/SEND4/rule.yml | 184 +- Unpublished/SENDIG/SEND41/rule.yml | 42 +- Unpublished/SENDIG/SEND49/rule.yml | 247 ++- Unpublished/SENDIG/SEND5/rule.yml | 204 ++- Unpublished/SENDIG/SEND50.99/rule.yml | 52 +- Unpublished/SENDIG/SEND50/rule.yml | 224 ++- Unpublished/SENDIG/SEND57.1/rule.yml | 233 ++- Unpublished/SENDIG/SEND7/rule.yml | 204 ++- Unpublished/SENDIG/SEND98/rule.yml | 54 +- .../SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml | 1502 ++++++++--------- Unpublished/TIG/TIG0031/rule.yml | 72 +- Unpublished/TIG/TIG0044/rule.yml | 93 +- Unpublished/USDM/DDF00262/rule.yml | 43 +- Unpublished/USDM/USDM_TEMPLATE/rule.yml | 84 +- 1185 files changed, 93447 insertions(+), 97457 deletions(-) diff --git a/Published/CORE-000001/rule.yml b/Published/CORE-000001/rule.yml index 2a5755509..5fa8ef6bb 100644 --- a/Published/CORE-000001/rule.yml +++ b/Published/CORE-000001/rule.yml @@ -2,84 +2,79 @@ # Condition: IECAT = 'INCLUSION' # Rule: IEORRES = 'N' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: SDTM v3.4 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: TIG 1.0 - Item: Assumption 1 - Section: '2.8.10.13' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0405 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: SDTM v3.4 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.2 + Item: Assumption 2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: TIG 1.0 + Item: Assumption 1 + Section: '2.8.10.13' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0405 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IECAT - operator: equal_to - value: INCLUSION - value_is_literal: true - - name: IEORRES - operator: not_equal_to - value: N - value_is_literal: true + - name: IECAT + operator: equal_to + value: INCLUSION + value_is_literal: true + - name: IEORRES + operator: not_equal_to + value: N + value_is_literal: true Core: Id: CORE-000001 Status: Published Version: '1' -Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is - not equal to 'N'. +Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is not equal to 'N'. Executability: Fully Executable Outcome: Message: IEORRES is not equal to 'N' when IECAT equals 'INCLUSION'. @@ -87,9 +82,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000004/rule.yml b/Published/CORE-000004/rule.yml index 8176f8cde..7923d0aa2 100644 --- a/Published/CORE-000004/rule.yml +++ b/Published/CORE-000004/rule.yml @@ -2,139 +2,125 @@ # Condition: ECOCCUR = 'N' # Rule: ECDOSE = null or > 0 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL - is infused at a visit, then ECOCCUR = 'N' is the standard - representation of the collected doses not taken, not - given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative - method for indicating doses not taken, not given, or missed. - Document: IG v3.4 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases - where the sponsor feels it is necessary and/or appropriate to - represent specific dose amounts not taken, not given, or - missed. - Document: IG v3.4 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken - within a timeframe or 0 mL infused at a visit, then ECOCCUR = - 'N' is the standard representation of the collected doses not - taken, not given, or missed. Dose amount variables (e.g., - ECDOSE, ECDOSTXT) must not be set to zero (0) as an - alternative method for indicating doses not taken, not given, - or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that - indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated - with positive (non-zero) values in cases where the sponsor - feels it is necessary and/or appropriate to represent specific - dose amounts not taken, not given, or missed.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 4a]|IG v3.2[6.1][Assumption 4b] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are - taken within a timeframe or 0 mL infused at a visit, then - ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables - (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as an - alternative method for indicating doses not taken, not given, - or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that - indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated - with positive (non-zero) values in cases where the sponsor - feels it is necessary and/or appropriate to represent specific - dose amounts not taken, not given, or missed.] - Document: IG v3.3 - Item: IG v3.3[6.1.3.2][Assumption 4a]|IG v3.3[6.1.3.2][Assumption 4b] - Section: IG v3.3[6.1.3.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: '[Assumption 4a][For example, if 0 tablets are taken within a - timeframe or 0 mL is infused at a visit, then ECOCCUR = ''N'' - is the standard representation of the collected doses not - taken, not given, or missed. Dose amount variables (e.g., - ECDOSE, ECDOSTXT) must not be set to zero (0) as an - alternative method for indicating doses not taken, not given, - or missed.' - Document: TIG 1.0 - Item: Assumption 4a - Section: 2.8.10.11 - - Cited Guidance: '[Assumption 4b][Qualifiers that indicate dose amount (e.g., - ECDOSE, ECDOSTXT) may be populated with positive (non-zero) - values in cases where the sponsor feels it is necessary and/or - appropriate to represent specific dose amounts not taken, not - given, or missed.]' - Document: TIG 1.0 - Item: Assumption 4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0366 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL is infused at + a visit, then ECOCCUR = 'N' is the standard representation of the collected doses not + taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be + set to zero (0) as an alternative method for indicating doses not taken, not given, or + missed. + Document: IG v3.4 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken within a + timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of + the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, + ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not + taken, not given, or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that indicate dose + amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases + where the sponsor feels it is necessary and/or appropriate to represent specific dose + amounts not taken, not given, or missed.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 4a]|IG v3.2[6.1][Assumption 4b] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are taken within a + timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of + the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, + ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not + taken, not given, or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that indicate + dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in + cases where the sponsor feels it is necessary and/or appropriate to represent specific + dose amounts not taken, not given, or missed.] + Document: IG v3.3 + Item: IG v3.3[6.1.3.2][Assumption 4a]|IG v3.3[6.1.3.2][Assumption 4b] + Section: IG v3.3[6.1.3.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: '[Assumption 4a][For example, if 0 tablets are taken within a timeframe or 0 mL + is infused at a visit, then ECOCCUR = ''N'' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not + be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed.' + Document: TIG 1.0 + Item: Assumption 4a + Section: 2.8.10.11 + - Cited Guidance: '[Assumption 4b][Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed.]' + Document: TIG 1.0 + Item: Assumption 4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0366 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ECOCCUR # The condition is ECOCCUR = "N" - operator: equal_to - value: N - - name: ECDOSE + - name: ECOCCUR # The condition is ECOCCUR = "N" + operator: equal_to + value: N + - name: ECDOSE # The rule is ECDOSE is null or > 0 # so the failure criteria is not empty and LE 0 # which is the same as just LE 0 - operator: less_than_or_equal_to - value: 0 + operator: less_than_or_equal_to + value: 0 Core: Id: CORE-000004 Status: Published Version: '1' -Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or > - 0; it cannot be used to indicate a dose wasn't taken. +Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used + to indicate a dose wasn't taken. Executability: Fully Executable Outcome: - Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a - value less than or equal to 0 + Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or + equal to 0 Output Variables: - - ECDOSE - - ECOCCUR + - ECDOSE + - ECOCCUR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000006/rule.yml b/Published/CORE-000006/rule.yml index 12620bfbb..4b5f21ac4 100644 --- a/Published/CORE-000006/rule.yml +++ b/Published/CORE-000006/rule.yml @@ -2,67 +2,67 @@ # Condition: # Rule: DTHFL in ('Y',null) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Should be "Y" or null - Document: Model v2.0 - Item: DTHFL - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Should be Y or null. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ' Should be "Y" or null.' - Document: Model v1.7 - Item: DTHFL Description - Section: Table 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ' Should be "Y" or null.' - Document: SDTM v2.1 - Item: DTHFL - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0381 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Should be "Y" or null + Document: Model v2.0 + Item: DTHFL + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Should be Y or null. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ' Should be "Y" or null.' + Document: Model v1.7 + Item: DTHFL Description + Section: Table 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: ' Should be "Y" or null.' + Document: SDTM v2.1 + Item: DTHFL + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0381 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DTHFL - operator: not_equal_to - value: Y - - name: DTHFL - operator: non_empty + - name: DTHFL + operator: not_equal_to + value: Y + - name: DTHFL + operator: non_empty Core: Id: CORE-000006 Status: Published @@ -72,14 +72,14 @@ Executability: Fully Executable Outcome: Message: DTHFL is not "Y" or null Output Variables: - - DTHFL + - DTHFL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000007/rule.yml b/Published/CORE-000007/rule.yml index 46bca41b6..e2618565f 100644 --- a/Published/CORE-000007/rule.yml +++ b/Published/CORE-000007/rule.yml @@ -2,134 +2,131 @@ # Condition: DTHDTC ^= null # Rule: DTHFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DTHDTC[The date or date and time of death, represented in a - standardized character format.] DTHFL[An indication that the - subject died.] - Document: Model v2.0 - Item: DTHDTC|DTHFL - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value of 'Y' indicates the subject died. Should be Y or null. - Should be populated even when the death date is unknown. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value of "Y" indicates the subject died. Should be "Y" or - null. Should be populated even when the death date is unknown. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: DTHDTC[The date or date and time of death, represented in a - standardized character format.]|DTHFL[An indication that the - subject died.] - Document: SDTM v2.1 - Item: DTHDTC|DTHFL - Section: 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0587 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: DTHDTC[The date or date and time of death, represented in a standardized + character format.] DTHFL[An indication that the subject died.] + Document: Model v2.0 + Item: DTHDTC|DTHFL + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A value of 'Y' indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A value of "Y" indicates the subject died. Should be "Y" or null. Should be + populated even when the death date is unknown. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: DTHDTC[The date or date and time of death, represented in a standardized + character format.]|DTHFL[An indication that the subject died.] + Document: SDTM v2.1 + Item: DTHDTC|DTHFL + Section: 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0587 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' #CG0435 is identical to rule FB0606. Added metadata for FB0606. - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: DTHDTC - operator: non_empty - - name: DTHFL - operator: not_equal_to - value: Y + - name: DTHDTC + operator: non_empty + - name: DTHFL + operator: not_equal_to + value: Y Core: Id: CORE-000007 Status: Published Version: '1' -Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated - then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the - corresponding subject. +Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL) + should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Outcome: Message: DTHDTC is populated but DTHFL in DM dataset is not "Y". Output Variables: - - DTHDTC - - DTHFL + - DTHDTC + - DTHFL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000009/rule.yml b/Published/CORE-000009/rule.yml index dd4916805..be626e322 100644 --- a/Published/CORE-000009/rule.yml +++ b/Published/CORE-000009/rule.yml @@ -2,195 +2,185 @@ # Condition: ETCD = 'UNPLAN' # Rule: ELEMENT = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of 'UNPLAN' then - ELEMENT should be null. - Document: SDTMIG v3.4 - Item: Specification - Section: 5.3 Specification - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then - ELEMENT should be null. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then - ELEMENT should be null. - Document: IG v3.3 - Item: Specification - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If ETCD has a value of UNPLAN, then Element should be blank. - Document: SENDIG v3.0 - Item: Specification - Section: 5.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element.For unplanned Elements, - ETCD should be populated with 'UNPLAN', ELEMENT should be left - blank, and SEUPDES should be populated with a description of - the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element.For unplanned Elements, - ETCD should be populated with 'UNPLAN', ELEMENT should be left - blank, and SEUPDES should be populated with a description of - the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element.For unplanned Elements, - ETCD should be populated with 'UNPLAN', ELEMENT should be left - blank, and SEUPDES should be populated with a description of - the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element.For unplanned Elements, - ETCD should be populated with 'UNPLAN', ELEMENT should be left - blank, and SEUPDES should be populated with a description of - the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element.For unplanned Elements, - ETCD should be populated with 'UNPLAN', ELEMENT should be left - blank, and SEUPDES should be populated with a description of - the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ETCD has a value of "UNPLAN", then ELEMENT should be null. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0393 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: TIG v1.0 - Item: Assumption 5 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0061 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The name of the Element. If ETCD has a value of 'UNPLAN' then ELEMENT should + be null. + Document: SDTMIG v3.4 + Item: Specification + Section: 5.3 Specification + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should + be null. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should + be null. + Document: IG v3.3 + Item: Specification + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If ETCD has a value of UNPLAN, then Element should be blank. + Document: SENDIG v3.0 + Item: Specification + Section: 5.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: If ETCD has a value of "UNPLAN", then ELEMENT should be null. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0393 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: TIG v1.0 + Item: Assumption 5 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0061 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: ETCD - operator: equal_to - value: UNPLAN - - name: ELEMENT - operator: non_empty + - name: ETCD + operator: equal_to + value: UNPLAN + - name: ELEMENT + operator: non_empty Core: Id: CORE-000009 Status: Published @@ -200,15 +190,15 @@ Executability: Fully Executable Outcome: Message: ELEMENT variable has a non-null value when ETCD has a value of 'UNPLAN' Output Variables: - - ETCD - - ELEMENT + - ETCD + - ELEMENT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000010/rule.yml b/Published/CORE-000010/rule.yml index 33aa09d2d..95676aa3b 100644 --- a/Published/CORE-000010/rule.yml +++ b/Published/CORE-000010/rule.yml @@ -2,69 +2,68 @@ # Condition: # Rule: ARMCD value length <= 20 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have the - character restrictions that apply to --TESTCD - Document: SDTMIG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.2 - Section: 4.1.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.3 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. The maximum length of ARMCD is longer - than that for other short variables to accommodate the kind of - values that are likely to be needed for crossover trials. - Document: TIG 1.0 - Item: Specification ARMCD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0394 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have the character + restrictions that apply to --TESTCD + Document: SDTMIG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Section: 4.1.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.3 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. The maximum length of ARMCD is longer than that for other short variables to + accommodate the kind of values that are likely to be needed for crossover trials. + Document: TIG 1.0 + Item: Specification ARMCD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0394 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: matches_regex - value: ^(.){21,}$ + - name: ARMCD + operator: matches_regex + value: ^(.){21,}$ Core: Id: CORE-000010 Status: Published @@ -74,16 +73,16 @@ Executability: Fully Executable Outcome: Message: ARMCD value length is greater than 20 Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TA + - DM + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000011/rule.yml b/Published/CORE-000011/rule.yml index 1f620c3ce..cd5ab9fc3 100644 --- a/Published/CORE-000011/rule.yml +++ b/Published/CORE-000011/rule.yml @@ -2,98 +2,93 @@ # Condition: IECAT = 'EXCLUSION' # Rule: IEORRES = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only - those criteria that the subject did not meet, and not the - responses to all criteria.  - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only - those criteria that the subject did not meet, and not the - responses to all criteria. - Document: TIG 1.0 - Item: Assumption 1 - Section: '2.8.10.13' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0404 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria.  + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.2 + Item: Assumption 2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: TIG 1.0 + Item: Assumption 1 + Section: '2.8.10.13' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0404 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IECAT - operator: equal_to - value: EXCLUSION - value_is_literal: true - - name: IEORRES - operator: not_equal_to - value: Y - value_is_literal: true + - name: IECAT + operator: equal_to + value: EXCLUSION + value_is_literal: true + - name: IEORRES + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000011 Status: Published Version: '1' -Description: Raise an error when IECAT is equal to 'EXCLUSION' and IEORRES is - not equal to 'Y'. +Description: Raise an error when IECAT is equal to 'EXCLUSION' and IEORRES is not equal to 'Y'. Executability: Fully Executable Outcome: Message: IEORRES is not equal to 'Y' when IECAT equals 'EXCLUSION'. Output Variables: - - IECAT - - IEORRES + - IECAT + - IEORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000012/rule.yml b/Published/CORE-000012/rule.yml index 959b6b98b..44e8f70de 100644 --- a/Published/CORE-000012/rule.yml +++ b/Published/CORE-000012/rule.yml @@ -2,81 +2,76 @@ # Condition: # Rule: AEOCCUR not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, - --STAT, and --REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred. - Document: SDTMIG v3.4 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, - --STAT, and--REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred. - Document: SDTMIG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, - --STAT, and--REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred. - Document: SDTMIG v3.2 - Item: Assumption 8 - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, - --STAT, and--REASND. They are the only qualifiers from the - SDTM Events class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred.''' - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0319 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, and + --REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.4 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.2 + Item: Assumption 8 + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred.''' + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0319 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AEOCCUR - operator: exists + - name: AEOCCUR + operator: exists Core: Id: CORE-000012 Status: Published @@ -86,14 +81,14 @@ Executability: Fully Executable Outcome: Message: AEOCCUR is present in AE dataset. Output Variables: - - AEOCCUR + - AEOCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000013/rule.yml b/Published/CORE-000013/rule.yml index ca67f1cef..a5c4a8486 100644 --- a/Published/CORE-000013/rule.yml +++ b/Published/CORE-000013/rule.yml @@ -2,83 +2,78 @@ # Condition: # Rule: AESTAT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", - "--STAT", and "--REASND". They are the only Qualifiers from - the SDTM Events Class not in the AE domain. They are not - permitted because the AE domain contains only records for - adverse events that actually occurred. - Document: SDTMIG v3.4 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", - "--STAT", and "--REASND". They are the only Qualifiers from - the SDTM Events Class not in the AE domain. They are not - permitted because the AE domain contains only records for - adverse events that actually occurred. - Document: SDTMIG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", - "--STAT", and "--REASND". They are the only Qualifiers from - the SDTM Events Class not in the AE domain. They are not - permitted because the AE domain contains only records for - adverse events that actually occurred. - Document: SDTMIG v3.2 - Item: Assumption 8 - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, - --STAT, and--REASND. They are the only qualifiers from the - SDTM Events class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred. See Assumption 4b for information on - how to deal with negative responses or missing responses to - probing questions for prespecified adverse events.' - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0323 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.4 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.2 + Item: Assumption 8 + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred. See Assumption + 4b for information on how to deal with negative responses or missing responses to probing questions + for prespecified adverse events.' + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0323 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESTAT - operator: exists + - name: AESTAT + operator: exists Core: Id: CORE-000013 Status: Published @@ -88,14 +83,14 @@ Executability: Fully Executable Outcome: Message: AESTAT variable is present in AE dataset. Output Variables: - - AESTAT + - AESTAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000014/rule.yml b/Published/CORE-000014/rule.yml index fa64c9888..473b6515e 100644 --- a/Published/CORE-000014/rule.yml +++ b/Published/CORE-000014/rule.yml @@ -2,164 +2,142 @@ # Condition: (--PRESP ^= 'Y' and --OCCUR is present in dataset) or (--STAT=NOT DONE) # Rule: --OCCUR = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Item: --PRESP|--OCCUR|--STAT - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or have a value of NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or have a value of NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The - Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0352 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Item: --PRESP|--OCCUR|--STAT + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0352 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - any: - - all: - - any: - - name: --PRESP - operator: not_exists - - name: --PRESP - operator: not_equal_to - value: Y - - name: --OCCUR - operator: exists - - name: --OCCUR - operator: non_empty - - all: - - name: --STAT - operator: equal_to - value: NOT DONE + - any: - all: - - name: --OCCUR - operator: non_empty + - any: + - name: --PRESP + operator: not_exists + - name: --PRESP + operator: not_equal_to + value: Y + - name: --OCCUR + operator: exists + - name: --OCCUR + operator: non_empty + - all: + - name: --STAT + operator: equal_to + value: NOT DONE + - all: + - name: --OCCUR + operator: non_empty Core: Id: CORE-000014 Status: Published Version: '1' -Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is - present in dataset or --STAT is equal to "NOT DONE" and --OCCUR is not blank +Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or + --STAT is equal to "NOT DONE" and --OCCUR is not blank Executability: Fully Executable Outcome: Message: --OCCUR should only be provided when --PRESP is equal to "Y". Output Variables: - - --PRESP - - --OCCUR - - --STAT + - --PRESP + - --OCCUR + - --STAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000015/rule.yml b/Published/CORE-000015/rule.yml index d4956b7a8..aec1ea367 100644 --- a/Published/CORE-000015/rule.yml +++ b/Published/CORE-000015/rule.yml @@ -2,113 +2,95 @@ # Condition: --PRESP not present in dataset # Rule: --OCCUR not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.]|Model v1.4[2.2.2 - (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported - events.][--OCCUR: Used to record whether a pre-specified event - occurred when information about the occurrence of a specific - event is solicited.]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.]|Model v1.7[2.2.2 - (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported - events.][--OCCUR: Used to record whether a pre-specified event - occurred when information about the occurrence of a specific - event is solicited.]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The - Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0353 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0353 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: not_exists - - name: --OCCUR - operator: exists + - name: --PRESP + operator: not_exists + - name: --OCCUR + operator: exists Core: Id: CORE-000015 Status: Published @@ -118,19 +100,19 @@ Executability: Fully Executable Outcome: Message: --PRESP is missing in dataset when --OCCUR is present. Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000016/rule.yml b/Published/CORE-000016/rule.yml index 48183190c..b7cbb4a56 100644 --- a/Published/CORE-000016/rule.yml +++ b/Published/CORE-000016/rule.yml @@ -2,108 +2,96 @@ # Condition: --OCCUR ^= null # Rule: --PRESP = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.] - Document: Model v2.0 - Section: Events - - Cited Guidance: Interventions[--PRESP][An indication that the intervention was - prospectively stated or detailed on the CRF. Values should be - "Y" or null.]|Interventions[--OCCUR][An indication as to - whether a prespecified intervention has occurred.] - Document: Model v2.0 - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.]|Model v1.4[2.2.2 - (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported - events.][--OCCUR: Used to record whether a pre-specified event - occurred when information about the occurrence of a specific - event is solicited.]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.]|Model v1.7[2.2.2 - (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported - events.][--OCCUR: Used to record whether a pre-specified event - occurred when information about the occurrence of a specific - event is solicited.]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: (--PRESP) An indication that the event was prospectively stated - or detailed on the CRF. Values should be "Y" or null. - (--OCCUR) An indication as to whether a prespecified event has - occurred. - Document: SDTM v2.1 - Item: --PRESP|--OCCUR - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: (--PRESP) An indication that the intervention was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.(--OCCUR) An indication as to whether a prespecified - intervention has occurred. - Document: SDTM v2.1 - Item: --PRESP|--OCCUR - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0354 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.] + Document: Model v2.0 + Section: Events + - Cited Guidance: Interventions[--PRESP][An indication that the intervention was prospectively + stated or detailed on the CRF. Values should be "Y" or null.]|Interventions[--OCCUR][An + indication as to whether a prespecified intervention has occurred.] + Document: Model v2.0 + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: (--PRESP) An indication that the event was prospectively stated or detailed + on the CRF. Values should be "Y" or null. (--OCCUR) An indication as to whether a + prespecified event has occurred. + Document: SDTM v2.1 + Item: --PRESP|--OCCUR + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: (--PRESP) An indication that the intervention was prospectively stated or + detailed on the CRF. Values should be "Y" or null.(--OCCUR) An indication as to whether a + prespecified intervention has occurred. + Document: SDTM v2.1 + Item: --PRESP|--OCCUR + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0354 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --OCCUR - operator: non_empty - - any: - - name: --PRESP - operator: not_exists - - name: --PRESP - operator: not_equal_to - value: Y - value_is_literal: true + - name: --OCCUR + operator: non_empty + - any: + - name: --PRESP + operator: not_exists + - name: --PRESP + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000016 Status: Published @@ -113,19 +101,19 @@ Executability: Fully Executable Outcome: Message: --PRESP should be populated as "Y" when --OCCUR is provided. Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000017/rule.yml b/Published/CORE-000017/rule.yml index 6c639bb0e..2f7eacbbf 100644 --- a/Published/CORE-000017/rule.yml +++ b/Published/CORE-000017/rule.yml @@ -2,79 +2,77 @@ # Condition: IDVARVAL ^= null # Rule: RDOMAIN ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent - record(s). Null for comments collected on a general comments - or additional information CRF page. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). Used only - when individual comments are related to domain records. null - for comments collected on separate CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). Used only - when individual comments are related to domain records. null - for comments collected on separate CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent - record(s). Null for comments collected on a general comments - or additional information CRF page. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0398 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). Null for + comments collected on a general comments or additional information CRF page. + Document: SDTMIG v3.4 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). Used only when + individual comments are related to domain records. null for comments collected on separate + CRFs. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). Used only when + individual comments are related to domain records. null for comments collected on separate + CRFs. + Document: IG v3.3 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). Null for + comments collected on a general comments or additional information CRF page. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0398 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVARVAL - operator: non_empty - - any: - - name: RDOMAIN - operator: empty - - name: RDOMAIN - operator: not_exists + - name: IDVARVAL + operator: non_empty + - any: + - name: RDOMAIN + operator: empty + - name: RDOMAIN + operator: not_exists Core: Id: CORE-000017 Status: Published @@ -84,16 +82,16 @@ Executability: Fully Executable Outcome: Message: RDOMAIN has a missing value when IDVARVAL has a non-missing value. Output Variables: - - RDOMAIN - - IDVARVAL - - IDVAR + - RDOMAIN + - IDVARVAL + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000018/rule.yml b/Published/CORE-000018/rule.yml index 4651c6d63..279f64db5 100644 --- a/Published/CORE-000018/rule.yml +++ b/Published/CORE-000018/rule.yml @@ -2,153 +2,131 @@ # Condition: --PRESP = 'Y' and --STAT = null and --OCCUR is present in dataset # Rule: --OCCUR ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Item: --PRESP|--OCCUR|--STAT - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or have a value of NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or have a value of NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF. Values should be "Y" or - null.]|Events|[--OCCUR][An indication as to whether a - prespecified event has occurred.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE".]|Interventions[--PRESP][An indication - that the intervention was prospectively stated or detailed on - the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The - Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0351 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Item: --PRESP|--OCCUR|--STAT + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0351 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --STAT - operator: empty - - name: --OCCUR - operator: exists - - name: --OCCUR - operator: empty + - name: --PRESP + operator: equal_to + value: Y + - name: --STAT + operator: empty + - name: --OCCUR + operator: exists + - name: --OCCUR + operator: empty Core: Id: CORE-000018 Status: Published Version: '1' -Description: Raise an error when --PRESP is equal to "Y", --STAT is blank, - --OCCUR is present in dataset and --OCCUR is blank +Description: Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in + dataset and --OCCUR is blank Executability: Fully Executable Outcome: Message: --OCCUR is blank when --PRESP is equal to "Y" and --STAT is not provided. Output Variables: - - --PRESP - - --OCCUR - - --STAT + - --PRESP + - --OCCUR + - --STAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000019/rule.yml b/Published/CORE-000019/rule.yml index aa190bd88..b038bbe0c 100644 --- a/Published/CORE-000019/rule.yml +++ b/Published/CORE-000019/rule.yml @@ -2,164 +2,160 @@ # Condition: # Rule: Variable label length <= 40 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should - be provided as data variable labels for all variables, - including Supplemental Qualifier variables. - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should - be provided as data variable labels for all variables, - including Supplemental Qualifier variables. - Document: IG v3.3 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be - provided as data variable labels for all variables, including - Supplemental Qualifier variables. - Document: TIG 1.0 - Item: 'Num 5' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0486 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be - provided as data variable labels for all variables, including - Supplemental Qualifier variables. - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 5 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0211 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should be provided + as data variable labels for all variables, including Supplemental Qualifier variables. + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset + Document: IG v3.2 + Section: '2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should be provided + as data variable labels for all variables, including Supplemental Qualifier variables. + Document: IG v3.3 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG 1.0 + Item: 'Num 5' + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0486 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 5 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0211 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_label - operator: longer_than - value: 40 + - name: variable_label + operator: longer_than + value: 40 Core: Id: CORE-000019 Status: Published @@ -172,9 +168,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000020/rule.yml b/Published/CORE-000020/rule.yml index 8fd41d560..e1fa1d5e7 100644 --- a/Published/CORE-000020/rule.yml +++ b/Published/CORE-000020/rule.yml @@ -2,102 +2,92 @@ # Condition: ETCD = 'UNPLAN' # Rule: TAETORD = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not - planned for the Arm to which the subject was assigned. Thus, - TAETORD will not be populated for any Element with an ETCD - value of UNPLAN. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not - planned for the Arm to which the subject was assigned. Thus, - TAETORD will not be populated for any Element with an ETCD - value of "UNPLAN". TAETORD will also not be populated if a - subject passed through an Element that, although defined in - the TE dataset, was out of place for the Arm to which the - subject was assigned. For example, if a subject in a parallel - study of Drug A vs. Drug B was assigned to receive Drug A, but - received Drug B instead, then TAETORD would be left blank for - the SE record for their Drug B Element. If a subject was - assigned to receive the sequence of Elements A, B, C, D, and - instead received A, D, B, C, then the sponsor would have to - decide for which of these subject Element records TAETORD - should be populated. The rationale for this decision should be - documented in the Comments column of the define.xml. - Document: IG v3.2 - Item: Assumption 8 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not - planned for the Arm to which the subject was assigned. Thus, - TAETORD will not be populated for any Element with an ETCD - value of "UNPLAN". TAETORD will also not be populated if a - subject passed through an Element that, although defined in - the TE dataset, was out of place for the Arm to which the - subject was assigned. For example, if a subject in a parallel - study of Drug A vs. Drug B was assigned to receive Drug A, but - received Drug B instead, then TAETORD would be left blank for - the SE record for their Drug B Element. If a subject was - assigned to receive the sequence of Elements A, B, C, D, and - instead received A, D, B, C, then the sponsor would have to - decide for which of these subject Element records TAETORD - should be populated. The rationale for this decision should be - documented in the Comments column of the define.xml. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not - planned for the Arm to which the subject was assigned. Thus, - TAETORD will not be populated for any Element with an ETCD - value of “UNPLAN”. - Document: TIG 1.0 - Item: Assumption 5 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0426 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of UNPLAN. + Document: IG v3.4 + Item: Assumption 6 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject + passed through an Element that, although defined in the TE dataset, was out of place for + the Arm to which the subject was assigned. For example, if a subject in a parallel study + of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then + TAETORD would be left blank for the SE record for their Drug B Element. If a subject was + assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, + then the sponsor would have to decide for which of these subject Element records TAETORD + should be populated. The rationale for this decision should be documented in the Comments + column of the define.xml. + Document: IG v3.2 + Item: Assumption 8 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject + passed through an Element that, although defined in the TE dataset, was out of place for + the Arm to which the subject was assigned. For example, if a subject in a parallel study + of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then + TAETORD would be left blank for the SE record for their Drug B Element. If a subject was + assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, + then the sponsor would have to decide for which of these subject Element records TAETORD + should be populated. The rationale for this decision should be documented in the Comments + column of the define.xml. + Document: IG v3.3 + Item: Assumption 6 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of “UNPLAN”. + Document: TIG 1.0 + Item: Assumption 5 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0426 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ETCD - operator: equal_to - value: UNPLAN - - name: TAETORD - operator: non_empty + - name: ETCD + operator: equal_to + value: UNPLAN + - name: TAETORD + operator: non_empty Core: Id: CORE-000020 Status: Published @@ -107,15 +97,15 @@ Executability: Fully Executable Outcome: Message: TAETORD should be null when ETCD = 'UNPLAN'. Output Variables: - - ETCD - - TAETORD + - ETCD + - TAETORD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000021/rule.yml b/Published/CORE-000021/rule.yml index 9130757ee..39bdca0d5 100644 --- a/Published/CORE-000021/rule.yml +++ b/Published/CORE-000021/rule.yml @@ -2,113 +2,99 @@ # Condition: --ORRES ^= null or --DRVFL = 'Y' # Rule: --STRESC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v2.0[Findings][The standardized result of the measurement, - test, or examination in character format. --STRESC should - store all results or findings in character format; if results - are numeric, they should also be stored in numeric format in - --STRESN. If various tests have results "NONE", "NEG", and - "NEGATIVE" in --ORRES and these results effectively have the - same meaning, they could be represented in standard format in - --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result - value for all findings, copied or derived from LBORRES in a - standard format or standard units.] - Document: Model v2.0|IG v3.4 - Item: Specification - Section: Findings|6.3.5.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.3 LB][Contains the result value for all findings; - copied or derived from LBORRES in a standard format or - standard units. LBSTRESC should store all results or findings - in character format; if results are numeric; they should also - be stored in numeric format in LBSTRESN. For example; if a - test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and - these results effectively have the same meaning; they could be - represented in standard format in LBSTRESC as 'NEGATIVE'. For - other examples; see general assumptions.]|Model - v1.4[2.2.3][Contains the result value for all findings; copied - or derived from --ORRES in a standard format or in standard - units.] - Document: IG v3.2|Model v1.4 - Section: IG v3.2[6.3 LB]|Model v1.4[2.2.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.3.6][Contains the result value for all findings; - copied or derived from --ORRES in a standard format or in - standard units.]|Model v1.7[2.2.3] Contains the result value - for all findings; copied or derived from LBORRES in a standard - format or standard units. LBSTRESC should store all results or - findings in character format; if results are numeric; they - should also be stored in numeric format in LBSTRESN. For - example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE' - in LBORRES and these results effectively have the same - meaning; they could be represented in standard format in - LBSTRESC as 'NEGATIVE'. For other examples; see general - assumptions.] - Document: IG v3.3|Model v1.7 - Section: IG v3.3[6.3.6]|Model v1.7[2.2.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The standardized result of the measurement, test, or examination - in character format. --STRESC should store all results or - findings in character format; if results are numeric, they - should also be stored in numeric format in --STRESN. If - various tests have results "NONE", "NEG", and "NEGATIVE" in - --ORRES and these results effectively have the same meaning, - they could be represented in standard format in --STRESC as - "NEGATIVE" - Document: SDTM v2.1 - Section: 3.3.3 The Findings Observation Class - - Cited Guidance: Values will be populated in --STRESC when --ORRES is populated. - Numeric values represented in --STRESC will be assigned to - --STRESN. - Document: TIG v1.0 - Item: Table 3 Num 3 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0559 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Model v2.0[Findings][The standardized result of the measurement, test, or + examination in character format. --STRESC should store all results or findings in + character format; if results are numeric, they should also be stored in numeric format in + --STRESN. If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these + results effectively have the same meaning, they could be represented in standard format in + --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result value for all findings, + copied or derived from LBORRES in a standard format or standard units.] + Document: Model v2.0|IG v3.4 + Item: Specification + Section: Findings|6.3.5.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[6.3 LB][Contains the result value for all findings; copied or + derived from LBORRES in a standard format or standard units. LBSTRESC should store all + results or findings in character format; if results are numeric; they should also be + stored in numeric format in LBSTRESN. For example; if a test has results 'NONE'; 'NEG'; + and 'NEGATIVE' in LBORRES and these results effectively have the same meaning; they could + be represented in standard format in LBSTRESC as 'NEGATIVE'. For other examples; see + general assumptions.]|Model v1.4[2.2.3][Contains the result value for all findings; copied + or derived from --ORRES in a standard format or in standard units.] + Document: IG v3.2|Model v1.4 + Section: IG v3.2[6.3 LB]|Model v1.4[2.2.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[6.3.6][Contains the result value for all findings; copied or derived + from --ORRES in a standard format or in standard units.]|Model v1.7[2.2.3] Contains the + result value for all findings; copied or derived from LBORRES in a standard format or + standard units. LBSTRESC should store all results or findings in character format; if + results are numeric; they should also be stored in numeric format in LBSTRESN. For + example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and these results + effectively have the same meaning; they could be represented in standard format in + LBSTRESC as 'NEGATIVE'. For other examples; see general assumptions.] + Document: IG v3.3|Model v1.7 + Section: IG v3.3[6.3.6]|Model v1.7[2.2.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The standardized result of the measurement, test, or examination in + character format. --STRESC should store all results or findings in character format; if + results are numeric, they should also be stored in numeric format in --STRESN. If various + tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively + have the same meaning, they could be represented in standard format in --STRESC as + "NEGATIVE" + Document: SDTM v2.1 + Section: 3.3.3 The Findings Observation Class + - Cited Guidance: Values will be populated in --STRESC when --ORRES is populated. Numeric + values represented in --STRESC will be assigned to --STRESN. + Document: TIG v1.0 + Item: Table 3 Num 3 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0559 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - any: - - name: --ORRES - operator: non_empty - - name: --DRVFL - operator: equal_to - value: Y - - all: - - name: --STRESC - operator: empty + - any: + - name: --ORRES + operator: non_empty + - name: --DRVFL + operator: equal_to + value: Y + - all: + - name: --STRESC + operator: empty Core: Id: CORE-000021 Status: Published @@ -116,19 +102,18 @@ Core: Description: Raise an error when the value for --STRESC is null. Executability: Fully Executable Outcome: - Message: --STRESC should not be blank when either --ORRES is provided or --DRVFL - = 'Y' . + Message: --STRESC should not be blank when either --ORRES is provided or --DRVFL = 'Y' . Output Variables: - - --ORRES - - --DRVFL - - --STRESC + - --ORRES + - --DRVFL + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000022/rule.yml b/Published/CORE-000022/rule.yml index e2a75c58b..bfa9fe72c 100644 --- a/Published/CORE-000022/rule.yml +++ b/Published/CORE-000022/rule.yml @@ -2,153 +2,145 @@ # Condition: AESCAN = 'Y' or AESCONG = 'Y' or AESDISAB = 'Y' or AESDTH = 'Y' or AESHOSP = 'Y' or AESLIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' # Rule: AESER = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables maybe - null. However, if Serious is answered "Yes", at least one of - them will have a "Y" response. - Document: SDTMIG v3.4 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables maybe - null. However, if Serious is answered "Yes", at least one of - them will have a "Y" response. - Document: SDTMIG v3.3 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables may - be null. However, if Serious is answered "Yes", at least one - of them will have a "Y" response. - Document: SDTMIG v3.2 - Item: Assumption 6a - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question the values of the variables that capture - reasons an event is considered serious (e.g., AESCAN, AESCONG) - may be null. On the other hand, if the CRF is structured so - that a response is collected for each seriousness category, - all category variables (e.g., AESDTH, AESHOSP) would be - populated and AESER would be derived. - Document: TIG 1.0 - Item: Assumption 7a - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0320 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables maybe null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.4 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables maybe null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.3 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables may be null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.2 + Item: Assumption 6a + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question the values of the variables that capture reasons an event is considered serious + (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a + response is collected for each seriousness category, all category variables (e.g., AESDTH, + AESHOSP) would be populated and AESER would be derived. + Document: TIG 1.0 + Item: Assumption 7a + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0320 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - any: - - name: AESCAN - operator: equal_to - value: Y - value_is_literal: true - - name: AESCONG - operator: equal_to - value: Y - value_is_literal: true - - name: AESDISAB - operator: equal_to - value: Y - value_is_literal: true - - name: AESDTH - operator: equal_to - value: Y - value_is_literal: true - - name: AESHOSP - operator: equal_to - value: Y - value_is_literal: true - - name: AESLIFE - operator: equal_to - value: Y - value_is_literal: true - - name: AESOD - operator: equal_to - value: Y - value_is_literal: true - - name: AESMIE - operator: equal_to - value: Y - value_is_literal: true - - name: AESER - operator: not_equal_to + - any: + - name: AESCAN + operator: equal_to value: Y value_is_literal: true + - name: AESCONG + operator: equal_to + value: Y + value_is_literal: true + - name: AESDISAB + operator: equal_to + value: Y + value_is_literal: true + - name: AESDTH + operator: equal_to + value: Y + value_is_literal: true + - name: AESHOSP + operator: equal_to + value: Y + value_is_literal: true + - name: AESLIFE + operator: equal_to + value: Y + value_is_literal: true + - name: AESOD + operator: equal_to + value: Y + value_is_literal: true + - name: AESMIE + operator: equal_to + value: Y + value_is_literal: true + - name: AESER + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000022 Status: Published Version: '1' -Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, - AESLIFE, AESOD or AESMIE = 'Y' and AESER = 'N' or is empty. +Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or + AESMIE = 'Y' and AESER = 'N' or is empty. Executability: Fully Executable Outcome: - Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, - AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty. + Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, + AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty. Output Variables: - - AETERM - - AESTDTC - - AESER - - AESCAN - - AESCONG - - AESDISAB - - AESDTH - - AESHOSP - - AESLIFE - - AESOD - - AESMIE + - AETERM + - AESTDTC + - AESER + - AESCAN + - AESCONG + - AESDISAB + - AESDTH + - AESHOSP + - AESLIFE + - AESOD + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000023/rule.yml b/Published/CORE-000023/rule.yml index 022a3ba10..ca9cc19a9 100644 --- a/Published/CORE-000023/rule.yml +++ b/Published/CORE-000023/rule.yml @@ -2,99 +2,99 @@ # Condition: --TOXGR not present in dataset # Rule: --TOX not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--TOX][Variable Qualifier of - --TOXGR]|Findings[--TOX][Variable Qualifier of --TOXGR] - Document: SDTM v2.1 - Item: --TOX - Section: Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0349 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--TOX][Variable Qualifier of --TOXGR]|Findings[--TOX][Variable + Qualifier of --TOXGR] + Document: SDTM v2.1 + Item: --TOX + Section: Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings Observation + Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0349 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TOXGR - operator: not_exists - - name: --TOX # checking failure criteria; when --TOXGR is not present, but --TOX is, there's a problem because --TOX is only supposed to be there to qualify --TOXGR - operator: exists + - name: --TOXGR + operator: not_exists + - name: --TOX # checking failure criteria; when --TOXGR is not present, but --TOX is, there's a problem because --TOX is only supposed to be there to qualify --TOXGR + operator: exists Core: Id: CORE-000023 Status: Published @@ -107,10 +107,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000024/rule.yml b/Published/CORE-000024/rule.yml index 4b01d859d..55c50b53e 100644 --- a/Published/CORE-000024/rule.yml +++ b/Published/CORE-000024/rule.yml @@ -2,65 +2,65 @@ # Condition: --BODSYS ^= null # Rule: --BDSYCD ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: Model v2.0 - Item: --BODSYS - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.4 - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: SDTM v2.1 - Item: --BODSYS - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0347 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.4 + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: SDTM v2.1 + Item: --BODSYS + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0347 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --BODSYS - operator: non_empty - - name: --BDSYCD - operator: empty + - name: --BODSYS + operator: non_empty + - name: --BDSYCD + operator: empty Core: Id: CORE-000024 Status: Published @@ -73,9 +73,9 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000025/rule.yml b/Published/CORE-000025/rule.yml index dea598aee..536087a2c 100644 --- a/Published/CORE-000025/rule.yml +++ b/Published/CORE-000025/rule.yml @@ -2,70 +2,66 @@ # Condition: # Rule: IESTRESC = IEORRES Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard - format - Document: SDTMIG v3.4 - Item: '' - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard - format. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard - format. - Document: IG v3.3 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard - format. - Document: TIG 1.0 - Item: Specification-IESTRESC - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0406 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format + Document: SDTMIG v3.4 + Item: '' + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: IG v3.3 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: TIG 1.0 + Item: Specification-IESTRESC + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0406 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IESTRESC - operator: not_equal_to - value: IEORRES + - name: IESTRESC + operator: not_equal_to + value: IEORRES Core: Id: CORE-000025 Status: Published @@ -75,15 +71,15 @@ Executability: Fully Executable Outcome: Message: IESTRESC is not equal to IEORRES Output Variables: - - IEORRES - - IESTRESC + - IEORRES + - IESTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000026/rule.yml b/Published/CORE-000026/rule.yml index 7ef69d819..455ab694b 100644 --- a/Published/CORE-000026/rule.yml +++ b/Published/CORE-000026/rule.yml @@ -2,83 +2,76 @@ # Condition: --TPT present in dataset # Rule: --TPTNUM present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT - and --TPTNUM must be used. - Document: IG v3.3 - Section: 4.4.10 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are used, --TPTNUM is expected. Within the - context that defines uniqueness for a time point, which may - include domain, visit, and reference time point, there must be - a one-to-relationship between values of --TPT and --TPTNUM. in - other words, if domain, visit, and reference time point - uniquely identify subject data, then if two subjects have - records with the same values of DOMAIN, VISITNUM, --TPTREF, - and --TPTNUM, then these records may not have different time - point descriptions in --TPT. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are used, --TPTNUM is expected. Within the - context that defines uniqueness for a time point, which may - include domain, visit, and reference time point, there must be - a one-to-relationship between values of --TPT and --TPTNUM. in - other words, if domain, visit, and reference time point - uniquely identify subject data, then if two subjects have - records with the same values of DOMAIN, VISITNUM, --TPTREF, - and --TPTNUM, then these records may not have different time - point descriptions in --TPT. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Time points will be represented using both --TPT and --TPTNUM. - There will be a one-to-one relationship between values of - --TPT and --TPTNUM. - Document: TIG 1.0 - Item: Num 5 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0598 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT and --TPTNUM + must be used. + Document: IG v3.3 + Section: 4.4.10 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When time points are used, --TPTNUM is expected. Within the context that + defines uniqueness for a time point, which may include domain, visit, and reference time + point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other + words, if domain, visit, and reference time point uniquely identify subject data, then if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different time point descriptions in --TPT. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When time points are used, --TPTNUM is expected. Within the context that + defines uniqueness for a time point, which may include domain, visit, and reference time + point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other + words, if domain, visit, and reference time point uniquely identify subject data, then if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different time point descriptions in --TPT. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Time points will be represented using both --TPT and --TPTNUM. There will be + a one-to-one relationship between values of --TPT and --TPTNUM. + Document: TIG 1.0 + Item: Num 5 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0598 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TPT - operator: exists - - name: --TPTNUM - operator: not_exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: not_exists Core: Id: CORE-000026 Status: Published @@ -91,9 +84,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000027/rule.yml b/Published/CORE-000027/rule.yml index 664ead6be..1d4a39b61 100644 --- a/Published/CORE-000027/rule.yml +++ b/Published/CORE-000027/rule.yml @@ -2,254 +2,251 @@ # Condition: TEDUR = null # Rule: TEENRL ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. - Document: SDTMIG v3.4 - Item: Specification - Section: 7.2.2 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be - populated. - Document: SDTMIG v3.4 - Item: Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must - be populated. Both may be populated.] - Document: IG v3.2 - Item: Specification|Assumption 12 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must - be populated. Both may be populated.] - Document: IG v3.3 - Item: Specification|Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. - Document: TIG 1.0 - Item: Specification TEENRL - Section: 2.8.10.28 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be - populated. - Document: TIG 1.0 - Item: Assumption 12 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0496 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be populated for each Element. - Document: IG v3.4 - Item: Specification - Section: 7.2.2 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be - populated. - Document: IG v3.4 - Item: Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must - be populated. Both may be populated.] - Document: IG v3.2 - Item: Specification|Assumption 12 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must - be populated. Both may be populated.] - Document: IG v3.3 - Item: Specification|Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification TEENRL [Either TEENRL or TEDUR must be present for - each Element. - Document: TIG 1.0 - Item: Specification TEENRL - Section: 2.8.10.28 - - Cited Guidance: Assumption 12[At least one of TEENRL and TEDUR must be - populated. Both may be populated.] - Document: TIG 1.0 - Item: Assumption 12 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0497 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.0 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both - may be present. - Document: TIG v1.0 - Item: TEENRL CDISC Notes - Section: 2.8.9.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0141 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. + Document: SDTMIG v3.4 + Item: Specification + Section: 7.2.2 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: SDTMIG v3.4 + Item: Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.2 + Item: Specification|Assumption 12 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.3 + Item: Specification|Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. + Document: TIG 1.0 + Item: Specification TEENRL + Section: 2.8.10.28 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: TIG 1.0 + Item: Assumption 12 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0496 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be populated for each Element. + Document: IG v3.4 + Item: Specification + Section: 7.2.2 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: IG v3.4 + Item: Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.2 + Item: Specification|Assumption 12 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.3 + Item: Specification|Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification TEENRL [Either TEENRL or TEDUR must be present for each + Element. + Document: TIG 1.0 + Item: Specification TEENRL + Section: 2.8.10.28 + - Cited Guidance: Assumption 12[At least one of TEENRL and TEDUR must be populated. Both may + be populated.] + Document: TIG 1.0 + Item: Assumption 12 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0497 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.0 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: TIG v1.0 + Item: TEENRL CDISC Notes + Section: 2.8.9.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0141 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - any: - - name: TEDUR - operator: empty - - name: TEDUR - operator: not_exists - - any: - - name: TEENRL - operator: empty - - name: TEENRL - operator: not_exists + - any: + - name: TEDUR + operator: empty + - name: TEDUR + operator: not_exists + - any: + - name: TEENRL + operator: empty + - name: TEENRL + operator: not_exists Core: Id: CORE-000027 Status: Published @@ -259,16 +256,16 @@ Executability: Fully Executable Outcome: Message: At least one of TEENRL and TEDUR must be populated. Output Variables: - - ETCD - - TEDUR - - TEENRL + - ETCD + - TEDUR + - TEENRL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000028/rule.yml b/Published/CORE-000028/rule.yml index 803e743dc..010878334 100644 --- a/Published/CORE-000028/rule.yml +++ b/Published/CORE-000028/rule.yml @@ -2,81 +2,76 @@ # Condition: --TPTREF = null # Rule: --ELTM = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The interval of time between a planned time point and a fixed - reference point, represented in a standardized character - format. The fixed reference point is in --TPTREF. - Document: SDTM Model v2.0 - Item: --ELTM - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Planned Elapsed time relative to a planned fixed reference - (--TPTREF) such as "Previous Dose" or "Previous Meal". This - variable is useful where there are repetitive measures. Not a - clock time or a date/time variable, but an - interval. Format=ISO8601 - Document: SDTM Model v1.7 - Item: Table 2.2.5, --ELTM - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Planned Elapsed time in ISO 8601 character format relative to a - planned fixed reference (--TPTREF) such as "Previous Dose" or - "Previous Meal". - Document: SDTM Model v1.4 - Item: Table 2.2.5, --ELTM - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: "When instances of an activity are scheduled at planned time - intervals relative to a fixed reference point (e.g., an - exposure), the following timing variables will be used: - --TPTREF- Represents a description of the fixed reference - point from which the planned observation will be made.-ELTM - represents the planned elapsed time from the fixed timepoint - reference to the planned observation." - Document: TIG 1.0 - Item: Table 2 Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0293 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The interval of time between a planned time point and a fixed reference + point, represented in a standardized character format. The fixed reference point is in + --TPTREF. + Document: SDTM Model v2.0 + Item: --ELTM + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Planned Elapsed time relative to a planned fixed reference (--TPTREF) such + as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive + measures. Not a clock time or a date/time variable, but an interval. Format=ISO8601 + Document: SDTM Model v1.7 + Item: Table 2.2.5, --ELTM + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Planned Elapsed time in ISO 8601 character format relative to a planned + fixed reference (--TPTREF) such as "Previous Dose" or "Previous Meal". + Document: SDTM Model v1.4 + Item: Table 2.2.5, --ELTM + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: "When instances of an activity are scheduled at planned time intervals relative + to a fixed reference point (e.g., an exposure), the following timing variables will be used: + --TPTREF- Represents a description of the fixed reference point from which the planned observation + will be made.-ELTM represents the planned elapsed time from the fixed timepoint reference to + the planned observation." + Document: TIG 1.0 + Item: Table 2 Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0293 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TPTREF - operator: empty - - name: --ELTM - operator: non_empty + - name: --TPTREF + operator: empty + - name: --ELTM + operator: non_empty Core: Id: CORE-000028 Status: Published @@ -86,15 +81,15 @@ Executability: Fully Executable Outcome: Message: --TPTREF is empty and --ELTM is not empty Output Variables: - - --TPTREF - - --ELTM + - --TPTREF + - --ELTM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000029/rule.yml b/Published/CORE-000029/rule.yml index 289d509db..8886532ea 100644 --- a/Published/CORE-000029/rule.yml +++ b/Published/CORE-000029/rule.yml @@ -2,43 +2,42 @@ # Condition: --TPTNUM present in dataset # Rule: --TPT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT - and --TPTNUM must be used. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0661 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: TIG 1.0 - Document: Time points will be represented using both --TPT and --TPTNUM. There - will be a one-to-one relationship between values of --TPT and - --TPTNUM. - Item: Planned Timing table NUM 5 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0697 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT and --TPTNUM + must be used. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0661 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: TIG 1.0 + Document: Time points will be represented using both --TPT and --TPTNUM. There will be a + one-to-one relationship between values of --TPT and --TPTNUM. + Item: Planned Timing table NUM 5 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0697 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: not_exists + - name: --TPTNUM + operator: exists + - name: --TPT + operator: not_exists Core: Id: CORE-000029 Status: Published @@ -46,16 +45,15 @@ Core: Description: Raise an error when --TPTNUM exists in a dataset and --TPT does not exist. Executability: Fully Executable Outcome: - Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time - points are represented in SDTMIG domains, both --TPT and --TPTNUM must be - used. + Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented + in SDTMIG domains, both --TPT and --TPTNUM must be used. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000030/rule.yml b/Published/CORE-000030/rule.yml index e037b3aea..60432e289 100644 --- a/Published/CORE-000030/rule.yml +++ b/Published/CORE-000030/rule.yml @@ -2,103 +2,95 @@ # Condition: --PRESP not present in dataset # Rule: --REASND not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP[An indication that the event or intervention was - prospectively stated or detailed on the CRF.]|--OCCUR[An - indication as to whether a prespecified event or intervention - has occurred.] - Document: SDTM v2.0 - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by - --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported events. - (--PRESP/Interventions) Used when a specific intervention is - pre-specified on a CRF. Values should be "Y" or null. - (--REASND) Used in conjunction with --STAT when value is NOT - DONE - Document: SDTM v1.7 - Section: 2.2.1 (Interventions )|2.2.2 (Events) - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by - --TERM was pre-specified on a CRF. Value is Y for - pre-specified events, null for spontaneously reported events. - (--PRESP/Interventions) Used when a specific intervention is - pre-specified on a CRF. Values should be "Y" or null. - (--REASND) Used in conjunction with --STAT when value is NOT - DONE - Document: SDTM v1.4 - Section: 2.2.1 (Interventions )|2.2.2 (Events) - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --PRESP[An indication that the event or intervention was - prospectively stated or detailed on the CRF.]|--OCCUR[An - indication as to whether a prespecified event or intervention - has occurred.] - Document: SDTM v2.1 - Item: '--PRESP|--STAT' - Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation - Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0329 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --PRESP[An indication that the event or intervention was prospectively + stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event + or intervention has occurred.] + Document: SDTM v2.0 + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by --TERM was + pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events. (--PRESP/Interventions) Used when a specific intervention is + pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with + --STAT when value is NOT DONE + Document: SDTM v1.7 + Section: 2.2.1 (Interventions )|2.2.2 (Events) + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by --TERM was + pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events. (--PRESP/Interventions) Used when a specific intervention is + pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with + --STAT when value is NOT DONE + Document: SDTM v1.4 + Section: 2.2.1 (Interventions )|2.2.2 (Events) + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: --PRESP[An indication that the event or intervention was prospectively + stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event + or intervention has occurred.] + Document: SDTM v2.1 + Item: '--PRESP|--STAT' + Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0329 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: not_exists - - name: --REASND - operator: exists + - name: --PRESP + operator: not_exists + - name: --REASND + operator: exists Core: Id: CORE-000030 Status: Published Version: '1' -Description: Raise and error when --REASND is present in dataset and --PRESP is - not present in dataset +Description: Raise and error when --REASND is present in dataset and --PRESP is not present in + dataset Executability: Fully Executable Outcome: - Message: --REASND should not be present in dataset when --PRESP is not present - in dataset + Message: --REASND should not be present in dataset when --PRESP is not present in dataset Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000033/rule.yml b/Published/CORE-000033/rule.yml index b56e22526..a47a1b0f5 100644 --- a/Published/CORE-000033/rule.yml +++ b/Published/CORE-000033/rule.yml @@ -2,71 +2,71 @@ # Condition: DSTERM = 'COMPLETED' # Rule: DSDECOD = 'COMPLETED' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from - the controlled terminology codelist NCOMPLT. - Document: SDTMIG v3.4 - Item: Assumption 3.b.i. - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. - Document: SDTMIG v3.3 - Item: Assumption 3b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. - Document: SDTMIG v3.2 - Item: Assumption 3b - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from - the Controlled Terminology codelist NCOMPLT. - Document: TIG 1.0 - Item: Assumption 3.b.i. - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0337 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + controlled terminology codelist NCOMPLT. + Document: SDTMIG v3.4 + Item: Assumption 3.b.i. + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. + Document: SDTMIG v3.3 + Item: Assumption 3b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. + Document: SDTMIG v3.2 + Item: Assumption 3b + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + Controlled Terminology codelist NCOMPLT. + Document: TIG 1.0 + Item: Assumption 3.b.i. + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0337 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DSTERM - operator: equal_to - value: COMPLETED - - name: DSDECOD - operator: not_equal_to - value: COMPLETED + - name: DSTERM + operator: equal_to + value: COMPLETED + - name: DSDECOD + operator: not_equal_to + value: COMPLETED Core: Id: CORE-000033 Status: Published @@ -76,15 +76,15 @@ Executability: Fully Executable Outcome: Message: DSDECOD is not equal to "COMPLETED" when DSTERM equals "COMPLETED". Output Variables: - - DSTERM - - DSDECOD + - DSTERM + - DSDECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000034/rule.yml b/Published/CORE-000034/rule.yml index 2552c4643..caf89127b 100644 --- a/Published/CORE-000034/rule.yml +++ b/Published/CORE-000034/rule.yml @@ -2,101 +2,96 @@ # Condition: DSDECOD = 'DEATH' # Rule: DSSTDTC = DM.DTHDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. - Should represent the date/time that is captured in the - clinical-trial database. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. - Should represent the date/time that is captured in the - clinical-trial database. - Document: SDTMIG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. - Should represent the date/time that is captured in the - clinical-trial database. - Document: SDTMIG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. - Should represent the date/time that is captured in the - clinical-trial database. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0339 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0339 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DSDECOD - operator: equal_to - value: DEATH - - name: DSSTDTC - operator: not_equal_to - value: DTHDTC + - name: DSDECOD + operator: equal_to + value: DEATH + - name: DSSTDTC + operator: not_equal_to + value: DTHDTC Core: Id: CORE-000034 Status: Published Version: '1' -Description: Raise an error when DSSTDTC is not equal to DM.DTHDTC and DSDECOD - is equal to "DEATH" +Description: Raise an error when DSSTDTC is not equal to DM.DTHDTC and DSDECOD is equal to "DEATH" Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: DSSTDTC does not equal DM.DTHDTC, when DSDECOD equals "DEATH". Output Variables: - - DSDECOD - - DSSTDTC - - DTHDTC + - DSDECOD + - DSSTDTC + - DTHDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000035/rule.yml b/Published/CORE-000035/rule.yml index f241920c2..993112798 100644 --- a/Published/CORE-000035/rule.yml +++ b/Published/CORE-000035/rule.yml @@ -2,42 +2,42 @@ # Condition: SVPRESP = null # Rule: VISITDY = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be - populated for unplanned visits. - Document: SDTMIG v3.4 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0658 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The planned study day of visit variable (VISITDY) should not be - populated for unplanned visits. - Document: TIG 1.0 - Item: Assumption 8 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0696 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be populated for + unplanned visits. + Document: SDTMIG v3.4 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0658 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: The planned study day of visit variable (VISITDY) should not be populated + for unplanned visits. + Document: TIG 1.0 + Item: Assumption 8 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0696 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: empty - - name: VISITDY - operator: non_empty + - name: SVPRESP + operator: empty + - name: VISITDY + operator: non_empty Core: Id: CORE-000035 Status: Published @@ -45,15 +45,15 @@ Core: Description: Raise an error when SVPRESP is null and VISITDY is not null. Executability: Fully Executable Outcome: - Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned - Study Day of a visit. It should not be populated for unplanned visits. + Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit. + It should not be populated for unplanned visits. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000036/rule.yml b/Published/CORE-000036/rule.yml index 1bbe1d3b6..61e69e6ee 100644 --- a/Published/CORE-000036/rule.yml +++ b/Published/CORE-000036/rule.yml @@ -2,63 +2,58 @@ # Condition: SVPRESP = 'Y' # Rule: VISIT in TV.VISIT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned Visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned Visits.... If - a subject-level dataset includes both VISITNUM and VISIT, then - records that include values of VISITNUM that appear in the TV - dataset should also include the corresponding values of VISIT - from the TV dataset. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0657 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned - visits, null for unplanned visits.]|Section 10.8.33[Assumption - 6] [The values of VISITNUM in the TV dataset are the valid - values of VISITNUM for planned Visits. Any values of VISITNUM - that appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned Visits. If a - subject-level dataset includes both VISITNUM and VISIT, then - records that include values of VISITNUM that appear in the TV - dataset should also include the corresponding values of VISIT - from the TV dataset.] - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.25|2.8.10.33 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0695 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: '5.5' + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits.... If a + subject-level dataset includes both VISITNUM and VISIT, then records that include values + of VISITNUM that appear in the TV dataset should also include the corresponding values of + VISIT from the TV dataset. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0657 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned visits, null + for unplanned visits.]|Section 10.8.33[Assumption 6] [The values of VISITNUM in the TV + dataset are the valid values of VISITNUM for planned Visits. Any values of VISITNUM that + appear in subject-level datasets that are not in the TV dataset are assumed to correspond + to unplanned Visits. If a subject-level dataset includes both VISITNUM and VISIT, then + records that include values of VISITNUM that appear in the TV dataset should also include + the corresponding values of VISIT from the TV dataset.] + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.25|2.8.10.33 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0695 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISIT - operator: is_not_contained_by - value: $tv_visit + - name: SVPRESP + operator: equal_to + value: Y + - name: VISIT + operator: is_not_contained_by + value: $tv_visit Core: Id: CORE-000036 Status: Published @@ -66,19 +61,19 @@ Core: Description: Raise an error when SVPRESP is "Y" and VISIT is not present in TV.VISIT. Executability: Fully Executable Operations: - - domain: TV - id: $tv_visit - name: VISIT - operator: distinct +- domain: TV + id: $tv_visit + name: VISIT + operator: distinct Outcome: Message: Planned visit is not found in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000037/rule.yml b/Published/CORE-000037/rule.yml index b05b08de3..b6e889530 100644 --- a/Published/CORE-000037/rule.yml +++ b/Published/CORE-000037/rule.yml @@ -2,41 +2,41 @@ # Condition: # Rule: SVPRESP in ("Y", null) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values should be "Y" or null. - Document: SDTM v2.0 - Section: Subject Visits - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0653 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject Visits[SVPRESP][Values should be "Y" or null.] - Document: SDTM v2.1 - Item: SVPRESP - Section: 3.2.3.3 Subject Visits - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0691 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values should be "Y" or null. + Document: SDTM v2.0 + Section: Subject Visits + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0653 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Subject Visits[SVPRESP][Values should be "Y" or null.] + Document: SDTM v2.1 + Item: SVPRESP + Section: 3.2.3.3 Subject Visits + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0691 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: not_equal_to - value: Y - - name: SVPRESP - operator: non_empty + - name: SVPRESP + operator: not_equal_to + value: Y + - name: SVPRESP + operator: non_empty Core: Id: CORE-000037 Status: Published @@ -49,9 +49,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000038/rule.yml b/Published/CORE-000038/rule.yml index 127f9e25b..bf6a245c7 100644 --- a/Published/CORE-000038/rule.yml +++ b/Published/CORE-000038/rule.yml @@ -2,54 +2,52 @@ # Condition: SVOCCUR ^= null # Rule: SVPRESP = "Y" Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the visit is planned. Values should be "Y" or - null. - Document: SDTM v2.0 - Item: SVPRESP - Section: Subject Visits - - Cited Guidance: An indication as to whether a prespecified (planned) visit has - occurred. - Document: SDTM v2.0 - Item: SVOCCUR - Section: Subject Visits - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0654 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject Visits[SVPRESP][An indication that the visit is planned. - Values should be "Y" or null.] - Document: SDTM v1.0 - Item: SVPRESP - Section: 3.2.3.3 Subject Visits - - Cited Guidance: Subject Visits[SVOCCUR][An indication as to whether a - prespecified (planned) visit has occurred.] - Document: SDTM v1.0 - Item: SVOCCUR - Section: 3.2.3.3 Subject Visits - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0692 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the visit is planned. Values should be "Y" or null. + Document: SDTM v2.0 + Item: SVPRESP + Section: Subject Visits + - Cited Guidance: An indication as to whether a prespecified (planned) visit has occurred. + Document: SDTM v2.0 + Item: SVOCCUR + Section: Subject Visits + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0654 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Subject Visits[SVPRESP][An indication that the visit is planned. Values + should be "Y" or null.] + Document: SDTM v1.0 + Item: SVPRESP + Section: 3.2.3.3 Subject Visits + - Cited Guidance: Subject Visits[SVOCCUR][An indication as to whether a prespecified (planned) + visit has occurred.] + Document: SDTM v1.0 + Item: SVOCCUR + Section: 3.2.3.3 Subject Visits + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0692 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVOCCUR - operator: non_empty - - name: SVPRESP - operator: not_equal_to - value: Y + - name: SVOCCUR + operator: non_empty + - name: SVPRESP + operator: not_equal_to + value: Y Core: Id: CORE-000038 Status: Published @@ -62,9 +60,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000039/rule.yml b/Published/CORE-000039/rule.yml index 474819f80..63270a86e 100644 --- a/Published/CORE-000039/rule.yml +++ b/Published/CORE-000039/rule.yml @@ -2,58 +2,55 @@ # Condition: SVPRESP = 'Y' # Rule: VISITNUM in TV.VISITNUM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned Visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned Visits. This - applies, in particular, to the subject-level Subject Visits - (SV) dataset; see SV under Section 5, Models for - Special-Purpose Domains, for additional information about - handling unplanned Visits. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0655 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was - planned (i.e., visits specified in the TV domain). Value is - "Y" for planned visits, null for unplanned visits. Planned and - unplanned visits with a subject, whether or not they are - physical visits to the site, are represented in this domain. - Document: TIG 1.0 - Item: Specifications - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0693 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: '5.5' + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in + particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, + Models for Special-Purpose Domains, for additional information about handling unplanned + Visits. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0655 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was planned (i.e., + visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned + visits. Planned and unplanned visits with a subject, whether or not they are physical + visits to the site, are represented in this domain. + Document: TIG 1.0 + Item: Specifications + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0693 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISITNUM - operator: is_not_contained_by - value: $tv_visitnum + - name: SVPRESP + operator: equal_to + value: Y + - name: VISITNUM + operator: is_not_contained_by + value: $tv_visitnum Core: Id: CORE-000039 Status: Published @@ -61,19 +58,19 @@ Core: Description: Raise an error when SVPRESP="Y" and VISITNUM is not in TV.VISITNUM Executability: Fully Executable Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM for planned visit is not in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000040/rule.yml b/Published/CORE-000040/rule.yml index 6186ddc04..3c23c0373 100644 --- a/Published/CORE-000040/rule.yml +++ b/Published/CORE-000040/rule.yml @@ -2,57 +2,54 @@ # Condition: SVPRESP = null # Rule: VISITNUM not in TV.VISITNUM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned Visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned Visits. This - applies, in particular, to the subject-level Subject Visits - (SV) dataset; see SV under Section 5, Models for - Special-Purpose Domains, for additional information about - handling unplanned Visits. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0656 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was - planned (i.e., visits specified in the TV domain). Value is - "Y" for planned visits, null for unplanned visits. Planned and - unplanned visits with a subject, whether or not they are - physical visits to the site, are represented in this domain. - Document: TIG 1.0 - Item: Specifications - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0694 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: '5.5' + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in + particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, + Models for Special-Purpose Domains, for additional information about handling unplanned + Visits. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0656 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was planned (i.e., + visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned + visits. Planned and unplanned visits with a subject, whether or not they are physical + visits to the site, are represented in this domain. + Document: TIG 1.0 + Item: Specifications + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0694 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: empty - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum + - name: SVPRESP + operator: empty + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum Core: Id: CORE-000040 Status: Published @@ -60,19 +57,19 @@ Core: Description: Raise an error when SVPRESP is null and VISITNUM is present in TV.VISITNUM Executability: Fully Executable Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM for unplanned visit is present in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000041/rule.yml b/Published/CORE-000041/rule.yml index 847540a68..e9fa4326d 100644 --- a/Published/CORE-000041/rule.yml +++ b/Published/CORE-000041/rule.yml @@ -2,118 +2,110 @@ # Condition: TSVAL not populated with values or synonyms of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null flavors), unless the term is included in published terminology. # Rule: TSVALNF = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Some codelists used for TSVAL include terms which are also null - flavors. For example, the Pharmaceutical Dosage Form codelist - includes the values 'UNKNOWN' and 'NOT APPLICABLE. In such - cases, TSVAL should have the term from the codelist and - TSVALNF should be null. - Document: SDTMIG v3.4 - Item: Assumption 11 - Section: 7.4.2 - - Cited Guidance: While it would be possible to allow a value such as NONE or - UNBOUNDED to be entered in TSVAL, validation programs would - then have to recognize this special term as an exception to - the expected data format. Therefore, it was decided that a - separate null flavor variable that uses the ISO 21090 null - flavor terminology would be a better solution. - Document: SDTMIG v3.4 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0649 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Some codelists used for TSVAL include terms which are also null - flavors. For example, the Pharmaceutical Dosage Form codelist - includes the values "UNKNOWN" and "NOT APPLICABLE". In such - cases, TSVAL should have the term from the codelist and - TSVALNF should be null. - Document: TIG v1.0 - Item: Assumption 11 - Section: 2.8.10.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0689 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: While it would be possible to allow a value such as NONE or - UNBOUNDED to be entered in TSVAL, validation programs would - then have to recognize this special term as an exception to - the expected data format. Therefore, it was decided that a - separate null flavor variable that uses the ISO 21090 null - flavor terminology would be a better solution. - Document: IG v3.2 - Section: 'Section 7.4-TS: Use of Null Flavor Enumeration' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0459 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The variable TSVALNF is based on the idea of a "null flavor" as - embodied in the ISO 21090 standard; "Health Informatics' - Harmonized data types for information exchange." A null flavor - is an ancillary piece of data that provides additional - information when its primary piece of data is null (has a - missing value). There is controlled terminology for the null - flavor data item which includes such familiar values as - Unknown; Other; and Not Applicable among its fourteen terms - Document: IG v3.3 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0459 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Some codelists used for TSVAL include terms which are also null flavors. For + example, the Pharmaceutical Dosage Form codelist includes the values 'UNKNOWN' and 'NOT + APPLICABLE. In such cases, TSVAL should have the term from the codelist and TSVALNF should + be null. + Document: SDTMIG v3.4 + Item: Assumption 11 + Section: 7.4.2 + - Cited Guidance: While it would be possible to allow a value such as NONE or UNBOUNDED to be + entered in TSVAL, validation programs would then have to recognize this special term as + an exception to the expected data format. Therefore, it was decided that a separate null + flavor variable that uses the ISO 21090 null flavor terminology would be a better + solution. + Document: SDTMIG v3.4 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0649 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Some codelists used for TSVAL include terms which are also null flavors. For + example, the Pharmaceutical Dosage Form codelist includes the values "UNKNOWN" and "NOT + APPLICABLE". In such cases, TSVAL should have the term from the codelist and TSVALNF + should be null. + Document: TIG v1.0 + Item: Assumption 11 + Section: 2.8.10.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0689 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: While it would be possible to allow a value such as NONE or UNBOUNDED to be + entered in TSVAL, validation programs would then have to recognize this special term as an + exception to the expected data format. Therefore, it was decided that a separate null + flavor variable that uses the ISO 21090 null flavor terminology would be a better + solution. + Document: IG v3.2 + Section: 'Section 7.4-TS: Use of Null Flavor Enumeration' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0459 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The variable TSVALNF is based on the idea of a "null flavor" as embodied in + the ISO 21090 standard; "Health Informatics' Harmonized data types for information + exchange." A null flavor is an ancillary piece of data that provides additional + information when its primary piece of data is null (has a missing value). There is + controlled terminology for the null flavor data item which includes such familiar values + as Unknown; Other; and Not Applicable among its fourteen terms + Document: IG v3.3 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0459 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: TSVAL - operator: non_empty - - name: TSVAL - operator: not_matches_regex - value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive - infinity|NINF|Negative - infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but - unknown|NAV|Temporarily unavailable|NASK|Not - asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$) - - name: TSVALNF - operator: non_empty + - name: TSVAL + operator: non_empty + - name: TSVAL + operator: not_matches_regex + value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative + infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but unknown|NAV|Temporarily + unavailable|NASK|Not asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$) + - name: TSVALNF + operator: non_empty Core: Id: CORE-000041 Status: Published Version: '1' -Description: Raise and error when TSVAL is not populated TSVAL is populated with - values or synonyms of values in the ISO 21090 null flavor codelist (or other - terms that can be represented as null flavors) but TSVALNF is completed. +Description: Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms + of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null + flavors) but TSVALNF is completed. Executability: Fully Executable Outcome: - Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor - description but TSVALNF is populated. + Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor description but + TSVALNF is populated. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000042/rule.yml b/Published/CORE-000042/rule.yml index b48acd3de..3e7f9244a 100644 --- a/Published/CORE-000042/rule.yml +++ b/Published/CORE-000042/rule.yml @@ -2,37 +2,37 @@ # Condition: # Rule: TJ dataset not present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The TT dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Trial Repro Stages - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0647 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 5.1.3.1 Trial Repro Stages - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0687 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The TT dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Trial Repro Stages + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0647 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 5.1.3.1 Trial Repro Stages + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0687 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - name: TT - operator: exists + - name: TT + operator: exists Core: Id: CORE-000042 Status: Published @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - TT + - TT Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000043/rule.yml b/Published/CORE-000043/rule.yml index 9512b9598..7fc307256 100644 --- a/Published/CORE-000043/rule.yml +++ b/Published/CORE-000043/rule.yml @@ -2,37 +2,37 @@ # Condition: # Rule: TP dataset not present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The TP dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Trial Repro Paths - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0648 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 5.1.3.2 Trial Repro Paths - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0688 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The TP dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Trial Repro Paths + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0648 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 5.1.3.2 Trial Repro Paths + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0688 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TP - operator: exists + - name: TP + operator: exists Core: Id: CORE-000043 Status: Published @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - TP + - TP Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000044/rule.yml b/Published/CORE-000044/rule.yml index caf6d33e0..fd7f1d04e 100644 --- a/Published/CORE-000044/rule.yml +++ b/Published/CORE-000044/rule.yml @@ -2,37 +2,37 @@ # Condition: # Rule: SJ dataset not present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SJ dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Subject Repro Stages - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0646 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 3.2.3.2 Subject Repro Stages - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0686 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The SJ dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Subject Repro Stages + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0646 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 3.2.3.2 Subject Repro Stages + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0686 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - name: SJ - operator: exists + - name: SJ + operator: exists Core: Id: CORE-000044 Status: Published @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SJ + - SJ Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000045/rule.yml b/Published/CORE-000045/rule.yml index 71319be25..17b8c1826 100644 --- a/Published/CORE-000045/rule.yml +++ b/Published/CORE-000045/rule.yml @@ -2,64 +2,61 @@ # Condition: ARMCD = null # Rule: ARMNRS^=null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm, ARMCD is - null and ARMNRS is populated - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0517 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0517 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm, ARMCD is - null and ARMNRS is populated - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0612 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0517 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0517 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0612 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: empty - - name: ARMNRS - operator: empty + - name: ARMCD + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000045 Status: Published @@ -69,15 +66,15 @@ Executability: Fully Executable Outcome: Message: ARMNRS value is missing when ARMCD value is missing Output Variables: - - ARMCD - - ARMNRS + - ARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000046/rule.yml b/Published/CORE-000046/rule.yml index 66c03538f..35390cde0 100644 --- a/Published/CORE-000046/rule.yml +++ b/Published/CORE-000046/rule.yml @@ -2,65 +2,61 @@ # Condition: ARM = null # Rule: ARMNRS^=null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm, ARM is null and - ARMNRS is populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0519 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0519 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned arm, ARM is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0614 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm, ARM + is null and ARMNRS is populated. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0519 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0519 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0614 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARM - operator: empty - - name: ARMNRS - operator: empty + - name: ARM + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000046 Status: Published @@ -70,15 +66,15 @@ Executability: Fully Executable Outcome: Message: ARMNRS is missing when ARM value is missing Output Variables: - - ARM - - ARMNRS + - ARM + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index c4ea2ffd9..edd6802ca 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -2,97 +2,91 @@ # Condition: Study does not use multi-stage arm assignments and ACTARM ^= null # Rule: ARM in TA.ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned arm, ARM is null and ARMNRS is - populated." - Document: SDTMIG v3.4 - Item: Specification and ACTARM CDISC Notes - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned arm, ARM is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0613 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated." + Document: SDTMIG v3.4 + Item: Specification and ACTARM CDISC Notes + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0613 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARM - operator: non_empty - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ACTARM + operator: non_empty + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000047 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ARM is - populated, ARM must be present in TA.ARM. This rule has been executed to - identify all cases when ARM is not present in TA.ARM and therefore - acknowledges that false positives may be recorded when multi-stage arm +Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be + present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in + TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: - Message: ARM value in DM dataset is not among the values of ARM variable in TA - dataset. This is allowed only in a multistage study with incomplete ARM - assignment. Please confirm if your study is a multistage assignment study + Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is + allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study + is a multistage assignment study Output Variables: - - ARM + - ARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000048/rule.yml b/Published/CORE-000048/rule.yml index 520c0da96..bdadf8ebe 100644 --- a/Published/CORE-000048/rule.yml +++ b/Published/CORE-000048/rule.yml @@ -2,39 +2,39 @@ # Condition: # Rule: --METHOD not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not be used in human clinical trials. - Document: SDTM v2.0 - Item: --METHOD - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0621 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --METHOD - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0662 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not be used in human clinical trials. + Document: SDTM v2.0 + Item: --METHOD + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0621 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --METHOD + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0662 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --METHOD - operator: exists + - name: --METHOD + operator: exists Core: Id: CORE-000048 Status: Published @@ -47,9 +47,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000049/rule.yml b/Published/CORE-000049/rule.yml index fd7cee701..5e0a42009 100644 --- a/Published/CORE-000049/rule.yml +++ b/Published/CORE-000049/rule.yml @@ -2,95 +2,89 @@ # Condition: # Rule: --USCHFL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials, --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0507 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --USCHFL - Section: Interventions|Events|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0622 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0507 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--USCHFL - Section: Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 - - The Events Observations Class | Section 3.1.1 - The Findings - Observations Class | 2.8.2 How Extend Domains | 2.8.3 How to - Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0602 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --USCHFL - Section: Interventions|Events|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0663 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, + --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), + --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing + Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0507 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --USCHFL + Section: Interventions|Events|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0622 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0507 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--USCHFL + Section: Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 - The Events + Observations Class | Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend + Domains | 2.8.3 How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0602 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --USCHFL + Section: Interventions|Events|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0663 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --USCHFL - operator: exists + - name: --USCHFL + operator: exists Core: Id: CORE-000049 Status: Published @@ -103,9 +97,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000050/rule.yml b/Published/CORE-000050/rule.yml index 5cf9a138b..b104b28f8 100644 --- a/Published/CORE-000050/rule.yml +++ b/Published/CORE-000050/rule.yml @@ -2,39 +2,39 @@ # Condition: # Rule: --RSTIND not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RSTIND - Section: Interventions|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0623 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RSTIND - Section: Interventions|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0664 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RSTIND + Section: Interventions|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0623 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RSTIND + Section: Interventions|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0664 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RSTIND - operator: exists + - name: --RSTIND + operator: exists Core: Id: CORE-000050 Status: Published @@ -47,10 +47,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000051/rule.yml b/Published/CORE-000051/rule.yml index ababf00d4..3cc331b90 100644 --- a/Published/CORE-000051/rule.yml +++ b/Published/CORE-000051/rule.yml @@ -2,39 +2,39 @@ # Condition: # Rule: --RSTMOD not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RSTMOD - Section: Interventions|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0624 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RSTMOD - Section: Interventions|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0665 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RSTMOD + Section: Interventions|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0624 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RSTMOD + Section: Interventions|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0665 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RSTMOD - operator: exists + - name: --RSTMOD + operator: exists Core: Id: CORE-000051 Status: Published @@ -47,10 +47,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000052/rule.yml b/Published/CORE-000052/rule.yml index 0f317dae5..248d1a981 100644 --- a/Published/CORE-000052/rule.yml +++ b/Published/CORE-000052/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --IMPBL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --IMPLBL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0625 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --IMPLBL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0666 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --IMPLBL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0625 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --IMPLBL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0666 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --IMPLBL - operator: exists + - name: --IMPLBL + operator: exists Core: Id: CORE-000052 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000054/rule.yml b/Published/CORE-000054/rule.yml index 7e38177ac..cc7da647f 100644 --- a/Published/CORE-000054/rule.yml +++ b/Published/CORE-000054/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --DTHREL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --DTHREL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0627 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --DTHREL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0668 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --DTHREL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0627 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --DTHREL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0668 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DTHREL - operator: exists + - name: --DTHREL + operator: exists Core: Id: CORE-000054 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000055/rule.yml b/Published/CORE-000055/rule.yml index d7b2c2174..0e5dd8d09 100644 --- a/Published/CORE-000055/rule.yml +++ b/Published/CORE-000055/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --EXCLFL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --EXCLFL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0628 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --EXCLFL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0669 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --EXCLFL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0628 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --EXCLFL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0669 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --EXCLFL - operator: exists + - name: --EXCLFL + operator: exists Core: Id: CORE-000055 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000056/rule.yml b/Published/CORE-000056/rule.yml index 8ecd10e2c..45fe7e6d4 100644 --- a/Published/CORE-000056/rule.yml +++ b/Published/CORE-000056/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --REASEX not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --REASEX is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0629 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --REASEX - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0670 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --REASEX is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0629 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --REASEX + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0670 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --REASEX - operator: exists + - name: --REASEX + operator: exists Core: Id: CORE-000056 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000057/rule.yml b/Published/CORE-000057/rule.yml index 505b839f8..d4adc8d9f 100644 --- a/Published/CORE-000057/rule.yml +++ b/Published/CORE-000057/rule.yml @@ -2,92 +2,87 @@ # Condition: # Rule: FETUSID not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: FETUSID is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Identifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0509 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials --USCHFL - (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0630 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0509 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--FETUSID - Section: Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains - |2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0604 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: FETUSID - Section: Identifiers - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0671 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: FETUSID is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Identifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0509 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0630 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0509 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--FETUSID + Section: Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains |2.8.3 How + to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0604 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: FETUSID + Section: Identifiers + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0671 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: FETUSID - operator: exists + - name: FETUSID + operator: exists Core: Id: CORE-000057 Status: Published @@ -100,9 +95,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000058/rule.yml b/Published/CORE-000058/rule.yml index b91cebb0c..cb33cc49d 100644 --- a/Published/CORE-000058/rule.yml +++ b/Published/CORE-000058/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: RPHASE not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPHASE is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0631 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPHASE - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0672 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPHASE is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0631 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPHASE + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0672 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RPHASE - operator: exists + - name: RPHASE + operator: exists Core: Id: CORE-000058 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000059/rule.yml b/Published/CORE-000059/rule.yml index 00a0ee9a1..eb7326d94 100644 --- a/Published/CORE-000059/rule.yml +++ b/Published/CORE-000059/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: RPPLDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0632 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPPLDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0673 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0632 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPPLDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0673 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RPPLDY - operator: exists + - name: RPPLDY + operator: exists Core: Id: CORE-000059 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000060/rule.yml b/Published/CORE-000060/rule.yml index 5af07411f..7f48b5073 100644 --- a/Published/CORE-000060/rule.yml +++ b/Published/CORE-000060/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: RPPLSTDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLSTDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0633 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPPLSTDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0674 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLSTDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0633 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPPLSTDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0674 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RPPLSTDY - operator: exists + - name: RPPLSTDY + operator: exists Core: Id: CORE-000060 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000061/rule.yml b/Published/CORE-000061/rule.yml index d92a95f2f..33f9c595e 100644 --- a/Published/CORE-000061/rule.yml +++ b/Published/CORE-000061/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: RPLENDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLENDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0634 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPLENDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0675 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLENDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0634 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPLENDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0675 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RPPLENDY - operator: exists + - name: RPPLENDY + operator: exists Core: Id: CORE-000061 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000064/rule.yml b/Published/CORE-000064/rule.yml index 42e077510..e44549d85 100644 --- a/Published/CORE-000064/rule.yml +++ b/Published/CORE-000064/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --NOMLBL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0637 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0678 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0637 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0678 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RPDY - operator: exists + - name: --RPDY + operator: exists Core: Id: CORE-000064 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000065/rule.yml b/Published/CORE-000065/rule.yml index 50876da13..f6a58c03f 100644 --- a/Published/CORE-000065/rule.yml +++ b/Published/CORE-000065/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --RPSTDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPSTDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0638 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPSTDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0679 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPSTDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0638 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPSTDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0679 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RPSTDY - operator: exists + - name: --RPSTDY + operator: exists Core: Id: CORE-000065 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000066/rule.yml b/Published/CORE-000066/rule.yml index c0d80dd28..049dad592 100644 --- a/Published/CORE-000066/rule.yml +++ b/Published/CORE-000066/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --RPENDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPENDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0639 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPENDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0680 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPENDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0639 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPENDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0680 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RPENDY - operator: exists + - name: --RPENDY + operator: exists Core: Id: CORE-000066 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000067/rule.yml b/Published/CORE-000067/rule.yml index 08a84c001..a385bf775 100644 --- a/Published/CORE-000067/rule.yml +++ b/Published/CORE-000067/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --DETECT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --DETECT is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0640 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --DETECT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0681 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --DETECT is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0640 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --DETECT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0681 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DETECT - operator: exists + - name: --DETECT + operator: exists Core: Id: CORE-000067 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000068/rule.yml b/Published/CORE-000068/rule.yml index 5e952d962..d7f06d869 100644 --- a/Published/CORE-000068/rule.yml +++ b/Published/CORE-000068/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: AGETXT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AGETXT is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0641 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0682 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: AGETXT is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0641 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0682 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AGETXT - operator: exists + - name: AGETXT + operator: exists Core: Id: CORE-000068 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000069/rule.yml b/Published/CORE-000069/rule.yml index f73a3818e..e28128ae0 100644 --- a/Published/CORE-000069/rule.yml +++ b/Published/CORE-000069/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: SPECIES not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SPECIES is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0642 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: SPECIES - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0683 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SPECIES is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0642 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: SPECIES + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0683 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SPECIES - operator: exists + - name: SPECIES + operator: exists Core: Id: CORE-000069 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000070/rule.yml b/Published/CORE-000070/rule.yml index 0a9dace03..c6981caee 100644 --- a/Published/CORE-000070/rule.yml +++ b/Published/CORE-000070/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: STRAIN not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: STRAIN is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0643 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: STRAIN - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0684 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: STRAIN is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0643 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: STRAIN + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0684 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: STRAIN - operator: exists + - name: STRAIN + operator: exists Core: Id: CORE-000070 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000071/rule.yml b/Published/CORE-000071/rule.yml index baca3ce86..3f955909b 100644 --- a/Published/CORE-000071/rule.yml +++ b/Published/CORE-000071/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: SBSTRAIN not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SBSTRAIN is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0644 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: SBSTRAIN - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0685 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SBSTRAIN is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0644 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: SBSTRAIN + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0685 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SBSTRAIN - operator: exists + - name: SBSTRAIN + operator: exists Core: Id: CORE-000071 Status: Published @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000074/rule.yml b/Published/CORE-000074/rule.yml index eb901189c..7d565ddb2 100644 --- a/Published/CORE-000074/rule.yml +++ b/Published/CORE-000074/rule.yml @@ -2,66 +2,61 @@ # Condition: # Rule: --IMPLBL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials, --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0508 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0508 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--IMPLBL - Section: Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend - Domains |2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0603 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, + --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), + --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing + Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0508 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0508 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--IMPLBL + Section: Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0603 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --IMPLBL - operator: exists + - name: --IMPLBL + operator: exists Core: Id: CORE-000074 Status: Published @@ -71,14 +66,14 @@ Executability: Fully Executable Outcome: Message: --IMPLBL is present. Output Variables: - - --IMPLBL + - --IMPLBL Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000075/rule.yml b/Published/CORE-000075/rule.yml index ecfd4663c..ac66408eb 100644 --- a/Published/CORE-000075/rule.yml +++ b/Published/CORE-000075/rule.yml @@ -2,80 +2,74 @@ # Condition: # Rule: AEREASND not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR, - --STAT, and--REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred. - Document: IG v3.4 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, - --STAT, and--REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred.' - Document: IG v3.2 - Item: Assumption 8 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, - --STAT, and--REASND. They are the only Qualifiers from the - SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred.' - Document: IG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR, - --STAT, and--REASND. They are the only qualifiers from the - SDTM Events class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events - that actually occurred - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0481 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: IG v3.4 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred.' + Document: IG v3.2 + Item: Assumption 8 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred.' + Document: IG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only qualifiers from the SDTM Events class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0481 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AEREASND - operator: exists + - name: AEREASND + operator: exists Core: Id: CORE-000075 Status: Published @@ -85,14 +79,14 @@ Executability: Fully Executable Outcome: Message: AEREASND is present. Output Variables: - - AEREASND + - AEREASND Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000080/rule.yml b/Published/CORE-000080/rule.yml index 15343f6ad..bb559c8bc 100644 --- a/Published/CORE-000080/rule.yml +++ b/Published/CORE-000080/rule.yml @@ -2,102 +2,98 @@ # Condition: --ELTM, --TPTNUM, and --TPT not present in dataset # Rule: --TPTREF not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference - for a series of planned time points, used for study data - tabulation. Description of the fixed reference point referred - to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: Model v2.0 - Item: --TPTREF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '(--TPTREF) Description of the fixed reference point referred to - by --ELTM, --TPTNUM, and --TPT. Examples: PREVIOUS DOSE, - PREVIOUS MEAL.' - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of the fixed reference point referred to by --ELTM, - --TPTNUM, --TPT, --STINT, and --ENINT. Examples: "PREVIOUS - DOSE", "PREVIOUS MEAL".' - Document: Model v1.7 - Item: 'Table 2.2.5.1: --TPTREF' - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference - for a series of planned time points, used for study data - tabulation. Description of the fixed reference point referred - to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: SDTM v2.1 - Item: --TPTREF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0358 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: Model v2.0 + Item: --TPTREF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '(--TPTREF) Description of the fixed reference point referred to by --ELTM, --TPTNUM, + and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.' + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, + --STINT, and --ENINT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".' + Document: Model v1.7 + Item: 'Table 2.2.5.1: --TPTREF' + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: SDTM v2.1 + Item: --TPTREF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0358 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ELTM - operator: not_exists - - name: --TPTNUM - operator: not_exists - - name: --TPT - operator: not_exists - - name: --TPTREF - operator: exists + - name: --ELTM + operator: not_exists + - name: --TPTNUM + operator: not_exists + - name: --TPT + operator: not_exists + - name: --TPTREF + operator: exists Core: Id: CORE-000080 Status: Published Version: '1' -Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in - dataset, but --TPTREF is present. +Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but + --TPTREF is present. Executability: Fully Executable Outcome: Message: --TPTREF is present when --ELTM, --TPTNUM, and --TPT are not present. Output Variables: - - --TPTREF - - --ELTM - - --TPTNUM - - --TPT + - --TPTREF + - --ELTM + - --TPTNUM + - --TPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000081/rule.yml b/Published/CORE-000081/rule.yml index 2226fa03e..c9565484c 100644 --- a/Published/CORE-000081/rule.yml +++ b/Published/CORE-000081/rule.yml @@ -2,178 +2,155 @@ # Condition: --PRESP not present in dataset # Rule: --STAT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated - or detailed on the CRF. --STAT, used to indicate when a - question about the occurrence of a prespecified event was not - answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively - stated or detailed on the CRF. --STAT, used to indicate when - a question about the occurrence of a prespecified intervention - was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated - or detailed on the CRF. --STAT, used to indicate when a - question about the occurrence of a prespecified event was not - answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively - stated or detailed on the CRF. --STAT, used to indicate when - a question about the occurrence of a prespecified intervention - was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated - or detailed on the CRF. --STAT, used to indicate when a - question about the occurrence of a prespecified event was not - answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively - stated or detailed on the CRF. --STAT, used to indicate when - a question about the occurrence of a prespecified intervention - was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the - event describe by --TERM was pre-specified on a CRF. Value is - Y for pre-specified events, null for spontaneously reported - events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or hav a value of NOT DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF.]|Events[--STAT][Used to - indicate when a question about the occurrence of a - prespecified event was not - answered.]|Interventions[--PRESP][An indication that the - intervention was prospectively stated or detailed on the - CRF.]|Interventions[--STAT][Used to indicate when a question - about the occurrence of a prespecified intervention was not - answered.]' - Document: SDTM v2.1 - Item: --PRESP|--STAT - Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation - Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0330 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'Events[--PRESP][An indication that the event was prospectively stated or detailed + on the CRF.]|Events[--STAT][Used to indicate when a question about the occurrence of a prespecified + event was not answered.]|Interventions[--PRESP][An indication that the intervention was prospectively + stated or detailed on the CRF.]|Interventions[--STAT][Used to indicate when a question about + the occurrence of a prespecified intervention was not answered.]' + Document: SDTM v2.1 + Item: --PRESP|--STAT + Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0330 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: not_exists - - name: --STAT - operator: exists + - name: --PRESP + operator: not_exists + - name: --STAT + operator: exists Core: Id: CORE-000081 Status: Published @@ -186,12 +163,12 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000083/rule.yml b/Published/CORE-000083/rule.yml index d208c1b32..fe79ab590 100644 --- a/Published/CORE-000083/rule.yml +++ b/Published/CORE-000083/rule.yml @@ -2,87 +2,85 @@ # Condition: --LOBXFL = 'Y' and --DRVFL = null # Rule: --ORRES ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Result value is in - --STRESC. Should be "Y" or null. - Document: Model v2.0 - Item: --LOBXFL - Section: The Findings Observation Class - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0553 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Should be "Y" or null. - Document: Model v1.7 - Item: --LOBXFL - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0553 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Operationally derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Result value is in - --STRESC. Should be "Y" or null. - Document: SDTM v2.1 - Item: --LOBXFL - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0641 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Operationally derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. + Document: Model v2.0 + Item: --LOBXFL + Section: The Findings Observation Class + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0553 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Should be "Y" or null. + Document: Model v1.7 + Item: --LOBXFL + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0553 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Operationally derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. + Document: SDTM v2.1 + Item: --LOBXFL + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0641 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ORRES - operator: empty - - name: --LOBXFL - operator: equal_to + - name: --ORRES + operator: empty + - name: --LOBXFL + operator: equal_to + value: Y + - any: + - name: --DRVFL + operator: not_exists + - name: --DRVFL + operator: not_equal_to value: Y - - any: - - name: --DRVFL - operator: not_exists - - name: --DRVFL - operator: not_equal_to - value: Y Core: Id: CORE-000083 Status: Published Version: '1' -Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null - or --DRVFL is not present in the dataset +Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not + present in the dataset Executability: Fully Executable Outcome: - Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not - present in dataset or is not equal to "Y" + Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset + or is not equal to "Y" Output Variables: - - --ORRES - - --LOBXFL - - --DRVFL + - --ORRES + - --LOBXFL + - --DRVFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000084/rule.yml b/Published/CORE-000084/rule.yml index 9424602f6..b8074e722 100644 --- a/Published/CORE-000084/rule.yml +++ b/Published/CORE-000084/rule.yml @@ -2,75 +2,71 @@ # Condition: --ENTPT present in dataset # Rule: --ENRTPT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a - reference time point. The sponsor-defined reference time point - is in --ENTPT. - Document: Model v2.0 - Item: --ENRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable - --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENRTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before - or after the sponsor-defined reference time point defined by - variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a - reference time point. The sponsor-defined reference time point - is in --ENTPT. - Document: SDTM v2.1 - Item: --ENRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0331 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: Model v2.0 + Item: --ENRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENRTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: SDTM v2.1 + Item: --ENRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0331 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ENTPT - operator: exists - - name: --ENRTPT - operator: not_exists + - name: --ENTPT + operator: exists + - name: --ENRTPT + operator: not_exists Core: Id: CORE-000084 Status: Published @@ -80,14 +76,14 @@ Executability: Fully Executable Outcome: Message: --ENTPT exists in a dataset, but --ENRTPT does not exist. Output Variables: - - --ENTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000085/rule.yml b/Published/CORE-000085/rule.yml index 44c102060..a5dbb4c0c 100644 --- a/Published/CORE-000085/rule.yml +++ b/Published/CORE-000085/rule.yml @@ -2,75 +2,71 @@ # Condition: --STTPT ^= null # Rule: --STRTPT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - a reference time point. The sponsor-defined reference time - point is in --STTPT. - Document: Model v2.0 - Item: --STRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before or after - the sponsor-defined reference time point defined by variable - --STTPT. - Document: Model v1.7 - Item: Table 2.2.5.1, --STRTPT - Section: 2.2.5. Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STRTPT) Identifies the start of the observation as being - before or after the sponsor-defined reference time point - defined by variable --STTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - a reference time point. The sponsor-defined reference time - point is in --STTPT. - Document: SDTM v2.1 - Item: --STRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0333 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: Model v2.0 + Item: --STRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before or after the + sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.7 + Item: Table 2.2.5.1, --STRTPT + Section: 2.2.5. Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--STRTPT) Identifies the start of the observation as being before or after + the sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: SDTM v2.1 + Item: --STRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0333 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --STTPT - operator: non_empty - - name: --STRTPT - operator: empty + - name: --STTPT + operator: non_empty + - name: --STRTPT + operator: empty Core: Id: CORE-000085 Status: Published @@ -80,15 +76,15 @@ Executability: Fully Executable Outcome: Message: --STTPT is completed and --STRTPT is empty Output Variables: - - --STTPT - - --STRTPT + - --STTPT + - --STRTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000086/rule.yml b/Published/CORE-000086/rule.yml index d47e14294..47204e931 100644 --- a/Published/CORE-000086/rule.yml +++ b/Published/CORE-000086/rule.yml @@ -2,86 +2,81 @@ # Condition: # Rule: DVSTDTC >= DM.RFICDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to capture protocol deviations - that occurred during the course of the study (see ICH E3 - Section 10.2 at - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). - Usually these are deviations that occur after the subject has - been randomized or received the first treatment. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to capture protocol deviations - that occurred during the course of the study (see ICH E3 - Section 10.2 at - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). - Usually these are deviations that occur after the subject has - been randomized or received the first treatment. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain is to capture protocol violations and - deviations during the course of the study and will store only - those criteria violation by or deviated from by the subject - and not a response to each violation or deviation. - Document: IG v3.2 - Item: '' - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 1. The DV domain is an Events model for collected protocol - deviations and not for derived protocol deviations that are - more likely to be part of analysis. Events typically include - what the event was, captured in --TERM (the topic variable), - and when it happened (captured in its start and/or end dates). - The intent of the domain model is to capture protocol - deviations that occurred during the course of the study (see - ICH E3, Section 10.2[1]). - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.19 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0341 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to capture protocol deviations that + occurred during the course of the study (see ICH E3 Section 10.2 at + http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). + Usually these are deviations that occur after the subject has been randomized or received + the first treatment. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain model is to capture protocol deviations that + occurred during the course of the study (see ICH E3 Section 10.2 at + http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). + Usually these are deviations that occur after the subject has been randomized or received + the first treatment. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The intent of the domain is to capture protocol violations and deviations + during the course of the study and will store only those criteria violation by or deviated + from by the subject and not a response to each violation or deviation. + Document: IG v3.2 + Item: '' + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: 1. The DV domain is an Events model for collected protocol deviations and + not for derived protocol deviations that are more likely to be part of analysis. Events + typically include what the event was, captured in --TERM (the topic variable), and when it + happened (captured in its start and/or end dates). The intent of the domain model is to + capture protocol deviations that occurred during the course of the study (see ICH E3, + Section 10.2[1]). + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.19 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0341 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DVSTDTC - operator: date_less_than - value: RFICDTC + - name: DVSTDTC + operator: date_less_than + value: RFICDTC Core: Id: CORE-000086 Status: Published @@ -89,21 +84,21 @@ Core: Description: Raise an error when DVSTDTC is earlier than RFICDTC in DM. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: DVSTDTC is earlier than RFICDTC in DM. Output Variables: - - DVSTDTC - - RFICDTC + - DVSTDTC + - RFICDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DV + - DV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000087/rule.yml b/Published/CORE-000087/rule.yml index a91bd482e..997fc80fa 100644 --- a/Published/CORE-000087/rule.yml +++ b/Published/CORE-000087/rule.yml @@ -2,70 +2,70 @@ # Condition: --SER ^= null # Rule: --SER in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: Model v2.0 - Item: --SER - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. - Document: Model v1.7 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: SDTM v2.1 - Item: --SER - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0549 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: Model v2.0 + Item: --SER + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. + Document: Model v1.7 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: SDTM v2.1 + Item: --SER + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0549 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESER - operator: non_empty - - name: AESER - operator: is_not_contained_by - value: - - Y - - N + - name: AESER + operator: non_empty + - name: AESER + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000087 Status: Published @@ -75,14 +75,14 @@ Executability: Fully Executable Outcome: Message: AESER is completed, but not equal to "N" or "Y" Output Variables: - - AESER + - AESER Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000088/rule.yml b/Published/CORE-000088/rule.yml index d5f18d1f9..5c72ba2b0 100644 --- a/Published/CORE-000088/rule.yml +++ b/Published/CORE-000088/rule.yml @@ -2,175 +2,169 @@ # Condition: # Rule: SETCD value length <= 8 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v2.0 - Item: SETCD - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Short name of the Trial Set. The same element may occur more - than once within an Arm. Maximum 8 characters. - Document: TIG v1.0 - Item: SETCD CDISC Notes - Section: 2.8.9.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0169 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: SDTM v2.1 - Item: SETCD - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0390 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v2.0 + Item: SETCD + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Short name of the Trial Set. The same element may occur more than once + within an Arm. Maximum 8 characters. + Document: TIG v1.0 + Item: SETCD CDISC Notes + Section: 2.8.9.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0169 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: SDTM v2.1 + Item: SETCD + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0390 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SETCD - operator: matches_regex - value: ^(.){9,}$ + - name: SETCD + operator: matches_regex + value: ^(.){9,}$ Core: Id: CORE-000088 Status: Published @@ -180,16 +174,16 @@ Executability: Fully Executable Outcome: Message: SETCD value length is greater than 8 Output Variables: - - SETCD + - SETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TX + - DM + - TX Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000090/rule.yml b/Published/CORE-000090/rule.yml index 67c031838..03781f133 100644 --- a/Published/CORE-000090/rule.yml +++ b/Published/CORE-000090/rule.yml @@ -2,80 +2,76 @@ # Condition: RDOMAIN = null # Rule: IDVAR = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records.Null for comments collected on separate CRFs. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. null for comments collected on separate CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. null for comments collected on separate CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. Null for comments collected on separate CRFs. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0397 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual + comments are related to domain records.Null for comments collected on separate CRFs. + Document: SDTMIG v3.4 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.3 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0397 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVAR - operator: non_empty - - name: RDOMAIN - operator: empty + - name: IDVAR + operator: non_empty + - name: RDOMAIN + operator: empty Core: Id: CORE-000090 Status: Published @@ -85,15 +81,15 @@ Executability: Fully Executable Outcome: Message: RDOMAIN has a missing value but IDVAR has a non-missing value Output Variables: - - RDOMAIN - - IDVAR + - RDOMAIN + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000092/rule.yml b/Published/CORE-000092/rule.yml index f9414e6a7..0fe853965 100644 --- a/Published/CORE-000092/rule.yml +++ b/Published/CORE-000092/rule.yml @@ -2,122 +2,120 @@ # Condition: --DOSTXT ^= null # Rule: --DOSE = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSTXT is populated. - Document: Model v2.0 - Item: --DOSE - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: Model v2.0 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is - populated. - Document: Model v1.4 - Item: --DOSE Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated - Document: Model v1.4 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is - populated. - Document: Model v1.7 - Item: --DOSE Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: Model v1.7 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSTXT is populated. - Document: SDTM v2.1 - Item: --DOSE - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0374 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: SDTM v2.1 - Item: --DOSTXT - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0375 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSTXT is populated. + Document: Model v2.0 + Item: --DOSE + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: Model v2.0 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. + Document: Model v1.4 + Item: --DOSE Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated + Document: Model v1.4 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. + Document: Model v1.7 + Item: --DOSE Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: Model v1.7 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSTXT is populated. + Document: SDTM v2.1 + Item: --DOSE + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0374 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: SDTM v2.1 + Item: --DOSTXT + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0375 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DOSTXT - operator: non_empty - - name: --DOSE - operator: non_empty + - name: --DOSTXT + operator: non_empty + - name: --DOSE + operator: non_empty Core: Id: CORE-000092 Status: Published @@ -127,15 +125,15 @@ Executability: Fully Executable Outcome: Message: Both --DOSE and --DOSTXT values are populated Output Variables: - - --DOSE - - --DOSTXT + - --DOSE + - --DOSTXT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000093/rule.yml b/Published/CORE-000093/rule.yml index 408b2bcc1..aa29644eb 100644 --- a/Published/CORE-000093/rule.yml +++ b/Published/CORE-000093/rule.yml @@ -2,95 +2,93 @@ # Condition: --DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null # Rule: --DOSU ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT - Document: Model v2.0 - Item: --DOSU - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, - mg/kg).' - Document: Model v1.4 - Item: --DOSU Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", - "mg/kg".' - Document: Model v1.7 - Item: Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT - Document: SDTM v2.1 - Item: --DOSU - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0377 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT + Document: Model v2.0 + Item: --DOSU + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).' + Document: Model v1.4 + Item: --DOSU Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", "mg/kg".' + Document: Model v1.7 + Item: Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT + Document: SDTM v2.1 + Item: --DOSU + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0377 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DOSU - operator: empty - - any: - - name: --DOSE - operator: non_empty - - name: --DOSTXT - operator: non_empty - - name: --DOSTOT - operator: non_empty + - name: --DOSU + operator: empty + - any: + - name: --DOSE + operator: non_empty + - name: --DOSTXT + operator: non_empty + - name: --DOSTOT + operator: non_empty Core: Id: CORE-000093 Status: Published Version: '1' -Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT - ^= null or --DOSTXT ^= null) +Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT + ^= null) Executability: Fully Executable Outcome: Message: Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided Output Variables: - - --DOSE - - --DOSTXT - - --DOSTOT - - --DOSU + - --DOSE + - --DOSTXT + - --DOSTOT + - --DOSU Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000094/rule.yml b/Published/CORE-000094/rule.yml index 509d34d5d..6fec9fe17 100644 --- a/Published/CORE-000094/rule.yml +++ b/Published/CORE-000094/rule.yml @@ -2,73 +2,71 @@ # Condition: # Rule: --DOSTXT value is non-numeric Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, - substance, radiation) taken or absorbed at a single - administration. - Document: Model v2.0 - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per - day, 200-400. Not populated when --DOSE is populated.' - Document: Model v1.4 - Item: 'Specification: --DOSTXT' - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per - day, 200-400. Not populated when --DOSE is populated.' - Document: Model v1.7 - Item: Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, - substance, radiation) taken or absorbed at a single - administration. - Document: SDTM v2.1 - Item: --DOSTXT - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0376 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, substance, + radiation) taken or absorbed at a single administration. + Document: Model v2.0 + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per day, 200-400. Not + populated when --DOSE is populated.' + Document: Model v1.4 + Item: 'Specification: --DOSTXT' + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per day, 200-400. Not + populated when --DOSE is populated.' + Document: Model v1.7 + Item: Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, substance, + radiation) taken or absorbed at a single administration. + Document: SDTM v2.1 + Item: --DOSTXT + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0376 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DOSTXT - operator: matches_regex - value: ^\d*\.?\d*$ - - name: --DOSTXT - operator: non_empty + - name: --DOSTXT + operator: matches_regex + value: ^\d*\.?\d*$ + - name: --DOSTXT + operator: non_empty Core: Id: CORE-000094 Status: Published @@ -81,9 +79,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000095/rule.yml b/Published/CORE-000095/rule.yml index f5a7cc9ad..c54843546 100644 --- a/Published/CORE-000095/rule.yml +++ b/Published/CORE-000095/rule.yml @@ -2,90 +2,83 @@ # Condition: SEUPDES ^= null # Rule: ETCD = 'UNPLAN' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element. The value of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should be populated - with a description of the unplanned Element. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element. The value of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should be populated - with a description of the unplanned Element only if ETCD has - the value of "UNPLAN". - Document: IG v3.2 - Item: Assumption 6 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element. The value of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should be populated - with a description of the unplanned Element only if ETCD has - the value of "UNPLAN". - Document: IG v3.3 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the applicant decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned elements, then that period of time should be - represented as an unplanned element. The value of ETCD for an - unplanned element is “UNPLAN” and SEUPDES should be populated - with a description of the unplanned element. - Document: TIG 1.0 - Item: Assumption 3 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0430 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element. + Document: IG v3.4 + Item: Assumption 4 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.2 + Item: Assumption 6 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.3 + Item: Assumption 4 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If the applicant decides that the subject's experience for a particular + period of time cannot be represented with one of the planned elements, then that period of + time should be represented as an unplanned element. The value of ETCD for an unplanned + element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned + element. + Document: TIG 1.0 + Item: Assumption 3 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0430 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SEUPDES - operator: non_empty - - name: ETCD - operator: not_equal_to - value: UNPLAN + - name: SEUPDES + operator: non_empty + - name: ETCD + operator: not_equal_to + value: UNPLAN Core: Id: CORE-000095 Status: Published @@ -98,9 +91,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000096/rule.yml b/Published/CORE-000096/rule.yml index 922a2067a..3f95f561d 100644 --- a/Published/CORE-000096/rule.yml +++ b/Published/CORE-000096/rule.yml @@ -2,80 +2,78 @@ # Condition: --LOC not present in dataset # Rule: --PORTOT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifer of --LOC.] Interventions[Variable - Qualifer of --LOC.] Findings[Variable Qualifer of --LOC.] - Document: Model v2.0 - Item: --PORTOT - Section: Events Interventions Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing the - distribution, which means arrangement of, apportioning of the - intervention administration. - Document: Model v1.4 - Item: --PORTOT Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing the - distribution, which means arrangement of, apportioning of the - intervention administration. - Document: Model v1.7 - Item: --PORTOT Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: Findings[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0378 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[Variable Qualifer of --LOC.] Interventions[Variable Qualifer of + --LOC.] Findings[Variable Qualifer of --LOC.] + Document: Model v2.0 + Item: --PORTOT + Section: Events Interventions Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing the distribution, which + means arrangement of, apportioning of the intervention administration. + Document: Model v1.4 + Item: --PORTOT Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing the distribution, which + means arrangement of, apportioning of the intervention administration. + Document: Model v1.7 + Item: --PORTOT Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: Findings[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0378 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --LOC - operator: not_exists - - name: --PORTOT - operator: exists + - name: --LOC + operator: not_exists + - name: --PORTOT + operator: exists Core: Id: CORE-000096 Status: Published @@ -83,20 +81,19 @@ Core: Description: Raise an error when --LOC does not exists in a dataset, --PORTOT exists. Executability: Fully Executable Outcome: - Message: --PORTOT variable is present, when --LOC variable does not exist in a - dataset. + Message: --PORTOT variable is present, when --LOC variable does not exist in a dataset. Output Variables: - - --LOC - - --PORTOT + - --LOC + - --PORTOT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 48327a98e..dfc02d39b 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -2,105 +2,102 @@ # Condition: EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC # Rule: EPOCH = SE.EPOCH Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: IG v3.4 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.2 - Item: Assumption 11 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.3 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: TIG 1.0 - Item: Assumption 11 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0432 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: IG v3.4 + Item: Assumption 11 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.2 + Item: Assumption 11 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.3 + Item: Assumption 11 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: TIG 1.0 + Item: Assumption 11 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0432 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: EPOCH - operator: exists - - name: SESTDTC - operator: date_less_than_or_equal_to - value: SVSTDTC - - name: SVSTDTC - operator: date_less_than_or_equal_to - value: SEENDTC - - name: EPOCH - operator: not_equal_to - value: SE.EPOCH + - name: EPOCH + operator: exists + - name: SESTDTC + operator: date_less_than_or_equal_to + value: SVSTDTC + - name: SVSTDTC + operator: date_less_than_or_equal_to + value: SEENDTC + - name: EPOCH + operator: not_equal_to + value: SE.EPOCH Core: Id: CORE-000097 Status: Published Version: '1' -Description: Raise an error when variable EPOCH values don't match between - Subject Visits (SV) and Subject Elements (SE) datasets. +Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and + Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - USUBJID - Name: SE +- Keys: + - USUBJID + Name: SE Outcome: - Message: EPOCH values don't match between Subject Visits (SV) and Subject - Elements (SE) datasets. + Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000098/rule.yml b/Published/CORE-000098/rule.yml index 2fddb9db2..b40f32c6e 100644 --- a/Published/CORE-000098/rule.yml +++ b/Published/CORE-000098/rule.yml @@ -2,85 +2,83 @@ # Condition: --LOC not present in dataset # Rule: --DIR not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Events - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Interventions - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing - directionality ... - Document: Model v1.4 - Item: --DIR Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing - directionality ... - Document: Model v1.7 - Item: --DIR Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: Findings[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0379 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Events + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Interventions + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing directionality ... + Document: Model v1.4 + Item: --DIR Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing directionality ... + Document: Model v1.7 + Item: --DIR Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: Findings[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0379 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --LOC - operator: not_exists - - name: --DIR - operator: exists + - name: --LOC + operator: not_exists + - name: --DIR + operator: exists Core: Id: CORE-000098 Status: Published @@ -90,17 +88,17 @@ Executability: Fully Executable Outcome: Message: --DIR variable is present, when --LOC variable does not exist in a dataset. Output Variables: - - --LOC - - --DIR + - --LOC + - --DIR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000099/rule.yml b/Published/CORE-000099/rule.yml index 18f01d0b5..71ae9323b 100644 --- a/Published/CORE-000099/rule.yml +++ b/Published/CORE-000099/rule.yml @@ -2,79 +2,77 @@ # Condition: --ORRES ^= null # Rule: --STAT = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The --ORRES variable contains the result of the measurement or - finding as originally received or collected. --ORRES is an - expected variable and should always be populated, except (1) - when --STAT = "NOT DONE" (because there is no result for such - a record) or (2) for derived records. - Document: IG v3.4 - Item: --STAT - Section: 4.5.1.1 - - Cited Guidance: Should be null or have a value of "NOT DONE". - Document: Model v2.0 - Item: --STAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to indicate exam not done. Should be null if a result - exists in LBORRES. - Document: IG v3.2 - Section: 6.3 LB - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to indicate exam not done. Should be null if a result - exists in LBORRES. - Document: IG v3.3 - Section: 6.3.6 LB - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2.8.7.3 This section describes how to populate --ORRES. Tests - Not Done have --ORRES null and --STAT "NOT DONE". {All - Findings Domain Specifications- --STAT} Used to indicate that - a test was not done or a measurement was not taken. Should be - null if a result exists in REORRES. - Document: TIG 1.0 - Item: Findings Class Domains- Num 3 and Num 5 - Section: 2.8.7.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0577 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The --ORRES variable contains the result of the measurement or finding as + originally received or collected. --ORRES is an expected variable and should always be + populated, except (1) when --STAT = "NOT DONE" (because there is no result for such a + record) or (2) for derived records. + Document: IG v3.4 + Item: --STAT + Section: 4.5.1.1 + - Cited Guidance: Should be null or have a value of "NOT DONE". + Document: Model v2.0 + Item: --STAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in + LBORRES. + Document: IG v3.2 + Section: 6.3 LB + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in + LBORRES. + Document: IG v3.3 + Section: 6.3.6 LB + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 2.8.7.3 This section describes how to populate --ORRES. Tests Not Done have + --ORRES null and --STAT "NOT DONE". {All Findings Domain Specifications- --STAT} Used + to indicate that a test was not done or a measurement was not taken. Should be null if a + result exists in REORRES. + Document: TIG 1.0 + Item: Findings Class Domains- Num 3 and Num 5 + Section: 2.8.7.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0577 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ORRES - operator: non_empty - - name: --STAT - operator: non_empty + - name: --ORRES + operator: non_empty + - name: --STAT + operator: non_empty Core: Id: CORE-000099 Status: Published @@ -84,15 +82,15 @@ Executability: Fully Executable Outcome: Message: Value for --STAT is populated, when --ORRES is populated Output Variables: - - --ORRES - - --STAT + - --ORRES + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000100/rule.yml b/Published/CORE-000100/rule.yml index 9766ed427..29d521835 100644 --- a/Published/CORE-000100/rule.yml +++ b/Published/CORE-000100/rule.yml @@ -2,83 +2,78 @@ # Condition: --VAMT ^= null # Rule: --TRTV ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A carrier or inert medium in which a medicinally active agent is - administered. - Document: Model v2.0 - Item: --TRTV - Section: Interventions - - Cited Guidance: Amount of the prepared product (treatment plus vehicle) - administered. - Document: Model v2.0 - Item: --VAMT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a - liquid in which the treatment drug is dissolved. Example: - SALINE. --VAMT: Amount of the prepared product (treatment + - vehicle) administered or given. Note: should not be diluent - amount alone. --VAMTU: Units for the prepared product - (treatment + vehicle). Examples: mL; mg.' - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a - liquid in which the treatment drug is dissolved. Example: - SALINE. --VAMT: Amount of the prepared product (treatment + - vehicle) administered or given. Note: should not be diluent - amount alone. --VAMTU: Units for the prepared product - (treatment + vehicle). Examples: mL; mg.' - Document: Model v1.7 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: --TRTV[A carrier or inert medium in which a medicinally active - agent is administered.]|--VAMT[Amount of the prepared product - (treatment plus vehicle) administered.] - Document: SDTM v2.1 - Item: Specifications '--TRTV|'--VAMT - Section: Section 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0578 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A carrier or inert medium in which a medicinally active agent is + administered. + Document: Model v2.0 + Item: --TRTV + Section: Interventions + - Cited Guidance: Amount of the prepared product (treatment plus vehicle) administered. + Document: Model v2.0 + Item: --VAMT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a liquid in which the + treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for + the prepared product (treatment + vehicle). Examples: mL; mg.' + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a liquid in which the + treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for + the prepared product (treatment + vehicle). Examples: mL; mg.' + Document: Model v1.7 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: --TRTV[A carrier or inert medium in which a medicinally active agent is + administered.]|--VAMT[Amount of the prepared product (treatment plus vehicle) + administered.] + Document: SDTM v2.1 + Item: Specifications '--TRTV|'--VAMT + Section: Section 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0578 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --VAMT - operator: non_empty - - name: --TRTV - operator: empty + - name: --VAMT + operator: non_empty + - name: --TRTV + operator: empty Core: Id: CORE-000100 Status: Published @@ -88,15 +83,15 @@ Executability: Fully Executable Outcome: Message: Missing --TRTV value, when --VAMT value is populated. Output Variables: - - --TRTV - - --VAMT + - --TRTV + - --VAMT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000101/rule.yml b/Published/CORE-000101/rule.yml index a29672d77..880a2d6c0 100644 --- a/Published/CORE-000101/rule.yml +++ b/Published/CORE-000101/rule.yml @@ -2,71 +2,71 @@ # Condition: --RESCAT ^= null # Rule: --STRESC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A grouping or classification of the results of an assessment. - The result is in --STRESC. - Document: Model v2.0 - Item: --RESCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or - derived from --ORRES in a standard format or in standard - units. --RESCAT: used to categorize the result of a finding.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or - derived from --ORRES in a standard format or in standard - units. --RESCAT: used to categorize the result of a finding.' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: --RESCAT A grouping or classification of the results of an - assessment. The result is in --STRESC. - Document: SDTM v2.1 - Item: Specification --RESCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0581 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A grouping or classification of the results of an assessment. The result is + in --STRESC. + Document: Model v2.0 + Item: --RESCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or derived from + --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of + a finding.' + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or derived from + --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of + a finding.' + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: --RESCAT A grouping or classification of the results of an assessment. The + result is in --STRESC. + Document: SDTM v2.1 + Item: Specification --RESCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0581 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RESCAT - operator: non_empty - - name: --STRESC - operator: empty + - name: --RESCAT + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000101 Status: Published @@ -76,15 +76,15 @@ Executability: Fully Executable Outcome: Message: Missing --STRESC value, when --RESCAT value is populated. Output Variables: - - --RESCAT - - --STRESC + - --RESCAT + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000102/rule.yml b/Published/CORE-000102/rule.yml index 9dd5ba0fc..d78bb6b10 100644 --- a/Published/CORE-000102/rule.yml +++ b/Published/CORE-000102/rule.yml @@ -2,75 +2,73 @@ # Condition: --TOX ^= null # Rule: --TOXGR ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE - Short Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor - should specify which scale and version is used in the Sponsor - Comments column of the Define-XML document.' - Document: Model v1.4 - Item: --TOX - Section: 2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE - Short Name. Examples: HYPERCALCEMIA; HYPOCALCEMIA. Sponsor - should specify which scale and version is used in the Sponsor - Comments column of the Define-XML document.' - Document: Model v1.7 - Item: --TOX - Section: 2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: SDTM v2.1 - Item: --TOX - Section: Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0582 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: + HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor + Comments column of the Define-XML document.' + Document: Model v1.4 + Item: --TOX + Section: 2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: + HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor + Comments column of the Define-XML document.' + Document: Model v1.7 + Item: --TOX + Section: 2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: SDTM v2.1 + Item: --TOX + Section: Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation + Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0582 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TOX - operator: non_empty - - name: --TOXGR - operator: empty + - name: --TOX + operator: non_empty + - name: --TOXGR + operator: empty Core: Id: CORE-000102 Status: Published @@ -80,22 +78,22 @@ Executability: Fully Executable Outcome: Message: --TOXGR should not be null when --TOX is populated. Output Variables: - - --TOX - - --TOXGR + - --TOX + - --TOXGR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - AE - - MH - - CE - - EG - - LB - - PC - - PP + - AE + - MH + - CE + - EG + - LB + - PC + - PP Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000103/rule.yml b/Published/CORE-000103/rule.yml index ae964d68a..1f1cd6d2b 100644 --- a/Published/CORE-000103/rule.yml +++ b/Published/CORE-000103/rule.yml @@ -2,94 +2,85 @@ # Condition: --SCAT ^= null # Rule: --CAT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further - categorization of --CAT values.]|2.2.2[Table 3.2.2 - --SCAT][Used to define a further categorization of --CAT - values.]|2.2.3[Table 3.2.3 --SCAT][Used to define a further - categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: - --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Interventions[A further grouping or classification of the - category for the topic of the finding, event, or intervention. - The category is in --CAT.]|Events[A further grouping or - classification of the category for the topic of the finding, - event, or intervention. The category is in --CAT.]|Findings[A - further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT.] - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The - Events Observation Class Section|3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0583 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table + 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used + to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Interventions[A further grouping or classification of the category for the + topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further + grouping or classification of the category for the topic of the finding, event, or + intervention. The category is in --CAT.]|Findings[A further grouping or classification of + the category for the topic of the finding, event, or intervention. The category is in + --CAT.] + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Observation Class Section|3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0583 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: non_empty - - name: --CAT - operator: empty + - name: --SCAT + operator: non_empty + - name: --CAT + operator: empty Core: Id: CORE-000103 Status: Published @@ -99,15 +90,15 @@ Executability: Fully Executable Outcome: Message: --CAT should not be null when --SCAT is populated Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000104/rule.yml b/Published/CORE-000104/rule.yml index 71aca76f4..104f70d03 100644 --- a/Published/CORE-000104/rule.yml +++ b/Published/CORE-000104/rule.yml @@ -2,114 +2,106 @@ # Condition: --SCAT present in dataset # Rule: --CAT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: - --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.2 The Events Observation Class Section - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0584 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.2 The Events Observation Class Section + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0584 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: exists - - name: --CAT - operator: not_exists + - name: --SCAT + operator: exists + - name: --CAT + operator: not_exists Core: Id: CORE-000104 Status: Published Version: '1' -Description: Part A - Raise an error when --SCAT exists in a dataset, but --CAT - does not exist. +Description: Part A - Raise an error when --SCAT exists in a dataset, but --CAT does not exist. Executability: Fully Executable Outcome: Message: --SCAT exists in a dataset, but --CAT does not exist. Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000105/rule.yml b/Published/CORE-000105/rule.yml index 4472327f0..a70b22783 100644 --- a/Published/CORE-000105/rule.yml +++ b/Published/CORE-000105/rule.yml @@ -2,89 +2,87 @@ # Condition: --LOBXFL = 'Y' # Rule: --STRESC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Result value is in - --STRESC. - Document: Model v2.0 - Item: --STRESC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0569 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Should be "Y" or null. - Document: Model v1.7 - Item: --LOXBFL - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0569 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last - non-missing value prior to RFXSTDTC. Result value is in - --STRESC. - Document: SDTM v2.1 - Item: --STRESC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0653 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2602 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. + Document: Model v2.0 + Item: --STRESC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0569 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Should be "Y" or null. + Document: Model v1.7 + Item: --LOXBFL + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0569 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. + Document: SDTM v2.1 + Item: --STRESC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0653 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2602 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2602 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: --LOBXFL - operator: equal_to - value: Y - value_is_literal: true - - name: --STRESC - operator: empty + - name: --LOBXFL + operator: equal_to + value: Y + value_is_literal: true + - name: --STRESC + operator: empty Core: Id: CORE-000105 Status: Published @@ -94,16 +92,16 @@ Executability: Fully Executable Outcome: Message: --LOBXFL = 'Y', but --STRESC is empty. Output Variables: - - --LOBXFL - - --TESTCD - - --STRESC + - --LOBXFL + - --TESTCD + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000106/rule.yml b/Published/CORE-000106/rule.yml index a81a28f25..dd210a660 100644 --- a/Published/CORE-000106/rule.yml +++ b/Published/CORE-000106/rule.yml @@ -2,77 +2,73 @@ # Condition: --ENTPT ^= null # Rule: --ENRTPT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the end of an - observation. This is the sponsor-defined reference point - referred to by --ENRTPT. - Document: Model v2.0 - Item: --ENTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable - --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before - or after the sponsor-defined reference time point defined by - variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the end of an - observation. This is the sponsor-defined reference point - referred to by --ENRTPT - Document: SDTM v2.1 - Item: --ENTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0324 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: Model v2.0 + Item: --ENTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT + Document: SDTM v2.1 + Item: --ENTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0324 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENRTPT - operator: empty + - name: --ENTPT + operator: non_empty + - name: --ENRTPT + operator: empty Core: Id: CORE-000106 Status: Published @@ -82,15 +78,15 @@ Executability: Fully Executable Outcome: Message: --ENTPT is completed, but --ENRTPT is not completed. Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000107/rule.yml b/Published/CORE-000107/rule.yml index 677c730e7..4a430b627 100644 --- a/Published/CORE-000107/rule.yml +++ b/Published/CORE-000107/rule.yml @@ -2,113 +2,109 @@ # Condition: # Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on - one of the 3 general observation classes. Each general class - domain must also include at least one of the following subject - identifiers USUBJID, SPDEVID, or POOLID. - Document: Model v2.0 - Section: Identifiers - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all - AP datasets, and will identify records as AP data.' - Document: Model v2.0 - Section: Associated Persons Data - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0554 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'STUDYID, DOMAIN, and --SEQ are required in all domains based on - one of the 3 general observation classes. Each general class - domain must also include at least one of the following subject - identifiers: USUBJID, APID, SPDEVID, or POOLID.' - Document: Model v1.7 - Section: 2.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0554 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on - one of the 3 general observation classes. Each general class - domain must also include at least one of the following subject - identifiers - SUBJID, SPDEVID, or POOLID. - Document: SDTM v2.1 - Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all - AP datasets, and will identify records as AP data. - Document: SDTM v2.1 - Section: Section 4.0 Associated Persons Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0642 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers USUBJID, SPDEVID, or POOLID. + Document: Model v2.0 + Section: Identifiers + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data.' + Document: Model v2.0 + Section: Associated Persons Data + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0554 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of the + following subject identifiers: USUBJID, APID, SPDEVID, or POOLID.' + Document: Model v1.7 + Section: 2.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0554 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers - SUBJID, SPDEVID, or POOLID. + Document: SDTM v2.1 + Section: Section 3.1.4 Identifiers For All Classes + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data. + Document: SDTM v2.1 + Section: Section 4.0 Associated Persons Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0642 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: DOMAIN - operator: prefix_matches_regex - prefix: 2 - value: (AP|ap) - - name: APID - operator: not_exists - - all: - - name: DOMAIN - operator: not_prefix_matches_regex - prefix: 2 - value: (AP|ap) - - name: STUDYID - operator: exists - - name: --SEQ - operator: exists - - name: USUBJID - operator: not_exists - - name: SPDEVID - operator: not_exists - - name: POOLID - operator: not_exists + - all: + - name: DOMAIN + operator: prefix_matches_regex + prefix: 2 + value: (AP|ap) + - name: APID + operator: not_exists + - all: + - name: DOMAIN + operator: not_prefix_matches_regex + prefix: 2 + value: (AP|ap) + - name: STUDYID + operator: exists + - name: --SEQ + operator: exists + - name: USUBJID + operator: not_exists + - name: SPDEVID + operator: not_exists + - name: POOLID + operator: not_exists #added for TIG - - name: SPTOBID - operator: not_exists - - name: STOCONID - operator: not_exists + - name: SPTOBID + operator: not_exists + - name: STOCONID + operator: not_exists Core: Id: CORE-000107 Status: Published Version: '1' -Description: APID is required in all Associated Persons Data. In addition to - STUDYID, DOMAIN, and --SEQ being required for all domains based on one of the - 3 general observation classes, one of USUBJID, APID, SPDEVID, or POOLID must - also be present. +Description: APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and + --SEQ being required for all domains based on one of the 3 general observation classes, one of + USUBJID, APID, SPDEVID, or POOLID must also be present. Executability: Fully Executable Outcome: - Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID, - SPTOBID, POOLID, SPTOBID, STOCONID should be present. + Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID, + SPTOBID, STOCONID should be present. Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS - - FINDINGS ABOUT - - FINDINGS + - EVENTS + - INTERVENTIONS + - FINDINGS ABOUT + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000108/rule.yml b/Published/CORE-000108/rule.yml index d67ff5b20..d8d23a089 100644 --- a/Published/CORE-000108/rule.yml +++ b/Published/CORE-000108/rule.yml @@ -2,151 +2,149 @@ # Condition: DD record present for subject # Rule: DTHFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: A findings domain that contains the diagnosis of the cause of - death for a subject. - Document: IG v3.4 - Item: DD Description - Section: 6.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Indicates the subject died. Should be Y or null. - Should be populated even when the death date is unknown.]|DD - Assumption 1[This domain captures information pertaining to - the death of a subject, including the causes of death.] - Document: IG v3.2 - Item: Specification|DD Assumption 1 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[5.2][Indicates the subject died. Should be Y or null. - Should be populated even when the death date is unknown.]||IG - v3.3[6.3.2][A findings domain that contains the diagnosis of - the cause of death for a subject] - Document: IG v3.3 - Section: IG v3.3[5.2]|IG v3.3[6.3.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0382 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: '5.2' + - Cited Guidance: A findings domain that contains the diagnosis of the cause of death for a + subject. + Document: IG v3.4 + Item: DD Description + Section: 6.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown.]|DD Assumption 1[This domain captures + information pertaining to the death of a subject, including the causes of death.] + Document: IG v3.2 + Item: Specification|DD Assumption 1 + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[5.2][Indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown.]||IG v3.3[6.3.2][A findings domain that + contains the diagnosis of the cause of death for a subject] + Document: IG v3.3 + Section: IG v3.3[5.2]|IG v3.3[6.3.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0382 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' #CG0133 is identical to rule FB0602. Added metadata for FB0602. - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: DTHFL - operator: not_equal_to - value: 'Y' - - name: USUBJID - operator: is_contained_by - value: $usubjids_in_dd + - name: DTHFL + operator: not_equal_to + value: 'Y' + - name: USUBJID + operator: is_contained_by + value: $usubjids_in_dd Core: Id: CORE-000108 Status: Published Version: '1' -Description: When a record is present in the DD dataset then death flag (DTHFL) - should be populated as 'Y' in the DM dataset for the corresponding subject. +Description: When a record is present in the DD dataset then death flag (DTHFL) should be populated + as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DD +- Keys: + - USUBJID + Name: DD Operations: - - domain: DD - id: $usubjids_in_dd - name: USUBJID - operator: distinct +- domain: DD + id: $usubjids_in_dd + name: USUBJID + operator: distinct Outcome: Message: DD record is present, but DTHFL in DM dataset is not "Y". Output Variables: - - DTHFL - - USUBJID + - DTHFL + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000110/rule.yml b/Published/CORE-000110/rule.yml index 607a56406..2d9ca9a2b 100644 --- a/Published/CORE-000110/rule.yml +++ b/Published/CORE-000110/rule.yml @@ -2,61 +2,61 @@ # Condition: --ORREF ^= null or --DRVFL='Y' # Rule: --STREFC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from - --ORREF in a standard format. - Document: SDTM v2.0 - Item: --STREFC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0549 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from - --ORREF in a standard format. - Document: Model v1.7 - Item: --STREFC - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0549 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from - --ORREF in a standard format. - Document: SDTM v2.1 - Item: --STREFC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0637 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: SDTM v2.0 + Item: --STREFC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0549 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: Model v1.7 + Item: --STREFC + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0549 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: SDTM v2.1 + Item: --STREFC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0637 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - any: - - name: --ORREF - operator: non_empty - - name: --DRVFL - operator: equal_to - value: Y - - name: --STREFC - operator: empty + - any: + - name: --ORREF + operator: non_empty + - name: --DRVFL + operator: equal_to + value: Y + - name: --STREFC + operator: empty Core: Id: CORE-000110 Status: Published @@ -66,16 +66,16 @@ Executability: Fully Executable Outcome: Message: --STREFC is null when --ORREF is non-empty or --DRVFL is equal to 'Y' Output Variables: - - --ORREF - - --DRVFL - - --STREFC + - --ORREF + - --DRVFL + - --STREFC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000111/rule.yml b/Published/CORE-000111/rule.yml index 655d09582..1b5b0919c 100644 --- a/Published/CORE-000111/rule.yml +++ b/Published/CORE-000111/rule.yml @@ -2,55 +2,54 @@ # Condition: # Rule: --AGENT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --AGENT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0564 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in - SDTM v1.5. These variables are for use only in a specific - domain and will be identified in the appropriate - implementation guide. - Document: Model v1.7 - Item: MSAGENT - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0564 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --AGENT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0649 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --AGENT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0564 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSAGENT + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0564 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --AGENT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0649 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --AGENT - operator: exists + - name: --AGENT + operator: exists Core: Id: CORE-000111 Status: Published @@ -60,14 +59,14 @@ Executability: Fully Executable Outcome: Message: --AGENT is present in a dataset other than MS. Output Variables: - - --AGENT + - --AGENT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000112/rule.yml b/Published/CORE-000112/rule.yml index 8ce690ecc..b38d8d73d 100644 --- a/Published/CORE-000112/rule.yml +++ b/Published/CORE-000112/rule.yml @@ -2,55 +2,54 @@ # Condition: # Rule: --CONC not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --CONC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0565 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in - SDTM v1.5. These variables are for use only in a specific - domain and will be identified in the appropriate - implementation guide. - Document: Model v1.7 - Item: MSCONC - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0565 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --CONC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0650 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --CONC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0565 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSCONC + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0565 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --CONC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0650 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --CONC - operator: exists + - name: --CONC + operator: exists Core: Id: CORE-000112 Status: Published @@ -60,14 +59,14 @@ Executability: Fully Executable Outcome: Message: --CONC is present in a dataset other than MS. Output Variables: - - --CONC + - --CONC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000113/rule.yml b/Published/CORE-000113/rule.yml index cc06b6af4..07f40618c 100644 --- a/Published/CORE-000113/rule.yml +++ b/Published/CORE-000113/rule.yml @@ -2,55 +2,54 @@ # Condition: # Rule: --CONCU not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --CONCU - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0566 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in - SDTM v1.5. These variables are for use only in a specific - domain and will be identified in the appropriate - implementation guide. - Document: Model v1.7 - Item: MSCONCU - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0566 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --CONCU - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0651 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --CONCU + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0566 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSCONCU + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0566 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --CONCU + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0651 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --CONCU - operator: exists + - name: --CONCU + operator: exists Core: Id: CORE-000113 Status: Published @@ -60,14 +59,14 @@ Executability: Fully Executable Outcome: Message: --CONCU is present in a dataset other than MS. Output Variables: - - --CONCU + - --CONCU Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000114/rule.yml b/Published/CORE-000114/rule.yml index c93e7dc62..22f0fa310 100644 --- a/Published/CORE-000114/rule.yml +++ b/Published/CORE-000114/rule.yml @@ -2,55 +2,54 @@ # Condition: # Rule: --EVDTYP not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MH Domain only - Document: Model v2.0 - Item: --EVDTYP - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0567 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in - SDTM v1.5. These variables are for use only in a specific - domain and will be identified in the appropriate - implementation guide. - Document: Model v1.7 - Item: MHEVDTYP - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0567 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MH Domain only - Document: SDTM v2.1 - Item: --EVDTYP - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0652 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MH Domain only + Document: Model v2.0 + Item: --EVDTYP + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0567 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MHEVDTYP + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0567 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: MH Domain only + Document: SDTM v2.1 + Item: --EVDTYP + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0652 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --EVDTYP - operator: exists + - name: --EVDTYP + operator: exists Core: Id: CORE-000114 Status: Published @@ -60,15 +59,15 @@ Executability: Fully Executable Outcome: Message: --EVDTYP is present in a dataset other than MH. Output Variables: - - --EVDTYP + - --EVDTYP Rule Type: Record Data Scope: Classes: Include: # - FINDINGS - - EVENTS + - EVENTS Domains: Exclude: - - MH + - MH Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000116/rule.yml b/Published/CORE-000116/rule.yml index b8217d95e..37eb0bc8e 100644 --- a/Published/CORE-000116/rule.yml +++ b/Published/CORE-000116/rule.yml @@ -2,45 +2,45 @@ # Condition: # Rule: --SPCUFL = 'N' or null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value will be "N" if the specimen is not usable, and null if - the specimen is usable. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0619 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value will be "N" if the specimen is not usable, and null if - the specimen is usable. - Document: SDTM v2.1 - Item: Specification - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0660 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the + specimen is usable. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0619 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the + specimen is usable. + Document: SDTM v2.1 + Item: Specification + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0660 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SPCUFL - operator: exists - - name: --SPCUFL - operator: not_equal_to - value: N - - name: --SPCUFL - operator: non_empty + - name: --SPCUFL + operator: exists + - name: --SPCUFL + operator: not_equal_to + value: N + - name: --SPCUFL + operator: non_empty Core: Id: CORE-000116 Status: Published @@ -53,9 +53,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000117/rule.yml b/Published/CORE-000117/rule.yml index a8e00eca0..a5933368f 100644 --- a/Published/CORE-000117/rule.yml +++ b/Published/CORE-000117/rule.yml @@ -2,165 +2,144 @@ # Condition: --PRESP = 'Y' and --OCCUR = null # Rule: --STAT = 'NOT DONE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or - detailed on the CRF. - Document: Model v2.0 - Item: --PRESP - Section: Events - - Cited Guidance: An indication as to whether a prespecified event has occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Events - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified event was not answered. - Document: Model v2.0 - Item: STAT - Section: Events - - Cited Guidance: An indication that the intervention was prospectively stated or - detailed on the CRF. - Document: Model v2.0 - Item: --PRESP - Section: Interventions - - Cited Guidance: An indication as to whether a prespecified intervention has - occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Interventions - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified intervention was not answered. Should be null or - have a value of "NOT DONE". - Document: Model v2.0 - Item: STAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1.0' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE][--REASND: Used in conjunction with --STAT - when value is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: - Used to indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or hav a value of NOT DONE][--REASND: Used in - conjunction with --STAT when value is NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or hav a - value of NOT DONE][--REASND: Used in conjunction with --STAT - when value is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: - Used to indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered . Should - be null or hav a value of NOT DONE][--REASND: Used in - conjunction with --STAT when value is NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively - stated or detailed on the CRF.]|Events|[--OCCUR][An indication - as to whether a prespecified event has - occurred.]|Events[--STAT][Used to indicate when a question - about the occurrence of a prespecified event was not - answered.]|Interventions[--PRESP][An indication that the - intervention was prospectively stated or detailed on the - CRF.]|Interventions[--OCCUR][An indication as to whether a - prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a - question about the occurrence of a prespecified intervention - was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|STAT - Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation - Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0346 - Version: '1' - Version: '1.0' - Substandard: SDTM +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the + CRF. + Document: Model v2.0 + Item: --PRESP + Section: Events + - Cited Guidance: An indication as to whether a prespecified event has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Events + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + event was not answered. + Document: Model v2.0 + Item: STAT + Section: Events + - Cited Guidance: An indication that the intervention was prospectively stated or detailed on + the CRF. + Document: Model v2.0 + Item: --PRESP + Section: Interventions + - Cited Guidance: An indication as to whether a prespecified intervention has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Interventions + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + intervention was not answered. Should be null or have a value of "NOT DONE". + Document: Model v2.0 + Item: STAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 Version: '1.0' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value + is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe + by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information + about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question + about the occurrence of a pre-specified event was not answered . Should be null or hav a value + of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value + is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe + by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information + about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question + about the occurrence of a pre-specified event was not answered . Should be null or hav a value + of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF.]|Events|[--OCCUR][An indication as to whether a prespecified event + has occurred.]|Events[--STAT][Used to indicate when a question about the occurrence of a + prespecified event was not answered.]|Interventions[--PRESP][An indication that the + intervention was prospectively stated or detailed on the CRF.]|Interventions[--OCCUR][An + indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|STAT + Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0346 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --OCCUR - operator: empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --PRESP + operator: equal_to + value: Y + - name: --OCCUR + operator: empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000117 Status: Published Version: '1' -Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = - 'Y' and --OCCUR is null +Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is + null Executability: Fully Executable Outcome: Message: --STAT should equal 'NOT DONE' when --PRESP = 'Y' and --OCCUR = null Output Variables: - - --STAT - - --PRESP - - --OCCUR + - --STAT + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index 78443f33d..e921263a3 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -2,168 +2,148 @@ # Condition: --PRESP = 'Y' and --OCCUR = null # Rule: --STAT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or - detailed on the CRF - Document: SDTM v2.0 - Item: --PRESP - Section: Events - - Cited Guidance: An indication as to whether a prespecified event has occurred - Document: SDTM v2.0 - Item: --OCCUR - Section: Events - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Events - - Cited Guidance: An indication that the intervention was prospectively stated or - detailed on the CRF - Document: Model v2.0 - Item: --PRESP - Section: Interventions - - Cited Guidance: An indication as to whether a prespecified intervention has - occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Interventions - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified intervention was not answered. Should be null or - have a value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or have a - value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events; - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or have a value of NOT DONE]" - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a - specific intervention is pre-specified on a CRF. Values should - be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the - occurrence of a specific event is solicited.][--STAT: Used to - indicate when a question about the occurrence of a - pre-specified event was not answered. Should be null or have a - value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to - indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events; - null for spontaneously reported events.][--OCCUR: Used to - record whether a pre-specified event occurred when information - about the occurrence of a specific event is - solicited.][--STAT: Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should - be null or have a value of NOT DONE]" - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or - detailed on the CRF | An indication that the intervention was - prospectively stated or detailed on the CRF. - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - - Cited Guidance: An indication as to whether a prespecified event has occurred. | - An indication as to whether a prespecified intervention has - occurred - Document: SDTM v2.1 - Item: --OCCUR - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - - Cited Guidance: Used to indicate when a question about the occurrence of a - prespecified event was not answered. Should be null or have a - value of "NOT DONE" | Used to indicate when a question about - the occurrence of a prespecified intervention was not - answered. Should be null or have a value of "NOT DONE". - Document: SDTM v2.1 - Item: --STAT - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The - Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0562 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF + Document: SDTM v2.0 + Item: --PRESP + Section: Events + - Cited Guidance: An indication as to whether a prespecified event has occurred + Document: SDTM v2.0 + Item: --OCCUR + Section: Events + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Events + - Cited Guidance: An indication that the intervention was prospectively stated or detailed on + the CRF + Document: Model v2.0 + Item: --PRESP + Section: Interventions + - Cited Guidance: An indication as to whether a prespecified intervention has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Interventions + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + intervention was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF + | An indication that the intervention was prospectively stated or detailed on the CRF. + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: An indication as to whether a prespecified event has occurred. | An + indication as to whether a prespecified intervention has occurred + Document: SDTM v2.1 + Item: --OCCUR + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate + when a question about the occurrence of a prespecified intervention was not answered. + Should be null or have a value of "NOT DONE". + Document: SDTM v2.1 + Item: --STAT + Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0562 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --OCCUR - operator: empty - - name: --STAT - operator: not_exists + - name: --PRESP + operator: equal_to + value: Y + - name: --OCCUR + operator: empty + - name: --STAT + operator: not_exists Core: Id: CORE-000118 Status: Published Version: '1' -Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty - and --STAT is not present in dataset. +Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not + present in dataset. Executability: Fully Executable Outcome: - Message: --STAT is not present in dataset when --PRESP is equal to "Y" and - --OCCUR is blank + Message: --STAT is not present in dataset when --PRESP is equal to "Y" and --OCCUR is blank Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000119/rule.yml b/Published/CORE-000119/rule.yml index 754046a57..1d76bc25e 100644 --- a/Published/CORE-000119/rule.yml +++ b/Published/CORE-000119/rule.yml @@ -2,57 +2,57 @@ # Condition: ARMCD = null # Rule: ARM = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be - populated with the reason ARMCD is null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0521 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be - populated with the reason ARMCD is null. - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0521 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be - populated with the reason ARMCD is null. - Document: TIG 1.0 - Item: Assumption 4.a.ii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0616 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: IG v3.4 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0521 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: IG v3.3 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0521 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: TIG 1.0 + Item: Assumption 4.a.ii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0616 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: empty - - name: ARM - operator: non_empty + - name: ARMCD + operator: empty + - name: ARM + operator: non_empty Core: Id: CORE-000119 Status: Published @@ -62,15 +62,15 @@ Executability: Fully Executable Outcome: Message: ARM is populated, when ARMCD is NULL Output Variables: - - ARMCD - - ARM + - ARMCD + - ARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000120/rule.yml b/Published/CORE-000120/rule.yml index a6b36a9bc..8b36fd043 100644 --- a/Published/CORE-000120/rule.yml +++ b/Published/CORE-000120/rule.yml @@ -2,66 +2,59 @@ # Condition: ACTARMCD = null # Rule: ACTARM = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS - must be populated with the reason ACTARMCD is null. - - \ Both ARMCD and ACTARMCD will be null for - subjects who were not assigned to treatment.\ - - \ The same reason will provide the reason - that both are null.\"" - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0522 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be - populated with the reason ACTARMCD is null. - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0522 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be - populated with the reason ACTARMCD is null. Both ARMCD and - ACTARMCD will be null for subjects who were not assigned to an - arm. The same reason will provide the reason that both are - null. - Document: TIG 1.0 - Item: Assumption 4.a.ii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0617 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null.\n Both ARMCD and ACTARMCD will be null for subjects who were + not assigned to treatment. \n The same reason will provide the reason that both are null.\"" + Document: IG v3.4 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0522 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null. + Document: IG v3.3 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0522 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who + were not assigned to an arm. The same reason will provide the reason that both are null. + Document: TIG 1.0 + Item: Assumption 4.a.ii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0617 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARMCD - operator: empty - - name: ACTARM - operator: non_empty + - name: ACTARMCD + operator: empty + - name: ACTARM + operator: non_empty Core: Id: CORE-000120 Status: Published @@ -71,15 +64,15 @@ Executability: Fully Executable Outcome: Message: ACTARM is populated, when ACTARMCD is NULL Output Variables: - - ACTARMCD - - ACTARM + - ACTARMCD + - ACTARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000121/rule.yml b/Published/CORE-000121/rule.yml index a1c00324b..b613f5445 100644 --- a/Published/CORE-000121/rule.yml +++ b/Published/CORE-000121/rule.yml @@ -2,67 +2,62 @@ # Condition: ARMCD ^=null and ACTARMCD ^=null # Rule: ARMNRS = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"Specification [A coded reason that arm variables (ARM and - ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) are - null.] - - \ Assumption 4[ARMNRS may not be populated if both ARMCD and - ACTARMCD are populated]\"" - Document: IG v3.4 - Item: Specification|Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0520 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[A coded reason that arm variables (ARM and ARMCD) - and/or actual arm variables (ACTARM and ACTARMCD) are - null.]|Assumption 4[ARMNRS may not be populated if both ARMCD - and ACTARMCD are populated] - Document: IG v3.3 - Item: Specification|Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0520 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification ARMNRS [A coded reason that arm variables (ARM - and ARMCD) and/or actual arm variables (ACTARM and ACTARMCD) - are null.]|Assumption 4[ARMNRS may not be populated if both - ARMCD and ACTARMCD are populated] - Document: TIG 1.0 - Item: Specification|Assumption 4.a.iii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0615 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "\"Specification [A coded reason that arm variables (ARM and ARMCD) and/or actual + arm variables (ACTARM and ACTARMCD) are null.]\n Assumption 4[ARMNRS may not be populated if + both ARMCD and ACTARMCD are populated]\"" + Document: IG v3.4 + Item: Specification|Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0520 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[A coded reason that arm variables (ARM and ARMCD) and/or + actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not be + populated if both ARMCD and ACTARMCD are populated] + Document: IG v3.3 + Item: Specification|Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0520 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification ARMNRS [A coded reason that arm variables (ARM and ARMCD) + and/or actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not + be populated if both ARMCD and ACTARMCD are populated] + Document: TIG 1.0 + Item: Specification|Assumption 4.a.iii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0615 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: non_empty - - name: ACTARMCD - operator: non_empty - - name: ARMNRS - operator: non_empty + - name: ARMCD + operator: non_empty + - name: ACTARMCD + operator: non_empty + - name: ARMNRS + operator: non_empty Core: Id: CORE-000121 Status: Published @@ -70,19 +65,18 @@ Core: Description: Verify the value for ARMNRS, when both ARMCD and ACTARMCD values are populated Executability: Fully Executable Outcome: - Message: Value for ARMNRS is populated, when both ARMCD and ACTARMCD values are - populated + Message: Value for ARMNRS is populated, when both ARMCD and ACTARMCD values are populated Output Variables: - - ARMCD - - ACTARMCD - - ARMNRS + - ARMCD + - ACTARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000122/rule.yml b/Published/CORE-000122/rule.yml index f3ed80647..59a03c490 100644 --- a/Published/CORE-000122/rule.yml +++ b/Published/CORE-000122/rule.yml @@ -2,95 +2,94 @@ # Condition: AGEU ^= null and AGE = null # Rule: AGETXT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of AGE or AGETXT. - Document: Model v2.0 - Item: AGEU - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units associated with AGE or AGETXT. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units associated with AGE or AGETXT. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of AGE or AGETXT. - Document: SDTM v2.1 - Item: AGEU - Section: 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0586 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of AGE or AGETXT. + Document: Model v2.0 + Item: AGEU + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units associated with AGE or AGETXT. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units associated with AGE or AGETXT. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of AGE or AGETXT. + Document: SDTM v2.1 + Item: AGEU + Section: 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0586 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty - - name: AGETXT - operator: empty - - all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty - - name: AGETXT - operator: not_exists + - all: + - name: AGEU + operator: non_empty + - name: AGE + operator: empty + - name: AGETXT + operator: empty + - all: + - name: AGEU + operator: non_empty + - name: AGE + operator: empty + - name: AGETXT + operator: not_exists Core: Id: CORE-000122 Status: Published Version: '1' -Description: Raise an error when AGEU is completed but both AGETXT and AGE are - not completed. +Description: Raise an error when AGEU is completed but both AGETXT and AGE are not completed. Executability: Fully Executable Outcome: Message: AGEU is completed, but both AGE and AGETXT are not completed. Output Variables: - - AGE - - AGEU - - AGETXT + - AGE + - AGEU + - AGETXT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000123/rule.yml b/Published/CORE-000123/rule.yml index b13ad7be8..10bed53c8 100644 --- a/Published/CORE-000123/rule.yml +++ b/Published/CORE-000123/rule.yml @@ -2,71 +2,71 @@ # Condition: --SCAN ^= null # Rule: --SCAN in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SCAN - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SCAN - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was the event associated with the development of cancer? Valid - values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: SDTM v2.1 - Item: --SCAN - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0550 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SCAN + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SCAN + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Was the event associated with the development of cancer? Valid values are + 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: SDTM v2.1 + Item: --SCAN + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0550 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESCAN - operator: non_empty - - name: AESCAN - operator: is_not_contained_by - value: - - Y - - N + - name: AESCAN + operator: non_empty + - name: AESCAN + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000123 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESCAN is completed, but not equal to "N" or "Y" Output Variables: - - AESCAN + - AESCAN Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000124/rule.yml b/Published/CORE-000124/rule.yml index 36703a36a..974e84239 100644 --- a/Published/CORE-000124/rule.yml +++ b/Published/CORE-000124/rule.yml @@ -2,71 +2,71 @@ # Condition: --SCONG ^= null # Rule: --SCONG in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SCONG - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SCONG - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was the event associated with congenital anomaly or birth - defect? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SCONG - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0551 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SCONG + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SCONG + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Was the event associated with congenital anomaly or birth defect? Valid + values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SCONG + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0551 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESCONG - operator: non_empty - - name: AESCONG - operator: is_not_contained_by - value: - - Y - - N + - name: AESCONG + operator: non_empty + - name: AESCONG + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000124 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESCONG is completed, but not equal to "N" or "Y" Output Variables: - - AESCONG + - AESCONG Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000125/rule.yml b/Published/CORE-000125/rule.yml index bab5f2102..1fc2247f2 100644 --- a/Published/CORE-000125/rule.yml +++ b/Published/CORE-000125/rule.yml @@ -2,71 +2,71 @@ # Condition: --SDISAB ^= null # Rule: --SDISAB in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SDISAB - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SDISAB - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event result in persistent or significant - disability/incapacity? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SDISAB - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0552 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SDISAB + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SDISAB + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event result in persistent or significant disability/incapacity? + Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SDISAB + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0552 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESDISAB - operator: non_empty - - name: AESDISAB - operator: is_not_contained_by - value: - - Y - - N + - name: AESDISAB + operator: non_empty + - name: AESDISAB + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000125 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESDISAB is completed, but not equal to "N" or "Y" Output Variables: - - AESDISAB + - AESDISAB Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000126/rule.yml b/Published/CORE-000126/rule.yml index 8a60e362f..ce3e52760 100644 --- a/Published/CORE-000126/rule.yml +++ b/Published/CORE-000126/rule.yml @@ -2,70 +2,70 @@ # Condition: --SDTH ^= null # Rule: --SDTH in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SDTH - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SDTH - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event result in death? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SDTH - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0553 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SDTH + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SDTH + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event result in death? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SDTH + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0553 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESDTH - operator: non_empty - - name: AESDTH - operator: is_not_contained_by - value: - - Y - - N + - name: AESDTH + operator: non_empty + - name: AESDTH + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000126 Status: Published @@ -75,14 +75,14 @@ Executability: Fully Executable Outcome: Message: AESDTH is completed, but not equal to "N" or "Y" Output Variables: - - AESDTH + - AESDTH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000127/rule.yml b/Published/CORE-000127/rule.yml index 3492297f6..5419b72b6 100644 --- a/Published/CORE-000127/rule.yml +++ b/Published/CORE-000127/rule.yml @@ -2,71 +2,71 @@ # Condition: --SHOSP ^= null # Rule: --SHOSP in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SHOSP - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SHOSP - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event require or prolong hospitalization? Valid values - are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SHOSP - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0554 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SHOSP + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SHOSP + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event require or prolong hospitalization? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SHOSP + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0554 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESHOSP - operator: non_empty - - name: AESHOSP - operator: is_not_contained_by - value: - - Y - - N + - name: AESHOSP + operator: non_empty + - name: AESHOSP + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000127 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESHOSP is completed, but not equal to "N" or "Y" Output Variables: - - AESHOSP + - AESHOSP Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000128/rule.yml b/Published/CORE-000128/rule.yml index dbd56508a..ef131c84a 100644 --- a/Published/CORE-000128/rule.yml +++ b/Published/CORE-000128/rule.yml @@ -2,71 +2,71 @@ # Condition: --SLIFE ^= null # Rule: --SLIFE in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SLIFE - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SLIFE - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event require or prolong hospitalization? Valid values - are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SLIFE - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0555 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SLIFE + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SLIFE + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event require or prolong hospitalization? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SLIFE + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0555 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESLIFE - operator: non_empty - - name: AESLIFE - operator: is_not_contained_by - value: - - Y - - N + - name: AESLIFE + operator: non_empty + - name: AESLIFE + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000128 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESLIFE is completed, but not equal to "N" or "Y" Output Variables: - - AESLIFE + - AESLIFE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000129/rule.yml b/Published/CORE-000129/rule.yml index 0363bf1e3..714a2c511 100644 --- a/Published/CORE-000129/rule.yml +++ b/Published/CORE-000129/rule.yml @@ -2,71 +2,70 @@ # Condition: --SOD ^= null # Rule: --SOD in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SOD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SOD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and - 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SOD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0556 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SOD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SOD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SOD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0556 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESOD - operator: non_empty - - name: AESOD - operator: is_not_contained_by - value: - - Y - - N + - name: AESOD + operator: non_empty + - name: AESOD + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000129 Status: Published @@ -76,14 +75,14 @@ Executability: Fully Executable Outcome: Message: AESOD is completed, but not equal to "N" or "Y" Output Variables: - - AESOD + - AESOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000130/rule.yml b/Published/CORE-000130/rule.yml index 91cdc2c42..b5307e588 100644 --- a/Published/CORE-000130/rule.yml +++ b/Published/CORE-000130/rule.yml @@ -2,71 +2,71 @@ # Condition: --SMIE ^= null # Rule: --SMIE in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SMIE - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SMIE - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do additional categories for seriousness apply? Valid values are - 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SMIE - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0557 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SMIE + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SMIE + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Do additional categories for seriousness apply? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SMIE + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0557 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESMIE - operator: non_empty - - name: AESMIE - operator: is_not_contained_by - value: - - Y - - N + - name: AESMIE + operator: non_empty + - name: AESMIE + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000130 Status: Published @@ -76,14 +76,14 @@ Executability: Fully Executable Outcome: Message: AESMIE is completed, but not equal to "N" or "Y" Output Variables: - - AESMIE + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000131/rule.yml b/Published/CORE-000131/rule.yml index 5cfcf9875..b2033fc9b 100644 --- a/Published/CORE-000131/rule.yml +++ b/Published/CORE-000131/rule.yml @@ -2,72 +2,72 @@ # Condition: --CONTRT ^= null # Rule: --CONTRT in ('Y','N') Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --CONTRT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was another treatment given because of the occurrence of the - event? Valid values are "Y", "N", and null. - Document: Model v1.7 - Item: --CONTRT - Section: 2.2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was another treatment given because of the occurrence of the - event? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --CONTRT - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0558 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --CONTRT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Was another treatment given because of the occurrence of the event? Valid + values are "Y", "N", and null. + Document: Model v1.7 + Item: --CONTRT + Section: 2.2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Was another treatment given because of the occurrence of the event? Valid + values are 'Y' and 'N'. + Document: Model v1.4 + Item: '' + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --CONTRT + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0558 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AECONTRT - operator: non_empty - - name: AECONTRT - operator: is_not_contained_by - value: - - Y - - N + - name: AECONTRT + operator: non_empty + - name: AECONTRT + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000131 Status: Published @@ -77,14 +77,14 @@ Executability: Fully Executable Outcome: Message: AECONTRT is completed, but not equal to "N" or "Y" Output Variables: - - AECONTRT + - AECONTRT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000132/rule.yml b/Published/CORE-000132/rule.yml index 4ab241785..ca0eab16a 100644 --- a/Published/CORE-000132/rule.yml +++ b/Published/CORE-000132/rule.yml @@ -2,305 +2,289 @@ # Condition: ELEMENT present in dataset and ETCD present in dataset # Rule: ELEMENT and ETCD have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and - does not have special character restrictions. - Document: IG v3.4 - Item: Specification - Section: 5.3|7.2.1|7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and - does not have special character restrictions. - Document: IG v3.2 - Item: Specification - Section: 5|7.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and - does not have special character restrictions. - Document: IG v3.3 - Item: Specification - Section: 5.2|7.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.0 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.4 + Item: Specification + Section: 5.3|7.2.1|7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.2 + Item: Specification + Section: 5|7.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.3 + Item: Specification + Section: 5.2|7.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.0 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: '1' + Version: '5.0' + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: + - name: ETCD + operator: exists + - name: ELEMENT + operator: exists + - any: - name: ETCD - operator: exists + operator: is_not_unique_relationship + value: ELEMENT - name: ELEMENT - operator: exists - - any: - - name: ETCD - operator: is_not_unique_relationship - value: ELEMENT - - name: ELEMENT - operator: is_not_unique_relationship - value: ETCD + operator: is_not_unique_relationship + value: ETCD Core: Id: CORE-000132 Status: Published @@ -310,16 +294,16 @@ Executability: Fully Executable Outcome: Message: ETCD and ELEMENT do not have a one-to-one relationship. Output Variables: - - ETCD - - ELEMENT + - ETCD + - ELEMENT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE - - TA - - SE + - TE + - TA + - SE Sensitivity: Record diff --git a/Published/CORE-000133/rule.yml b/Published/CORE-000133/rule.yml index be8224842..7417f23e8 100644 --- a/Published/CORE-000133/rule.yml +++ b/Published/CORE-000133/rule.yml @@ -1,79 +1,76 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unit of measure for the standardized result of the - measurement, test, or examination. Variable(s) Qualified, - --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC - and --STREFN and --LLOQ and --ULOQ. - Document: Model v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC, --STRESN, - --STREFC, and --STREFN. Example: "mol/L".' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The unit of measure for the standardized result of the - measurement, test, or examination. Variable(s) Qualified: - --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC - and --STREFN and --LLOQ and --ULOQ.' - Document: SDTM v2.1 - Item: --STRESU - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0580 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified, --STRESC and --STRESN and --STNRLO and --STNRHI and + --STREFC and --STREFN and --LLOQ and --ULOQ. + Document: Model v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESU: Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. + Example: "mol/L".' + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC + and --STREFN and --LLOQ and --ULOQ.' + Document: SDTM v2.1 + Item: --STRESU + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0580 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --STRESC # Condition: --STRESU ^= null # Rule: --STRESC (in standard units) ^= null Check: all: - - name: --STRESU - operator: non_empty - - name: --STRESC - operator: empty + - name: --STRESU + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000133 Status: Published Version: '1' -Description: When --STRESU is populated, --STRESC must also be populated. Please - note that this rule, as executed, cannot check if --STRESC is populated with - the standardized unit. +Description: When --STRESU is populated, --STRESC must also be populated. Please note that this + rule, as executed, cannot check if --STRESC is populated with the standardized unit. Executability: Fully Executable Outcome: Message: Missing value for --STRESC, when --STRESU is provided @@ -81,9 +78,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000134/rule.yml b/Published/CORE-000134/rule.yml index 84993b4e0..0cc7e290f 100644 --- a/Published/CORE-000134/rule.yml +++ b/Published/CORE-000134/rule.yml @@ -2,90 +2,81 @@ # Condition: RDOMAIN ^= 'DM' # Rule: IDVAR ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN, - USUBJID, and IDVAR/IDVARVAL variables. An exception is SUPP-- - dataset records that are related to Demographics (DM) - records, where both IDVAR and IDVARVAL will be null because - the key variables STUDYID, RDOMAIN, and USUBJID are sufficient - to identify the unique parent record in DM (DM has one record - per USUBJID) - Document: SDTMIG v3.4 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN,and - IDVAR/IDVARVAL variables. An exception is SUPP-- dataset - records that are related to Demographics (DM) records, such as - the Intent To Treat (ITT) and Safety (SAFETY) subject-level - population flags, where both IDVAR and IDVARVAL will be null - because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has - one record per USUBJID). - Document: SDTMIG v3.3 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN,and - IDVAR/IDVARVAL variables. An exception is SUPP-- dataset - records that are related to Demographics (DM) records, such as - the Intent To Treat (ITT) and Safety (SAFETY) subject-level - population flags, where both IDVAR and IDVARVAL will be null - because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has - one record per USUBJID). - Document: SDTMIG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with - the exception of SUPPDM. IDVAR and IDVARVAL will not be - populated in SUPPDM. - Document: TIG 1.0 - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0423 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An + exception is SUPP-- dataset records that are related to Demographics (DM) records, where + both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and + USUBJID are sufficient to identify the unique parent record in DM (DM has one record per + USUBJID) + Document: SDTMIG v3.4 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.3 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM. + Document: TIG 1.0 + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0423 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: IDVAR - operator: empty + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: IDVAR + operator: empty Core: Id: CORE-000134 Status: Published @@ -95,17 +86,17 @@ Executability: Fully Executable Outcome: Message: RDOMAIN is not 'DM' but IDVAR is empty. Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL - - QNAM + - RDOMAIN + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000135/rule.yml b/Published/CORE-000135/rule.yml index 0415cfb5b..edea9f288 100644 --- a/Published/CORE-000135/rule.yml +++ b/Published/CORE-000135/rule.yml @@ -2,87 +2,79 @@ # Condition: IDVAR ^= null # Rule: IDVARVAL ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN, - USUBJID, and IDVAR/IDVARVAL variables. An exception is SUPP-- - dataset records that are related to Demographics (DM) - records, where both IDVAR and IDVARVAL will be null because - the key variables STUDYID, RDOMAIN, and USUBJID are sufficient - to identify the unique parent record in DM (DM has one record - per USUBJID) - Document: SDTMIG v3.4 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN, and - IDVAR/IDVARVAL variables. An exception is SUPP-- dataset - records that are related to Demographics (DM) records, such as - the Intent To Treat (ITT) and Safety (SAFETY) subject-level - population flags, where both IDVAR and IDVARVAL will be null - because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has - one record per USUBJID). - Document: SDTMIG v3.3 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent - record(s) via the key identified by the STUDYID, RDOMAIN, and - IDVAR/IDVARVAL variables. An exception is SUPP-- dataset - records that are related to Demographics (DM) records, such as - the Intent To Treat (ITT) and Safety (SAFETY) subject-level - population flags, where both IDVAR and IDVARVAL will be null - because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has - one record per USUBJID). - Document: SDTMIG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with - the exception of SUPPDM. - Document: TIG 1.0 - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0424 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An + exception is SUPP-- dataset records that are related to Demographics (DM) records, where + both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and + USUBJID are sufficient to identify the unique parent record in DM (DM has one record per + USUBJID) + Document: SDTMIG v3.4 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.3 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + exception of SUPPDM. + Document: TIG 1.0 + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0424 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVAR - operator: non_empty - - name: IDVARVAL - operator: empty + - name: IDVAR + operator: non_empty + - name: IDVARVAL + operator: empty Core: Id: CORE-000135 Status: Published @@ -92,16 +84,16 @@ Executability: Fully Executable Outcome: Message: IDVAR is not empty but IDVARVAL is empty. Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000136/rule.yml b/Published/CORE-000136/rule.yml index 9769ec3b7..1925cd4ee 100644 --- a/Published/CORE-000136/rule.yml +++ b/Published/CORE-000136/rule.yml @@ -2,85 +2,79 @@ # Condition: IDVARVAL = null and USUBJID = null # Rule: IDVAR ^= --SEQ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent - related information that is submitted as two datasets that - have a one-to-many relationship. in the example below all the - records in one domain are being related to all of the records - in the other, so both USUBJID and IDVARVAL are null.... Since - IDVAR identifies the keys that can be used to - merge/join records between the datasets, --SEQ cannot be used - because --SEQ only has meaning within a subject within a - dataset, not across datasets. - Document: IG v3.4 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent - related information that is submitted as two datasets that - have a one-to-many relationship. in the example below all the - records in one domain are being related to all of the records - in the other, so both USUBJID and IDVARVAL are null. - Document: IG v3.3 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent - related information that is submitted as two datasets that - have a one-to-many relationship. in the example below all the - records in one domain are being related to all of the records - in the other, so both USUBJID and IDVARVAL are null. - Document: IG v3.2 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Relationships between datasets are specified using the key - variables STUDYID, RDOMAIN, and IDVAR only. The values of - variables USUBJID and IDVARVAL will be null as relationships - between specific subject records will not be identified. - Document: TIG 1.0 - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0422 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in + the other, so both USUBJID and IDVARVAL are null.... Since IDVAR identifies the keys that + can be used to merge/join records between the datasets, --SEQ cannot be used because + --SEQ only has meaning within a subject within a dataset, not across datasets. + Document: IG v3.4 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in the + other, so both USUBJID and IDVARVAL are null. + Document: IG v3.3 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in the + other, so both USUBJID and IDVARVAL are null. + Document: IG v3.2 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Relationships between datasets are specified using the key variables + STUDYID, RDOMAIN, and IDVAR only. The values of variables USUBJID and IDVARVAL will be + null as relationships between specific subject records will not be identified. + Document: TIG 1.0 + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0422 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVARVAL - operator: empty - - name: USUBJID - operator: empty - - name: IDVAR - operator: ends_with - value: SEQ + - name: IDVARVAL + operator: empty + - name: USUBJID + operator: empty + - name: IDVAR + operator: ends_with + value: SEQ Core: Id: CORE-000136 Status: Published @@ -90,17 +84,17 @@ Executability: Fully Executable Outcome: Message: IDVARVAL and USUBJID are not completed, but IDVAR equals Sequence Number. Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL - - RELID + - RDOMAIN + - IDVAR + - IDVARVAL + - RELID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000137/rule.yml b/Published/CORE-000137/rule.yml index 2e1f60916..664feb533 100644 --- a/Published/CORE-000137/rule.yml +++ b/Published/CORE-000137/rule.yml @@ -2,186 +2,172 @@ # Condition: ECOCCUR ^= 'N' and ECSTAT = null and ECDOSTXT = null # Rule: ECDOSE > 0 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard - representation of the collected doses not taken, not given, or - missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating - doses not taken, not given, or missed. - Document: IG v3.4 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases - where the sponsor feels it is necessary and/or appropriate to - represent specific dose amounts not taken, not given, or - missed. - Document: IG v3.4 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard - representation of the collected doses not taken, not given, or - missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating - doses not taken, not given, or missed. - Document: IG v3.3 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases - where the sponsor feels it is necessary and/or appropriate to - represent specific dose amounts not taken, not given, or - missed. - Document: IG v3.3 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard - representation of the collected doses not taken, not given, or - missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating - doses not taken, not given, or missed. - Document: IG v3.2 - Item: Assumption 4a - Section: 6.1. - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases - where the sponsor feels it is necessary and/or appropriate to - represent specific dose amounts not taken, not given, or - missed. - Document: IG v3.2 - Item: Assumption 4b - Section: 6.1. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or missed.] - Document: TIG 1.0 - Item: Assumption 4a - Section: 2.8.10.11 - - Cited Guidance: Assumption 4b[Qualifiers that indicate dose amount (e.g., - ECDOSE, ECDOSTXT) may be populated with positive (non-zero) - values in cases where the sponsor feels it is necessary and/or - appropriate to represent specific dose amounts not taken, not - given, or missed.] - Document: TIG 1.0 - Item: Assumption 4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0365 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.3 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.3 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.2 + Item: Assumption 4a + Section: 6.1. + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.2 + Item: Assumption 4b + Section: 6.1. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.] + Document: TIG 1.0 + Item: Assumption 4a + Section: 2.8.10.11 + - Cited Guidance: Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: TIG 1.0 + Item: Assumption 4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0365 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: not_exists - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: not_exists - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: not_exists + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: not_exists + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 Core: Id: CORE-000137 Status: Published Version: '1' -Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and - ECDOSTXT are both empty but ECDOSE less than or equal to 0. +Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but + ECDOSE less than or equal to 0. Executability: Fully Executable Outcome: - Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is - less than or equal to 0. + Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal + to 0. Output Variables: - - ECOCCUR - - ECSTAT - - ECDOSTXT - - ECDOSE - - ECSTDTC + - ECOCCUR + - ECSTAT + - ECDOSTXT + - ECDOSE + - ECSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000138/rule.yml b/Published/CORE-000138/rule.yml index 1dfce1da1..13e2e0cef 100644 --- a/Published/CORE-000138/rule.yml +++ b/Published/CORE-000138/rule.yml @@ -2,140 +2,125 @@ # Condition: --STDTC or DM.RFSTDTC does not contain complete values in their date portion # Rule: --STDY = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics domain). - Document: IG v3.4 - Section: 4.4.4 - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 - if --DTC is on or after RFSTDTC, --DY = (date portion of - --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. - This algorithm should be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0435 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: IG v3.4 + Section: 4.4.4 + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, + --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This + algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.' + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0435 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: --STDTC - operator: is_incomplete_date - - name: --STDY - operator: non_empty - - all: - - name: RFSTDTC - operator: is_incomplete_date - - name: --STDY - operator: non_empty + - all: + - name: --STDTC + operator: is_incomplete_date + - name: --STDY + operator: non_empty + - all: + - name: RFSTDTC + operator: is_incomplete_date + - name: --STDY + operator: non_empty Core: Id: CORE-000138 Status: Published Version: '1' -Description: If --STDTC or DM.RFSTDTC does not contain a complete values, --STDY - must be null. +Description: If --STDTC or DM.RFSTDTC does not contain a complete values, --STDY must be null. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain - complete values in their date portion + Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in + their date portion Output Variables: - - --STDY - - --STDTC - - RFSTDTC + - --STDY + - --STDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000139/rule.yml b/Published/CORE-000139/rule.yml index 08b65df78..0f9e94b04 100644 --- a/Published/CORE-000139/rule.yml +++ b/Published/CORE-000139/rule.yml @@ -2,139 +2,123 @@ # Condition: --ENDTC or DM.RFSTDTC does not contain complete values in their date portion # Rule: --ENDY = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics domain). - All Study Day values are integers. Thus, to calculate Study - Day, --DY = (date portion of --DTC) - (date portion of - RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day, --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day, --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0437 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate Study + Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or + after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.' + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0437 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: --ENDTC - operator: is_incomplete_date - - name: --ENDY - operator: non_empty - - all: - - name: RFSTDTC - operator: is_incomplete_date - - name: --ENDY - operator: non_empty + - all: + - name: --ENDTC + operator: is_incomplete_date + - name: --ENDY + operator: non_empty + - all: + - name: RFSTDTC + operator: is_incomplete_date + - name: --ENDY + operator: non_empty Core: Id: CORE-000139 Status: Published Version: '1' -Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete - values in their date portion, and --ENDY is not null. +Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date + portion, and --ENDY is not null. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain - complete values in their date portion + Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in + their date portion Output Variables: - - --ENDTC - - RFSTDTC - - --ENDY + - --ENDTC + - RFSTDTC + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000140/rule.yml b/Published/CORE-000140/rule.yml index 662dda643..5f27cfcaf 100644 --- a/Published/CORE-000140/rule.yml +++ b/Published/CORE-000140/rule.yml @@ -2,77 +2,73 @@ # Condition: VISITNUM is NOT in TV.VISITNUM # Rule: VISITDY = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since - VISITDY is, by definition, the planned study day of visit, and - since the actual study day of an unplanned visit belongs in a - --DY variable. - Document: IG v3.4 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since - VISITDY is, by definition, the planned study day of visit, and - since the actual study day of an unplanned visit belongs in a - --DY variable. - Document: IG v3.3 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since - VISITDY is, by definition, the planned study day of visit, and - since the actual study day of an unplanned visit belongs in a - --DY variable. - Document: IG v3.2 - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since - VISITDY is, by definition, the planned study day of visit, and - since the actual study day of an unplanned visit belongs in a - --DY variable. - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0438 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.4 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.3 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.2 + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0438 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: VISITNUM - operator: is_not_contained_by - value: $tv_visitnum - - name: VISITDY - operator: non_empty + - name: VISITNUM + operator: is_not_contained_by + value: $tv_visitnum + - name: VISITDY + operator: non_empty Core: Id: CORE-000140 Status: Published @@ -80,22 +76,22 @@ Core: Description: Trigger error if VISITDY is populated when VISITNUM is not in TV. Executability: Fully Executable Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITDY is not null when VISITNUM is not in TV.VISITNUM Output Variables: - - VISITNUM - - VISITDY + - VISITNUM + - VISITDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000141/rule.yml b/Published/CORE-000141/rule.yml index adcfac4eb..765ed4877 100644 --- a/Published/CORE-000141/rule.yml +++ b/Published/CORE-000141/rule.yml @@ -2,156 +2,146 @@ # Condition: VISITNUM and --TPTREF are not present in dataset # Rule: --TPT and --TPTNUM have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - which may include domain, visit, and reference time point, - there must be a one-to-relationship between values of --TPT - and --TPTNUM. in other words, if domain, visit, and reference - time point uniquely identify subject data, then if two - subjects have records with the same values of DOMAIN, - VISITNUM, --TPTREF, and --TPTNUM, then these records may not - have different time point descriptions in --TPT. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. - There will be a one-to-one relationship between the values of - --TPT and --TPTNUM. - Document: TIG 1.0 - Item: Sub Section Planned Timing Num 5 - Section: '2.8.7.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0448 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. There will be + a one-to-one relationship between the values of --TPT and --TPTNUM. + Document: TIG 1.0 + Item: Sub Section Planned Timing Num 5 + Section: '2.8.7.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0448 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: VISITNUM - operator: not_exists - - name: --TPTREF - operator: not_exists - - name: --TPT - operator: is_not_unique_relationship - value: --TPTNUM + - name: VISITNUM + operator: not_exists + - name: --TPTREF + operator: not_exists + - name: --TPT + operator: is_not_unique_relationship + value: --TPTNUM Core: Id: CORE-000141 Status: Published Version: '1' -Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM - should have a one-to-one relationship. +Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one + relationship. Executability: Fully Executable Outcome: Message: --TPT and --TPTNUM do not have a one-to-one relationship. Output Variables: - - --TPT - - --TPTNUM + - --TPT + - --TPTNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000142/rule.yml b/Published/CORE-000142/rule.yml index fde217498..0ffbb4432 100644 --- a/Published/CORE-000142/rule.yml +++ b/Published/CORE-000142/rule.yml @@ -2,132 +2,120 @@ # Condition: --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null # Rule: --ELTM is the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - there is likely to be a one-to-one relationship between most - values of --TPT and --ELTM. However, since --ELTM can only be - populated with ISO 8601 periods of time (as described in - Section 4.4.3, Intervals of Time and Use of Duration for --DUR - Variables), --ELTM may not be populated for all time points. - For example, --ELTM is likely to be null for time points - described by text such as 'pre-dose' or 'before breakfast.' - When --ELTM is populated, if two subjects have records with - the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, - then these records may not have different values in --ELTM. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - there is likely to be a one-to-one relationship between most - values of --TPT and --ELTM. However, since --ELTM can only be - populated with ISO 8601 periods of time (as described in - Section 4.1.4.3, Intervals of Time and Use of Duration for - --DUR Variables), --ELTM may not be populated for all time - points. For example, --ELTM is likely to be null for time - points described by text such as 'pre-dose' or 'before - breakfast.' When --ELTM is populated, if two subjects have - records with the same values of DOMAIN, VISITNUM, --TPTREF, - and --TPTNUM, then these records may not have different values - in --ELTM. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, - there is likely to be a one-to-one relationship between most - values of --TPT and --ELTM. However, since --ELTM can only be - populated with ISO 8601 periods of time (as described in - Section 4.1.4.3, Intervals of Time and Use of Duration for - --DUR Variables), --ELTM may not be populated for all time - points. For example, --ELTM is likely to be null for time - points described by text such as 'pre-dose' or 'before - breakfast.' When --ELTM is populated, if two subjects have - records with the same values of DOMAIN, VISITNUM, --TPTREF, - and --TPTNUM, then these records may not have different values - in --ELTM. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Represents the planned elapsed time from the fixed timepoint - reference to the planned observation. The value of this - variable is usually also reflected in the value of variable - --TPT. - Document: TIG 1.0 - Item: Sub Section Timing Relative to Reference Points Num 3 - Section: '2.8.7.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0449 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section 4.4.3, + Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be populated + for all time points. For example, --ELTM is likely to be null for time points described by + text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if two subjects + have records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these + records may not have different values in --ELTM. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section + 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be + populated for all time points. For example, --ELTM is likely to be null for time points + described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different values in --ELTM. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section + 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be + populated for all time points. For example, --ELTM is likely to be null for time points + described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different values in --ELTM. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Represents the planned elapsed time from the fixed timepoint reference to + the planned observation. The value of this variable is usually also reflected in the value + of variable --TPT. + Document: TIG 1.0 + Item: Sub Section Timing Relative to Reference Points Num 3 + Section: '2.8.7.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0449 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: non_empty - - name: --ELTM - operator: non_empty - - name: --ELTM - operator: is_inconsistent_across_dataset - value: - - DOMAIN - - VISITNUM - - --TPTREF - - --TPTNUM + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: non_empty + - name: --ELTM + operator: non_empty + - name: --ELTM + operator: is_inconsistent_across_dataset + value: + - DOMAIN + - VISITNUM + - --TPTREF + - --TPTNUM Core: Id: CORE-000142 Status: Published Version: '1' -Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM - ^= null and --ELTM does not have the same value across records with the same - values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. +Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM + does not have the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, + and --TPTNUM. Executability: Fully Executable Outcome: - Message: --ELTM is not the same value across records with the same values of - DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. + Message: --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM, + --TPTREF, and --TPTNUM. Output Variables: - - --TPT - - --TPTNUM - - --ELTM - - VISITNUM - - DOMAIN + - --TPT + - --TPTNUM + - --ELTM + - VISITNUM + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000143/rule.yml b/Published/CORE-000143/rule.yml index e94daaa12..262b0e0bd 100644 --- a/Published/CORE-000143/rule.yml +++ b/Published/CORE-000143/rule.yml @@ -2,190 +2,183 @@ # Condition: # Rule: ETCD value length <= 8 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: '5.3' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.3 - Item: Specification - Section: '5.2' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.3 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.2 - Item: Specification - Section: '5' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and - does not have special character restrictions. These values - should be short for ease of use in programming, but it is not - expected that ETCD will need to serve as a variable name. - Document: TIG 1.0 - Item: Specification:ECTD - Section: 2.8.10.24|2.8.10.29|2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0450 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters, but - do not have special character restrictions. - Document: TIG v1.0 - Item: SE CDISC Notes - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0165 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: '5.3' + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.3 + Item: Specification + Section: '5.2' + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.3 + Item: Specification + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.2 + Item: Specification + Section: '5' + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.2 + Item: Specification + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. These values should be short for ease of use in + programming, but it is not expected that ETCD will need to serve as a variable name. + Document: TIG 1.0 + Item: Specification:ECTD + Section: 2.8.10.24|2.8.10.29|2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0450 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters, but do not have + special character restrictions. + Document: TIG v1.0 + Item: SE CDISC Notes + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0165 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: ETCD - operator: longer_than - value: 8 + - name: ETCD + operator: longer_than + value: 8 Core: Id: CORE-000143 Status: Published @@ -195,17 +188,17 @@ Executability: Fully Executable Outcome: Message: ETCD value is greater than 8 Output Variables: - - ETCD + - ETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - TA - - TE - - SE + - TA + - TE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000144/rule.yml b/Published/CORE-000144/rule.yml index 5e9cb3b2f..60efb0603 100644 --- a/Published/CORE-000144/rule.yml +++ b/Published/CORE-000144/rule.yml @@ -2,67 +2,67 @@ # Condition: # Rule: TAETORD is unique within an ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.3 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: TIG 1.0 - Item: Specification;TAETORD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0451 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.3 + Item: Specification + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.2 + Item: Specification + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: TIG 1.0 + Item: Specification;TAETORD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0451 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TAETORD - operator: is_not_unique_set - value: - - ARM + - name: TAETORD + operator: is_not_unique_set + value: + - ARM Core: Id: CORE-000144 Status: Published @@ -72,15 +72,15 @@ Executability: Fully Executable Outcome: Message: TAETORD is not unique within ARM Output Variables: - - TAETORD - - ARM + - TAETORD + - ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000147/rule.yml b/Published/CORE-000147/rule.yml index 997f532f1..d789a03d1 100644 --- a/Published/CORE-000147/rule.yml +++ b/Published/CORE-000147/rule.yml @@ -1,181 +1,175 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters - and does not have special character restrictions. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters - and does not have special character restrictions. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters - and does not have special character restrictions. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a - specific Trial Set), and TSPARMCD (the companion to TSPARM) - are limited to 8 characters, but do not have special character - restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD. Value must be 8 characters or less. - Document: TIG v1.0 - Item: TSPARMCD CDISC Notes - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0178 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters - and does not have special character restrictions. - Document: TIG 1.0 - Item: Specification:TSPARMCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0461 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: TSPARMCD. Value must be 8 characters or less. + Document: TIG v1.0 + Item: TSPARMCD CDISC Notes + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0178 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: TIG 1.0 + Item: Specification:TSPARMCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0461 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: TSPARMCD # Condition: # Rule: TSPARMCD value length <= 8 Check: all: - - name: TSPARMCD - operator: longer_than - value: 8 + - name: TSPARMCD + operator: longer_than + value: 8 Core: Id: CORE-000147 Status: Published @@ -185,15 +179,15 @@ Executability: Fully Executable Outcome: Message: Length of TSPARMCD is greater than 8 Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000148/rule.yml b/Published/CORE-000148/rule.yml index 33de930f3..3b332922a 100644 --- a/Published/CORE-000148/rule.yml +++ b/Published/CORE-000148/rule.yml @@ -1,67 +1,67 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: TIG 1.0 - Item: Specification:TSPARM - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0462 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: TIG 1.0 + Item: Specification:TSPARM + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0462 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: TSPARM # Condition: # Rule: TSPARM value length <= 40 Check: all: - - name: TSPARM - operator: longer_than - value: 40 + - name: TSPARM + operator: longer_than + value: 40 Core: Id: CORE-000148 Status: Published @@ -71,15 +71,15 @@ Executability: Fully Executable Outcome: Message: Length of TSPARM is greater than 40 Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000151/rule.yml b/Published/CORE-000151/rule.yml index 5a3c2f4fa..07dfdfb15 100644 --- a/Published/CORE-000151/rule.yml +++ b/Published/CORE-000151/rule.yml @@ -2,147 +2,138 @@ # Condition: TSVAL1 ^= null # Rule: TSVAL ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns - TSVAL1-TSVALn. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns - TSVAL1-TSVALn. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns - TSVAL1-TSVALn. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: '1' + Version: '2.0' + Version: '3.3' # Extended for SEND rule SEND281 by Jozef - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.0 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple - variables (TSVAL-TSVALn), in order to accommodate values - longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.0 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: TSVAL1 - operator: non_empty - - name: TSVAL - operator: empty + - name: TSVAL1 + operator: non_empty + - name: TSVAL + operator: empty Core: Id: CORE-000151 Status: Published @@ -155,8 +146,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000152/rule.yml b/Published/CORE-000152/rule.yml index 0ac963d43..0d63168fe 100644 --- a/Published/CORE-000152/rule.yml +++ b/Published/CORE-000152/rule.yml @@ -2,89 +2,89 @@ # Condition: TSVAL ^= null and TSVALCD ^= null # Rule: TSVALCD and TSVAL have a one-to-one relationship. Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: TIG 1.0 - Item: Specification:TSVALCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0467 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: TIG 1.0 + Item: Specification:TSVALCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0467 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TSVAL - operator: non_empty - - name: TSVALCD - operator: non_empty - - name: TSVAL - operator: is_not_unique_relationship - value: TSVALCD + - name: TSVAL + operator: non_empty + - name: TSVALCD + operator: non_empty + - name: TSVAL + operator: is_not_unique_relationship + value: TSVALCD Core: Id: CORE-000152 Status: Published Version: '1' -Description: When TSVAL and TSVALCD are populated, there must be a one-to-one - relationship between TSVALCD and TSVAL +Description: When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between + TSVALCD and TSVAL Executability: Fully Executable Outcome: Message: There is not a one-to-one relationship between TSVAL and TSVALCD Output Variables: - - TSVAL - - TSVALCD + - TSVAL + - TSVALCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000154/rule.yml b/Published/CORE-000154/rule.yml index 45b125b9f..dde08a808 100644 --- a/Published/CORE-000154/rule.yml +++ b/Published/CORE-000154/rule.yml @@ -2,193 +2,178 @@ # Condition: TSPARMCD not unique # Rule: TSSEQ is unique for each distinct value of TSPARMCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. - Allows inclusion of multiple records for the same TSPARMCD. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSSEQ has a different value for each record for the same - parameter. - Document: IG v3.2 - Item: Assumption 5 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSSEQ has a different value for each record for the same - parameter. - Document: IG v3.3 - Item: Assumption 5 - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.0 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and - is Required to identify each record as unique in cases where - the same TSPARMCD is used within the dataset. The TSSEQ - variable must be populated for all records within the TS - dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is required to identify each record as - unique, in cases where the same TSPARMCD is used within the - dataset. The TSSEQ variable must be populated for all records - within the TS dataset.' - Document: TIG v1.0 - Item: Assumption 7 - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0167 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. - Allows inclusion of multiple records for the same TSPARMCD. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0470 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows + inclusion of multiple records for the same TSPARMCD. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSSEQ has a different value for each record for the same parameter. + Document: IG v3.2 + Item: Assumption 5 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSSEQ has a different value for each record for the same parameter. + Document: IG v3.3 + Item: Assumption 5 + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.0 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.1 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.1.1 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.1 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.1.1 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset.' + Document: IG v3.1.1 + Item: Assumption 7 + Section: '7.6.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The TSSEQ variable is required to identify each record as unique, in cases where + the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records + within the TS dataset.' + Document: TIG v1.0 + Item: Assumption 7 + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0167 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows + inclusion of multiple records for the same TSPARMCD. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0470 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN - - name: TSSEQ - operator: is_not_unique_set - value: TSPARMCD + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN + - name: TSSEQ + operator: is_not_unique_set + value: TSPARMCD Core: Id: CORE-000154 Status: Published @@ -198,15 +183,15 @@ Executability: Fully Executable Outcome: Message: TSSEQ is not unique within TSPARMCD Output Variables: - - TSSEQ - - TSPARMCD + - TSSEQ + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000155/rule.yml b/Published/CORE-000155/rule.yml index 549d56e0a..83d4d76bd 100644 --- a/Published/CORE-000155/rule.yml +++ b/Published/CORE-000155/rule.yml @@ -2,72 +2,72 @@ # Condition: ARMCD ^= null # Rule: ARMCD in TA.ARMCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which - ARM a subject is in, then ARMCD should be null. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which - ARM a subject is in, then ARMCD should be null. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which - ARM a subject is in, then ARMCD should be null. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which - ARM a subject is in, then ARMCD should be null. - Document: TIG 1.0 - Item: Specification ARMCD - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0475 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: TIG 1.0 + Item: Specification ARMCD + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0475 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000155 Status: Published @@ -75,21 +75,21 @@ Core: Description: Trigger error when ARMCD is populated and ARMCD is not in TA.ARMCD Executability: Fully Executable Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not in TA.ARMCD Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000156/rule.yml b/Published/CORE-000156/rule.yml index 39e1965e1..9533a3a67 100644 --- a/Published/CORE-000156/rule.yml +++ b/Published/CORE-000156/rule.yml @@ -2,76 +2,73 @@ # Condition: ARM ^= null # Rule: ARM in TA.ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of - visits for a trial does not depend on which Arm a subject is - in, then Arm should be left blank. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of - Visits for a trial does not depend on which Arm a subject is - in, then Arm should be left blank. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of - Visits for a trial does not depend on which Arm a subject is - in, then Arm should be left blank. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Product Exposure Group. 2. If the - timing of Visits for a trial does not depend on which Arm a - subject is in, then Arm should be left blank. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0476 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 1. Name given to an Arm or Product Exposure Group. 2. If the timing of + Visits for a trial does not depend on which Arm a subject is in, then Arm should be left + blank. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0476 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000156 Status: Published @@ -79,19 +76,19 @@ Core: Description: Trigger error when ARM is populated and ARM is not in TA.ARM Executability: Fully Executable Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARM is not in TA.ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000157/rule.yml b/Published/CORE-000157/rule.yml index 1aa7b075e..8fd16cfca 100644 --- a/Published/CORE-000157/rule.yml +++ b/Published/CORE-000157/rule.yml @@ -2,70 +2,70 @@ # Condition: # Rule: ARMCD value length <= 20 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special - character restrictions. - Document: TIG 1.0 - Item: Specification:ARMCD - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0479 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: TIG 1.0 + Item: Specification:ARMCD + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0479 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: longer_than - value: 20 + - name: ARMCD + operator: longer_than + value: 20 Core: Id: CORE-000157 Status: Published @@ -75,14 +75,14 @@ Executability: Fully Executable Outcome: Message: Length of ARMCD is greater than 20 Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000158/rule.yml b/Published/CORE-000158/rule.yml index 1e1369ac2..91fb682ee 100644 --- a/Published/CORE-000158/rule.yml +++ b/Published/CORE-000158/rule.yml @@ -2,85 +2,81 @@ # Condition: Comment related to Domain Records and RDOMAIN not in (null, 'DM') # Rule: IDVAR ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. Null for comments collected on separate CRFs. - Document: IG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. null for comments collected on separate CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. null for comments collected on separate CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. Null for comments collected on separate CRFs. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0396 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: IG v3.4 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.3 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0396 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: RDOMAIN - operator: non_empty - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: IDVAR - operator: empty + - all: + - name: RDOMAIN + operator: non_empty + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: IDVAR + operator: empty Core: Id: CORE-000158 Status: Published @@ -90,15 +86,15 @@ Executability: Fully Executable Outcome: Message: IDVAR should not be missing when RDOMAIN is not in (empty, DM). Output Variables: - - RDOMAIN - - IDVAR + - RDOMAIN + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000159/rule.yml b/Published/CORE-000159/rule.yml index 08e3f1702..940c066c4 100644 --- a/Published/CORE-000159/rule.yml +++ b/Published/CORE-000159/rule.yml @@ -2,86 +2,76 @@ # Condition: # Rule: --TESTCD ^= 'OTHER' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other, Specify" for tests may be handled similarly - to Interventions. --TESTCD and --TEST should be populated with - the code and description of the test found in the specified - text. If specific tests are not prespecified on the CRF and - the investigator has the option of writing in tests, then the - name of the test would have to be coded to ensure that all - --TESTCD and --TEST values are consistent with the test - controlled terminology.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly - to Interventions. --TESTCD and --TEST should be populated with - the code and description of the test found in the specified - text. If specific tests are not prespecified on the CRF and - the investigator has the option of writing in tests, then the - name of the test would have to be coded to ensure that all - --TESTCD and --TEST values are consistent with the test - controlled terminology.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly - to Interventions. --TESTCD and --TEST should be populated with - the code and description of the test found in the specified - text. If specific tests are not prespecified on the CRF and - the investigator has the option of writing free text for - tests; then the name of the test would have to be coded to - ensure that all --TESTCD and --TEST values are controlled - terminology and are not free text.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Findings general observations class domains, each collected - value will be represented in --TESTCD and --TEST in its own - record per controlled terminology. - Document: TIG 1.0 - Item: Num 3 - Section: '2.8.7.4' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0506 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Findings: "Other, Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing in tests, then the name of the test would have to be coded to ensure that + all --TESTCD and --TEST values are consistent with the test controlled terminology.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing in tests, then the name of the test would have to be coded to ensure that + all --TESTCD and --TEST values are consistent with the test controlled terminology.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing free text for tests; then the name of the test would have to be coded to ensure + that all --TESTCD and --TEST values are controlled terminology and are not free text.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: For Findings general observations class domains, each collected value will + be represented in --TESTCD and --TEST in its own record per controlled terminology. + Document: TIG 1.0 + Item: Num 3 + Section: '2.8.7.4' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0506 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TESTCD - operator: equal_to - value: OTHER + - name: --TESTCD + operator: equal_to + value: OTHER Core: Id: CORE-000159 Status: Published @@ -91,14 +81,14 @@ Executability: Fully Executable Outcome: Message: --TESTCD is equal to 'OTHER' Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000160/rule.yml b/Published/CORE-000160/rule.yml index f97c5c14d..99db2fe6c 100644 --- a/Published/CORE-000160/rule.yml +++ b/Published/CORE-000160/rule.yml @@ -2,71 +2,67 @@ # Condition: # Rule: --TRT ^= 'OTHER' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided - along with "Other, Specify", --TRT should be populated with - the name of the treatment found in the specified text.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided - along with "Other, Specify", --TRT should be populated with - the name of the treatment found in the specified text.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided - along with "Other, Specify", --TRT should be populated with - the name of the treatment found in the specified text.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Interventions general observations class domains, each - collected value will be represented in --TRT in its own - record. - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0507 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: For Interventions general observations class domains, each collected value + will be represented in --TRT in its own record. + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0507 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TRT - operator: equal_to - value: OTHER + - name: --TRT + operator: equal_to + value: OTHER Core: Id: CORE-000160 Status: Published @@ -76,14 +72,14 @@ Executability: Fully Executable Outcome: Message: --TRT is equal to 'OTHER' Output Variables: - - --TRT + - --TRT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000161/rule.yml b/Published/CORE-000161/rule.yml index 1ed900346..ba572f81b 100644 --- a/Published/CORE-000161/rule.yml +++ b/Published/CORE-000161/rule.yml @@ -2,77 +2,71 @@ # Condition: # Rule: --TERM ^= 'OTHER' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to - Interventions. --TERM should be populated with the description - of the event found in the specified text and --PRESP could be - used to distinguish between prespecified and free text - responses.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to - Interventions. --TERM should be populated with the description - of the event found in the specified text and --PRESP could be - used to distinguish between prespecified and free text - responses.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to - Interventions. --TERM should be populated with the description - of the event found in the specified text and --PRESP could be - used to distinguish between prespecified and free text - responses.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Events general observations class domains, each collected - value will be represented in --TERM in its own record. - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0508 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: For Events general observations class domains, each collected value will be + represented in --TERM in its own record. + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0508 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TERM - operator: equal_to - value: OTHER + - name: --TERM + operator: equal_to + value: OTHER Core: Id: CORE-000161 Status: Published @@ -82,14 +76,14 @@ Executability: Fully Executable Outcome: Message: --TERM is equal to 'OTHER' Output Variables: - - --TERM + - --TERM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000162/rule.yml b/Published/CORE-000162/rule.yml index 58e9fa565..b27e7cbff 100644 --- a/Published/CORE-000162/rule.yml +++ b/Published/CORE-000162/rule.yml @@ -2,77 +2,73 @@ # Condition: # Rule: --TESTCD ^= 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a - Findings class dataset, multiple records should be submitted - for that --TESTCD. - Document: IG v3.4 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset); it is - assumed that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity as per the - sponsor's standard data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset); it is - assumed that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity as per the - sponsor's standard data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple result values (represented in --ORRES) are collected - for a test, then multiple records will be represented for the - test (represented in --TESTCD) - Document: TIG 1.0 - Item: Num 2 - Section: 2.8.7.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0509 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings + class dataset, multiple records should be submitted for that --TESTCD. + Document: IG v3.4 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: If multiple result values (represented in --ORRES) are collected for a test, + then multiple records will be represented for the test (represented in --TESTCD) + Document: TIG 1.0 + Item: Num 2 + Section: 2.8.7.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0509 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TESTCD - operator: equal_to - value: MULTIPLE + - name: --TESTCD + operator: equal_to + value: MULTIPLE Core: Id: CORE-000162 Status: Published @@ -82,14 +78,14 @@ Executability: Fully Executable Outcome: Message: --TESTCD is equal to 'MULTIPLE' Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000163/rule.yml b/Published/CORE-000163/rule.yml index c576a59d9..3a84d8dfc 100644 --- a/Published/CORE-000163/rule.yml +++ b/Published/CORE-000163/rule.yml @@ -2,83 +2,79 @@ # Condition: # Rule: --TRT ^= 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset), it is - expected that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity per the - sponsor's data management standard operating procedures. - Document: IG v3.4 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset); it is - assumed that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity as per the - sponsor's standard data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset); it is - assumed that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity as per the - sponsor's standard data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset), it is - expected that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity per the - sponsor's data management standard operating procedures. - Document: TIG 1.0 - Item: Num 1, Num 2 - Section: '2.8.7.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0510 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: IG v3.4 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: TIG 1.0 + Item: Num 1, Num 2 + Section: '2.8.7.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0510 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TRT - operator: equal_to - value: MULTIPLE + - name: --TRT + operator: equal_to + value: MULTIPLE Core: Id: CORE-000163 Status: Published @@ -88,14 +84,14 @@ Executability: Fully Executable Outcome: Message: --TRT is equal to 'MULTIPLE' Output Variables: - - --TRT + - --TRT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000164/rule.yml b/Published/CORE-000164/rule.yml index 61a883215..bc6efe2b1 100644 --- a/Published/CORE-000164/rule.yml +++ b/Published/CORE-000164/rule.yml @@ -2,83 +2,79 @@ # Condition: # Rule: --TERM ^= 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset), it is - expected that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity per the - sponsor's data management standard operating procedures. - Document: IG v3.4 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset); it is - assumed that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity as per the - sponsor's standard data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; - --TRT in an Interventions general-observation-class - dataset or --TERM in an Events general-observation-class - dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as - per the sponsor's standard data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., - --TRT in an Interventions general-observation-class dataset or - --TERM in an Events general-observation-class dataset), it is - expected that the sponsor will split the values into multiple - records or otherwise resolve the multiplicity per the - sponsor's data management standard operating procedures. - Document: TIG 1.0 - Item: Num 1, Num 2 - Section: '2.8.7.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0511 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: IG v3.4 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: TIG 1.0 + Item: Num 1, Num 2 + Section: '2.8.7.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0511 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TERM - operator: equal_to - value: MULTIPLE + - name: --TERM + operator: equal_to + value: MULTIPLE Core: Id: CORE-000164 Status: Published @@ -88,14 +84,14 @@ Executability: Fully Executable Outcome: Message: --TERM is equal to 'MULTIPLE' Output Variables: - - --TERM + - --TERM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000165/rule.yml b/Published/CORE-000165/rule.yml index 60f63548b..621929f9a 100644 --- a/Published/CORE-000165/rule.yml +++ b/Published/CORE-000165/rule.yml @@ -2,226 +2,213 @@ # Condition: --RFTDTC present in dataset # Rule: --TPTREF present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"The actual date or date and time of a time point that acts as - a fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF"' - Document: Model v2.0 - Item: RFTDTC - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"Date/time for a fixed reference time point defined by - --TPTREF."' - Document: Model v1.7 - Item: Table 2.2.5.1 --RFTDTC - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"(--RFTDTC) Date/time for a fixed reference time point defined - by --TPTREF in ISO 8601 character format."' - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a - fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF. - Document: SDTM v2.1 - Item: --RFTDTC - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0355 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"The actual date or date and time of a time point that acts as a fixed reference + for a series of planned time points, represented in a standardized character format. The fixed + reference point is in --TPTREF"' + Document: Model v2.0 + Item: RFTDTC + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"Date/time for a fixed reference time point defined by --TPTREF."' + Document: Model v1.7 + Item: Table 2.2.5.1 --RFTDTC + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"(--RFTDTC) Date/time for a fixed reference time point defined by --TPTREF in + ISO 8601 character format."' + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF. + Document: SDTM v2.1 + Item: --RFTDTC + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0355 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --RFTDTC - operator: exists - - name: --TPTREF - operator: not_exists + - name: --RFTDTC + operator: exists + - name: --TPTREF + operator: not_exists Core: Id: CORE-000165 Status: Published Version: '1' -Description: Time point reference (--TPTREF) should be present in the dataset, - when reference time point (--RFTDTC) is also present in the dataset. +Description: Time point reference (--TPTREF) should be present in the dataset, when reference time + point (--RFTDTC) is also present in the dataset. Executability: Fully Executable Outcome: Message: --TPTREF is missing when --RFTDTC is present. Output Variables: - - --RFTDTC - - --TPTREF + - --RFTDTC + - --TPTREF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000166/rule.yml b/Published/CORE-000166/rule.yml index 19ccb3758..93dcb9d4c 100644 --- a/Published/CORE-000166/rule.yml +++ b/Published/CORE-000166/rule.yml @@ -1,41 +1,41 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"The description of the time when a protocol-defined activity - is planned to occur, used for study data tabulation."' - Document: Model v2.0 - Item: --TPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0091 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of the time when a protocol-defined activity is - planned to occur, used for study data tabulation. - Document: SDTM v2.1 - Item: --TPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0356 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"The description of the time when a protocol-defined activity is planned to occur, + used for study data tabulation."' + Document: Model v2.0 + Item: --TPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0091 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description of the time when a protocol-defined activity is planned to + occur, used for study data tabulation. + Document: SDTM v2.1 + Item: --TPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0356 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: not_exists + - name: --TPTNUM + operator: exists + - name: --TPT + operator: not_exists Core: Id: CORE-000166 Status: Published @@ -45,15 +45,15 @@ Executability: Fully Executable Outcome: Message: --TPT is not present when --TPTNUM is present in a dataset Output Variables: - - --TPTNUM - - --TPT + - --TPTNUM + - --TPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000167/rule.yml b/Published/CORE-000167/rule.yml index 4878dbec7..c1bd1a5a9 100644 --- a/Published/CORE-000167/rule.yml +++ b/Published/CORE-000167/rule.yml @@ -2,95 +2,84 @@ # Condition: --ELTM present in dataset # Rule: --TPTREF present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference - for a series of planned time points, used for study data - tabulation. Description of the fixed reference point referred - to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: Model v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.5 Timing Variables for All - Classes][Specification][(--TPTREF) Description of the fixed - reference point referred to by --ELTM, --TPTNUM, and --TPT. - Examples: PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10 - Representing Time Points][If the protocol describes the - scheduling of a dose using a reference intervention or - assessment, then --TPTREF should be populated, even if it does - not contribute to uniqueness. The fact that time points are - related to a reference time point, and what that reference - time point is, are important for interpreting the data - collected at the time point.]' - Document: Model v1.4|IG v3.2 - Item: Model v1.4[2.2.5 Timing Variables for All Classes][Specification] - Section: Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10 - Representing Time Points] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table - 2.2.5.1: --TPTREF]Description of the fixed reference point - referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10 - Representing Time Points][If the protocol describes the - scheduling of a dose using a reference intervention or - assessment, then --TPTREF should be populated, even if it does - not contribute to uniqueness. The fact that time points are - related to a reference time point, and what that reference - time point is, are important for interpreting the data - collected at the time point.]' - Document: Model v1.7|IG v3.3 - Item: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: - --TPTREF]' - Section: Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10 - Representing Time Points] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference - for a series of planned time points, used for study data - tabulation. Description of the fixed reference point referred - to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: SDTM v2.1 - Item: --TPTREF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0357 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed + reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: Model v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.4[2.2.5 Timing Variables for All Classes][Specification][(--TPTREF) + Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: + PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10 Representing Time Points][If the protocol describes + the scheduling of a dose using a reference intervention or assessment, then --TPTREF should + be populated, even if it does not contribute to uniqueness. The fact that time points are related + to a reference time point, and what that reference time point is, are important for interpreting + the data collected at the time point.]' + Document: Model v1.4|IG v3.2 + Item: Model v1.4[2.2.5 Timing Variables for All Classes][Specification] + Section: Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10 Representing + Time Points] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]Description + of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. Examples: + "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10 Representing Time Points][If the protocol + describes the scheduling of a dose using a reference intervention or assessment, then --TPTREF + should be populated, even if it does not contribute to uniqueness. The fact that time points + are related to a reference time point, and what that reference time point is, are important + for interpreting the data collected at the time point.]' + Document: Model v1.7|IG v3.3 + Item: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]' + Section: Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10 Representing Time + Points] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: SDTM v2.1 + Item: --TPTREF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0357 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ELTM - operator: exists - - name: --TPTREF - operator: not_exists + - name: --ELTM + operator: exists + - name: --TPTREF + operator: not_exists Core: Id: CORE-000167 Status: Published @@ -100,15 +89,15 @@ Executability: Fully Executable Outcome: Message: --TPTREF must be present when --ELTM is present in a dataset Output Variables: - - --ELTM - - --TPTREF + - --ELTM + - --TPTREF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000168/rule.yml b/Published/CORE-000168/rule.yml index 50f7e0aac..e7691af60 100644 --- a/Published/CORE-000168/rule.yml +++ b/Published/CORE-000168/rule.yml @@ -2,77 +2,73 @@ # Condition: VISITNUM ^= null # Rule: VISITNUM in SV.VISITNUM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the - timing of subject visits that is otherwise spread over domains - that include the visit variables (VISITNUM and possibly VISIT - and/or VISITDY). - Document: IG v3.4 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the - timing of subject visits that is otherwise spread over domains - that include the visit variables (VISITNUM and possibly VISIT - and/or VISITDY). - Document: IG v3.3 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the - timing of subject visits that is otherwise spread over domains - that include the visit variables (VISITNUM and possibly VISIT - and/or VISITDY). - Document: IG v3.2 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the - timing of subject visits that is otherwise spread over domains - that include the visit variables (VISITNUM and possibly VISIT - and/or VISITDY). - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0315 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.4 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.3 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.2 + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0315 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: VISITNUM - operator: non_empty - - name: VISITNUM - operator: is_not_contained_by - value: $sv_visitnum + - name: VISITNUM + operator: non_empty + - name: VISITNUM + operator: is_not_contained_by + value: $sv_visitnum Core: Id: CORE-000168 Status: Published @@ -80,23 +76,23 @@ Core: Description: If VISITNUM is not null then VISITNUM should be among SV.VISITNUM Executability: Fully Executable Operations: - - domain: SV - group: - - USUBJID - id: $sv_visitnum - name: VISITNUM - operator: distinct +- domain: SV + group: + - USUBJID + id: $sv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM is not among VISITNUM in SV domain. Output Variables: - - VISITNUM + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000169/rule.yml b/Published/CORE-000169/rule.yml index 04d8546e1..e30a57ee0 100644 --- a/Published/CORE-000169/rule.yml +++ b/Published/CORE-000169/rule.yml @@ -2,74 +2,74 @@ # Condition: Numeric scale used # Rule: LBTOXGR is a numeric value Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"If value is from a numeric scale, represent only the - number (e.g., "2" and not "Grade 2")."' - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If value is from a numeric scale, represent only the number - (e.g., "2" and not "Grade 2"). - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If value is from a numeric scale, represent only the number - (e.g., "2" and not "Grade 2"). - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Records toxicity grade value using a standard toxicity scale - (such as the NCI CTCAE). If value is from a numeric scale, - represent only the number (e.g., "2" and not "Grade 2"). - Document: TIG 1.0 - Item: Specification-LBTOXGR - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0414 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2")."' + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2"). + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2"). + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Records toxicity grade value using a standard toxicity scale (such as the + NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not + "Grade 2"). + Document: TIG 1.0 + Item: Specification-LBTOXGR + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0414 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: LBTOXGR - operator: matches_regex - value: .*[a-zA-Z].* # identifiers string contains characters - - name: LBTOXGR - operator: matches_regex - value: .*[0-9].* #identifies that string also contains a number + - name: LBTOXGR + operator: matches_regex + value: .*[a-zA-Z].* # identifiers string contains characters + - name: LBTOXGR + operator: matches_regex + value: .*[0-9].* #identifies that string also contains a number Core: Id: CORE-000169 Status: Published @@ -79,15 +79,15 @@ Executability: Fully Executable Outcome: Message: Verify that LBTOXGR value is not from a numeric scale Output Variables: - - LBTOXGR - - LBTOX + - LBTOXGR + - LBTOX Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000170/rule.yml b/Published/CORE-000170/rule.yml index 46f2c787f..dbe34f1a3 100644 --- a/Published/CORE-000170/rule.yml +++ b/Published/CORE-000170/rule.yml @@ -2,55 +2,55 @@ # Condition: # Rule: Value must be 'Y' or null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: IG v3.4 - Item: Specification - Section: Various Findings Domains - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0541 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: IG v3.3 - Item: CDISC Notes - Section: Various Findings Domains - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0541 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: TIG 1.0 - Item: Specification:--LOBXFL - Section: Various Finding Domains - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0634 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: IG v3.4 + Item: Specification + Section: Various Findings Domains + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0541 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: IG v3.3 + Item: CDISC Notes + Section: Various Findings Domains + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0541 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: TIG 1.0 + Item: Specification:--LOBXFL + Section: Various Finding Domains + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0634 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --LOBXFL - operator: not_equal_to - value: Y - - name: --LOBXFL - operator: non_empty + - name: --LOBXFL + operator: not_equal_to + value: Y + - name: --LOBXFL + operator: non_empty Core: Id: CORE-000170 Status: Published @@ -60,17 +60,17 @@ Executability: Fully Executable Outcome: Message: Value of --LOBXFL must be 'Y' or null Output Variables: - - --CAT - - --TEST - - --TESTCD - - --LOBXFL + - --CAT + - --TEST + - --TESTCD + - --LOBXFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000171/rule.yml b/Published/CORE-000171/rule.yml index f118e3934..64e187098 100644 --- a/Published/CORE-000171/rule.yml +++ b/Published/CORE-000171/rule.yml @@ -2,96 +2,94 @@ # Condition: --ENRTPT present in dataset # Rule: --ENTPT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the end of an - observation. This is the sponsor-defined reference point - referred to by --ENRTPT. - Document: Model v2.0 - Item: --ENTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format - of the sponsor-defined reference point referred to by - --ENRTPT. Examples "2003-12-25" or "VISIT 2". - Document: Model v1.7 - Item: Table 2.2.5.1, --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENTPT) Description or date/time in ISO 8601 or other - character format of the sponsor-defined reference point - referred to by --ENRTPT. Examples "2003-12-25" or "VISIT 2". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the end of an - observation. This is the sponsor-defined reference point - referred to by --ENRTPT. - Document: SDTM v2.1 - Item: --ENTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0332 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: Model v2.0 + Item: --ENTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or "VISIT + 2". + Document: Model v1.7 + Item: Table 2.2.5.1, --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--ENTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or + "VISIT 2". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: SDTM v2.1 + Item: --ENTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0332 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --ENRTPT - operator: exists - - name: --ENTPT - operator: not_exists + - name: --ENRTPT + operator: exists + - name: --ENTPT + operator: not_exists Core: Id: CORE-000171 Status: Published Version: '1' -Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is - not present in dataset. +Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in + dataset. Executability: Fully Executable Outcome: Message: --ENTPT should be present when --ENRTPT is present in a dataset Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000172/rule.yml b/Published/CORE-000172/rule.yml index ca3de6a78..23a03f99e 100644 --- a/Published/CORE-000172/rule.yml +++ b/Published/CORE-000172/rule.yml @@ -2,173 +2,168 @@ # Condition: # Rule: STUDYID = DM.STUDYID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records - that describe that study. - Document: IG v3.4 - Item: 2.B.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records - that describe that study - Document: IG v3.3 - Item: 2.B.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records - that describe that study - Document: IG v3.2 - Item: 2.B.1 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records with the same STUDYID value are a group of records that describe + that study. + Document: IG v3.4 + Item: 2.B.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records with the same STUDYID value are a group of records that describe + that study + Document: IG v3.3 + Item: 2.B.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records with the same STUDYID value are a group of records that describe + that study + Document: IG v3.2 + Item: 2.B.1 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG # IMPORTANT: Rule is different from SEND249, which is for SENDIG-3.0 ONLY, # and which explicitely requires STUDYID=TS.STUDYID - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records - across the study. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records - across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records - across the study. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records - across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records - across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique identifier for a study. - Document: TIG v1.0 - Item: STUDYID CDISC Notes - Section: 2.8.9.32, and all domains - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0168 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique identifier that describe that study - Document: TIG 1.0 - Item: Specifications STUDYID - Section: All Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0565 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Unique identifier for a study. + Document: TIG v1.0 + Item: STUDYID CDISC Notes + Section: 2.8.9.32, and all domains + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0168 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Unique identifier that describe that study + Document: TIG 1.0 + Item: Specifications STUDYID + Section: All Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0565 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: STUDYID - operator: is_not_contained_by - value: $dm_studyid + - name: STUDYID + operator: is_not_contained_by + value: $dm_studyid Core: Id: CORE-000172 Status: Published Version: '1' -Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID - in all domains must be the same in all records across the study. +Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must + be the same in all records across the study. Executability: Fully Executable Operations: - - domain: DM - id: $dm_studyid - name: STUDYID - operator: distinct +- domain: DM + id: $dm_studyid + name: STUDYID + operator: distinct Outcome: Message: STUDYID is not equal to DM.STUDYID Output Variables: - - STUDYID + - STUDYID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000173/rule.yml b/Published/CORE-000173/rule.yml index 49647c376..2ffaa6204 100644 --- a/Published/CORE-000173/rule.yml +++ b/Published/CORE-000173/rule.yml @@ -2,94 +2,87 @@ # Condition: ETCD ^= 'UNPLAN' # Rule: ETCD = TE.ETCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the - timing of the trial Elements a subject actually passed through - in their participation in the trial. Read Section 7.2.2, Trial - Elements, on the Trial Elements (TE) dataset and Section - 7.2.1, Trial Arms, on the Trial Arms (TA) dataset, as these - datasets define a trial's planned Elements and describe the - planned sequences of Elements for the Arms of the trial. - Document: IG V3.4 - Item: Assumptions - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the - timing of the trial Elements a subject actually passed through - in their participation in the trial. Please read Section 7.2.2 - - Experimental Design; Trial Elements (TE); on the Trial - Elements dataset and Section 7.2.1 - Experimental Design; - Trial Arms (TA); on the Trial Arms dataset; as these datasets - define a trial's planned Elements; and describe the planned - sequences of lements for the Arms of the trial. - Document: IG V3.3 - Item: Assumptions - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the - timing of the trial Elements a subject actually passed through - in their participation in the trial. Please read Section 7.2 - - Experimental Design; Trial Elements (TE); on the Trial - Elements dataset and Section 7.2 - Experimental Design; Trial - Arms (TA); on the Trial Arms dataset; as these datasets define - a trial's planned Elements; and describe the planned sequences - of lements for the Arms of the trial. - Document: IG V3.2 - Item: Assumptions 2 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the - timing of the trial Elements a subject actually passed through - in their participation in the trial. Section 10.8.30 Trial - Elements and Section 10.8.29 Trial Arms, as these datasets - define a trial's planned Elements and describe the planned - sequences of Elements for the Arms of the trial. - Document: TIG 1.0 - Item: Assumptions - Section: 2.8.10.24|2.8.10.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0569 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Read Section 7.2.2, Trial Elements, on the Trial Elements (TE) dataset and Section 7.2.1, + Trial Arms, on the Trial Arms (TA) dataset, as these datasets define a trial's planned + Elements and describe the planned sequences of Elements for the Arms of the trial. + Document: IG V3.4 + Item: Assumptions + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Please read Section 7.2.2 - Experimental Design; Trial Elements (TE); on the Trial + Elements dataset and Section 7.2.1 - Experimental Design; Trial Arms (TA); on the Trial + Arms dataset; as these datasets define a trial's planned Elements; and describe the + planned sequences of lements for the Arms of the trial. + Document: IG V3.3 + Item: Assumptions + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Please read Section 7.2 - Experimental Design; Trial Elements (TE); on the Trial Elements + dataset and Section 7.2 - Experimental Design; Trial Arms (TA); on the Trial Arms dataset; + as these datasets define a trial's planned Elements; and describe the planned sequences of + lements for the Arms of the trial. + Document: IG V3.2 + Item: Assumptions 2 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Section 10.8.30 Trial Elements and Section 10.8.29 Trial Arms, as these datasets define + a trial's planned Elements and describe the planned sequences of Elements for the Arms of + the trial. + Document: TIG 1.0 + Item: Assumptions + Section: 2.8.10.24|2.8.10.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0569 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ETCD - operator: not_equal_to - value: UNPLAN - - name: ETCD - operator: is_not_contained_by - value: $te_etcd + - name: ETCD + operator: not_equal_to + value: UNPLAN + - name: ETCD + operator: is_not_contained_by + value: $te_etcd Core: Id: CORE-000173 Status: Published @@ -97,23 +90,23 @@ Core: Description: Raise an error when ETCD is not equal to 'UNPLAN' and not equal to TE.ETCD Executability: Fully Executable Operations: - - domain: TE - id: $te_etcd - name: ETCD - operator: distinct +- domain: TE + id: $te_etcd + name: ETCD + operator: distinct Outcome: Message: ETCD is not equal to 'UNPLAN' and not equal to TE.ETCD Output Variables: - - ETCD + - ETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - SE - - TA + - SE + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000177/rule.yml b/Published/CORE-000177/rule.yml index afeb12ac9..07d42ca30 100644 --- a/Published/CORE-000177/rule.yml +++ b/Published/CORE-000177/rule.yml @@ -2,84 +2,78 @@ # Condition: DM.RFENDTC = null # Rule: --ENRF = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: Model v2.0 - Item: --ENRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before, during or - after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENRF - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before, during or - after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --ENRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0440 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --ENRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before, during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENRF + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before, during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --ENRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0440 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RFENDTC - operator: empty - - name: --ENRF - operator: non_empty + - name: RFENDTC + operator: empty + - name: --ENRF + operator: non_empty Core: Id: CORE-000177 Status: Published @@ -87,20 +81,20 @@ Core: Description: Raise an error when DM.RFENDTC is empty and --ENRF is not empty. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: DM.RFENDTC is empty, but --ENRF is completed. Output Variables: - - --ENRF + - --ENRF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000179/rule.yml b/Published/CORE-000179/rule.yml index 961b2205e..22237728e 100644 --- a/Published/CORE-000179/rule.yml +++ b/Published/CORE-000179/rule.yml @@ -2,218 +2,208 @@ # Condition: # Rule: TSPARM and TSPARMCD have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "'TSPARMCD (the companion to TSPARM)'" - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: TIG 1.0 - Item: Specification:TSPARMCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0482 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "'TSPARMCD (the companion to TSPARM)'" + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: TIG 1.0 + Item: Specification:TSPARMCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0482 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TSPARM - operator: is_not_unique_relationship - value: TSPARMCD + - name: TSPARM + operator: is_not_unique_relationship + value: TSPARMCD Core: Id: CORE-000179 Status: Published @@ -223,15 +213,15 @@ Executability: Fully Executable Outcome: Message: TSPARM and TSPARMCD do not have a one-to-one relationship. Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000180/rule.yml b/Published/CORE-000180/rule.yml index 8f63bc6ff..807f4bf2f 100644 --- a/Published/CORE-000180/rule.yml +++ b/Published/CORE-000180/rule.yml @@ -2,70 +2,66 @@ # Condition: # Rule: DOMAIN value length = 2 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character - code - Document: IG v3.4 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character - code - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character - code - Document: IG v3.3 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Domain datasets based on the SDTM general observations classes - will be named using the two-character code for the domain or - using the applicable four-character code when a dataset is - split. - Document: TIG 1.0 - Item: Num 2 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0483 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.4 + Section: '2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.2 + Section: '2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.3 + Section: '2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Domain datasets based on the SDTM general observations classes will be named + using the two-character code for the domain or using the applicable four-character code + when a dataset is split. + Document: TIG 1.0 + Item: Num 2 + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0483 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DOMAIN - operator: longer_than - value: 2 + - name: DOMAIN + operator: longer_than + value: 2 Core: Id: CORE-000180 Status: Published @@ -78,9 +74,9 @@ Rule Type: Record Data Scope: Classes: Exclude: - - RELATIONSHIP + - RELATIONSHIP Domains: Exclude: - - AP-- + - AP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000182/rule.yml b/Published/CORE-000182/rule.yml index bbfd2ec7f..d9351f271 100644 --- a/Published/CORE-000182/rule.yml +++ b/Published/CORE-000182/rule.yml @@ -2,159 +2,159 @@ # Condition: # Rule: Variable name length <= 8 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In some cases, the standard variable name will be shortened to - meet the 8-character variable name requirement... - Document: IG v3.4 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS Transport format) - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In some cases, the standard variable name will be shortened to - meet the 8-character variable name requirement... - Document: IG v3.3 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable names will be 8 characters or less and upper case. - Document: TIG 1.0 - Item: 'Num 4' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0485 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility - with the SAS v5 Transport format). - Document: TIG v1.0 - Item: Text - Section: 2.6 Guidance for Datasets, tabulation table Num 4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0128 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In some cases, the standard variable name will be shortened to meet the + 8-character variable name requirement... + Document: IG v3.4 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS + Transport format) + Document: IG v3.2 + Section: '2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In some cases, the standard variable name will be shortened to meet the + 8-character variable name requirement... + Document: IG v3.3 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable names will be 8 characters or less and upper case. + Document: TIG 1.0 + Item: 'Num 4' + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0485 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: TIG v1.0 + Item: Text + Section: 2.6 Guidance for Datasets, tabulation table Num 4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0128 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_name - operator: longer_than - value: 8 + - name: variable_name + operator: longer_than + value: 8 Core: Id: CORE-000182 Status: Published @@ -167,9 +167,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000183/rule.yml b/Published/CORE-000183/rule.yml index ff5fb77d3..723f924c0 100644 --- a/Published/CORE-000183/rule.yml +++ b/Published/CORE-000183/rule.yml @@ -2,90 +2,88 @@ # Condition: PP dataset present in study # Rule: PC dataset present in study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note, domain pairs have been modeled for microbiology data - (MB/MS domains) and PK data (PC/PP domains) to enable - dataset-level relationships to be described using RELREC. - Document: IG v3.4 - Item: '1' - Section: '2.6' - - Cited Guidance: A findings domain that contains pharmacokinetic parameters - derived from pharmacokinetic concentration-time (PC) data. - Document: IG v3.4 - Item: PP - Description/Overview - Section: 6.3.5.6.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to - group parent records (e.g., MB) from child records (e.g., MS) - and enables a dataset-level relationship to be described in - RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived - from pharmacokinetic concentration-time (PC) data.] - Document: IG v3.2 - Item: IG v3.2[2.6]|IG v3.2[6.3][PP] - Section: IG v3.2[2.6]|IG v3.2[6.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an - Identifier to group parent records (e.g., MB) from child - records (e.g., MS) and enables a dataset-level relationship to - be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain - that contains pharmacokinetic parameters derived from - pharmacokinetic concentration-time (PC) data.] - Document: IG v3.3 - Item: IG v3.3[2.6]|IG v3.3[6.3.11.2] - Section: IG v3.3[2.6]|IG v3.3[6.3.11.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A findings domain that contains pharmacokinetic parameters - derived from pharmacokinetic concentration-time (PC) data. - Document: TIG 1.0 - Item: Description - Section: 2.8.10.17 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0489 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Note, domain pairs have been modeled for microbiology data (MB/MS domains) + and PK data (PC/PP domains) to enable dataset-level relationships to be described using + RELREC. + Document: IG v3.4 + Item: '1' + Section: '2.6' + - Cited Guidance: A findings domain that contains pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data. + Document: IG v3.4 + Item: PP - Description/Overview + Section: 6.3.5.6.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to group parent + records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship + to be described in RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data.] + Document: IG v3.2 + Item: IG v3.2[2.6]|IG v3.2[6.3][PP] + Section: IG v3.2[2.6]|IG v3.2[6.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an Identifier + to group parent records (e.g., MB) from child records (e.g., MS) and enables a + dataset-level relationship to be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain + that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time + (PC) data.] + Document: IG v3.3 + Item: IG v3.3[2.6]|IG v3.3[6.3.11.2] + Section: IG v3.3[2.6]|IG v3.3[6.3.11.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A findings domain that contains pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data. + Document: TIG 1.0 + Item: Description + Section: 2.8.10.17 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0489 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: PP - operator: exists - - name: PC - operator: not_exists + - name: PP + operator: exists + - name: PC + operator: not_exists Core: Id: CORE-000183 Status: Published Version: '1' -Description: Raise an error when a PP dataset is present in study, but a PC - dataset is not present in study. +Description: Raise an error when a PP dataset is present in study, but a PC dataset is not present + in study. Executability: Fully Executable Outcome: Message: PP dataset is present in study, but PC dataset is not present in study. @@ -93,10 +91,10 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC - - PP + - PC + - PP Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000184/rule.yml b/Published/CORE-000184/rule.yml index 26d0803d8..1fdfef081 100644 --- a/Published/CORE-000184/rule.yml +++ b/Published/CORE-000184/rule.yml @@ -2,115 +2,112 @@ # Condition: # Rule: --BDSYCD and --BODSYS have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: Model v2.0 - Item: --BODSYS - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: SDTM v2.1 - Item: --BODSYS - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0348 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: SDTM v2.1 + Item: --BODSYS + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0348 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: --BDSYCD - operator: exists - - name: --BODSYS - operator: exists - - name: --BDSYCD - operator: is_not_unique_relationship - value: --BODSYS + - name: --BDSYCD + operator: exists + - name: --BODSYS + operator: exists + - name: --BDSYCD + operator: is_not_unique_relationship + value: --BODSYS Core: Id: CORE-000184 Status: Published @@ -120,15 +117,15 @@ Executability: Fully Executable Outcome: Message: --BODSYS and --BDSYCD do not have a one-to-one relationship. Output Variables: - - --BODSYS - - --BDSYCD + - --BODSYS + - --BDSYCD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000185/rule.yml b/Published/CORE-000185/rule.yml index 71fe9f9b0..e6b2e3192 100644 --- a/Published/CORE-000185/rule.yml +++ b/Published/CORE-000185/rule.yml @@ -2,73 +2,70 @@ # Condition: # Rule: ACTARMCD value length <= 20 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is - not subject to the character restrictions that apply to - TESTCD. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ACTARMCD is limited to 20 characters and does not have special - character restrictions. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is - not subject to the character restrictions that apply to - TESTCD. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is - not subject to the character restrictions that apply to - TESTCD. - Document: TIG 1.0 - Item: ACTARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0380 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ACTARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: TIG 1.0 + Item: ACTARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0380 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARMCD - operator: longer_than - value: 20 + - name: ACTARMCD + operator: longer_than + value: 20 Core: Id: CORE-000185 Status: Published @@ -78,14 +75,14 @@ Executability: Fully Executable Outcome: Message: Length of ACTARMCD is greater than 20 characters Output Variables: - - ACTARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000186/rule.yml b/Published/CORE-000186/rule.yml index 272240164..eaced6b10 100644 --- a/Published/CORE-000186/rule.yml +++ b/Published/CORE-000186/rule.yml @@ -2,67 +2,67 @@ # Condition: # Rule: SUBJID unique within a study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0391 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0391 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SUBJID - operator: is_not_unique_set - value: - - STUDYID + - name: SUBJID + operator: is_not_unique_set + value: + - STUDYID Core: Id: CORE-000186 Status: Published @@ -72,14 +72,14 @@ Executability: Fully Executable Outcome: Message: SUBJID is not unique within study Output Variables: - - SUBJID + - SUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000187/rule.yml b/Published/CORE-000187/rule.yml index 19823a7fe..d4faaf592 100644 --- a/Published/CORE-000187/rule.yml +++ b/Published/CORE-000187/rule.yml @@ -2,115 +2,100 @@ # Condition: IDVAR ^= null # Rule: CODTC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of comment on dedicated comment form. Should be null - if this is a child record of another domain or if comment date - was not collected. - Document: IG v3.4 - Item: Specification - Section: '5.1' - - Cited Guidance: Those related to a specific parent record or group of parent - records, in which case the value of the variable RDOMAIN is - set to the DOMAIN code of the parent record(s) and the - variables IDVAR and IDVARVAL are populated with the key - variable name and value of the parent record(s). Assumptions - for populating IDVAR and IDVARVAL are further described in - Section 8.5, Relating Comments to a Parent Domain. CODTC - should be null because the timing of the parent record(s) is - inherited by the comment record. See example, Rows 3-5. - Document: IG v3.4 - Item: Assumption 2c - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null - if this is a child record of another domain or if comment date - was not collected.][Those related to a specific parent record - or group of parent records, in which case the value of the - variable RDOMAIN is set to the DOMAIN code of the parent - record(s) and the variables IDVAR and IDVARVAL are populated - with the key variable name and value of the parent - record(s).][Assumptions for populating IDVAR and IDVARVAL are - further described in Section 8: 8.5, Relating Comments To A - Parent Domain. CODTC should be null because the timing of the - parent record(s) is inherited by the comment record. See - example, Rows 3-5.]' - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null - if this is a child record of another domain or if comment date - was not collected.][Those related to a specific parent record - or group of parent records, in which case the value of the - variable RDOMAIN is set to the DOMAIN code of the parent - record(s) and the variables IDVAR and IDVARVAL are populated - with the key variable name and value of the parent - record(s).][Assumptions for populating IDVAR and IDVARVAL are - further described in Section 8: 8.5, Relating Comments To A - Parent Domain. CODTC should be null because the timing of the - parent record(s) is inherited by the comment record. See - example, Rows 3-5.]' - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification[Date/time of comment on dedicated comment form. - Should be null if this is a child record of another domain or - if comment date was not collected.]|Assumption 2c[Those - related to a specific parent record or group of parent - records, in which case the value of the variable RDOMAIN is - set to the DOMAIN code of the parent record(s) and the - variables IDVAR and IDVARVAL are populated with the key - variable name and value of the parent record(s). Assumptions - for populating IDVAR and IDVARVAL are further described in - Section 2.8.5.4 Relating Comments to a Domain. CODTC should - be null because the timing of the parent record(s) is - inherited by the comment record - Document: TIG 1.0 - Item: Specification|Assumption 3c - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0400 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected. + Document: IG v3.4 + Item: Specification + Section: '5.1' + - Cited Guidance: Those related to a specific parent record or group of parent records, in + which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent + record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name + and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are + further described in Section 8.5, Relating Comments to a Parent Domain. CODTC should be + null because the timing of the parent record(s) is inherited by the comment record. See + example, Rows 3-5. + Document: IG v3.4 + Item: Assumption 2c + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected.][Those related to a specific + parent record or group of parent records, in which case the value of the variable RDOMAIN is + set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated + with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR + and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. + CODTC should be null because the timing of the parent record(s) is inherited by the comment + record. See example, Rows 3-5.]' + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected.][Those related to a specific + parent record or group of parent records, in which case the value of the variable RDOMAIN is + set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated + with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR + and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. + CODTC should be null because the timing of the parent record(s) is inherited by the comment + record. See example, Rows 3-5.]' + Document: IG v3.3 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification[Date/time of comment on dedicated comment form. Should be null + if this is a child record of another domain or if comment date was not + collected.]|Assumption 2c[Those related to a specific parent record or group of parent + records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the + parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable + name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are + further described in Section 2.8.5.4 Relating Comments to a Domain. CODTC should be null + because the timing of the parent record(s) is inherited by the comment record + Document: TIG 1.0 + Item: Specification|Assumption 3c + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0400 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVAR - operator: non_empty - - name: CODTC - operator: non_empty + - name: IDVAR + operator: non_empty + - name: CODTC + operator: non_empty Core: Id: CORE-000187 Status: Published @@ -120,16 +105,16 @@ Executability: Fully Executable Outcome: Message: CODTC is populated when IDVAR is also populated Output Variables: - - USUBJID - - IDVAR - - CODTC + - USUBJID + - IDVAR + - CODTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000189/rule.yml b/Published/CORE-000189/rule.yml index fcaaf3049..4a38696fa 100644 --- a/Published/CORE-000189/rule.yml +++ b/Published/CORE-000189/rule.yml @@ -2,43 +2,41 @@ # Condition: AGE ^= null # Rule: AGEU ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human - clinical trials.' - Document: Model v2.0 - Item: AGEU|AGETXT - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0665 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human - clinical trials.' - Document: SDTM v2.1 - Item: AGEU|AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0699 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' + Document: Model v2.0 + Item: AGEU|AGETXT + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0665 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' + Document: SDTM v2.1 + Item: AGEU|AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0699 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AGE - operator: non_empty - - name: AGEU - operator: empty + - name: AGE + operator: non_empty + - name: AGEU + operator: empty Core: Id: CORE-000189 Status: Published @@ -48,15 +46,15 @@ Executability: Fully Executable Outcome: Message: AGEU is missing when AGE is provided. Output Variables: - - AGE - - AGEU + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000190/rule.yml b/Published/CORE-000190/rule.yml index 8f5cd04d0..57f625069 100644 --- a/Published/CORE-000190/rule.yml +++ b/Published/CORE-000190/rule.yml @@ -2,43 +2,41 @@ # Condition: AGEU ^= null # Rule: AGE ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human - clinical trials.' - Document: Model v2.0 - Item: AGEU|AGETXT - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0666 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human - clinical trials.' - Document: SDTM v2.1 - Item: AGEU|AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0700 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' + Document: Model v2.0 + Item: AGEU|AGETXT + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0666 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' + Document: SDTM v2.1 + Item: AGEU|AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0700 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty + - name: AGEU + operator: non_empty + - name: AGE + operator: empty Core: Id: CORE-000190 Status: Published @@ -48,15 +46,15 @@ Executability: Fully Executable Outcome: Message: AGE is missing when AGEU is provided. Output Variables: - - AGE - - AGEU + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000191/rule.yml b/Published/CORE-000191/rule.yml index 235a6e236..68361d7e0 100644 --- a/Published/CORE-000191/rule.yml +++ b/Published/CORE-000191/rule.yml @@ -2,57 +2,57 @@ # Condition: ARM ^= null # Rule: RFENDTC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0529 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0529 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: TIG 1.0 - Item: Specification:RFENDTC - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0622 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0529 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0529 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: TIG 1.0 + Item: Specification:RFENDTC + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0622 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARM - operator: non_empty - - name: RFENDTC - operator: empty + - name: ARM + operator: non_empty + - name: RFENDTC + operator: empty Core: Id: CORE-000191 Status: Published @@ -62,15 +62,15 @@ Executability: Fully Executable Outcome: Message: RFENDTC is missing when ARM is provided. Output Variables: - - ARM - - RFENDTC + - ARM + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000192/rule.yml b/Published/CORE-000192/rule.yml index dd4e4e241..b2f536ccc 100644 --- a/Published/CORE-000192/rule.yml +++ b/Published/CORE-000192/rule.yml @@ -2,57 +2,57 @@ # Condition: ARMNRS ^= null # Rule: RFENDTC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0530 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0530 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures - or unassigned subjects. - Document: TIG 1.0 - Item: Specification:RFENDTC - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0623 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0530 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0530 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: TIG 1.0 + Item: Specification:RFENDTC + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0623 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMNRS - operator: non_empty - - name: RFENDTC - operator: non_empty + - name: ARMNRS + operator: non_empty + - name: RFENDTC + operator: non_empty Core: Id: CORE-000192 Status: Published @@ -62,15 +62,15 @@ Executability: Fully Executable Outcome: Message: RFENDTC is not blank when ARMNRS is provided. Output Variables: - - ARMNRS - - RFENDTC + - ARMNRS + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000195/rule.yml b/Published/CORE-000195/rule.yml index bdcb04b4e..ee8354775 100644 --- a/Published/CORE-000195/rule.yml +++ b/Published/CORE-000195/rule.yml @@ -2,70 +2,67 @@ # Condition: # Rule: --SCAT ^= --DECOD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0503 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0503 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: --DECOD + - name: --SCAT + operator: equal_to_case_insensitive + value: --DECOD Core: Id: CORE-000195 Status: Published @@ -75,15 +72,15 @@ Executability: Fully Executable Outcome: Message: --SCAT is equal to --DECOD. Output Variables: - - --DECOD - - --SCAT + - --DECOD + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000196/rule.yml b/Published/CORE-000196/rule.yml index 28633f2bd..7235f137c 100644 --- a/Published/CORE-000196/rule.yml +++ b/Published/CORE-000196/rule.yml @@ -2,70 +2,67 @@ # Condition: # Rule: --CAT ^= --DECOD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0502 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0502 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: --DECOD + - name: --CAT + operator: equal_to_case_insensitive + value: --DECOD Core: Id: CORE-000196 Status: Published @@ -75,15 +72,15 @@ Executability: Fully Executable Outcome: Message: --CAT is equal to --DECOD. Output Variables: - - --DECOD - - --CAT + - --DECOD + - --CAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000197/rule.yml b/Published/CORE-000197/rule.yml index 1a8a0fcc8..f3a6db373 100644 --- a/Published/CORE-000197/rule.yml +++ b/Published/CORE-000197/rule.yml @@ -2,70 +2,67 @@ # Condition: # Rule: --CAT ^= --BODSYS Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0504 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0504 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: --BODSYS + - name: --CAT + operator: equal_to_case_insensitive + value: --BODSYS Core: Id: CORE-000197 Status: Published @@ -75,16 +72,16 @@ Executability: Fully Executable Outcome: Message: --CAT is equal to --BODSYS. Output Variables: - - --TERM - - --CAT - - --BODSYS + - --TERM + - --CAT + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000198/rule.yml b/Published/CORE-000198/rule.yml index b892dc8e9..94121e3c4 100644 --- a/Published/CORE-000198/rule.yml +++ b/Published/CORE-000198/rule.yml @@ -2,70 +2,67 @@ # Condition: # Rule: --SCAT ^= --BODSYS Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0505 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0505 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: --BODSYS + - name: --SCAT + operator: equal_to_case_insensitive + value: --BODSYS Core: Id: CORE-000198 Status: Published @@ -75,16 +72,16 @@ Executability: Fully Executable Outcome: Message: --SCAT is equal to --BODSYS. Output Variables: - - --TERM - - --SCAT - - --BODSYS + - --TERM + - --SCAT + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000199/rule.yml b/Published/CORE-000199/rule.yml index ca8546685..384329d14 100644 --- a/Published/CORE-000199/rule.yml +++ b/Published/CORE-000199/rule.yml @@ -2,170 +2,155 @@ # Condition: # Rule: --TEST length <= 40 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since the --TEST variable is meant to serve as a label for a - --TESTCD when a Findings dataset is transposed to a more - horizontal format, the length of --TEST is limited to 40 - characters (except as noted below) to conform to the - limitations of the SAS v5 Transport format currently used for - submission datasets.... IETEST values in IE and TI are - exceptions to the above 40-character rule and are limited to - 200 characters, since they are not expected to be transformed - to column labels. - Document: IG v3.4 - Section: 4.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The length of --TEST is normally limited to 40 characters to - conform to the limitations of the SAS V5 Transport format - currently used for submission datasets. IETEST values in IE - and TI are exceptions to the above 40-character rule and are - limited to 200 characters since they are not expected to be - transformed to a column labels. - Document: IG v3.3 - Section: 4.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The length of --TEST is normally limited to 40 characters to - conform to the limitations of the SAS V5 Transport format - currently used for submission datasets. IETEST values in IE - and TI are exceptions to the above 40-character rule and are - limited to 200 characters since they are not expected to be - transformed to a column labels. - Document: IG v3.2 - Section: 4.1.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because of limitations of SAS v5 Transport files, the lengths of - data values cannot exceed 200 characters. Because --TEST - values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.0 - Section: 4.5.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 - characters. - Document: IG v3.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 - characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 - characters. - Document: IG v3.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 - characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 - characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Since the --TEST variable is meant to serve as a label for a - --TESTCD when a Findings dataset is transposed to a more - horizontal format, the length of --TEST is limited to 40 - characters (except as noted below) to conform to the - limitations of the SAS v5 Transport format currently used for - submission datasets. - Document: TIG 1.0 - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0563 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Since the --TEST variable is meant to serve as a label for a --TESTCD when a + Findings dataset is transposed to a more horizontal format, the length of --TEST is + limited to 40 characters (except as noted below) to conform to the limitations of the SAS + v5 Transport format currently used for submission datasets.... IETEST values in IE and TI + are exceptions to the above 40-character rule and are limited to 200 characters, since + they are not expected to be transformed to column labels. + Document: IG v3.4 + Section: 4.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The length of --TEST is normally limited to 40 characters to conform to the + limitations of the SAS V5 Transport format currently used for submission datasets. IETEST + values in IE and TI are exceptions to the above 40-character rule and are limited to 200 + characters since they are not expected to be transformed to a column labels. + Document: IG v3.3 + Section: 4.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The length of --TEST is normally limited to 40 characters to conform to the + limitations of the SAS V5 Transport format currently used for submission datasets. IETEST + values in IE and TI are exceptions to the above 40-character rule and are limited to 200 + characters since they are not expected to be transformed to a column labels. + Document: IG v3.2 + Section: 4.1.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Because of limitations of SAS v5 Transport files, the lengths of data values + cannot exceed 200 characters. Because --TEST values may become column labels upon + transformation, the SDTM additionally restricts them to 40 characters. + Document: IG v3.0 + Section: 4.5.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Since the --TEST variable is meant to serve as a label for a --TESTCD when a + Findings dataset is transposed to a more horizontal format, the length of --TEST is + limited to 40 characters (except as noted below) to conform to the limitations of the SAS + v5 Transport format currently used for submission datasets. + Document: TIG 1.0 + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0563 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --TEST - operator: longer_than - value: 40 + - name: --TEST + operator: longer_than + value: 40 Core: Id: CORE-000199 Status: Published @@ -175,14 +160,14 @@ Executability: Fully Executable Outcome: Message: Value length of --TEST > 40. Output Variables: - - --TEST + - --TEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - IE + - IE Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000200/rule.yml b/Published/CORE-000200/rule.yml index e1eab4299..ff96518c6 100644 --- a/Published/CORE-000200/rule.yml +++ b/Published/CORE-000200/rule.yml @@ -2,122 +2,117 @@ # Condition: --STAT = null or --DRVFL ^= 'Y' # Rule: --ORRES ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "--ORRES variable contains the result of the measurement or - finding as originally received or collected. --ORRES is an - expected variable and should always be populated, with two - exceptions':' When --STAT = \"NOT DONE\" since there is no - result for such a record When --DRVFL = \"Y\" since the - distinction between an original result and a standard result - is not applicable for records for which --DRVFL = \"Y\" " - Document: IG v3.4 - Item: ' ' - Section: 4.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "The --ORRES variable contains the result of the measurement or - finding as originally received or collected. --ORRES is an - expected variable and should always be populated; with two - exceptions: When --STAT = 'NOT DONE'. --ORRES should generally - not be populated for derived records." - Document: IG v3.2 - Section: 4.1.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "The --ORRES variable contains the result of the measurement or - finding as originally received or collected. --ORRES is an - expected variable and should always be populated; with two - exceptions: When --STAT = 'NOT DONE'. --ORRES should generally - not be populated for derived records." - Document: IG v3.3 - Section: 4.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: In general observation class domains, --STAT will be populated - with "NOT DONE" when data are not collected for the topic of - the observation. - Document: TIG 1.0 - Item: Findings table Num 5 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0513 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "--ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated, with + two exceptions':' When --STAT = \"NOT DONE\" since there is no result for such a record When + --DRVFL = \"Y\" since the distinction between an original result and a standard result is not + applicable for records for which --DRVFL = \"Y\" " + Document: IG v3.4 + Item: ' ' + Section: 4.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "The --ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated; with + two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived + records." + Document: IG v3.2 + Section: 4.1.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "The --ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated; with + two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived + records." + Document: IG v3.3 + Section: 4.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: In general observation class domains, --STAT will be populated with "NOT + DONE" when data are not collected for the topic of the observation. + Document: TIG 1.0 + Item: Findings table Num 5 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0513 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: --STAT - operator: empty - - name: --DRVFL - operator: not_equal_to - value: 'Y' - value_is_literal: true - - name: --ORRES - operator: empty - - all: - - name: --STAT - operator: empty - - name: --DRVFL - operator: not_exists - - name: --ORRES - operator: empty - - all: - - name: --STAT - operator: not_exists - - name: --DRVFL - operator: not_equal_to - value: 'Y' - value_is_literal: true - - name: --ORRES - operator: empty + - all: + - name: --STAT + operator: empty + - name: --DRVFL + operator: not_equal_to + value: 'Y' + value_is_literal: true + - name: --ORRES + operator: empty + - all: + - name: --STAT + operator: empty + - name: --DRVFL + operator: not_exists + - name: --ORRES + operator: empty + - all: + - name: --STAT + operator: not_exists + - name: --DRVFL + operator: not_equal_to + value: 'Y' + value_is_literal: true + - name: --ORRES + operator: empty Core: Id: CORE-000200 Status: Published Version: '1' -Description: Verify that --ORRES is not missing when either --STAT is null or - --DRVFL not equal to 'Y' +Description: Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to + 'Y' Executability: Fully Executable Outcome: Message: --ORRES cannot be null when --STAT is null or --DRVFL not equal to 'Y' Output Variables: - - --STAT - - --DRVFL - - --ORRES + - --STAT + - --DRVFL + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000201/rule.yml b/Published/CORE-000201/rule.yml index b6ffd4270..bbe4e5579 100644 --- a/Published/CORE-000201/rule.yml +++ b/Published/CORE-000201/rule.yml @@ -2,204 +2,199 @@ # Condition: Domain Not in ('AP--') # Rule: USUBJID in DM.USUBJID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) is required in all - datasets containing subject-level data. USUBJID values must be - unique for each trial participant (subject) across all trials - in the submission. - Document: IG v3.4 - Section: 4.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) is required in all - datasets containing subject-level data. USUBJID values must be - unique for each trial participant (subject) across all trials - in the submission. - Document: IG v3.3 - Section: 4.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '... a unique identifier (USUBJID) should be assigned and - included in all datasets. The unique subject identifier - (USUBJID) is required in all datasets containing subject-level - data.' - Document: IG v3.2 - Section: 4.1.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies for all applications or submissions involving the - product. This must be a unique value, and could be a compound - identifier formed by concatenating STUDYID-SITEID-SUBJID. - Document: TIG 1.0 - Item: Specification- USUBJID - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0311 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.0 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.5.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique - identifier (USUBJID) should be assigned and included in all - subject-related datasets in the submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies for all applications or submissions involving the - product. - Document: TIG 1.0 - Item: USUBJID CDISC Notes - Section: 2.8.9.6 SEND Demographics (DM) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0046 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets + containing subject-level data. USUBJID values must be unique for each trial participant + (subject) across all trials in the submission. + Document: IG v3.4 + Section: 4.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets + containing subject-level data. USUBJID values must be unique for each trial participant + (subject) across all trials in the submission. + Document: IG v3.3 + Section: 4.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '... a unique identifier (USUBJID) should be assigned and included in all datasets. + The unique subject identifier (USUBJID) is required in all datasets containing subject-level + data.' + Document: IG v3.2 + Section: 4.1.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. This must be a unique value, and could + be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. + Document: TIG 1.0 + Item: Specification- USUBJID + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0311 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.0 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.5.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: TIG 1.0 + Item: USUBJID CDISC Notes + Section: 2.8.9.6 SEND Demographics (DM) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0046 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: USUBJID - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid + - name: USUBJID + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid Core: Id: CORE-000201 Status: Published Version: '1' -Description: Trigger error when domain is not an AP-- domain and USUBJID is not - present in DM.USUBJID +Description: Trigger error when domain is not an AP-- domain and USUBJID is not present in + DM.USUBJID Executability: Fully Executable Operations: - - domain: DM - id: $dm_usubjid - name: USUBJID - operator: distinct +- domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct Outcome: Message: USUBJID is not found in DM.USUBJID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - AP-- + - AP-- Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000202/rule.yml b/Published/CORE-000202/rule.yml index 43937667b..f961ae4df 100644 --- a/Published/CORE-000202/rule.yml +++ b/Published/CORE-000202/rule.yml @@ -2,95 +2,88 @@ # Condition: IDVAR populated with a --SEQ value # Rule: RELTYPE = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY. Used only - when identifying a relationship between datasets (as described - in Section 8.3, Relating Datasets). - Document: IG 3.4 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join - records between the datasets, --SEQ cannot be used because - --SEQ only has meaning within a subject within a dataset, not - across datasets. - Document: IG 3.4 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY. Used only - when identifying a relationship between datasets (as described - in Section 8.3, Relating Datasets). - Document: IG v3.2 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join - records between the datasets, --SEQ cannot be used because - --SEQ only has meaning within a subject within a dataset, not - across datasets. - Document: IG v3.2 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY. Used only - when identifying a relationship between datasets (as described - in Section 8.3, Relating Datasets). - Document: IG 3.3 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join - records between the datasets, --SEQ cannot be used because - --SEQ only has meaning within a subject within a dataset, not - across datasets. - Document: IG 3.3 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY. Used only - when identifying a relationship between datasets (as described - in Section 2.8.5.2. - Document: TIG 1.0 - Section: 2.8.5.2|2.8.10.21 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0574 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG 3.4 + Section: 8.2.1 + - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG 3.4 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG v3.2 + Section: 8.2.1 + - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG v3.2 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG 3.3 + Section: 8.2.1 + - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG 3.3 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 2.8.5.2. + Document: TIG 1.0 + Section: 2.8.5.2|2.8.10.21 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0574 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IDVAR - operator: suffix_matches_regex - suffix: 3 - value: SEQ - - name: RELTYPE - operator: non_empty + - name: IDVAR + operator: suffix_matches_regex + suffix: 3 + value: SEQ + - name: RELTYPE + operator: non_empty Core: Id: CORE-000202 Status: Published @@ -100,15 +93,15 @@ Executability: Fully Executable Outcome: Message: RELTYPE is populated when IDVAR is populated with a 'SEQ' value. Output Variables: - - IDVAR - - RELTYPE + - IDVAR + - RELTYPE Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000203/rule.yml b/Published/CORE-000203/rule.yml index e91a100c3..0ef07d96f 100644 --- a/Published/CORE-000203/rule.yml +++ b/Published/CORE-000203/rule.yml @@ -2,112 +2,108 @@ # Condition: # Rule: IDVAR, IDVARVAL, and QNAM a unique combination per parent subject record Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The combined set of values for the first six columns - (STUDYID…QNAM) should be unique for every record. That is, - there should not be multiple records in a SUPP-- dataset for - the same QNAM value, as it relates to IDVAR/IDVARVAL for a - USUBJID in a domain. - Document: IG v3.4 - Section: '8.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per IDVAR, IDVARVAL, and QNAM value per subject - Document: IG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The combined set of values for the first six columns - (STUDYID-QNAM) should be unique for every record. That is; - there should not be multiple records in a SUPP-- dataset for - the same QNAM value; as it relates to IDVAR/IDVARVAL for a - USUBJID in a domain. - Document: IG v3.3 - Section: '8.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A relationship dataset used to describe nonstandard variables - and their association to parent records in general-observation - class datasets. - Document: TIG 1.0 - Item: Specifications IDVAR,IDVARVAL,QNAM|Description - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0567 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The combined set of values for the first six columns (STUDYID…QNAM) should + be unique for every record. That is, there should not be multiple records in a SUPP-- + dataset for the same QNAM value, as it relates to IDVAR/IDVARVAL for a USUBJID in a + domain. + Document: IG v3.4 + Section: '8.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per IDVAR, IDVARVAL, and QNAM value per subject + Document: IG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The combined set of values for the first six columns (STUDYID-QNAM) should + be unique for every record. That is; there should not be multiple records in a SUPP-- + dataset for the same QNAM value; as it relates to IDVAR/IDVARVAL for a USUBJID in a + domain. + Document: IG v3.3 + Section: '8.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A relationship dataset used to describe nonstandard variables and their + association to parent records in general-observation class datasets. + Document: TIG 1.0 + Item: Specifications IDVAR,IDVARVAL,QNAM|Description + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0567 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: RDOMAIN - operator: equal_to - value: DM - value_is_literal: true - - name: USUBJID - operator: is_not_unique_set - value: - - QNAM - - all: - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: USUBJID - operator: is_not_unique_set - value: - - IDVAR - - IDVARVAL - - QNAM + - all: + - name: RDOMAIN + operator: equal_to + value: DM + value_is_literal: true + - name: USUBJID + operator: is_not_unique_set + value: + - QNAM + - all: + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: USUBJID + operator: is_not_unique_set + value: + - IDVAR + - IDVARVAL + - QNAM Core: Id: CORE-000203 Status: Published Version: '1' -Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is - not unique per parent subject record +Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per + parent subject record Executability: Fully Executable Outcome: - Message: The combination of IDVAR, IDVARVAL, and QNAM is not unique per parent - subject record + Message: The combination of IDVAR, IDVARVAL, and QNAM is not unique per parent subject record Output Variables: - - USUBJID - - IDVAR - - IDVARVAL - - QNAM + - USUBJID + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000204/rule.yml b/Published/CORE-000204/rule.yml index a041d62f7..e614de541 100644 --- a/Published/CORE-000204/rule.yml +++ b/Published/CORE-000204/rule.yml @@ -2,115 +2,108 @@ # Condition: Scheduled or Contingent visit (exists in TV) # Rule: VISITNUM identifies unique record within subject Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: IG v3.4 - Item: 7.3.1.1 TV - Section: '5.5' - - Cited Guidance: Some data collection is contingent on the occurrence of a - "trigger" event, or disease milestone (see the Trial Disease - Milestones (TM) dataset under Section 7.3, Schedule for - Assessments (TV, TD, and TM)). When such planned data - collection involves an additional clinic visit, a "contingent" - Visit may be included in the trial visits table, with start a - rule that describes the circumstances under which it will take - place. Since values of VISITNUM must be assigned to all - records in the Trial Visits dataset, a contingent Visit - included in the Trial Visits dataset must have a VISITNUM, but - the VISITNUM value may not be a "chronological" value, due to - the uncertain timing of a contingent Visit. If contingent - visits are not included in the TV dataset, then they would be - treated as unplanned visits in the Subject Visits (SV) domain. - Document: IG v3.4 - Item: TV Issues 4 - Section: 7.3.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: IG v3.2 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[5.5 SV][One record per subject per actual visit.]|IG - v3.3[7.3.1.1 TV][TV Issues 4][Some data collection is - contingent on the occurrence of a "trigger" event; or disease - milestone (see Section 7.3.3 Trial Disease Milestones). When - such planned data collection involves an additional clinic - visit; a "contingent" Visit may be included in the trial - visits table;] - Document: IG v3.3 - Item: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV][TV Issues 4] - Section: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: TIG v1.0 - Item: Assumption 1 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0566 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: IG v3.4 + Item: 7.3.1.1 TV + Section: '5.5' + - Cited Guidance: Some data collection is contingent on the occurrence of a "trigger" event, + or disease milestone (see the Trial Disease Milestones (TM) dataset under Section 7.3, + Schedule for Assessments (TV, TD, and TM)). When such planned data collection involves an + additional clinic visit, a "contingent" Visit may be included in the trial visits table, + with start a rule that describes the circumstances under which it will take place. Since + values of VISITNUM must be assigned to all records in the Trial Visits dataset, a + contingent Visit included in the Trial Visits dataset must have a VISITNUM, but the + VISITNUM value may not be a "chronological" value, due to the uncertain timing of a + contingent Visit. If contingent visits are not included in the TV dataset, then they would + be treated as unplanned visits in the Subject Visits (SV) domain. + Document: IG v3.4 + Item: TV Issues 4 + Section: 7.3.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: IG v3.2 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[5.5 SV][One record per subject per actual visit.]|IG v3.3[7.3.1.1 + TV][TV Issues 4][Some data collection is contingent on the occurrence of a "trigger" + event; or disease milestone (see Section 7.3.3 Trial Disease Milestones). When such + planned data collection involves an additional clinic visit; a "contingent" Visit may be + included in the trial visits table;] + Document: IG v3.3 + Item: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV][TV Issues 4] + Section: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: TIG v1.0 + Item: Assumption 1 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0566 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISITNUM - operator: is_not_unique_set - value: USUBJID + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISITNUM + operator: is_not_unique_set + value: USUBJID Core: Id: CORE-000204 Status: Published Version: '1' -Description: When VISITNUM is present in TV.VISITNUM, SV.VISITNUM must be unique - within subject +Description: When VISITNUM is present in TV.VISITNUM, SV.VISITNUM must be unique within subject Executability: Fully Executable Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: Scheduled or Contingent visit is not unique within subject Output Variables: - - USUBJID - - VISITNUM + - USUBJID + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000206/rule.yml b/Published/CORE-000206/rule.yml index 53ffee142..1c50110ce 100644 --- a/Published/CORE-000206/rule.yml +++ b/Published/CORE-000206/rule.yml @@ -1,260 +1,249 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v2.0 - Item: IDVARVAL - Section: Comments - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v2.0 - Item: IDVARVAL - Section: Supplemental Qualifiers - - Cited Guidance: Value of identifying variable described in IDVAR. - Document: Model v2.0 - Item: IDVARVAL - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: SDTM v2.1 - Item: IDVARVAL - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVARVAL - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVARVAL - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0535 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of - the parent record(s)to which the comment applies.' and 'Value - of identifying variable of the parent record(s).', - respectively." - Document: SENDIG v3.0 - Item: Assumption 3.a - Section: 5.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). Assumptions for populating - IDVAR and IDVARVAL are further described in Section 8.2. - Document: SENDIG v3.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). Assumptions for populating - IDVAR and IDVARVAL are further described in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). Assumptions for populating - IDVAR and IDVARVAL are further described in Section 8.2. - Document: SENDIG v3.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). Assumptions for populating - IDVAR and IDVARVAL are further described in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). Assumptions for populating - IDVAR and IDVARVAL are further described in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, - in which case the value of the variable RDOMAIN is set to the - DOMAIN code of the parent record(s), and the variables IDVAR - and IDVARVAL are populated with the key variable name and - value of the parent record(s). - Document: TIG v1.0 - Item: Assumption 3.a - Section: 2.8.9.4 SEND Comments (CO) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0058 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v2.0 + Item: IDVARVAL + Section: Comments + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v2.0 + Item: IDVARVAL + Section: Supplemental Qualifiers + - Cited Guidance: Value of identifying variable described in IDVAR. + Document: Model v2.0 + Item: IDVARVAL + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVARVAL + Section: 3.2.2 Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVARVAL + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVARVAL + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0535 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of the parent record(s)to + which the comment applies.' and 'Value of identifying variable of the parent record(s).', respectively." + Document: SENDIG v3.0 + Item: Assumption 3.a + Section: 5.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). + Document: TIG v1.0 + Item: Assumption 3.a + Section: 2.8.9.4 SEND Comments (CO) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0058 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # Variable: IDVARVAL # Condition: IDVAR ^= null # Rule: IDVARVAL = value of variable = IDVAR in domain = RDOMAIN Check: all: - - name: IDVAR - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: IDVARVAL - operator: not_equal_to - type_insensitive: true - value: IDVAR - value_is_reference: true + - name: IDVAR + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: IDVARVAL + operator: not_equal_to + type_insensitive: true + value: IDVAR + value_is_reference: true Core: Id: CORE-000206 Status: Published Version: '1' -Description: When IDVAR is populated, IDVARVAL must equal a value of the - variable referenced by IDVAR within the domain referenced by RDOMAIN +Description: When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by + IDVAR within the domain referenced by RDOMAIN Executability: Fully Executable Match Datasets: - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: SUPP-- - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: CO - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: RELREC +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: SUPP-- +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: CO +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: RELREC Outcome: - Message: IDVARVAL does not equal a value of the variable referenced by IDVAR in - domain = RDOMAIN. + Message: IDVARVAL does not equal a value of the variable referenced by IDVAR in domain = RDOMAIN. Output Variables: - - RDOMAIN - - USUBJID - - IDVAR - - IDVARVAL + - RDOMAIN + - USUBJID + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - RELATIONSHIP + - SPECIAL PURPOSE + - RELATIONSHIP Domains: Include: - - CO - - SUPP-- - - RELREC + - CO + - SUPP-- + - RELREC Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000207/rule.yml b/Published/CORE-000207/rule.yml index 03b29f687..8146e75de 100644 --- a/Published/CORE-000207/rule.yml +++ b/Published/CORE-000207/rule.yml @@ -2,246 +2,218 @@ # Condition: # Rule: --STDTC not present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that --STDTC should not be used in the Findings general - observation class and is therefore blank in the following - table. - Document: IG v3.4 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[4.1.1.3][Additional Timing variables can be added as - needed to a standard domain model based on the three general - observation classes except where discouraged in Assumption - 4.1.4.8 and specific domain assumptions. Timing variables can - be added to special-purpose domains only where specified in - the SDTMIG domain model assumptions. Timing variables cannot - be added to SUPPQUAL datasets or to RELREC]|IG - v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g., - "2006-11-02"Date and Time Reported in a Domain Based on - Findings. When the date/time of collection is reported in any - domain, the date/time should go into the --DTC field (e.g., - EGDTC for Date/Time of ECG). For any domain based on the - Findings general observation class, such as lab tests which - are based on a specimen, the collection date is likely to be - tied to when the specimen or source of the finding was - captured, not necessarily when the data was recorded. In order - to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used - to represent the time of specimen collection. For example, in - the LB domain the LBDTC variable would be used for all - single-point blood collections or spot urine collections. For - timed lab collections (e.g., 24-hour urine collections) the - LBDTC variable would be used for the start date/time of the - collection and LBENDTC for the end date/time of the - collection. This approach will allow the single-point and - interval collections to use the same date/time variables - consistently across all datasets for the Findings general - observation class. The table below illustrates the proper use - of these variables. Note that --STDTC is not used for - collection dates over an interval, so is blank in the - following table.] - Document: IG v3.2 - Section: IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[4.1.3][Additional Timing variables can be added as - needed to a standard domain model based on the three general - observation classes except where discouraged in Assumption - 4.4.8 and specific domain assumptions. Timing variables can be - added to special-purpose domains only where specified in the - SDTMIG domain model assumptions. Timing variables cannot be - added to SUPPQUAL datasets or to RELREC]|IG v3.3[4.4.8][When - the date/time of collection is reported in any domain, the - date/time should go into the --DTC field (e.g., EGDTC for - Date/Time of ECG). For any domain based on the Findings - general observation class, such as lab tests which are based - on a specimen, the collection date is likely to be tied to - when the specimen or source of the finding was captured, not - necessarily when the data was recorded. In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection. For example, in the LB domain the - LBDTC variable would be used for all single-point blood - collections or spot urine collections. For timed lab - collections (e.g., 24-hour urine collections) the LBDTC - variable would be used for the start date/time of the - collection and LBENDTC for the end date/time of the - collection. This approach will allow the single-point and - interval collections to use the same date/time variables - consistently across all datasets for the Findings general - observation class. The table below illustrates the proper use - of these variables. Note that --STDTC is not used for - collection dates over an interval, so is blank in the - following table.] - Document: IG v3.3 - Section: IG v3.3[4.1.3]|IG v3.3[4.4.8] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.0 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in Findings class domains | Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--STDTC - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend - Domains | 2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0597 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the - date/time should go into the --DTC field...In order to ensure - that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used - for collection dates over an interval. - Document: TIG v1.0 - Item: text - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0276 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Note that --STDTC should not be used in the Findings general observation + class and is therefore blank in the following table. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[4.1.1.3][Additional Timing variables can be added as needed to a + standard domain model based on the three general observation classes except where + discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be + added to special-purpose domains only where specified in the SDTMIG domain model + assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG + v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g., "2006-11-02"Date and Time + Reported in a Domain Based on Findings. When the date/time of collection is reported in + any domain, the date/time should go into the --DTC field (e.g., EGDTC for Date/Time of + ECG). For any domain based on the Findings general observation class, such as lab tests + which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. For example, in the LB domain the LBDTC variable would be used for all + single-point blood collections or spot urine collections. For timed lab collections (e.g., + 24-hour urine collections) the LBDTC variable would be used for the start date/time of the + collection and LBENDTC for the end date/time of the collection. This approach will allow + the single-point and interval collections to use the same date/time variables consistently + across all datasets for the Findings general observation class. The table below + illustrates the proper use of these variables. Note that --STDTC is not used for + collection dates over an interval, so is blank in the following table.] + Document: IG v3.2 + Section: IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[4.1.3][Additional Timing variables can be added as needed to a + standard domain model based on the three general observation classes except where + discouraged in Assumption 4.4.8 and specific domain assumptions. Timing variables can be + added to special-purpose domains only where specified in the SDTMIG domain model + assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG + v3.3[4.4.8][When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field (e.g., EGDTC for Date/Time of ECG). For any domain based on + the Findings general observation class, such as lab tests which are based on a specimen, + the collection date is likely to be tied to when the specimen or source of the finding was + captured, not necessarily when the data was recorded. In order to ensure that the critical + timing information is always represented in the same variable, the --DTC variable is used + to represent the time of specimen collection. For example, in the LB domain the LBDTC + variable would be used for all single-point blood collections or spot urine collections. + For timed lab collections (e.g., 24-hour urine collections) the LBDTC variable would be + used for the start date/time of the collection and LBENDTC for the end date/time of the + collection. This approach will allow the single-point and interval collections to use the + same date/time variables consistently across all datasets for the Findings general + observation class. The table below illustrates the proper use of these variables. Note + that --STDTC is not used for collection dates over an interval, so is blank in the + following table.] + Document: IG v3.3 + Section: IG v3.3[4.1.3]|IG v3.3[4.4.8] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.0 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in Findings class domains | Select variables for the domain from the + SDTM. Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--STDTC + Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains | 2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0597 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval. + Document: TIG v1.0 + Item: text + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0276 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --STDTC - operator: exists + - name: --STDTC + operator: exists Core: Id: CORE-000207 Status: Published @@ -251,14 +223,14 @@ Executability: Fully Executable Outcome: Message: --STDTC is present in a Findings general observation class Output Variables: - - --STDTC + - --STDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000208/rule.yml b/Published/CORE-000208/rule.yml index ab31ae2ae..d06967232 100644 --- a/Published/CORE-000208/rule.yml +++ b/Published/CORE-000208/rule.yml @@ -2,90 +2,87 @@ # Condition: Study does not use multi-stage arm assignments and ACTARMCD ^= null # Rule: ACTARMCD in TA.ARMCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0512 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0512 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ACTARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0607 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0512 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0512 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ACTARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0607 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARMCD - operator: non_empty - - name: ACTARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ACTARMCD + operator: non_empty + - name: ACTARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000208 Status: Published Version: '1' -Description: Trigger error when study does not use multi-stage arm assignments - and ACTARMCD ^= null, and ACTARMCD is not in TA.ARMCD +Description: Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null, + and ACTARMCD is not in TA.ARMCD Executability: Partially Executable - Possible Overreporting Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ACTARMCD is not in TA.ARMCD Output Variables: - - ACTARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000209/rule.yml b/Published/CORE-000209/rule.yml index 8230360e0..234801b61 100644 --- a/Published/CORE-000209/rule.yml +++ b/Published/CORE-000209/rule.yml @@ -2,96 +2,91 @@ # Condition: Study does not use multi-stage arm assignments and ACTARM ^= null # Rule: ACTARM in TA.ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned Arm, ACTARM is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0514 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0514 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ACTARM - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0609 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARM is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0514 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0514 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ACTARM + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0609 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARM - operator: non_empty - - name: ACTARM - operator: is_not_contained_by - value: $ta_arm + - name: ACTARM + operator: non_empty + - name: ACTARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000209 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ACTARM is - populated, ACTARM must be present in TA.ARM. This rule has been executed to - identify all cases when ACTARM is not present in TA.ARM and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM + must be present in TA.ARM. This rule has been executed to identify all cases when ACTARM is not + present in TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage + arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: - Message: ACTARM value in DM dataset is not among the values of ARM variable in - the TA dataset. This is allowed only in a multistage study with incomplete - ARM assignment. Please confirm if your study is a multistage assignment - study. + Message: ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset. + This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if + your study is a multistage assignment study. Output Variables: - - ACTARM + - ACTARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000210/rule.yml b/Published/CORE-000210/rule.yml index ef2b2b857..ef643265d 100644 --- a/Published/CORE-000210/rule.yml +++ b/Published/CORE-000210/rule.yml @@ -2,89 +2,85 @@ # Condition: Study does not use multi-stage arm assignments and ARMCD ^= null # Rule: ARMCD in TA.ARMCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm, ARMCD is - null and ARMNRS is populated - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0516 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0516 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm, ARMCD is - null and ARMNRS is populated - Document: TIG 1.0 - Item: Specification:ARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0611 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0516 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0516 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: TIG 1.0 + Item: Specification:ARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0611 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000210 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is - populated, ARMCD must be present in TA.ARMCD. This rule has been executed to - identify all cases when ARMCD is not present in TA.ARMCD and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000212/rule.yml b/Published/CORE-000212/rule.yml index 202efdf9e..e91d37704 100644 --- a/Published/CORE-000212/rule.yml +++ b/Published/CORE-000212/rule.yml @@ -2,104 +2,96 @@ # Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' # Rule: DSSCAT must be present Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either - disposition of study participation or of a study - treatment. It describes whether a subject completed study - participation or a study treatment, and if not, the reason - they did not complete it. Dispositions may be described for - each Epoch (e.g., screening, initial treatment, washout, - cross-over treatment, follow-up) or for the study as a whole. - If disposition events for both study participation and study - treatment(s) are to be represented, then DSSCAT provides this - distinction. The value of DSSCAT is based on the sponsor's - controlled terminology, however for records with DSCAT = - "DISPOSITION EVENT", DSSCAT = "STUDY PARTICIPATION" is used to - represent disposition of study participation. DSSCAT = "STUDY - TREATMENT" can be used as a generic identifier when a study - has only a single treatment. If a study has multiple - treatments, then DSSCAT should name the individual treatment. - Document: IG v3.4 - Item: DS – Assumption 2b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If separate disposition events for both study participation and - study treatment(s) are to be represented, then DSSCAT provides - this distinction. - Document: IG v3.3 - Item: Assumption 2.b - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either - disposition of study participation or of a product exposure. - It describes whether a subject completed study participation - or a product exposure and, if not, the reason they did not - complete it. Dispositions may be described for each epoch - (e.g., screening, initial exposure, washout, cross-over, - follow-up) or for the study as a whole. If disposition events - for both study participation and product exposure(s) are to be - represented, then DSSCAT provides this distinction. - Document: TIG 1.0 - Item: Assumption 2b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0628 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a study treatment. It describes whether a subject completed + study participation or a study treatment, and if not, the reason they did not complete it. + Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout, + cross-over treatment, follow-up) or for the study as a whole. If disposition events for + both study participation and study treatment(s) are to be represented, then DSSCAT + provides this distinction. The value of DSSCAT is based on the sponsor's controlled + terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY + PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY + TREATMENT" can be used as a generic identifier when a study has only a single treatment. + If a study has multiple treatments, then DSSCAT should name the individual treatment. + Document: IG v3.4 + Item: DS – Assumption 2b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If separate disposition events for both study participation and study + treatment(s) are to be represented, then DSSCAT provides this distinction. + Document: IG v3.3 + Item: Assumption 2.b + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a product exposure. It describes whether a subject completed + study participation or a product exposure and, if not, the reason they did not complete + it. Dispositions may be described for each epoch (e.g., screening, initial exposure, + washout, cross-over, follow-up) or for the study as a whole. If disposition events for + both study participation and product exposure(s) are to be represented, then DSSCAT + provides this distinction. + Document: TIG 1.0 + Item: Assumption 2b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0628 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - - name: DSSCAT - operator: not_exists + - name: DSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + - name: DSSCAT + operator: not_exists Core: Id: CORE-000212 Status: Published Version: '1' -Description: When subject has more than one record per Epoch with DSCAT = - DISPOSITION EVENT, DSSCAT must be present. +Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT + must be present. Executability: Fully Executable Outcome: - Message: DSSCAT is not present when subject has more than one record per Epoch - with DSCAT = 'DISPOSITION EVENT'. + Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT = + 'DISPOSITION EVENT'. Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000213/rule.yml b/Published/CORE-000213/rule.yml index 6ecc79698..0293a6346 100644 --- a/Published/CORE-000213/rule.yml +++ b/Published/CORE-000213/rule.yml @@ -2,107 +2,97 @@ # Condition: DSCAT = 'DISPOSITION EVENT' and DSSCAT is present in dataset. # Rule: At most one record per subject per DSSCAT per epoch, including null values of DSSCAT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and study - treatment(s) are to be represented, then DSSCAT provides this - distinction. - Document: IG v3.4 - Item: Assumption 2.b - Section: 6.2.3 - - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for - discontinuation' should be presented, and that summaries - should be 'grouped by treatment and by major reason.' The - CDISC SDS Team interprets this guidance as requiring one - standardized disposition term (DSDECOD) per disposition event. - If multiple reasons are reported, the sponsor should identify - a primary reason and use that to populate DSTERM and DSDECOD. - Additional reasons should be submitted in SUPPDS." - Document: IG v3.4 - Item: Assumption 5 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0536 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Assumption 2.b[If disposition events for both study - participation and study treatment(s) are to be represented, - then DSSCAT provides this distinction.]|Assumption - 2.b|Assumption 5[ICH E3: Section 10.1 indicates that 'the - specific reason for discontinuation' should be presented, and - that summaries should be 'grouped by treatment and by major - reason.' The CDISC SDS Team interprets this guidance as - requiring one standardized disposition term (DSDECOD) per - disposition event. If multiple reasons are reported, the - sponsor should identify a primary reason and use that to - populate DSTERM and DSDECOD. Additional reasons should be - submitted in SUPPDS.]" - Document: IG v3.3 - Item: Assumption 2.b|Assumption 5 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0536 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and product - exposure(s) are to be represented, then DSSCAT provides this - distinction - Document: TIG 1.0 - Item: Assumption 2.b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0629 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction. + Document: IG v3.4 + Item: Assumption 2.b + Section: 6.2.3 + - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' + should be presented, and that summaries should be 'grouped by treatment and by major reason.' + The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) + per disposition event. If multiple reasons are reported, the sponsor should identify a primary + reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in + SUPPDS." + Document: IG v3.4 + Item: Assumption 5 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0536 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Assumption 2.b[If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction.]|Assumption 2.b|Assumption 5[ICH + E3: Section 10.1 indicates that 'the specific reason for discontinuation' should be presented, + and that summaries should be 'grouped by treatment and by major reason.' The CDISC SDS Team + interprets this guidance as requiring one standardized disposition term (DSDECOD) per disposition + event. If multiple reasons are reported, the sponsor should identify a primary reason and use + that to populate DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" + Document: IG v3.3 + Item: Assumption 2.b|Assumption 5 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0536 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If disposition events for both study participation and product exposure(s) + are to be represented, then DSSCAT provides this distinction + Document: TIG 1.0 + Item: Assumption 2.b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0629 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - value_is_literal: true - - name: DSSCAT - operator: exists - - name: EPOCH - operator: is_not_unique_set - value: - - USUBJID - - DSSCAT + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + value_is_literal: true + - name: DSSCAT + operator: exists + - name: EPOCH + operator: is_not_unique_set + value: + - USUBJID + - DSSCAT Core: Id: CORE-000213 Status: Published Version: '1' -Description: Trigger error when there is more than one record per subject per - DSSCAT per EPOCH +Description: Trigger error when there is more than one record per subject per DSSCAT per EPOCH Executability: Fully Executable Outcome: Message: More than one record per subject per DSSCAT per EPOCH Output Variables: - - DSSCAT - - EPOCH + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000214/rule.yml b/Published/CORE-000214/rule.yml index 026188586..734842fca 100644 --- a/Published/CORE-000214/rule.yml +++ b/Published/CORE-000214/rule.yml @@ -2,98 +2,97 @@ # Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' # Rule: No more than 1 record per subject has DSSCAT = 'STUDY PARTICIPATION' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition - of study participation - Document: IG v3.4 - Item: Assumption 2.b.1 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0538 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition - of study participation. - Document: IG v3.3 - Item: Assumption 2.b.1 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0538 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition - of study participation. - Document: TIG 1.0 - Item: 2.b.i - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0631 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation + Document: IG v3.4 + Item: Assumption 2.b.1 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0538 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation. + Document: IG v3.3 + Item: Assumption 2.b.1 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0538 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation. + Document: TIG 1.0 + Item: 2.b.i + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0631 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $disposition_event_count - operator: greater_than - value: 1 - - name: DSSCAT - operator: equal_to - value: STUDY PARTICIPATION - value_is_literal: true - - name: DSSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH + - name: $disposition_event_count + operator: greater_than + value: 1 + - name: DSSCAT + operator: equal_to + value: STUDY PARTICIPATION + value_is_literal: true + - name: DSSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH Core: Id: CORE-000214 Status: Published Version: '1' -Description: Trigger error when subject has more than one record per Epoch with - DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY - PARTICIPATION' +Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION + EVENT' and more than one record where DSSCAT = 'STUDY PARTICIPATION' Executability: Fully Executable Operations: - - domain: DS - filter: - DSCAT: DISPOSITION EVENT - group: - - USUBJID - - EPOCH - id: $disposition_event_count - name: DSCAT - operator: record_count +- domain: DS + filter: + DSCAT: DISPOSITION EVENT + group: + - USUBJID + - EPOCH + id: $disposition_event_count + name: DSCAT + operator: record_count Outcome: - Message: More than 1 record exists per subject per EPOCH with DSCAT = - 'DISPOSITION EVENT' and DSSCAT = 'STUDY PARTICIPATION'. + Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + DSSCAT = 'STUDY PARTICIPATION'. Output Variables: - - DSSCAT - - USUBJID - - EPOCH - - DSCAT + - DSSCAT + - USUBJID + - EPOCH + - DSCAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml index 79c2a524b..d367cf211 100644 --- a/Published/CORE-000217/rule.yml +++ b/Published/CORE-000217/rule.yml @@ -2,165 +2,153 @@ # Condition: ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT = null # Rule: ECDOSTXT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.4 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.3 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.2 - Item: Assumption 4a|Assumption 4b - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is - the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method - for indicating doses not taken, not given, or - missed.]|Assumption 4b[Qualifiers that indicate dose amount - (e.g., ECDOSE, ECDOSTXT) may be populated with positive - (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: TIG 1.0 - Item: Assumption 4a|4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0592 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.4 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.3 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.2 + Item: Assumption 4a|Assumption 4b + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: TIG 1.0 + Item: Assumption 4a|4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0592 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty Core: Id: CORE-000217 Status: Published Version: '1' -Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', - ECSTAT is empty and ECDOSTXT is empty +Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and + ECDOSTXT is empty Executability: Fully Executable Outcome: - Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but - ECDOSTXT is also empty. + Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also + empty. Output Variables: - - ECDOSE - - ECOCCUR - - ECSTAT - - ECDOSTXT + - ECDOSE + - ECOCCUR + - ECSTAT + - ECDOSTXT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000218/rule.yml b/Published/CORE-000218/rule.yml index 66b57641e..992246afa 100644 --- a/Published/CORE-000218/rule.yml +++ b/Published/CORE-000218/rule.yml @@ -2,178 +2,176 @@ # Condition: IDVAR = null # Rule: IDVARVAL = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Comments[Value of identifying variable of the parent - record(s).]|Supplemental Qualifiers[Value of identifying - variable of the parent record(s).] - Document: Model v2.0 - Item: IDVARVAL - Section: Comments|Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. Null for comments collected on separate CRFs. - Value of identifying variable of the parent record(s). Null - for comments collected on separate CRFs. - Document: Model v1.7 - Item: '' - Section: 2.2.7|5.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. Examples AESEQ or - CMGRPID. Used only when individual comments are related to - domain records. Null for comments collected on separate CRFs. - Value of identifying variable of the parent record(s). Null - for comments collected on separate CRFs. - Document: Model v1.4 - Item: '' - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.0 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.1.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.1.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to - domain records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification IDVARVAL - Document: SDTM v2.1 - Item: IDVARVAL - Section: Section 3.2.2 Comments|Section 6.2 Supplemental Qualifiers - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0595 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: TIG v1.0 - Item: IDVARVAL CDISC Notes - Section: 2.8.9.4 SEND Comments (CO) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0055 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Comments[Value of identifying variable of the parent + record(s).]|Supplemental Qualifiers[Value of identifying variable of the parent + record(s).] + Document: Model v2.0 + Item: IDVARVAL + Section: Comments|Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. Value of + identifying variable of the parent record(s). Null for comments collected on separate + CRFs. + Document: Model v1.7 + Item: '' + Section: 2.2.7|5.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. Value of + identifying variable of the parent record(s). Null for comments collected on separate + CRFs. + Document: Model v1.4 + Item: '' + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.0 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification IDVARVAL + Document: SDTM v2.1 + Item: IDVARVAL + Section: Section 3.2.2 Comments|Section 6.2 Supplemental Qualifiers + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0595 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Used only when individual comments are related to domain records. Cannot be + populated if IDVAR is null. + Document: TIG v1.0 + Item: IDVARVAL CDISC Notes + Section: 2.8.9.4 SEND Comments (CO) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0055 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: IDVAR - operator: empty - - name: IDVARVAL - operator: non_empty + - name: IDVAR + operator: empty + - name: IDVARVAL + operator: non_empty Core: Id: CORE-000218 Status: Published @@ -183,17 +181,17 @@ Executability: Fully Executable Outcome: Message: IDVAR is empty but IDVARVAL is not empty Output Variables: - - IDVAR - - IDVARVAL + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - RELATIONSHIP + - SPECIAL PURPOSE + - RELATIONSHIP Domains: Include: - - CO - - SUPP-- + - CO + - SUPP-- Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000219/rule.yml b/Published/CORE-000219/rule.yml index fccca1dfe..bfe1e99a4 100644 --- a/Published/CORE-000219/rule.yml +++ b/Published/CORE-000219/rule.yml @@ -2,154 +2,145 @@ # Condition: # Rule: --SCAT ^= Domain Name Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: '2.8.7.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0515 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: '2.8.7.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0515 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: $domain_label + - name: --SCAT + operator: equal_to_case_insensitive + value: $domain_label Core: Id: CORE-000219 Status: Published @@ -157,19 +148,19 @@ Core: Description: Raise an error when --SCAT = domain dataset label. Executability: Fully Executable Operations: - - id: $domain_label - operator: domain_label +- id: $domain_label + operator: domain_label Outcome: Message: --SCAT is equal to domain dataset label. Output Variables: - - --SCAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000220/rule.yml b/Published/CORE-000220/rule.yml index 67f180b49..bc0d3b869 100644 --- a/Published/CORE-000220/rule.yml +++ b/Published/CORE-000220/rule.yml @@ -2,103 +2,97 @@ # Condition: # Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.3 - Section: 7.4.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor - can it start with a number (e.g., '1TEST'). IETESTCD cannot - contain characters other than letters; numbers; or - underscores. - Document: Model v1.7 - Section: 3.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.2 - Section: 4.1.2.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor - can it start with a number (e.g., '1TEST'). IETESTCD cannot - contain characters other than letters; numbers; or - underscores. - Document: Model v1.4 - Section: 3.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor - can it start with a number (e.g., "1TEST" is not valid). - --TESTCD cannot contain characters other than letters, - numbers, or underscores. - Document: TIG 1.0 - Item: Specifications --TESTCD - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0536 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.3 + Section: 7.4.1 + - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.7 + Section: 3.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.2 + Section: 4.1.2.1 + - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.4 + Section: 3.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor can it start + with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than + letters, numbers, or underscores. + Document: TIG 1.0 + Item: Specifications --TESTCD + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0536 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - name: --TESTCD - operator: not_matches_regex - value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ + - name: --TESTCD + operator: not_matches_regex + value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ Core: Id: CORE-000220 Status: Published Version: '1' -Description: Part A - Raise an error when --TESTCD > 8 chars or contains more - than only letters, numbers and underscores, or starts with a number. +Description: Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters, + numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: --TESTCD > 8 chars or contains more than only letters, numbers, - underscores, or starts with a number. + Message: --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + with a number. Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000221/rule.yml b/Published/CORE-000221/rule.yml index 1bb910bcf..8bf1abc2f 100644 --- a/Published/CORE-000221/rule.yml +++ b/Published/CORE-000221/rule.yml @@ -2,109 +2,109 @@ # Condition: # Rule: QNAM value length <=8 and cannot start with a number and cannot contain characters other than letters in upper case, numbers, or underscores Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it - start with a number (e.g., '1TEST'). QNAM cannot contain - characters other than letters; numbers; or underscores. - Document: Model v2.0 - Item: QNAM - Section: Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it - start with a number (e.g., '1TEST'). QNAM cannot contain - characters other than letters; numbers; or underscores. - Document: Model v1.7 - Item: QNAM - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it - start with a number (e.g., '1TEST'). QNAM cannot contain - characters other than letters; numbers; or underscores. - Document: Model v1.4 - Item: QNAM - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it - start with a number (e.g., '1TEST'). QNAM cannot contain - characters other than letters; numbers; or underscores. - Document: Model v1.4 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it - start with a number (e.g., '1TEST'). QNAM cannot contain - characters other than letters; numbers; or underscores. - Document: SDTM v2.1 - Item: QNAM - Section: Section 6.2 Supplemental Qualifiers Data set - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0572 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v2.0 + Item: QNAM + Section: Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.7 + Item: QNAM + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.4 + Item: QNAM + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.4 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: SDTM v2.1 + Item: QNAM + Section: Section 6.2 Supplemental Qualifiers Data set + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0572 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z_][A-Z0-9_]{0,7}$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z_][A-Z0-9_]{0,7}$ Core: Id: CORE-000221 Status: Published Version: '1' -Description: Raise an error when QNAM > 8 chars or contains more than only - letters in uppercase, numbers and underscores, or starts with a number. +Description: Raise an error when QNAM > 8 chars or contains more than only letters in uppercase, + numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: QNAM > 8 chars or contains letters that are in not in uppercase, more - than only letters, numbers, underscores, or starts with a number. + Message: QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters, + numbers, underscores, or starts with a number. Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000222/rule.yml b/Published/CORE-000222/rule.yml index 5fa55f596..5ed9e3bb9 100644 --- a/Published/CORE-000222/rule.yml +++ b/Published/CORE-000222/rule.yml @@ -2,72 +2,72 @@ # Condition: # Rule: QLABEL value length <= 40 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value - in QLABEL cannot be longer than 40 characters. This will often - be the column label in the sponsor's original dataset. - Document: Model v2.0 - Item: QLABEL - Section: Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value - in QLABEL cannot be longer than 40 characters. This will often - be the column label in the sponsor's original dataset. - Document: Model v1.7 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value - in QLABEL cannot be longer than 40 characters. This will often - be the column label in the sponsor's original dataset. - Document: Model v1.4 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value - in QLABEL cannot be longer than 40 characters. This will often - be the column label in the sponsor's original dataset. - Document: SDTM v2.1 - Item: QLABEL - Section: Section 6.2 Supplemental Qualifiers Data set - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0571 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v2.0 + Item: QLABEL + Section: Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v1.7 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v1.4 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: SDTM v2.1 + Item: QLABEL + Section: Section 6.2 Supplemental Qualifiers Data set + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0571 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: QLABEL - operator: longer_than - value: 40 + - name: QLABEL + operator: longer_than + value: 40 Core: Id: CORE-000222 Status: Published @@ -77,16 +77,16 @@ Executability: Fully Executable Outcome: Message: QLABEL > 40 chars. Output Variables: - - IDVAR - - IDVARVAL - - QLABEL + - IDVAR + - IDVARVAL + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000223/rule.yml b/Published/CORE-000223/rule.yml index 5c4b0ee12..c56e689a4 100644 --- a/Published/CORE-000223/rule.yml +++ b/Published/CORE-000223/rule.yml @@ -2,66 +2,63 @@ # Condition: ACTARMCD = null # Rule: ARMNRS^=null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0513 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0513 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0608 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0513 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0513 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0608 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARMCD - operator: empty - - name: ARMNRS - operator: empty + - name: ACTARMCD + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000223 Status: Published @@ -71,15 +68,15 @@ Executability: Fully Executable Outcome: Message: ACTARMCD is empty, but ARMNRS is not completed. Output Variables: - - ACTARMCD - - ARMNRS + - ACTARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000224/rule.yml b/Published/CORE-000224/rule.yml index 68c6960bb..4ca4ba115 100644 --- a/Published/CORE-000224/rule.yml +++ b/Published/CORE-000224/rule.yml @@ -2,66 +2,63 @@ # Condition: ACTARM = null # Rule: ARMNRS^=null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARM in the Trial Arms Dataset. - If the subject was not assigned to an Arm or followed a course - not described by any planned Arm, ACTARM is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0515 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an arm or followed - a course not described by any planned arm, ACTARMCD is null - and ARMNRS is populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0515 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm - assignments, must be a value of ARMCD in the Trial Arms - Dataset. If the subject was not assigned to an Arm or followed - a course not described by any planned Arm, ACTARMCD is null - and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0610 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARM is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0515 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0515 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0610 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARM - operator: empty - - name: ARMNRS - operator: empty + - name: ACTARM + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000224 Status: Published @@ -71,15 +68,15 @@ Executability: Fully Executable Outcome: Message: ACTARM is empty, but ARMNRS is not completed. Output Variables: - - ACTARM - - ARMNRS + - ACTARM + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000225/rule.yml b/Published/CORE-000225/rule.yml index 1a38fe316..bc915551b 100644 --- a/Published/CORE-000225/rule.yml +++ b/Published/CORE-000225/rule.yml @@ -1,87 +1,82 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The explanation for why requested information was not available. - Used in conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Interventions - - Cited Guidance: The explanation for why requested information was not available. - Used in conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Events - - Cited Guidance: The explanation for why requested information was not available. - Used in conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is - NOT DONE. - Document: Model v1.4 - Item: The Findings Observation Class - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is - "NOT DONE". - Document: Model v1.7 - Item: 'Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND' - Section: 2.2.1|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[The explanation for why requested information was not - available. Used in conjunction with --STAT when value is "NOT - DONE".]|Interventions[The explanation for why requested - information was not available. Used in conjunction with --STAT - when value is "NOT DONE".]|Findings[The explanation for why - requested information was not available. Used in conjunction - with --STAT when value is "NOT DONE".] - Document: SDTM v2.1 - Item: --REASND - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The - Interventions Observation Class|Section 3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0359 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Interventions + - Cited Guidance: The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Events + - Cited Guidance: The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is NOT DONE. + Document: Model v1.4 + Item: The Findings Observation Class + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is "NOT DONE". + Document: Model v1.7 + Item: 'Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND' + Section: 2.2.1|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[The explanation for why requested information was not available. Used + in conjunction with --STAT when value is "NOT DONE".]|Interventions[The explanation for + why requested information was not available. Used in conjunction with --STAT when value is + "NOT DONE".]|Findings[The explanation for why requested information was not available. + Used in conjunction with --STAT when value is "NOT DONE".] + Document: SDTM v2.1 + Item: --REASND + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class|Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0359 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --STAT # Condition: --REASND ^= null # Rule: --STAT = 'NOT DONE' Check: all: - - name: --REASND - operator: non_empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --REASND + operator: non_empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000225 Status: Published @@ -91,19 +86,19 @@ Executability: Fully Executable Outcome: Message: --STAT should be "NOT DONE" when --REASND is provided. Output Variables: - - --STAT - - --REASND + - --STAT + - --REASND Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - EX - - AE - - DS - - DV - - IE + - EX + - AE + - DS + - DV + - IE Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000227/rule.yml b/Published/CORE-000227/rule.yml index dcdd46f74..51e23bcc0 100644 --- a/Published/CORE-000227/rule.yml +++ b/Published/CORE-000227/rule.yml @@ -2,76 +2,73 @@ # Condition: # Rule: IETEST in TI.IETEST Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found - in the Trial Inclusion/Exclusion Criteria (TI) dataset - described in Section 7.4.1, Trial Inclusion/Exclusion - Criteria. - Document: IG v3.4 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found - in the TI trial inclusion/exclusion criteria dataset described - in Section 7.4 - Trial Summary and Eligibility: Trial - Inclusion/Exclusion Criteria (TI).' - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found - in the TI trial inclusion/exclusion criteria dataset described - in Section 7.4 - Trial Summary and Eligibility: Trial - Inclusion/Exclusion Criteria (TI).' - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found - in the Trial Inclusion/Exclusion Criteria (TI) dataset. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0407 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.4 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI).' + Document: IG v3.2 + Item: Assumption 2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI).' + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0407 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IETEST - operator: is_not_contained_by - value: $ti_ietest + - name: IETEST + operator: is_not_contained_by + value: $ti_ietest Core: Id: CORE-000227 Status: Published @@ -79,19 +76,19 @@ Core: Description: Check if IETEST is not in TI.IETEST Executability: Fully Executable Operations: - - domain: TI - id: $ti_ietest - name: IETEST - operator: distinct +- domain: TI + id: $ti_ietest + name: IETEST + operator: distinct Outcome: Message: IETEST is not in TI.IETEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000228/rule.yml b/Published/CORE-000228/rule.yml index fadab684e..4ce66b037 100644 --- a/Published/CORE-000228/rule.yml +++ b/Published/CORE-000228/rule.yml @@ -2,76 +2,73 @@ # Condition: # Rule: IETESTCD in TI.IETESTCD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found - in the Trial Inclusion/Exclusion Criteria (TI) dataset - described in Section 7.4.1, Trial Inclusion/Exclusion - Criteria. - Document: IG v3.4 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found - in the TI trial inclusion/exclusion criteria dataset described - in Section 7.4 - Trial Summary and Eligibility: Trial - Inclusion/Exclusion Criteria (TI).' - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found - in the Trial Inclusion/Exclusion Criteria (TI) dataset - described in Section 7.4.1, Trial Inclusion/Exclusion - Criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found - in the Trial Inclusion/Exclusion Criteria (TI) dataset. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0408 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.4 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI).' + Document: IG v3.2 + Item: Assumption 2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0408 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IETESTCD - operator: is_not_contained_by - value: $ti_ietestcd + - name: IETESTCD + operator: is_not_contained_by + value: $ti_ietestcd Core: Id: CORE-000228 Status: Published @@ -79,21 +76,21 @@ Core: Description: Check if IETESTCD is present in TI.IETESTCD Executability: Fully Executable Operations: - - domain: TI - id: $ti_ietestcd - name: IETESTCD - operator: distinct +- domain: TI + id: $ti_ietestcd + name: IETESTCD + operator: distinct Outcome: Message: IETESTCD from IE domain does not exist in IETESTCD of TI domain. Output Variables: - - IETESTCD + - IETESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000236/rule.yml b/Published/CORE-000236/rule.yml index 3155c389c..3a7d823cc 100644 --- a/Published/CORE-000236/rule.yml +++ b/Published/CORE-000236/rule.yml @@ -2,115 +2,100 @@ # Condition: MHSTDTC ^= null # Rule: MHSTDTC < DM.RFSTDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that Adverse Events and - Medical History are an exception to this best practice because - of regulatory reporting needs. - Document: IG v3.4 - Item: '1' - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events - (CE), for example, are conceptually the same data, the only - differences being when the event started relative to the study - start and whether the event is considered a - regulatory-reportable adverse event in the study. - Document: SDTMIG v3.4 - Item: 3a - Section: 4.2.6 - - Cited Guidance: An events domain that contains data that includes the subject's - prior medical history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "IG v3.2[2.6][Section 2.6: Do not create separate domains based - on time, rather represent both prior and current observations - in a domain (e.g., CM for all non-study medications). Note - that AE and MH are an exception to this best practice because - of regulatory reporting needs.]|IG v3.2[4.1.2.6][Section - 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse - Events (AE), Medical History (MH) and Clinical Events (CE), - for example, are conceptually the same data, the only - differences being when the event started relative to the study - start and whether the event is considered a regulatory - reportable adverse event in the study.]|IG v3.2[6.2][Domain - Code Table: The medical history dataset includes the subject's - prior history at the start of the trial.][MH: The medical - history dataset includes the subject's prior history at the - start of the trial.][Assumption 1:The Medical History dataset - generally includes the subject's prior and concomitant - conditions at the start of the trial.]" - Document: IG v3.2 - Section: IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG v3.2[6.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "IG v3.3[2.6][Do not create separate domains based on time; - rather, represent both prior and current observations in a - domain (e.g., CM for all non-study medications). Note that AE - and MH are an exception to this best practice because of - regulatory reporting needs]|IG v3.3[4.2.6][Item 2.B.3.A - (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical - History (MH), and Clinical Events (CE), for example, are - conceptually the same data, the only differences being when - the event started relative to the study start and whether the - event is considered a regulatory reportable adverse event in - the study.]|IG v3.3[6.2][Domain Code Table: The medical - history dataset includes the subject's prior history at the - start of the trial.][MH: The medical history dataset includes - the subject's prior history at the start of the trial.]" - Document: IG v3.3 - Section: IG v3.3[2.6]|IG v3.3[4.2.6]|IG v3.3[6.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Custom domains will be used to represent logically related - observations based on the scientific subject matter of the - data and will not be created based on:The timing of collected - observations (e.g., all vital signs measurements will be - represented in domain Vital Signs (VS) irrespective of when - measurements occurred). - Document: TIG 1.0 - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0345 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: IG v3.4 + Item: '1' + Section: '2.6' + - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 3a + Section: 4.2.6 + - Cited Guidance: An events domain that contains data that includes the subject's prior + medical history at the start of the trial. + Document: SDTMIG v3.4 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather + represent both prior and current observations in a domain (e.g., CM for all non-study medications). + Note that AE and MH are an exception to this best practice because of regulatory reporting needs.]|IG + v3.2[4.1.2.6][Section 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), + Medical History (MH) and Clinical Events (CE), for example, are conceptually the same data, + the only differences being when the event started relative to the study start and whether the + event is considered a regulatory reportable adverse event in the study.]|IG v3.2[6.2][Domain + Code Table: The medical history dataset includes the subject's prior history at the start of + the trial.][MH: The medical history dataset includes the subject's prior history at the start + of the trial.][Assumption 1:The Medical History dataset generally includes the subject's prior + and concomitant conditions at the start of the trial.]" + Document: IG v3.2 + Section: IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG v3.2[6.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "IG v3.3[2.6][Do not create separate domains based on time; rather, represent + both prior and current observations in a domain (e.g., CM for all non-study medications). Note + that AE and MH are an exception to this best practice because of regulatory reporting needs]|IG + v3.3[4.2.6][Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History + (MH), and Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is considered + a regulatory reportable adverse event in the study.]|IG v3.3[6.2][Domain Code Table: The medical + history dataset includes the subject's prior history at the start of the trial.][MH: The medical + history dataset includes the subject's prior history at the start of the trial.]" + Document: IG v3.3 + Section: IG v3.3[2.6]|IG v3.3[4.2.6]|IG v3.3[6.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Custom domains will be used to represent logically related observations + based on the scientific subject matter of the data and will not be created based on:The + timing of collected observations (e.g., all vital signs measurements will be represented + in domain Vital Signs (VS) irrespective of when measurements occurred). + Document: TIG 1.0 + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0345 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: MHSTDTC - operator: non_empty - - name: MHSTDTC - operator: date_greater_than_or_equal_to - value: RFSTDTC + - name: MHSTDTC + operator: non_empty + - name: MHSTDTC + operator: date_greater_than_or_equal_to + value: RFSTDTC Core: Id: CORE-000236 Status: Published @@ -118,23 +103,22 @@ Core: Description: Raise an issue if MHSTDTC has a non-empty date that later than DM.RFSTDTC Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical - history dataset should include the subject's prior history at the start of - the trial. + Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset + should include the subject's prior history at the start of the trial. Output Variables: - - MHSTDTC - - RFSTDTC + - MHSTDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - MH + - MH Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000237/rule.yml b/Published/CORE-000237/rule.yml index 735f91608..59a2033f2 100644 --- a/Published/CORE-000237/rule.yml +++ b/Published/CORE-000237/rule.yml @@ -2,156 +2,148 @@ # Condition: --SCAT ^= null # Rule: --SCAT ^= --CAT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.7 - Item: --SCAT - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Item: Table 2.2.1, --SCAT - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: --SCAT - Section: 3.1.4 Identifiers for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0309 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.7 + Item: --SCAT + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Item: Table 2.2.1, --SCAT + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: --SCAT + Section: 3.1.4 Identifiers for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0309 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SCAT - operator: non_empty - - name: --SCAT - operator: equal_to - value: --CAT + - name: --SCAT + operator: non_empty + - name: --SCAT + operator: equal_to + value: --CAT Core: Id: CORE-000237 Status: Published @@ -161,15 +153,15 @@ Executability: Fully Executable Outcome: Message: --SCAT is equal to --CAT Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000238/rule.yml b/Published/CORE-000238/rule.yml index a22b0996c..edc0e7661 100644 --- a/Published/CORE-000238/rule.yml +++ b/Published/CORE-000238/rule.yml @@ -2,114 +2,114 @@ # Condition: EX records present for subject # Rule: RFXENDTC = latest value of EX.EXSTDTC or EX.EXENDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of - EXSTDTC if EXENDTC was not collected or is missing). - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of - EXSTDTC if EXENDTC was not collected or is missing). - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of - EXSTDTC if EXENDTC was not collected or is missing). - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified product, - equal to the latest value of EXENDTC (or the latest value of - EXSTDTC if EXENDTC was not collected or is missing). - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0388 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified product, equal to the + latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is + missing). + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0388 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exstdtc - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exendtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exstdtc + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exendtc Core: Id: CORE-000238 Status: Published Version: '1' -Description: Raise an error when EX records are present for subject but RFXENDTC - does not equal the latest value of EX.EXSTDTC or EX.EXENDTC +Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the + latest value of EX.EXSTDTC or EX.EXENDTC Executability: Fully Executable Operations: - - domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct - - domain: EX - group: - - USUBJID - id: $max_ex_exstdtc - name: EXSTDTC - operator: max_date - - domain: EX - group: - - USUBJID - id: $max_ex_exendtc - name: EXENDTC - operator: max_date +- domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct +- domain: EX + group: + - USUBJID + id: $max_ex_exstdtc + name: EXSTDTC + operator: max_date +- domain: EX + group: + - USUBJID + id: $max_ex_exendtc + name: EXENDTC + operator: max_date Outcome: Message: RFXENDTC does not equal the latest value of EX.EXSTDTC or EX.EXENDTC Output Variables: - - RFXENDTC - - $max_ex_exstdtc - - $max_ex_exendtc + - RFXENDTC + - $max_ex_exstdtc + - $max_ex_exendtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000239/rule.yml b/Published/CORE-000239/rule.yml index 1c86355a7..4008fb206 100644 --- a/Published/CORE-000239/rule.yml +++ b/Published/CORE-000239/rule.yml @@ -2,104 +2,104 @@ # Condition: EX records present for subject # Rule: RFXSTDTC = earliest EX.EXSTDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date of exposure to any protocol-specified treatment or - therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: First date of exposure to any protocol-specified treatment or therapy, equal + to the earliest value of EXSTDTC. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: '2' + Version: '2.0' + Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date of exposure to any protocol-specified treatment or - therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified product, - equal to the earliest value of EXSTDTC. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0389 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: First date of exposure to any protocol-specified treatment or therapy, equal + to the earliest value of EXSTDTC. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified product, equal to the + earliest value of EXSTDTC. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0389 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXSTDTC - operator: not_equal_to - value: $min_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXSTDTC + operator: not_equal_to + value: $min_ex_exstdtc Core: Id: CORE-000239 Status: Published Version: '1' -Description: Raise an error when EX records are present for subject but RFXSTDTC - does not equal the earliest value of EX.EXSTDTC +Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the + earliest value of EX.EXSTDTC Executability: Fully Executable Operations: - - domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct - - domain: EX - group: - - USUBJID - id: $min_ex_exstdtc - name: EXSTDTC - operator: min_date +- domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct +- domain: EX + group: + - USUBJID + id: $min_ex_exstdtc + name: EXSTDTC + operator: min_date Outcome: Message: RFXSTDTC does not equal the earliest value of EX.EXSTDTC Output Variables: - - RFXSTDTC - - $min_ex_exstdtc + - RFXSTDTC + - $min_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000240/rule.yml b/Published/CORE-000240/rule.yml index 117f59801..f65b78609 100644 --- a/Published/CORE-000240/rule.yml +++ b/Published/CORE-000240/rule.yml @@ -2,84 +2,78 @@ # Condition: --OCCUR = 'N' # Rule: --STRF = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: Model v2.0 - Item: --STRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before; during; - or after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before; during; - or after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --STRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0575 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --STRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before; during; or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before; during; or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --STRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0575 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --OCCUR - operator: equal_to - value: N - - name: --STRF - operator: non_empty + - name: --OCCUR + operator: equal_to + value: N + - name: --STRF + operator: non_empty Core: Id: CORE-000240 Status: Published @@ -89,15 +83,15 @@ Executability: Fully Executable Outcome: Message: --STRF is populated when --OCCUR = "N" Output Variables: - - --STRF + - --STRF Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000241/rule.yml b/Published/CORE-000241/rule.yml index b75f0c470..9030f7b31 100644 --- a/Published/CORE-000241/rule.yml +++ b/Published/CORE-000241/rule.yml @@ -2,84 +2,78 @@ # Condition: --OCCUR = 'N' # Rule: --ENRF = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: Model v2.0 - Item: --ENRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before; during or - after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before; during or - after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --ENRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0576 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --ENRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before; during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before; during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --ENRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0576 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --OCCUR - operator: equal_to - value: N - - name: --ENRF - operator: non_empty + - name: --OCCUR + operator: equal_to + value: N + - name: --ENRF + operator: non_empty Core: Id: CORE-000241 Status: Published @@ -89,15 +83,15 @@ Executability: Fully Executable Outcome: Message: --ENRF is populated when --OCCUR = "N" Output Variables: - - --ENRF + - --ENRF Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000242/rule.yml b/Published/CORE-000242/rule.yml index b8c00abe2..0be397e34 100644 --- a/Published/CORE-000242/rule.yml +++ b/Published/CORE-000242/rule.yml @@ -2,77 +2,72 @@ # Condition: # Rule: --EXCLFL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--EXCLFL - Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend - Domains 2.8.3 How to Create New Specifications" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0518 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.4 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.2 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--EXCLFL + Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to + Create New Specifications" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0518 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --EXCLFL - operator: exists + - name: --EXCLFL + operator: exists Core: Id: CORE-000242 Status: Published @@ -82,14 +77,14 @@ Executability: Fully Executable Outcome: Message: --EXCLFL must never be used in SDTM-based human trials Output Variables: - - --EXCLFL + - --EXCLFL Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000243/rule.yml b/Published/CORE-000243/rule.yml index a4272457a..71aeaa03c 100644 --- a/Published/CORE-000243/rule.yml +++ b/Published/CORE-000243/rule.yml @@ -2,77 +2,72 @@ # Condition: # Rule: --REASEX not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "Not in human clinical trials Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. " - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--REASEX - Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend - Domains 2.8.3 How to Create New Specifications" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0519 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.4 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.2 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: "Not in human clinical trials Select variables for the domain from the SDTM. Selection + of variables must align with SDTM Usage Restrictions. " + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--REASEX + Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to + Create New Specifications" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0519 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --REASEX - operator: exists + - name: --REASEX + operator: exists Core: Id: CORE-000243 Status: Published @@ -82,14 +77,14 @@ Executability: Fully Executable Outcome: Message: --REASEX must never be used in SDTM-based human clinical trials Output Variables: - - --REASEX + - --REASEX Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000244/rule.yml b/Published/CORE-000244/rule.yml index 7555240f2..5577e1bd8 100644 --- a/Published/CORE-000244/rule.yml +++ b/Published/CORE-000244/rule.yml @@ -2,77 +2,72 @@ # Condition: # Rule: --DETECT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--DETECT - Section: Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend - Domains | 2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0520 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.4 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + Document: IG v3.2 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--DETECT + Section: Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend Domains | 2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0520 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DETECT - operator: exists + - name: --DETECT + operator: exists Core: Id: CORE-000244 Status: Published @@ -82,14 +77,14 @@ Executability: Fully Executable Outcome: Message: --DETECT must never be used in SDTM-based human trials Output Variables: - - --DETECT + - --DETECT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000245/rule.yml b/Published/CORE-000245/rule.yml index 655a6a8a2..974b63041 100644 --- a/Published/CORE-000245/rule.yml +++ b/Published/CORE-000245/rule.yml @@ -2,92 +2,87 @@ # Condition: # Rule: --NOMDY not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials --USCHFL - (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0510 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0510 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--NOMDY - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend - Domains |2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0605 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --NOMDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0635 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --NOMDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0676 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0510 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0510 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--NOMDY + Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0605 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --NOMDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0635 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --NOMDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0676 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --NOMDY - operator: exists + - name: --NOMDY + operator: exists Core: Id: CORE-000245 Status: Published @@ -100,9 +95,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000246/rule.yml b/Published/CORE-000246/rule.yml index 24bc9c7a1..a536c1381 100644 --- a/Published/CORE-000246/rule.yml +++ b/Published/CORE-000246/rule.yml @@ -2,92 +2,87 @@ # Condition: # Rule: --NOMLBL not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical - studies (SEND), must NEVER be used in the submission of - SDTM-based data for human clinical trials --USCHFL - (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL - (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID - (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0511 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical - studies (SEND); must NEVER be used in the submission of - SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), - --EXCLFL (Findings), --REASEX (Findings), --IMPLBL (Findings), - --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY - (Timing Variables), --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0511 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain - from the SDTM. Selection of variables must align with SDTM - Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--NOMLBL - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend - Domains |2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0606 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --NOMLBL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0636 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --NOMLBL - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0677 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0511 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)' + Document: IG v3.3 + Section: '2.7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0511 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--NOMLBL + Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0606 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --NOMLBL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0636 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --NOMLBL + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0677 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --NOMLBL - operator: exists + - name: --NOMLBL + operator: exists Core: Id: CORE-000246 Status: Published @@ -100,9 +95,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000247/rule.yml b/Published/CORE-000247/rule.yml index 8aa41d153..21ac062ea 100644 --- a/Published/CORE-000247/rule.yml +++ b/Published/CORE-000247/rule.yml @@ -2,79 +2,79 @@ # Condition: # Rule: --RESLOC not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not be used in human clinical trials. - Document: Model v2.0 - Item: --RESLOC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0552 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not to be used with human clinical trials. - Document: Model v1.7 - Item: --RESLOC - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0552 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RESLOC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0640 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RESLOC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0626 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RESLOC - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0667 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not be used in human clinical trials. + Document: Model v2.0 + Item: --RESLOC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0552 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not to be used with human clinical trials. + Document: Model v1.7 + Item: --RESLOC + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0552 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RESLOC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0640 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RESLOC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0626 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RESLOC + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0667 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --RESLOC - operator: exists + - name: --RESLOC + operator: exists Core: Id: CORE-000247 Status: Published @@ -87,9 +87,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000248/rule.yml b/Published/CORE-000248/rule.yml index 5b7ca3734..fb44bd9f8 100644 --- a/Published/CORE-000248/rule.yml +++ b/Published/CORE-000248/rule.yml @@ -2,316 +2,296 @@ # Condition: --TPTREF = null # Rule: --RFTDTC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a - fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF - Document: Model v2.0 - Item: --RFTDTC - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF - Document: Model v1.7 - Item: --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF - in ISO 8601 character format. - Document: Model v1.4 - Item: Table 2.2.5, --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be - provided. - Document: IG v3.0 - Section: 4.4.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed - reference point (--TPTREF), the --TPTREF should be provided - whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: "When instances of an activity are scheduled at planned time - intervals relative to a fixed reference point (e.g., an - exposure), the following timing variables will be used - --TPTREF Represents a description of the fixed reference point - from which the planned observation will be made. --RFTDTC - Represents the actual date/time of the value of --TPTREF" - Document: TIG v1.0 - Item: Timing Relative to Reference Points, Table Num 3 - Section: 2.8.7.6 Representing References and Relative Timing - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0265 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a - fixed reference for a series of planned time points, - represented in a standardized character format. The fixed - reference point is in --TPTREF. - Document: SDTM v2.1 - Item: --RFTDTC - Section: 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0308 - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time - point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF + Document: Model v2.0 + Item: --RFTDTC + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF + Document: Model v1.7 + Item: --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 + character format. + Document: Model v1.4 + Item: Table 2.2.5, --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be provided. + Document: IG v3.0 + Section: 4.4.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: "When instances of an activity are scheduled at planned time intervals relative + to a fixed reference point (e.g., an exposure), the following timing variables will be used + --TPTREF Represents a description of the fixed reference point from which the planned observation + will be made. --RFTDTC Represents the actual date/time of the value of --TPTREF" + Document: TIG v1.0 + Item: Timing Relative to Reference Points, Table Num 3 + Section: 2.8.7.6 Representing References and Relative Timing + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0265 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF. + Document: SDTM v2.1 + Item: --RFTDTC + Section: 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0308 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --TPTREF - operator: empty - - name: --RFTDTC - operator: exists - - name: --RFTDTC - operator: non_empty + - name: --TPTREF + operator: empty + - name: --RFTDTC + operator: exists + - name: --RFTDTC + operator: non_empty Core: Id: CORE-000248 Status: Published Version: '1' -Description: Time point reference (--TPTREF) should be populated when reference - time point (--RFTDTC) is populated. +Description: Time point reference (--TPTREF) should be populated when reference time point + (--RFTDTC) is populated. Executability: Fully Executable Outcome: Message: --TPTREF value is missing when --RFTDTC is populated. @@ -319,9 +299,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000249/rule.yml b/Published/CORE-000249/rule.yml index 47bfc6530..b7861c9e1 100644 --- a/Published/CORE-000249/rule.yml +++ b/Published/CORE-000249/rule.yml @@ -2,87 +2,84 @@ # Condition: VISITNUM is in TV.VISITNUM # Rule: VISITDY = TV.VISITDY Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits (TV) dataset (Section - 7.3.1, Trial Visits). - Document: IG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset, - Document: IG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset, - Document: IG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned visits. There - will be a one-to-one relationship between values of VISIT and - VISITNUM in TV. If a subject-level dataset includes both - VISITNUM and VISIT, then records that include values of - VISITNUM that appear in the TV dataset should also include the - corresponding values of VISIT from the TV dataset. - Document: TIG 1.0 - Item: 2.8.10.31 Assumption 6 - Section: 2.8.7.5 - - Cited Guidance: Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Specification VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0313 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: IG v3.4 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.3 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.2 + Item: '' + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. + Document: TIG 1.0 + Item: 2.8.10.31 Assumption 6 + Section: 2.8.7.5 + - Cited Guidance: Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Specification VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0313 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: VISITDY - operator: exists - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISITDY - operator: not_equal_to - value: TV.VISITDY + - name: VISITDY + operator: exists + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISITDY + operator: not_equal_to + value: TV.VISITDY Core: Id: CORE-000249 Status: Published @@ -90,26 +87,26 @@ Core: Description: Verify that visitdy is planned and exists in TV Executability: Fully Executable Match Datasets: - - Keys: - - VISITNUM - Name: TV +- Keys: + - VISITNUM + Name: TV Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: Visit Day cannot be found in Trial Visit (TV) domain Output Variables: - - VISITDY - - VISITNUM + - VISITDY + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000250/rule.yml b/Published/CORE-000250/rule.yml index 22e4eaf7a..adf3bb565 100644 --- a/Published/CORE-000250/rule.yml +++ b/Published/CORE-000250/rule.yml @@ -2,255 +2,217 @@ # Condition: MHENDTC ^= null # Rule: MHENDTC < DM.RFSTDTC Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that Adverse Events and - Medical History are an exception to this best practice because - of regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events - (CE), for example, are conceptually the same data, the only - differences being when the event started relative to the study - start and whether the event is considered a - regulatory-reportable adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the - subject's prior history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical - History (MH), and Clinical Events (CE), for example, are - conceptually the same data, the only differences being when - the event started relative to the study start and whether the - event is considered a regulatory reportable adverse event in - the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History - (MH) and Clinical Events (CE), for example, are conceptually - the same data, the only differences being when the event - started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial.][Assumption 1:The Medical History dataset generally - includes the subject's prior and concomitant conditions at the - start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that Adverse Events and - Medical History are an exception to this best practice because - of regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events - (CE), for example, are conceptually the same data, the only - differences being when the event started relative to the study - start and whether the event is considered a - regulatory-reportable adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the - subject's prior history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical - History (MH), and Clinical Events (CE), for example, are - conceptually the same data, the only differences being when - the event started relative to the study start and whether the - event is considered a regulatory reportable adverse event in - the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History - (MH) and Clinical Events (CE), for example, are conceptually - the same data, the only differences being when the event - started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial.][Assumption 1:The Medical History dataset generally - includes the subject's prior and concomitant conditions at the - start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that Adverse Events and - Medical History are an exception to this best practice because - of regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events - (CE), for example, are conceptually the same data, the only - differences being when the event started relative to the study - start and whether the event is considered a - regulatory-reportable adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the - subject's prior history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical - History (MH), and Clinical Events (CE), for example, are - conceptually the same data, the only differences being when - the event started relative to the study start and whether the - event is considered a regulatory reportable adverse event in - the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent - both prior and current observations in a domain (e.g., CM for - all non-study medications). Note that AE and MH are an - exception to this best practice because of regulatory - reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History - (MH) and Clinical Events (CE), for example, are conceptually - the same data, the only differences being when the event - started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history - at the start of the trial.][MH The medical history dataset - includes the subject's prior history at the start of the - trial.][Assumption 1:The Medical History dataset generally - includes the subject's prior and concomitant conditions at the - start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Custom domains will be used to represent logically related - observations based on the scientific subject matter of the - data and will not be created based on:The timing of collected - observations (e.g., all vital signs measurements will be - represented in domain Vital Signs (VS) irrespective of when - measurements occurred). - Document: TIG 1.0 - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0344 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: '2.6' + - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: '2.6' + - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: '2.6' + - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: '2.6' + - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: '2.6' + - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: '2.6' + - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: '2.6' + - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: '2.6' + - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: '6.2' + - Cited Guidance: Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: '2.6' + - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Custom domains will be used to represent logically related observations + based on the scientific subject matter of the data and will not be created based on:The + timing of collected observations (e.g., all vital signs measurements will be represented + in domain Vital Signs (VS) irrespective of when measurements occurred). + Document: TIG 1.0 + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0344 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: MHENDTC - operator: non_empty - - name: MHENDTC - operator: date_greater_than_or_equal_to - value: RFSTDTC + - name: MHENDTC + operator: non_empty + - name: MHENDTC + operator: date_greater_than_or_equal_to + value: RFSTDTC Core: Id: CORE-000250 Status: Published @@ -258,23 +220,22 @@ Core: Description: Raise an issue if MHENDTC has a non-empty date that is on or after DM.RFSTDTC Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical - history dataset should include the subject's prior history at the start of - the trial. + Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset + should include the subject's prior history at the start of the trial. Output Variables: - - MHENDTC - - RFSTDTC + - MHENDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - MH + - MH Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000252/rule.yml b/Published/CORE-000252/rule.yml index 817848ba9..b693bb601 100644 --- a/Published/CORE-000252/rule.yml +++ b/Published/CORE-000252/rule.yml @@ -2,138 +2,137 @@ # Condition: DS record with DSDECOD= "DEATH" present for the subject # Rule: DTHFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0385 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0385 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: DSDECOD - operator: equal_to - value: DEATH - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: DSDECOD + operator: equal_to + value: DEATH + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000252 Status: Published Version: '1' -Description: When a record is present in the DS dataset where DSDECOD = 'DEATH' - then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the - corresponding subject. +Description: When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag + (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DS +- Keys: + - USUBJID + Name: DS Outcome: Message: DSDECOD is 'DEATH' in DS dataset, but DTHFL in DM dataset is not "Y". Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000253/rule.yml b/Published/CORE-000253/rule.yml index b9b095076..d63f22ff9 100644 --- a/Published/CORE-000253/rule.yml +++ b/Published/CORE-000253/rule.yml @@ -2,138 +2,137 @@ # Condition: AE record with AESDTH= "Y" present for the subject # Rule: DTHFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0384 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0384 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: AESDTH - operator: equal_to - value: Y - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: AESDTH + operator: equal_to + value: Y + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000253 Status: Published Version: '1' -Description: When a record is present in the AE dataset where AESDTH = 'Y' then - death flag (DTHFL) should be populated as 'Y' in the DM dataset for the - corresponding subject. +Description: When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL) + should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: AE +- Keys: + - USUBJID + Name: AE Outcome: Message: AESDTH is 'Y' in AE dataset, but DTHFL in DM dataset is not "Y". Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000254/rule.yml b/Published/CORE-000254/rule.yml index 1f16c9aa1..7d5dbca60 100644 --- a/Published/CORE-000254/rule.yml +++ b/Published/CORE-000254/rule.yml @@ -2,141 +2,140 @@ # Condition: AE record with AEOUT= "FATAL" present for the subject # Rule: DTHFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0383 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0383 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died - during the study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: AEOUT - operator: equal_to - value: FATAL - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: AEOUT + operator: equal_to + value: FATAL + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000254 Status: Published Version: '1' -Description: When a record is present in the AE dataset where AEOUT = 'FATAL' - then death flag (DTHFL) should be populated as 'Y' in the DM dataset for - the corresponding subject. +Description: When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag + (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: AE +- Keys: + - USUBJID + Name: AE Outcome: Message: AEOUT is 'FATAL' in AE dataset, but DTHFL in DM dataset is not "Y". Output Variables: - - DTHFL - - AEOUT + - DTHFL + - AEOUT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000255/rule.yml b/Published/CORE-000255/rule.yml index dc6150063..b576a44c6 100644 --- a/Published/CORE-000255/rule.yml +++ b/Published/CORE-000255/rule.yml @@ -1,109 +1,109 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --STAT - operator: not_equal_to - value: NOT DONE - - name: --ORRES - operator: empty + - name: --STAT + operator: not_equal_to + value: NOT DONE + - name: --ORRES + operator: empty Core: Id: CORE-000255 Status: Published Version: '1' -Description: There should always be data presented in the --ORRES variable - unless --STAT = "NOT DONE". +Description: There should always be data presented in the --ORRES variable unless --STAT = "NOT + DONE". Executability: Fully Executable Outcome: Message: --ORRES must be populated as --STAT is not equal to 'NOT DONE' Output Variables: - - --STAT - - --ORRES + - --STAT + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000256/rule.yml b/Published/CORE-000256/rule.yml index 940346524..81a0857d1 100644 --- a/Published/CORE-000256/rule.yml +++ b/Published/CORE-000256/rule.yml @@ -2,195 +2,188 @@ # Condition: SEUPDES = null # Rule: ETCD ^= 'UNPLAN' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular\ \ period of time cannot be represented with one of - the planned Elements, then\ \ that period of time should be - represented as an unplanned Element. The value\ \ of ETCD for - an unplanned Element is "UNPLAN" and SEUPDES should\ \ be - populated with a description of the unplanned Element. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element. The value of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should be populated - with a description of the unplanned Element only if ETCD has - the value of "UNPLAN". - Document: IG v3.2 - Item: Assumption 6 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned Elements, then that period of time should be - represented as an unplanned Element. The value of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should be populated - with a description of the unplanned Element only if ETCD has - the value of "UNPLAN". - Document: IG v3.3 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the applicant decides that the subject's experience for a - particular period of time cannot be represented with one of - the planned elements, then that period of time should be - represented as an unplanned element. The value of ETCD for an - unplanned element is “UNPLAN” and SEUPDES should be populated - with a description of the unplanned element. - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0429 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Description of what happened to the subject during this - unplanned Element. - Document: SENDIG v3.0 - Item: Specification - Section: 5.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, - ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: TIG v1.0 - Item: Assumption 5 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0062 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular\ \ + period of time cannot be represented with one of the planned Elements, then\ \ that period + of time should be represented as an unplanned Element. The value\ \ of ETCD for an + unplanned Element is "UNPLAN" and SEUPDES should\ \ be populated with a description of the + unplanned Element. + Document: IG v3.4 + Item: Assumption 4 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.2 + Item: Assumption 6 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.3 + Item: Assumption 4 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If the applicant decides that the subject's experience for a particular + period of time cannot be represented with one of the planned elements, then that period of + time should be represented as an unplanned element. The value of ETCD for an unplanned + element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned + element. + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0429 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Description of what happened to the subject during this unplanned Element. + Document: SENDIG v3.0 + Item: Specification + Section: 5.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: TIG v1.0 + Item: Assumption 5 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0062 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: SEUPDES - operator: empty - - name: ETCD - operator: equal_to - value: UNPLAN + - name: SEUPDES + operator: empty + - name: ETCD + operator: equal_to + value: UNPLAN Core: Id: CORE-000256 Status: Published @@ -203,9 +196,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000257/rule.yml b/Published/CORE-000257/rule.yml index 5013d652c..10a6965e5 100644 --- a/Published/CORE-000257/rule.yml +++ b/Published/CORE-000257/rule.yml @@ -2,238 +2,227 @@ # Condition: --STRTPT ^= null # Rule: --STTPT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the start of an - observation. This is the sponsor-defined reference point - referred to by --STRTPT. - Document: Model v2.0 - Item: --STTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format - of the sponsor-defined reference point referred to by - --STRTPT. Examples; "2003-12-15" or "VISIT 1". - Document: Model v1.7 - Item: Table 2.2.5.1 --STTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other - character format of the sponsor-defined reference point - referred to by --STRTPT. Examples; "2003-12-15" or "VISIT 1". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the start of an - observation. This is the sponsor-defined reference point - referred to by --STRTPT. - Document: SDTM v2.1 - Item: --STTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0335 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: Model v2.0 + Item: --STTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT + 1". + Document: Model v1.7 + Item: Table 2.2.5.1 --STTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or + "VISIT 1". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: SDTM v2.1 + Item: --STTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0335 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # FDA rule FB4401 is identical - added Jozef 2024-12-19 - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the - time point established by --STTPT to characterize the start of - an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4401' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STRTPT - operator: non_empty - - name: --STTPT - operator: empty + - name: --STRTPT + operator: non_empty + - name: --STTPT + operator: empty Core: Id: CORE-000257 Status: Published Version: '1' -Description: 'When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time Point (--STTPT) should also be populated.' +Description: 'When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time + Point (--STTPT) should also be populated.' Executability: Fully Executable Outcome: Message: --STRTPT is populated, but --STTPT is missing. Output Variables: - - --STRTPT - - --STTPT + - --STRTPT + - --STTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000258/rule.yml b/Published/CORE-000258/rule.yml index a1742a28d..dc3991179 100644 --- a/Published/CORE-000258/rule.yml +++ b/Published/CORE-000258/rule.yml @@ -2,95 +2,93 @@ # Condition: --STRTPT present in dataset # Rule: --STTPT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the start of an - observation. This is the sponsor-defined reference point - referred to by --STRTPT. - Document: Model v2.0 - Item: --STTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format - of the sponsor-defined reference point referred to by - --STRTPT. Examples; "2003-12-15" or "VISIT 1". - Document: Model v1.7 - Item: Table 2.2.5.1 --STTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other - character format of the sponsor-defined reference point - referred to by --STRTPT. Examples; "2003-12-15" or "VISIT 1". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as - a fixed reference for characterizing the start of an - observation. This is the sponsor-defined reference point - referred to by --STRTPT. - Document: SDTM v2.1 - Item: --STTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0336 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: Model v2.0 + Item: --STTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT + 1". + Document: Model v1.7 + Item: Table 2.2.5.1 --STTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or + "VISIT 1". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: SDTM v2.1 + Item: --STTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0336 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --STRTPT - operator: exists - - name: --STTPT - operator: not_exists + - name: --STRTPT + operator: exists + - name: --STTPT + operator: not_exists Core: Id: CORE-000258 Status: Published Version: '1' -Description: Raise an error when --STRTPT is present in dataset and --STTPT is - not present in dataset. +Description: Raise an error when --STRTPT is present in dataset and --STTPT is not present in + dataset. Executability: Fully Executable Outcome: Message: --STRTPT is present in dataset, but --STTPT is not present in dataset. Output Variables: - - --STRTPT + - --STRTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000260/rule.yml b/Published/CORE-000260/rule.yml index 439f4a0a0..fad11b357 100644 --- a/Published/CORE-000260/rule.yml +++ b/Published/CORE-000260/rule.yml @@ -2,80 +2,77 @@ # Condition: # Rule: --PRESP in ('Y', null) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for - spontaneously reported events.] Interventions[--PRESP][Values - should be "Y" or null.] - Document: Model v2.0 - Item: --PRESP - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y" - or null.] | Model v1.7[2.2.2 (Events)][--PRESP; Values should - be "Y" or null.] - Document: Model v1.7 - Item: '' - Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y" - or null.] |Model v1.4[2.2.2 (Events)][--PRESP; Values should - be "Y" or null.] - Document: Model v1.4 - Item: '' - Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for - spontaneously reported events.] - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[--PRESP][Values should be "Y" or null.] - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0350 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously + reported events.] Interventions[--PRESP][Values should be "Y" or null.] + Document: Model v2.0 + Item: --PRESP + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] | + Model v1.7[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] + Document: Model v1.7 + Item: '' + Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] + |Model v1.4[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] + Document: Model v1.4 + Item: '' + Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously + reported events.] + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[--PRESP][Values should be "Y" or null.] + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0350 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PRESP - operator: non_empty - - name: --PRESP - operator: not_equal_to - value: Y - value_is_literal: true + - name: --PRESP + operator: non_empty + - name: --PRESP + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000260 Status: Published @@ -85,17 +82,17 @@ Executability: Fully Executable Outcome: Message: --PRESP does not equal 'Y' or is not empty. Output Variables: - - --PRESP + - --PRESP Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000261/rule.yml b/Published/CORE-000261/rule.yml index 2f3ddbf9c..236312311 100644 --- a/Published/CORE-000261/rule.yml +++ b/Published/CORE-000261/rule.yml @@ -2,93 +2,89 @@ # Condition: --STTPT present in dataset # Rule: --STRTPT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - a reference time point. The sponsor-defined reference time - point is in --STTPT. - Document: Model v2.0 - Item: --STRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before or after - the sponsor-defined reference time point defined by variable - --STTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --STRTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STRTPT) Identifies the start of the observation as being - before or after the sponsor-defined reference time point - defined by variable --STTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - a reference time point. The sponsor-defined reference time - point is in --STTPT. - Document: SDTM v2.1 - Item: --STRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0334 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: Model v2.0 + Item: --STRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before or after the + sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --STRTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--STRTPT) Identifies the start of the observation as being before or after + the sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: SDTM v2.1 + Item: --STRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0334 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --STTPT - operator: exists - - name: --STRTPT - operator: not_exists + - name: --STTPT + operator: exists + - name: --STRTPT + operator: not_exists Core: Id: CORE-000261 Status: Published Version: '1' -Description: Raise an error when --STTPT is present in dataset and --STRTPT is - not present in dataset. +Description: Raise an error when --STTPT is present in dataset and --STRTPT is not present in + dataset. Executability: Fully Executable Outcome: Message: --STTPT is present in dataset, but --STRTPT is not present in dataset. Output Variables: - - --STTPT + - --STTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000262/rule.yml b/Published/CORE-000262/rule.yml index 86f4d386d..7e83872a3 100644 --- a/Published/CORE-000262/rule.yml +++ b/Published/CORE-000262/rule.yml @@ -2,84 +2,78 @@ # Condition: DM.RFSTDTC = null # Rule: --STRF = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: Model 2.0 - Item: --STRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before, during, - or after the sponsor-defined reference period.The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model 1.7 - Item: 'Table 2.2.5.1: --STRF' - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before, during, - or after the sponsor-defined reference period. The - sponsor-defined reference period is a continuous period of - time defined by a discrete starting point and a discrete - ending point represented by RFSTDTC and RFENDTC in - Demographics. - Document: Model 1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to - the study reference period. The sponsor-defined reference - period is a continuous period of time defined by a discrete - starting point and a discrete ending point represented by - RFSTDTC and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --STRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0439 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model 2.0 + Item: --STRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before, during, or after + the sponsor-defined reference period.The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model 1.7 + Item: 'Table 2.2.5.1: --STRF' + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the start of the observation as being before, during, or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model 1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --STRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0439 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RFSTDTC - operator: empty - - name: --STRF - operator: non_empty + - name: RFSTDTC + operator: empty + - name: --STRF + operator: non_empty Core: Id: CORE-000262 Status: Published @@ -87,20 +81,20 @@ Core: Description: Raise an error when RFSTDTC in DM is empty and --STRF is not empty. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: RFSTDTC in DM dataset is empty but --STRF is completed. Output Variables: - - --STRF + - --STRF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000265/rule.yml b/Published/CORE-000265/rule.yml index 23a264d10..69a0043c1 100644 --- a/Published/CORE-000265/rule.yml +++ b/Published/CORE-000265/rule.yml @@ -2,236 +2,223 @@ # Condition: --ENRTPT ^= null # Rule: --ENTPT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a - reference time point. The sponsor-defined reference time - point is in --ENTPT. - Document: Model v2.0 - Item: --ENRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable - --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before - or after the sponsor-defined reference time point defined by - variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a - reference time point. The sponsor-defined reference time point - is in --ENTPT. - Document: SDTM v2.1 - Item: --ENRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0325 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: Model v2.0 + Item: --ENRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: SDTM v2.1 + Item: --ENRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0325 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the - time point established by --ENTPT to characterize the start of - an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4402' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --ENRTPT - operator: non_empty - - name: --ENTPT - operator: empty + - name: --ENRTPT + operator: non_empty + - name: --ENTPT + operator: empty Core: Id: CORE-000265 Status: Published Version: '1' -Description: 'When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point (--ENTPT) should also be populated.' +Description: 'When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point + (--ENTPT) should also be populated.' Executability: Fully Executable Outcome: Message: --ENRTPT is populated, but --ENTPT is missing. Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000266/rule.yml b/Published/CORE-000266/rule.yml index 6d6390ff0..1b0872b80 100644 --- a/Published/CORE-000266/rule.yml +++ b/Published/CORE-000266/rule.yml @@ -2,170 +2,158 @@ # Condition: AESCAN ^= 'Y' and AESCONG ^= 'Y' and AESDISAB ^= 'Y' and AESDTH ^= 'Y' and AESHOSP ^= 'Y' and AESLIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE ^= 'Y' # Rule: AESER = 'N' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious = \"No\", the values for these variables may be null. - However, if Serious = \"Yes\", at least one of them will have - a \"Y\" response. - - - - \ " - Document: IG v3.4 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No, " the values for these variables may - be null. However, if Serious is answered "Yes, " at least one - of them will have a "Y" response. - Document: IG v3.2 - Item: Assumption 6a - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question, as in the example below, the values of the - variables that capture reasons an event is considered serious - (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No, " the values for these variables may - be null. However, if Serious is answered "Yes, " at least one - of them will have a "Y" response. - Document: IG v3.3 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a - leading question the values of the variables that capture - reasons an event is considered serious (e.g., AESCAN, AESCONG) - may be null. On the other hand, if the CRF is structured so - that a response is collected for each seriousness category, - all category variables (e.g., AESDTH, AESHOSP) would be - populated and AESER would be derived. - Document: TIG 1.0 - Item: Assumption 7a - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0321 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If categories of serious events are collected secondarily to a leading question, + as in the example below, the values of the variables that capture reasons an event is considered + serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if Serious = \"No\", the values + for these variables may be null. However, if Serious = \"Yes\", at least one of them will have + a \"Y\" response.\n\n\n " + Document: IG v3.4 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No, " the values for these variables may be null. However, if Serious + is answered "Yes, " at least one of them will have a "Y" response. + Document: IG v3.2 + Item: Assumption 6a + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No, " the values for these variables may be null. However, if Serious + is answered "Yes, " at least one of them will have a "Y" response. + Document: IG v3.3 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If categories of serious events are collected secondarily to a leading + question the values of the variables that capture reasons an event is considered serious + (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a + response is collected for each seriousness category, all category variables (e.g., AESDTH, + AESHOSP) would be populated and AESER would be derived. + Document: TIG 1.0 + Item: Assumption 7a + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0321 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: AESER - operator: not_equal_to - value: N - - all: - - any: - - name: AESCAN - operator: not_exists - - name: AESCAN - operator: not_equal_to - value: Y - - any: - - name: AESCONG - operator: not_exists - - name: AESCONG - operator: not_equal_to - value: Y - - any: - - name: AESDISAB - operator: not_exists - - name: AESDISAB - operator: not_equal_to - value: Y - - any: - - name: AESDTH - operator: not_exists - - name: AESDTH - operator: not_equal_to - value: Y - - any: - - name: AESHOSP - operator: not_exists - - name: AESHOSP - operator: not_equal_to - value: Y - - any: - - name: AESLIFE - operator: not_exists - - name: AESLIFE - operator: not_equal_to - value: Y - - any: - - name: AESOD - operator: not_exists - - name: AESOD - operator: not_equal_to - value: Y - - any: - - name: AESMIE - operator: not_exists - - name: AESMIE - operator: not_equal_to - value: Y + - name: AESER + operator: not_equal_to + value: N + - all: + - any: + - name: AESCAN + operator: not_exists + - name: AESCAN + operator: not_equal_to + value: Y + - any: + - name: AESCONG + operator: not_exists + - name: AESCONG + operator: not_equal_to + value: Y + - any: + - name: AESDISAB + operator: not_exists + - name: AESDISAB + operator: not_equal_to + value: Y + - any: + - name: AESDTH + operator: not_exists + - name: AESDTH + operator: not_equal_to + value: Y + - any: + - name: AESHOSP + operator: not_exists + - name: AESHOSP + operator: not_equal_to + value: Y + - any: + - name: AESLIFE + operator: not_exists + - name: AESLIFE + operator: not_equal_to + value: Y + - any: + - name: AESOD + operator: not_exists + - name: AESOD + operator: not_equal_to + value: Y + - any: + - name: AESMIE + operator: not_exists + - name: AESMIE + operator: not_equal_to + value: Y Core: Id: CORE-000266 Status: Published Version: '1' -Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and - AESHOSP and AESLIFE and AESOD and AESMIE ^= "Y" However, AESER ^= "N" +Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE + and AESOD and AESMIE ^= "Y" However, AESER ^= "N" Executability: Fully Executable Outcome: - Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, - AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y". + Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, + AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y". Output Variables: - - AESER - - AESCAN - - AESCONG - - AESDISAB - - AESDTH - - AESHOSP - - AESLIFE - - AESOD - - AESMIE + - AESER + - AESCAN + - AESCONG + - AESDISAB + - AESDTH + - AESHOSP + - AESLIFE + - AESOD + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000267/rule.yml b/Published/CORE-000267/rule.yml index 7444237ec..9663e8d34 100644 --- a/Published/CORE-000267/rule.yml +++ b/Published/CORE-000267/rule.yml @@ -2,70 +2,69 @@ # Condition: --PTCD ^= null # Rule: --DECOD ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The preferred term code assigned to the event from MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the - description of an event or intervention. Equivalent to the - Preferred Term (PT in MedDRA).]|--PTCD[The preferred term code - assigned to the event from MedDRA.] - Document: SDTM v2.1 - Item: --PTCD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0328 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the description of an + event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The + preferred term code assigned to the event from MedDRA.] + Document: SDTM v2.1 + Item: --PTCD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0328 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --PTCD - operator: non_empty - - name: --DECOD - operator: empty + - name: --PTCD + operator: non_empty + - name: --DECOD + operator: empty Core: Id: CORE-000267 Status: Published @@ -75,16 +74,16 @@ Executability: Fully Executable Outcome: Message: --DECOD should be populated when --PTCD is populated Output Variables: - - --TERM - - --PTCD - - --DECOD + - --TERM + - --PTCD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000268/rule.yml b/Published/CORE-000268/rule.yml index f037a1474..32ed61b78 100644 --- a/Published/CORE-000268/rule.yml +++ b/Published/CORE-000268/rule.yml @@ -2,140 +2,133 @@ # Condition: # Rule: --DECOD and --PTCD have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized or dictionary-derived text for the description of - an event or intervention. Equivalent to the Preferred Term (PT - in MedDRA). - Document: Model v2.0 - Item: --DECOD - Section: Events - - Cited Guidance: The preferred term code assigned to the event from MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the - topic variable, --TERM, or the modified topic variable - (--MODIFY), if applicable. Equivalent to the Preferred Term - (PT in MedDRA). - Document: Model v1.7 - Item: --DECOD - Section: 2.2.2 - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the - topic variable, --TERM, or the modified topic variable - (--MODIFY), if applicable. Equivalent to the Preferred Term - (PT in MedDRA). - Document: Model v1.4 - Item: --DECOD - Section: 2.2.2 - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the - description of an event or intervention. Equivalent to the - Preferred Term (PT in MedDRA).]|--PTCD[The preferred term code - assigned to the event from MedDRA.] - Document: SDTM v2.1 - Item: --DECOD|--PTCD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0327 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standardized or dictionary-derived text for the description of an event or + intervention. Equivalent to the Preferred Term (PT in MedDRA). + Document: Model v2.0 + Item: --DECOD + Section: Events + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic + variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.7 + Item: --DECOD + Section: 2.2.2 + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic + variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.4 + Item: --DECOD + Section: 2.2.2 + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the description of an + event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The + preferred term code assigned to the event from MedDRA.] + Document: SDTM v2.1 + Item: --DECOD|--PTCD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0327 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: --DECOD - operator: exists - - name: --PTCD - operator: exists - - name: --PTCD - operator: is_not_unique_relationship - value: --DECOD + - name: --DECOD + operator: exists + - name: --PTCD + operator: exists + - name: --PTCD + operator: is_not_unique_relationship + value: --DECOD Core: Id: CORE-000268 Status: Published @@ -145,15 +138,15 @@ Executability: Fully Executable Outcome: Message: --DECOD and --PTCD do not have a one-to-one relationship. Output Variables: - - --PTCD - - --DECOD + - --PTCD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000269/rule.yml b/Published/CORE-000269/rule.yml index 0cf235d32..053f09738 100644 --- a/Published/CORE-000269/rule.yml +++ b/Published/CORE-000269/rule.yml @@ -2,117 +2,114 @@ # Condition: VISIT ^= null and is planned # Rule: VISIT in TV.VISIT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits (TV) dataset (Section - 7.3.1, Trial Visits). - Document: IG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset, - Document: IG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset, - Document: IG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned visits. There - will be a one-to-one relationship between values of VISIT and - VISITNUM in TV. If a subject-level dataset includes both - VISITNUM and VISIT, then records that include values of - VISITNUM that appear in the TV dataset should also include the - corresponding values of VISIT from the TV dataset. - Document: TIG 1.0 - Item: 2.8.10.31 Assumption 6 - Section: 2.8.7.5 - - Cited Guidance: Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Specification VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0312 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: IG v3.4 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.3 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.2 + Item: '' + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. + Document: TIG 1.0 + Item: 2.8.10.31 Assumption 6 + Section: 2.8.7.5 + - Cited Guidance: Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Specification VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0312 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: VISIT - operator: non_empty - - name: SVPRESP - operator: equal_to - value: Y - - name: VISIT - operator: is_not_contained_by - value: $tv_visit + - name: VISIT + operator: non_empty + - name: SVPRESP + operator: equal_to + value: Y + - name: VISIT + operator: is_not_contained_by + value: $tv_visit Core: Id: CORE-000269 Status: Published Version: '1' -Description: Verify when VISIT is not null in any given domain and VISIT is - planned (SVPRESP = 'Y'), then VISIT should be among TV.VISIT. +Description: Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'), + then VISIT should be among TV.VISIT. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - - VISIT - Name: SV +- Keys: + - USUBJID + - VISIT + Name: SV Operations: - - domain: TV - id: $tv_visit - name: VISIT - operator: distinct +- domain: TV + id: $tv_visit + name: VISIT + operator: distinct Outcome: - Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be - among those present in TV.VISIT. + Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present + in TV.VISIT. Output Variables: - - VISIT - - VISITNUM + - VISIT + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000270/rule.yml b/Published/CORE-000270/rule.yml index b5a53f52c..f212bc408 100644 --- a/Published/CORE-000270/rule.yml +++ b/Published/CORE-000270/rule.yml @@ -2,112 +2,108 @@ # Condition: VISITNUM ^= null and is planned # Rule: VISITNUM in TV.VISITNUM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits (TV) dataset (Section - 7.3.1, Trial Visits). - Document: SDTMIG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset. - Document: SDTMIG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must - be those defined in the Trial Visits dataset. - Document: SDTMIG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of - VISITNUM for planned visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV - dataset are assumed to correspond to unplanned visits. There - will be a one-to-one relationship between values of VISIT and - VISITNUM in TV. If a subject-level dataset includes both - VISITNUM and VISIT, then records that include values of - VISITNUM that appear in the TV dataset should also include the - corresponding values of VISIT from the TV dataset. - Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Assumption 6 |Specifications VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0314 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: SDTMIG v3.4 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset. + Document: SDTMIG v3.3 + Item: '' + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset. + Document: SDTMIG v3.2 + Item: '' + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Assumption 6 |Specifications VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0314 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISITNUM - operator: is_not_contained_by - value: $TV_VISITNUM + - name: SVPRESP + operator: equal_to + value: Y + - name: VISITNUM + operator: is_not_contained_by + value: $TV_VISITNUM Core: Id: CORE-000270 Status: Published Version: '1' -Description: Verify when VISITNUM is not null in any given domain and VISITNUM - is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISITNUM. +Description: Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP = + 'Y'), then VISIT should be among TV.VISITNUM. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - - VISITNUM - Name: SV +- Keys: + - USUBJID + - VISITNUM + Name: SV Operations: - - domain: TV - id: $TV_VISITNUM - name: VISITNUM - operator: distinct +- domain: TV + id: $TV_VISITNUM + name: VISITNUM + operator: distinct Outcome: - Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be - among those present in TV.VISITNUM. in TV.VISITNUM + Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those + present in TV.VISITNUM. in TV.VISITNUM Output Variables: - - VISITNUM - - SVPRESP + - VISITNUM + - SVPRESP Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000271/rule.yml b/Published/CORE-000271/rule.yml index 9964e38e5..a99a8c698 100644 --- a/Published/CORE-000271/rule.yml +++ b/Published/CORE-000271/rule.yml @@ -2,80 +2,76 @@ # Condition: # Rule: EPOCH in TA.EPOCH Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other - general-observation-class domains. In DS, EPOCH is based on - DSSTDTC. The values of EPOCH are drawn from the Trial Arms(TA) - dataset (Section 7.2.1, Trial Arms). - Document: SDTMIG v3.4 - Item: DS, Assumption 4.c - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other - general-observation-class domains. In DS, EPOCH is based on - DSSTDTC. The values of EPOCH are drawn from the Trial Arms - (TA) dataset (Section 7.2.1, Trial Arms). - Document: SDTMIG v3.3 - Item: DS, Assumption 4.c - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '...EPOCH, as a Timing variable, is the name of the Epoch during - which --STDTC or --DTC falls. The values of EPOCH are drawn - from the Trial Arms domain, Section 7.2 - Experimental Design - Trial Arms (TA)' - Document: SDTMIG v3.2 - Item: DS, Assumption 3.c - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other general - observation-class domains. In DS, EPOCH is based on DSSTDTC. - The values of EPOCH are drawn from the Trial Arms (TA) - dataset. - Document: TIG 1.0 - Item: Assumption 4.c - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0294 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: EPOCH may be included as a timing variable as in other + general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH + are drawn from the Trial Arms(TA) dataset (Section 7.2.1, Trial Arms). + Document: SDTMIG v3.4 + Item: DS, Assumption 4.c + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: EPOCH may be included as a timing variable as in other + general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH + are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms). + Document: SDTMIG v3.3 + Item: DS, Assumption 4.c + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '...EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC + or --DTC falls. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2 - Experimental + Design Trial Arms (TA)' + Document: SDTMIG v3.2 + Item: DS, Assumption 3.c + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: EPOCH may be included as a timing variable as in other general + observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn + from the Trial Arms (TA) dataset. + Document: TIG 1.0 + Item: Assumption 4.c + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0294 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: EPOCH - operator: is_not_contained_by - value: $ta_epoch - - name: EPOCH - operator: non_empty + - name: EPOCH + operator: is_not_contained_by + value: $ta_epoch + - name: EPOCH + operator: non_empty Core: Id: CORE-000271 Status: Published @@ -83,21 +79,21 @@ Core: Description: Raise an error when EPOCH is not in TA.EPOCH Executability: Fully Executable Operations: - - domain: TA - id: $ta_epoch - name: EPOCH - operator: distinct +- domain: TA + id: $ta_epoch + name: EPOCH + operator: distinct Outcome: Message: EPOCH is not in TA.EPOCH Output Variables: - - EPOCH + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000272/rule.yml b/Published/CORE-000272/rule.yml index 44e4c3c8c..b867e060f 100644 --- a/Published/CORE-000272/rule.yml +++ b/Published/CORE-000272/rule.yml @@ -2,154 +2,145 @@ # Condition: # Rule: --CAT ^= Domain Name Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain name or dictionary classification provided by --DECOD - and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or - dictionary classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: '2.8.7.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0501 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: '2.8.7.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0501 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: $domain_label + - name: --CAT + operator: equal_to_case_insensitive + value: $domain_label Core: Id: CORE-000272 Status: Published @@ -157,19 +148,19 @@ Core: Description: Raise an error when --CAT = DOMAIN. Executability: Fully Executable Operations: - - id: $domain_label - operator: domain_label +- id: $domain_label + operator: domain_label Outcome: Message: --CAT is equal to DOMAIN. Output Variables: - - --CAT + - --CAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000273/rule.yml b/Published/CORE-000273/rule.yml index 8e2554038..b6a618255 100644 --- a/Published/CORE-000273/rule.yml +++ b/Published/CORE-000273/rule.yml @@ -1,145 +1,134 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, - or underscores. - Document: TIG v1.0 - Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG - Domains) - Section: 2.8.9.14 (and all other domains with --TESTCD) - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0118 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) + Section: 2.8.9.14 (and all other domains with --TESTCD) + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0118 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - name: --TESTCD - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: --TESTCD + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000273 Status: Published Version: '1' -Description: Raise an error when --TESTCD contains anything else than a letter, - number or underscore +Description: Raise an error when --TESTCD contains anything else than a letter, number or underscore Executability: Fully Executable Outcome: - Message: --TESTCD value cannot contain characters other than letters, numbers or - underscores + Message: --TESTCD value cannot contain characters other than letters, numbers or underscores Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000274/rule.yml b/Published/CORE-000274/rule.yml index b4f33da17..a82f62f2c 100644 --- a/Published/CORE-000274/rule.yml +++ b/Published/CORE-000274/rule.yml @@ -1,126 +1,117 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: TIG v1.0 - Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG - Domains) - Section: 2.8.9.14 (and all other domains with --TESTCD) - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0099 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) + Section: 2.8.9.14 (and all other domains with --TESTCD) + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0099 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - name: --TESTCD - operator: longer_than - value: 8 + - name: --TESTCD + operator: longer_than + value: 8 Core: Id: CORE-000274 Status: Published @@ -130,14 +121,14 @@ Executability: Fully Executable Outcome: Message: --TESTCD > 8 chars Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000289/rule.yml b/Published/CORE-000289/rule.yml index 57657437a..78197baf9 100644 --- a/Published/CORE-000289/rule.yml +++ b/Published/CORE-000289/rule.yml @@ -2,92 +2,87 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBORNRHI = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement in - original units. Should be populated only for continuous - results. - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement in - original units. Should be populated only for continuous - results. - Document: TIG 1.0 - Item: Specification-LBORNRHI - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0410 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBORNRHI + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0410 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex + - name: LBORRES + operator: not_matches_regex # value: ^-?(0|[1-9]\d*)(\.\d+)?$ # Change by Jozef Aerts to allow values starting with a dot, e.g. ".25" # Also see Github ticket https://github.com/cdisc-org/cdisc-rules-engine/issues/520 - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBORNRHI - operator: non_empty - - name: LBORRES - operator: non_empty + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBORNRHI + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000289 Status: Published Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and - LBORNRHI is not empty. The interpretation of the guidance is that LBORRES is - populated (not null). +Description: Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty. + The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: Message: LBORRES is not a continuous measurement but LBORNRHI is not empty. @@ -95,9 +90,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000290/rule.yml b/Published/CORE-000290/rule.yml index aab3d3e30..de04b0fee 100644 --- a/Published/CORE-000290/rule.yml +++ b/Published/CORE-000290/rule.yml @@ -2,89 +2,84 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBORNRLO = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. Should be populated - only for continuous results. - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurement in - original units. Should be populated only for continuous - results. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0409 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0409 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBORNRLO - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBORNRLO + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000290 Status: Published Version: '1' -Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO - is not empty. The interpretation of the guidance is that LBORRES is populated - (not null). +Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The + interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: Message: LBORRES is not a continuous measurement but LBORNRLO is not empty. @@ -92,9 +87,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000291/rule.yml b/Published/CORE-000291/rule.yml index 1de3b5976..2e34656eb 100644 --- a/Published/CORE-000291/rule.yml +++ b/Published/CORE-000291/rule.yml @@ -2,79 +2,77 @@ # Condition: EC domain is present # Rule: EXVAMT not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"When the EC domain is implemented in conjunction with the EX - domain, EXVAMT and EXVAMTU should not be used in - EX; collected values instead would be represented in ECDOSE - and ECDOSU."' - Document: IG v3.4 - Item: Assumption 6c - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the EC domain is implemented in conjunction with the EX - domain, EXVAMT and EXVAMTU should not be used in EX; collected - values instead would be represented in ECDOSE and ECDOSU. - Document: IG v3.3 - Item: Assumption 6c - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented in - conjunction with the EX domain, EXVAMT and EXVAMTU should not - be used in EX; collected values instead would be represented - in ECDOSE and ECDOSU - Document: IG v3.2 - Item: Assumption 6c - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: When the EC domain is implemented in conjunction with the EX - domain, EXVAMT and EXVAMTU should not be used in EX; collected - values instead would be represented in ECDOSE and ECDOSU. - Document: TIG 1.0 - Item: Assumption 6c - Section: 2.8.10.10 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0370 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE + and ECDOSU."' + Document: IG v3.4 + Item: Assumption 6c + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in + ECDOSE and ECDOSU. + Document: IG v3.3 + Item: Assumption 6c + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented in conjunction with + the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would + be represented in ECDOSE and ECDOSU + Document: IG v3.2 + Item: Assumption 6c + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in + ECDOSE and ECDOSU. + Document: TIG 1.0 + Item: Assumption 6c + Section: 2.8.10.10 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0370 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $EXVAMT_EXISTS - operator: equal_to - value: true - - name: EC - operator: exists + - name: $EXVAMT_EXISTS + operator: equal_to + value: true + - name: EC + operator: exists Core: Id: CORE-000291 Status: Published @@ -82,24 +80,24 @@ Core: Description: When EC exists, EXVAMT should not be used. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: EX +- Keys: + - USUBJID + Name: EX Operations: - - id: $EXVAMT_EXISTS - name: EXVAMT - operator: variable_exists +- id: $EXVAMT_EXISTS + name: EXVAMT + operator: variable_exists Outcome: Message: EXVAMT is present when EC exists. Output Variables: - - $EXVAMT_EXISTS + - $EXVAMT_EXISTS Rule Type: Domain Presence Check Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000293/rule.yml b/Published/CORE-000293/rule.yml index f8d8f6be6..6bc3b424d 100644 --- a/Published/CORE-000293/rule.yml +++ b/Published/CORE-000293/rule.yml @@ -2,91 +2,80 @@ # Condition: # Rule: Suppqual dataset names <= 8 characters Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"When data have been split into multiple datasets (see Section - 4.1.7, Splitting Domains), longer names such as SUPPFAMH may - be needed. In cases where data about Associated Persons (see - Associated Persons Implementation Guide) have been collected, - Supplemental Qualifiers for Findings About events or - interventions for an associated person may need to be - represented. A dataset name with the SUPP fragment, e.g., - SUPPAPFAMH, would be too long. In this case only, the 'SUPP' - portion should be shortened to 'SQ', resulting in a dataset - name such as SQAPFAMH.\"" - Document: IG v3.4 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When data have been split into multiple datasets (see Section - 4: 4.1.1.7, Splitting Domains), longer names such as SUPPFAMH - may be needed. In cases where data about Associated Persons - (see Associated Persons Implementation Guide) have been - collected, an associated person with Supplemental Qualifiers - for Findings About their medical history, the resulting - dataset name SUPPAPFAMH) would be too long so that, in this - case only, the "SUPP" portion should be shortened to "SQ". - resulting in a dataset name of SQAPFAMH.' - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When data have been split into multiple datasets (see Section - 4: 4.1.1.7, Splitting Domains), longer names such as SUPPFAMH - may be needed. In cases where data about Associated Persons - (see Associated Persons Implementation Guide) have been - collected, an associated person with Supplemental Qualifiers - for Findings About their medical history, the resulting - dataset name SUPPAPFAMH) would be too long so that, in this - case only, the "SUPP" portion should be shortened to "SQ". - resulting in a dataset name of SQAPFAMH.' - Document: IG v3.3 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets will be named using convention - SUPP concatenated with the two-character domain code or - four-character code when a dataset is split (e.g., SUPPDM, - SUPPFA, SUPPFACM). - Document: TIG 1.0 - Item: Tabulation table NUM 2 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0425 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "\"When data have been split into multiple datasets (see Section 4.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, Supplemental Qualifiers + for Findings About events or interventions for an associated person may need to be represented. + A dataset name with the SUPP fragment, e.g., SUPPAPFAMH, would be too long. In this case only, + the 'SUPP' portion should be shortened to 'SQ', resulting in a dataset name such as SQAPFAMH.\"" + Document: IG v3.4 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, an associated person + with Supplemental Qualifiers for Findings About their medical history, the resulting dataset + name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be + shortened to "SQ". resulting in a dataset name of SQAPFAMH.' + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, an associated person + with Supplemental Qualifiers for Findings About their medical history, the resulting dataset + name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be + shortened to "SQ". resulting in a dataset name of SQAPFAMH.' + Document: IG v3.3 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets will be named using convention SUPP + concatenated with the two-character domain code or four-character code when a dataset is + split (e.g., SUPPDM, SUPPFA, SUPPFACM). + Document: TIG 1.0 + Item: Tabulation table NUM 2 + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0425 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: dataset_name - operator: longer_than - value: 8 + - name: dataset_name + operator: longer_than + value: 8 Core: Id: CORE-000293 Status: Published @@ -99,9 +88,9 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000294/rule.yml b/Published/CORE-000294/rule.yml index 638fcb9b6..d91430b58 100644 --- a/Published/CORE-000294/rule.yml +++ b/Published/CORE-000294/rule.yml @@ -2,86 +2,83 @@ # Condition: TSPARMCD = 'AGEMAX' and TSVAL ^= null # Rule: TSVAL conforms to ISO 8601 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the trial summary parameter is AGEMAX, then TSVAL should - have a value expressed as an ISO8601 time duration (e.g., P43Y - for 43 years old or P6M for 6 months old). - Document: IG v3.4 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in - Table 1. TSVAL may have controlled terminology depending on - the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included Appendix - C1, Trial Summary Codes. TSVAL may have controlled terminology - depending on the value of TSPARMCD. Conditions for including - parameters are included in Appendix C1, Trial Summary Codes. - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of - dates and/or times, intervals of time, and durations of time - in ISO 8601 format as defined by the International - Organization for Standardization (ISO) (http://www.iso.org). - Document: TIG 1.0 - Item: '' - Section: '2.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0471 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the trial summary parameter is AGEMAX, then TSVAL should have a value + expressed as an ISO8601 time duration (e.g., P43Y for 43 years old or P6M for 6 months + old). + Document: IG v3.4 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included Appendix C1, Trial + Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. + Conditions for including parameters are included in Appendix C1, Trial Summary Codes. + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). + Document: TIG 1.0 + Item: '' + Section: '2.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0471 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TSPARMCD - operator: equal_to - value: AGEMAX - - name: TSVAL - operator: non_empty - - name: TSVAL - negative: false - operator: invalid_duration + - name: TSPARMCD + operator: equal_to + value: AGEMAX + - name: TSVAL + operator: non_empty + - name: TSVAL + negative: false + operator: invalid_duration Core: Id: CORE-000294 Status: Published Version: '1' -Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL - does not conform to ISO 8601 +Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to + ISO 8601 Executability: Fully Executable Outcome: Message: TSVAL is not in ISO 8601 format @@ -89,9 +86,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000295/rule.yml b/Published/CORE-000295/rule.yml index e25211818..65f5cebff 100644 --- a/Published/CORE-000295/rule.yml +++ b/Published/CORE-000295/rule.yml @@ -2,60 +2,57 @@ # Condition: --STREFC ^= null # Rule: --STREFN ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in - standard format or in standard units. --STREFN uses the same - units as --STRESN, if applicable. - Document: SDTM v2.0 - Item: --STREFN - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0550 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in - standard format or in standard units. --STREFN uses the same - units as --STRESN, if applicable - Document: Model v1.7 - Item: --STREFN - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0550 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in - standard format or in standard units. --STREFN uses the same - units as --STRESN, if applicable. - Document: SDTM v2.1 - Item: --STREFN - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0638 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: SDTM v2.0 + Item: --STREFN + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0550 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable + Document: Model v1.7 + Item: --STREFN + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0550 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: SDTM v2.1 + Item: --STREFN + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0638 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --STREFC - operator: non_empty - - name: --STREFN - operator: empty + - name: --STREFC + operator: non_empty + - name: --STREFN + operator: empty Core: Id: CORE-000295 Status: Published @@ -68,9 +65,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000296/rule.yml b/Published/CORE-000296/rule.yml index 3f69f26be..769fe89ad 100644 --- a/Published/CORE-000296/rule.yml +++ b/Published/CORE-000296/rule.yml @@ -2,72 +2,66 @@ # Condition: DM.ACTARMCD not null # Rule: DS records present for subject Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Disposition dataset provides an accounting for all subjects - who entered the study and may include protocol milestones, - such as randomization, as well as the subject's completion - status or reason for discontinuation for the entire study or - each phase or segment of the study, including screening and - post-treatment follow-up. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0540 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Disposition dataset provides an accounting for all subjects - who entered the study and may include protocol milestones, - such as randomization, as well as the subject's completion - status or reason for discontinuation for the entire study or - each phase or segment of the study, including screening and - post-treatment follow-up. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0540 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Disposition (DS) dataset provides an accounting for all - subjects who entered the study and may include protocol - milestones, such as randomization, as well as the subject's - completion status or reason for discontinuation for the entire - study or each phase or segment of the study, including - screening and follow-up. Applicants may choose which - disposition events and milestones to submit for a study in - alignment with regulatory requirements. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0633 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Disposition dataset provides an accounting for all subjects who entered + the study and may include protocol milestones, such as randomization, as well as the + subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and post-treatment follow-up. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0540 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Disposition dataset provides an accounting for all subjects who entered + the study and may include protocol milestones, such as randomization, as well as the + subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and post-treatment follow-up. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0540 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The Disposition (DS) dataset provides an accounting for all subjects who + entered the study and may include protocol milestones, such as randomization, as well as + the subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and follow-up. Applicants may choose + which disposition events and milestones to submit for a study in alignment with regulatory + requirements. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0633 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ACTARMCD - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $ds_usubjid + - name: ACTARMCD + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $ds_usubjid Core: Id: CORE-000296 Status: Published @@ -75,21 +69,21 @@ Core: Description: When ACTARMCD is populated, disposition data for subject must be present Executability: Fully Executable Operations: - - domain: DS - id: $ds_usubjid - name: USUBJID - operator: distinct +- domain: DS + id: $ds_usubjid + name: USUBJID + operator: distinct Outcome: Message: There are no DS records for subject who was assigned treatment Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000298/rule.yml b/Published/CORE-000298/rule.yml index d85cf8750..fd947757f 100644 --- a/Published/CORE-000298/rule.yml +++ b/Published/CORE-000298/rule.yml @@ -2,89 +2,84 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBSTNRLO = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. Should be - populated only for continuous results. ' - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. Should be populated - only for continuous results. - Document: TIG 1.0 - Item: Specification-LBSTNRLO - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0411 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN + in standardized units. Should be populated only for continuous results. ' + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBSTNRLO + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0411 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRLO - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRLO + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000298 Status: Published Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and - LBSTNRLO is not empty. The interpretation of the guidance is that LBORRES is - populated (not null). +Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty. + The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: Message: LBORRES is not a continuous measurment but LBSTNRLO is not empty. @@ -92,9 +87,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000299/rule.yml b/Published/CORE-000299/rule.yml index 45fc3f166..1fdc1f9ae 100644 --- a/Published/CORE-000299/rule.yml +++ b/Published/CORE-000299/rule.yml @@ -2,88 +2,83 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBSTNRHI = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Upper end of reference range for continuous measurements in - standardized units. Should be populated only for continuous - results. ' - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in - original units. Should be populated only for continuous - results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in - standardized units. Should be populated only for continuous - results. - Document: TIG 1.0 - Item: Specification-LBSTNRHI - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0412 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Upper end of reference range for continuous measurements in standardized units. + Should be populated only for continuous results. ' + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in standardized + units. Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBSTNRHI + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0412 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRHI - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRHI + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000299 Status: Published Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and - LBSTNRHI is not empty. The interpretation of the guidance is that LBORRES is - populated (not null). +Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty. + The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: Message: LBORRES is not a continuous measurement but LBSTNRHI is not empty. @@ -91,9 +86,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000302/rule.yml b/Published/CORE-000302/rule.yml index 2f31f4825..e406d3db6 100644 --- a/Published/CORE-000302/rule.yml +++ b/Published/CORE-000302/rule.yml @@ -1,161 +1,151 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: QLABEL - operator: is_not_unique_relationship - value: QNAM + - name: QLABEL + operator: is_not_unique_relationship + value: QNAM Core: Id: CORE-000302 Status: Published @@ -165,14 +155,14 @@ Executability: Fully Executable Outcome: Message: QNAM and QLABEL do not have a one-to-one relationship. Output Variables: - - QNAM - - QLABEL + - QNAM + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000303/rule.yml b/Published/CORE-000303/rule.yml index cb41a29c2..e3fad7ca0 100644 --- a/Published/CORE-000303/rule.yml +++ b/Published/CORE-000303/rule.yml @@ -1,161 +1,151 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --TEST - operator: is_not_unique_relationship - value: --TESTCD + - name: --TEST + operator: is_not_unique_relationship + value: --TESTCD Core: Id: CORE-000303 Status: Published @@ -165,15 +155,15 @@ Executability: Fully Executable Outcome: Message: --TESTCD and --TEST do not have a one-to-one relationship. Output Variables: - - --TESTCD - - --TEST + - --TESTCD + - --TEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000305/rule.yml b/Published/CORE-000305/rule.yml index 153561e03..4b3ffb60b 100644 --- a/Published/CORE-000305/rule.yml +++ b/Published/CORE-000305/rule.yml @@ -1,153 +1,153 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DUR - operator: non_empty - - name: --DUR - operator: contains - value: '-' + - name: --DUR + operator: non_empty + - name: --DUR + operator: contains + value: '-' Core: Id: CORE-000305 Status: Published @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000308/rule.yml b/Published/CORE-000308/rule.yml index 52043c0de..7e4aab943 100644 --- a/Published/CORE-000308/rule.yml +++ b/Published/CORE-000308/rule.yml @@ -1,153 +1,153 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DOSE - operator: non_empty - - name: --DOSE - operator: less_than - value: 0 + - name: --DOSE + operator: non_empty + - name: --DOSE + operator: less_than + value: 0 Core: Id: CORE-000308 Status: Published @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000310/rule.yml b/Published/CORE-000310/rule.yml index bc920b9f0..d96341c18 100644 --- a/Published/CORE-000310/rule.yml +++ b/Published/CORE-000310/rule.yml @@ -1,151 +1,151 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: AGE - operator: less_than - value: 0 + - name: AGE + operator: less_than + value: 0 Core: Id: CORE-000310 Status: Published @@ -158,8 +158,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000318/rule.yml b/Published/CORE-000318/rule.yml index 426f6b93c..69fcfa5c5 100644 --- a/Published/CORE-000318/rule.yml +++ b/Published/CORE-000318/rule.yml @@ -1,161 +1,151 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: ARM - operator: is_not_unique_relationship - value: ARMCD + - name: ARM + operator: is_not_unique_relationship + value: ARMCD Core: Id: CORE-000318 Status: Published @@ -165,17 +155,17 @@ Executability: Fully Executable Outcome: Message: ARMCD and ARM do not have a one-to-one relationship. Output Variables: - - ARMCD - - ARM + - ARMCD + - ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - TA - - TV - - DM + - TA + - TV + - DM Sensitivity: Record diff --git a/Published/CORE-000321/rule.yml b/Published/CORE-000321/rule.yml index 52422bf3f..14fb71070 100644 --- a/Published/CORE-000321/rule.yml +++ b/Published/CORE-000321/rule.yml @@ -1,169 +1,158 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DY - operator: not_exists - - name: --DTC - operator: exists + - name: --DY + operator: not_exists + - name: --DTC + operator: exists Core: Id: CORE-000321 Status: Published Version: '1' -Description: When Date/Time of Collection (--DTC) is present in the dataset, - then the Study Day of Visit/Collection/Exam (--DY) should also present in the - dataset. +Description: When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of + Visit/Collection/Exam (--DY) should also present in the dataset. Executability: Fully Executable Outcome: - Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when - Date/Time of Collection (--DTC) is present. + Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of + Collection (--DTC) is present. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000324/rule.yml b/Published/CORE-000324/rule.yml index 4ae2d19ae..a4b59e6f2 100644 --- a/Published/CORE-000324/rule.yml +++ b/Published/CORE-000324/rule.yml @@ -1,142 +1,122 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when - it ended or if it was ongoing. AFTER is not a valid value in - this case because it would represent an event after the date - of collection. If the reference time point is prior to the - date of collection or assessment: Start values: - an observation can start BEFORE the reference point, can - start COINCIDENT with the reference point, can start AFTER - the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the - reference point, can end COINCIDENT with the reference point, - can end AFTER the reference point, can be known that it - didn't end but was ONGOING, or it is unknown (U) when it ended - or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection." - Document: TIG 1.0 - Item: Num 2 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0443 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection. + If the reference time point is prior to the date of collection or assessment: Start values: + an observation can start BEFORE the reference point, can start COINCIDENT with the reference + point, can start AFTER the reference point, or it may not be known (U) when it started. End + values: an observation can end BEFORE the reference point, can end COINCIDENT with the reference + point, can end AFTER the reference point, can be known that it didn't end but was ONGOING, + or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: TIG 1.0 + Item: Num 2 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0443 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --ENRTPT # Condition: --ENTPT corresponds to the date of collection or assessment. # Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --ENTPT - operator: date_equal_to - value: --DTC - - name: --ENRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - ONGOING - - UNKNOWN + - name: --ENTPT + operator: non_empty + - name: --ENTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --ENTPT + operator: date_equal_to + value: --DTC + - name: --ENRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - ONGOING + - UNKNOWN Core: Id: CORE-000324 Status: Published Version: '1' -Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', - 'ONGOING', 'UNKNOWN') +Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Executability: Partially Executable Outcome: Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Output Variables: - - --ENTPT - - --ENRTPT - - --DTC + - --ENTPT + - --ENRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000325/rule.yml b/Published/CORE-000325/rule.yml index c68d9f55c..3fbd366ef 100644 --- a/Published/CORE-000325/rule.yml +++ b/Published/CORE-000325/rule.yml @@ -1,96 +1,96 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: SENDIG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: SENDIG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: SENDIG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special - character restrictions. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - name: ARMCD + - name: ARMCD + operator: longer_than + value: 20 + - all: + - name: TXPARMCD + operator: equal_to + value: ARMCD + - name: TXVAL operator: longer_than value: 20 - - all: - - name: TXPARMCD - operator: equal_to - value: ARMCD - - name: TXVAL - operator: longer_than - value: 20 Core: Id: CORE-000325 Status: Published @@ -100,18 +100,18 @@ Executability: Fully Executable Outcome: Message: ARMCD value length is greater than 20 Output Variables: - - ARMCD - - TXPARMCD - - TXVAL + - ARMCD + - TXPARMCD + - TXVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TA - - TX + - DM + - TA + - TX Sensitivity: Record diff --git a/Published/CORE-000328/rule.yml b/Published/CORE-000328/rule.yml index 6a2af447e..1300f0978 100644 --- a/Published/CORE-000328/rule.yml +++ b/Published/CORE-000328/rule.yml @@ -1,172 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STDY - operator: not_exists - - name: --STDTC - operator: exists + - name: --STDY + operator: not_exists + - name: --STDTC + operator: exists Core: Id: CORE-000328 Status: Published Version: '1' -Description: Study Day of Start (--STDY) variable should be included into - dataset, when Start Study Date/Time (--STDTC) variable is present. +Description: Study Day of Start (--STDY) variable should be included into dataset, when Start Study + Date/Time (--STDTC) variable is present. Executability: Fully Executable Outcome: - Message: The Study Day of Start of Observation (--STDY) is not present in the - dataset when Start Date/Time of Observation (--STDTC) is present. + Message: The Study Day of Start of Observation (--STDY) is not present in the dataset when Start + Date/Time of Observation (--STDTC) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000334/rule.yml b/Published/CORE-000334/rule.yml index 0b3aa0315..74c853dbd 100644 --- a/Published/CORE-000334/rule.yml +++ b/Published/CORE-000334/rule.yml @@ -2,200 +2,182 @@ # Condition: Variable Core Status = Expected # Rule: Variable present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When the study does not include the data item for an expected - variable, however, a null column must still be included in the - dataset, and a comment must be included in the Define-XML - document to state that the study does not include the data - item." - Document: SDTM v1.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When no data has been collected for an expected variable, - however, a null column must still be included in the dataset, - and a comment must be included in the define.xml to state that - data was not collected." - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When no data has been collected for an expected variable - however, a null column must still be included in the dataset, - and a comment must be included in the define.xml to state that - data was not collected." - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as - columns - Document: TIG v1.0 - Item: Table 2 Num - Section: 2.5. - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0301 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record - useful in the context of a specific domain. Columns for - Expected variables must be present in each submitted dataset - even if all values are null. Expected variables may contain - some null values, but in most cases will not contain null - values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Exp for variables which are Expected to be included in the - resulting dataset, even if all values are null. Such variables - are considered necessary to make the data record useful in the - context of the domain. - Document: TIG v1.0 - Item: Table Row 7 - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0065 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "When the study does not include the data item for an expected variable, however, + a null column must still be included in the dataset, and a comment must be included in the Define-XML + document to state that the study does not include the data item." + Document: SDTM v1.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "When no data has been collected for an expected variable, however, a null column + must still be included in the dataset, and a comment must be included in the define.xml to state + that data was not collected." + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "When no data has been collected for an expected variable however, a null column + must still be included in the dataset, and a comment must be included in the define.xml to state + that data was not collected." + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: All Required and Expected tabulation variables are included as columns + Document: TIG v1.0 + Item: Table 2 Num + Section: 2.5. + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0301 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Exp for variables which are Expected to be included in the resulting + dataset, even if all values are null. Such variables are considered necessary to make the + data record useful in the context of the domain. + Document: TIG v1.0 + Item: Table Row 7 + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0065 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_name - operator: not_contains_all - value: - - $expected_variables + - name: variable_name + operator: not_contains_all + value: + - $expected_variables Core: Id: CORE-000334 Status: Published @@ -203,22 +185,22 @@ Core: Description: Raise an error when an expected variable is not present in the dataset. Executability: Fully Executable Operations: - - id: $expected_variables - operator: expected_variables - - id: $dataset_variables - operator: get_column_order_from_dataset +- id: $expected_variables + operator: expected_variables +- id: $dataset_variables + operator: get_column_order_from_dataset Outcome: Message: At least one expected variable is missing from dataset Output Variables: - - $dataset_variables - - $expected_variables + - $dataset_variables + - $expected_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000337/rule.yml b/Published/CORE-000337/rule.yml index 1a14dd37b..4895da31c 100644 --- a/Published/CORE-000337/rule.yml +++ b/Published/CORE-000337/rule.yml @@ -2,108 +2,103 @@ # Condition: Multiple records in SUPPDM where RACE captured # Rule: RACE = 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be - 'MULTIPLE' and the additional information will be included in - the Supplemental Qualifiers dataset. - Document: IG v3.2 - Item: Assumption 6 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be - 'MULTIPLE' and the additional information will be included in - the Supplemental Qualifiers dataset. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be - 'MULTIPLE' and the additional information will be included in - the Supplemental Qualifiers dataset. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be - 'MULTIPLE' and the additional information will be included in - the Supplemental Qualifiers dataset. - Document: TIG 1.0 - Item: Assumption 6 - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0386 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.2 + Item: Assumption 6 + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.3 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.4 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: TIG 1.0 + Item: Assumption 6 + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0386 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RACE - operator: not_equal_to - value: MULTIPLE - - name: QNAM - operator: starts_with - value: RACE - value_is_literal: true - - name: QNAM - operator: suffix_matches_regex - suffix: 1 - value: ^[A-Z0-9] - - name: QNAM - operator: not_suffix_matches_regex - suffix: 3 - value: (OTH) + - name: RACE + operator: not_equal_to + value: MULTIPLE + - name: QNAM + operator: starts_with + value: RACE + value_is_literal: true + - name: QNAM + operator: suffix_matches_regex + suffix: 1 + value: ^[A-Z0-9] + - name: QNAM + operator: not_suffix_matches_regex + suffix: 3 + value: (OTH) Core: Id: CORE-000337 Status: Published Version: '1' -Description: 'Raise an error when multiple races are collected in SUPPDM but - RACE in DM does not equal "MULTIPLE".' +Description: 'Raise an error when multiple races are collected in SUPPDM but RACE in DM does not equal + "MULTIPLE".' Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: 'Multiple races are collected in SUPPDM but RACE in DM does not equal - "MULTIPLE".' + Message: 'Multiple races are collected in SUPPDM but RACE in DM does not equal "MULTIPLE".' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPPDM + - SUPPDM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000341/rule.yml b/Published/CORE-000341/rule.yml index 296683e79..fdd6e0e75 100644 --- a/Published/CORE-000341/rule.yml +++ b/Published/CORE-000341/rule.yml @@ -1,106 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, - regardless of whether the data values are character or - numeric. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0279 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0279 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --ORRES - operator: non_empty - - name: --STRESC - operator: empty + - name: --ORRES + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000341 Status: Published @@ -110,15 +109,15 @@ Executability: Fully Executable Outcome: Message: --STRESC must be populated as --ORRES is populated. Output Variables: - - --ORRES - - --STRESC + - --ORRES + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000342/rule.yml b/Published/CORE-000342/rule.yml index a3adb92b4..4bf15d1e9 100644 --- a/Published/CORE-000342/rule.yml +++ b/Published/CORE-000342/rule.yml @@ -1,226 +1,224 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique - within the trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD that is unique - within the trial. - Document: TIG v1.0 - Item: Assumption 2 - Section: 2.8.9.28 Assumption 2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0161 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Each Trial Set must be identified by a SETCD that is unique within the + trial. + Document: TIG v1.0 + Item: Assumption 2 + Section: 2.8.9.28 Assumption 2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0161 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # FDA BUsiness Rule metadata added as both have the same logic - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for - nonclinical data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: '1' + Version: '1.5' + Version: '1.0' Check: # SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET all: - - name: SETCD - operator: is_not_unique_set - value: - - TXPARMCD - - TXPARM - - TXVAL - - SET + - name: SETCD + operator: is_not_unique_set + value: + - TXPARMCD + - TXPARM + - TXVAL + - SET Core: Id: CORE-000342 Status: Published Version: '1' -Description: SETCD must be unique for the combination of value in TXPARMCD, - TXPARM, TXVAL, and SET +Description: SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET Executability: Fully Executable Outcome: - Message: SETCD is not unique for the combination of value in TXPARMCD, TXPARM, - TXVAL, and SET + Message: SETCD is not unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000351/rule.yml b/Published/CORE-000351/rule.yml index a08a3c9eb..460066613 100644 --- a/Published/CORE-000351/rule.yml +++ b/Published/CORE-000351/rule.yml @@ -2,172 +2,161 @@ # Condition: # Rule: USUBJID unique within a submission Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies for all applications or submissions involving the - product. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all - studies for all applications or submissions involving the - product. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0392 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.0 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a - submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a subject - across all studies for all applications or submissions - involving the product. - Document: TIG v1.0 - Item: Text - Section: SDTM v2.1, Identifiers for All Classes, USUBJID - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0255 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0392 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.0 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: A sequence of characters used to uniquely identify a subject across all + studies for all applications or submissions involving the product. + Document: TIG v1.0 + Item: Text + Section: SDTM v2.1, Identifiers for All Classes, USUBJID + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0255 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: USUBJID - operator: is_not_unique_set - value: DOMAIN + - name: USUBJID + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000351 Status: Published @@ -177,14 +166,14 @@ Executability: Partially Executable Outcome: Message: USUBJID is not unique within study Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000352/rule.yml b/Published/CORE-000352/rule.yml index b0b1b9f0b..a4027fb71 100644 --- a/Published/CORE-000352/rule.yml +++ b/Published/CORE-000352/rule.yml @@ -2,94 +2,91 @@ # Condition: Next ELEMENT present in dataset # Rule: SEENDTC = SESTDTC of next ELEMENT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element. - Document: IG v3.4 - Item: Assumption 8 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element - Document: IG v3.2 - Item: Assumption 10 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element - Document: IG v3.3 - Item: Assumption 8 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC - value for one element will always be the same as the SESTDTC - value for the next Element. - Document: IG v3.0 - Item: Assumption 1 - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND126 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element. Because there are, - by definition, no gaps between elements, the value of SEENDTC - for one element will always be the same as the value of - SESTDTC for the next element. - Document: TIG 1.0 - Item: Assumption 7 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0427 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. + Document: IG v3.4 + Item: Assumption 8 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element + Document: IG v3.2 + Item: Assumption 10 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element + Document: IG v3.3 + Item: Assumption 8 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC value for one + element will always be the same as the SESTDTC value for the next Element. + Document: IG v3.0 + Item: Assumption 1 + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND126 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. Because there are, by definition, no gaps between elements, the value of SEENDTC + for one element will always be the same as the value of SESTDTC for the next element. + Document: TIG 1.0 + Item: Assumption 7 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0427 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SEENDTC - operator: does_not_have_next_corresponding_record - ordering: SESEQ - value: SESTDTC - within: USUBJID + - name: SEENDTC + operator: does_not_have_next_corresponding_record + ordering: SESEQ + value: SESTDTC + within: USUBJID Core: Id: CORE-000352 Status: Published @@ -102,9 +99,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000353/rule.yml b/Published/CORE-000353/rule.yml index c0b359cad..c24e8af5c 100644 --- a/Published/CORE-000353/rule.yml +++ b/Published/CORE-000353/rule.yml @@ -1,190 +1,189 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.0 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the - appropriate ISO 8601 format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.0 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: '1' + Version: '5.0' + Version: '1.0' # Applies for: # date/datetime: TSVAL = EXPENDTC, EXPSTDTC, STSTENDTC, DOSENDTC, DOSSTDTC, or STENDTC # duration: TRMSAC, INTSAC, SLENGTH, RECSAC Check: any: # Date/datetime parameter values - - all: - - name: TSPARMCD - operator: equal_to - value: EXPENDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: EXPSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: STSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: DOSENDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: DOSSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: STENDTC - - name: TSVAL - operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: EXPENDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: EXPSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: STSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: DOSENDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: DOSSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: STENDTC + - name: TSVAL + operator: invalid_date # Duration parameter values - P.S. negative durations are allowed - - all: - - name: TSPARMCD - operator: equal_to - value: DOSDUR - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: TRMSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: INTSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: SLENGTH - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: RECSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: DOSDUR + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: TRMSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: INTSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: SLENGTH + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: RECSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ Core: Id: CORE-000353 Status: Published Version: '1' -Description: Dates or durations represented in TSVAL must be in the appropriate - ISO 8601 format. +Description: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 format. Executability: Fully Executable Outcome: Message: Invalid date/datetime or duration format @@ -192,8 +191,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000354/rule.yml b/Published/CORE-000354/rule.yml index 90d353bd0..aa8201077 100644 --- a/Published/CORE-000354/rule.yml +++ b/Published/CORE-000354/rule.yml @@ -2,109 +2,104 @@ # Condition: The date portion of --DTC ^= complete date or the date portion of DM.RFSTDTC ^= complete date # Rule: --DY = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . - . . are determined by comparing the date portion of the - respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date - (RFSTDTC from the Demographics domain) - Document: SDTMIG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . - . . are determined by comparing the date portion of the - respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date - (RFSTDTC from the Demographics domain). - Document: SDTMIG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . - . . are determined by comparing the date portion of the - respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date - (RFSTDTC from the Demographics domain). - Document: SDTMIG v3.2 - Section: 4.1.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Variables --DY, --STDY, and --ENDY represent the timing of - observations in days relative to the reference start date in - RFSTDTC where the value of --DY is the relative day of the - date populated in --DTC for the observation,--STDTC is the - relative day of the date populated in --STDTC for the - observation; an--ENDY is the relative day of the of the date - populated in --ENDTC for the observation. - Document: TIG 1.0 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0292 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain) + Document: SDTMIG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: SDTMIG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: SDTMIG v3.2 + Section: 4.1.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Variables --DY, --STDY, and --ENDY represent the timing of observations in + days relative to the reference start date in RFSTDTC where the value of --DY is the + relative day of the date populated in --DTC for the observation,--STDTC is the relative + day of the date populated in --STDTC for the observation; an--ENDY is the relative day of + the of the date populated in --ENDTC for the observation. + Document: TIG 1.0 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0292 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DY - operator: non_empty - - any: - - name: --DTC - operator: is_incomplete_date - - name: RFSTDTC - operator: is_incomplete_date + - name: --DY + operator: non_empty + - any: + - name: --DTC + operator: is_incomplete_date + - name: RFSTDTC + operator: is_incomplete_date Core: Id: CORE-000354 Status: Published Version: '1' -Description: Raise an error when the date portion of --DTC is an incomplete date - or the date portion of DM.RFSTDTC is an incomplete date, but --DY is not empty +Description: Raise an error when the date portion of --DTC is an incomplete date or the date portion + of DM.RFSTDTC is an incomplete date, but --DY is not empty Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: The date portion of --DTC is not complete date or the date portion of - DM.RFSTDTC is not complete date, but --DY is not empty + Message: The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not + complete date, but --DY is not empty Output Variables: - - --DY - - --DTC - - RFSTDTC + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000355/rule.yml b/Published/CORE-000355/rule.yml index 48c7a95cd..e29ce0a58 100644 --- a/Published/CORE-000355/rule.yml +++ b/Published/CORE-000355/rule.yml @@ -2,188 +2,185 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as - columns in the dataset. Required tabulation variables are - populated for all records in the dataset. - Document: TIG 1.0 - Item: Table 2 Num 6 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0299 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Req for variables which are Required and must be included in the - resulting dataset and cannot be null for any record. Such - variables are basic to the identification of a data record or - are necessary to make the record meaningful. - Document: TIG 1.0 - Item: Text - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0057 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: All Required and Expected tabulation variables are included as columns in + the dataset. Required tabulation variables are populated for all records in the dataset. + Document: TIG 1.0 + Item: Table 2 Num 6 + Section: '2.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0299 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Req for variables which are Required and must be included in the resulting + dataset and cannot be null for any record. Such variables are basic to the identification + of a data record or are necessary to make the record meaningful. + Document: TIG 1.0 + Item: Text + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0057 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_name - operator: not_contains_all - value: - - $required_variables + - name: variable_name + operator: not_contains_all + value: + - $required_variables Core: Id: CORE-000355 Status: Published Version: '1' -Description: 'Part A: Raise an error when a Required variable is not present in - the dataset.' +Description: 'Part A: Raise an error when a Required variable is not present in the dataset.' Executability: Fully Executable Operations: - - id: $required_variables - operator: required_variables - - id: $dataset_variables - operator: get_column_order_from_dataset +- id: $required_variables + operator: required_variables +- id: $dataset_variables + operator: get_column_order_from_dataset Outcome: Message: At least one required variable is missing from dataset Output Variables: - - $dataset_variables - - $required_variables + - $dataset_variables + - $required_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000356/rule.yml b/Published/CORE-000356/rule.yml index 5574d97b2..b0bc4029a 100644 --- a/Published/CORE-000356/rule.yml +++ b/Published/CORE-000356/rule.yml @@ -2,167 +2,165 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and - cannot be null for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as - columns in the dataset. Required tabulation variables are - populated for all records in the dataset. - Document: TIG 1.0 - Item: Table 2 Num 6 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0299 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Req for variables which are Required and must be included in the - resulting dataset and cannot be null for any record. Such - variables are basic to the identification of a data record or - are necessary to make the record meaningful. - Document: TIG 1.0 - Item: Text - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0057 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: All Required and Expected tabulation variables are included as columns in + the dataset. Required tabulation variables are populated for all records in the dataset. + Document: TIG 1.0 + Item: Table 2 Num 6 + Section: '2.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0299 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Req for variables which are Required and must be included in the resulting + dataset and cannot be null for any record. Such variables are basic to the identification + of a data record or are necessary to make the record meaningful. + Document: TIG 1.0 + Item: Text + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0057 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: $required_variables - operator: exists - - name: variable_name - operator: is_contained_by - value: $required_variables - - name: variable_value - operator: empty + - name: $required_variables + operator: exists + - name: variable_name + operator: is_contained_by + value: $required_variables + - name: variable_value + operator: empty Core: Id: CORE-000356 Status: Published @@ -170,20 +168,20 @@ Core: Description: 'Part B: Raise an error when a Required variable is null.' Executability: Fully Executable Operations: - - id: $required_variables - operator: required_variables +- id: $required_variables + operator: required_variables Outcome: Message: At least one Required variable has a null value Output Variables: - - variable_name - - variable_value + - variable_name + - variable_value Rule Type: Value Check with Dataset Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000357/rule.yml b/Published/CORE-000357/rule.yml index 71c7cc876..f7dde4e25 100644 --- a/Published/CORE-000357/rule.yml +++ b/Published/CORE-000357/rule.yml @@ -2,93 +2,92 @@ # Condition: Supplemental Qualifier datasets # Rule: Split dataset names length <= 8 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset. - Document: IG v3.4 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset. - Document: IG v3.2 - Item: Rule 7 - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset. - Document: IG v3.3 - Item: Rule 7 - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature will include the additional one to two - characters used to identify the split dataset (e.g., SUPPLBHM, - SUPPFACM). - Document: TIG 1.0 - Item: Num 9.3.ii - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0303 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.4 + Item: '7' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.2 + Item: Rule 7 + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.3 + Item: Rule 7 + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature will include the additional one to two characters used to identify the split + dataset (e.g., SUPPLBHM, SUPPFACM). + Document: TIG 1.0 + Item: Num 9.3.ii + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0303 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: dataset_name - operator: longer_than - value: 8 + - name: dataset_name + operator: longer_than + value: 8 Core: Id: CORE-000357 Status: Published Version: '1' -Description: When a supplemental qualifier dataset is associated with a split - dataset, the dataset name length must not be greater than 8 characters. +Description: When a supplemental qualifier dataset is associated with a split dataset, the dataset + name length must not be greater than 8 characters. Executability: Fully Executable Outcome: - Message: Supplemental qualifier dataset associated with a split dataset is - greater than 8 characters in length + Message: Supplemental qualifier dataset associated with a split dataset is greater than 8 + characters in length Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- include_split_datasets: true Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000358/rule.yml b/Published/CORE-000358/rule.yml index d784d3a64..cf1770a5e 100644 --- a/Published/CORE-000358/rule.yml +++ b/Published/CORE-000358/rule.yml @@ -2,106 +2,104 @@ # Condition: --LNKGRP present in a domain # Rule: --LNKGRP present in another domain Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of - records in one domain that is related to a record in another - domain, often forming a many-to-one relationship. - Document: SDTMIG v3.4 - Item: 2.E.2 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of - records in one domain that is related to a record in another - domain, often forming a many-to-one relationship. - Document: SDTMIG v3.3 - Item: 2.E.2 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to link related, grouped records across domains. - Document: SDTMIG v3.2 - Item: Specification - Section: 6.1. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a group of - records, for a subject, in one domain and link it to 1 or more - records for that subject in another domain. - Document: SDTM v2.1 - Item: --LNKGRP, Definition column - Section: SDTM- 3.1.4 Identifiers for All Classes - - Cited Guidance: Groups of records can be related by using grouping variables - such as --LNKID or --LNKGRP in IDVAR. Using --LNKID or - --LNKGRP can be a more efficient method of representing - relationships in RELREC when relating a single or group of - records in one dataset to a group of records in another - dataset. - Document: SDTM v2.1 - Item: --LNKGRP, Definition column - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0306 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of records in one + domain that is related to a record in another domain, often forming a many-to-one + relationship. + Document: SDTMIG v3.4 + Item: 2.E.2 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of records in one + domain that is related to a record in another domain, often forming a many-to-one + relationship. + Document: SDTMIG v3.3 + Item: 2.E.2 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to link related, grouped records across domains. + Document: SDTMIG v3.2 + Item: Specification + Section: 6.1. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: A sequence of characters used to uniquely identify a group of records, for a + subject, in one domain and link it to 1 or more records for that subject in another + domain. + Document: SDTM v2.1 + Item: --LNKGRP, Definition column + Section: SDTM- 3.1.4 Identifiers for All Classes + - Cited Guidance: Groups of records can be related by using grouping variables such as --LNKID + or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of + representing relationships in RELREC when relating a single or group of records in one + dataset to a group of records in another dataset. + Document: SDTM v2.1 + Item: --LNKGRP, Definition column + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0306 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --LNKGRP - operator: exists - - name: $VARIABLE_COUNT - operator: less_than - value: 2 + - name: --LNKGRP + operator: exists + - name: $VARIABLE_COUNT + operator: less_than + value: 2 Core: Id: CORE-000358 Status: Published Version: '1' -Description: Verify that when --LNKGRP is present in one domain it is also - present in another domain. +Description: Verify that when --LNKGRP is present in one domain it is also present in another + domain. Executability: Fully Executable Operations: - - id: $VARIABLE_COUNT - name: --LNKGRP - operator: variable_count +- id: $VARIABLE_COUNT + name: --LNKGRP + operator: variable_count Outcome: Message: LNKGRP variable is not found in any of the other domains. Output Variables: - - --LNKGRP - - $VARIABLE_COUNT + - --LNKGRP + - $VARIABLE_COUNT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000359/rule.yml b/Published/CORE-000359/rule.yml index d4abfcd5b..d03ea0f7e 100644 --- a/Published/CORE-000359/rule.yml +++ b/Published/CORE-000359/rule.yml @@ -1,78 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section - 4.4.2, cannot be used for DSSTDTC. - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section - 4.4.2, cannot be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section - 4.4.2, cannot be used for DSSTDTC. - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section - 4.4.2, cannot be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section - 4.4.2, cannot be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND317' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND317' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND317' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND317' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND317' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: DSSTDTC - operator: non_empty - - name: DSSTDTC - operator: contains - value: / + - name: DSSTDTC + operator: non_empty + - name: DSSTDTC + operator: contains + value: / Core: Id: CORE-000359 Status: Published @@ -85,8 +85,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000361/rule.yml b/Published/CORE-000361/rule.yml index b8b47433b..e98b9667b 100644 --- a/Published/CORE-000361/rule.yml +++ b/Published/CORE-000361/rule.yml @@ -2,146 +2,143 @@ # Condition: VISITNUM in TV.VISITNUM # Rule: VISIT and VISITNUM have a one-to-one relationship Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of - VISIT and VISITNUM. - Document: IG v3.4 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of - VISIT and VISITNUM. - Document: IG v3.3 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of - VISIT and VISITNUM. - Document: IG v3.2 - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: There will be a one-to-one relationship between values of VISIT - and VISITNUM in TV. - Document: TIG 1.0 - Item: Assumption 6 - Section: 2.8.10.31 - - Cited Guidance: Values of VISIT, VISITNUM, and VISITDY will be represented as - defined in the Trial Visits (TV) dataset. - Document: TIG 1.0 - Item: Planned Timing table NUM 1 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0316 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.4 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.3 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.2 + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: There will be a one-to-one relationship between values of VISIT and VISITNUM + in TV. + Document: TIG 1.0 + Item: Assumption 6 + Section: 2.8.10.31 + - Cited Guidance: Values of VISIT, VISITNUM, and VISITDY will be represented as defined in the + Trial Visits (TV) dataset. + Document: TIG 1.0 + Item: Planned Timing table NUM 1 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0316 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISIT - operator: is_not_unique_relationship - value: VISITNUM + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISIT + operator: is_not_unique_relationship + value: VISITNUM Core: Id: CORE-000361 Status: Published Version: '1' -Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a - one-to-one relationship. +Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one + relationship. Executability: Fully Executable Operations: - - domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct +- domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISIT and VISITNUM do not have a one-to-one relationship. Output Variables: - - VISITNUM - - VISIT + - VISITNUM + - VISIT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000363/rule.yml b/Published/CORE-000363/rule.yml index 998a5194b..2f4704a8b 100644 --- a/Published/CORE-000363/rule.yml +++ b/Published/CORE-000363/rule.yml @@ -1,118 +1,116 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This - will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This - will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This - will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This - will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0338 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.4 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.3 + Item: Specification + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0338 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: DSSTDTC # Condition: Multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT OBTAINED' # Rule: For each subject, earliest DSSTDTC = DM.RFICDTC Check: all: - - name: DSDECOD - operator: present_on_multiple_rows_within - within: USUBJID - - name: DSDECOD - operator: equal_to - value: INFORMED CONSENT OBTAINED - - name: $min_ds_dsstdtc - operator: not_equal_to - value: RFICDTC - - name: $min_ds_dsstdtc - operator: equal_to - value: DSSTDTC + - name: DSDECOD + operator: present_on_multiple_rows_within + within: USUBJID + - name: DSDECOD + operator: equal_to + value: INFORMED CONSENT OBTAINED + - name: $min_ds_dsstdtc + operator: not_equal_to + value: RFICDTC + - name: $min_ds_dsstdtc + operator: equal_to + value: DSSTDTC Core: Id: CORE-000363 Status: Published Version: '1' -Description: When there are multiple informed consents obtained and DSDECOD = - 'INFORMED CONSENT OBTAINED', the earliest DSSTDTC for each subject should be - equal to DM.RFICDTC. +Description: When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT + OBTAINED', the earliest DSSTDTC for each subject should be equal to DM.RFICDTC. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - domain: DS - group: - - USUBJID - id: $min_ds_dsstdtc - name: DSSTDTC - operator: min_date +- domain: DS + group: + - USUBJID + id: $min_ds_dsstdtc + name: DSSTDTC + operator: min_date Outcome: - Message: The earliest disposition date for "INFORMED CONSENT OBTAINED" is not - equal to DM.RFICDTC + Message: The earliest disposition date for "INFORMED CONSENT OBTAINED" is not equal to DM.RFICDTC Output Variables: - - RFICDTC - - $min_ds_dsstdtc - - DSDECOD - - DSSTDTC + - RFICDTC + - $min_ds_dsstdtc + - DSDECOD + - DSSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000370/rule.yml b/Published/CORE-000370/rule.yml index b6a5ea93e..df3c6e0f2 100644 --- a/Published/CORE-000370/rule.yml +++ b/Published/CORE-000370/rule.yml @@ -1,138 +1,127 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is - documented. Would be null only in studies not collecting the - date of informed consent. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: "RFICDTC should correspond to the date of the informed consent - protocol milestone in DS, if that protocol milestone is - documented in DS. - - \ In the event that there are multiple informed consents, this - will be the date of the first one." - Document: SDTMIG v3.4 - Item: Assumption 10c - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[This will be the same as the date of informed - consent in the Disposition domain, if that protocol milestone - is documented. Would be null only in studies not collecting - the date of informed consent.]|Assumption 13[RFICDTC should - correspond to the date of the informed . . . In the event that - there are multiple informed consents, this will be the date of - the first one.] - Document: IG v3.2 - Item: Specification|Assumption 13 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[This will be the same as the date of informed - consent in the Disposition domain, if that protocol milestone - is documented. Would be null only in studies not collecting - the date of informed consent.]|Assumption 10c[In the event - that there are multiple informed consents, this will be the - date of the first one.] - Document: IG v3.3 - Item: Specification|Assumption 10c - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: RFICDTC should correspond to the date of the informed consent - protocol milestone in Disposition (DS), if that protocol - milestone is documented in DS. In the event that there are - multiple informed consents, this will be the date of the - first. RFPENDTC will be the last date of participation for a - subject for data included in a submission. This should be the - last date of any record for the subject in the database at the - time it is locked for submission. As such, it may not be the - last date of participation in the study if the submission - includes interim data. - Document: TIG 1.0 - Item: Specification|Assumption 10c - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0387 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This will be the same as the date of informed consent in the Disposition + domain, if that protocol milestone is documented. Would be null only in studies not + collecting the date of informed consent. + Document: SDTMIG v3.4 + Item: Specification + Section: '5.2' + - Cited Guidance: "RFICDTC should correspond to the date of the informed consent protocol milestone + in DS, if that protocol milestone is documented in DS.\n In the event that there are multiple + informed consents, this will be the date of the first one." + Document: SDTMIG v3.4 + Item: Assumption 10c + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[This will be the same as the date of informed consent in the + Disposition domain, if that protocol milestone is documented. Would be null only in + studies not collecting the date of informed consent.]|Assumption 13[RFICDTC should + correspond to the date of the informed . . . In the event that there are multiple informed + consents, this will be the date of the first one.] + Document: IG v3.2 + Item: Specification|Assumption 13 + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[This will be the same as the date of informed consent in the + Disposition domain, if that protocol milestone is documented. Would be null only in + studies not collecting the date of informed consent.]|Assumption 10c[In the event that + there are multiple informed consents, this will be the date of the first one.] + Document: IG v3.3 + Item: Specification|Assumption 10c + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: RFICDTC should correspond to the date of the informed consent protocol + milestone in Disposition (DS), if that protocol milestone is documented in DS. In the + event that there are multiple informed consents, this will be the date of the first. + RFPENDTC will be the last date of participation for a subject for data included in a + submission. This should be the last date of any record for the subject in the database at + the time it is locked for submission. As such, it may not be the last date of + participation in the study if the submission includes interim data. + Document: TIG 1.0 + Item: Specification|Assumption 10c + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0387 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: RFICDTC # Condition: DS.DSTERM indicates informed consent obtained # Rule: RFICDTC = earliest DS.DSSTDTC Check: all: - - name: DSTERM - operator: contains - value: INFORMED CONSENT - - name: RFICDTC - operator: date_not_equal_to - value: $min_ds_dsstdtc - - name: $min_ds_dsstdtc - operator: equal_to - value: DSSTDTC + - name: DSTERM + operator: contains + value: INFORMED CONSENT + - name: RFICDTC + operator: date_not_equal_to + value: $min_ds_dsstdtc + - name: $min_ds_dsstdtc + operator: equal_to + value: DSSTDTC Core: Id: CORE-000370 Status: Published Version: '1' -Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates - informed consent obtained. +Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent + obtained. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - domain: DS - group: - - USUBJID - id: $min_ds_dsstdtc - name: DSSTDTC - operator: min_date +- domain: DS + group: + - USUBJID + id: $min_ds_dsstdtc + name: DSSTDTC + operator: min_date Outcome: - Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates - Informed consent obtained. + Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent + obtained. Output Variables: - - DSDECOD - - RFICDTC - - DSSTDTC - - $min_ds_dsstdtc + - DSDECOD + - RFICDTC + - DSSTDTC + - $min_ds_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000374/rule.yml b/Published/CORE-000374/rule.yml index 52dacaa8c..b76781648 100644 --- a/Published/CORE-000374/rule.yml +++ b/Published/CORE-000374/rule.yml @@ -2,88 +2,80 @@ # Condition: DSCAT = 'DISPOSITION EVENT' and DSSCAT is NOT present in dataset. # Rule: At most one record per subject per epoch Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and study - treatment(s) are to be represented, then DSSCAT provides this - distinction. - Document: IG v3.4 - Item: Assumption 2.b - Section: 6.2.3 - - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for - discontinuation' should be presented, and that summaries - should be 'grouped by treatment and by major reason.' The - CDISC SDS Team interprets this guidance as requiring one - standardized disposition term (DSDECOD) per disposition event. - If multiple reasons are reported, the sponsor should identify - a primary reason and use that to populate DSTERM and DSDECOD. - Additional reasons should be submitted in SUPPDS." - Document: IG v3.4 - Item: Assumption 5 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0537 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Assumption 2.b[If disposition events for both study - participation and study treatment(s) are to be represented, - then DSSCAT provides this distinction]|Assumption 5[ICH E3: - Section 10.1 indicates that 'the specific reason for - discontinuation' should be presented, and that summaries - should be 'grouped by treatment and by major reason.' The - CDISC SDS Team interprets this guidance as requiring one - standardized disposition term (DSDECOD) per disposition event. - If multiple reasons are reported, the sponsor should identify - a primary reason and use that to populate DSTERM and DSDECOD. - Additional reasons should be submitted in SUPPDS.]" - Document: IG v3.3 - Item: Assumption 2.b|Assumption 5 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0537 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY - PARTICIPATION"" is used to represent disposition of study - participation. DSSCAT = ""PRODUCT EXPOSURE"" is used when a - study has only a single product. If a study has multiple - products, then DSSCAT should name the individual product." - Document: TIG 1.0 - Item: Assumption 2b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0630 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction. + Document: IG v3.4 + Item: Assumption 2.b + Section: 6.2.3 + - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' + should be presented, and that summaries should be 'grouped by treatment and by major reason.' + The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) + per disposition event. If multiple reasons are reported, the sponsor should identify a primary + reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in + SUPPDS." + Document: IG v3.4 + Item: Assumption 5 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0537 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Assumption 2.b[If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction]|Assumption 5[ICH E3: Section 10.1 + indicates that 'the specific reason for discontinuation' should be presented, and that summaries + should be 'grouped by treatment and by major reason.' The CDISC SDS Team interprets this guidance + as requiring one standardized disposition term (DSDECOD) per disposition event. If multiple + reasons are reported, the sponsor should identify a primary reason and use that to populate + DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" + Document: IG v3.3 + Item: Assumption 2.b|Assumption 5 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0537 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY + PARTICIPATION"" is used to represent disposition of study participation. DSSCAT = + ""PRODUCT EXPOSURE"" is used when a study has only a single product. If a study has + multiple products, then DSSCAT should name the individual product." + Document: TIG 1.0 + Item: Assumption 2b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0630 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - value_is_literal: true - - name: DSSCAT - operator: not_exists - - name: DSCAT - operator: is_not_unique_set - value: - - EPOCH - - USUBJID + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + value_is_literal: true + - name: DSSCAT + operator: not_exists + - name: DSCAT + operator: is_not_unique_set + value: + - EPOCH + - USUBJID Core: Id: CORE-000374 Status: Published @@ -93,16 +85,16 @@ Executability: Fully Executable Outcome: Message: There is more than one record per subject per EPOCH Output Variables: - - DSCAT - - DSSCAT - - EPOCH + - DSCAT + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000376/rule.yml b/Published/CORE-000376/rule.yml index 446fcdcb7..a67eb3939 100644 --- a/Published/CORE-000376/rule.yml +++ b/Published/CORE-000376/rule.yml @@ -2,153 +2,140 @@ # Condition: Custom domain and variable name is not STUDYID, DOMAIN, USUBJID, POOLID, SPDEVID, VISIT, VISITNUM, VISITDY, ELEMENT, TAETORD, EPOCH. # Rule: First 2 characters of the Variable Name = the 2-character domain code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following variables are exceptions to the philosophy that - all variable names are prefixed with the Domain Identifier: - -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly - used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY) - All Demographics domain (DM) variables other than DMDTC and - DMDY -All variables in RELREC and SUPPQUAL, and some variables - in Comments and Trial Design datasets. Required Identifiers - are not prefixed because they are usually used as keys when - merging/joining observations. The --SEQ and the optional - Identifiers --GRPID and --REFID are prefixed because they may - be used as keys when relating observations across domains.' - Document: IG v3.4 - Section: 4.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The philosophy applied to determine which variable names use a - prefix was that all variable names are prefixed with the - Domain Identifier in which they originate except the - following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID). - b. Commonly used grouping and merge Keys (VISIT; VISITNUM; - VISITDY); and many of the variables in trial design (such as - ELEMENT and ARM). c. All Demographics domain (DM) variables - other than DMDTC and DMDY. d. All variables in RELREC and - SUPPQUAL; and some variables in Comments and Trial Design - datasets.' - Document: IG v3.2 - Section: 4.1.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following variables are exceptions to the philosophy that - all variable names are prefixed with the Domain Identifier: - - Required Identifiers (STUDYID; DOMAIN; USUBJID). -Commonly - used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY). - -All Demographics domain (DM) variables other than DMDTC and - DMDY. -All variables in RELREC and SUPPQUAL; and some - variables in Comments and Trial Design datasets. Required - Identifiers are not prefixed because they are usually used as - keys when merging/joining observations. The --SEQ and the - optional Identifiers --GRPID and --REFID are prefixed because - they may be used as keys when relating observations across - domains.' - Document: IG v3.3 - Section: 4.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'Apply the domain code to the appropriate variables in the - domain by replacing all variable prefixes (shown in the SDTM - as “--“) with the domain code.' - Document: TIG 1.0 - Item: 5a - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0514 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following variables are exceptions to the philosophy that all variable names + are prefixed with the Domain Identifier: -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly + used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY) All Demographics domain (DM) variables + other than DMDTC and DMDY -All variables in RELREC and SUPPQUAL, and some variables in Comments + and Trial Design datasets. Required Identifiers are not prefixed because they are usually used + as keys when merging/joining observations. The --SEQ and the optional Identifiers --GRPID and + --REFID are prefixed because they may be used as keys when relating observations across domains.' + Document: IG v3.4 + Section: 4.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The philosophy applied to determine which variable names use a prefix was that + all variable names are prefixed with the Domain Identifier in which they originate except the + following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID). b. Commonly used grouping and + merge Keys (VISIT; VISITNUM; VISITDY); and many of the variables in trial design (such as ELEMENT + and ARM). c. All Demographics domain (DM) variables other than DMDTC and DMDY. d. All variables + in RELREC and SUPPQUAL; and some variables in Comments and Trial Design datasets.' + Document: IG v3.2 + Section: 4.1.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The following variables are exceptions to the philosophy that all variable names + are prefixed with the Domain Identifier: - Required Identifiers (STUDYID; DOMAIN; USUBJID). + -Commonly used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY). -All Demographics domain + (DM) variables other than DMDTC and DMDY. -All variables in RELREC and SUPPQUAL; and some variables + in Comments and Trial Design datasets. Required Identifiers are not prefixed because they are + usually used as keys when merging/joining observations. The --SEQ and the optional Identifiers + --GRPID and --REFID are prefixed because they may be used as keys when relating observations + across domains.' + Document: IG v3.3 + Section: 4.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'Apply the domain code to the appropriate variables in the domain by replacing + all variable prefixes (shown in the SDTM as “--“) with the domain code.' + Document: TIG 1.0 + Item: 5a + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0514 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $domain_is_custom - operator: equal_to - value: true - - name: variable_name - operator: is_not_contained_by - value: - - STUDYID - - DOMAIN - - USUBJID - - POOLID - - SPDEVID - - VISIT - - VISITNUM - - VISITDY - - ELEMENT - - TAETORD - - EPOCH - - NHOID - - FOCID - - SPTOBID - - STOCONID - - IGDCMPID - - MIDS - - RELMIDS - - MIDSDTC - - RSUBJID - - RDEVID - - SREL - - APID - - name: variable_name - operator: prefix_is_not_contained_by - prefix: 2 - value: $domain_list + - name: $domain_is_custom + operator: equal_to + value: true + - name: variable_name + operator: is_not_contained_by + value: + - STUDYID + - DOMAIN + - USUBJID + - POOLID + - SPDEVID + - VISIT + - VISITNUM + - VISITDY + - ELEMENT + - TAETORD + - EPOCH + - NHOID + - FOCID + - SPTOBID + - STOCONID + - IGDCMPID + - MIDS + - RELMIDS + - MIDSDTC + - RSUBJID + - RDEVID + - SREL + - APID + - name: variable_name + operator: prefix_is_not_contained_by + prefix: 2 + value: $domain_list Core: Id: CORE-000376 Status: Published Version: '1' -Description: Raise an error when the two first characters of a prefixed variable - within a custom domain do not match the DOMAIN value. +Description: Raise an error when the two first characters of a prefixed variable within a custom + domain do not match the DOMAIN value. Executability: Fully Executable Operations: - - id: $domain_list - name: DOMAIN - operator: distinct - - id: $domain_is_custom - operator: domain_is_custom +- id: $domain_list + name: DOMAIN + operator: distinct +- id: $domain_is_custom + operator: domain_is_custom Outcome: - Message: First 2 characters of prefixed variable within custom domain do not - match the DOMAIN value. + Message: First 2 characters of prefixed variable within custom domain do not match the DOMAIN + value. Output Variables: - - $domain_list - - variable_name + - $domain_list + - variable_name Rule Type: Variable Metadata Check Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS - - EVENTS + - FINDINGS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000381/rule.yml b/Published/CORE-000381/rule.yml index 2a53a085e..0e05b7fd0 100644 --- a/Published/CORE-000381/rule.yml +++ b/Published/CORE-000381/rule.yml @@ -1,101 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --TESTCD - operator: matches_regex - value: ^[0-9] + - name: --TESTCD + operator: matches_regex + value: ^[0-9] Core: Id: CORE-000381 Status: Published @@ -105,13 +99,13 @@ Executability: Fully Executable Outcome: Message: --TESTCD may not start with a number Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000382/rule.yml b/Published/CORE-000382/rule.yml index bd41e93bc..eecadf6c1 100644 --- a/Published/CORE-000382/rule.yml +++ b/Published/CORE-000382/rule.yml @@ -1,95 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per - subject, Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: USUBJID - operator: is_not_unique_set - value: DOMAIN + - name: USUBJID + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000382 Status: Published @@ -99,13 +99,13 @@ Executability: Fully Executable Outcome: Message: USUBJID is not unique within DM Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000383/rule.yml b/Published/CORE-000383/rule.yml index fb131136e..d04e594f5 100644 --- a/Published/CORE-000383/rule.yml +++ b/Published/CORE-000383/rule.yml @@ -1,85 +1,80 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission - containing this dataset. Only a single record should be - provided in the Trial Summary dataset. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission - containing this dataset. Only a single record should be - provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission - containing this dataset. Only a single record should be - provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission - containing this dataset. Only a single record should be - provided in the Trial Summary dataset. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission - containing this dataset. Only a single record should be - provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: TSPARMCD - operator: equal_to - value: SNDIGVER - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SNDIGVER + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000383 Status: Published @@ -92,8 +87,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000384/rule.yml b/Published/CORE-000384/rule.yml index 29560cd00..d732b6583 100644 --- a/Published/CORE-000384/rule.yml +++ b/Published/CORE-000384/rule.yml @@ -2,69 +2,66 @@ # Condition: RELREC dataset present in study # Rule: Dataset present in study with DOMAIN = RELREC.RDOMAIN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Two-character abbreviation for the domain of the parent - record(s). ' - Document: Model v2.0 - Item: RDOMAIN - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent - record(s). - Document: Model v1.4 - Item: RDOMAIN Description - Section: 4.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2-character abbreviation for the domain of the parent record(s). - Document: Model v1.7 - Item: RDOMAIN Description - Section: 4.1.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent - record(s). - Document: SDTM v2.1 - Item: RDOMAIN - Section: 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0538 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Two-character abbreviation for the domain of the parent record(s). ' + Document: Model v2.0 + Item: RDOMAIN + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). + Document: Model v1.4 + Item: RDOMAIN Description + Section: 4.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 2-character abbreviation for the domain of the parent record(s). + Document: Model v1.7 + Item: RDOMAIN Description + Section: 4.1.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). + Document: SDTM v2.1 + Item: RDOMAIN + Section: 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0538 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000384 Status: Published @@ -72,19 +69,19 @@ Core: Description: RELREC.RDOMAIN must represent a dataset that is present in the study. Executability: Fully Executable Operations: - - id: $study_domains - operator: study_domains +- id: $study_domains + operator: study_domains Outcome: Message: RELREC.RDOMAIN does not represent a dataset present in the study Output Variables: - - RDOMAIN + - RDOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000385/rule.yml b/Published/CORE-000385/rule.yml index 754fb61e0..5f6b346af 100644 --- a/Published/CORE-000385/rule.yml +++ b/Published/CORE-000385/rule.yml @@ -1,113 +1,103 @@ Authorities: # REMARK: not applicable to SENDIG-3.0 - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. In the - Events or Interventions general observation class, this could - be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per - subject per administration site (as identified in FOCID). A - constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated - with a specific lot at a constant dose level. - Document: IG v3.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. In the - Events or Interventions general observation class, this could - be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per - subject per administration site (as identified in FOCID). A - constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated - with a specific lot at a constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. In the - Events or Interventions general observation class, this could - be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per - subject per administration site (as identified in FOCID). A - constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated - with a specific lot at a constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. In the - Events or Interventions general observation class, this could - be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per - subject per administration site (as identified in FOCID). A - constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated - with a specific lot at a constant dose level. - Document: IG v3.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. In the - Events or Interventions general observation class, this could - be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per - subject per administration site (as identified in FOCID). A - constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated - with a specific lot at a constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND291' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND291' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND291' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND291' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND291' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: --STDTC - operator: empty - - name: --STDY - operator: empty + - name: --STDTC + operator: empty + - name: --STDY + operator: empty Core: Id: CORE-000385 Status: Published @@ -120,8 +110,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000386/rule.yml b/Published/CORE-000386/rule.yml index fc240bd67..3d0d14849 100644 --- a/Published/CORE-000386/rule.yml +++ b/Published/CORE-000386/rule.yml @@ -1,75 +1,69 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The values of SJSTDTC provide the chronological order of the - actual subject Stages. SJSEQ should be assigned to be - consistent with the chronological order of the Stages per - subject. Note: The requirement that SJSEQ be consistent with - chronological order is more stringent than in most other - domains where --SEQ values need only be unique within - subject." - Document: IG-DART v1.1 - Item: Assumption 7 - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND354 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The values of SJSTDTC provide the chronological order of the - actual subject Stages. SJSEQ should be assigned to be - consistent with the chronological order of the Stages per - subject. Note: The requirement that SJSEQ be consistent with - chronological order is more stringent than in most other - domains where --SEQ values need only be unique within - subject." - Document: IG-DART v1.2 - Item: Assumption 7 - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND354 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The values of SJSTDTC provide the chronological order of the actual subject Stages. + SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. + Note: The requirement that SJSEQ be consistent with chronological order is more stringent than + in most other domains where --SEQ values need only be unique within subject." + Document: IG-DART v1.1 + Item: Assumption 7 + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND354 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The values of SJSTDTC provide the chronological order of the actual subject Stages. + SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. + Note: The requirement that SJSEQ be consistent with chronological order is more stringent than + in most other domains where --SEQ values need only be unique within subject." + Document: IG-DART v1.2 + Item: Assumption 7 + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND354 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: SJSEQ - operator: target_is_not_sorted_by - value: - - name: SJSTDTC + - name: SJSEQ + operator: target_is_not_sorted_by + value: + - name: SJSTDTC # What is "null_position" doing? - null_position: last - sort_order: asc - within: USUBJID + null_position: last + sort_order: asc + within: USUBJID Core: Id: CORE-000386 Status: Published Version: '1' -Description: Trigger error when the order of SJSEQ is not chronologically (based - on SJSTDTC) within USUBJID +Description: Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within + USUBJID Executability: Fully Executable Outcome: Message: SJSEQ is not chronologically (based on SJSTDTC) within USUBJID Output Variables: - - USUBJID - - SJSEQ - - SJSTDTC + - USUBJID + - SJSEQ + - SJSTDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000387/rule.yml b/Published/CORE-000387/rule.yml index 2cc366eb0..b4d2904af 100644 --- a/Published/CORE-000387/rule.yml +++ b/Published/CORE-000387/rule.yml @@ -1,85 +1,85 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # case that USUBJID ("expected") is populated all: - - name: USUBJID - operator: non_empty - - name: COSEQ - operator: is_not_unique_set - value: USUBJID + - name: USUBJID + operator: non_empty + - name: COSEQ + operator: is_not_unique_set + value: USUBJID # case that USUBJID is not populated #- all: # - name: USUBJID @@ -101,8 +101,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000388/rule.yml b/Published/CORE-000388/rule.yml index 3c472a801..4ca56c130 100644 --- a/Published/CORE-000388/rule.yml +++ b/Published/CORE-000388/rule.yml @@ -1,132 +1,132 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule 121) - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: SENDIG v3.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: SENDIG v3.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL - are populated; RELTYPE is null) - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0202 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1 + Item: Assumption 3 + Section: '8.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND286' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: '8.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND286' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: '8.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND286' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1 + Item: Assumption 3 + Section: '8.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND286' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: '8.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND286' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0202 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: RELTYPE - operator: non_empty - - all: - - name: POOLID - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: RELTYPE - operator: non_empty + - all: + - name: USUBJID + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: RELTYPE + operator: non_empty + - all: + - name: POOLID + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: RELTYPE + operator: non_empty Core: Id: CORE-000388 Status: Published Version: '1' -Description: When USUBJID or POOLID are populated, and IDVARVAL is populated, - then RELTYPE must be null. +Description: When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be + null. Executability: Fully Executable Outcome: - Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and - IDVARVAL is populated + Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is + populated Output Variables: - - RDOMAIN - - USUBJID - - POOLID - - IDVAR - - IDVARVAL - - RELTYPE + - RDOMAIN + - USUBJID + - POOLID + - IDVAR + - IDVARVAL + - RELTYPE Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000389/rule.yml b/Published/CORE-000389/rule.yml index 0cb3d776e..d113e0b48 100644 --- a/Published/CORE-000389/rule.yml +++ b/Published/CORE-000389/rule.yml @@ -1,85 +1,85 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a - USUBJID or POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: '5.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # case that POOLID ("permissible") is populated all: - - name: POOLID - operator: non_empty - - name: COSEQ - operator: is_not_unique_set - value: POOLID + - name: POOLID + operator: non_empty + - name: COSEQ + operator: is_not_unique_set + value: POOLID Core: Id: CORE-000389 Status: Published @@ -92,8 +92,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000390/rule.yml b/Published/CORE-000390/rule.yml index c79abbd15..a1ea93c96 100644 --- a/Published/CORE-000390/rule.yml +++ b/Published/CORE-000390/rule.yml @@ -1,105 +1,99 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # Implemented as that combination of USUBJID, CVTESTCD and CVDTC must be unique all: - - name: CVTESTCD - operator: is_not_unique_set - value: - - USUBJID - - CVDTC + - name: CVTESTCD + operator: is_not_unique_set + value: + - USUBJID + - CVDTC Core: Id: CORE-000390 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular cardiovascular test for a subject and measurement date/time +Description: Raise an error when there is more than one record present for any particular + cardiovascular test for a subject and measurement date/time Executability: Fully Executable Outcome: - Message: The cardiovascular test is not unique for this subject and measurement - datetime. + Message: The cardiovascular test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - CVTESTCD - - CVDTC + - USUBJID + - CVTESTCD + - CVDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CV + - CV Sensitivity: Record diff --git a/Published/CORE-000391/rule.yml b/Published/CORE-000391/rule.yml index efa8c520c..b0bfff76c 100644 --- a/Published/CORE-000391/rule.yml +++ b/Published/CORE-000391/rule.yml @@ -1,24 +1,23 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in DDTESTCD...In this domain the value should always - be DEATHD. - Document: IG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND164 - Version: "1" - Version: "5.0" - Version: "3.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in DDTESTCD...In this domain the value should always be DEATHD. + Document: IG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND164 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: DDTESTCD - operator: not_equal_to - value: DEATHD + - name: DDTESTCD + operator: not_equal_to + value: DEATHD Core: Id: CORE-000391 Status: Published @@ -28,13 +27,13 @@ Executability: Fully Executable Outcome: Message: The value of DDTESTCD is not 'DEATHD' Output Variables: - - DDTESTCD + - DDTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000392/rule.yml b/Published/CORE-000392/rule.yml index 1ce3b6c3c..99a12dc8b 100644 --- a/Published/CORE-000392/rule.yml +++ b/Published/CORE-000392/rule.yml @@ -1,23 +1,23 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in DDTEST should always be 'Death Diagnosis'. - Document: IG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND165 - Version: "1" - Version: "5.0" - Version: "3.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in DDTEST should always be 'Death Diagnosis'. + Document: IG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND165 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: DDTEST - operator: not_equal_to - value: Death Diagnosis + - name: DDTEST + operator: not_equal_to + value: Death Diagnosis Core: Id: CORE-000392 Status: Published @@ -27,13 +27,13 @@ Executability: Fully Executable Outcome: Message: The value of DDTESTCD is not 'Death Diagnosis' Output Variables: - - DDTEST + - DDTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000393/rule.yml b/Published/CORE-000393/rule.yml index 5beeb07a1..f58ce8a6a 100644 --- a/Published/CORE-000393/rule.yml +++ b/Published/CORE-000393/rule.yml @@ -1,137 +1,125 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points can be represented using the time point variables, - --TPT, --TPTNUM, --ELTM, and the time point anchors, --TPTREF - (text description) and --RFTDTC (the date/time).; See also - --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed - time (in ISO 8601) format relative to the planned fixed - reference (EXTPTREF).") - Document: IG v3.0 - Item: Specification - Section: 4.4.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or - anchor from which the planned observation will be made, - usually the dose ...--ELTM: the planned elapsed time from the - fixed reference point event (e.g., a dose) to the planned - observation." - Document: IG v3.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or - anchor from which the planned observation will be made, - usually the dose ...--ELTM: the planned elapsed time from the - fixed reference point event (e.g., a dose) to the planned - observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or - anchor from which the planned observation will be made, - usually the dose ...--ELTM: the planned elapsed time from the - fixed reference point event (e.g., a dose) to the planned - observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or - anchor from which the planned observation will be made, - usually the dose ...--ELTM: the planned elapsed time from the - fixed reference point event (e.g., a dose) to the planned - observation." - Document: IG v3.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or - anchor from which the planned observation will be made, - usually the dose ...--ELTM: the planned elapsed time from the - fixed reference point event (e.g., a dose) to the planned - observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: >- - When instances of an activity are scheduled at planned time - intervals relative to a fixed reference point (e.g., an - exposure), the following timing variables will be - used:… --TPTREF Represents a description of the fixed - reference point from which the planned observation will be - made. --ELTM Represents the planned elapsed time from the - fixed timepoint reference to the planned observation. - Document: TIG v1.0 - Item: Table Num 3 - Section: 2.8.7.6 Representing References and Relative Timing, Timing Relative to - Reference Points - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0195 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time points can be represented using the time point variables, --TPT, + --TPTNUM, --ELTM, and the time point anchors, --TPTREF (text description) and --RFTDTC + (the date/time).; See also --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed + time (in ISO 8601) format relative to the planned fixed reference (EXTPTREF).") + Document: IG v3.0 + Item: Specification + Section: 4.4.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: >- + When instances of an activity are scheduled at planned time + intervals relative to a fixed reference point (e.g., an + exposure), the following timing variables will be + used:… --TPTREF Represents a description of the fixed + reference point from which the planned observation will be + made. --ELTM Represents the planned elapsed time from the + fixed timepoint reference to the planned observation. + Document: TIG v1.0 + Item: Table Num 3 + Section: 2.8.7.6 Representing References and Relative Timing, Timing Relative to Reference + Points + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0195 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --TPTREF - operator: empty - - name: --ELTM - operator: non_empty + - name: --TPTREF + operator: empty + - name: --ELTM + operator: non_empty Core: Id: CORE-000393 Status: Published @@ -141,16 +129,16 @@ Executability: Fully Executable Outcome: Message: --TPTREF is empty and --ELTM is not empty Output Variables: - - --TPTREF - - --ELTM + - --TPTREF + - --ELTM Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS + - FINDINGS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000394/rule.yml b/Published/CORE-000394/rule.yml index 05d5cda65..be26f37ed 100644 --- a/Published/CORE-000394/rule.yml +++ b/Published/CORE-000394/rule.yml @@ -1,85 +1,85 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall - conduct of the nonclinical study. The parameter contains the - name of the specific individual, e.g. 'Dr. William Spock.' - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall - conduct of the nonclinical study. The parameter contains the - name of the specific individual, e.g. 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall - conduct of the nonclinical study. The parameter contains the - name of the specific individual, e.g. 'Dr. William Spock.' - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall - conduct of the nonclinical study. The parameter contains the - name of the specific individual, e.g. 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall - conduct of the nonclinical study. The parameter contains the - name of the specific individual, e.g. 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: STDIR - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: STDIR + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000394 Status: Published @@ -92,8 +92,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000395/rule.yml b/Published/CORE-000395/rule.yml index 7b29fce33..438316e7b 100644 --- a/Published/CORE-000395/rule.yml +++ b/Published/CORE-000395/rule.yml @@ -1,81 +1,81 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.0" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: STCAT - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: STCAT + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000395 Status: Published @@ -88,8 +88,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000396/rule.yml b/Published/CORE-000396/rule.yml index d2d9d244a..8603d34a4 100644 --- a/Published/CORE-000396/rule.yml +++ b/Published/CORE-000396/rule.yml @@ -1,80 +1,80 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SSTYP - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SSTYP + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000396 Status: Published @@ -87,8 +87,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000397/rule.yml b/Published/CORE-000397/rule.yml index 3e91399cb..97a79e968 100644 --- a/Published/CORE-000397/rule.yml +++ b/Published/CORE-000397/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.2" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: TSPARMCD - operator: equal_to - value: SNDCTVER - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SNDCTVER + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000397 Status: Published @@ -82,8 +82,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000398/rule.yml b/Published/CORE-000398/rule.yml index cf4c8bcd6..f9752f7ff 100644 --- a/Published/CORE-000398/rule.yml +++ b/Published/CORE-000398/rule.yml @@ -1,129 +1,129 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified variable labels for all standard domains - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0303 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.0 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all - standard domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified variable labels for all standard domains + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0303 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.0 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.0" # The implementation successfully skips invalid variables (e.g. VSINVALID) # and skips variables that are not in the IG, but come from the model (e.g. VSLOBXFL) Check: all: # Precondition: variable (label) is in the IG - - name: variable_name - operator: equal_to - value: library_variable_name - - name: library_variable_label - operator: non_empty + - name: variable_name + operator: equal_to + value: library_variable_name + - name: library_variable_label + operator: non_empty # variable label must be equal to that in the CDISC-library - - name: variable_label - operator: not_equal_to - value: library_variable_label + - name: variable_label + operator: not_equal_to + value: library_variable_label Core: Id: CORE-000398 Status: Published Version: "1" -Description: Raise an error when the variable label for an IG-variable does not - correspond to the variable label in the Implementation Guide. +Description: Raise an error when the variable label for an IG-variable does not correspond to the + variable label in the Implementation Guide. Executability: Fully Executable Outcome: Message: The label of the variable does not correspond to the label in the IG Output Variables: - - variable_name - - variable_label - - library_variable_label + - variable_name + - variable_label + - library_variable_label Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000400/rule.yml b/Published/CORE-000400/rule.yml index 368f18096..c4af0d92f 100644 --- a/Published/CORE-000400/rule.yml +++ b/Published/CORE-000400/rule.yml @@ -1,59 +1,58 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then - a reason (attribute reasonDurationWillVary) must be given and - vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00004' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute + reasonDurationWillVary) must be given and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00004' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'AdministrationDuration' - - any: - - name: durationWillVary - operator: not_equal_to - value: false - - name: reasonDurationWillVary - operator: non_empty - - not: - all: - - name: durationWillVary - operator: equal_to - value: true - - name: reasonDurationWillVary - operator: non_empty + - name: instanceType + operator: equal_to + value: 'AdministrationDuration' + - any: + - name: durationWillVary + operator: not_equal_to + value: false + - name: reasonDurationWillVary + operator: non_empty + - not: + all: + - name: durationWillVary + operator: equal_to + value: true + - name: reasonDurationWillVary + operator: non_empty Core: Id: 'CORE-000400' Status: Published Version: '1' -Description: 'If duration will vary (attribute durationWillVary is True) then a - reason (attribute reasonDurationWillVary) must be given and vice versa.' +Description: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) + must be given and vice versa.' Executability: Fully Executable Outcome: - Message: The administration duration will vary (durationWillVary is not 'false' - or reasonDurationWillVary is populated), but it is not fully defined - (durationWillVary is not 'true' or reasonDurationWillVary is missing). + Message: The administration duration will vary (durationWillVary is not 'false' or + reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not + 'true' or reasonDurationWillVary is missing). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - durationWillVary - - reasonDurationWillVary + - parent_entity + - parent_id + - parent_rel + - id + - description + - durationWillVary + - reasonDurationWillVary Rule Type: Record Data Scope: Entities: Include: - - AdministrationDuration + - AdministrationDuration Sensitivity: Record diff --git a/Published/CORE-000401/rule.yml b/Published/CORE-000401/rule.yml index d9185a2b2..77741a3d2 100644 --- a/Published/CORE-000401/rule.yml +++ b/Published/CORE-000401/rule.yml @@ -1,68 +1,66 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have exactly one study identifier with - an identifier scope that references a clinical study sponsor - organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00005' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study version must have exactly one study identifier with an identifier + scope that references a clinical study sponsor organization.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00005' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $num_sponsor_ids - operator: empty - - name: $num_sponsor_ids - operator: not_equal_to - value: 1 + - name: instanceType + operator: equal_to + value: 'StudyVersion' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: $num_sponsor_ids + operator: empty + - name: $num_sponsor_ids + operator: not_equal_to + value: 1 Core: Id: 'CORE-000401' Status: Published Version: '1' -Description: 'Every study version must have exactly one study identifier with an - identifier scope that references a clinical study sponsor organization.' +Description: 'Every study version must have exactly one study identifier with an identifier scope that + references a clinical study sponsor organization.' Executability: Fully Executable Operations: - - domain: StudyIdentifier - filter: - parent_entity: 'StudyVersion' - parent_rel: 'studyIdentifiers' - rel_type: 'definition' - studyIdentifierScope.organizationType.code: 'C70793' - studyIdentifierScope.organizationType.codeSystem: 'http://www.cdisc.org' - group: - - parent_id - group_aliases: - - id - id: $num_sponsor_ids - operator: record_count +- domain: StudyIdentifier + filter: + parent_entity: 'StudyVersion' + parent_rel: 'studyIdentifiers' + rel_type: 'definition' + studyIdentifierScope.organizationType.code: 'C70793' + studyIdentifierScope.organizationType.codeSystem: 'http://www.cdisc.org' + group: + - parent_id + group_aliases: + - id + id: $num_sponsor_ids + operator: record_count Outcome: - Message: 'The study version does not have exactly one sponsor identifier (i.e., - a study identifier whose scope is an organization with an type code system - of "http://www.cdisc.org" and a type code of "C70793")' + Message: 'The study version does not have exactly one sponsor identifier (i.e., a study identifier whose + scope is an organization with an type code system of "http://www.cdisc.org" and a type code of "C70793")' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $num_sponsor_ids + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $num_sponsor_ids Rule Type: Record Data Scope: Entities: Include: - - StudyVersion + - StudyVersion Sensitivity: Record diff --git a/Published/CORE-000402/rule.yml b/Published/CORE-000402/rule.yml index 30a126dc3..62b6a9e99 100644 --- a/Published/CORE-000402/rule.yml +++ b/Published/CORE-000402/rule.yml @@ -1,79 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Timing windows must be fully defined, if one of the window - attributes (i.e., window label, window lower, and window - upper) is defined then all must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00006' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Timing windows must be fully defined, if one of the window - attributes (i.e., window label, window lower, and window - upper) is defined then all must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00006' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Timing windows must be fully defined, if one of the window attributes (i.e., + window label, window lower, and window upper) is defined then all must be specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00006' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Timing windows must be fully defined, if one of the window attributes (i.e., + window label, window lower, and window upper) is defined then all must be specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00006' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty - - not: - all: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty + - name: instanceType + operator: equal_to + value: 'Timing' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty + - not: + all: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty Core: Id: 'CORE-000402' Status: Published Version: '1' -Description: 'Timing windows must be fully defined, if one of the window - attributes (i.e., window label, window lower, and window upper) is defined - then all must be specified.' +Description: 'Timing windows must be fully defined, if one of the window attributes (i.e., window label, + window lower, and window upper) is defined then all must be specified.' Executability: Fully Executable Outcome: - Message: 'One or more of the window attributes (windowLabel, windowLower, - windowUpper) is missing.' + Message: 'One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - valueLabel - - windowLabel - - windowLower - - windowUpper + - parent_entity + - parent_id + - parent_rel + - id + - name + - valueLabel + - windowLabel + - windowLower + - windowUpper Rule Type: Record Data Scope: Entities: Include: - - Timing + - Timing Sensitivity: Record diff --git a/Published/CORE-000403/rule.yml b/Published/CORE-000403/rule.yml index a9f7a116d..89bdce043 100644 --- a/Published/CORE-000403/rule.yml +++ b/Published/CORE-000403/rule.yml @@ -1,77 +1,73 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only - one scheduled instance (e.g. attribute - relativeToScheduledInstance must be equal to - relativeFromScheduledInstance or it must be missing).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00007' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only - one scheduled instance (e.g. attribute - relativeToScheduledInstance must be equal to - relativeFromScheduledInstance or it must be missing).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00007' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only one scheduled + instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance + or it must be missing).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00007' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only one scheduled + instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance + or it must be missing).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00007' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: C201358 - - not: - any: - - name: relativeToScheduledInstanceId - operator: empty - - name: relativeToScheduledInstanceId - operator: not_exists - - name: relativeToScheduledInstanceId - operator: equal_to - value: relativeFromScheduledInstanceId + - name: rel_type + operator: equal_to + value: 'definition' + - name: type.code + operator: equal_to + value: C201358 + - not: + any: + - name: relativeToScheduledInstanceId + operator: empty + - name: relativeToScheduledInstanceId + operator: not_exists + - name: relativeToScheduledInstanceId + operator: equal_to + value: relativeFromScheduledInstanceId Core: Id: 'CORE-000403' Status: Published Version: '1' -Description: 'If timing type is "Fixed Reference" then it must point to only one - scheduled instance (e.g. attribute relativeToScheduledInstance must be equal - to relativeFromScheduledInstance or it must be missing).' +Description: 'If timing type is "Fixed Reference" then it must point to only one scheduled instance (e.g. + attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance or it must be missing).' Executability: Fully Executable Outcome: - Message: 'The Timing type is "Fixed Reference" (type.code=C201358) but it does - not point to only one scheduled instance - relativeToScheduledInstanceId is - not missing and does not contain the same value as - relativeFromScheduledInstanceId.' + Message: 'The Timing type is "Fixed Reference" (type.code=C201358) but it does not point to only one + scheduled instance - relativeToScheduledInstanceId is not missing and does not contain the same value + as relativeFromScheduledInstanceId.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - relativeToScheduledInstanceId + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - relativeToScheduledInstanceId Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000404/rule.yml b/Published/CORE-000404/rule.yml index 457b489e1..e257fe5e8 100644 --- a/Published/CORE-000404/rule.yml +++ b/Published/CORE-000404/rule.yml @@ -1,70 +1,69 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must refer to either a default - condition or a timeline exit, but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00008' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must refer to either a default - condition or a timeline exit, but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00008' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must refer to either a default condition or a timeline + exit, but not both.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00008' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must refer to either a default condition or a timeline + exit, but not both.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00008' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - any: - - all: - - name: defaultConditionId - operator: empty - - name: timelineExitId - operator: empty - - all: - - name: defaultConditionId - operator: non_empty - - name: timelineExitId - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: instanceType + operator: equal_to + value: 'ScheduledActivityInstance' + - any: + - all: + - name: defaultConditionId + operator: empty + - name: timelineExitId + operator: empty + - all: + - name: defaultConditionId + operator: non_empty + - name: timelineExitId + operator: non_empty Core: Id: 'CORE-000404' Status: Published Version: '1' -Description: 'A scheduled activity instance must refer to either a default - condition or a timeline exit, but not both.' +Description: 'A scheduled activity instance must refer to either a default condition or a timeline exit, + but not both.' Executability: Fully Executable Outcome: - Message: 'The defaultConditionId and timelineExitId attributes are either both - populated or both empty.' + Message: 'The defaultConditionId and timelineExitId attributes are either both populated or both empty.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId - - timelineExitId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId + - timelineExitId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance + - ScheduledActivityInstance Sensitivity: Record diff --git a/Published/CORE-000407/rule.yml b/Published/CORE-000407/rule.yml index 344704764..3942505f9 100644 --- a/Published/CORE-000407/rule.yml +++ b/Published/CORE-000407/rule.yml @@ -1,30 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, there must be exactly one scheduled - timeline which identifies as the main Timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00012' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, there must be exactly one scheduled - timeline which identifies as the main Timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00012' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, there must be exactly one scheduled timeline which identifies + as the main Timeline.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00012' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, there must be exactly one scheduled timeline which identifies + as the main Timeline.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00012' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.versions.studyDesigns. { @@ -40,20 +40,20 @@ Core: Id: 'CORE-000407' Status: Published Version: '1' -Description: 'Within a study design, there must be exactly one scheduled - timeline which identifies as the main Timeline.' +Description: 'Within a study design, there must be exactly one scheduled timeline which identifies as + the main Timeline.' Executability: Fully Executable Outcome: Message: 'The study design does not have exactly one main timeline.' Output Variables: - - name - - '# Main timelines' - - 'Main timelines' + - name + - '# Main timelines' + - 'Main timelines' Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000408/rule.yml b/Published/CORE-000408/rule.yml index 74befc3f1..bb7ba1c5f 100644 --- a/Published/CORE-000408/rule.yml +++ b/Published/CORE-000408/rule.yml @@ -1,73 +1,71 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept property is required then it must also - be enabled, while if it is not enabled then it must not be - required.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00013' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept property is required then it must also - be enabled, while if it is not enabled then it must not be - required.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00013' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a biomedical concept property is required then it must also be enabled, while + if it is not enabled then it must not be required.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00013' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a biomedical concept property is required then it must also be enabled, while + if it is not enabled then it must not be required.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00013' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptProperty' - - any: - - all: - - name: isRequired - operator: equal_to - value: true - - name: isEnabled - operator: not_equal_to - value: true - - all: - - name: isEnabled - operator: equal_to - value: false - - name: isRequired - operator: not_equal_to - value: false + - name: instanceType + operator: equal_to + value: 'BiomedicalConceptProperty' + - any: + - all: + - name: isRequired + operator: equal_to + value: true + - name: isEnabled + operator: not_equal_to + value: true + - all: + - name: isEnabled + operator: equal_to + value: false + - name: isRequired + operator: not_equal_to + value: false Core: Id: 'CORE-000408' Status: Published Version: '1' -Description: 'If a biomedical concept property is required then it must also be - enabled, while if it is not enabled then it must not be required.' +Description: 'If a biomedical concept property is required then it must also be enabled, while if it is + not enabled then it must not be required.' Executability: Fully Executable Outcome: - Message: 'A required biomedical concept property (isRequired=true) is not - enabled (isEnabled is not true), or a disabled biomedical concept property - (isEnabled=false) is required (isRequired is not false).' + Message: 'A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not + true), or a disabled biomedical concept property (isEnabled=false) is required (isRequired is not + false).' Output Variables: - - parent_entity - - parent_id - - id - - name - - isRequired - - isEnabled + - parent_entity + - parent_id + - id + - name + - isRequired + - isEnabled Rule Type: Record Data Scope: Entities: Include: - - BiomedicalConceptProperty + - BiomedicalConceptProperty Sensitivity: Record diff --git a/Published/CORE-000413/rule.yml b/Published/CORE-000413/rule.yml index df14dfe2d..5daa27896 100644 --- a/Published/CORE-000413/rule.yml +++ b/Published/CORE-000413/rule.yml @@ -1,61 +1,59 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'USDM' - Document: 'USDM v2.6' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00020' - Version: '1' - Validator Rule Message: If the reason for a study amendment is 'Other' then this - must be specified (attribute otherReason must be completed), and - vice versa. - Version: '1.0' - Version: '4.0' +- Organization: 'CDISC' + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'USDM' + Document: 'USDM v2.6' + Origin: USDM Conformance Rules + Rule Identifier: + Id: 'DDF00020' + Version: '1' + Validator Rule Message: If the reason for a study amendment is 'Other' then this must be + specified (attribute otherReason must be completed), and vice versa. + Version: '1.0' + Version: '4.0' Check: any: - - all: - - name: code.code - operator: equal_to - value: 'C17649' - - any: - - name: otherReason - operator: not_exists - - name: otherReason - operator: empty - - all: - - name: code.code - operator: not_equal_to - value: 'C17649' - - name: otherReason - operator: exists - - name: otherReason - operator: non_empty + - all: + - name: code.code + operator: equal_to + value: 'C17649' + - any: + - name: otherReason + operator: not_exists + - name: otherReason + operator: empty + - all: + - name: code.code + operator: not_equal_to + value: 'C17649' + - name: otherReason + operator: exists + - name: otherReason + operator: non_empty Core: Id: 'CORE-000413' Status: Published Version: '1' -Description: If the reason for a study amendment is 'Other' then this must be - specified (attribute otherReason must be completed), and vice versa. +Description: If the reason for a study amendment is 'Other' then this must be specified (attribute + otherReason must be completed), and vice versa. Executability: Fully Executable Outcome: - Message: Population of otherReason is not consistent with code - code.code is - C17649 ('Other') but otherReason is blank, or otherReason is present but - code.code is not C17649 ('Other'). + Message: Population of otherReason is not consistent with code - code.code is C17649 ('Other') but + otherReason is blank, or otherReason is present but code.code is not C17649 ('Other'). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code.code - - code.decode - - otherReason + - parent_entity + - parent_id + - parent_rel + - id + - code.code + - code.decode + - otherReason Rule Type: Record Data Scope: Entities: Include: - - StudyAmendmentReason + - StudyAmendmentReason Sensitivity: Record diff --git a/Published/CORE-000414/rule.yml b/Published/CORE-000414/rule.yml index 144b09c85..f331fa2c1 100644 --- a/Published/CORE-000414/rule.yml +++ b/Published/CORE-000414/rule.yml @@ -1,40 +1,38 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its previous - instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00021' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its previous - instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00021' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not refer to itself as its previous instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00021' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not refer to itself as its previous instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00021' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: previousId - operator: exists - - name: previousId - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: 'definition' + - name: previousId + operator: exists + - name: previousId + operator: equal_to + value: id Core: Id: CORE-000414 Status: Published @@ -44,15 +42,15 @@ Executability: Fully Executable Outcome: Message: 'An instance of a class is referencing itself as its previous instance.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000416/rule.yml b/Published/CORE-000416/rule.yml index 52878c5d4..c4ab8bb60 100644 --- a/Published/CORE-000416/rule.yml +++ b/Published/CORE-000416/rule.yml @@ -1,82 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, when both previous and next - attributes are available within an entity the previous id - value must match the next id value of the referred instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00023' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, when both previous and next - attributes are available within an entity the previous id - value must match the next id value of the referred instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00023' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'To ensure consistent ordering, when both previous and next attributes are available + within an entity the previous id value must match the next id value of the referred instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00023' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'To ensure consistent ordering, when both previous and next attributes are available + within an entity the previous id value must match the next id value of the referred instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00023' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: previousId - operator: exists - - name: nextId - operator: exists - - name: rel_type - operator: equal_to - value: 'reference' - - any: - - all: - - name: parent_rel - operator: equal_to - value: 'previousId' - value_is_literal: true - - name: nextId - operator: not_equal_to - value: parent_id - - all: - - name: parent_rel - operator: equal_to - value: 'nextId' - value_is_literal: true - - name: previousId - operator: not_equal_to - value: parent_id + - name: previousId + operator: exists + - name: nextId + operator: exists + - name: rel_type + operator: equal_to + value: 'reference' + - any: + - all: + - name: parent_rel + operator: equal_to + value: 'previousId' + value_is_literal: true + - name: nextId + operator: not_equal_to + value: parent_id + - all: + - name: parent_rel + operator: equal_to + value: 'nextId' + value_is_literal: true + - name: previousId + operator: not_equal_to + value: parent_id Core: Id: 'CORE-000416' Status: Published Version: '1' -Description: 'To ensure consistent ordering, when both previous and next - attributes are available within an entity the previous id value must match the - next id value of the referred instance.' +Description: 'To ensure consistent ordering, when both previous and next attributes are available within + an entity the previous id value must match the next id value of the referred instance.' Executability: Fully Executable Outcome: - Message: 'The next and previous relationships are not reciprocal - the instance - is the "previous" instance (parent_rel is "previousId") for an instance that - is not its "next" instance (nextId is not the same as parent_id), or vice - versa.' + Message: 'The next and previous relationships are not reciprocal - the instance is the "previous" instance + (parent_rel is "previousId") for an instance that is not its "next" instance (nextId is not the same + as parent_id), or vice versa.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000417/rule.yml b/Published/CORE-000417/rule.yml index a020311fe..d17e83697 100644 --- a/Published/CORE-000417/rule.yml +++ b/Published/CORE-000417/rule.yml @@ -1,70 +1,66 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type - is "Fixed Reference").' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00025' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type - is "Fixed Reference").' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00025' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00025' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00025' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: type.code + operator: equal_to + value: 'C201358' + - any: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty Core: Id: CORE-000417 Status: Published Version: '1' -Description: 'A window must not be defined for an anchor timing (i.e., type is - "Fixed Reference").' +Description: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' Executability: Fully Executable Outcome: - Message: 'One or more of the window attributes (windowLabel, windowLower, - windowUpper) contains a value for a Fixed Reference timing - (type.code=C201358).' + Message: 'One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value + for a Fixed Reference timing (type.code=C201358).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - windowLabel - - windowLower - - windowUpper + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - windowLabel + - windowLower + - windowUpper Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000419/rule.yml b/Published/CORE-000419/rule.yml index da20bf1aa..190791008 100644 --- a/Published/CORE-000419/rule.yml +++ b/Published/CORE-000419/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, the same instance must not be - referenced more than once as previous or next.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00027' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, the same instance must not be - referenced more than once as previous or next.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00027' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'To ensure consistent ordering, the same instance must not be referenced more + than once as previous or next.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00027' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'To ensure consistent ordering, the same instance must not be referenced more + than once as previous or next.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00027' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - all: - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - all: + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel Core: Id: 'CORE-000419' Status: Published Version: '1' -Description: 'To ensure consistent ordering, the same instance must not be - referenced more than once as previous or next.' +Description: 'To ensure consistent ordering, the same instance must not be referenced more than once as + previous or next.' Executability: Fully Executable Outcome: - Message: 'The same instance is referenced more than once as previous or next - - nextId or previousId values are not unique.' + Message: 'The same instance is referenced more than once as previous or next - nextId or previousId + values are not unique.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - nextId - - previousId + - parent_entity + - parent_id + - parent_rel + - id + - name + - nextId + - previousId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000423/rule.yml b/Published/CORE-000423/rule.yml index e341ef2ee..fc1a1bd2a 100644 --- a/Published/CORE-000423/rule.yml +++ b/Published/CORE-000423/rule.yml @@ -1,81 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to - two scheduled instances (e.g. the - relativeFromScheduledInstance and relativeToScheduledInstance - attributes must not be missing and must not be equal to each - other).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00031' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to - two scheduled instances (e.g. the - relativeFromScheduledInstance and relativeToScheduledInstance - attributes must not be missing and must not be equal to each - other).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00031' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances + (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not + be missing and must not be equal to each other).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00031' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances + (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not + be missing and must not be equal to each other).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00031' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type + - name: rel_type + operator: equal_to + value: 'definition' + - name: type.code + operator: not_equal_to + value: C201358 + - any: + - name: relativeFromScheduledInstanceId + operator: empty + - name: relativeToScheduledInstanceId + operator: not_exists + - name: relativeToScheduledInstanceId + operator: empty + - name: relativeFromScheduledInstanceId operator: equal_to - value: 'definition' - - name: type.code - operator: not_equal_to - value: C201358 - - any: - - name: relativeFromScheduledInstanceId - operator: empty - - name: relativeToScheduledInstanceId - operator: not_exists - - name: relativeToScheduledInstanceId - operator: empty - - name: relativeFromScheduledInstanceId - operator: equal_to - value: relativeToScheduledInstanceId + value: relativeToScheduledInstanceId Core: Id: 'CORE-000423' Status: Published Version: '1' -Description: 'If timing type is not "Fixed Reference" then it must point to two - scheduled instances (e.g. the relativeFromScheduledInstance and - relativeToScheduledInstance attributes must not be missing and must not be - equal to each other).' +Description: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances (e.g. + the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not be missing and + must not be equal to each other).' Executability: Fully Executable Outcome: - Message: 'The Timing type is not "Fixed Reference" (type.code is not C201358) - but it does not point to two different scheduled instances - - relativeFromScheduledInstanceId and/or relativeToScheduledInstanceId is - missing, or they both contain the same value.' + Message: 'The Timing type is not "Fixed Reference" (type.code is not C201358) but it does not point + to two different scheduled instances - relativeFromScheduledInstanceId and/or relativeToScheduledInstanceId + is missing, or they both contain the same value.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - relativeToScheduledInstanceId + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - relativeToScheduledInstanceId Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000424/rule.yml b/Published/CORE-000424/rule.yml index b0c9df6a1..f24205689 100644 --- a/Published/CORE-000424/rule.yml +++ b/Published/CORE-000424/rule.yml @@ -1,72 +1,71 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if more than 1 business therapeutic - area is defined then they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00032' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if more than 1 business therapeutic - area is defined then they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00032' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, if more than 1 business therapeutic area is defined then + they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00032' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, if more than 1 business therapeutic area is defined then + they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00032' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyVersion' - - name: parent_rel - operator: equal_to - value: 'businessTherapeuticAreas' - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyVersion' + - name: parent_rel + operator: equal_to + value: 'businessTherapeuticAreas' + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - codeSystem + - codeSystemVersion Core: Id: CORE-000424 Status: Published Version: '1' -Description: 'Within a study version, if more than 1 business therapeutic area - is defined then they must be distinct.' +Description: 'Within a study version, if more than 1 business therapeutic area is defined then they must + be distinct.' Executability: Fully Executable Outcome: - Message: 'The business therapeutic areas of the study version are not unique - - the same code is used more than once with the same codeSystem and - codeSystemVersion.' + Message: 'The business therapeutic areas of the study version are not unique - the same code is used + more than once with the same codeSystem and codeSystemVersion.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000427/rule.yml b/Published/CORE-000427/rule.yml index d381bb933..6a7ba5c3f 100644 --- a/Published/CORE-000427/rule.yml +++ b/Published/CORE-000427/rule.yml @@ -1,84 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a code system and corresponding version, a one-to-one - relationship between code and decode is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00035' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a code system and corresponding version, a one-to-one - relationship between code and decode is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00035' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a code system and corresponding version, a one-to-one relationship between + code and decode is expected.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00035' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a code system and corresponding version, a one-to-one relationship between + code and decode is expected.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00035' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - any: - - name: $num_records_in_codesystemversion_with_code - operator: not_equal_to - value: $num_records_in_codesystemversion_with_code_decode - - name: $num_records_in_codesystemversion_with_decode - operator: not_equal_to - value: $num_records_in_codesystemversion_with_code_decode + - name: instanceType + operator: equal_to + value: 'Code' + - any: + - name: $num_records_in_codesystemversion_with_code + operator: not_equal_to + value: $num_records_in_codesystemversion_with_code_decode + - name: $num_records_in_codesystemversion_with_decode + operator: not_equal_to + value: $num_records_in_codesystemversion_with_code_decode Core: Id: CORE-000427 Status: Published Version: '1' -Description: 'Within a code system and corresponding version, a one-to-one - relationship between code and decode is expected.' +Description: 'Within a code system and corresponding version, a one-to-one relationship between code and + decode is expected.' Executability: Partially Executable - Possible Overreporting Operations: - - group: - - codeSystem - - codeSystemVersion - - code - id: $num_records_in_codesystemversion_with_code - operator: record_count - - group: - - codeSystem - - codeSystemVersion - - decode - id: $num_records_in_codesystemversion_with_decode - operator: record_count - - group: - - codeSystem - - codeSystemVersion - - code - - decode - id: $num_records_in_codesystemversion_with_code_decode - operator: record_count +- group: + - codeSystem + - codeSystemVersion + - code + id: $num_records_in_codesystemversion_with_code + operator: record_count +- group: + - codeSystem + - codeSystemVersion + - decode + id: $num_records_in_codesystemversion_with_decode + operator: record_count +- group: + - codeSystem + - codeSystemVersion + - code + - decode + id: $num_records_in_codesystemversion_with_code_decode + operator: record_count Outcome: - Message: 'There is not a one-to-one relationship between code and decode within - a codeSytem and corresponding codeSystemVersion' + Message: 'There is not a one-to-one relationship between code and decode within a codeSytem and corresponding + codeSystemVersion' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - codeSystem - - codeSystemVersion - - code - - decode + - parent_entity + - parent_id + - parent_rel + - id + - codeSystem + - codeSystemVersion + - code + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000428/rule.yml b/Published/CORE-000428/rule.yml index 41f1548b2..397db8f8d 100644 --- a/Published/CORE-000428/rule.yml +++ b/Published/CORE-000428/rule.yml @@ -1,70 +1,67 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding - attribute relativeToFrom must be filled with "Start to - Start".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00036' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding - attribute relativeToFrom must be filled with "Start to - Start".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00036' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom + must be filled with "Start to Start".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00036' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom + must be filled with "Start to Start".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00036' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: relativeToFrom.code - operator: empty - - name: relativeToFrom.code - operator: not_equal_to - value: 'C201355' + - name: rel_type + operator: equal_to + value: 'definition' + - name: type.code + operator: equal_to + value: 'C201358' + - any: + - name: relativeToFrom.code + operator: empty + - name: relativeToFrom.code + operator: not_equal_to + value: 'C201355' Core: Id: CORE-000428 Status: Published Version: '1' -Description: 'If timing type is "Fixed Reference" then the corresponding - attribute relativeToFrom must be filled with "Start to Start".' +Description: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom must + be filled with "Start to Start".' Executability: Fully Executable Outcome: - Message: 'Type is "Fixed Reference" (type.code=C201358) for the timing but - relativeToFrom is not "Start to Start" (relativeToFrom.code is not - C201355).' + Message: 'Type is "Fixed Reference" (type.code=C201358) for the timing but relativeToFrom is not "Start + to Start" (relativeToFrom.code is not C201355).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeToFrom.code - - relativeToFrom.decode + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeToFrom.code + - relativeToFrom.decode Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000429/rule.yml b/Published/CORE-000429/rule.yml index 493186149..5c7687924 100644 --- a/Published/CORE-000429/rule.yml +++ b/Published/CORE-000429/rule.yml @@ -1,36 +1,35 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Only applies to SENDIG-3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is outside the Limit of Quantification, a. - PCSTRESN must be null and not populated with the value of zero - (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND329' - Version: '1' - Version: '5.0' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN + must be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND329' + Version: '1' + Version: '5.0' + Version: '3.1.1' Check: all: - - name: PCORRES - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' + - name: PCORRES + operator: not_matches_regex + value: '[+-]?([0-9]*[.])?[0-9]+$' # report an error when either PCORRES does not represent a number - all: # and PCSTRESN is populated - - name: PCSTRESN - operator: non_empty + - name: PCSTRESN + operator: non_empty Core: Id: CORE-000429 Status: Published Version: '1' -Description: If the PCORRES result is outside the Limit of Quantification, a. - PCSTRESN must be null and not populated with the value of zero (0). +Description: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null + and not populated with the value of zero (0). Executability: Fully Executable Outcome: Message: PCORRES does not represent a number but PCSTRESN is populated @@ -38,8 +37,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000430/rule.yml b/Published/CORE-000430/rule.yml index d009c3b8d..c7711cf2b 100644 --- a/Published/CORE-000430/rule.yml +++ b/Published/CORE-000430/rule.yml @@ -1,118 +1,111 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.0 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: WThe variable, --STRESC, is derived either by the conversion of - values in --ORRES to values with standard units, or by the - assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Derived by the conversion of numeric values in --ORRES to - numeric values with standard units. The assigned of the value - of --ORRES. - Document: TIG v1.0 - Item: Second Table, Num 2 - Section: 2.8.7.1 General Guidance - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0183 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.0 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: WThe variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Derived by the conversion of numeric values in --ORRES to numeric values + with standard units. The assigned of the value of --ORRES. + Document: TIG v1.0 + Item: Second Table, Num 2 + Section: 2.8.7.1 General Guidance + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0183 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: empty - - name: --STRESC - operator: non_empty + - name: --ORRES + operator: empty + - name: --STRESC + operator: non_empty Core: Id: CORE-000430 Status: Published @@ -122,15 +115,15 @@ Executability: Fully Executable Outcome: Message: --STRESC must be be null as --ORRES is null. Output Variables: - - --ORRES - - --STRESC + - --ORRES + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000431/rule.yml b/Published/CORE-000431/rule.yml index e61dbe8e3..cd0887c0d 100644 --- a/Published/CORE-000431/rule.yml +++ b/Published/CORE-000431/rule.yml @@ -1,90 +1,90 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.0 - Item: Assumption 1.b - Section: 8.7.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.0 + Item: Assumption 1.b + Section: 8.7.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: POOLID - operator: non_empty - - name: USUBJID - operator: empty + - name: POOLID + operator: non_empty + - name: USUBJID + operator: empty Core: Id: CORE-000431 Status: Published @@ -97,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Published/CORE-000432/rule.yml b/Published/CORE-000432/rule.yml index 10fc61100..0850bda32 100644 --- a/Published/CORE-000432/rule.yml +++ b/Published/CORE-000432/rule.yml @@ -1,116 +1,116 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: TIG v1.0 - Item: TXPARMCD CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0160 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Short character value for the Trial Set parameter described in TXPARM. + Maximum 8 characters. + Document: TIG v1.0 + Item: TXPARMCD CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0160 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXPARMCD - operator: longer_than - value: 8 + - name: TXPARMCD + operator: longer_than + value: 8 Core: Id: CORE-000432 Status: Published Version: "1" -Description: TXPARMCD Short character value for the Trial Set parameter - described in TXPARM. Maximum 8 characters. +Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. + Maximum 8 characters. Executability: Fully Executable Outcome: Message: TXPARMCD value has more than 8 characters @@ -118,9 +118,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000433/rule.yml b/Published/CORE-000433/rule.yml index a8dade76e..cd60b1255 100644 --- a/Published/CORE-000433/rule.yml +++ b/Published/CORE-000433/rule.yml @@ -1,117 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This - sequence should be unique within the entire dataset because - there is no USUBJID.) - Document: TIG v1.0 - Item: TXSEQ CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0159 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: TIG v1.0 + Item: TXSEQ CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0159 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXSEQ - operator: is_not_unique_set - value: DOMAIN + - name: TXSEQ + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000433 Status: Published @@ -124,9 +117,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000436/rule.yml b/Published/CORE-000436/rule.yml index aba63da57..bffcd553b 100644 --- a/Published/CORE-000436/rule.yml +++ b/Published/CORE-000436/rule.yml @@ -1,149 +1,140 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study - Day: --DY = (date portion of --DTC) - (date portion of - RFSTDTC) if --DTC precedes RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0275 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0275 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY # checking failure criteria - operator: not_equal_to - value: $val_dy # this is created in the operations statement that follows + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY # checking failure criteria + operator: not_equal_to + value: $val_dy # this is created in the operations statement that follows Core: Id: CORE-000436 Status: Published Version: '1' -Description: Raise an error when --DY is not calculated as per the study day - algorithm as a non-zero integer value when the date portion of --DTC is - complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not - empty +Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero + integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a + complete date AND --DY is not empty Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - id: $val_dy # ex in devops 2538 used -- but that threw an error - name: --DTC - operator: dy # does dy op take into acct +1? +- id: $val_dy # ex in devops 2538 used -- but that threw an error + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: - Message: --DY is not calculated correctly even though the date portion of --DTC - is complete, the date portion of DM.RFSTDTC is a complete date, and --DY is - not empty. + Message: --DY is not calculated correctly even though the date portion of --DTC is complete, the + date portion of DM.RFSTDTC is a complete date, and --DY is not empty. Output Variables: - - --DY - - --DTC - - RFSTDTC + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000438/rule.yml b/Published/CORE-000438/rule.yml index 3d9127e83..5449526d4 100644 --- a/Published/CORE-000438/rule.yml +++ b/Published/CORE-000438/rule.yml @@ -1,104 +1,103 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.0 - Item: Specification - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Result of, response to, or value associated with QNAM. A value - for this column is required; no records can be in SUPP-- with - a null value for QVAL. - Document: TIG v1.0 - Item: QVAL CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (SUPP--) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0175 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.0 + Item: Specification + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1 + Item: Specification + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1 + Item: Specification + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Result of, response to, or value associated with QNAM. A value for this + column is required; no records can be in SUPP-- with a null value for QVAL. + Document: TIG v1.0 + Item: QVAL CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (SUPP--) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0175 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: QVAL - operator: empty + - name: QVAL + operator: empty Core: Id: CORE-000438 Status: Published @@ -108,15 +107,15 @@ Executability: Fully Executable Outcome: Message: The record does not have a value for QVAL Output Variables: - - QNAM - - QLABEL + - QNAM + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000440/rule.yml b/Published/CORE-000440/rule.yml index 6095444c8..664f15849 100644 --- a/Published/CORE-000440/rule.yml +++ b/Published/CORE-000440/rule.yml @@ -1,113 +1,106 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.0 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as scheduled in the - study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the - reason for not completing the evaluation as described in the - study plan. - Document: TIG v1.0 - Item: Assumption 4.h.ii - Section: 2.8.9.16 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0196 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.0 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND280' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as described in the study plan. + Document: TIG v1.0 + Item: Assumption 4.h.ii + Section: 2.8.9.16 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0196 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - - name: --REASND - operator: empty + - name: --STAT + operator: equal_to + value: NOT DONE + - name: --REASND + operator: empty Core: Id: CORE-000440 Status: Published @@ -120,10 +113,10 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - MI + - LB + - MI Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000441/rule.yml b/Published/CORE-000441/rule.yml index a424c28da..89a59f51a 100644 --- a/Published/CORE-000441/rule.yml +++ b/Published/CORE-000441/rule.yml @@ -1,31 +1,31 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TFDTHREL must be "Y", "N", or "U" - Document: SENDIG v3.0 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND201 - Version: '1' - Version: '5.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TFDTHREL must be "Y", "N", or "U" + Document: SENDIG v3.0 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND201 + Version: '1' + Version: '5.0' # ATTENTION: for SENDIG 3.0 only - Version: '3.0' + Version: '3.0' Check: all: # Remark: TFTDTREL cannot be null - - name: TFDTHREL - operator: not_equal_to - value: Y - - name: TFDTHREL - operator: not_equal_to - value: N - - name: TFDTHREL - operator: not_equal_to - value: U + - name: TFDTHREL + operator: not_equal_to + value: Y + - name: TFDTHREL + operator: not_equal_to + value: N + - name: TFDTHREL + operator: not_equal_to + value: U Core: Id: CORE-000441 Status: Published @@ -38,8 +38,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Published/CORE-000442/rule.yml b/Published/CORE-000442/rule.yml index d0f46e33e..0e1d5b77f 100644 --- a/Published/CORE-000442/rule.yml +++ b/Published/CORE-000442/rule.yml @@ -1,26 +1,26 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'VSTPTNUM: Numerical version of VSTPT to aid in sorting; - required if time points are included within the domain.' - Document: IG v3.0 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND207 - Version: '1' - Version: '5.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'VSTPTNUM: Numerical version of VSTPT to aid in sorting; required if time points + are included within the domain.' + Document: IG v3.0 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND207 + Version: '1' + Version: '5.0' + Version: '3.0' Check: all: - - name: VSTPT - operator: non_empty - - name: VSTPTNUM - operator: empty + - name: VSTPT + operator: non_empty + - name: VSTPTNUM + operator: empty Core: Id: CORE-000442 Status: Published @@ -30,14 +30,14 @@ Executability: Fully Executable Outcome: Message: VSTPTNUM is not populated although VSTPT is populated Output Variables: - - VSTPT - - VSTPTNUM + - VSTPT + - VSTPTNUM Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - VS + - VS Sensitivity: Record diff --git a/Published/CORE-000444/rule.yml b/Published/CORE-000444/rule.yml index da87527df..b3d391387 100644 --- a/Published/CORE-000444/rule.yml +++ b/Published/CORE-000444/rule.yml @@ -1,78 +1,74 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Does not apply to SENDIG-3.0 and SENDIG-3.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with - the term "BLQ" for results below the limit and "ALQ" for - results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with - the term "BLQ" for results below the limit and "ALQ" for - results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with - the term "BLQ" for results below the limit and "ALQ" for - results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND324' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND324' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND324' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: PCORRES - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' + - name: PCORRES + operator: not_matches_regex + value: '[+-]?([0-9]*[.])?[0-9]+$' # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ" - - name: PCSTRESC - operator: not_equal_to - value: 'BLQ' - - name: PCSTRESC - operator: not_equal_to - value: 'ALQ' + - name: PCSTRESC + operator: not_equal_to + value: 'BLQ' + - name: PCSTRESC + operator: not_equal_to + value: 'ALQ' Core: Id: CORE-000444 Status: Published Version: '1' -Description: When Result is outside the Limit of Quantification, i.e. it is not - a number (e.g. <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ" +Description: When Result is outside the Limit of Quantification, i.e. it is not a number (e.g. + <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ" Executability: Fully Executable Outcome: - Message: The value in PCORRES is not a number (so represents a value outside the - Limit of Quantification), in which case PCSTRESC must be either "BLQ" or - "ALQ" + Message: The value in PCORRES is not a number (so represents a value outside the Limit of + Quantification), in which case PCSTRESC must be either "BLQ" or "ALQ" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000445/rule.yml b/Published/CORE-000445/rule.yml index bbc103172..18a0be0f2 100644 --- a/Published/CORE-000445/rule.yml +++ b/Published/CORE-000445/rule.yml @@ -1,54 +1,54 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as - a number and populated in EXDOSE, this field is used to - describe the amount of treatment administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as - a number and populated in EXDOSE, this field is used to - describe the amount of treatment administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as - a number and populated in EXDOSE, this field is used to - describe the amount of treatment administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND314' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND314' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND314' + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: EXDOSTXT - operator: non_empty - - name: EXDOSE - operator: non_empty + - name: EXDOSTXT + operator: non_empty + - name: EXDOSE + operator: non_empty Core: Id: CORE-000445 Status: Published @@ -61,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000446/rule.yml b/Published/CORE-000446/rule.yml index 233a66173..710b084b9 100644 --- a/Published/CORE-000446/rule.yml +++ b/Published/CORE-000446/rule.yml @@ -1,103 +1,103 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.0 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to - the death of a subject (Y=caused death, N=did not cause death, - U=unknown). May be left null if not available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.0 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --DTHREL - operator: non_empty - - name: --DTHREL - operator: not_equal_to - value: Y - - name: --DTHREL - operator: not_equal_to - value: U - - name: --DTHREL - operator: not_equal_to - value: N + - name: --DTHREL + operator: non_empty + - name: --DTHREL + operator: not_equal_to + value: Y + - name: --DTHREL + operator: not_equal_to + value: U + - name: --DTHREL + operator: not_equal_to + value: N Core: Id: CORE-000446 Status: Published @@ -110,9 +110,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA - - MI + - MA + - MI Sensitivity: Record diff --git a/Published/CORE-000447/rule.yml b/Published/CORE-000447/rule.yml index ddd2d9019..69db57dc7 100644 --- a/Published/CORE-000447/rule.yml +++ b/Published/CORE-000447/rule.yml @@ -1,97 +1,97 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.0 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.0 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: MATEST - operator: equal_to - value: Clinical Signs Follow-up - - name: MASPEC - operator: non_empty + - name: MATEST + operator: equal_to + value: Clinical Signs Follow-up + - name: MASPEC + operator: non_empty Core: Id: CORE-000447 Status: Published @@ -104,8 +104,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Sensitivity: Record diff --git a/Published/CORE-000449/rule.yml b/Published/CORE-000449/rule.yml index c10cacd14..1a711d0e7 100644 --- a/Published/CORE-000449/rule.yml +++ b/Published/CORE-000449/rule.yml @@ -1,44 +1,42 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study element must be referenced by at least one study - cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00040' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study element must be referenced by at least one study - cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00040' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each study element must be referenced by at least one study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00040' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each study element must be referenced by at least one study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00040' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'StudyElement' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: $num_el_refs + operator: empty + - name: $num_el_refs operator: equal_to - value: 'StudyElement' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $num_el_refs - operator: empty - - name: $num_el_refs - operator: equal_to - value: 0 + value: 0 Core: Id: "CORE-000449" Status: Published @@ -46,25 +44,25 @@ Core: Description: 'Each study element must be referenced by at least one study cell.' Executability: Fully Executable Operations: - - filter: - parent_entity: 'StudyCell' - parent_rel: 'elementIds' - rel_type: 'reference' - group: - - id - id: $num_el_refs - operator: record_count +- filter: + parent_entity: 'StudyCell' + parent_rel: 'elementIds' + rel_type: 'reference' + group: + - id + id: $num_el_refs + operator: record_count Outcome: Message: 'The study element is not referenced by any study cell.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - StudyElement + - StudyElement Sensitivity: Record diff --git a/Published/CORE-000451/rule.yml b/Published/CORE-000451/rule.yml index 0b39e8d90..727430957 100644 --- a/Published/CORE-000451/rule.yml +++ b/Published/CORE-000451/rule.yml @@ -1,218 +1,210 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of a specific Trial Set. SET: Long - description of a specific Trial Set, as defined by the - sponsor.' - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a - specific Trial Set, as defined by the sponsor.' - Document: TIG v1.0 - Item: SETCD CDISC Notes | SET CDISC Notes - Section: 2.8.9.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0163 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of a specific Trial Set. SET: Long description of a specific + Trial Set, as defined by the sponsor.' + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND237' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor.' + Document: TIG v1.0 + Item: SETCD CDISC Notes | SET CDISC Notes + Section: 2.8.9.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0163 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: SETCD - operator: is_not_unique_relationship - value: SET + - name: SETCD + operator: is_not_unique_relationship + value: SET Core: Id: CORE-000451 Status: Published @@ -222,15 +214,15 @@ Executability: Fully Executable Outcome: Message: SET and SETCD do not have a one-to-one relationship. Output Variables: - - SET - - SETCD + - SET + - SETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000454/rule.yml b/Published/CORE-000454/rule.yml index ddab34829..7c18a6706 100644 --- a/Published/CORE-000454/rule.yml +++ b/Published/CORE-000454/rule.yml @@ -1,134 +1,129 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment - or therapy, equal to the latest value of EXENDTC (or the - latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment - or therapy, equal to the latest value of EXENDTC (or the - latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment - or therapy, equal to the latest value of EXENDTC (or the - latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment - or therapy, equal to the latest value of EXENDTC (or the - latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment - or therapy, equal to the latest value of EXENDTC (or the - latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: '2' + Version: '5.0' + Version: '1.0' Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exendtc - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exendtc + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exstdtc Core: Id: CORE-000454 Status: Published Version: '1' -Description: Raise an error when EX records are present for subject but RFXENDTC - does not equal the latest value of EX.EXENDTC +Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the + latest value of EX.EXENDTC Executability: Fully Executable Operations: - - domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct - - domain: EX - group: - - USUBJID - id: $max_ex_exstdtc - name: EXSTDTC - operator: max_date - - domain: EX - group: - - USUBJID - id: $max_ex_exendtc - name: EXENDTC - operator: max_date +- domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct +- domain: EX + group: + - USUBJID + id: $max_ex_exstdtc + name: EXSTDTC + operator: max_date +- domain: EX + group: + - USUBJID + id: $max_ex_exendtc + name: EXENDTC + operator: max_date Outcome: - Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest - value of EX.EXSTDTC if EX.EXENDTC is not present or not populated. + Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC + if EX.EXENDTC is not present or not populated. Output Variables: - - RFXSTDTC - - $max_ex_exendtc - - $max_ex_exstdtc + - RFXSTDTC + - $max_ex_exendtc + - $max_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000455/rule.yml b/Published/CORE-000455/rule.yml index a23a25edc..fbf6a8768 100644 --- a/Published/CORE-000455/rule.yml +++ b/Published/CORE-000455/rule.yml @@ -1,113 +1,113 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment - or therapy, equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: '2' + Version: '5.0' + Version: '1.0' Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXSTDTC - operator: not_equal_to - value: $min_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXSTDTC + operator: not_equal_to + value: $min_ex_exstdtc Core: Id: CORE-000455 Status: Published Version: '1' -Description: Raise an error when EX records are present for subject but RFXSTDTC - does not equal the earliest value of EX.EXSTDTC +Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the + earliest value of EX.EXSTDTC Executability: Fully Executable Operations: - - domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct - - domain: EX - group: - - USUBJID - id: $min_ex_exstdtc - name: EXSTDTC - operator: min_date +- domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct +- domain: EX + group: + - USUBJID + id: $min_ex_exstdtc + name: EXSTDTC + operator: min_date Outcome: Message: RFXSTDTC does not equal the earliest value of EX.EXSTDTC Output Variables: - - RFXSTDTC - - $min_ex_exstdtc + - RFXSTDTC + - $min_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000456/rule.yml b/Published/CORE-000456/rule.yml index 2ba951230..e81d60f07 100644 --- a/Published/CORE-000456/rule.yml +++ b/Published/CORE-000456/rule.yml @@ -1,103 +1,103 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.0 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required - when MATEST is 'Gross Pathological Examination'. It should not - be used when MATEST is 'Clinical Signs Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.0 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: MATEST - operator: equal_to - value: Gross Pathological Examination - - name: MASPEC - operator: empty + - name: MATEST + operator: equal_to + value: Gross Pathological Examination + - name: MASPEC + operator: empty Core: Id: CORE-000456 Status: Published @@ -110,8 +110,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Sensitivity: Record diff --git a/Published/CORE-000457/rule.yml b/Published/CORE-000457/rule.yml index 10fc9a4fa..64c06b3b9 100644 --- a/Published/CORE-000457/rule.yml +++ b/Published/CORE-000457/rule.yml @@ -2,106 +2,98 @@ # Condition: SUPP-- dataset present in study # Rule: Dataset present in study with DOMAIN = SUPP--.RDOMAIN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset - and it's Supplemental Qualifier dataset by creating one - SUPPQUAL for each domain dataset. The single SUPPQUAL dataset - option that was introduced in SDTMIG v3.1.1 is now - deprecated. The set of Supplemental Qualifiers for each - domain is included in a separate dataset with the name SUPP-- - where “--“ denotes the source domain which the supplemental - Qualifiers relate back to. - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset - and it's Supplemental Qualifier dataset by creating one - SUPPQUAL for each domain dataset. The single SUPPQUAL dataset - option that was introduced in SDTMIG v3.1.1 is now deprecated. - The set of Supplemental Qualifiers for each domain is included - in a separate dataset with the name SUPP-- where '--' denotes - the source domain which the supplemental Qualifiers relate - back to. - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset - and its Supplemental Qualifier dataset. The single SUPPQUAL - dataset option that was introduced in SDTMIG v3.1 was - deprecated. The set of Supplemental Qualifiers for each domain - is included in a separate dataset with the name SUPP-- where - "--" denotes the source domain which the Supplemental - Qualifiers relate back to. - Document: IG v3.3 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: There will be only one SUPP-- dataset for a parent dataset. - Relationships between records in the SUPP-- dataset and - observations in the parent dataset are specified using the key - variables STUDYID, RDOMAIN (the domain code of the observation - in the relationship), USUBJID - Document: TIG 1.0 - Item: '' - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0537 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There is a one-to-one correspondence between a domain dataset and it's + Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The + single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. + The set of Supplemental Qualifiers for each domain is included in a separate dataset with + the name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers + relate back to. + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There is a one-to-one correspondence between a domain dataset and it's + Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The + single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The + set of Supplemental Qualifiers for each domain is included in a separate dataset with the + name SUPP-- where '--' denotes the source domain which the supplemental Qualifiers relate + back to. + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There is a one-to-one correspondence between a domain dataset and its + Supplemental Qualifier dataset. The single SUPPQUAL dataset option that was introduced in + SDTMIG v3.1 was deprecated. The set of Supplemental Qualifiers for each domain is included + in a separate dataset with the name SUPP-- where "--" denotes the source domain which the + Supplemental Qualifiers relate back to. + Document: IG v3.3 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: There will be only one SUPP-- dataset for a parent dataset. Relationships + between records in the SUPP-- dataset and observations in the parent dataset are specified + using the key variables STUDYID, RDOMAIN (the domain code of the observation in the + relationship), USUBJID + Document: TIG 1.0 + Item: '' + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0537 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000457 Status: Published Version: '1' -Description: Trigger error when SUPP--.RDOMAIN does not represent a dataset - present in the study +Description: Trigger error when SUPP--.RDOMAIN does not represent a dataset present in the study Executability: Fully Executable Operations: - - id: $study_domains - operator: study_domains +- id: $study_domains + operator: study_domains Outcome: Message: SUPP--.RDOMAIN does not represent a dataset present in the study Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000458/rule.yml b/Published/CORE-000458/rule.yml index 66392d21e..77dfdc31d 100644 --- a/Published/CORE-000458/rule.yml +++ b/Published/CORE-000458/rule.yml @@ -1,141 +1,140 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness of subject records - within a domain. May be any valid number. - Document: SENDIG v3.0 - Item: EXSEQ CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a - record for a given USUBJID within a domain. - Document: SENDIG v3.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a - record for a given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a - record for a given USUBJID within a domain. - Document: SENDIG v3.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a - record for a given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a - record for a given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: --SEQ Values uniquely identify records for subjects within a - domain - Document: TIG v1.0 - Item: Table Row 4 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0074 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sequence number given to ensure uniqueness of subject records within a + domain. May be any valid number. + Document: SENDIG v3.0 + Item: EXSEQ CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1 + Item: Text + Section: '8' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: '8' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1 + Item: Text + Section: '8' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: '8' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: '8' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: --SEQ Values uniquely identify records for subjects within a domain + Document: TIG v1.0 + Item: Table Row 4 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0074 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: is_not_unique_set - value: USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: is_not_unique_set - value: POOLID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: is_not_unique_set + value: USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: is_not_unique_set + value: POOLID Core: Id: CORE-000458 Status: Published Version: '1' -Description: Sequence number given to ensure uniqueness of subject records - within a domain. May be any valid number. +Description: Sequence number given to ensure uniqueness of subject records within a domain. May be + any valid number. Executability: Fully Executable Outcome: Message: --SEQ is not unique within USUBJID or POOLID Output Variables: - - USUBJID - - POOLID - - --SEQ + - USUBJID + - POOLID + - --SEQ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000459/rule.yml b/Published/CORE-000459/rule.yml index 418206457..8428fa372 100644 --- a/Published/CORE-000459/rule.yml +++ b/Published/CORE-000459/rule.yml @@ -1,112 +1,111 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only - "C" or "F" is acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: TXPARMCD - operator: equal_to - value: ENVTEMPU + - name: TXPARMCD + operator: equal_to + value: ENVTEMPU # addition Jozef 2024-03-16 # pre-condition is that TXVAL is not null - - name: TXVAL - operator: non_empty + - name: TXVAL + operator: non_empty # end of addition - - name: TXVAL - operator: not_equal_to - value: C - - name: TXVAL - operator: not_equal_to - value: F + - name: TXVAL + operator: not_equal_to + value: C + - name: TXVAL + operator: not_equal_to + value: F Core: Id: CORE-000459 Status: Published Version: '1' -Description: The units associated with the environmental temperature; only "C" - or "F" is acceptable. +Description: The units associated with the environmental temperature; only "C" or "F" is acceptable. Executability: Fully Executable Outcome: Message: The value of TXVAL may only be "C" or "F" for TXPARMCD=ENTEMPU @@ -114,8 +113,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000460/rule.yml b/Published/CORE-000460/rule.yml index 117689449..e869076a2 100644 --- a/Published/CORE-000460/rule.yml +++ b/Published/CORE-000460/rule.yml @@ -1,107 +1,107 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - any: - - name: TXPARMCD - operator: equal_to - value: DOSENDTC - - name: TXPARMCD - operator: equal_to - value: DOSSTDTC - - name: TXVAL - operator: invalid_date + - any: + - name: TXPARMCD + operator: equal_to + value: DOSENDTC + - name: TXPARMCD + operator: equal_to + value: DOSSTDTC + - name: TXVAL + operator: invalid_date Core: Id: CORE-000460 Status: Published Version: '1' -Description: Trial Set Parameters that include dates are required to be - presented according to the international standard ISO 8601 +Description: Trial Set Parameters that include dates are required to be presented according to the + international standard ISO 8601 Executability: Fully Executable Outcome: Message: The value of TXVAL is not in ISO 8601 date/datetime format @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000461/rule.yml b/Published/CORE-000461/rule.yml index 3be7c2faf..bd8d6d29d 100644 --- a/Published/CORE-000461/rule.yml +++ b/Published/CORE-000461/rule.yml @@ -1,27 +1,27 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.0 - Section: 6.3.7 | 6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182 - Version: '1' - Version: '5.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.0 + Section: 6.3.7 | 6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182 + Version: '1' + Version: '5.0' # ATTENTION: for SENDIG 3.0, only applicable to MA, MI. Not to LB, PC. - Version: '3.0' + Version: '3.0' Check: all: - - name: --SPCUFL - operator: non_empty - - name: --SPCUFL - operator: not_equal_to - value: N + - name: --SPCUFL + operator: non_empty + - name: --SPCUFL + operator: not_equal_to + value: N Core: Id: CORE-000461 Status: Published @@ -34,9 +34,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA - - MI + - MA + - MI Sensitivity: Record diff --git a/Published/CORE-000462/rule.yml b/Published/CORE-000462/rule.yml index 2d27e7e6f..2ead0a713 100644 --- a/Published/CORE-000462/rule.yml +++ b/Published/CORE-000462/rule.yml @@ -1,78 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. - Example, N = the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --SPCUFL - operator: non_empty - - name: --SPCUFL - operator: not_equal_to - value: N + - name: --SPCUFL + operator: non_empty + - name: --SPCUFL + operator: not_equal_to + value: N Core: Id: CORE-000462 Status: Published @@ -85,11 +85,11 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - MA - - MI - - PC + - LB + - MA + - MI + - PC Sensitivity: Record diff --git a/Published/CORE-000463/rule.yml b/Published/CORE-000463/rule.yml index d91a8ae47..cfdd91f71 100644 --- a/Published/CORE-000463/rule.yml +++ b/Published/CORE-000463/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG v3.0 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG v3.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG v3.1.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG-DART v1.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG-DART v1.2 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: SENDIG-GENETOX v1.0 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or - null. - Document: TIG v1.0 - Item: LBDRVFL CDISC Notes - Section: 2.8.9.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0102 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.0 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.1.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-DART v1.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-DART v1.2 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-GENETOX v1.0 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: TIG v1.0 + Item: LBDRVFL CDISC Notes + Section: 2.8.9.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0102 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --DRVFL - operator: non_empty - - name: --DRVFL - operator: not_equal_to - value: Y + - name: --DRVFL + operator: non_empty + - name: --DRVFL + operator: not_equal_to + value: Y Core: Id: CORE-000463 Status: Published @@ -113,9 +106,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000465/rule.yml b/Published/CORE-000465/rule.yml index fc50987e9..39b2c03b6 100644 --- a/Published/CORE-000465/rule.yml +++ b/Published/CORE-000465/rule.yml @@ -1,69 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND295' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND295' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND295' + Version: '1' + Version: '5.0' + Version: '1.1' Check: any: - - all: - - name: --STINT - operator: empty - - name: --ENINT - operator: non_empty - - all: - - name: --ENINT - operator: empty - - name: --STINT - operator: non_empty + - all: + - name: --STINT + operator: empty + - name: --ENINT + operator: non_empty + - all: + - name: --ENINT + operator: empty + - name: --STINT + operator: non_empty Core: Id: CORE-000465 Status: Published Version: '1' -Description: WHEN --STINT ^= null OR --ENINT ^= null THEN --STINT ^= null AND - --ENINT ^= null +Description: WHEN --STINT ^= null OR --ENINT ^= null THEN --STINT ^= null AND --ENINT ^= null Executability: Fully Executable Outcome: Message: --STINT and --ENINT must both be populated or none of them must be populated @@ -71,8 +67,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000466/rule.yml b/Published/CORE-000466/rule.yml index 218d2f777..e349dc73d 100644 --- a/Published/CORE-000466/rule.yml +++ b/Published/CORE-000466/rule.yml @@ -1,76 +1,75 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the - timing of a performed test or observation was not driven by - the study schedule. | Expected values are Y or null. - Document: IG v3.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the - timing of a performed test or observation was not driven by - the study schedule. | Expected values are Y or null. - Document: IG v3.1.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the - timing of a performed test or observation was not driven by - the study schedule. | Expected values are Y or null. - Document: IG v3.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the - timing of a performed test or observation was not driven by - the study schedule. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.5 - - Cited Guidance: Expected values are Y or null. - Document: TIG v1.0 - Item: DSUSCHFL CDISC Notes - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0215 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1 + Section: '4.2.9|6.2.1 ' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND303' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1.1 + Section: '4.2.9|6.2.1 ' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND303' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1 + Section: '4.2.9|6.2.1 ' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND303' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: TIG + References: + - Citations: + - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.5 + - Cited Guidance: Expected values are Y or null. + Document: TIG v1.0 + Item: DSUSCHFL CDISC Notes + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0215 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --USCHFL - operator: non_empty - - name: --USCHFL - operator: not_equal_to - value: Y + - name: --USCHFL + operator: non_empty + - name: --USCHFL + operator: not_equal_to + value: Y Core: Id: CORE-000466 Status: Published @@ -83,11 +82,11 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - EVENTS - - INTERVENTIONS + - FINDINGS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000471/rule.yml b/Published/CORE-000471/rule.yml index 977d2031b..fded2c069 100644 --- a/Published/CORE-000471/rule.yml +++ b/Published/CORE-000471/rule.yml @@ -1,72 +1,72 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should - be null for records that contain collected or derived data.' - Document: IG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should - be null for records that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should - be null for records that contain collected or derived data.' - Document: IG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should - be null for records that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should - be null for records that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data.' + Document: IG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND334' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data.' + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND334' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data.' + Document: IG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND334' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data.' + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND334' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data.' + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND334' + Version: '1' + Version: '5.0' + Version: '1.0' Check: # After discussion with SEND team: implemented as that # - When EGCAT = MEASUREMENT then EGEVAL is null @@ -76,25 +76,25 @@ Check: any: # report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated # Q: shouldn't be "case-sensitive" as it is under controlled terminology (which is uppercase) - - all: - - name: EGCAT - operator: equal_to_case_insensitive - value: 'MEASUREMENT' - - name: EGEVAL - operator: non_empty + - all: + - name: EGCAT + operator: equal_to_case_insensitive + value: 'MEASUREMENT' + - name: EGEVAL + operator: non_empty # report an error when EGORRESU is not null and EGEVAL is populated # the idea is that evaluations do not have a unit - - all: - - name: EGORRESU - operator: non_empty - - name: EGEVAL - operator: non_empty + - all: + - name: EGORRESU + operator: non_empty + - name: EGEVAL + operator: non_empty Core: Id: CORE-000471 Status: Published Version: '1' -Description: 'Report an error when EGCAT=MEASUREMENT (case-insensitive) and - EGEVAL is populated, or when EGORRESU is not null and EGEVAL is populated' +Description: 'Report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated, or when + EGORRESU is not null and EGEVAL is populated' Executability: Partially Executable Outcome: Message: EGEVAL must be null for results that are collected or derived @@ -102,8 +102,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - EG + - EG Sensitivity: Record diff --git a/Published/CORE-000472/rule.yml b/Published/CORE-000472/rule.yml index 3f9744d9d..e4d6e85d7 100644 --- a/Published/CORE-000472/rule.yml +++ b/Published/CORE-000472/rule.yml @@ -1,108 +1,107 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: BGDTC - operator: non_empty - - name: BGTESTCD - operator: is_not_unique_set - value: - - USUBJID - - BGDTC + - name: BGDTC + operator: non_empty + - name: BGTESTCD + operator: is_not_unique_set + value: + - USUBJID + - BGDTC Core: Id: CORE-000472 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Body Weight Gain test, in the BG Domain, for a subject on a - particular date. +Description: Raise an error when there is more than one record present for any particular Body + Weight Gain test, in the BG Domain, for a subject on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where BGDTC is null Outcome: Message: The Body Weight Gain test is not unique for this subject and date/time. Output Variables: - - USUBJID - - BGTESTCD - - BGDTC + - USUBJID + - BGTESTCD + - BGDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000474/rule.yml b/Published/CORE-000474/rule.yml index ddf162186..41b6bb149 100644 --- a/Published/CORE-000474/rule.yml +++ b/Published/CORE-000474/rule.yml @@ -1,104 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: EGTESTCD - operator: is_not_unique_set - value: - - USUBJID - - EGDTC + - name: EGTESTCD + operator: is_not_unique_set + value: + - USUBJID + - EGDTC Core: Id: CORE-000474 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular ECG test for a subject and measurement date/time. +Description: Raise an error when there is more than one record present for any particular ECG test + for a subject and measurement date/time. Executability: Partially Executable - Possible Underreporting Outcome: Message: The ECG test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - EGTESTCD - - EGDTC + - USUBJID + - EGTESTCD + - EGDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - EG + - EG Sensitivity: Record diff --git a/Published/CORE-000475/rule.yml b/Published/CORE-000475/rule.yml index f1b13c466..d93d72ec3 100644 --- a/Published/CORE-000475/rule.yml +++ b/Published/CORE-000475/rule.yml @@ -1,131 +1,124 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.0 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per - subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.0 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: PCDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: PCTESTCD - operator: is_not_unique_set - value: - - USUBJID - - PCSPEC - - PCDTC - - all: - - name: PCDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: PCTESTCD - operator: is_not_unique_set - value: - - POOLID - - PCSPEC - - PCDTC + - all: + - name: PCDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: PCTESTCD + operator: is_not_unique_set + value: + - USUBJID + - PCSPEC + - PCDTC + - all: + - name: PCDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: PCTESTCD + operator: is_not_unique_set + value: + - POOLID + - PCSPEC + - PCDTC Core: Id: CORE-000475 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Pharmacokinetics Concentration, in the PC Domain, for a subject or - pool on a particular date. +Description: Raise an error when there is more than one record present for any particular + Pharmacokinetics Concentration, in the PC Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: - Message: The Pharmacokinetics Concentration test is not unique for this subject - or pool and specimen and date/time. + Message: The Pharmacokinetics Concentration test is not unique for this subject or pool and + specimen and date/time. Output Variables: - - USUBJID - - POOLID - - PCTESTCD - - PCSPEC - - PCDTC + - USUBJID + - POOLID + - PCTESTCD + - PCSPEC + - PCDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000476/rule.yml b/Published/CORE-000476/rule.yml index 8cd8e822d..0d2140097 100644 --- a/Published/CORE-000476/rule.yml +++ b/Published/CORE-000476/rule.yml @@ -1,48 +1,46 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # Remark: not applicable to SENDIG-3.1.1, which excludes PC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually - collected at multiple study days, either --DTC or --DY must be - used. - Document: IG v3.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually - collected at multiple study days, either --DTC or --DY must be - used. - Document: IG v3.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289' - Version: '1' - Version: '5.0' - Version: '1.1' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1 + Section: '4.4' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND289' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1 + Section: '4.4' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND289' + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty Core: Id: CORE-000476 Status: Published Version: '1' -Description: When a domain belongs to the Findings General Observation Class, - and the domain is one in which data are usually collected at multiple study - days, at least --DTC or --DY must be populated. +Description: When a domain belongs to the Findings General Observation Class, and the domain is one + in which data are usually collected at multiple study days, at least --DTC or --DY must be + populated. Executability: Fully Executable Outcome: Message: Neither --DTC nor --DY is populated @@ -50,19 +48,19 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW - - BG - - CL - - FW - - LB - - OM - - PM - - PC - - VS - - EG - - CV - - RE + - BW + - BG + - CL + - FW + - LB + - OM + - PM + - PC + - VS + - EG + - CV + - RE Sensitivity: Record diff --git a/Published/CORE-000477/rule.yml b/Published/CORE-000477/rule.yml index 7748a4c1d..a8010f1d5 100644 --- a/Published/CORE-000477/rule.yml +++ b/Published/CORE-000477/rule.yml @@ -1,62 +1,59 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # Remark: This is the version for SENDIG-3.1.1, which excludes PC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually - collected at multiple study days, either --DTC or --DY must be - used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually - collected at multiple study days, either --DTC or --DY must be - used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually - collected at multiple study days, either --DTC or --DY must be - used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '1.0' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: '4.4' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND289.1' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: '4.4' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND289.1' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: '4.4' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND289.1' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty Core: Id: CORE-000477 Status: Published Version: '1' -Description: When a domain belongs to the Findings General Observation Class, - and the domain is one in which data are usually collected at multiple study - days, at least --DTC or --DY must be populated. +Description: When a domain belongs to the Findings General Observation Class, and the domain is one + in which data are usually collected at multiple study days, at least --DTC or --DY must be + populated. Executability: Fully Executable Outcome: Message: Neither --DTC nor --DY is populated @@ -64,19 +61,19 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW - - BG - - CL - - FW - - LB - - OM - - PM + - BW + - BG + - CL + - FW + - LB + - OM + - PM # REMARK that for SENDIG-3.1.1, PC is not in the list anymore - - VS - - EG - - CV - - RE + - VS + - EG + - CV + - RE Sensitivity: Record diff --git a/Published/CORE-000478/rule.yml b/Published/CORE-000478/rule.yml index 1661765cb..a88c6bcb9 100644 --- a/Published/CORE-000478/rule.yml +++ b/Published/CORE-000478/rule.yml @@ -1,96 +1,90 @@ Authorities: # ATTENTION: Not applicable to SENDIG-3.0 - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically - include the --STINT and --ENINT variables, which specify the - start and end of the period over which the assessment was - evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND294' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND294' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND294' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND294' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND294' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --STINT - operator: non_empty - - name: --ENINT - operator: non_empty - - name: --TPTREF - operator: empty + - name: --STINT + operator: non_empty + - name: --ENINT + operator: non_empty + - name: --TPTREF + operator: empty Core: Id: CORE-000478 Status: Published Version: '1' -Description: Raise an error when --STINT and -ENINT are populated but --TPTREF - is not populated. +Description: Raise an error when --STINT and -ENINT are populated but --TPTREF is not populated. Executability: Fully Executable Outcome: Message: --STINT and --ENINT are populated but --TPTREF is not populated @@ -98,8 +92,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000479/rule.yml b/Published/CORE-000479/rule.yml index 3271ff0ab..e5f885712 100644 --- a/Published/CORE-000479/rule.yml +++ b/Published/CORE-000479/rule.yml @@ -1,101 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.0 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or - "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.0 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SRANDOM - - name: TSVAL - operator: not_equal_to - value: Y - - name: TSVAL - operator: not_equal_to - value: N + - name: TSPARMCD + operator: equal_to + value: SRANDOM + - name: TSVAL + operator: not_equal_to + value: Y + - name: TSVAL + operator: not_equal_to + value: N Core: Id: CORE-000479 Status: Published @@ -108,8 +102,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000480/rule.yml b/Published/CORE-000480/rule.yml index 345fdce43..3633ed919 100644 --- a/Published/CORE-000480/rule.yml +++ b/Published/CORE-000480/rule.yml @@ -1,104 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: VSTESTCD - operator: is_not_unique_set - value: - - USUBJID - - VSDTC + - name: VSTESTCD + operator: is_not_unique_set + value: + - USUBJID + - VSDTC Core: Id: CORE-000480 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Vital Signs test for a subject and measurement date/time. +Description: Raise an error when there is more than one record present for any particular Vital + Signs test for a subject and measurement date/time. Executability: Fully Executable Outcome: Message: The Vital Signs test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - VSTESTCD - - VSDTC + - USUBJID + - VSTESTCD + - VSDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - VS + - VS Sensitivity: Record diff --git a/Published/CORE-000481/rule.yml b/Published/CORE-000481/rule.yml index 47a6f2646..629d5929a 100644 --- a/Published/CORE-000481/rule.yml +++ b/Published/CORE-000481/rule.yml @@ -1,91 +1,91 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. - Used only when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --EXCLFL - operator: not_equal_to - value: Y - - name: --REASEX - operator: non_empty + - name: --EXCLFL + operator: not_equal_to + value: Y + - name: --REASEX + operator: non_empty Core: Id: CORE-000481 Status: Published @@ -98,8 +98,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000482/rule.yml b/Published/CORE-000482/rule.yml index 7fbd51f07..f19e79203 100644 --- a/Published/CORE-000482/rule.yml +++ b/Published/CORE-000482/rule.yml @@ -1,112 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.0 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, - otherwise null. - Document: TIG v1.0 - Item: BWEXCLFL CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0084 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.0 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: TIG v1.0 + Item: BWEXCLFL CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0084 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --EXCLFL - operator: non_empty - - name: --EXCLFL - operator: not_equal_to - value: Y + - name: --EXCLFL + operator: non_empty + - name: --EXCLFL + operator: not_equal_to + value: Y Core: Id: CORE-000482 Status: Published @@ -119,9 +112,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000484/rule.yml b/Published/CORE-000484/rule.yml index 8dd92e7f0..9466ab1b8 100644 --- a/Published/CORE-000484/rule.yml +++ b/Published/CORE-000484/rule.yml @@ -1,89 +1,88 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are - considered "related/associated." - Document: IG v3.4 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are - considered "related/associated." - Document: IG v3.2 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are - considered "related/associated." - Document: IG v3.3 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are - considered "related/associated." - Document: TIG 1.0 - Item: Specification-RELID - Section: 2.8.10.21 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0421 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.4 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.2 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.3 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: TIG 1.0 + Item: Specification-RELID + Section: 2.8.10.21 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0421 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: RELID # Condition: # Rule: Within a subject each unique RELID is present on multiple RELREC records Check: all: - - name: RELID - operator: not_present_on_multiple_rows_within - within: USUBJID + - name: RELID + operator: not_present_on_multiple_rows_within + within: USUBJID Core: Id: CORE-000484 Status: Published Version: '1' -Description: Within a subject, each unique RELID should be present on multiple - RELREC records +Description: Within a subject, each unique RELID should be present on multiple RELREC records Executability: Fully Executable Outcome: Message: Unique RELID is NOT present on multiple RELREC records within a subject. Output Variables: - - RELID + - RELID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000485/rule.yml b/Published/CORE-000485/rule.yml index f0904a96f..59dd20c00 100644 --- a/Published/CORE-000485/rule.yml +++ b/Published/CORE-000485/rule.yml @@ -1,116 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it - start with a number (e.g., "1TEST" is not valid). - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0129 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it start with a + number (e.g., "1TEST" is not valid). + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0129 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: QNAM - operator: longer_than - value: 8 + - name: QNAM + operator: longer_than + value: 8 Core: Id: CORE-000485 Status: Published @@ -120,16 +114,16 @@ Executability: Fully Executable Outcome: Message: The value of QNAM has more than 8 chars Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000486/rule.yml b/Published/CORE-000486/rule.yml index efa542ba8..caeb48142 100644 --- a/Published/CORE-000486/rule.yml +++ b/Published/CORE-000486/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.0 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.0 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: SCTESTCD - operator: is_not_unique_set - value: - - USUBJID + - name: SCTESTCD + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000486 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Subject Characteristics test for a subject. +Description: Raise an error when there is more than one record present for any particular Subject + Characteristics test for a subject. Executability: Fully Executable Outcome: Message: The Subject Characteristics test is not unique for this subject. Output Variables: - - USUBJID - - SCTESTCD + - USUBJID + - SCTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - SC + - SC Sensitivity: Record diff --git a/Published/CORE-000487/rule.yml b/Published/CORE-000487/rule.yml index 95120a3c6..08896cd07 100644 --- a/Published/CORE-000487/rule.yml +++ b/Published/CORE-000487/rule.yml @@ -1,95 +1,89 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first - character, and A-Z, 0 to 9 for the second character and is - always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000487 Status: Published @@ -99,13 +93,13 @@ Executability: Fully Executable Outcome: Message: DOMAIN value must be uppercase Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000490/rule.yml b/Published/CORE-000490/rule.yml index 00fd0006e..a2e100228 100644 --- a/Published/CORE-000490/rule.yml +++ b/Published/CORE-000490/rule.yml @@ -1,144 +1,137 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.0' - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.1' - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.1' - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.2' - - Organization: CDISC - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.0' - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: QNAM serves the same purpose as --TESTCD within supplemental - qualifier datasets, and so values of QNAM are subject to the - same restrictions as values of --TESTCD - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 4 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0157 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When extending a controlled terminology list, the - case-sensitivity convention of that list should be followed. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0157 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '3.1.1' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND23' + Version: '1' + Version: '5.0' + Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: QNAM serves the same purpose as --TESTCD within supplemental qualifier + datasets, and so values of QNAM are subject to the same restrictions as values of --TESTCD + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 4 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0157 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: When extending a controlled terminology list, the case-sensitivity + convention of that list should be followed. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0157 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000490 Status: Published @@ -148,16 +141,16 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: --QNAM value must be uppercase Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000491/rule.yml b/Published/CORE-000491/rule.yml index 38603b3b0..aa21c9688 100644 --- a/Published/CORE-000491/rule.yml +++ b/Published/CORE-000491/rule.yml @@ -1,121 +1,113 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000491 Status: Published Version: '1' -Description: Raise an error when QNAM contains anything else than a letter, - number or underscore +Description: Raise an error when QNAM contains anything else than a letter, number or underscore Executability: Fully Executable Outcome: - Message: QNAM value cannot contain characters other than letters, numbers or - underscores + Message: QNAM value cannot contain characters other than letters, numbers or underscores Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000492/rule.yml b/Published/CORE-000492/rule.yml index 4f292ee65..2f33bd1eb 100644 --- a/Published/CORE-000492/rule.yml +++ b/Published/CORE-000492/rule.yml @@ -1,118 +1,111 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 - characters, and cannot start with a number, nor can they - contain characters other than letters, numbers, or - underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it - start with a number (e.g., "1TEST" is not valid). QNAM cannot - contain characters other than letters, numbers, or - underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0137 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it start with a + number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, + numbers, or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0137 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: QNAM - operator: matches_regex - value: ^[0-9] + - name: QNAM + operator: matches_regex + value: ^[0-9] Core: Id: CORE-000492 Status: Published @@ -122,16 +115,16 @@ Executability: Fully Executable Outcome: Message: QNAM may not start with a number Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000493/rule.yml b/Published/CORE-000493/rule.yml index 35ca7c567..1ef9e0ae1 100644 --- a/Published/CORE-000493/rule.yml +++ b/Published/CORE-000493/rule.yml @@ -1,173 +1,163 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. It should be presented in - number-number format.. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. It should be presented in - number-number format.. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. It should be presented in - number-number format.. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. It should be presented in - number-number format.. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: '1' + Version: '5.0' + Version: '1.1' # FDA Business rule FB5301 is identical, so extending the scope here # FB5301 as of SEND 3.1 - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5301' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: AGETXT - operator: non_empty - - name: AGETXT - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: AGETXT + operator: non_empty + - name: AGETXT + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000493 Status: Published Version: '1' -Description: Age Range (AGETXT) should be populated with a number-number format - when age range is supplied. +Description: Age Range (AGETXT) should be populated with a number-number format when age range is + supplied. Executability: Fully Executable Outcome: Message: AGETXT is not in number - number format. Output Variables: - - USUBJID - - AGETXT + - USUBJID + - AGETXT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000494/rule.yml b/Published/CORE-000494/rule.yml index dc155f95e..cfbea0475 100644 --- a/Published/CORE-000494/rule.yml +++ b/Published/CORE-000494/rule.yml @@ -1,149 +1,137 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.0 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Role of the - variable, which determines how the variable is used in the - dataset. For SEND Domain. Models, Roles are used to represent - the categories of variables such as Identifier, Topic, Timing, - or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.0 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.0" # REMARK: this will ONLY validate the define.xml dataset definitions # for which a dataset is actually being provided Check: all: - - name: define_variable_name - operator: equal_to - value: library_variable_name - - name: define_variable_role - operator: not_equal_to - value: library_variable_role + - name: define_variable_name + operator: equal_to + value: library_variable_name + - name: define_variable_role + operator: not_equal_to + value: library_variable_role Core: Id: CORE-000494 Status: Published Version: "1" -Description: Raise an error when the role provided in the define.xml does not - correspond to the role in the IG +Description: Raise an error when the role provided in the define.xml does not correspond to the role + in the IG Executability: Fully Executable Outcome: - Message: The Role of the variable in the define.xml does not correspond to the - Role given by the Implementation Guide + Message: The Role of the variable in the define.xml does not correspond to the Role given by the + Implementation Guide Output Variables: - - define_variable_label - - define_variable_name - - define_variable_role - - library_variable_name - - library_variable_role + - define_variable_label + - define_variable_name + - define_variable_role + - library_variable_name + - library_variable_role # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000495/rule.yml b/Published/CORE-000495/rule.yml index ab0cae137..9c066c492 100644 --- a/Published/CORE-000495/rule.yml +++ b/Published/CORE-000495/rule.yml @@ -1,127 +1,126 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ma.xpt, Macroscopic Findings - Findings. One record per finding - per specimen per subject, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.15 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0104 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: ma.xpt, Macroscopic Findings - Findings. One record per finding per specimen + per subject, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.15 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0104 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: MAORRES - operator: non_empty - - name: MASPEC - operator: non_empty - - name: MAORRES - operator: is_not_unique_set - value: - - USUBJID - - MATESTCD - - MASPEC + - name: MAORRES + operator: non_empty + - name: MASPEC + operator: non_empty + - name: MAORRES + operator: is_not_unique_set + value: + - USUBJID + - MATESTCD + - MASPEC Core: Id: CORE-000495 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Macroscopic Finding test and result in the MA Domain, within a - subject. +Description: Raise an error when there is more than one record present for any particular + Macroscopic Finding test and result in the MA Domain, within a subject. Executability: Fully Executable Outcome: Message: The Macroscopic Finding test result is not unique for this subject and test. Output Variables: - - USUBJID - - MATESTCD - - MAORRES - - MASPEC + - USUBJID + - MATESTCD + - MAORRES + - MASPEC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000496/rule.yml b/Published/CORE-000496/rule.yml index 8daea794d..1259aab61 100644 --- a/Published/CORE-000496/rule.yml +++ b/Published/CORE-000496/rule.yml @@ -1,134 +1,134 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.0' - Item: 'Domain table header' - Section: '6.3.5' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.0' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.1' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.1.1' - Item: 'Domain table header' - Section: '6.3.5' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.1.1' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.1' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.1.1' - Item: 'Domain table header' - Section: '6.3.5' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.1.1' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per - interval per subject or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject + or pool' + Document: 'IG v.3.1' + Item: 'Domain table header' + Section: '6.3.5' # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: fw.xpt, Food and Water Consumption - Findings. One record per - test per interval per subject or pool, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.12 + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND168' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: fw.xpt, Food and Water Consumption - Findings. One record per test per + interval per subject or pool, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.12 # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0097 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0097 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - all: + - all: # we must first test on USUBJID being populated - - name: USUBJID - operator: non_empty - - name: FWTESTCD - operator: 'is_not_unique_set' - value: - - USUBJID - - FWDTC - - FWENDTC - - all: + - name: USUBJID + operator: non_empty + - name: FWTESTCD + operator: 'is_not_unique_set' + value: + - USUBJID + - FWDTC + - FWENDTC + - all: # we must first test on POOLID being populated - - name: POOLID - operator: non_empty - - name: FWTESTCD - operator: 'is_not_unique_set' - value: - - POOLID - - FWDTC - - FWENDTC + - name: POOLID + operator: non_empty + - name: FWTESTCD + operator: 'is_not_unique_set' + value: + - POOLID + - FWDTC + - FWENDTC Core: Id: CORE-000496 Status: Published @@ -136,15 +136,15 @@ Core: Description: '' Executability: Fully Executable Outcome: - Message: 'Structure must be one record per test per interval (as defined by - FWDTC and FWENDTC) per subject or pool' + Message: 'Structure must be one record per test per interval (as defined by FWDTC and FWENDTC) per subject + or pool' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - FW + - FW Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000498/rule.yml b/Published/CORE-000498/rule.yml index f735d2b9e..679929cb5 100644 --- a/Published/CORE-000498/rule.yml +++ b/Published/CORE-000498/rule.yml @@ -1,126 +1,125 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both - BRTHDTC and AGE should not be populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: AGETXT + - name: AGETXT + operator: non_empty + - any: + - name: BRTHDTC + operator: non_empty + - name: AGE operator: non_empty - - any: - - name: BRTHDTC - operator: non_empty - - name: AGE - operator: non_empty Core: Id: CORE-000498 Status: Published Version: '1' -Description: AGETXT is used to present the age range in situations where the - exact birthdate is not known. If AGETXT is included both BRTHDTC and AGE - should not be populated. +Description: AGETXT is used to present the age range in situations where the exact birthdate is not + known. If AGETXT is included both BRTHDTC and AGE should not be populated. Executability: Fully Executable Outcome: Message: AGETXT is populated, so neither BRTHDTC nor AGE may be populated Output Variables: - - USUBJID - - AGETXT - - BRTHDTC - - AGE + - USUBJID + - AGETXT + - BRTHDTC + - AGE Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000499/rule.yml b/Published/CORE-000499/rule.yml index 13e23588d..068cbc791 100644 --- a/Published/CORE-000499/rule.yml +++ b/Published/CORE-000499/rule.yml @@ -1,114 +1,114 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.0 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per - specimen per subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.0 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.0" # IMPORTANT REMARK: after discussion with the SEND team, it was decided to NOT include other variables # like OMLAT, OMDIR, OMDTC, as these relate to very unusual situations. Check: all: - - name: OMSPEC - operator: non_empty - - name: OMSPEC - operator: is_not_unique_set - value: - - USUBJID - - OMTESTCD + - name: OMSPEC + operator: non_empty + - name: OMSPEC + operator: is_not_unique_set + value: + - USUBJID + - OMTESTCD Core: Id: CORE-000499 Status: Published Version: "1" -Description: Raise an error when there is more than one record present per - subject for any particular Organ Measurement test in the OM Domain +Description: Raise an error when there is more than one record present per subject for any + particular Organ Measurement test in the OM Domain Executability: Fully Executable Outcome: Message: The Organ Measurement test is not unique for this subject. Output Variables: - - USUBJID - - OMTESTCD - - OMSPEC + - USUBJID + - OMTESTCD + - OMSPEC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Published/CORE-000500/rule.yml b/Published/CORE-000500/rule.yml index 4eb9f2166..d885e725b 100644 --- a/Published/CORE-000500/rule.yml +++ b/Published/CORE-000500/rule.yml @@ -1,82 +1,77 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter - per Trial Set - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter - per Trial Set - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter - per Trial Set - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter - per Trial Set - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: TIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter - per Trial Set. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0158 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: TIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0158 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: TXPARMCD - operator: is_not_unique_set - value: SETCD + - name: TXPARMCD + operator: is_not_unique_set + value: SETCD Core: Id: CORE-000500 Status: Published @@ -89,9 +84,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000502/rule.yml b/Published/CORE-000502/rule.yml index ce549ea4c..8f61fd7a2 100644 --- a/Published/CORE-000502/rule.yml +++ b/Published/CORE-000502/rule.yml @@ -2,112 +2,107 @@ # Condition: RDOMAIN ^= null # Rule: RDOMAIN is dataset in study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include 1 standardized set of observations in a - specific structure; this is the Demographics domain described - here. - Document: Model v2.0 - Item: RDOMAIN - Section: Comments - - Cited Guidance: Each study must include 1 standardized set of observations in a - specific structure; this is the Demographics domain described - here. - Document: Model v2.0 - Item: RDOMAIN - Section: Supplemental Qualifiers - - Cited Guidance: Each study must incude 1 standardized set of observations in a - specific structure; this is the Demographics domain described - here. - Document: Model v2.0 - Item: RDOMAIN - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Domain Abbreviation of the parent record(s). - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Domain Abbreviation of the parent record(s). - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Comments[Each study must include 1 standardized set of - observations in a specific structure; this is the Demographics - domain described here.]|Supplemental Qualifiers[Each study - must include 1 standardized set of observations in a specific - structure; this is the Demographics domain described - here.]|Related Records[Each study must include 1 standardized - set of observations in a specific structure; this is the - Demographics domain described here.] - Document: SDTM v2.1 - Item: RDOMAIN - Section: 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1 - Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0533 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Comments + - Cited Guidance: Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Supplemental Qualifiers + - Cited Guidance: Each study must incude 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Domain Abbreviation of the parent record(s). + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Domain Abbreviation of the parent record(s). + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Comments[Each study must include 1 standardized set of observations in a + specific structure; this is the Demographics domain described here.]|Supplemental + Qualifiers[Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here.]|Related Records[Each study + must include 1 standardized set of observations in a specific structure; this is the + Demographics domain described here.] + Document: SDTM v2.1 + Item: RDOMAIN + Section: 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1 Related Records + Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0533 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: non_empty - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: non_empty + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000502 Status: Published Version: '1' -Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN - doesn't exist as a dataset in the present study +Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a + dataset in the present study Executability: Fully Executable Operations: - - id: $study_domains - operator: study_domains +- id: $study_domains + operator: study_domains Outcome: Message: RDOMAIN does not represent a dataset present in the study. Output Variables: - - RDOMAIN - - $study_domains + - RDOMAIN + - $study_domains Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - CO - - RELREC - - SUPP-- + - CO + - RELREC + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000503/rule.yml b/Published/CORE-000503/rule.yml index ed63ec3d6..cd922a879 100644 --- a/Published/CORE-000503/rule.yml +++ b/Published/CORE-000503/rule.yml @@ -1,123 +1,123 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.0 - Item: QORIG CDISC Notes - Section: "8.5" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible - values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: TIG v1.0 - Item: QORIG CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0173 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.0 + Item: QORIG CDISC Notes + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: TIG v1.0 + Item: QORIG CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0173 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QORIG - operator: exists - - name: QORIG - operator: non_empty - - name: QORIG - operator: not_equal_to - value: COLLECTED - - name: QORIG - operator: not_equal_to - value: DERIVED - - name: QORIG - operator: not_equal_to - value: OTHER - - name: QORIG - operator: not_equal_to - value: NOT AVAILABLE + - name: QORIG + operator: exists + - name: QORIG + operator: non_empty + - name: QORIG + operator: not_equal_to + value: COLLECTED + - name: QORIG + operator: not_equal_to + value: DERIVED + - name: QORIG + operator: not_equal_to + value: OTHER + - name: QORIG + operator: not_equal_to + value: NOT AVAILABLE # Simplification 2024-05-21 # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation # see e.g. CG0118 @@ -132,19 +132,19 @@ Core: Id: CORE-000503 Status: Published Version: "1" -Description: QORIG is used to indicate the origin of the data. Possible values - are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. +Description: QORIG is used to indicate the origin of the data. Possible values are COLLECTED, + DERIVED, OTHER, and NOT AVAILABLE. Executability: Fully Executable Outcome: - Message: When populated, the possible values for QORIG are limited to COLLECTED, - DERIVED, OTHER, and NOT AVAILABLE. + Message: When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER, + and NOT AVAILABLE. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000505/rule.yml b/Published/CORE-000505/rule.yml index eab8f734d..8a585c89b 100644 --- a/Published/CORE-000505/rule.yml +++ b/Published/CORE-000505/rule.yml @@ -2,206 +2,194 @@ # Condition: TSPARMCD = SSTDTC (Study Start Date) # Rule: TSVAL conforms to ISO 8601 date Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in - Table 1. TSVAL may have controlled terminology depending on - the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0285 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included Appendix - C1, Trial Summary Codes. TSVAL may have controlled terminology - depending on the value of TSPARMCD. Conditions for including - parameters are included in Appendix C1, Trial Summary Codes. - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0285 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0285 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included Appendix C1, Trial + Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. + Conditions for including parameters are included in Appendix C1, Trial Summary Codes. + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0285 + Version: '1' + Version: '2.0' + Version: '3.3' ##CGO285 is similar to TRC1734c. Added FDA Business rule. - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TSPARMCD - operator: equal_to - value: SSTDTC - - name: TSVAL - operator: invalid_date + - name: TSPARMCD + operator: equal_to + value: SSTDTC + - name: TSVAL + operator: invalid_date Core: Id: CORE-000505 Status: Published Version: '1' -Description: Study Start Date (SSTDTC) value in the TS dataset should be - populated in ISO 8601 format. +Description: Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601 + format. Executability: Fully Executable Outcome: Message: TSVAL where TSPARMCD = SSTDTC is not in ISO 8601 format. @@ -209,8 +197,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000507/rule.yml b/Published/CORE-000507/rule.yml index 5af21784c..3e7c85b22 100644 --- a/Published/CORE-000507/rule.yml +++ b/Published/CORE-000507/rule.yml @@ -1,111 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.0 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.0 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # IMPORTANT: Order is important ... - - name: variable_label - operator: not_equal_to - value: define_variable_label + - name: variable_label + operator: not_equal_to + value: define_variable_label Core: Id: CORE-000507 Status: Published Version: '1' -Description: 'Raise an error when the variable label in the define.xml does not - correspond to the variable label dataset. NOTE: This rule has been split in - two parts: A. check define variable label against IG label B. check define - variable label against the label in the dataset ' +Description: 'Raise an error when the variable label in the define.xml does not correspond to the variable + label dataset. NOTE: This rule has been split in two parts: A. check define variable label against IG + label B. check define variable label against the label in the dataset ' Executability: Fully Executable Outcome: Message: The label of the variable is incorrect Output Variables: - - define_variable_name - - define_variable_label - - variable_label + - define_variable_name + - define_variable_label + - variable_label Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000508/rule.yml b/Published/CORE-000508/rule.yml index 04840cfb5..4e0b10e83 100644 --- a/Published/CORE-000508/rule.yml +++ b/Published/CORE-000508/rule.yml @@ -1,116 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.0 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND191' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: PMDTC - operator: non_empty - - name: PMDTC - operator: is_not_unique_set - value: - - USUBJID - - PMTESTCD - - PMORRES + - name: PMDTC + operator: non_empty + - name: PMDTC + operator: is_not_unique_set + value: + - USUBJID + - PMTESTCD + - PMORRES Core: Id: CORE-000508 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Palpable Mass test per Palpable Mass test in the PM Domain, for a - subject on a particular date. +Description: Raise an error when there is more than one record present for any particular Palpable + Mass test per Palpable Mass test in the PM Domain, for a subject on a particular date. Executability: Fully Executable Outcome: - Message: The palpable mass test and result is not unique for this subject and - date/time. + Message: The palpable mass test and result is not unique for this subject and date/time. Output Variables: - - USUBJID - - PMTESTCD - - PMORRES - - PMDTC + - USUBJID + - PMTESTCD + - PMORRES + - PMDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PM + - PM Sensitivity: Record diff --git a/Published/CORE-000509/rule.yml b/Published/CORE-000509/rule.yml index caef2f70f..0e95de5ff 100644 --- a/Published/CORE-000509/rule.yml +++ b/Published/CORE-000509/rule.yml @@ -1,133 +1,133 @@ # Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.0 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.0 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: + - all: # count # record for which TSPARMCD=AGETXT and for which TXPARMCD=AGE # throw error when both counts >= 1 - - name: $record_count_AGETXT - operator: greater_than_or_equal_to - value: 1 - - name: $record_count_AGE - operator: greater_than_or_equal_to - value: 1 + - name: $record_count_AGETXT + operator: greater_than_or_equal_to + value: 1 + - name: $record_count_AGE + operator: greater_than_or_equal_to + value: 1 # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present # Both counts are 0 - - all: - - name: $record_count_AGETXT - operator: equal_to - value: 0 - - name: $record_count_AGE - operator: equal_to - value: 0 + - all: + - name: $record_count_AGETXT + operator: equal_to + value: 0 + - name: $record_count_AGE + operator: equal_to + value: 0 Core: Id: CORE-000509 Status: Published Version: '1' -Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should - be present, but not both. +Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not + both. Executability: Fully Executable Operations: # Record count for TSPARMCD=AGE (for reporting reasons) - - filter: - TSPARMCD: AGE - id: $record_count_AGE - operator: record_count +- filter: + TSPARMCD: AGE + id: $record_count_AGE + operator: record_count # Record count for TSPARMCD=AGETXT - - filter: - TSPARMCD: AGETXT - id: $record_count_AGETXT - operator: record_count +- filter: + TSPARMCD: AGETXT + id: $record_count_AGETXT + operator: record_count Outcome: - Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be - present, but not both. + Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not + both. Output Variables: #- TSPARMCD #- TSVAL - - $record_count_AGE - - $record_count_AGETXT + - $record_count_AGE + - $record_count_AGETXT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS # IMPORTANT: Sensitivity=Dataset Sensitivity: Dataset diff --git a/Published/CORE-000511/rule.yml b/Published/CORE-000511/rule.yml index a8b757c24..f5abd94f7 100644 --- a/Published/CORE-000511/rule.yml +++ b/Published/CORE-000511/rule.yml @@ -1,100 +1,95 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # ATTENTION: Rules 189 and 189.1 have been combined as only the "cited guidance" differs. - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight will be recorded in the BW domain and this - is indicated by the test code (BWTESTCD) of TERMBW. - Document: IG v3.0 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM - domain. - Document: IG v3.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM - domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM - domain. - Document: IG v3.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM - domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM - domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Terminal Body Weight will be recorded in the BW domain and this is indicated + by the test code (BWTESTCD) of TERMBW. + Document: IG v3.0 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # implemented as that --TESTCD=TERMBW may only appear for DOMAIN=BWn(in Findings) - - name: DOMAIN - operator: not_equal_to - value: BW - - name: --TESTCD - operator: equal_to - value: TERMBW + - name: DOMAIN + operator: not_equal_to + value: BW + - name: --TESTCD + operator: equal_to + value: TERMBW Core: Id: CORE-000511 @@ -106,15 +101,15 @@ Executability: Fully Executable Outcome: Message: --TESTCD=TERMBW may only be used in the BW domain Output Variables: - - DOMAIN - - --TESTCD + - DOMAIN + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000513/rule.yml b/Published/CORE-000513/rule.yml index f8d20a817..24947f7ab 100644 --- a/Published/CORE-000513/rule.yml +++ b/Published/CORE-000513/rule.yml @@ -1,27 +1,27 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: BGENDTC must be populated when BGTESTCD is representing Average - Body Weight Gain (BWGAINA) - Document: IG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND152.1 - Version: '1' - Version: '5.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: BGENDTC must be populated when BGTESTCD is representing Average Body Weight + Gain (BWGAINA) + Document: IG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND152.1 + Version: '1' + Version: '5.0' + Version: '3.0' # REMARK: this rule is only applicable to SENDIG-3.0, not to later versions Check: all: - - name: BGTESTCD - operator: equal_to - value: BWGAINA - - name: BGENDTC - operator: empty + - name: BGTESTCD + operator: equal_to + value: BWGAINA + - name: BGENDTC + operator: empty Core: Id: CORE-000513 Status: Published @@ -31,13 +31,13 @@ Executability: Fully Executable Outcome: Message: BGENDTC is empty for BGTESTCD=BWGAINA Output Variables: - - BGTESTCD + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000514/rule.yml b/Published/CORE-000514/rule.yml index 654b275dd..fa5ad0dd1 100644 --- a/Published/CORE-000514/rule.yml +++ b/Published/CORE-000514/rule.yml @@ -1,27 +1,27 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Date/time of the end of the weight interval in ISO 8601 - format. This must be populated when BGTESTCD is BWGAINA. - Document: IG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND151.1 - Version: '1' - Version: '5.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Date/time of the end of the weight interval in ISO 8601 format. This must + be populated when BGTESTCD is BWGAINA. + Document: IG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND151.1 + Version: '1' + Version: '5.0' + Version: '3.0' # REMARK: this rule is only applicable to SENDIG-3.0, not to later versions Check: all: - - name: BGTESTCD - operator: equal_to - value: BWGAINA - - name: BGDTC - operator: empty + - name: BGTESTCD + operator: equal_to + value: BWGAINA + - name: BGDTC + operator: empty Core: Id: CORE-000514 Status: Published @@ -31,13 +31,13 @@ Executability: Fully Executable Outcome: Message: BGDTC is empty for BGTESTCD=BWGAINA Output Variables: - - BGTESTCD + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000516/rule.yml b/Published/CORE-000516/rule.yml index 8f9304467..89a5a4f48 100644 --- a/Published/CORE-000516/rule.yml +++ b/Published/CORE-000516/rule.yml @@ -1,162 +1,153 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure - treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: '1' + Version: '1.5' + Version: '1.0' Check: any: - - name: --STDY - operator: less_than - value: 0 - - name: --ENDY - operator: less_than - value: 0 + - name: --STDY + operator: less_than + value: 0 + - name: --ENDY + operator: less_than + value: 0 Core: Id: CORE-000516 Status: Published Version: '1' -Description: 'Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should not be negative for exposure treatments.' +Description: 'Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should + not be negative for exposure treatments.' Executability: Fully Executable Outcome: Message: Negative value of Study Day variable. Output Variables: - - --STDY - - --ENDY + - --STDY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Published/CORE-000517/rule.yml b/Published/CORE-000517/rule.yml index 1e82c3b0e..5dd91d4b5 100644 --- a/Published/CORE-000517/rule.yml +++ b/Published/CORE-000517/rule.yml @@ -1,153 +1,153 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DOSTOT - operator: non_empty - - name: --DOSTOT - operator: less_than - value: 0 + - name: --DOSTOT + operator: non_empty + - name: --DOSTOT + operator: less_than + value: 0 Core: Id: 'CORE-000517' Status: Published @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000518/rule.yml b/Published/CORE-000518/rule.yml index 143ebf85c..0eda83345 100644 --- a/Published/CORE-000518/rule.yml +++ b/Published/CORE-000518/rule.yml @@ -1,153 +1,153 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --VAMT - operator: non_empty - - name: --VAMT - operator: less_than - value: 0 + - name: --VAMT + operator: non_empty + - name: --VAMT + operator: less_than + value: 0 Core: Id: CORE-000518 Status: Published @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000519/rule.yml b/Published/CORE-000519/rule.yml index 23a68fda9..269e0d874 100644 --- a/Published/CORE-000519/rule.yml +++ b/Published/CORE-000519/rule.yml @@ -1,106 +1,106 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z].* + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z].* Core: Id: CORE-000519 Status: Published Version: '1' -Description: Raise an error when the value of DOMAIN has a character other than - A-Z as the first character +Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first + character Executability: Fully Executable Outcome: Message: First character of DOMAIN value must be in the range A-Z Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000520/rule.yml b/Published/CORE-000520/rule.yml index ff5b3633c..ebace34b7 100644 --- a/Published/CORE-000520/rule.yml +++ b/Published/CORE-000520/rule.yml @@ -1,104 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Describes why BWSTAT is NOT DONE. - Document: TIG v1.0 - Item: BWREASND CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0082 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Describes why BWSTAT is NOT DONE. + Document: TIG v1.0 + Item: BWREASND CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0082 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --STAT - operator: empty - - name: --REASND - operator: non_empty + - name: --STAT + operator: empty + - name: --REASND + operator: non_empty Core: Id: CORE-000520 Status: Published @@ -111,9 +111,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000521/rule.yml b/Published/CORE-000521/rule.yml index c92391404..786248da3 100644 --- a/Published/CORE-000521/rule.yml +++ b/Published/CORE-000521/rule.yml @@ -1,113 +1,106 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or - changes from baseline. Value should be Y or null. The baseline - flag is sponsor-defined. - Document: TIG v1.0 - Item: BWBLFL CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0083 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: TIG v1.0 + Item: BWBLFL CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0083 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --BLFL - operator: non_empty - - name: --BLFL - operator: not_equal_to - value: Y + - name: --BLFL + operator: non_empty + - name: --BLFL + operator: not_equal_to + value: Y Core: Id: CORE-000521 Status: Published @@ -120,9 +113,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000523/rule.yml b/Published/CORE-000523/rule.yml index 8577eb316..ff321fea4 100644 --- a/Published/CORE-000523/rule.yml +++ b/Published/CORE-000523/rule.yml @@ -1,107 +1,107 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable - is limited to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z][A-Z0-9].* + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z][A-Z0-9].* Core: Id: CORE-000523 Status: Published Version: '1' -Description: Raise an error when the value of DOMAIN has a character other than - A-Z as the first character or a character A-Z, 0-9 for the second character +Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first + character or a character A-Z, 0-9 for the second character Executability: Fully Executable Outcome: - Message: First two characters of DOMAIN value must be in the range A-Z for the - first, and A-Z,0-9 for the second + Message: First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9 + for the second Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000524/rule.yml b/Published/CORE-000524/rule.yml index 35de9a8ca..751b93c39 100644 --- a/Published/CORE-000524/rule.yml +++ b/Published/CORE-000524/rule.yml @@ -1,111 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.0 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, - USUBJID will be null and if a USUBJID is recorded, the POOLID - will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0068 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.0 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0068 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: POOLID - operator: non_empty - - name: USUBJID - operator: non_empty + - name: POOLID + operator: non_empty + - name: USUBJID + operator: non_empty Core: Id: CORE-000524 Status: Published @@ -115,16 +109,16 @@ Executability: Fully Executable Outcome: Message: When POOLID is populated, USUBJID may not be populated Output Variables: - - USUBJID - - POOLID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000526/rule.yml b/Published/CORE-000526/rule.yml index 0cdef4cea..8fb6da449 100644 --- a/Published/CORE-000526/rule.yml +++ b/Published/CORE-000526/rule.yml @@ -1,133 +1,126 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject or pool, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject or pool, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject or pool, Tabulation. - Document: IG v3.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject or pool, Tabulation. - Document: IG v3.1.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per - pharmacokinetic parameter per time-concentration profile per - specimen per subject or pool, Tabulation. - Document: IG v3.1.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195 + Version: '2' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: '2' + Version: '5.0' + Version: '1.0' Check: # "time-concentration profile" is defined the combination of PPCAT and PPTPTREF # "pharmacokinetic parameter" is defined by PPTESTCD # but we also need PPSPEC any: # Implementation with USUBJID - - name: PPTESTCD - operator: is_not_unique_set - value: - - USUBJID - - PPCAT - - PPSPEC - - PPTPTREF + - name: PPTESTCD + operator: is_not_unique_set + value: + - USUBJID + - PPCAT + - PPSPEC + - PPTPTREF # Implementation with POOLID - - name: PPTESTCD - operator: is_not_unique_set - value: - - POOLID - - PPCAT - - PPSPEC - - PPTPTREF + - name: PPTESTCD + operator: is_not_unique_set + value: + - POOLID + - PPCAT + - PPSPEC + - PPTPTREF Core: Id: CORE-000526 Status: Published Version: '1' -Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and - PPTPTREF must be unique. +Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be + unique. Executability: Fully Executable Outcome: - Message: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and - PPTPTREF is not unique + Message: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF is not unique Output Variables: - - POOLID - - PPTESTCD - - PPCAT - - PPSPEC - - PPTPTREF + - POOLID + - PPTESTCD + - PPCAT + - PPSPEC + - PPTPTREF Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000527/rule.yml b/Published/CORE-000527/rule.yml index 270b8cee9..a52cee6a7 100644 --- a/Published/CORE-000527/rule.yml +++ b/Published/CORE-000527/rule.yml @@ -2,119 +2,105 @@ # Condition: Not last record # Rule: SEENDTC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element. ' - Document: IG v3.4 - Item: Assumption 8 - Section: '5.3' - - Cited Guidance: '"Note that SESTDTC is required, although --STDTC is not - required in any other subject-level dataset. The purpose of - the dataset is to record the Elements a subject actually - passed through. We assume that if it is known that a subject - passed through a particular Element, then there must be some - information on when it started, even if that information is - imprecise. Thus, SESTDTC may not be null, although some - records may not have all the components (e.g., year, month, - day, hour, minute) of the date/time value collected."' - Document: IG v3.4 - Item: Assumption 9 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 10[Since there are, by definition, no gaps between - Elements, the value of SEENDTC for one Element will always be - the same as the value of SESTDTC for the next - Element.]|Assumption 11[Note that SESTDTC is required, - although --STDTC is not required in any other subject-level - dataset. The purpose of the dataset is to record the Elements - a subject actually passed through. We assume that if it is - known that a subject passed through a particular Element, then - there must be some information on when it started, even if - that information is imprecise. Thus, SESTDTC may not be null, - although some records may not have all the components (e.g., - year, month, day, hour, minute) of the date/time value - collected.] - Document: IG v3.2 - Item: Assumption 10|Assumption 11 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 8[Since there are, by definition, no gaps between - Elements, the value of SEENDTC for one Element will always be - the same as the value of SESTDTC for the next - Element.]|Assumption 9[Note that SESTDTC is required, although - --STDTC is not required in any other subject-level dataset. - The purpose of the dataset is to record the Elements a subject - actually passed through. We assume that if it is known that a - subject passed through a particular Element, then there must - be some information on when it started, even if that - information is imprecise. Thus, SESTDTC may not be null, - although some records may not have all the components (e.g., - year, month, day, hour, minute) of the date/time value - collected.] - Document: IG v3.3 - Item: Assumption 8|Assumption 9 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as - the value of SESTDTC for the next Element. - Document: TIG 1.0 - Item: Assumption 7 - Section: 2.8.10.24 - - Cited Guidance: Note that SESTDTC is required, although --STDTC is not required - in any other subject-level dataset. The purpose of the dataset - is to record the Elements a subject actually passed through. - We assume that if it is known that a subject passed through a - particular Element, then there must be some information on - when it started, even if that information is imprecise. Thus, - SESTDTC may not be null, although some records may not have - all the components (e.g., year, month, day, hour, minute) of - the date/time value collected. - Document: TIG 1.0 - Item: Assumption 8 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0428 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Since there are, by definition, no gaps between Elements, the value of SEENDTC + for one Element will always be the same as the value of SESTDTC for the next Element. ' + Document: IG v3.4 + Item: Assumption 8 + Section: '5.3' + - Cited Guidance: '"Note that SESTDTC is required, although --STDTC is not required in any other + subject-level dataset. The purpose of the dataset is to record the Elements a subject actually + passed through. We assume that if it is known that a subject passed through a particular Element, + then there must be some information on when it started, even if that information is imprecise. + Thus, SESTDTC may not be null, although some records may not have all the components (e.g., + year, month, day, hour, minute) of the date/time value collected."' + Document: IG v3.4 + Item: Assumption 9 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 10[Since there are, by definition, no gaps between Elements, the + value of SEENDTC for one Element will always be the same as the value of SESTDTC for the + next Element.]|Assumption 11[Note that SESTDTC is required, although --STDTC is not + required in any other subject-level dataset. The purpose of the dataset is to record the + Elements a subject actually passed through. We assume that if it is known that a subject + passed through a particular Element, then there must be some information on when it + started, even if that information is imprecise. Thus, SESTDTC may not be null, although + some records may not have all the components (e.g., year, month, day, hour, minute) of the + date/time value collected.] + Document: IG v3.2 + Item: Assumption 10|Assumption 11 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Assumption 8[Since there are, by definition, no gaps between Elements, the + value of SEENDTC for one Element will always be the same as the value of SESTDTC for the + next Element.]|Assumption 9[Note that SESTDTC is required, although --STDTC is not + required in any other subject-level dataset. The purpose of the dataset is to record the + Elements a subject actually passed through. We assume that if it is known that a subject + passed through a particular Element, then there must be some information on when it + started, even if that information is imprecise. Thus, SESTDTC may not be null, although + some records may not have all the components (e.g., year, month, day, hour, minute) of the + date/time value collected.] + Document: IG v3.3 + Item: Assumption 8|Assumption 9 + Section: '5.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. + Document: TIG 1.0 + Item: Assumption 7 + Section: 2.8.10.24 + - Cited Guidance: Note that SESTDTC is required, although --STDTC is not required in any other + subject-level dataset. The purpose of the dataset is to record the Elements a subject + actually passed through. We assume that if it is known that a subject passed through a + particular Element, then there must be some information on when it started, even if that + information is imprecise. Thus, SESTDTC may not be null, although some records may not + have all the components (e.g., year, month, day, hour, minute) of the date/time value + collected. + Document: TIG 1.0 + Item: Assumption 8 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0428 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SEENDTC - operator: empty_within_except_last_row - ordering: SESTDTC - value: USUBJID + - name: SEENDTC + operator: empty_within_except_last_row + ordering: SESTDTC + value: USUBJID Core: Id: CORE-000527 Status: Published @@ -124,15 +110,15 @@ Executability: Fully Executable Outcome: Message: SEENDTC is null when element is not the last. Output Variables: - - SESTDTC - - SEENDTC + - SESTDTC + - SEENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000529/rule.yml b/Published/CORE-000529/rule.yml index b261d50dc..1310391b9 100644 --- a/Published/CORE-000529/rule.yml +++ b/Published/CORE-000529/rule.yml @@ -1,476 +1,448 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Study Day value is incremented by 1 for each date following - RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the - date preceding RFSTDTC designated as Study Day -1 (there is no - Study Day 0)....All Study Day values are integers. Thus to - calculate Study Day, --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains. - Document: SDTMIG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for - each date following RFSTDTC. Dates prior to RFSTDTC are - decreased by 1, with the date preceding RFSTDTC designated as - Study Day -1 (there is no Study Day 0). . . . All Study Day - values are integers.]IG v3.2[4.1.4.4][Thus, to calculate Study - Day: --DY = (date portion of --DTC) - (date portion of - RFSTDTC) + 1 if --DTC is on or after RFSTDTC --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC This algorithm should be used across all - domains.]' - Document: IG v3.2 - Section: 4.1.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.3[4.4.4][The Study Day value is incremented by 1 for each - date following RFSTDTC. Dates prior to RFSTDTC are decreased - by 1, with the date preceding RFSTDTC designated as Study Day - -1 (there is no Study Day 0). . . . All Study Day values are - integers.]''IG v3.3[4.4.4][ Thus, to calculate Study - Day: --DY = (date portion of --DTC) - (date portion of - RFSTDTC) + 1 if --DTC is on or after RFSTDTC --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC This algorithm should be used across all - domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: All relative day values will be integers and there will be no - study day 0. The reference start date is considered day 1 and - the study day value is increased by 1 for each date following - the reference start date and decreased by 1 for each date - prior to the reference start date, e.g.; --DY = (date portion - of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or - after RFSTDTC --DY = (date portion of --DTC) - (date portion - of RFSTDTC) if --DTC precedes RFSTDTC - Document: TIG v1.0 - Item: Table 1 Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0291 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.0 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day - --DY = (date portion of --DTC) minus (date portion of RFSTDTC) - + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study - Day: --DY = (date portion of --DTC) - (date portion of - RFSTDTC) + 1 if --DTC is on or after RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0274 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.0 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if - --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study - Day: --DY = (date portion of --DTC) - (date portion of - RFSTDTC) if --DTC precedes RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0275 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Study Day value is incremented by 1 for each date following RFSTDTC. + Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated as + Study Day -1 (there is no Study Day 0)....All Study Day values are integers. Thus to + calculate Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if + --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC. This algorithm should be used across all domains. + Document: SDTMIG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for each date following + RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated + as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]IG v3.2[4.1.4.4][Thus, + to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC + is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes + RFSTDTC This algorithm should be used across all domains.]' + Document: IG v3.2 + Section: 4.1.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'IG v3.3[4.4.4][The Study Day value is incremented by 1 for each date following + RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated + as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]''IG v3.3[4.4.4][ + Thus, to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + + 1 if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC This algorithm should be used across all domains.]' + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: All relative day values will be integers and there will be no study day 0. + The reference start date is considered day 1 and the study day value is increased by 1 for + each date following the reference start date and decreased by 1 for each date prior to the + reference start date, e.g.; --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 + if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC + Document: TIG v1.0 + Item: Table 1 Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0291 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.0 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0274 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.0 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: '2' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0275 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY # checking failure criteria - operator: not_equal_to - value: $val_dy # this is created in the operations statement that follows + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY # checking failure criteria + operator: not_equal_to + value: $val_dy # this is created in the operations statement that follows Core: Id: CORE-000529 Status: Published Version: '1' -Description: Raise an error when --DY is not calculated as per the study day - algorithm as a non-zero integer value when the date portion of --DTC is - complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not - empty +Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero + integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a + complete date AND --DY is not empty Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - id: $val_dy # ex in devops 2538 used -- but that threw an error - name: --DTC - operator: dy # does dy op take into acct +1? +- id: $val_dy # ex in devops 2538 used -- but that threw an error + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: - Message: --DY is not correctly calculated even though the date portion of --DTC - is complete, the date portion of RFSTDTC is complete, and --DY is not empty. + Message: --DY is not correctly calculated even though the date portion of --DTC is complete, the + date portion of RFSTDTC is complete, and --DY is not empty. Output Variables: - - $val_dy - - --DY - - --DTC - - RFSTDTC + - $val_dy + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000534/rule.yml b/Published/CORE-000534/rule.yml index f3b52bcec..36a7c4314 100644 --- a/Published/CORE-000534/rule.yml +++ b/Published/CORE-000534/rule.yml @@ -1,153 +1,153 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.4 - Item: Assumption 1 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.2 - Item: Assumption 1 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.3 - Item: Assumption 1 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.0 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: TIG 1.0 - Item: Specification;TAETORD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0452 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: This value should be an integer. - Document: TIG 1.0 - Item: TAETORD CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0148 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.4 + Item: Assumption 1 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.2 + Item: Assumption 1 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.3 + Item: Assumption 1 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.0 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: TIG 1.0 + Item: Specification;TAETORD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0452 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: This value should be an integer. + Document: TIG 1.0 + Item: TAETORD CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0148 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # Variable: TAETORD # Condition: # Rule: TAETORD is an integer Check: all: - - name: TAETORD - operator: not_matches_regex - value: ^(-?[1-9]\d*|0)$ + - name: TAETORD + operator: not_matches_regex + value: ^(-?[1-9]\d*|0)$ Core: Id: CORE-000534 Status: Published @@ -157,14 +157,14 @@ Executability: Fully Executable Outcome: Message: TAETORD is not an integer Output Variables: - - TAETORD + - TAETORD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000535/rule.yml b/Published/CORE-000535/rule.yml index da96aedd4..0038e9c96 100644 --- a/Published/CORE-000535/rule.yml +++ b/Published/CORE-000535/rule.yml @@ -2,208 +2,197 @@ # Condition: # Rule: --SEQ is in a consistent chronological order Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sequence Number given to ensure uniqueness of subject records - within a domain. Should be assigned to be consistent - chronological order. - Document: IG v3.2 - Item: Specification - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0662 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of - subject records within a domain. Should be assigned to be - consistent chronological order.]5.4[Specification][Sequence - number to ensure uniqueness of subject records. Should be - assigned to be consistent chronological order.] - Document: IG v3.3 - Item: Specification - Section: 5.3|5.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0620 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of - subject records within a domain. Should be assigned to be - consistent chronological order]|5.4[Specification][Sequence - number to ensure uniqueness of subject records. Should be - assigned to be consistent chronological order.] - Document: IG v3.4 - Item: Specification - Section: 5.3|5.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0620 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject Elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the - actual subject elements. SESEQ should be assigned to be - consistent with the chronological order. - Document: TIG v1.0 - Item: Assumption 7 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0066 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness of subject records - within a domain. Should be assigned to be consistent - chronological order. - Document: TIG v1.0 - Item: Specifications - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0661 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Sequence Number given to ensure uniqueness of subject records within a + domain. Should be assigned to be consistent chronological order. + Document: IG v3.2 + Item: Specification + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0662 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of subject + records within a domain. Should be assigned to be consistent chronological + order.]5.4[Specification][Sequence number to ensure uniqueness of subject records. Should + be assigned to be consistent chronological order.] + Document: IG v3.3 + Item: Specification + Section: 5.3|5.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0620 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of subject + records within a domain. Should be assigned to be consistent chronological + order]|5.4[Specification][Sequence number to ensure uniqueness of subject records. Should + be assigned to be consistent chronological order.] + Document: IG v3.4 + Item: Specification + Section: 5.3|5.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0620 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject + elements. SESEQ should be assigned to be consistent with the chronological order. + Document: TIG v1.0 + Item: Assumption 7 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0066 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Sequence number given to ensure uniqueness of subject records within a + domain. Should be assigned to be consistent chronological order. + Document: TIG v1.0 + Item: Specifications + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0661 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --SEQ - operator: target_is_not_sorted_by - value: - - name: --STDTC - null_position: last - sort_order: asc - within: USUBJID + - name: --SEQ + operator: target_is_not_sorted_by + value: + - name: --STDTC + null_position: last + sort_order: asc + within: USUBJID Core: Id: CORE-000535 Status: Published Version: '1' -Description: Trigger error when the order of --SEQ is not chronological (based - on --STDTC) within USUBJID +Description: Trigger error when the order of --SEQ is not chronological (based on --STDTC) within + USUBJID Executability: Fully Executable Outcome: Message: --SEQ is not chronological (based on --STDTC) within USUBJID Output Variables: - - --SEQ - - --STDTC + - --SEQ + - --STDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SM - - SE + - SM + - SE Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000537/rule.yml b/Published/CORE-000537/rule.yml index 344accb94..6e3cd5e1e 100644 --- a/Published/CORE-000537/rule.yml +++ b/Published/CORE-000537/rule.yml @@ -1,81 +1,81 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: Rule 342 is not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, - should be included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.0' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND342' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND342' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND342' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND342' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND342' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: TSPARMCD - operator: equal_to - value: SDESIGN - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SDESIGN + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000537 Status: Published @@ -88,8 +88,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000538/rule.yml b/Published/CORE-000538/rule.yml index ec5d0380f..8a6a5c4b3 100644 --- a/Published/CORE-000538/rule.yml +++ b/Published/CORE-000538/rule.yml @@ -1,107 +1,100 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset - (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- - datasets would be the two-character domain code (e.g., QS, - FA). - Document: IG v3.4 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset - (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- - datasets would be the two-character domain code (e.g., QS; - FA). - Document: IG v3.2 - Item: '7' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be - split. The nomenclature would include the additional - one-to-two characters used to identify the split dataset - (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- - datasets would be the two-character domain code (e.g., QS; - FA). - Document: IG v3.3 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains will also be - split. The nomenclature will include the additional one to two - characters used to identify the split dataset (e.g., SUPPLBHM, - SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would - be the two-character domain code (e.g., LB, FA). - Document: TIG 1.0 - Item: 'Num 9.e.ii' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0500 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS, FA). + Document: IG v3.4 + Item: '7' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS; FA). + Document: IG v3.2 + Item: '7' + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS; FA). + Document: IG v3.3 + Item: '7' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Supplemental Qualifier datasets for split domains will also be split. The + nomenclature will include the additional one to two characters used to identify the split + dataset (e.g., SUPPLBHM, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., LB, FA). + Document: TIG 1.0 + Item: 'Num 9.e.ii' + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0500 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: does_not_equal_string_part - regex: .{4}(..).* - value: $dataset_name + - name: RDOMAIN + operator: does_not_equal_string_part + regex: .{4}(..).* + value: $dataset_name Core: Id: CORE-000538 Status: Published Version: '1' -Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the - Supplementary dataset name +Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary + dataset name Executability: Fully Executable Operations: - - id: $dataset_name - name: dataset_name - operator: extract_metadata +- id: $dataset_name + name: dataset_name + operator: extract_metadata Outcome: Message: RDOMAIN does not match characters 5 and 6 of the dataset name Output Variables: - - $dataset_name - - RDOMAIN + - $dataset_name + - RDOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000539/rule.yml b/Published/CORE-000539/rule.yml index 4aef70606..52f24ade6 100644 --- a/Published/CORE-000539/rule.yml +++ b/Published/CORE-000539/rule.yml @@ -2,124 +2,115 @@ # Condition: Dataset name length = 3 or 4 and dataset name does not begin with 'AP' or 'FA' # Rule: The first two characters of the dataset name must equal a domain that is present in the study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'For domains with two-letter domain codes (i.e., other than - SUPPxx and RELREC), split dataset names can be up to four - characters in length. For example, if splitting by --CAT, then - dataset names would be the domain name plus up to two - additional characters (e.g., QS36 for SF-36). If splitting - Findings About by parent domain, then the dataset name would - be the domain code, "FA", plus the two-character domain code - for parent domain code (e.g., "FACM"). The four-character - dataset-name limitation allows the use of a Supplemental - Qualifier dataset associated with the split dataset. ' - Document: IG v3.4 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For - example; if splitting by --CAT; then dataset names would be - the domain name plus up to two additional characters (e.g., - QS36 for SF-36). If splitting Findings About by parent domain; - then the dataset name would be the domain name plus the - two-character domain code describing the parent domain code - (e.g., FACM). The four-character dataset-name limitation - allows the use of a Supplemental Qualifier dataset associated - with the split dataset. - Document: IG v3.2 - Item: '6' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For - example; if splitting by --CAT; then dataset names would be - the domain name plus up to two additional characters (e.g., - QS36 for SF-36). If splitting Findings About by parent domain; - then the dataset name would be the domain name plus the - two-character domain code describing the parent domain code - (e.g., FACM). The four-character dataset-name limitation - allows the use of a Supplemental Qualifier dataset associated - with the split dataset. - Document: IG v3.3 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For domains with 2-letter domain codes, split dataset names can - be up to 4 characters in length - Document: TIG 1.0 - Item: Num 9.e.i - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0498 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'For domains with two-letter domain codes (i.e., other than SUPPxx and RELREC), + split dataset names can be up to four characters in length. For example, if splitting by --CAT, + then dataset names would be the domain name plus up to two additional characters (e.g., QS36 + for SF-36). If splitting Findings About by parent domain, then the dataset name would be the + domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). + The four-character dataset-name limitation allows the use of a Supplemental Qualifier dataset + associated with the split dataset. ' + Document: IG v3.4 + Item: '6' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.2 + Item: '6' + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.3 + Item: '6' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: For domains with 2-letter domain codes, split dataset names can be up to 4 + characters in length + Document: TIG 1.0 + Item: Num 9.e.i + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0498 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: dataset_name - operator: matches_regex - value: ^[a-z(?-i)]{2}[a-z0-9(?-i)]{1,2} - - name: dataset_name - operator: not_prefix_matches_regex - prefix: 2 - value: (AP|FA) - - name: dataset_name - operator: prefix_is_not_contained_by - prefix: 2 - value: $list_dataset_names + - name: dataset_name + operator: matches_regex + value: ^[a-z(?-i)]{2}[a-z0-9(?-i)]{1,2} + - name: dataset_name + operator: not_prefix_matches_regex + prefix: 2 + value: (AP|FA) + - name: dataset_name + operator: prefix_is_not_contained_by + prefix: 2 + value: $list_dataset_names Core: Id: CORE-000539 Status: Published Version: '1' -Description: Raise an error when split domains (i.e three/four-letter domain - name) do not have a two-letter parent domain present in the study. +Description: Raise an error when split domains (i.e three/four-letter domain name) do not have a + two-letter parent domain present in the study. Executability: Fully Executable Operations: - - id: $list_dataset_names - operator: dataset_names +- id: $list_dataset_names + operator: dataset_names Outcome: Message: Split dataset is present but the two-Letter parent domain is missing. Output Variables: - - dataset_name - - $list_dataset_names + - dataset_name + - $list_dataset_names Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - RELREC - - RELSUB - - SUPP-- + - RELREC + - RELSUB + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000540/rule.yml b/Published/CORE-000540/rule.yml index ecad2a536..7757a33fb 100644 --- a/Published/CORE-000540/rule.yml +++ b/Published/CORE-000540/rule.yml @@ -2,121 +2,111 @@ # Condition: Dataset split by parent domain and dataset name length > 2 and dataset name begins with 'FA' # Rule: The characters of the dataset name after 'FA' equal a domain that present in the study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'If splitting Findings About by parent domain, then the dataset - name would be the domain code, "FA", plus the two-character - domain code for parent domain code (e.g., "FACM"). ' - Document: IG v3.4 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For - example; if splitting by --CAT; then dataset names would be - the domain name plus up to two additional characters (e.g., - QS36 for SF-36). If splitting Findings About by parent domain; - then the dataset name would be the domain name plus the - two-character domain code describing the parent domain code - (e.g., FACM). The four-character dataset-name limitation - allows the use of a Supplemental Qualifier dataset associated - with the split dataset. - Document: IG v3.2 - Item: '6' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For - example; if splitting by --CAT; then dataset names would be - the domain name plus up to two additional characters (e.g., - QS36 for SF-36). If splitting Findings About by parent domain; - then the dataset name would be the domain name plus the - two-character domain code describing the parent domain code - (e.g., FACM). The four-character dataset-name limitation - allows the use of a Supplemental Qualifier dataset associated - with the split dataset. - Document: IG v3.3 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If splitting Findings About by parent domain, then the dataset - name would be the domain code, "FA", plus the two-character - domain code for parent domain code (e.g., "FACM"). The - four-character dataset-name limitation allows the use of a - Supplemental Qualifier dataset associated with the split - dataset. - Document: TIG 1.0 - Item: Num 9.e.i - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0499 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'If splitting Findings About by parent domain, then the dataset name would be + the domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). ' + Document: IG v3.4 + Item: '6' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.2 + Item: '6' + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.3 + Item: '6' + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If splitting Findings About by parent domain, then the dataset name would be + the domain code, "FA", plus the two-character domain code for parent domain code (e.g., + "FACM"). The four-character dataset-name limitation allows the use of a Supplemental + Qualifier dataset associated with the split dataset. + Document: TIG 1.0 + Item: Num 9.e.i + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0499 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: dataset_name - operator: matches_regex - value: ^[a-z(?-i)]{2}[a-z(?-i)]{1,2} - - name: dataset_name - operator: prefix_equal_to - prefix: 2 - value: 'FA' - - name: dataset_name - operator: suffix_is_not_contained_by - suffix: 2 - value: $list_dataset_names + - name: dataset_name + operator: matches_regex + value: ^[a-z(?-i)]{2}[a-z(?-i)]{1,2} + - name: dataset_name + operator: prefix_equal_to + prefix: 2 + value: 'FA' + - name: dataset_name + operator: suffix_is_not_contained_by + suffix: 2 + value: $list_dataset_names Core: Id: CORE-000540 Status: Published Version: '1' -Description: Raise an error when parent domain referenced in Findings About - dataset name is not present in the study. +Description: Raise an error when parent domain referenced in Findings About dataset name is not + present in the study. Executability: Fully Executable Operations: - - id: $list_dataset_names - operator: dataset_names +- id: $list_dataset_names + operator: dataset_names Outcome: - Message: Parent domain referenced in Findings About dataset name is not present - in the study + Message: Parent domain referenced in Findings About dataset name is not present in the study Output Variables: - - dataset_name - - $list_dataset_names + - dataset_name + - $list_dataset_names Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000541/rule.yml b/Published/CORE-000541/rule.yml index 9d2cc9a5d..cf9836452 100644 --- a/Published/CORE-000541/rule.yml +++ b/Published/CORE-000541/rule.yml @@ -2,103 +2,97 @@ # Condition: # Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.3 - Section: 7.4.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor - can it start with a number (e.g., '1TEST'). IETESTCD cannot - contain characters other than letters; numbers; or - underscores. - Document: Model v1.7 - Section: 3.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot - start with a number; nor can they contain characters other - than letters; numbers; or underscores - Document: IG v3.2 - Section: 4.1.2.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor - can it start with a number (e.g., '1TEST'). IETESTCD cannot - contain characters other than letters; numbers; or - underscores. - Document: Model v1.4 - Section: 3.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor - can it start with a number (e.g., "1TEST" is not valid). - --TESTCD cannot contain characters other than letters, - numbers, or underscores. - Document: TIG 1.0 - Item: Specifications --TESTCD - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0536 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.3 + Section: 7.4.1 + - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.7 + Section: 3.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.2 + Section: 4.1.2.1 + - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.4 + Section: 3.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor can it start + with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than + letters, numbers, or underscores. + Document: TIG 1.0 + Item: Specifications --TESTCD + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0536 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - name: IETESTCD - operator: not_matches_regex - value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ + - name: IETESTCD + operator: not_matches_regex + value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ Core: Id: "CORE-000541" Status: Published Version: '1' -Description: Part B - Raise an error when IETESTCD > 8 chars or contains more - than only letters, numbers and underscores, or starts with a number. +Description: Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters, + numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: IETESTCD > 8 chars or contains more than only letters, numbers, - underscores, or starts with a number. + Message: IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + with a number. Output Variables: - - IETESTCD + - IETESTCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000542/rule.yml b/Published/CORE-000542/rule.yml index f60bc8274..a38a36a2e 100644 --- a/Published/CORE-000542/rule.yml +++ b/Published/CORE-000542/rule.yml @@ -1,275 +1,258 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.0 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric - values. These are converted to numeric type and written to - --STRESN. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0280 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.0 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0280 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3102' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: + - name: --STRESC + operator: non_empty + - name: --STRESC + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - any: + - name: --STRESN + operator: empty - name: --STRESC - operator: non_empty - - name: --STRESC - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - any: - - name: --STRESN - operator: empty - - name: --STRESC - operator: not_equal_to - type_insensitive: true - value: --STRESN + operator: not_equal_to + type_insensitive: true + value: --STRESN Core: Id: CORE-000542 Status: Published Version: '1' -Description: Raise an error when --STRESC is populated with a numeric value, but - --STRESN is not populated, or --STRESN is not equal to --STRESC. +Description: Raise an error when --STRESC is populated with a numeric value, but --STRESN is not + populated, or --STRESN is not equal to --STRESC. Executability: Fully Executable Outcome: Message: --STRESC is numeric but --STRESN is not populated or not equal to --STRESC. Output Variables: - - --STRESC - - --STRESN - - --TESTCD + - --STRESC + - --STRESN + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000545/rule.yml b/Published/CORE-000545/rule.yml index 086da8d37..c00766bb9 100644 --- a/Published/CORE-000545/rule.yml +++ b/Published/CORE-000545/rule.yml @@ -1,128 +1,125 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values - presented in --STRESC are numeric values - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values - presented in --STRESC are numeric values - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values - presented in --STRESC are numeric values - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: #- name: --SCAT # operator: non_empty - - all: - - name: --SCAT - operator: non_empty - - name: --DECOD - operator: non_empty - - name: --SCAT - operator: equal_to - value: --DECOD - - all: - - name: --SCAT - operator: non_empty - - name: --BODSYS - operator: non_empty - - name: --SCAT - operator: equal_to - value: --BODSYS + - all: + - name: --SCAT + operator: non_empty + - name: --DECOD + operator: non_empty + - name: --SCAT + operator: equal_to + value: --DECOD + - all: + - name: --SCAT + operator: non_empty + - name: --BODSYS + operator: non_empty + - name: --SCAT + operator: equal_to + value: --BODSYS Core: Id: CORE-000545 Status: Published Version: '1' -Description: Trigger error when --SCAT is not null and --SCAT is equal to - --DECOD or --SCAT is equal to --BODSYS +Description: Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal + to --BODSYS Executability: Fully Executable Outcome: Message: --SCAT is equal to --DECOD, or --SCAT is equal to --BODSYS Output Variables: - - --CAT - - --SCAT - - --DECOD - - --BODSYS + - --CAT + - --SCAT + - --DECOD + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000546/rule.yml b/Published/CORE-000546/rule.yml index 7dec60f63..2fe752ac1 100644 --- a/Published/CORE-000546/rule.yml +++ b/Published/CORE-000546/rule.yml @@ -1,129 +1,123 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the - domain or dictionary classification provided by --DECOD and - --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: # - name: --CAT # operator: non_empty - - all: - - name: --CAT - operator: non_empty - - name: --DECOD - operator: non_empty - - name: --CAT - operator: equal_to - value: --DECOD - - all: - - name: --CAT - operator: non_empty - - name: --BODSYS - operator: non_empty - - name: --CAT - operator: equal_to - value: --BODSYS + - all: + - name: --CAT + operator: non_empty + - name: --DECOD + operator: non_empty + - name: --CAT + operator: equal_to + value: --DECOD + - all: + - name: --CAT + operator: non_empty + - name: --BODSYS + operator: non_empty + - name: --CAT + operator: equal_to + value: --BODSYS Core: Id: CORE-000546 Status: Published Version: '1' -Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD - or --CAT is equal to --BODSYS +Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to + --BODSYS Executability: Fully Executable Outcome: Message: --CAT is equal to --DECOD, or --CAT is equal to --BODSYS Output Variables: - - --CAT - - --DECOD - - --BODSYS + - --CAT + - --DECOD + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000547/rule.yml b/Published/CORE-000547/rule.yml index 7e7cb649b..30377fddf 100644 --- a/Published/CORE-000547/rule.yml +++ b/Published/CORE-000547/rule.yml @@ -1,359 +1,340 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # SEND66 added here as code for SEND67 also covers SEND66 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.0 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored - according to the international standard ISO 8601 - (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SDTM and SENDIG require use of the ISO 8601 Extended format, - which requires hyphen delimiters for date components and colon - delimiters for time components. The ISO 8601 basic format, - which does not require delimiters, should not be used in SDTM - datasets. - Document: SENDIG v3.0 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, - should not be used. - Document: SENDIG v3.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, - should not be used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, - should not be used. - Document: SENDIG v3.1 - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, - should not be used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, - should not be used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.0 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SDTM and SENDIG require use of the ISO 8601 Extended format, which + requires hyphen delimiters for date components and colon delimiters for time components. + The ISO 8601 basic format, which does not require delimiters, should not be used in SDTM + datasets. + Document: SENDIG v3.0 + Item: Text + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1 + Item: Text + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1 + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: '4.4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: '1' + Version: '5.0' + Version: '1.0' # SEND68 added here as code for SEND66 and SEND67 also covers SEND68 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.0 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a - date/time), the date is written in front of the time and the - time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of - dates and/or times, intervals of time, and durations of time - in ISO 8601 format as defined by the International - Organization for Standardization (ISO) (http://www.iso.org). - The appropriate date and/or time ISO format must be used when - specified. - Document: TIG v1.0 - Item: Text - Section: '2.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0267 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of - dates and/or times, intervals of time, and durations of time - in ISO 8601 format as defined by the International - Organization for Standardization (ISO) (http://www.iso.org). - The appropriate date and/or time ISO format must be used when - specified. - Document: TIG v1.0 - Item: Text - Section: 2.3 Controlled Terminology and Formats - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0268 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of - dates and/or times, intervals of time, and durations of time - in ISO 8601 format as defined by the International - Organization for Standardization (ISO) (http://www.iso.org). - The appropriate date and/or time ISO format must be used when - specified. - Document: TIG v1.0 - Item: Text - Section: 2.3 Controlled Terminology and Formats - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0269 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.0 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: '2.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0267 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: 2.3 Controlled Terminology and Formats + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0268 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: 2.3 Controlled Terminology and Formats + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0269 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - name: RFSTDTC - operator: invalid_date - - name: RFENDTC - operator: invalid_date - - name: BRTHDTC - operator: invalid_date - - name: --STDTC - operator: invalid_date - - name: --ENDTC - operator: invalid_date - - name: --DTC - operator: invalid_date - - name: --RFTDTC - operator: invalid_date + - name: RFSTDTC + operator: invalid_date + - name: RFENDTC + operator: invalid_date + - name: BRTHDTC + operator: invalid_date + - name: --STDTC + operator: invalid_date + - name: --ENDTC + operator: invalid_date + - name: --DTC + operator: invalid_date + - name: --RFTDTC + operator: invalid_date Core: Id: CORE-000547 Status: Published Version: '1' -Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, - --DTC, --RFTDTC must be correct ISO-8601 dates / datetimes +Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must + be correct ISO-8601 dates / datetimes Executability: Fully Executable Outcome: Message: Variable value is not in correct ISO 8601 date or datetime format @@ -365,9 +346,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000548/rule.yml b/Published/CORE-000548/rule.yml index c94239b2d..d414225eb 100644 --- a/Published/CORE-000548/rule.yml +++ b/Published/CORE-000548/rule.yml @@ -1,193 +1,175 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Other variables that represent durations or elapsed times - include --EVLINT and --ELTM. These should be represented in - accordance with the ISO 8601 standard. Both duration and - duration units can be represented in a single --DUR variable, - in accordance with the ISO 8601 standard as follows... For the - purposes of data submission, an additional format is allowed - to represent "negative" intervals of time (intervals of time - preceding a reference point). - Document: IG v3.0 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the - duration timing variable (--DUR) should generally be used in a - domain if it was collected in lieu of a start date/time - (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC - are collected, durations can be calculated by the difference - in these two values and need not be in the submission dataset. - Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as - follows...For the purposes of data submission, an additional - format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the - duration timing variable (--DUR) should generally be used in a - domain if it was collected in lieu of a start date/time - (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC - are collected, durations can be calculated by the difference - in these two values and need not be in the submission dataset. - Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as - follows...For the purposes of data submission, an additional - format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the - duration timing variable (--DUR) should generally be used in a - domain if it was collected in lieu of a start date/time - (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC - are collected, durations can be calculated by the difference - in these two values and need not be in the submission dataset. - Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as - follows...For the purposes of data submission, an additional - format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the - duration timing variable (--DUR) should generally be used in a - domain if it was collected in lieu of a start date/time - (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC - are collected, durations can be calculated by the difference - in these two values and need not be in the submission dataset. - Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as - follows...For the purposes of data submission, an additional - format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the - duration timing variable (--DUR) should generally be used in a - domain if it was collected in lieu of a start date/time - (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC - are collected, durations can be calculated by the difference - in these two values and need not be in the submission dataset. - Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as - follows...For the purposes of data submission, an additional - format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Other variables that represent durations or elapsed times include --EVLINT + and --ELTM. These should be represented in accordance with the ISO 8601 standard. Both + duration and duration units can be represented in a single --DUR variable, in accordance + with the ISO 8601 standard as follows... For the purposes of data submission, an + additional format is allowed to represent "negative" intervals of time (intervals of time + preceding a reference point). + Document: IG v3.0 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: --DUR - operator: non_empty - - name: --DUR - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --DUR - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: --EVLINT - operator: non_empty - - name: --EVLINT - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --EVLINT - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: --ELTM - operator: non_empty - - name: --ELTM - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --ELTM - operator: not_matches_regex - value: ^-?P([0-9]+W)$ + - all: + - name: --DUR + operator: non_empty + - name: --DUR + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --DUR + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: --EVLINT + operator: non_empty + - name: --EVLINT + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --EVLINT + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: --ELTM + operator: non_empty + - name: --ELTM + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --ELTM + operator: not_matches_regex + value: ^-?P([0-9]+W)$ Core: Id: CORE-000548 Status: Published Version: '1' -Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, - including the additional format that allows the representation of "negative" - intervals of time. +Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional + format that allows the representation of "negative" intervals of time. Executability: Fully Executable Outcome: Message: --DUR, --EVLINT or --ELTM is not in ISO 8601 Duration format Output Variables: - - USUBJID - - --ELTM - - --EVLINT - - --DUR + - USUBJID + - --ELTM + - --EVLINT + - --DUR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000549/rule.yml b/Published/CORE-000549/rule.yml index 37cd578b9..6d4402a26 100644 --- a/Published/CORE-000549/rule.yml +++ b/Published/CORE-000549/rule.yml @@ -1,43 +1,41 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: TODO: Add SENDIG-DART 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and - SJUPDES should be populated with a description of the - unplanned Stage. - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND352 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and - SJUPDES should be populated with a description of the - unplanned Stage. - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND352 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be + populated with a description of the unplanned Stage. + Document: IG-DART v1.1 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND352 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be + populated with a description of the unplanned Stage. + Document: IG-DART v1.2 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND352 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: RSTGCD - operator: not_equal_to - value: UNPLAN - - name: SJUPDES - operator: non_empty + - name: RSTGCD + operator: not_equal_to + value: UNPLAN + - name: SJUPDES + operator: non_empty Core: Id: CORE-000549 Status: Published @@ -50,8 +48,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000550/rule.yml b/Published/CORE-000550/rule.yml index b911ee9b9..a11f1d8d7 100644 --- a/Published/CORE-000550/rule.yml +++ b/Published/CORE-000550/rule.yml @@ -6,46 +6,45 @@ # as SDTMIG has "domain-specific" variables: # which are NOT in the "SDTM Model" Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sponsors may not add any variables other than those described in - the preceding three bullets. . . . Standard variables must not - be renamed or modified for novel usage. - Document: IG v3.4 - Section: '2.5' - - Cited Guidance: Each observation consists of a series of named variables. - Document: Model v2.0 - Section: Model Concepts and Terms --Variables - - Cited Guidance: Domain-specific variables, a concept introduced in SDTM v1.5, - are for use in a limited number of designated domains and will - be identified in the appropriate implementation guide.] - Document: Model v2.0 - Section: The General Observation Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0013 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[2.5][Sponsors may not add any other variables. . . . - Standard variables must not be renamed or modified for novel - usage. Using SDTM-specified standard variable names.]|Model - v1.4[3.2.22][Each observation can be described by a series of - named variables.] - Document: IG v3.2|Model v1.4 - Section: IG v3.2[2.5]|Model v1.4[3.2.22] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0013 - Version: '1' - Version: '2.0' - Version: '3.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Sponsors may not add any variables other than those described in the + preceding three bullets. . . . Standard variables must not be renamed or modified for + novel usage. + Document: IG v3.4 + Section: '2.5' + - Cited Guidance: Each observation consists of a series of named variables. + Document: Model v2.0 + Section: Model Concepts and Terms --Variables + - Cited Guidance: Domain-specific variables, a concept introduced in SDTM v1.5, are for use in + a limited number of designated domains and will be identified in the appropriate + implementation guide.] + Document: Model v2.0 + Section: The General Observation Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0013 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[2.5][Sponsors may not add any other variables. . . . Standard + variables must not be renamed or modified for novel usage. Using SDTM-specified standard + variable names.]|Model v1.4[3.2.22][Each observation can be described by a series of named + variables.] + Document: IG v3.2|Model v1.4 + Section: IG v3.2[2.5]|Model v1.4[3.2.22] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0013 + Version: '1' + Version: '2.0' + Version: '3.2' # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here, # as SDTMIG has "domain-specific" variables: # which are NOT in the "SDTM Model" @@ -70,50 +69,49 @@ Authorities: # Version: '1' # Version: '2.0' # Version: '3.3' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A dataset is created using a domain specification in this guide - when the scientific nature or role of the data is within the - scope of a domain. Domains are extended or custom domain - specifications are only used when data are different in nature - and are not in scope for domains in this guide. - Document: TIG 1.0 - Item: Table 2 Num 2 - Section: 2.8.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0298 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard variable names - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0351 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard variable names - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0351 - Version: '1' - Version: '2.0' - Version: '3.2' + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: A dataset is created using a domain specification in this guide when the + scientific nature or role of the data is within the scope of a domain. Domains are + extended or custom domain specifications are only used when data are different in nature + and are not in scope for domains in this guide. + Document: TIG 1.0 + Item: Table 2 Num 2 + Section: 2.8.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0298 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard variable names + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0351 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard variable names + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0351 + Version: '1' + Version: '2.0' + Version: '3.2' #- Name: SDTMIG # References: # - Citations: @@ -128,29 +126,28 @@ Authorities: # Version: '3.3' Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CORE-000550 Status: Published Version: '1' -Description: Raise an error when a variable is not an allowed variable for an - Observation Class +Description: Raise an error when a variable is not an allowed variable for an Observation Class Executability: Partially Executable - Possible Underreporting Operations: - - id: $allowed_variables - operator: get_model_column_order +- id: $allowed_variables + operator: get_model_column_order Outcome: - Message: Variables not listed in the Model List of Allowed Variables for - Observation Class should be in SUPPQUAL. + Message: Variables not listed in the Model List of Allowed Variables for Observation Class should + be in SUPPQUAL. Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000551/rule.yml b/Published/CORE-000551/rule.yml index 835c28a64..4515ea063 100644 --- a/Published/CORE-000551/rule.yml +++ b/Published/CORE-000551/rule.yml @@ -1,161 +1,160 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # SENDIG-3.0: rule 254 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per IDVAR, IDVARVAL, and - QNAM value per subject per related domain, Tabulation. - Document: IG v3.0 - Item: Domain Table Header - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254' - Version: '1' - Version: '5.0' - Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, + Tabulation. + Document: IG v3.0 + Item: Domain Table Header + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254' + Version: '1' + Version: '5.0' + Version: '3.0' # SENDIG-3.1: rule 254.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per supplemental qualifier - per related parent domain record(s), Tabulation. - Document: IG v3.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1 + Item: Domain Table Header + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254.1' + Version: '1' + Version: '5.0' + Version: '3.1' # SENDIG-3.1: rule 254.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per supplemental qualifier - per related parent domain record(s), Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254.1' + Version: '1' + Version: '5.0' + Version: '3.1.1' # SENDIG-DART-1.1: rule 254.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per supplemental qualifier - per related parent domain record(s), Tabulation. - Document: IG v3.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1 + Item: Domain Table Header + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254.1' + Version: '1' + Version: '5.0' + Version: '1.1' # SENDIG-DART-1.2: rule 254.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per supplemental qualifier - per related parent domain record(s), Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254.1' + Version: '1' + Version: '5.0' + Version: '1.2' # SENDIG-GENETOX-1.0: rule 254.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - - Relationship Datasets. One record per supplemental qualifier - per related parent domain record(s), Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for [domain name] — - Relationship. One record per IDVAR, IDVARVAL, and QNAM value - per subject per related domain, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0172 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND254.1' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for [domain name] — Relationship. One + record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0172 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: QNAM - operator: is_not_unique_set - value: - - USUBJID - - RDOMAIN - - IDVAR - - IDVARVAL - - all: - - name: POOLID - operator: non_empty - - name: QNAM - operator: is_not_unique_set - value: - - POOLID - - RDOMAIN - - IDVAR - - IDVARVAL + - all: + - name: USUBJID + operator: non_empty + - name: QNAM + operator: is_not_unique_set + value: + - USUBJID + - RDOMAIN + - IDVAR + - IDVARVAL + - all: + - name: POOLID + operator: non_empty + - name: QNAM + operator: is_not_unique_set + value: + - POOLID + - RDOMAIN + - IDVAR + - IDVARVAL Core: Id: CORE-000551 Status: Published Version: '1' -Description: There may be only be one record in a SUPP-- dataset with the same - QNAM value within USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL. +Description: There may be only be one record in a SUPP-- dataset with the same QNAM value within + USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL. Executability: Fully Executable Outcome: - Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, - IDVAR, IDVARVAL with QNAM + Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with + QNAM Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL + - RDOMAIN + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000552/rule.yml b/Published/CORE-000552/rule.yml index 03654e5c2..0c6f64b8b 100644 --- a/Published/CORE-000552/rule.yml +++ b/Published/CORE-000552/rule.yml @@ -2,111 +2,95 @@ # Condition: --STDTC and DM.RFSTDTC both contain complete values in their date portion # Rule: --STDY is properly calculated per study day algorithm Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with - the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time - variables (--DTC, --STDTC, and --ENDTC) to the date portion - of the Subject Reference Start Date (RFSTDTC from the - Demographics domain). All Study Day values are - integers. Thus, to calculate Study Day, --DY = (date portion - of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or - after RFSTDTC, --DY = (date portion of --DTC) - (date portion - of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should - be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day; --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0434 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate + Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on + or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.' + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0434 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --STDTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --STDY # checking failure criteria - operator: not_equal_to - value: $val_stdy # this is created in the operations statement that follows + - name: --STDTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --STDY # checking failure criteria + operator: not_equal_to + value: $val_stdy # this is created in the operations statement that follows Core: Id: CORE-000552 Status: Published @@ -114,28 +98,28 @@ Core: Description: Study day must be calculated using the algorithm detailed in the SDTMIG. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: #domain: DM - - id: $val_stdy - name: --STDTC - operator: dy +- id: $val_stdy + name: --STDTC + operator: dy Outcome: Message: --STDY is not properly calculated per study day algorithm Output Variables: - - --STDY - - --STDTC - - $val_stdy - - RFSTDTC + - --STDY + - --STDTC + - $val_stdy + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000553/rule.yml b/Published/CORE-000553/rule.yml index 3bbe557ac..3510cbaa7 100644 --- a/Published/CORE-000553/rule.yml +++ b/Published/CORE-000553/rule.yml @@ -2,113 +2,97 @@ # Condition: --ENDTC and DM.RFSTDTC both contain complete values in their date portion # Rule: --ENDY is properly calculated per study day algorithm Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with - the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time variables - (--DTC, --STDTC, and --ENDTC) to the date portion of the - Subject Reference Start Date (RFSTDTC from the Demographics - domain). All Study Day values are integers. Thus, to calculate - Study Day, --DY = (date portion of --DTC) - (date portion of - RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day: --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. They are determined by comparing the - date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject - Reference Start Date (RFSTDTC from the Demographics - domain).][All Study Day values are integers. Thus, to - calculate Study Day; --DY = (date portion of --DTC) - (date - portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY - = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all - domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0436 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate Study + Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or + after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]' + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.' + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0436 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: # - name: --ENDY # operator: non_empty - - name: --ENDTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --ENDY # checking failure criteria - operator: not_equal_to - value: $val_endy # this is created in the operations statement that follows + - name: --ENDTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --ENDY # checking failure criteria + operator: not_equal_to + value: $val_endy # this is created in the operations statement that follows Core: Id: CORE-000553 Status: Published @@ -116,27 +100,27 @@ Core: Description: Study day must be calculated using the algorithm detailed in the SDTMIG. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - id: $val_endy - name: --ENDTC - operator: dy +- id: $val_endy + name: --ENDTC + operator: dy Outcome: Message: --ENDY is not properly calculated per study day algorithm Output Variables: - - --ENDY - - --ENDTC - - $val_endy - - RFSTDTC + - --ENDY + - --ENDTC + - $val_endy + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000554/rule.yml b/Published/CORE-000554/rule.yml index 20630db4e..62af26113 100644 --- a/Published/CORE-000554/rule.yml +++ b/Published/CORE-000554/rule.yml @@ -1,38 +1,38 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND350 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND350 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. + Document: IG-DART v1.1 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND350 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. + Document: IG-DART v1.2 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND350 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: RSTGCD - operator: equal_to - value: UNPLAN - - name: RSTAGE - operator: non_empty + - name: RSTGCD + operator: equal_to + value: UNPLAN + - name: RSTAGE + operator: non_empty Core: Id: CORE-000554 Status: Published @@ -45,8 +45,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000555/rule.yml b/Published/CORE-000555/rule.yml index 8c8584afd..e1426ffd8 100644 --- a/Published/CORE-000555/rule.yml +++ b/Published/CORE-000555/rule.yml @@ -1,119 +1,112 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths - only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # Implemented as uniqueness of DDORRES and/or DDSTRESC per USUBJID # as decided by the SEND team any: - - name: DDORRES - operator: is_not_unique_set - value: - - USUBJID - - name: DDSTRESC - operator: is_not_unique_set - value: - - USUBJID + - name: DDORRES + operator: is_not_unique_set + value: + - USUBJID + - name: DDSTRESC + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000555 Status: Published Version: '1' -Description: Raise an error when there is more than one record present the - combination of USUBJID and DDORRES or for the combination of USUBJID and - DDSTRESC. +Description: Raise an error when there is more than one record present the combination of USUBJID + and DDORRES or for the combination of USUBJID and DDSTRESC. Executability: Fully Executable Outcome: - Message: There is more than one for the combination of USUBJID and DDORRES or - the combination of USUBJID and DDSTRESC + Message: There is more than one for the combination of USUBJID and DDORRES or the combination of + USUBJID and DDSTRESC Output Variables: - - USUBJID - - DDORRES - - DDSTRESC + - USUBJID + - DDORRES + - DDSTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000556/rule.yml b/Published/CORE-000556/rule.yml index c30c6df74..4537d6d02 100644 --- a/Published/CORE-000556/rule.yml +++ b/Published/CORE-000556/rule.yml @@ -1,95 +1,94 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.0 - Section: 8.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One - record per subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.0 + Section: 8.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: POOLID - operator: is_not_unique_set - value: USUBJID + - name: POOLID + operator: is_not_unique_set + value: USUBJID Core: Id: CORE-000556 Status: Published Version: '1' -Description: 'Generate a message when the there are duplicate combinations of - USUBJID and POOLID' +Description: 'Generate a message when the there are duplicate combinations of USUBJID and POOLID' Executability: Fully Executable Outcome: Message: 'A duplicate combination of USUBJID and POOLID was found' @@ -97,8 +96,8 @@ Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Published/CORE-000557/rule.yml b/Published/CORE-000557/rule.yml index 3fc357da9..1288cde11 100644 --- a/Published/CORE-000557/rule.yml +++ b/Published/CORE-000557/rule.yml @@ -1,160 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: RELTYPE; Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY, only when - --SPID is used. However, values are only necessary when - identifying a relationship between datasets. - Document: SENDIG v3.0 - Item: RELTYPE CDISC Notes - Section: 8.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL - are null; RELTYPE is populated) - Document: SENDIG v3.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL - are null; RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL - are null; RELTYPE is populated) - Document: SENDIG v3.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL - are null; RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL - are null; RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The variable RELTYPE will identify the type of relationship - between the datasets (e.g., a one-to-one or parent-child - relationship). The allowable values for RELYPE are ONE and - MANY per CDISC Controlled Terminology. - Document: TIG v1.0 - Item: Text - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0171 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: RELTYPE; Identifies the hierarchical level of the records in the + relationship. Values should be either ONE or MANY, only when --SPID is used. However, + values are only necessary when identifying a relationship between datasets. + Document: SENDIG v3.0 + Item: RELTYPE CDISC Notes + Section: 8.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253.1' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253.1' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253.1' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253.1' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND253.1' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: The variable RELTYPE will identify the type of relationship between the + datasets (e.g., a one-to-one or parent-child relationship). The allowable values for + RELYPE are ONE and MANY per CDISC Controlled Terminology. + Document: TIG v1.0 + Item: Text + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0171 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # We must take into account that POOLID is "permissible" and may be absent # USUBJID is "expected" and the column must then always be present Check: any: # Case that the POOLID column is not present - - all: - - name: USUBJID - operator: empty - - name: POOLID - operator: not_exists - - name: IDVARVAL - operator: empty - - name: RELTYPE - operator: not_equal_to - value: ONE - - name: RELTYPE - operator: not_equal_to - value: MANY + - all: + - name: USUBJID + operator: empty + - name: POOLID + operator: not_exists + - name: IDVARVAL + operator: empty + - name: RELTYPE + operator: not_equal_to + value: ONE + - name: RELTYPE + operator: not_equal_to + value: MANY # Case that the POOLID column is present - - all: - - name: USUBJID - operator: empty - - name: POOLID - operator: exists - - name: POOLID - operator: empty - - name: IDVARVAL - operator: empty - - name: RELTYPE - operator: not_equal_to - value: ONE - - name: RELTYPE - operator: not_equal_to - value: MANY + - all: + - name: USUBJID + operator: empty + - name: POOLID + operator: exists + - name: POOLID + operator: empty + - name: IDVARVAL + operator: empty + - name: RELTYPE + operator: not_equal_to + value: ONE + - name: RELTYPE + operator: not_equal_to + value: MANY Core: Id: CORE-000557 Status: Published Version: '1' -Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be - "ONE" or "MANY" +Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be "ONE" or "MANY" Executability: Fully Executable Outcome: - Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, - and IDVARVAL are null + Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are + null Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000558/rule.yml b/Published/CORE-000558/rule.yml index 11ae4803e..b219fdd1e 100644 --- a/Published/CORE-000558/rule.yml +++ b/Published/CORE-000558/rule.yml @@ -1,109 +1,109 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0273 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0273 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: #- name: --DY # operator: equal_to # value: 0 - - name: --DY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: --STDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: --ENDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: VISITDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ + - name: --DY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: --STDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: --ENDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: VISITDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ Core: Id: CORE-000558 Status: Published @@ -113,17 +113,17 @@ Executability: Fully Executable Outcome: Message: Study day variable (--DY/--STDY/--ENDY/VISITDY) is not a non-zero integer Output Variables: - - --DY - - --STDY - - --ENDY - - VISITDY + - --DY + - --STDY + - --ENDY + - VISITDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000559/rule.yml b/Published/CORE-000559/rule.yml index cedcfac07..a34c24a1e 100644 --- a/Published/CORE-000559/rule.yml +++ b/Published/CORE-000559/rule.yml @@ -1,137 +1,130 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd - - all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - all: + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd + - all: + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000559 Status: Published Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is - populated, ARMCD must be present in TA.ARMCD. This rule has been executed to - identify all cases when ARMCD is not present in TA.ARMCD and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + multi-stage arm assignments are in use. Executability: Fully Executable Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000560/rule.yml b/Published/CORE-000560/rule.yml index 84f1bf6ee..cab9b36f6 100644 --- a/Published/CORE-000560/rule.yml +++ b/Published/CORE-000560/rule.yml @@ -1,90 +1,82 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL contains one record per subject, regardless of the type of - clinical trial design. The label of the ADSL dataset is - "Subject-Level Analysis Dataset." In a study, there is only - one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", - and its name is ADSL. - Document: ADaM IG v1.3 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL contains one record per subject, regardless of the type of - clinical trial design. The label of the ADSL dataset is - "Subject-Level Analysis Dataset." In a study, there is only - one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", - and its name is ADSL. - Document: ADaM IG v1.2 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: ADaM IG v1.1 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based - submission of data from a clinical trial even if no other - analysis datasets are submitted. - Document: ADaM IG v1.0 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: '6' + - Cited Guidance: ADSL contains one record per subject, regardless of the type of clinical + trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a + study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its + name is ADSL. + Document: ADaM IG v1.3 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '1' + Version: '1' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: '6' + - Cited Guidance: ADSL contains one record per subject, regardless of the type of clinical + trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a + study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its + name is ADSL. + Document: ADaM IG v1.2 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '1' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: '6' + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: ADaM IG v1.1 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '1' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: '6' + - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: ADaM IG v1.0 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '1' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: ADSL - operator: not_exists + - name: ADSL + operator: not_exists Core: Id: CORE-000560 Status: Published @@ -97,8 +89,8 @@ Rule Type: Domain Presence Check Scope: Data Structures: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000561/rule.yml b/Published/CORE-000561/rule.yml index 8745f3767..77bf3130a 100644 --- a/Published/CORE-000561/rule.yml +++ b/Published/CORE-000561/rule.yml @@ -1,78 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # REMARK 2024-03-20: This may be "overreporting" # (after having discussed with Christy Kubin, on occasion of Tatiana's remark), @@ -80,46 +80,46 @@ Check: # TFANTREG is however "permissible" and not always used. # We will first develop some test files. any: - - all: - - name: TFANTREG - operator: exists - - name: TFORRES - operator: is_not_unique_set - value: - - USUBJID - - TFSPEC - - TFANTREG + - all: + - name: TFANTREG + operator: exists + - name: TFORRES + operator: is_not_unique_set + value: + - USUBJID + - TFSPEC + - TFANTREG # case that TFANTREG is not present - - all: - - name: TFANTREG - operator: not_exists - - name: TFORRES - operator: is_not_unique_set - value: - - USUBJID - - TFSPEC + - all: + - name: TFANTREG + operator: not_exists + - name: TFORRES + operator: is_not_unique_set + value: + - USUBJID + - TFSPEC Core: Id: CORE-000561 Status: Published Version: "1" -Description: Raise an error when there is more than one record present for any - particular tumor test result for a subject and specimen. +Description: Raise an error when there is more than one record present for any particular tumor test + result for a subject and specimen. Executability: Fully Executable Outcome: Message: The Tumor Findings test result is not unique for this subject and specimen. Output Variables: - - USUBJID - - TFTESTCD - - TFORRES - - TFSPEC - - TFANTREG + - USUBJID + - TFTESTCD + - TFORRES + - TFSPEC + - TFANTREG Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Published/CORE-000567/rule.yml b/Published/CORE-000567/rule.yml index 51467c0f8..eab67dcf9 100644 --- a/Published/CORE-000567/rule.yml +++ b/Published/CORE-000567/rule.yml @@ -1,105 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: TIG v1.0 - Item: BWSTAT Controlled Terms, Codelist, or Format - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0079 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: TIG v1.0 + Item: BWSTAT Controlled Terms, Codelist, or Format + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0079 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --STAT - operator: non_empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --STAT + operator: non_empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000567 Status: Published Version: '1' -Description: Trigger error when --STAT is non-empty and does not contain a value - from the ND codelist +Description: Trigger error when --STAT is non-empty and does not contain a value from the ND + codelist Executability: Fully Executable Outcome: Message: --STAT does not contain a value from the (ND) codelist @@ -107,9 +107,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000568/rule.yml b/Published/CORE-000568/rule.yml index 092de58cd..8eb622ad1 100644 --- a/Published/CORE-000568/rule.yml +++ b/Published/CORE-000568/rule.yml @@ -1,105 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: TIG v1.0 - Item: BWSTAT CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0081 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: TIG v1.0 + Item: BWSTAT CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0081 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --ORRES - operator: non_empty - - name: --STAT - operator: non_empty + - name: --ORRES + operator: non_empty + - name: --STAT + operator: non_empty Core: Id: CORE-000568 Status: Published @@ -112,9 +112,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000569/rule.yml b/Published/CORE-000569/rule.yml index 994abc608..2c9eb109d 100644 --- a/Published/CORE-000569/rule.yml +++ b/Published/CORE-000569/rule.yml @@ -1,97 +1,97 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: TIG v1.0 - Item: Text - Section: "2.6, 2.8.3 (5.c)" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0212 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: TIG v1.0 + Item: Text + Section: "2.6, 2.8.3 (5.c)" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0212 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_name - operator: not_matches_regex - value: ^[A-Z0-9]*$ + - name: variable_name + operator: not_matches_regex + value: ^[A-Z0-9]*$ Core: Id: CORE-000569 Status: Published @@ -104,9 +104,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000570/rule.yml b/Published/CORE-000570/rule.yml index ccc1cbc8c..d7f40d1d9 100644 --- a/Published/CORE-000570/rule.yml +++ b/Published/CORE-000570/rule.yml @@ -1,96 +1,90 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.0 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier - (POOLID) is Required in all datasets containing subject-level - or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.0 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: USUBJID - operator: empty - - name: POOLID - operator: empty + - name: USUBJID + operator: empty + - name: POOLID + operator: empty Core: Id: CORE-000570 Status: Published @@ -100,16 +94,16 @@ Executability: Fully Executable Outcome: Message: Both USUBJID and POOID are empty Output Variables: - - USUBJID - - POOLID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000571/rule.yml b/Published/CORE-000571/rule.yml index 7b60669ed..077acdef2 100644 --- a/Published/CORE-000571/rule.yml +++ b/Published/CORE-000571/rule.yml @@ -2,103 +2,97 @@ # Condition: --LNKID present in a domain # Rule: --LNKID present in another domain Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKID is a grouping identifier used to identify a record in - one domain that is related to records in another domain, often - forming a one-to-many relationship. - Document: IG v3.4 - Item: 2.E.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKID is a grouping identifier used to identify a record in - one domain that is related to records in another domain, often - forming a one-to-many relationship. - Document: IG v3.3 - Item: 2.E.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to link related records across domains. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a record, for - a subject, in one domain and link it to 1 or more records for - that subject in another domain. - Document: SDTM v2.1 - Item: -LNKID, Definition column - Section: SDTM 3.1.4 Identifiers for All Classes - - Cited Guidance: Groups of records can be related by using grouping variables - such as --LNKID or --LNKGRP in IDVAR. Using --LNKID or - --LNKGRP can be a more efficient method of representing - relationships in RELREC when relating a single or group of - records in one dataset to a group of records in another - dataset. - Document: TIG v1.0 - Item: -LNKID, Definition column - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0307 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --LNKID is a grouping identifier used to identify a record in one domain + that is related to records in another domain, often forming a one-to-many relationship. + Document: IG v3.4 + Item: 2.E.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --LNKID is a grouping identifier used to identify a record in one domain + that is related to records in another domain, often forming a one-to-many relationship. + Document: IG v3.3 + Item: 2.E.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to link related records across domains. + Document: IG v3.2 + Item: Specification + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: A sequence of characters used to uniquely identify a record, for a subject, + in one domain and link it to 1 or more records for that subject in another domain. + Document: SDTM v2.1 + Item: -LNKID, Definition column + Section: SDTM 3.1.4 Identifiers for All Classes + - Cited Guidance: Groups of records can be related by using grouping variables such as --LNKID + or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of + representing relationships in RELREC when relating a single or group of records in one + dataset to a group of records in another dataset. + Document: TIG v1.0 + Item: -LNKID, Definition column + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0307 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --LNKID - operator: exists - - name: $VARIABLE_COUNT - operator: less_than - value: 2 + - name: --LNKID + operator: exists + - name: $VARIABLE_COUNT + operator: less_than + value: 2 Core: Id: "CORE-000571" Status: Published Version: '1' -Description: Verify that when --LNKID is present in one domain it is also - present in another domain. +Description: Verify that when --LNKID is present in one domain it is also present in another domain. Executability: Fully Executable Operations: - - id: $VARIABLE_COUNT - name: --LNKID - operator: variable_count +- id: $VARIABLE_COUNT + name: --LNKID + operator: variable_count Outcome: Message: "LNKID variable is only found in one domain." Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000572/rule.yml b/Published/CORE-000572/rule.yml index e7223371e..874a8a064 100644 --- a/Published/CORE-000572/rule.yml +++ b/Published/CORE-000572/rule.yml @@ -1,130 +1,118 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment; Start values; an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values; an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0444 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment; + Start values; an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values; an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0444 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --ENRTPT # Condition: --ENTPT is prior to the date of collection or assessment. # Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --ENTPT - operator: date_less_than - value: --DTC - - name: --ENRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - ONGOING - - AFTER - - UNKNOWN + - name: --ENTPT + operator: non_empty + - name: --ENTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --ENTPT + operator: date_less_than + value: --DTC + - name: --ENRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - ONGOING + - AFTER + - UNKNOWN Core: Id: CORE-000572 Status: Published Version: '1' -Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', - 'ONGOING', 'AFTER', 'UNKNOWN') +Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', + 'UNKNOWN') Executability: Partially Executable Outcome: Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Output Variables: - - --ENTPT - - --ENRTPT - - --DTC + - --ENTPT + - --ENRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000573/rule.yml b/Published/CORE-000573/rule.yml index dc183bb1c..cc6d36002 100644 --- a/Published/CORE-000573/rule.yml +++ b/Published/CORE-000573/rule.yml @@ -1,95 +1,89 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.0 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: $record_count - operator: equal_to - value: 0 + - name: $record_count + operator: equal_to + value: 0 Core: Id: CORE-000573 Status: Published @@ -97,20 +91,20 @@ Core: Description: Trigger error when a dataset has no records Executability: Fully Executable Operations: - - id: $record_count - operator: record_count +- id: $record_count + operator: record_count Outcome: Message: Dataset may not be empty, it must contain records Output Variables: - - dataset_name - - dataset_label - - $record_count + - dataset_name + - dataset_label + - $record_count Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000575/rule.yml b/Published/CORE-000575/rule.yml index e15223aef..f41f4e749 100644 --- a/Published/CORE-000575/rule.yml +++ b/Published/CORE-000575/rule.yml @@ -1,244 +1,227 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class, this could be the - start date of the event or intervention. In the Findings - observation class, where data are usually collected at - multiple visits, at least one Timing variable must be used. - Document: IG v3.4 - Section: '4.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation - classes should have at least one Timing variable. in the - Events or Interventions general observation class this could - be the start date of the event or intervention. in the - Findings observation class where data are usually collected at - multiple visits, at least one Timing variable must be used. - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class, this could be the - start date of the event or intervention. In the Findings - observation class, where data are usually collected at - multiple visits, at least one Timing variable must be used. - Document: IG v3.3 - Section: '4.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an - essential component of all SDTM subject-level domain - datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. - In the Events or Interventions general observation class this - could be the start date of the event or intervention. In the - Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must beused. - Document: SENDIG v3.0 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class this could be the - start date of the event or intervention. In the Findings - observation class where data are usually collected at multiple - study days, either --DTC or --DY must be used. - Document: SENDIG v3.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class this could be the - start date of the event or intervention. In the Findings - observation class where data are usually collected at multiple - study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class this could be the - start date of the event or intervention. In the Findings - observation class where data are usually collected at multiple - study days, either --DTC or --DY must be used. - Document: SENDIG v3.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class this could be the - start date of the event or intervention. In the Findings - observation class where data are usually collected at multiple - study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component - of all SDTM subject-level domain datasets. In general, all - domains based on the three general observation classes should - have at least one Timing variable. In the Events or - Interventions general observation class this could be the - start date of the event or intervention. In the Findings - observation class where data are usually collected at multiple - study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Include the applicable SDTM Timing variables. In general, the - domain must have at least one timing variable. - Document: TIG v1.0 - Item: 4d - Section: 2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0266 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Include the applicable SDTM Timing variables. In general, the - domain must have at least one timing variable. - Document: TIG v1.0 - Item: 4d - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0433 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class, this could be the start date of the event or + intervention. In the Findings observation class, where data are usually collected at + multiple visits, at least one Timing variable must be used. + Document: IG v3.4 + Section: '4.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In general, all domains based on the three general observation classes + should have at least one Timing variable. in the Events or Interventions general + observation class this could be the start date of the event or intervention. in the + Findings observation class where data are usually collected at multiple visits, at least + one Timing variable must be used. + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class, this could be the start date of the event or + intervention. In the Findings observation class, where data are usually collected at + multiple visits, at least one Timing variable must be used. + Document: IG v3.3 + Section: '4.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all + SDTM subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must beused. + Document: SENDIG v3.0 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Include the applicable SDTM Timing variables. In general, the domain must + have at least one timing variable. + Document: TIG v1.0 + Item: 4d + Section: 2.8.3 How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0266 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Include the applicable SDTM Timing variables. In general, the domain must + have at least one timing variable. + Document: TIG v1.0 + Item: 4d + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0433 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $dataset_variables - operator: shares_no_elements_with - value: $timing_variables + - name: $dataset_variables + operator: shares_no_elements_with + value: $timing_variables Core: Id: CORE-000575 Status: Published Version: '1' -Description: There must be at least one timing variable for any of the domains - based on the three general observation classes +Description: There must be at least one timing variable for any of the domains based on the three + general observation classes Executability: Partially Executable - Possible Underreporting Operations: - - id: $dataset_variables - operator: get_column_order_from_dataset - - id: $timing_variables - key_name: role - key_value: Timing - operator: get_model_filtered_variables +- id: $dataset_variables + operator: get_column_order_from_dataset +- id: $timing_variables + key_name: role + key_value: Timing + operator: get_model_filtered_variables Outcome: Message: No timing variable is provided Output Variables: - - $dataset_variables - - $timing_variables + - $dataset_variables + - $timing_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS - - EVENTS + - FINDINGS + - INTERVENTIONS + - EVENTS Domains: Exclude: - - IE - - SC + - IE + - SC Use Case: NONCLIN, INDH Sensitivity: Dataset diff --git a/Published/CORE-000576/rule.yml b/Published/CORE-000576/rule.yml index e1086c3d6..1f78ae6bc 100644 --- a/Published/CORE-000576/rule.yml +++ b/Published/CORE-000576/rule.yml @@ -1,143 +1,135 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. - For dose levels that vary over time within a set, a - semicolon-delimited string without spaces can be used (e.g., - 100;150;7). For more complex dosing regimens, sponsor should - enter "SEE PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND240.1' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: TXPARMCD - operator: equal_to - value: TRTDOS + - name: TXPARMCD + operator: equal_to + value: TRTDOS # check whether value is a number - - name: TXVAL - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' + - name: TXVAL + operator: not_matches_regex + value: '[+-]?([0-9]*[.])?[0-9]+$' # check whether a comma-separated list of values - - name: TXVAL - operator: not_matches_regex + - name: TXVAL + operator: not_matches_regex # see https://stackoverflow.com/questions/44374088/regex-to-match-comma-separated-numbers-or-stop-full-match-only - value: ^(\s*-?\d+(\.\d+)?)(\s*;\s*-?\d+(\.\d+)?)*$ - - name: TXVAL - operator: not_equal_to - value: SEE PROTOCOL + value: ^(\s*-?\d+(\.\d+)?)(\s*;\s*-?\d+(\.\d+)?)*$ + - name: TXVAL + operator: not_equal_to + value: SEE PROTOCOL Core: Id: CORE-000576 Status: Published Version: '1' -Description: The value of TRTDOS is either a number, a semicolon-delimited - string containing numbers without spaces, or "SEE PROTOCOL" for more complex - dosing regimens. +Description: The value of TRTDOS is either a number, a semicolon-delimited string containing numbers + without spaces, or "SEE PROTOCOL" for more complex dosing regimens. Executability: Fully Executable Outcome: - Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a - semicolon-delimited string containing numbers without spaces, or "SEE - PROTOCOL" + Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string + containing numbers without spaces, or "SEE PROTOCOL" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000577/rule.yml b/Published/CORE-000577/rule.yml index 6c45f3556..a6d03a033 100644 --- a/Published/CORE-000577/rule.yml +++ b/Published/CORE-000577/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per actual Repro Stage per subject - Document: IG-DART v1.1 - Section: '4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND349 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per actual Repro Stage per subject - Document: IG-DART v1.2 - Section: '4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND349 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per actual Repro Stage per subject + Document: IG-DART v1.1 + Section: '4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND349 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per actual Repro Stage per subject + Document: IG-DART v1.2 + Section: '4.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND349 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: RSTGCD - operator: is_not_unique_set - value: - - USUBJID + - name: RSTGCD + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000577 Status: Published @@ -45,8 +45,8 @@ Scope: Classes: Include: # P.S. "SJ" is not recognized as "SPECIAL PURPOSE", Github ticket 586 - - ALL + - ALL Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000578/rule.yml b/Published/CORE-000578/rule.yml index e259ceb19..a23e13f15 100644 --- a/Published/CORE-000578/rule.yml +++ b/Published/CORE-000578/rule.yml @@ -1,80 +1,79 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Only applies to SENDIG-3.1.1 and SENDIG-GENETOX 1.0 and SENDIG-DART 1.2 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of - Quantitation as indicated in PCSTRESC, then the PCLLOQ must be - populated and the PCSTRESU populated with the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of - Quantitation as indicated in PCSTRESC, then the PCLLOQ must be - populated and the PCSTRESU populated with the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of - Quantitation as indicated in PCSTRESC, then the PCLLOQ must be - populated and the PCSTRESU populated with the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND331' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND331' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND331' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: PCSTRESC - operator: equal_to - value: 'BLQ' + - name: PCSTRESC + operator: equal_to + value: 'BLQ' # report an error when either PCLLOQ is not populated or PCSTRESU is not populated - - any: - - name: PCLLOQ - operator: empty - - name: PCSTRESU - operator: empty + - any: + - name: PCLLOQ + operator: empty + - name: PCSTRESU + operator: empty Core: Id: CORE-000578 Status: Published Version: '1' -Description: If the test result in PCORRES is below the Lower Limit of - Quantitation as indicated in PCSTRESC, then the PCLLOQ must be populated and - the PCSTRESU populated with the appropriate unit +Description: If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in + PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with the appropriate unit Executability: Fully Executable Outcome: - Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ - and PCSTRESU must be populated + Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must + be populated Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000580/rule.yml b/Published/CORE-000580/rule.yml index 7da4e8091..18ef11334 100644 --- a/Published/CORE-000580/rule.yml +++ b/Published/CORE-000580/rule.yml @@ -1,113 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that Elements that have different start and end rules are - different Elements and must have different values of ELEMENT - and ETCD. - Document: IG v3.4 - Item: Assumption 13 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Expresses rule for ending Element. Either TEENRL - or TEDUR must be present for each Element.]|Assumption 15[Note - that Elements that have different start and end rules are - different Elements and must have different values of ELEMENT - and ETCD.] - Document: IG v3.2 - Item: Specification|Assumption 15 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that Elements that have different start and end rules are - different Elements and must have different values of ELEMENT - and ETCD. - Document: IG v3.3 - Item: Assumption 15 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Note that elements that have different start and end rules are - different elements and must have different values of ELEMENT - and ETCD. - Document: TIG 1.0 - Item: Assumption 15 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0495 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Note that Elements that have different start and end rules are different + Elements and must have different values of ELEMENT and ETCD. + Document: IG v3.4 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Expresses rule for ending Element. Either TEENRL or TEDUR must + be present for each Element.]|Assumption 15[Note that Elements that have different start + and end rules are different Elements and must have different values of ELEMENT and ETCD.] + Document: IG v3.2 + Item: Specification|Assumption 15 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Note that Elements that have different start and end rules are different + Elements and must have different values of ELEMENT and ETCD. + Document: IG v3.3 + Item: Assumption 15 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Note that elements that have different start and end rules are different + elements and must have different values of ELEMENT and ETCD. + Document: TIG 1.0 + Item: Assumption 15 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0495 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: ETCD # Condition: # Rule: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is unique for each ETCD Check: any: + - name: ETCD + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEENRL + - TEDUR + - all: - name: ETCD + operator: is_unique_set + value: + - ELEMENT + - TESTRL + - TEENRL + - TEDUR + - name: ELEMENT + operator: is_not_unique_set + value: + - TESTRL + - TEENRL + - TEDUR + - name: TESTRL operator: is_not_unique_set value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR - - all: - - name: ETCD - operator: is_unique_set - value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR - - name: ELEMENT - operator: is_not_unique_set - value: - - TESTRL - - TEENRL - - TEDUR - - name: TESTRL - operator: is_not_unique_set - value: - - ELEMENT - - TEENRL - - TEDUR - - name: TEENRL - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEDUR - - name: TEDUR - operator: is_not_unique_set - value: - - ELEMENT - - TEENRL - - TESTRL + - ELEMENT + - TEENRL + - TEDUR + - name: TEENRL + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEDUR + - name: TEDUR + operator: is_not_unique_set + value: + - ELEMENT + - TEENRL + - TESTRL Core: Id: CORE-000580 Status: Published @@ -117,18 +112,18 @@ Executability: Fully Executable Outcome: Message: The combination of TESTRL, TEENRL, and TEDUR is not unique for each ETCD. Output Variables: - - ETCD - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ETCD + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000581/rule.yml b/Published/CORE-000581/rule.yml index f039cc676..ec6cc5dbf 100644 --- a/Published/CORE-000581/rule.yml +++ b/Published/CORE-000581/rule.yml @@ -2,215 +2,208 @@ # Condition: Study on human subjects # Rule: DM dataset present in study Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include 1 standardized set of observations in a - specific structure; this is the Demographics domain described - here. - Document: Model v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include one standardized set of observations in - a specific structure; this is the Demographics domain - described in Table 2.2.6. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include one standardized set of observations in - a specific structure; this is the Demographics domain - described in Table 2.2.6. - Document: Model v1.7 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For studies that assess the impact of tobacco products on the - health of individuals, DM is required even if no other - datasets are generated. - Document: TIG 1.0 - Item: Table 2 Num 3 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0532 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and - define.xml must be submitted in Module 5, sections 5.3.1.1, - 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, - 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and - define.xml must be submitted in Module 5, sections 5.3.1.1, - 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, - 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and - define.xml must be submitted in Module 5, sections 5.3.1.1, - 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, - 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a - Demographic (DM) dataset and define.xml must be submitted in - Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each study must include one standardized set of observations in a specific + structure; this is the Demographics domain described in Table 2.2.6. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each study must include one standardized set of observations in a specific + structure; this is the Demographics domain described in Table 2.2.6. + Document: Model v1.7 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: For studies that assess the impact of tobacco products on the health of + individuals, DM is required even if no other datasets are generated. + Document: TIG 1.0 + Item: Table 2 Num 3 + Section: '2.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0532 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: DM - operator: not_exists + - name: DM + operator: not_exists Core: Id: CORE-000581 Status: Published @@ -223,9 +216,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000583/rule.yml b/Published/CORE-000583/rule.yml index 8e131cc8b..14ff23464 100644 --- a/Published/CORE-000583/rule.yml +++ b/Published/CORE-000583/rule.yml @@ -1,118 +1,112 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule xxx) - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be - included according to the trial summary code table below if - and only if TSVAL is null. - Document: TIG v1.0 - Item: TSVALNF CDISC Notes - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0204 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: TIG v1.0 + Item: TSVALNF CDISC Notes + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0204 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: # 2024-11-19: after discussion with SEND team, also raise an error # when NONE of TSVAL and TSVALNF are populated any: - - all: - - name: TSVAL - operator: non_empty - - name: TSVALNF - operator: non_empty - - all: - - name: TSVAL - operator: empty - - name: TSVALNF - operator: empty + - all: + - name: TSVAL + operator: non_empty + - name: TSVALNF + operator: non_empty + - all: + - name: TSVAL + operator: empty + - name: TSVALNF + operator: empty Core: Id: CORE-000583 Status: Published Version: "1" -Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error - when TSVAL and TSVALNF are populated, or when both variables are empty. +Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and + TSVALNF are populated, or when both variables are empty. Executability: Fully Executable Outcome: Message: Either both TSVALNF and TSVAL are populated, or both are empty. @@ -120,9 +114,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000584/rule.yml b/Published/CORE-000584/rule.yml index f7aef66a0..1b5104dc9 100644 --- a/Published/CORE-000584/rule.yml +++ b/Published/CORE-000584/rule.yml @@ -1,152 +1,150 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.0 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory Test Results — Findings. One record per test - per specimen per observation time per subject or pool, - Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0098 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.0 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND169' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: lb.xpt, Laboratory Test Results — Findings. One record per test per specimen + per observation time per subject or pool, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0098 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: any: - - all: - - name: LBDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: LBTESTCD - operator: is_not_unique_set - value: - - USUBJID - - LBSPEC - - LBDTC - - all: - - name: LBDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: LBTESTCD - operator: is_not_unique_set - value: - - POOLID - - LBSPEC - - LBDTC + - all: + - name: LBDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: LBTESTCD + operator: is_not_unique_set + value: + - USUBJID + - LBSPEC + - LBDTC + - all: + - name: LBDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: LBTESTCD + operator: is_not_unique_set + value: + - POOLID + - LBSPEC + - LBDTC Core: Id: CORE-000584 Status: Published Version: '1' -Description: Raise an error when there is more than one record present per test - per specimen, in the LB Domain, for a subject or pool on a particular date. +Description: Raise an error when there is more than one record present per test per specimen, in the + LB Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: - Message: The LB test result is not unique per specimen per subject or pool and - date/time. + Message: The LB test result is not unique per specimen per subject or pool and date/time. Output Variables: - - POOLID - - LBTESTCD - - LBSPEC - - LBDTC + - POOLID + - LBTESTCD + - LBSPEC + - LBDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000590/rule.yml b/Published/CORE-000590/rule.yml index e6b193457..f4d4e6cea 100644 --- a/Published/CORE-000590/rule.yml +++ b/Published/CORE-000590/rule.yml @@ -2,38 +2,35 @@ # Condition: Study of tobacco product(s) # Rule: TO dataset is required in all studies of tobacco products Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: 'TO is a study reference dataset that provides a consistent - identifier, the Applicant-defined Tobacco Product Identifier - (SPTOBID), for a tobacco product in a study. It contains the - identifying and descriptive characteristics of a tobacco - product and merges those characteristics on this single - identifier. This dataset is required for studies of tobacco - products.' - Document: 'TIG 1.0' - Item: 'assumption 1' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0001' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: 'TO is a study reference dataset that provides a consistent identifier, the Applicant-defined + Tobacco Product Identifier (SPTOBID), for a tobacco product in a study. It contains the identifying + and descriptive characteristics of a tobacco product and merges those characteristics on this + single identifier. This dataset is required for studies of tobacco products.' + Document: 'TIG 1.0' + Item: 'assumption 1' + Section: '2.8.8.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0001' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TO - operator: not_exists + - name: TO + operator: not_exists Core: Id: CORE-000590 Status: Published Version: '1' -Description: Raise an error when the study is a study of tobacco product(s) but - the TO dataset is not present. +Description: Raise an error when the study is a study of tobacco product(s) but the TO dataset is + not present. Executability: Fully Executable Outcome: Message: Required TO dataset for study of tobacco product(s) is not present. @@ -41,9 +38,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: PROD Sensitivity: Dataset diff --git a/Published/CORE-000591/rule.yml b/Published/CORE-000591/rule.yml index 465b6183a..19ad92e58 100644 --- a/Published/CORE-000591/rule.yml +++ b/Published/CORE-000591/rule.yml @@ -1,57 +1,56 @@ # Variable: TOPARMCD # Rule: TOPARMCD=TBPRDCAT present in dataset Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A minimally meaningful TO dataset must include at least the - parameter for tobacco product category (TOPARMCD = TPRDCAT) - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0003' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: A minimally meaningful TO dataset must include at least the parameter for + tobacco product category (TOPARMCD = TPRDCAT) + Document: 'TIG 1.0' + Item: 'assumption 2' + Section: '2.8.8.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0003' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $tbprdcat_count - operator: equal_to - value: 0 + - name: $tbprdcat_count + operator: equal_to + value: 0 Core: + Id: CORE-000591 Status: Published Version: '1' - Id: CORE-000591 -Description: Raise an error when there is no record present in TO per SPTOBID - where TOPARMCD equals TBPRDCAT. +Description: Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals + TBPRDCAT. Executability: Fully Executable Operations: - - domain: TO - filter: - TOPARMCD: TBPRDCAT - group: - - SPTOBID - id: $tbprdcat_count - name: TOPARMCD - operator: record_count +- domain: TO + filter: + TOPARMCD: TBPRDCAT + group: + - SPTOBID + id: $tbprdcat_count + name: TOPARMCD + operator: record_count Outcome: - Message: TO dataset does not include a record for each SPTOBID where TOPARMCD = - TBPRDCAT. + Message: TO dataset does not include a record for each SPTOBID where TOPARMCD = TBPRDCAT. Output Variables: - - SPTOBID - - $tbprdcat_count + - SPTOBID + - $tbprdcat_count Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000592/rule.yml b/Published/CORE-000592/rule.yml index 5d7e5195a..ef9161c43 100644 --- a/Published/CORE-000592/rule.yml +++ b/Published/CORE-000592/rule.yml @@ -2,49 +2,48 @@ # Condition: TOPARMCD = TBPRDCAT # Rule: TOVAL ^= null Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A minimally meaningful TO dataset must include at least the - parameter for tobacco product category (TOPARMCD = TPRDCAT) - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0004' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: A minimally meaningful TO dataset must include at least the parameter for + tobacco product category (TOPARMCD = TPRDCAT) + Document: 'TIG 1.0' + Item: 'assumption 2' + Section: '2.8.8.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0004' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TOPARMCD - operator: equal_to - value: TBPRDCAT - - name: TOVAL - operator: empty + - name: TOPARMCD + operator: equal_to + value: TBPRDCAT + - name: TOVAL + operator: empty Core: + Id: CORE-000592 Status: Published Version: '1' - Id: CORE-000592 -Description: Raise an error when TOVAL is not completed for records where - TOPARMCD equals TBPRDCAT. +Description: Raise an error when TOVAL is not completed for records where TOPARMCD equals TBPRDCAT. Executability: Fully Executable Outcome: Message: TOVAL is not completed when TOPARMCD = TBPRDCAT. Output Variables: - - TOPARMCD - - TOVAL + - TOPARMCD + - TOVAL Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000593/rule.yml b/Published/CORE-000593/rule.yml index 6a9cafbea..291c95b29 100644 --- a/Published/CORE-000593/rule.yml +++ b/Published/CORE-000593/rule.yml @@ -2,71 +2,69 @@ # Condition: PTMETHOD = null / PTXFN = null # Rule: PTXFN ^= null / PTMETHOD ^= null Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When lab methodology is too complex for the single PTMETHOD - variable, PTXFN should be used to reference a file name or - path to a file in the application that describes the - methodology used. One or the other of PTMETHOD or PTXFN should - be included in the data. - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0006' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When lab methodology is too complex for the single PTMETHOD - variable, PTXFN should be used to reference a file name or - path to a file in the application that describes the - methodology used. One or the other of PTMETHOD or PTXFN should - be included in the data. - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0007' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: When lab methodology is too complex for the single PTMETHOD variable, PTXFN + should be used to reference a file name or path to a file in the application that + describes the methodology used. One or the other of PTMETHOD or PTXFN should be included + in the data. + Document: 'TIG 1.0' + Item: 'assumption 6' + Section: '2.8.8.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0006' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: When lab methodology is too complex for the single PTMETHOD variable, PTXFN + should be used to reference a file name or path to a file in the application that + describes the methodology used. One or the other of PTMETHOD or PTXFN should be included + in the data. + Document: 'TIG 1.0' + Item: 'assumption 6' + Section: '2.8.8.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0007' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: PTMETHOD - operator: empty - - name: PTXFN - operator: empty + - name: PTMETHOD + operator: empty + - name: PTXFN + operator: empty Core: + Id: CORE-000593 Status: Published Version: '1' - Id: CORE-000593 Description: Raise an error when PTMETHOD and PTXFN are both not populated. Executability: Fully Executable Outcome: Message: At least one of PTMETHOD and PTXFN variables should be populated. Output Variables: - - SPTOBID - - PTMETHOD - - PTXFN + - SPTOBID + - PTMETHOD + - PTXFN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PT + - PT Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000594/rule.yml b/Published/CORE-000594/rule.yml index e2b41857f..eb9d721bd 100644 --- a/Published/CORE-000594/rule.yml +++ b/Published/CORE-000594/rule.yml @@ -2,174 +2,170 @@ # Condition: # Rule: Variable labels are in title case Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize - the first letter of every word except for articles, - prepositions, and conjunctions). - Document: IG v3.4 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize - the first letter of every word except for articles; - prepositions; and conjunctions). - Document: IG v3.2 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize - the first letter of every word except for articles; - prepositions; and conjunctions). - Document: IG v3.3 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in - title case, should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be - provided as data variable labels for all variables, including - Supplemental Qualifier variables. Use title case for all - labels - Document: TIG 1.0 - Item: Tabulation Datasets table NUM 5 - Section: 2.6|2.8.2|2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0524 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be - provided as data variable labels for all variables, including - Supplemental Qualifier variables. - Document: TIG 1.0 - Item: Tabulation Datasets table, Num 5 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0205 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Use title case for all labels (title case means to capitalize the first + letter of every word except for articles, prepositions, and conjunctions). + Document: IG v3.4 + Item: 3h + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Use title case for all labels (title case means to capitalize the first + letter of every word except for articles; prepositions; and conjunctions). + Document: IG v3.2 + Item: 3h + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Use title case for all labels (title case means to capitalize the first + letter of every word except for articles; prepositions; and conjunctions). + Document: IG v3.3 + Item: 3h + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. Use + title case for all labels + Document: TIG 1.0 + Item: Tabulation Datasets table NUM 5 + Section: 2.6|2.8.2|2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0524 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG 1.0 + Item: Tabulation Datasets table, Num 5 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0205 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: variable_label - operator: not_matches_regex + - name: variable_label + operator: not_matches_regex # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|([A-Z]\S*))\s*)*$ # Updated by Jozef Aerts, added "and/or", "is", "within" and "from" # as these appear in existing labels in SDTM Model 2.0 (I did not check in earlier model versions) # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|and/or|is|within|from|([A-Z]\S*))\s*)*$ # update 2025-07-24: - value: ^\s*[A-Z]\S*\s*((a|an|the|as|and|per|to|but|or|for|in|is|of|on|with|and\/or|is|within|from|([A-Z]\S*))\s*)*$ + value: + ^\s*[A-Z]\S*\s*((a|an|the|as|and|per|to|but|or|for|in|is|of|on|with|and\/or|is|within|from|([A-Z]\S*))\s*)*$ Core: Id: CORE-000594 Status: Published @@ -182,9 +178,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000595/rule.yml b/Published/CORE-000595/rule.yml index b0aa7c247..6e35f042f 100644 --- a/Published/CORE-000595/rule.yml +++ b/Published/CORE-000595/rule.yml @@ -2,62 +2,62 @@ # Condition: CASNO = null / UNII = null # Rule: UNII ^= null / CASNO ^= null Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: At least one of the two permissible variables CASNO or UNII - should also be provided if available. - Document: 'TIG 1.0' - Item: 'assumption 3.d.ii' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0010' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: At least one of the two permissible variables CASNO or UNII - should also be provided if available. - Document: 'TIG 1.0' - Item: 'assumption 3.d.ii' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0011' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: At least one of the two permissible variables CASNO or UNII should also be + provided if available. + Document: 'TIG 1.0' + Item: 'assumption 3.d.ii' + Section: '2.8.8.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0010' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: At least one of the two permissible variables CASNO or UNII should also be + provided if available. + Document: 'TIG 1.0' + Item: 'assumption 3.d.ii' + Section: '2.8.8.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0011' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: UNII - operator: empty - - name: CASNO - operator: empty - - all: - - name: UNII - operator: not_exists - - name: CASNO - operator: not_exists - - all: - - name: UNII - operator: not_exists - - name: CASNO - operator: empty - - all: - - name: CASNO - operator: not_exists - - name: UNII - operator: empty + - all: + - name: UNII + operator: empty + - name: CASNO + operator: empty + - all: + - name: UNII + operator: not_exists + - name: CASNO + operator: not_exists + - all: + - name: UNII + operator: not_exists + - name: CASNO + operator: empty + - all: + - name: CASNO + operator: not_exists + - name: UNII + operator: empty Core: Id: CORE-000595 Status: Published @@ -65,18 +65,18 @@ Core: Description: Raise an error when UNII and CASNO are both not populated. Executability: Fully Executable Outcome: - Message: At least one of the UNII and CASNO variables should be present and - populated for each ingredient if available. + Message: At least one of the UNII and CASNO variables should be present and populated for each + ingredient if available. Output Variables: - - UNII - - CASNO + - UNII + - CASNO Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000596/rule.yml b/Published/CORE-000596/rule.yml index cd5e4cd1c..cee818bff 100644 --- a/Published/CORE-000596/rule.yml +++ b/Published/CORE-000596/rule.yml @@ -2,60 +2,58 @@ # Condition: INGRADE = null AND INPURITY = null # Rule: TPMF ^= null Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Ingredient grade (INGRADE) and purity (INPURITY). According to - the PMTA rule, at least one of these two attributes must be - included. If the data are proprietary and only available via - the TPMF, then TPMF should be populated. - Document: 'TIG 1.0' - Item: 'assumption 3.f' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0012' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA + rule, at least one of these two attributes must be included. If the data are proprietary + and only available via the TPMF, then TPMF should be populated. + Document: 'TIG 1.0' + Item: 'assumption 3.f' + Section: '2.8.8.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0012' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: INGRADE + - name: INGRADE + operator: empty + - name: INPURITY + operator: empty + - any: + - name: TPMF operator: empty - - name: INPURITY - operator: empty - - any: - - name: TPMF - operator: empty - - name: TPMF - operator: not_exists + - name: TPMF + operator: not_exists Core: + Id: CORE-000596 Status: Published Version: '1' - Id: CORE-000596 Description: Raise an error when INGRADE, INPURITY and TPMF are all not populated. Executability: Fully Executable Outcome: - Message: At least one of INGRADE or INPURITY should be populated. If neither is - available due to the ingredient being proprietary and originating from a - third-party supplier, populate TPMF with the Tobacco Product Master File - number provided by the supplier. + Message: At least one of INGRADE or INPURITY should be populated. If neither is available due to + the ingredient being proprietary and originating from a third-party supplier, populate TPMF with + the Tobacco Product Master File number provided by the supplier. Output Variables: - - INGRADE - - INPURITY - - TPMF - - IGDCMPID - - SPTOBID + - INGRADE + - INPURITY + - TPMF + - IGDCMPID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000597/rule.yml b/Published/CORE-000597/rule.yml index d610d5527..383a3ed8e 100644 --- a/Published/CORE-000597/rule.yml +++ b/Published/CORE-000597/rule.yml @@ -2,82 +2,78 @@ # Condition: Record present in SUPPAE where SUPPAE.QNAM=AESOSP # Rule: AESMIE = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse - Events category is collected on a CRF, sponsors should place - the description in the SUPPAE dataset using the standard - supplemental qualifier name code AESOSP. - Document: IG v3.4 - Item: Asumtpion 6c - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse - Events category is collected on a CRF, sponsors should place - the description in the SUPPAE dataset using the standard - supplemental qualifier name code AESOSP. - Document: IG v3.2 - Item: Assumption 6c - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse - Events category is collected on a CRF, sponsors should place - the description in the SUPPAE dataset using the standard - supplemental qualifier name code AESOSP. - Document: IG v3.3 - Item: Assumption 6c - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: When a description of "Other Medically Important Serious Adverse - Events" category is collected on a CRF, applicants should - place the description in the SUPPAE dataset using the standard - supplemental qualifier name code AESOSP. - Document: TIG 1.0 - Item: Assumption 7c - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0322 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.4 + Item: Asumtpion 6c + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.2 + Item: Assumption 6c + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.3 + Item: Assumption 6c + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: When a description of "Other Medically Important Serious Adverse Events" + category is collected on a CRF, applicants should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: TIG 1.0 + Item: Assumption 7c + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0322 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: QNAM - operator: equal_to - value: AESOSP - value_is_literal: true - - name: AESMIE - operator: not_equal_to - value: Y + - name: QNAM + operator: equal_to + value: AESOSP + value_is_literal: true + - name: AESMIE + operator: not_equal_to + value: Y Core: Id: CORE-000597 Status: Published @@ -85,21 +81,21 @@ Core: Description: When SUPPAE.QNAM=AESOSP is present, a record with AESMIE=Y should be present Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: SUPPAE +- Keys: + - USUBJID + Name: SUPPAE Outcome: Message: Missing AESMIE=Y where SUPPAE.QNAM=AESOSP Output Variables: - - QNAM - - AESMIE + - QNAM + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000598/rule.yml b/Published/CORE-000598/rule.yml index d81b6da72..736f4096d 100644 --- a/Published/CORE-000598/rule.yml +++ b/Published/CORE-000598/rule.yml @@ -2,189 +2,174 @@ # Condition: # Rule: Dataset name begins with DOMAIN value Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study subject domain dataset is distinguished by a unique, - 2-character code that should be used consistently throughout - the submission. This code, which is stored in the SDTM - variable named DOMAIN, is used in the dataset name, as the - value of the DOMAIN variable in that dataset, and as a prefix - for most variable names in that dataset. - Document: Model v2.0 - Section: Study Subject Data - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'This code; which is stored in the SDTM variable named DOMAIN; - is used in four ways: as the dataset name; the value of the - DOMAIN variable in that dataset; as a prefix for most variable - names in that dataset; and as a value in the RDOMAIN variable - in relationship tables.' - Document: Model v1.4 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Each domain dataset is distinguished by a unique; 2-character - code that should be used consistently throughout the - submission. This code; which is stored in the SDTM variable - named DOMAIN; is used in 4 ways: as the dataset name; as the - value of the DOMAIN variable in that dataset; as a prefix for - most variable names in that dataset; and as a value in the - RDOMAIN variable in relationship tables.' - Document: Model v1.7 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each study subject domain dataset is distinguished by a unique - 2-character code. This code, which is stored in the SDTM - variable named DOMAIN, is used in the dataset name, as the - value of the DOMAIN variable in that dataset, and as a prefix - for most variable names in that dataset. - Document: SDTM v2.1 - Item: DOMAIN - Section: Section 3 Study Subject Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0568 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Domain datasets based on the SDTM general observations classes - will be named using the two-character code for the domain or - using the applicable four-character code when a dataset is - split. Supplemental Qualifier datasets will be named using - convention SUPP concatenated with the two-character domain - code or four-character code when a dataset is split (e.g., - SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named - using the code for the domain or dataset and (e.g., DM, - RELREC). - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 2 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0037 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each study subject domain dataset is distinguished by a unique, 2-character + code that should be used consistently throughout the submission. This code, which is + stored in the SDTM variable named DOMAIN, is used in the dataset name, as the value of the + DOMAIN variable in that dataset, and as a prefix for most variable names in that dataset. + Document: Model v2.0 + Section: Study Subject Data + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'This code; which is stored in the SDTM variable named DOMAIN; is used in four + ways: as the dataset name; the value of the DOMAIN variable in that dataset; as a prefix for + most variable names in that dataset; and as a value in the RDOMAIN variable in relationship + tables.' + Document: Model v1.4 + Section: '2.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Each domain dataset is distinguished by a unique; 2-character code that should + be used consistently throughout the submission. This code; which is stored in the SDTM variable + named DOMAIN; is used in 4 ways: as the dataset name; as the value of the DOMAIN variable in + that dataset; as a prefix for most variable names in that dataset; and as a value in the RDOMAIN + variable in relationship tables.' + Document: Model v1.7 + Section: '2.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Each study subject domain dataset is distinguished by a unique 2-character + code. This code, which is stored in the SDTM variable named DOMAIN, is used in the dataset + name, as the value of the DOMAIN variable in that dataset, and as a prefix for most + variable names in that dataset. + Document: SDTM v2.1 + Item: DOMAIN + Section: Section 3 Study Subject Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0568 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Domain datasets based on the SDTM general observations classes will be named + using the two-character code for the domain or using the applicable four-character code + when a dataset is split. Supplemental Qualifier datasets will be named using convention + SUPP concatenated with the two-character domain code or four-character code when a dataset + is split (e.g., SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named using the code + for the domain or dataset and (e.g., DM, RELREC). + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 2 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0037 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: dataset_name - operator: prefix_not_equal_to - prefix: 2 - value: DOMAIN + - name: dataset_name + operator: prefix_not_equal_to + prefix: 2 + value: DOMAIN Core: Id: CORE-000598 Status: Published @@ -197,12 +182,12 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - SUPP-- - - RELREC - - RELREF - - POOLDEF + - SUPP-- + - RELREC + - RELREF + - POOLDEF Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000599/rule.yml b/Published/CORE-000599/rule.yml index 388c68edf..dc5b12043 100644 --- a/Published/CORE-000599/rule.yml +++ b/Published/CORE-000599/rule.yml @@ -1,105 +1,105 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.0 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.0 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # Remark: In SEND, "no test article (as described in EXTRT) is administered", is depicted as EXDOSE=0 # and NOT by EXDOSE being empty. Information from Christy Kubin 2023-03-20 - - name: EXDOSE - operator: equal_to - value: 0 - - name: EXLOT - operator: non_empty + - name: EXDOSE + operator: equal_to + value: 0 + - name: EXLOT + operator: non_empty Core: Id: CORE-000599 Status: Published Version: '1' -Description: If no test article (as described in EXTRT) is administered (i.e., - EXDOSE is 0), EXLOT is null. +Description: If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT + is null. Executability: Fully Executable Outcome: Message: EXDOSE is 0, EXLOT may not be populated Output Variables: - - EXDOSE - - EXLOT + - EXDOSE + - EXLOT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000600/rule.yml b/Published/CORE-000600/rule.yml index 118a31598..7e24ffddd 100644 --- a/Published/CORE-000600/rule.yml +++ b/Published/CORE-000600/rule.yml @@ -1,67 +1,66 @@ # Variable: PARENT # Rule: For each value in PARENT there must exist one record with REFID value = PARENT value. Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Every value of PARENT must be defined once and only once. Every - PARENT must have a unique REFID which may be referenced by - multiple records with the same PARENT. (Each REFID with a - PARENT, has only one PARENT and that PARENT is described in a - unique PARENT record.). - Document: 'TIG 1.0' - Item: 'assumption 4' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0030' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Every value of PARENT must be defined once and only once. Every PARENT must + have a unique REFID which may be referenced by multiple records with the same PARENT. + (Each REFID with a PARENT, has only one PARENT and that PARENT is described in a unique + PARENT record.). + Document: 'TIG 1.0' + Item: 'assumption 4' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0030' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: LEVEL - operator: not_equal_to - value: 1 - - any: - - name: PARENT - operator: is_not_contained_by - value: $relref_refid - within: SETCD - - name: PARENT - operator: equal_to - value: REFID + - name: LEVEL + operator: not_equal_to + value: 1 + - any: + - name: PARENT + operator: is_not_contained_by + value: $relref_refid + within: SETCD + - name: PARENT + operator: equal_to + value: REFID Core: + Id: CORE-000600 Status: Published Version: '1' - Id: CORE-000600 -Description: Raise an error when a record has a PARENT value but no other record - exists with REFID value = PARENT value. +Description: Raise an error when a record has a PARENT value but no other record exists with REFID + value = PARENT value. Executability: Fully Executable Operations: - - domain: RELREF - group: - - SETCD - id: $relref_refid - name: REFID - operator: distinct +- domain: RELREF + group: + - SETCD + id: $relref_refid + name: REFID + operator: distinct Outcome: Message: Value for PARENT does not equal a REFID value from another record. Output Variables: - - LEVEL - - PARENT - - SETCD - - $relref_refid + - LEVEL + - PARENT + - SETCD + - $relref_refid Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000601/rule.yml b/Published/CORE-000601/rule.yml index 6ce2a73d7..1b4e9e79e 100644 --- a/Published/CORE-000601/rule.yml +++ b/Published/CORE-000601/rule.yml @@ -1,65 +1,65 @@ # Variable: IQPARENT # Rule: IQPARENT in IGDCMPID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IQPARENT must equal the IDGCMPID of another record in IQ (i.e., - the parent ingredient/component must be listed in IQ). - Document: 'TIG 1.0' - Item: 'assumption 4.a.i.' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0015' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: IQPARENT must equal the IDGCMPID of another record in IQ (i.e., the parent + ingredient/component must be listed in IQ). + Document: 'TIG 1.0' + Item: 'assumption 4.a.i.' + Section: '2.8.8.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0015' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IQLEVEL - operator: not_equal_to - value: 1 - - any: - - name: IQPARENT - operator: is_not_contained_by - value: $iq_igdcmpid - within: SPTOBID - - name: IQPARENT - operator: equal_to - value: IGDCMPID + - name: IQLEVEL + operator: not_equal_to + value: 1 + - any: + - name: IQPARENT + operator: is_not_contained_by + value: $iq_igdcmpid + within: SPTOBID + - name: IQPARENT + operator: equal_to + value: IGDCMPID Core: + Id: CORE-000601 Status: Published Version: '1' - Id: CORE-000601 -Description: Raise an error when per SPTOBID, the IQPARENT value does not match - any IGDCMPID value of another record. +Description: Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value + of another record. Executability: Fully Executable Operations: - - domain: IQ - group: - - SPTOBID - id: $iq_igdcmpid - name: IGDCMPID - operator: distinct +- domain: IQ + group: + - SPTOBID + id: $iq_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IQPARENT value does not match an ingredient represented in another - records IGDCMPID value. + Message: IQPARENT value does not match an ingredient represented in another records IGDCMPID + value. Output Variables: - - SPTOBID - - IGDCMPID - - IQPARENT - - $iq_igdcmpid + - SPTOBID + - IGDCMPID + - IQPARENT + - $iq_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000602/rule.yml b/Published/CORE-000602/rule.yml index 67bb8cb1a..760c90e26 100644 --- a/Published/CORE-000602/rule.yml +++ b/Published/CORE-000602/rule.yml @@ -2,50 +2,50 @@ # Condition: Record does not have associated PARENT records # Rule: Value for LEVEL = 1 Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: The value for LEVEL must be 1 for a record without a PARENT - record. This record may or may not have a child record. - Document: 'TIG 1.0' - Item: 'assumption 5' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0032' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: The value for LEVEL must be 1 for a record without a PARENT record. This + record may or may not have a child record. + Document: 'TIG 1.0' + Item: 'assumption 5' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0032' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: PARENT - operator: empty - - name: LEVEL - operator: not_equal_to - value: 1 + - name: PARENT + operator: empty + - name: LEVEL + operator: not_equal_to + value: 1 Core: + Id: CORE-000602 Status: Published Version: '1' - Id: CORE-000602 -Description: Raise an error when a record does not have associated PARENT - records but the value for LEVEL does not equal '1'. +Description: Raise an error when a record does not have associated PARENT records but the value for + LEVEL does not equal '1'. Executability: Fully Executable Outcome: Message: Record has no PARENT record in RELREF but LEVEL value does not equal '1'. Output Variables: - - LEVEL - - PARENT - - SETCD + - LEVEL + - PARENT + - SETCD Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000603/rule.yml b/Published/CORE-000603/rule.yml index 818f9ff4c..157047ece 100644 --- a/Published/CORE-000603/rule.yml +++ b/Published/CORE-000603/rule.yml @@ -1,45 +1,45 @@ # Variable: REFID # Rule: REFID value is unique Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: One record per Reference ID - Document: 'TIG 1.0' - Item: 'Domain Table Header' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0034' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: One record per Reference ID + Document: 'TIG 1.0' + Item: 'Domain Table Header' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0034' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: REFID - operator: is_not_unique_set - value: STUDYID + - name: REFID + operator: is_not_unique_set + value: STUDYID Core: + Id: CORE-000603 Status: Published Version: '1' - Id: CORE-000603 Description: Raise an error when the REFID value is not unique. Executability: Fully Executable Outcome: Message: REFID value is not unique. Output Variables: - - STUDYID - - REFID + - STUDYID + - REFID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000604/rule.yml b/Published/CORE-000604/rule.yml index 5e7fe0dec..9048ac0f8 100644 --- a/Published/CORE-000604/rule.yml +++ b/Published/CORE-000604/rule.yml @@ -2,66 +2,65 @@ # Condition: TOPARMCD where TOCAT="NEW PRODUCT" and TOSCAT="PRODUCT DESCRIPTOR" # Rule: TOPARMCD in PDPARMCD Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Design parameter data must be included for all new tobacco - products in the application - Document: 'TIG 1.0' - Item: 'assumption 4' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0005' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Design parameter data must be included for all new tobacco products in the + application + Document: 'TIG 1.0' + Item: 'assumption 4' + Section: '2.8.8.2' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0005' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TOCAT - operator: equal_to - value: NEW PRODUCT - value_is_literal: true - - name: TOSCAT - operator: equal_to - value: PRODUCT DESCRIPTOR - value_is_literal: true - - name: TOPARMCD - operator: is_not_contained_by - value: $distinct_pdparmcd - within: SPTOBID + - name: TOCAT + operator: equal_to + value: NEW PRODUCT + value_is_literal: true + - name: TOSCAT + operator: equal_to + value: PRODUCT DESCRIPTOR + value_is_literal: true + - name: TOPARMCD + operator: is_not_contained_by + value: $distinct_pdparmcd + within: SPTOBID Core: Id: CORE-000604 Status: Published Version: '1' -Description: Raise an error when a TOPARMCD in the TO dataset categorized as - TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR does not have a matching - PDPARMCD in the PD dataset. +Description: Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and + TOSCAT = PRODUCT DESCRIPTOR does not have a matching PDPARMCD in the PD dataset. Executability: Fully Executable Operations: - - domain: PD - group: - - SPTOBID - id: $distinct_pdparmcd - name: PDPARMCD - operator: distinct +- domain: PD + group: + - SPTOBID + id: $distinct_pdparmcd + name: PDPARMCD + operator: distinct Outcome: - Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = - PRODUCT DESCRIPTOR but does not have a matching PDPARMCD per SPTOBID in PD. + Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but + does not have a matching PDPARMCD per SPTOBID in PD. Output Variables: - - SPTOBID - - TOPARMCD - - $distinct_pdparmcd + - SPTOBID + - TOPARMCD + - $distinct_pdparmcd Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000605/rule.yml b/Published/CORE-000605/rule.yml index 835b875ca..0bfdc6087 100644 --- a/Published/CORE-000605/rule.yml +++ b/Published/CORE-000605/rule.yml @@ -2,76 +2,76 @@ # Condition: IQ domain present in study # Rule: IGDCMPID in IQ.IGDCMPID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every - value of IGDCMPID in IT) must be accounted for in IQ (see IQ - domain specification and assumptions for more information). - Document: 'TIG 1.0' - Item: 'assumption 2b' - Section: '2.8.8.4' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0008' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every - value of IGDCMPID in IN) must be accounted for in IQ (see IQ - domain specification and assumptions for more information). - Document: 'TIG 1.0' - Item: 'assumption 2b' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0009' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of + IGDCMPID in IT) must be accounted for in IQ (see IQ domain specification and assumptions + for more information). + Document: 'TIG 1.0' + Item: 'assumption 2b' + Section: '2.8.8.4' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0008' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of + IGDCMPID in IN) must be accounted for in IQ (see IQ domain specification and assumptions + for more information). + Document: 'TIG 1.0' + Item: 'assumption 2b' + Section: '2.8.8.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0009' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IGDCMPID - operator: is_not_contained_by - value: $iq_igdcmpid - within: SPTOBID + - name: IGDCMPID + operator: is_not_contained_by + value: $iq_igdcmpid + within: SPTOBID Core: + Id: CORE-000605 Status: Published Version: '1' - Id: CORE-000605 -Description: Raise an error when a IGDCMPID in the dataset does not have a - matching IGDCMPID in the IQ dataset per SPTOBID. +Description: Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the + IQ dataset per SPTOBID. Executability: Fully Executable Operations: - - domain: IQ - group: - - SPTOBID - id: $iq_igdcmpid - name: IGDCMPID - operator: distinct +- domain: IQ + group: + - SPTOBID + id: $iq_igdcmpid + name: IGDCMPID + operator: distinct Outcome: Message: IGDCMPID does not have a matching IGDCMPID per SPTOBID in IQ. Output Variables: - - SPTOBID - - IGDCMPID - - $iq_igdcmpid + - SPTOBID + - IGDCMPID + - $iq_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IT - - IN + - IT + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000606/rule.yml b/Published/CORE-000606/rule.yml index 56824240f..cc17e2e4d 100644 --- a/Published/CORE-000606/rule.yml +++ b/Published/CORE-000606/rule.yml @@ -2,65 +2,63 @@ # Condition: IQCAT = TOBACCO INGREDIENT # Rule: IGDCMPID in IT.IGDCMPID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IGDCMPID represents the unique ingredient name established in - either the Tobacco Ingredients (IT) domain or the Non-Tobacco - Ingredients (IN) domain. Therefore, every value of IDGCMPID in - the IQ domain must have an exact match in either IT or IN - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0013' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: IGDCMPID represents the unique ingredient name established in either the + Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, + every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN + Document: 'TIG 1.0' + Item: 'assumption 2' + Section: '2.8.8.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0013' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IQCAT - operator: equal_to - value: TOBACCO INGREDIENT - value_is_literal: true - - name: IGDCMPID - operator: is_not_contained_by - value: $it_igdcmpid - within: SPTOBID + - name: IQCAT + operator: equal_to + value: TOBACCO INGREDIENT + value_is_literal: true + - name: IGDCMPID + operator: is_not_contained_by + value: $it_igdcmpid + within: SPTOBID Core: + Id: CORE-000606 Status: Published Version: '1' - Id: CORE-000606 -Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ - dataset (IQCAT = TOBACCO INGREDIENT) does not have a matching IGDCMPID per - SPTOBID in the IT dataset +Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT = + TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IT dataset Executability: Fully Executable Operations: - - domain: IT - group: - - SPTOBID - id: $it_igdcmpid - name: IGDCMPID - operator: distinct +- domain: IT + group: + - SPTOBID + id: $it_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have - a matching IGDCMPID per SPTOBID in IT. + Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching + IGDCMPID per SPTOBID in IT. Output Variables: - - SPTOBID - - IGDCMPID - - IQCAT - - $it_igdcmpid + - SPTOBID + - IGDCMPID + - IQCAT + - $it_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000607/rule.yml b/Published/CORE-000607/rule.yml index 9408f72d6..2d9fe7f4d 100644 --- a/Published/CORE-000607/rule.yml +++ b/Published/CORE-000607/rule.yml @@ -1,54 +1,53 @@ # Variable: STOCONID # Rule: STOCONID in ES.STOCONID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Applicant-defined identifier for a set of storage conditions - that are represented in the ES domain, where this identifier - originates. - Document: 'TIG 1.0' - Item: 'STOCONID, CDISC Notes column' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0017' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Applicant-defined identifier for a set of storage conditions that are + represented in the ES domain, where this identifier originates. + Document: 'TIG 1.0' + Item: 'STOCONID, CDISC Notes column' + Section: '2.8.8.3' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0017' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: STOCONID - operator: is_not_contained_by - value: $es_stoconid + - name: STOCONID + operator: is_not_contained_by + value: $es_stoconid Core: + Id: CORE-000607 Status: Published Version: '1' - Id: CORE-000607 -Description: Raise an error when value for STOCONID in the PT dataset does not - match a STOCONID specified in the ES dataset. +Description: Raise an error when value for STOCONID in the PT dataset does not match a STOCONID + specified in the ES dataset. Executability: Fully Executable Operations: - - domain: ES - id: $es_stoconid - name: STOCONID - operator: distinct +- domain: ES + id: $es_stoconid + name: STOCONID + operator: distinct Outcome: Message: STOCONID does not have a matching STOCONID in ES. Output Variables: - - SPTOBID - - STOCONID - - $es_stoconid + - SPTOBID + - STOCONID + - $es_stoconid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PT + - PT Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000608/rule.yml b/Published/CORE-000608/rule.yml index c8ce8a59a..890b29949 100644 --- a/Published/CORE-000608/rule.yml +++ b/Published/CORE-000608/rule.yml @@ -1,106 +1,100 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval - per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: RETESTCD - operator: is_not_unique_set - value: - - USUBJID - - REDTC - - name: RETESTCD - operator: is_not_unique_set - value: - - USUBJID - - REDTC - - RESTINT + - name: RETESTCD + operator: is_not_unique_set + value: + - USUBJID + - REDTC + - name: RETESTCD + operator: is_not_unique_set + value: + - USUBJID + - REDTC + - RESTINT Core: Id: CORE-000608 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular respiratory test for a subject and measurement date/time or - evaluation interval. +Description: Raise an error when there is more than one record present for any particular + respiratory test for a subject and measurement date/time or evaluation interval. Executability: Fully Executable Outcome: - Message: The respiratory test is not unique for this subject and measurement - datetime and/or evaluation interval. + Message: The respiratory test is not unique for this subject and measurement datetime and/or + evaluation interval. Output Variables: - - USUBJID - - RETESTCD - - REDTC - - RESTINT + - USUBJID + - RETESTCD + - REDTC + - RESTINT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - RE + - RE Sensitivity: Record diff --git a/Published/CORE-000609/rule.yml b/Published/CORE-000609/rule.yml index a7224394c..a79f167ca 100644 --- a/Published/CORE-000609/rule.yml +++ b/Published/CORE-000609/rule.yml @@ -1,52 +1,50 @@ # Variable: SETCD # Rule: RELREF.SETCD = TX.SETCD for a given TX record Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: The SETCD column value must match a SETCD value in the TX - dataset - Document: 'TIG 1.0' - Item: 'assumption 7' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0033' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: The SETCD column value must match a SETCD value in the TX dataset + Document: 'TIG 1.0' + Item: 'assumption 7' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0033' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: SETCD - operator: is_not_contained_by - value: $tx_setcd + - name: SETCD + operator: is_not_contained_by + value: $tx_setcd Core: + Id: CORE-000609 Status: Published Version: '1' - Id: CORE-000609 -Description: Raise an error when the SETCD value doesn't match a SETCD value in - the TX dataset. +Description: Raise an error when the SETCD value doesn't match a SETCD value in the TX dataset. Executability: Fully Executable Operations: - - domain: TX - id: $tx_setcd - name: SETCD - operator: distinct +- domain: TX + id: $tx_setcd + name: SETCD + operator: distinct Outcome: Message: SETCD value doesn't match a SETCD value in the TX dataset. Output Variables: - - SETCD - - $tx_setcd + - SETCD + - $tx_setcd Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000610/rule.yml b/Published/CORE-000610/rule.yml index f7060faf0..74ac71ec7 100644 --- a/Published/CORE-000610/rule.yml +++ b/Published/CORE-000610/rule.yml @@ -2,52 +2,51 @@ # Condition: REFID value exists in GT domain # Rule: REFID value exists in RELREF domain Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the - RELREF dataset. - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0035' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the RELREF dataset. + Document: 'TIG 1.0' + Item: 'assumption 2' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0035' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: GTREFID - operator: is_not_contained_by - value: $relref_refid + - name: GTREFID + operator: is_not_contained_by + value: $relref_refid Core: + Id: CORE-000610 Status: Published Version: '1' - Id: CORE-000610 -Description: Raise an error when a REFID value in the GT dataset does not exist - in the RELREF dataset. +Description: Raise an error when a REFID value in the GT dataset does not exist in the RELREF + dataset. Executability: Fully Executable Operations: - - domain: RELREF - id: $relref_refid - name: REFID - operator: distinct +- domain: RELREF + id: $relref_refid + name: REFID + operator: distinct Outcome: Message: REFID value in GT does not exist in RELREF. Output Variables: - - GTREFID - - $relref_refid + - GTREFID + - $relref_refid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GT + - GT Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000611/rule.yml b/Published/CORE-000611/rule.yml index 12959eaf5..c3b23f640 100644 --- a/Published/CORE-000611/rule.yml +++ b/Published/CORE-000611/rule.yml @@ -2,52 +2,51 @@ # Condition: REFID value exists in RELREF domain # Rule: REFID value exists in GT domain Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the - GT dataset. - Document: 'TIG 1.0' - Item: 'assumption 3' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0036' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the GT dataset. + Document: 'TIG 1.0' + Item: 'assumption 3' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0036' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: REFID - operator: is_not_contained_by - value: $gt_refid + - name: REFID + operator: is_not_contained_by + value: $gt_refid Core: + Id: CORE-000611 Status: Published Version: '1' - Id: CORE-000611 -Description: Raise an error when a REFID value in the RELREF dataset does not - exist in the GT dataset. +Description: Raise an error when a REFID value in the RELREF dataset does not exist in the GT + dataset. Executability: Fully Executable Operations: - - domain: GT - id: $gt_refid - name: GTREFID - operator: distinct +- domain: GT + id: $gt_refid + name: GTREFID + operator: distinct Outcome: Message: REFID value in RELREF does not exist in GT. Output Variables: - - REFID - - $gt_refid + - REFID + - $gt_refid Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000612/rule.yml b/Published/CORE-000612/rule.yml index 6745ab415..6df6a275c 100644 --- a/Published/CORE-000612/rule.yml +++ b/Published/CORE-000612/rule.yml @@ -1,157 +1,148 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or - metabolite across pharmacokinetic datasets within a - submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: # ONLY for PPSTRESU/PPTESTCD and PCSTRESU/PCTESTCD - - name: --STRESU - operator: is_inconsistent_across_dataset - value: --TESTCD + - name: --STRESU + operator: is_inconsistent_across_dataset + value: --TESTCD Core: Id: CORE-000612 Status: Published Version: '1' -Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug or metabolite across pharmacokinetic datasets within a submission. +Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug + or metabolite across pharmacokinetic datasets within a submission. Executability: Fully Executable Outcome: Message: '--STRESU is not consistent per --TESTCD.' @@ -159,9 +150,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP - - PC + - PP + - PC Sensitivity: Record diff --git a/Published/CORE-000613/rule.yml b/Published/CORE-000613/rule.yml index 4056bfa17..38fc82a02 100644 --- a/Published/CORE-000613/rule.yml +++ b/Published/CORE-000613/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--ENTPT' - operator: exists + - name: '--ENTPT' + operator: exists Core: Id: CORE-000613 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000614/rule.yml b/Published/CORE-000614/rule.yml index 047a94a90..e65fcc703 100644 --- a/Published/CORE-000614/rule.yml +++ b/Published/CORE-000614/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--STRTPT' - operator: exists + - name: '--STRTPT' + operator: exists Core: Id: CORE-000614 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000615/rule.yml b/Published/CORE-000615/rule.yml index ec7413d4d..ce814ee5f 100644 --- a/Published/CORE-000615/rule.yml +++ b/Published/CORE-000615/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--STTPT' - operator: exists + - name: '--STTPT' + operator: exists Core: Id: CORE-000615 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000616/rule.yml b/Published/CORE-000616/rule.yml index 9a94cb5ef..348329099 100644 --- a/Published/CORE-000616/rule.yml +++ b/Published/CORE-000616/rule.yml @@ -1,129 +1,129 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.4' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '3.4' # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4403' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # REMARK: --TPTNUM and --STINT both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--STINT' - operator: exists - - name: '--STINT' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: '--TPTREF' + operator: exists + - name: '--STINT' + operator: exists + - name: '--STINT' + operator: 'non_empty' + - name: '--TPTREF' + operator: 'empty' Core: Id: CORE-000616 Status: Published Version: '1' -Description: 'When Planned Start of Assessment Interval (--STINT) is populated, - Time Point Reference (--TPTREF) should also be populated.' +Description: 'When Planned Start of Assessment Interval (--STINT) is populated, Time Point Reference (--TPTREF) + should also be populated.' Executability: Fully Executable Outcome: Message: --STINT is populated, but --TPTREF is missing. @@ -132,8 +132,8 @@ Scope: Classes: # TODO? Should we limit to "Findings" here? Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000617/rule.yml b/Published/CORE-000617/rule.yml index 6450aa874..d2ee64148 100644 --- a/Published/CORE-000617/rule.yml +++ b/Published/CORE-000617/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--ENRF' - operator: exists + - name: '--ENRF' + operator: exists Core: Id: CORE-000617 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000618/rule.yml b/Published/CORE-000618/rule.yml index d7b4c1c10..1e2ecafb7 100644 --- a/Published/CORE-000618/rule.yml +++ b/Published/CORE-000618/rule.yml @@ -1,141 +1,132 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled - terminology list, malignancy status in MIRESCAT should align - with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' + Document: 'FDA' + Section: 'FDAB085' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB8501' + Version: '1' + Version: '1.5' + Version: '1.0' Check: any: - - all: - - name: 'MISTRESC' + - all: + - name: 'MISTRESC' # 'contains' means 'contains the word' - operator: contains - value: 'BENIGN' - - name: 'MIRESCAT' - operator: not_equal_to - value: 'BENIGN' + operator: contains + value: 'BENIGN' + - name: 'MIRESCAT' + operator: not_equal_to + value: 'BENIGN' # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN - - all: - - name: 'MISTRESC' - operator: contains - value: 'MALIGNANT' - - name: 'MIRESCAT' - operator: is_not_contained_by - value: - - 'MALIGNANT' - - 'METASTATIC' + - all: + - name: 'MISTRESC' + operator: contains + value: 'MALIGNANT' + - name: 'MIRESCAT' + operator: is_not_contained_by + value: + - 'MALIGNANT' + - 'METASTATIC' Core: Id: CORE-000618 Status: Published Version: '1' -Description: 'When value of MISTRESC is using the NEOPLASM CT, it should align - with the value in MIRESCAT.' +Description: 'When value of MISTRESC is using the NEOPLASM CT, it should align with the value in MIRESCAT.' Executability: Fully Executable Outcome: # Or should the message be the other way? I.e. that value in MIRESCAT does not match the value in MISTRESC - Message: Value of MISTRESC is using the NEOPLASM CT and does not align with the - value in MIRESCAT. + Message: Value of MISTRESC is using the NEOPLASM CT and does not align with the value in MIRESCAT. Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Published/CORE-000619/rule.yml b/Published/CORE-000619/rule.yml index 2d19a6262..03b407396 100644 --- a/Published/CORE-000619/rule.yml +++ b/Published/CORE-000619/rule.yml @@ -1,98 +1,92 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5303' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TXPARMCD - operator: equal_to - value: 'AGETXT' - - name: TXVAL - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: TXPARMCD + operator: equal_to + value: 'AGETXT' + - name: TXVAL + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000619 Status: Published Version: '1' -Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be - populated with a number-number format when age range is supplied. +Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a + number-number format when age range is supplied. Executability: Fully Executable Outcome: Message: TXVAL value when TXPARMCD = AGETXT is not in number - number format. @@ -100,8 +94,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000620/rule.yml b/Published/CORE-000620/rule.yml index 07da5fcd3..6d68b3be2 100644 --- a/Published/CORE-000620/rule.yml +++ b/Published/CORE-000620/rule.yml @@ -1,161 +1,160 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.0 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.0 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: '1' + Version: '5.0' + Version: '1.1' # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.2' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Set code should match trial sets for nonclinical data.' + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: '1' + Version: '1.5' + Version: '1.2' # P.S. NOT applicable to SENDIG-AR Check: all: - - name: SETCD - operator: non_empty - - name: SETCD - operator: is_not_contained_by - value: $tx_setcd + - name: SETCD + operator: non_empty + - name: SETCD + operator: is_not_contained_by + value: $tx_setcd Core: Id: CORE-000620 Status: Published Version: '1' -Description: SETCD value in the DM dataset should match one of the SETCD values - in the TX dataset. +Description: SETCD value in the DM dataset should match one of the SETCD values in the TX dataset. Executability: Fully Executable Operations: - - domain: TX - id: $tx_setcd - name: SETCD - operator: distinct +- domain: TX + id: $tx_setcd + name: SETCD + operator: distinct Outcome: Message: SETCD value does not match a SETCD value in the TX dataset. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000621/rule.yml b/Published/CORE-000621/rule.yml index 5417fec1f..b78cf0876 100644 --- a/Published/CORE-000621/rule.yml +++ b/Published/CORE-000621/rule.yml @@ -1,118 +1,116 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SDISAB' - operator: exists + - name: '--SDISAB' + operator: exists Core: Id: CORE-000621 Status: Published Version: '1' -Description: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in - SEND dataset' +Description: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset' Executability: Fully Executable Outcome: - Message: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND - dataset' + Message: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000622/rule.yml b/Published/CORE-000622/rule.yml index e68ab1619..c9ddfef76 100644 --- a/Published/CORE-000622/rule.yml +++ b/Published/CORE-000622/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SDTH' - operator: exists + - name: '--SDTH' + operator: exists Core: Id: CORE-000622 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000623/rule.yml b/Published/CORE-000623/rule.yml index 4b21eb7f4..1b9b46f91 100644 --- a/Published/CORE-000623/rule.yml +++ b/Published/CORE-000623/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SHOSP' - operator: exists + - name: '--SHOSP' + operator: exists Core: Id: CORE-000623 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000624/rule.yml b/Published/CORE-000624/rule.yml index ca81434f3..acd493c54 100644 --- a/Published/CORE-000624/rule.yml +++ b/Published/CORE-000624/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SLIFE' - operator: exists + - name: '--SLIFE' + operator: exists Core: Id: CORE-000624 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000625/rule.yml b/Published/CORE-000625/rule.yml index 779685576..9ebf6d55d 100644 --- a/Published/CORE-000625/rule.yml +++ b/Published/CORE-000625/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SOD' - operator: exists + - name: '--SOD' + operator: exists Core: Id: CORE-000625 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000626/rule.yml b/Published/CORE-000626/rule.yml index a7974184c..a2e8f7f8d 100644 --- a/Published/CORE-000626/rule.yml +++ b/Published/CORE-000626/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SMIE' - operator: exists + - name: '--SMIE' + operator: exists Core: Id: CORE-000626 Status: Published @@ -104,14 +104,13 @@ Core: Description: '--SMIE (Other Medically Important Serious Event) must not be in SEND dataset' Executability: Fully Executable Outcome: - Message: '--SMIE (Other Medically Important Serious Event) must not be in SEND - dataset' + Message: '--SMIE (Other Medically Important Serious Event) must not be in SEND dataset' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000627/rule.yml b/Published/CORE-000627/rule.yml index a1893a065..bd99cce7c 100644 --- a/Published/CORE-000627/rule.yml +++ b/Published/CORE-000627/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SOC' - operator: exists + - name: '--SOC' + operator: exists Core: Id: CORE-000627 Status: Published @@ -104,14 +104,13 @@ Core: Description: '--SOC (Primary System Organ Class) must not be in SEND dataset' Executability: Fully Executable Outcome: - Message: '--SOC (Primary System Organ Class) must not be in SEND dataset) must - not be in SEND dataset' + Message: '--SOC (Primary System Organ Class) must not be in SEND dataset) must not be in SEND dataset' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000628/rule.yml b/Published/CORE-000628/rule.yml index e70636580..7b58f43c2 100644 --- a/Published/CORE-000628/rule.yml +++ b/Published/CORE-000628/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SOCCD' - operator: exists + - name: '--SOCCD' + operator: exists Core: Id: CORE-000628 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000629/rule.yml b/Published/CORE-000629/rule.yml index 8cfaf2b96..7a88ff636 100644 --- a/Published/CORE-000629/rule.yml +++ b/Published/CORE-000629/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--PRESP' - operator: exists + - name: '--PRESP' + operator: exists Core: Id: CORE-000629 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000630/rule.yml b/Published/CORE-000630/rule.yml index 20ce33906..4c3127bc9 100644 --- a/Published/CORE-000630/rule.yml +++ b/Published/CORE-000630/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--ENRTPT' - operator: exists + - name: '--ENRTPT' + operator: exists Core: Id: CORE-000630 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000631/rule.yml b/Published/CORE-000631/rule.yml index bacd41e4e..7c427ad07 100644 --- a/Published/CORE-000631/rule.yml +++ b/Published/CORE-000631/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'RFICDTC' - operator: exists + - name: 'RFICDTC' + operator: exists Core: Id: CORE-000631 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000632/rule.yml b/Published/CORE-000632/rule.yml index 308ef9a37..afb03089e 100644 --- a/Published/CORE-000632/rule.yml +++ b/Published/CORE-000632/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'RFPENDTC' - operator: exists + - name: 'RFPENDTC' + operator: exists Core: Id: CORE-000632 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000633/rule.yml b/Published/CORE-000633/rule.yml index 657ab00d1..62fbe2970 100644 --- a/Published/CORE-000633/rule.yml +++ b/Published/CORE-000633/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'RACE' - operator: exists + - name: 'RACE' + operator: exists Core: Id: CORE-000633 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000634/rule.yml b/Published/CORE-000634/rule.yml index ec4a3b2d1..d9c030de0 100644 --- a/Published/CORE-000634/rule.yml +++ b/Published/CORE-000634/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'INVNAM' - operator: exists + - name: 'INVNAM' + operator: exists Core: Id: CORE-000634 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000635/rule.yml b/Published/CORE-000635/rule.yml index 25b1223d6..1a1dbfd5a 100644 --- a/Published/CORE-000635/rule.yml +++ b/Published/CORE-000635/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'INVID' - operator: exists + - name: 'INVID' + operator: exists Core: Id: CORE-000635 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000636/rule.yml b/Published/CORE-000636/rule.yml index 63ba8878f..d415e7698 100644 --- a/Published/CORE-000636/rule.yml +++ b/Published/CORE-000636/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'ETHNIC' - operator: exists + - name: 'ETHNIC' + operator: exists Core: Id: CORE-000636 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000637/rule.yml b/Published/CORE-000637/rule.yml index f8162e3f5..474a885fb 100644 --- a/Published/CORE-000637/rule.yml +++ b/Published/CORE-000637/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'DTHFL' - operator: exists + - name: 'DTHFL' + operator: exists Core: Id: CORE-000637 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000638/rule.yml b/Published/CORE-000638/rule.yml index 3ca74a32b..d48f96a2a 100644 --- a/Published/CORE-000638/rule.yml +++ b/Published/CORE-000638/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'DTHDTC' - operator: exists + - name: 'DTHDTC' + operator: exists Core: Id: CORE-000638 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000639/rule.yml b/Published/CORE-000639/rule.yml index 3f28655a3..ed171b016 100644 --- a/Published/CORE-000639/rule.yml +++ b/Published/CORE-000639/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'COUNTRY' - operator: exists + - name: 'COUNTRY' + operator: exists Core: Id: CORE-000639 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000640/rule.yml b/Published/CORE-000640/rule.yml index ebf07a327..c1e74b9d9 100644 --- a/Published/CORE-000640/rule.yml +++ b/Published/CORE-000640/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'ACTARM' - operator: exists + - name: 'ACTARM' + operator: exists Core: Id: CORE-000640 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000641/rule.yml b/Published/CORE-000641/rule.yml index de83109b6..34413146a 100644 --- a/Published/CORE-000641/rule.yml +++ b/Published/CORE-000641/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'ACTARMCD' - operator: exists + - name: 'ACTARMCD' + operator: exists Core: Id: CORE-000641 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000642/rule.yml b/Published/CORE-000642/rule.yml index 7be3d414c..03516dfe2 100644 --- a/Published/CORE-000642/rule.yml +++ b/Published/CORE-000642/rule.yml @@ -1,129 +1,129 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.4' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '3.4' # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4404' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # REMARK: --TPTNUM and --ENINT both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--ENINT' - operator: exists - - name: '--ENINT' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: '--TPTREF' + operator: exists + - name: '--ENINT' + operator: exists + - name: '--ENINT' + operator: 'non_empty' + - name: '--TPTREF' + operator: 'empty' Core: Id: CORE-000642 Status: Published Version: '1' -Description: 'When Planned End of Assessment Interval (--ENINT) is populated, - Time Point Reference (--TPTREF) should also be populated.' +Description: 'When Planned End of Assessment Interval (--ENINT) is populated, Time Point Reference (--TPTREF) + should also be populated.' Executability: Fully Executable Outcome: Message: --ENINT is populated, but --TPTREF is missing. @@ -131,10 +131,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000643/rule.yml b/Published/CORE-000643/rule.yml index 83840d115..f212f66a5 100644 --- a/Published/CORE-000643/rule.yml +++ b/Published/CORE-000643/rule.yml @@ -1,150 +1,150 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding - standard result with a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with + a standardized unit where available.' + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --BLFL - operator: equal_to - value: 'Y' - - name: --STRESC - operator: empty + - name: --BLFL + operator: equal_to + value: 'Y' + - name: --STRESC + operator: empty Core: Id: 'CORE-000643' Status: Published Version: '1' -Description: 'Records with a baseline flag (--BLFL) have a non missing value in - character standard result variable (--STRESC)' +Description: 'Records with a baseline flag (--BLFL) have a non missing value in character standard result + variable (--STRESC)' Executability: Fully Executable Outcome: Message: 'BLFL is set to "Y", but no value for STRESC is provided' @@ -152,8 +152,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000645/rule.yml b/Published/CORE-000645/rule.yml index 2bde23efd..69251805c 100644 --- a/Published/CORE-000645/rule.yml +++ b/Published/CORE-000645/rule.yml @@ -1,97 +1,97 @@ Authorities: - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: # throw an error when both AGE and AGETXT are not present in DM - - name: AGE - operator: not_exists - - name: AGETXT - operator: not_exists + - name: AGE + operator: not_exists + - name: AGETXT + operator: not_exists Core: Id: CORE-000645 @@ -105,8 +105,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000648/rule.yml b/Published/CORE-000648/rule.yml index ec122a63a..f749255d0 100644 --- a/Published/CORE-000648/rule.yml +++ b/Published/CORE-000648/rule.yml @@ -1,90 +1,90 @@ Authorities: - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: '1' + Version: '1.5' + Version: '1.0' Check: any: # Commented out 2025-05-05: See Jora comment Nick de Donder https://jira.cdisc.org/browse/CORERULES-9331 @@ -94,12 +94,12 @@ Check: # operator: non_empty # - name: AGETXT # operator: non_empty - - all: + - all: # Case 2: throw an error when none of AGE and AGETXT is populated - - name: AGE - operator: empty - - name: AGETXT - operator: empty + - name: AGE + operator: empty + - name: AGETXT + operator: empty Core: Id: CORE-000648 @@ -113,8 +113,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000649/rule.yml b/Published/CORE-000649/rule.yml index 0f574406c..364feae72 100644 --- a/Published/CORE-000649/rule.yml +++ b/Published/CORE-000649/rule.yml @@ -1,118 +1,116 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--BDSYCD' - operator: exists + - name: '--BDSYCD' + operator: exists Core: Id: CORE-000649 Status: Published Version: '1' -Description: '--BDSYCD (Body System or Organ Class Code) must not be present in - SEND dataset' +Description: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset' Executability: Fully Executable Outcome: - Message: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND - dataset' + Message: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000650/rule.yml b/Published/CORE-000650/rule.yml index 3c1196ae5..fecb4d164 100644 --- a/Published/CORE-000650/rule.yml +++ b/Published/CORE-000650/rule.yml @@ -1,91 +1,91 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated - except when --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - - name: --ORRES - operator: non_empty + - name: --STAT + operator: equal_to + value: NOT DONE + - name: --ORRES + operator: non_empty Core: Id: CORE-000650 Status: Published @@ -95,14 +95,14 @@ Executability: Fully Executable Outcome: Message: --ORRES may not populated as --STAT is equal to 'NOT DONE' Output Variables: - - --STAT - - --ORRES + - --STAT + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000651/rule.yml b/Published/CORE-000651/rule.yml index 4dcdd266a..af5512369 100644 --- a/Published/CORE-000651/rule.yml +++ b/Published/CORE-000651/rule.yml @@ -1,228 +1,206 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.0' - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0926 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0926 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.0' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: '4.4.7.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND290' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: '4.4.7.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND290' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: '4.4.7.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND290' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: '4.4.7.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND290' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: '4.4.7.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND290' + Version: '1' + Version: '5.0' + Version: '1.0' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0926 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0926 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: '1' + Version: '1.5' + Version: '1.0' # The implementation only checks 1:1 relationship between --TPT and --TPTNUM Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: exists - - name: --TPTNUM - operator: non_empty - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: is_not_unique_relationship - value: --TPT + - name: --TPTNUM + operator: exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: non_empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: is_not_unique_relationship + value: --TPT Core: Id: CORE-000651 Status: Published @@ -235,8 +213,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000652/rule.yml b/Published/CORE-000652/rule.yml index 7d99fbc74..625ac1fdb 100644 --- a/Published/CORE-000652/rule.yml +++ b/Published/CORE-000652/rule.yml @@ -1,31 +1,30 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Only animals on the study are included, negative and/or positive - controls from another study are not included in the - domain. Study data are not typically directly compared - against the positive control data. - Document: SENDIG-GENETOX - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND410 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Only animals on the study are included, negative and/or positive controls + from another study are not included in the domain. Study data are not typically directly + compared against the positive control data. + Document: SENDIG-GENETOX + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND410 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid - - all: - - name: USUBJID - operator: is_not_contained_by - value: $ex_usubjid + - all: + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid + - all: + - name: USUBJID + operator: is_not_contained_by + value: $ex_usubjid # TODO?: no record in EX is expected when the subject is an "Untreated Control", # i.e. DM.SETCD has a value from TX.TXVAL='Untreated Control' for TXPARMCD=TCNTRL # After discussion with SEND team: we will NOT implement the second part "except when the subject is an untreated control", as this may cause false positives. @@ -33,26 +32,26 @@ Core: Id: CORE-000652 Status: Published Version: '1' -Description: 'Only animals on the study are included, negative and/or positive - controls from another study are not included in the domain' +Description: 'Only animals on the study are included, negative and/or positive controls from another study + are not included in the domain' Executability: Partially Executable - Possible Overreporting Operations: - - domain: DM - id: $dm_usubjid - name: USUBJID - operator: distinct - - domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct +- domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct +- domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct Outcome: Message: 'No record for USUBJID is found in DM or EC' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Published/CORE-000653/rule.yml b/Published/CORE-000653/rule.yml index 809abb483..69d84200a 100644 --- a/Published/CORE-000653/rule.yml +++ b/Published/CORE-000653/rule.yml @@ -1,110 +1,109 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.0 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be - calculated by the difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "The length of time an observation continues, i.e., the duration - of the observation, is represented using variables - --DTC or - --STDTC for the start of the observation and --ENDTC for the - end of the observation when date/times are collected." - Document: TIG v1.0 - Item: Text - Section: 2.8.7.5 Representing Planned and Actual Timing - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0264 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.0 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: "The length of time an observation continues, i.e., the duration of the observation, + is represented using variables - --DTC or --STDTC for the start of the observation and --ENDTC + for the end of the observation when date/times are collected." + Document: TIG v1.0 + Item: Text + Section: 2.8.7.5 Representing Planned and Actual Timing + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0264 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --ENDTC - operator: non_empty - - name: --DTC - operator: non_empty - - name: --DTC - operator: date_greater_than - value: --ENDTC + - name: --ENDTC + operator: non_empty + - name: --DTC + operator: non_empty + - name: --DTC + operator: date_greater_than + value: --ENDTC Core: Id: CORE-000653 Status: Published @@ -114,15 +113,15 @@ Executability: Fully Executable Outcome: Message: --ENDTC must be greater than or equal to --DTC Output Variables: - - --ENDTC - - --DTC + - --ENDTC + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000654/rule.yml b/Published/CORE-000654/rule.yml index 9a56a193f..870892e19 100644 --- a/Published/CORE-000654/rule.yml +++ b/Published/CORE-000654/rule.yml @@ -1,126 +1,110 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND292' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND292' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND292' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND292' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND292' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: exists - - name: --TPTNUM - operator: non_empty - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: is_not_unique_relationship - value: --TPT + - name: --TPTNUM + operator: exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: non_empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: is_not_unique_relationship + value: --TPT Core: Id: CORE-000654 Status: Published Version: '1' -Description: There must be a one-to-one relationship between the values of --TPT - and --TPTNUM +Description: There must be a one-to-one relationship between the values of --TPT and --TPTNUM Executability: Fully Executable Outcome: Message: The relationship between --TPT and --TPTNUM is not a one-to-one relationship @@ -128,8 +112,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000660/rule.yml b/Published/CORE-000660/rule.yml index 018895647..b1336d043 100644 --- a/Published/CORE-000660/rule.yml +++ b/Published/CORE-000660/rule.yml @@ -1,57 +1,55 @@ # Variable: SPTOBID # Rule: SPTOBID in TO.SPTOBID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients - (IT), Non-Tobacco Ingredients (IN), and Ingredient Quantities - by Component (IQ) domains, as well as any domain in the - general observation classes where there are records pertaining - to the tobacco product it identifies/describes (e.g., PT). - Every value of SPTOBID in any dataset must correspond to a - product described in the TO dataset. - Document: 'TIG 1.0' - Item: 'assumption 1b' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0002' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), + Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well + as any domain in the general observation classes where there are records pertaining to the + tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset + must correspond to a product described in the TO dataset. + Document: 'TIG 1.0' + Item: 'assumption 1b' + Section: '2.8.8.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0002' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SPTOBID - operator: is_not_contained_by - value: $to_sptobid + - name: SPTOBID + operator: is_not_contained_by + value: $to_sptobid Core: + Id: CORE-000660 Status: Published Version: '1' - Id: CORE-000660 -Description: Part A - Raise an error when the value of SPTOBID in the dataset - does not correspond to a SPTOBID value present in TO. +Description: Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to + a SPTOBID value present in TO. Executability: Fully Executable Operations: - - domain: TO - id: $to_sptobid - name: SPTOBID - operator: distinct +- domain: TO + id: $to_sptobid + name: SPTOBID + operator: distinct Outcome: Message: SPTOBID value in the dataset does not correspond to a SPTOBID value in TO. Output Variables: - - SPTOBID - - $to_sptobid + - SPTOBID + - $to_sptobid Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000661/rule.yml b/Published/CORE-000661/rule.yml index af5fe12a2..47577f500 100644 --- a/Published/CORE-000661/rule.yml +++ b/Published/CORE-000661/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--HLT' - operator: exists + - name: '--HLT' + operator: exists Core: Id: CORE-000661 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000662/rule.yml b/Published/CORE-000662/rule.yml index b574ad3d6..486ae735e 100644 --- a/Published/CORE-000662/rule.yml +++ b/Published/CORE-000662/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--HLTCD' - operator: exists + - name: '--HLTCD' + operator: exists Core: Id: CORE-000662 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000663/rule.yml b/Published/CORE-000663/rule.yml index 2b7c8f474..e61da096f 100644 --- a/Published/CORE-000663/rule.yml +++ b/Published/CORE-000663/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--HLGT' - operator: exists + - name: '--HLGT' + operator: exists Core: Id: CORE-000663 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000664/rule.yml b/Published/CORE-000664/rule.yml index f37c31fa3..2ecdad4b0 100644 --- a/Published/CORE-000664/rule.yml +++ b/Published/CORE-000664/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--LLT' - operator: exists + - name: '--LLT' + operator: exists Core: Id: CORE-000664 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000665/rule.yml b/Published/CORE-000665/rule.yml index d60910ae8..20418bba7 100644 --- a/Published/CORE-000665/rule.yml +++ b/Published/CORE-000665/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--LLTCD' - operator: exists + - name: '--LLTCD' + operator: exists Core: Id: CORE-000665 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000667/rule.yml b/Published/CORE-000667/rule.yml index 71ece93dc..a4da0566b 100644 --- a/Published/CORE-000667/rule.yml +++ b/Published/CORE-000667/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--PARTY' - operator: exists + - name: '--PARTY' + operator: exists Core: Id: CORE-000667 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000668/rule.yml b/Published/CORE-000668/rule.yml index dd741a0ac..309143bed 100644 --- a/Published/CORE-000668/rule.yml +++ b/Published/CORE-000668/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--PRTYID' - operator: exists + - name: '--PRTYID' + operator: exists Core: Id: CORE-000668 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000669/rule.yml b/Published/CORE-000669/rule.yml index c532fefab..c5a9426eb 100644 --- a/Published/CORE-000669/rule.yml +++ b/Published/CORE-000669/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--STRF' - operator: exists + - name: '--STRF' + operator: exists Core: Id: CORE-000669 Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000670/rule.yml b/Published/CORE-000670/rule.yml index 605d0f38a..96e5d540a 100644 --- a/Published/CORE-000670/rule.yml +++ b/Published/CORE-000670/rule.yml @@ -1,28 +1,27 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.0 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.0' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.0 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '3.0' Check: all: - - name: 'DDTESTCD' - operator: non_empty + - name: 'DDTESTCD' + operator: non_empty # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE # for "unscheduled" - - name: 'DSDECOD' + - name: 'DSDECOD' # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'" # WHY? #operator: is_not_contained_by @@ -31,17 +30,17 @@ Check: # - 'FOUND DEAD' # - 'MORIBUND SACRIFICE' # - 'NON-MORIBUND SACRIFICE' - operator: not_equal_to - value: 'ACCIDENTAL DEATH' - - name: 'DSDECOD' - operator: not_equal_to - value: 'FOUND DEAD' - - name: 'DSDECOD' - operator: not_equal_to - value: 'MORIBUND SACRIFICE' - - name: 'DSDECOD' - operator: not_equal_to - value: 'NON-MORIBUND SACRIFICE' + operator: not_equal_to + value: 'ACCIDENTAL DEATH' + - name: 'DSDECOD' + operator: not_equal_to + value: 'FOUND DEAD' + - name: 'DSDECOD' + operator: not_equal_to + value: 'MORIBUND SACRIFICE' + - name: 'DSDECOD' + operator: not_equal_to + value: 'NON-MORIBUND SACRIFICE' Core: Id: CORE-000670 Status: Published @@ -49,18 +48,18 @@ Core: Description: '' Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DS +- Keys: + - USUBJID + Name: DS Outcome: - Message: 'Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND - SACRIFICE,NON-MORIBUND SACRIFICE indicating unscheduled death' + Message: 'Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND SACRIFICE,NON-MORIBUND + SACRIFICE indicating unscheduled death' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000671/rule.yml b/Published/CORE-000671/rule.yml index b3895472b..45c062f58 100644 --- a/Published/CORE-000671/rule.yml +++ b/Published/CORE-000671/rule.yml @@ -1,83 +1,78 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an - unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.1 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.1.1 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.1 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.1.1 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' + Document: SENDIG v3.1.1 + Section: '6.3.4.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND167' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: 'DDTESTCD' - operator: non_empty - - name: 'DSUSCHFL' - operator: not_equal_to - value: 'Y' + - name: 'DDTESTCD' + operator: non_empty + - name: 'DSUSCHFL' + operator: not_equal_to + value: 'Y' Core: Id: CORE-000671 Status: Published @@ -85,17 +80,17 @@ Core: Description: '' Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DS +- Keys: + - USUBJID + Name: DS Outcome: Message: 'Record does not have DSUSCHFL=Y in DS' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000672/rule.yml b/Published/CORE-000672/rule.yml index e6bf30e90..1eb9e0263 100644 --- a/Published/CORE-000672/rule.yml +++ b/Published/CORE-000672/rule.yml @@ -1,164 +1,164 @@ Authorities: - - Organization: FDA - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3901' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STNRHI - operator: non_empty - - name: --STNRLO - operator: non_empty - - name: --STNRHI - operator: less_than_or_equal_to - value: --STNRLO + - name: --STNRHI + operator: non_empty + - name: --STNRLO + operator: non_empty + - name: --STNRHI + operator: less_than_or_equal_to + value: --STNRLO Core: Id: CORE-000672 Status: Published Version: '1' -Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be - greater than the Normal Range Lower Limit-Standard Units (--STNRLO). +Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal + Range Lower Limit-Standard Units (--STNRLO). Executability: Fully Executable Outcome: Message: --STNRHI is less than or equal to --STNRLO. Output Variables: - - --TESTCD - - --STNRLO - - --STNRHI + - --TESTCD + - --STNRLO + - --STNRHI Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000673/rule.yml b/Published/CORE-000673/rule.yml index 5534ecf6e..deb1ea404 100644 --- a/Published/CORE-000673/rule.yml +++ b/Published/CORE-000673/rule.yml @@ -2,54 +2,54 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016a' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: 'TIG 1.0' + Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' + Section: '2.8.8.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0016a' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMIN - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: less_than - value: --VALMIN + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMIN + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: less_than + value: --VALMIN Core: + Id: CORE-000673 Status: Published Version: '1' - Id: CORE-000673 -Description: Part A - Raise an error when --VALTRG is a number and is less than - the specified --VALMIN value. +Description: Part A - Raise an error when --VALTRG is a number and is less than the specified + --VALMIN value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or greater than the --VALMIN value. Output Variables: - - IGDCMPID - - SPTOBID - - --VALTRG - - --VALMIN + - IGDCMPID + - SPTOBID + - --VALTRG + - --VALMIN Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000674/rule.yml b/Published/CORE-000674/rule.yml index 79f4fb6fd..7b86f5e04 100644 --- a/Published/CORE-000674/rule.yml +++ b/Published/CORE-000674/rule.yml @@ -2,54 +2,54 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016a' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: 'TIG 1.0' + Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' + Section: '2.8.8.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0016a' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMAX - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: greater_than - value: --VALMAX + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMAX + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: greater_than + value: --VALMAX Core: + Id: CORE-000674 Status: Published Version: '1' - Id: CORE-000674 -Description: Part B - Raise an error when --VALTRG is a number and is greater - than the specified --VALMAX value. +Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified + --VALMAX value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or less than the --VALMAX value. Output Variables: - - IGDCMPID - - SPTOBID - - --VALTRG - - --VALMAX + - IGDCMPID + - SPTOBID + - --VALTRG + - --VALMAX Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000675/rule.yml b/Published/CORE-000675/rule.yml index 9c0ac25cb..86414ace1 100644 --- a/Published/CORE-000675/rule.yml +++ b/Published/CORE-000675/rule.yml @@ -1,171 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - value_is_literal: true - - any: - - name: --ORRES - operator: non_empty - - name: --STRESC - operator: non_empty - - name: --STRESN - operator: non_empty + - name: --STAT + operator: equal_to + value: NOT DONE + value_is_literal: true + - any: + - name: --ORRES + operator: non_empty + - name: --STRESC + operator: non_empty + - name: --STRESN + operator: non_empty Core: Id: CORE-000675 Status: Published Version: '1' -Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and --STRESC) should not be populated. +Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and + --STRESC) should not be populated. Executability: Fully Executable Outcome: Message: '--STAT = NOT DONE, but a result variable (--ORRES, --STRESC and/or --STRESN) is populated.' Output Variables: - - --TESTCD - - --ORRES - - --STRESC - - --STRESN - - --STAT + - --TESTCD + - --ORRES + - --STRESC + - --STRESN + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000676/rule.yml b/Published/CORE-000676/rule.yml index 53d9b5fe6..8cf358073 100644 --- a/Published/CORE-000676/rule.yml +++ b/Published/CORE-000676/rule.yml @@ -1,63 +1,60 @@ # Variable: SPTOBID # Rule: SPTOBID in TO.SPTOBID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients - (IT), Non-Tobacco Ingredients (IN), and Ingredient Quantities - by Component (IQ) domains, as well as any domain in the - general observation classes where there are records pertaining - to the tobacco product it identifies/describes (e.g., PT). - Every value of SPTOBID in any dataset must correspond to a - product described in the TO dataset. - Document: 'TIG 1.0' - Item: 'assumption 1b' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0002' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), + Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well + as any domain in the general observation classes where there are records pertaining to the + tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset + must correspond to a product described in the TO dataset. + Document: 'TIG 1.0' + Item: 'assumption 1b' + Section: '2.8.8.1' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0002' + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: TXPARMCD - operator: equal_to - value: SPTOBID - value_is_literal: true - - name: TXVAL - operator: is_not_contained_by - value: $to_sptobid + - name: TXPARMCD + operator: equal_to + value: SPTOBID + value_is_literal: true + - name: TXVAL + operator: is_not_contained_by + value: $to_sptobid Core: + Id: CORE-000676 Status: Published Version: '1' - Id: CORE-000676 -Description: Part B - Raise an error when the value of TXVAL for TXPARMCD = - SPTOBID in the TX dataset does not correspond to a SPTOBID value present in - TO. +Description: Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX + dataset does not correspond to a SPTOBID value present in TO. Executability: Fully Executable Operations: - - domain: TO - id: $to_sptobid - name: SPTOBID - operator: distinct +- domain: TO + id: $to_sptobid + name: SPTOBID + operator: distinct Outcome: - Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not - correspond to a SPTOBID value in TO. + Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID + value in TO. Output Variables: - - TXVAL - - $to_sptobid + - TXVAL + - $to_sptobid Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000677/rule.yml b/Published/CORE-000677/rule.yml index d60b6fc18..a2e2d9c80 100644 --- a/Published/CORE-000677/rule.yml +++ b/Published/CORE-000677/rule.yml @@ -1,132 +1,131 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.0 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.22 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0075 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.0 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.22 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0075 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: $poolid_exists - operator: equal_to - value: true - - name: POOLDEF - operator: not_exists + - name: $poolid_exists + operator: equal_to + value: true + - name: POOLDEF + operator: not_exists Core: Id: CORE-000677 Status: Published Version: '1' -Description: Part A - Raise error when POOLID exists in the dataset but POOLDEF - does not exist. +Description: Part A - Raise error when POOLID exists in the dataset but POOLDEF does not exist. Executability: Fully Executable Operations: - - id: $poolid_exists - name: POOLID - operator: variable_exists +- id: $poolid_exists + name: POOLID + operator: variable_exists Outcome: Message: POOLID variable exists in the dataset but POOLDEF dataset does not exist. Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000678/rule.yml b/Published/CORE-000678/rule.yml index 36d5961c1..5090c5a70 100644 --- a/Published/CORE-000678/rule.yml +++ b/Published/CORE-000678/rule.yml @@ -1,136 +1,136 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.0 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each - subject and the USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.22 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0075 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.0 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.22 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0075 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: POOLID - operator: non_empty - - name: POOLID - operator: is_not_contained_by - value: $pooldef_poolid + - name: POOLID + operator: non_empty + - name: POOLID + operator: is_not_contained_by + value: $pooldef_poolid Core: Id: CORE-000678 Status: Published Version: '1' -Description: Part B - Raise error when value for POOLID in the dataset is not a - POOLID value in POOLDEF. +Description: Part B - Raise error when value for POOLID in the dataset is not a POOLID value in + POOLDEF. Executability: Fully Executable Operations: - - domain: POOLDEF - id: $pooldef_poolid - name: POOLID - operator: distinct +- domain: POOLDEF + id: $pooldef_poolid + name: POOLID + operator: distinct Outcome: Message: POOLID value in the dataset does not correspond to a POOLID value in POOLDEF. Output Variables: - - POOLID - - $pooldef_poolid + - POOLID + - $pooldef_poolid Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000680/rule.yml b/Published/CORE-000680/rule.yml index a08a21e5e..29add310a 100644 --- a/Published/CORE-000680/rule.yml +++ b/Published/CORE-000680/rule.yml @@ -1,62 +1,60 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned enrollment number or - a planned completion number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00043' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A unit must not be specified for a planned enrollment number or a planned completion + number.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00043' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: is_contained_by - value: - - 'plannedCompletionNumber' - - 'plannedEnrollmentNumber' - - not: - any: - - name: unit - operator: equal_to - value: false - - name: unit - operator: empty - - name: unit - operator: not_exists + - name: instanceType + operator: equal_to + value: 'Range' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_rel + operator: is_contained_by + value: + - 'plannedCompletionNumber' + - 'plannedEnrollmentNumber' + - not: + any: + - name: unit + operator: equal_to + value: false + - name: unit + operator: empty + - name: unit + operator: not_exists Core: Id: 'CORE-000680' Status: Published Version: '1' -Description: 'A unit must not be specified for a planned enrollment number or a - planned completion number.' +Description: 'A unit must not be specified for a planned enrollment number or a planned completion number.' Executability: Fully Executable Outcome: - Message: 'A unit is specified for a planned enrollment number or a planned - completion number.' + Message: 'A unit is specified for a planned enrollment number or a planned completion number.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - minValue - - maxValue - - unit - - unit.decode + - parent_entity + - parent_id + - parent_rel + - id + - minValue + - maxValue + - unit + - unit.decode Rule Type: Record Data Scope: Entities: Include: - - Range + - Range Sensitivity: Record diff --git a/Published/CORE-000681/rule.yml b/Published/CORE-000681/rule.yml index 213f9cca6..f070d52d5 100644 --- a/Published/CORE-000681/rule.yml +++ b/Published/CORE-000681/rule.yml @@ -1,63 +1,63 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one attribute must be specified for an address.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00045' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least one attribute must be specified for an address.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00045' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'Address' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: text + operator: not_exists + - name: text + operator: empty + - any: + - name: line + operator: not_exists + - name: line + operator: empty + - any: + - name: district + operator: not_exists + - name: district + operator: empty + - any: + - name: city + operator: not_exists + - name: city + operator: empty + - any: + - name: postalCode + operator: not_exists + - name: postalCode + operator: empty + - any: + - name: state + operator: not_exists + - name: state + operator: empty + - any: + - name: country + operator: not_exists + - name: country + operator: empty + - name: country operator: equal_to - value: 'Address' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: text - operator: not_exists - - name: text - operator: empty - - any: - - name: line - operator: not_exists - - name: line - operator: empty - - any: - - name: district - operator: not_exists - - name: district - operator: empty - - any: - - name: city - operator: not_exists - - name: city - operator: empty - - any: - - name: postalCode - operator: not_exists - - name: postalCode - operator: empty - - any: - - name: state - operator: not_exists - - name: state - operator: empty - - any: - - name: country - operator: not_exists - - name: country - operator: empty - - name: country - operator: equal_to - value: false + value: false Core: Id: 'CORE-000681' Status: Published @@ -67,20 +67,20 @@ Executability: Fully Executable Outcome: Message: 'All attributes of the address are blank.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - line - - district - - city - - postalCode - - state - - country + - parent_entity + - parent_id + - parent_rel + - id + - text + - line + - district + - city + - postalCode + - state + - country Rule Type: Record Data Scope: Entities: Include: - - Address + - Address Sensitivity: Record diff --git a/Published/CORE-000682/rule.yml b/Published/CORE-000682/rule.yml index bc2bfbeb1..f58f7c91a 100644 --- a/Published/CORE-000682/rule.yml +++ b/Published/CORE-000682/rule.yml @@ -1,32 +1,31 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is not expected to refer to a - timeline exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00064' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled decision instance is not expected to refer to a timeline exit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00064' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - not: - any: - - name: timelineExitId - operator: not_exists - - name: timelineExitId - operator: empty + - name: instanceType + operator: equal_to + value: 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - not: + any: + - name: timelineExitId + operator: not_exists + - name: timelineExitId + operator: empty Core: Id: 'CORE-000682' Status: Published @@ -36,15 +35,15 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The scheduled decision instance refers to a timeline exit.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineExitId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineExitId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-000683/rule.yml b/Published/CORE-000683/rule.yml index 536c4bb36..e42ff86c3 100644 --- a/Published/CORE-000683/rule.yml +++ b/Published/CORE-000683/rule.yml @@ -1,32 +1,31 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is not expected to have a - sub-timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00065' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled decision instance is not expected to have a sub-timeline.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00065' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - not: - any: - - name: timelineId - operator: not_exists - - name: timelineId - operator: empty + - name: instanceType + operator: equal_to + value: 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - not: + any: + - name: timelineId + operator: not_exists + - name: timelineId + operator: empty Core: Id: 'CORE-000683' Status: Published @@ -36,15 +35,15 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The scheduled decision instance has a sub-timeline.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-000684/rule.yml b/Published/CORE-000684/rule.yml index bdd3acd66..079a32f21 100644 --- a/Published/CORE-000684/rule.yml +++ b/Published/CORE-000684/rule.yml @@ -1,49 +1,47 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The minimum value of a range must be less than or equal to the - maximum value of the range.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00070' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The minimum value of a range must be less than or equal to the maximum value + of the range.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00070' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: minValue - operator: greater_than - value: maxValue + - name: instanceType + operator: equal_to + value: 'Range' + - name: rel_type + operator: equal_to + value: 'definition' + - name: minValue + operator: greater_than + value: maxValue Core: Id: 'CORE-000684' Status: Published Version: '1' -Description: 'The minimum value of a range must be less than or equal to the - maximum value of the range.' +Description: 'The minimum value of a range must be less than or equal to the maximum value of the range.' Executability: Fully Executable Outcome: - Message: 'The minimum value of the range is not less than or equal to the - maximum value.' + Message: 'The minimum value of the range is not less than or equal to the maximum value.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - minValue - - maxValue + - parent_entity + - parent_id + - parent_rel + - id + - minValue + - maxValue Rule Type: Record Data Scope: Entities: Include: - - 'Range' + - 'Range' Sensitivity: Record diff --git a/Published/CORE-000690/rule.yml b/Published/CORE-000690/rule.yml index 2b5490a0c..97a55d74a 100644 --- a/Published/CORE-000690/rule.yml +++ b/Published/CORE-000690/rule.yml @@ -1,130 +1,128 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.0 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which - should be unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be - provided as data variable labels for all variables, including - Supplemental Qualifier variables - Document: TIG v1.0 - Item: Text - Section: 2.6 Guidance for Datasets, Tabulation Dataset, Num 5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0192 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.0 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables + Document: TIG v1.0 + Item: Text + Section: 2.6 Guidance for Datasets, Tabulation Dataset, Num 5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0192 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: is_not_unique_relationship - value: variable_label + - name: variable_name + operator: is_not_unique_relationship + value: variable_label Core: + Id: CORE-000690 Status: Published Version: '1' - Id: CORE-000690 -Description: Raise an error when the variable label is not unique for each - variable in the dataset +Description: Raise an error when the variable label is not unique for each variable in the dataset Executability: Fully Executable Outcome: Message: Variable label is not unique for each variable in the dataset. Output Variables: - - variable_label - - variable_name + - variable_label + - variable_name Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000691/rule.yml b/Published/CORE-000691/rule.yml index f6e797a6b..6d092a42d 100644 --- a/Published/CORE-000691/rule.yml +++ b/Published/CORE-000691/rule.yml @@ -1,38 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate environmental - settings.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00053' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an encounter there must be no duplicate environmental settings.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00053' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'environmentalSetting' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'Encounter' + - name: parent_rel + operator: equal_to + value: 'environmentalSetting' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000691" Status: Published @@ -40,27 +39,27 @@ Core: Description: 'Within an encounter there must be no duplicate environmental settings.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The environmental settings of the encounter are not unique - the same - code is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The environmental settings of the encounter are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000692/rule.yml b/Published/CORE-000692/rule.yml index f66ad7cfe..e9fbb1b66 100644 --- a/Published/CORE-000692/rule.yml +++ b/Published/CORE-000692/rule.yml @@ -1,67 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more trial types are defined, they - must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00055' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more trial types are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00055' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'trialTypes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: parent_rel + operator: equal_to + value: 'trialTypes' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000692" Status: Published Version: '1' -Description: 'Within a study design, if more trial types are defined, they must - be distinct.' +Description: 'Within a study design, if more trial types are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The trial types of the study design are not unique - the same code is - used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The trial types of the study design are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000693/rule.yml b/Published/CORE-000693/rule.yml index f477904a7..fa30779cd 100644 --- a/Published/CORE-000693/rule.yml +++ b/Published/CORE-000693/rule.yml @@ -1,67 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00056' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00056' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'therapeuticAreas' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: parent_rel + operator: equal_to + value: 'therapeuticAreas' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000693" Status: Published Version: '1' -Description: 'Within a study design, if more therapeutic areas are defined, they - must be distinct.' +Description: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The therapeutic areas of the study design are not unique - the same - code is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The therapeutic areas of the study design are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000694/rule.yml b/Published/CORE-000694/rule.yml index bc53bcd5a..120178793 100644 --- a/Published/CORE-000694/rule.yml +++ b/Published/CORE-000694/rule.yml @@ -1,67 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more trial intent types are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00057' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more trial intent types are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00057' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'trialIntentTypes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: parent_rel + operator: equal_to + value: 'trialIntentTypes' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000694" Status: Published Version: '1' -Description: 'Within a study design, if more trial intent types are defined, - they must be distinct.' +Description: 'Within a study design, if more trial intent types are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The trial intent types of the study design are not unique - the same - code is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The trial intent types of the study design are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000695/rule.yml b/Published/CORE-000695/rule.yml index 20cd07097..20026ee37 100644 --- a/Published/CORE-000695/rule.yml +++ b/Published/CORE-000695/rule.yml @@ -1,67 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more characteristics are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00134' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more characteristics are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00134' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'characteristics' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: parent_rel + operator: equal_to + value: 'characteristics' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000695" Status: Published Version: '1' -Description: 'Within a study design, if more characteristics are defined, they - must be distinct.' +Description: 'Within a study design, if more characteristics are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The characteristics of the study design are not unique - the same code - is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The characteristics of the study design are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000696/rule.yml b/Published/CORE-000696/rule.yml index 90d4ad10a..b1b623002 100644 --- a/Published/CORE-000696/rule.yml +++ b/Published/CORE-000696/rule.yml @@ -1,53 +1,50 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every identifier must be unique within the scope of an - identified organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00138' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every identifier must be unique within the scope of an identified organization.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00138' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyIdentifier' - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyIdentifier - operator: is_not_unique_set - value: - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - name: instanceType + operator: equal_to + value: 'StudyIdentifier' + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyIdentifier + operator: is_not_unique_set + value: + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Core: Id: 'CORE-000696' Status: Published Version: '1' -Description: 'Every identifier must be unique within the scope of an identified - organization.' +Description: 'Every identifier must be unique within the scope of an identified organization.' Executability: Fully Executable Outcome: - Message: 'The identifier is not unique within the scope of the identified - organization.' + Message: 'The identifier is not unique within the scope of the identified organization.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - studyIdentifier - - studyIdentifierScope.name - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - parent_entity + - parent_id + - parent_rel + - id + - studyIdentifier + - studyIdentifierScope.name + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Rule Type: Record Data Scope: Entities: Include: - - 'StudyIdentifier' + - 'StudyIdentifier' Sensitivity: Record diff --git a/Published/CORE-000697/rule.yml b/Published/CORE-000697/rule.yml index 53b80ffe0..185df688e 100644 --- a/Published/CORE-000697/rule.yml +++ b/Published/CORE-000697/rule.yml @@ -1,52 +1,51 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An identified organization is not expected to have more than - one identifier for the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00139' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An identified organization is not expected to have more than one identifier for + the study.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00139' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyIdentifier' - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyIdentifierScope.identifier - operator: is_not_unique_set - value: - - parent_id - - studyIdentifierScope.identifierScheme + - name: instanceType + operator: equal_to + value: 'StudyIdentifier' + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyIdentifierScope.identifier + operator: is_not_unique_set + value: + - parent_id + - studyIdentifierScope.identifierScheme Core: Id: 'CORE-000697' Status: Published Version: '1' -Description: 'An identified organization is not expected to have more than one - identifier for the study.' +Description: 'An identified organization is not expected to have more than one identifier for the study.' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The identified organization has more than one identifier for the study.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - studyIdentifier - - studyIdentifierScope.name - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - parent_entity + - parent_id + - parent_rel + - id + - studyIdentifier + - studyIdentifierScope.name + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Rule Type: Record Data Scope: Entities: Include: - - 'StudyIdentifier' + - 'StudyIdentifier' Sensitivity: Record diff --git a/Published/CORE-000698/rule.yml b/Published/CORE-000698/rule.yml index 96fca69d2..ba0339067 100644 --- a/Published/CORE-000698/rule.yml +++ b/Published/CORE-000698/rule.yml @@ -2,54 +2,54 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: 'TIG 1.0' + Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' + Section: '2.8.8.2' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0016' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMIN - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: less_than - value: --VALMIN + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMIN + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: less_than + value: --VALMIN Core: + Id: CORE-000698 Status: Published Version: '1' - Id: CORE-000698 -Description: Part A - Raise an error when --VALTRG is a number and is less than - the specified --VALMIN value. +Description: Part A - Raise an error when --VALTRG is a number and is less than the specified + --VALMIN value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or greater than the --VALMIN value. Output Variables: - - SPTOBID - - --VALTRG - - --VALMIN - - PDPARMCD + - SPTOBID + - --VALTRG + - --VALMIN + - PDPARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - PD + - PD Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000699/rule.yml b/Published/CORE-000699/rule.yml index 8083d91b9..552f938e0 100644 --- a/Published/CORE-000699/rule.yml +++ b/Published/CORE-000699/rule.yml @@ -1,182 +1,172 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD - values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STRESU - operator: is_inconsistent_across_dataset - value: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --STAT + - name: --STRESU + operator: is_inconsistent_across_dataset + value: + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --STAT Core: Id: CORE-000699 Status: Published Version: '1' -Description: Standard units should be consistent within the same assessment - (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values) +Description: Standard units should be consistent within the same assessment (having the same + --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values) Executability: Fully Executable Outcome: - Message: Standards units are inconsistent within the same test (category, - sub-category, specimen and method) + Message: Standards units are inconsistent within the same test (category, sub-category, specimen + and method) Output Variables: - - --STRESU - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --STAT + - --STRESU + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000700/rule.yml b/Published/CORE-000700/rule.yml index 857b58a50..095a0ed7e 100644 --- a/Published/CORE-000700/rule.yml +++ b/Published/CORE-000700/rule.yml @@ -1,173 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DY - operator: exists - - name: --DTC - operator: not_exists + - name: --DY + operator: exists + - name: --DTC + operator: not_exists Core: Id: CORE-000700 Status: Published Version: '1' -Description: When Study Day of Visit/Collection/Exam (--DY) is present in the - dataset, then the Date/Time of Collection (--DTC) should also be present in - the dataset +Description: When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the + Date/Time of Collection (--DTC) should also be present in the dataset Executability: Fully Executable Outcome: - Message: Date/Time of Collection (--DTC) variable is missing when Study Day of + Message: Date/Time of Collection (--DTC) variable is missing when Study Day of Visit/Collection/Exam (--DY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000702/rule.yml b/Published/CORE-000702/rule.yml index 7c22c51fc..2a06869e8 100644 --- a/Published/CORE-000702/rule.yml +++ b/Published/CORE-000702/rule.yml @@ -1,31 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is expected to refer to a default - condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00066' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled decision instance is expected to refer to a default condition.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00066' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: defaultConditionId - operator: not_exists - - name: defaultConditionId - operator: empty + - name: instanceType + operator: equal_to + value: 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: defaultConditionId + operator: not_exists + - name: defaultConditionId + operator: empty Core: Id: 'CORE-000702' Status: Published @@ -35,15 +34,15 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The scheduled decision instance does not refer to a default condition.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-000703/rule.yml b/Published/CORE-000703/rule.yml index c80fb32d8..1a5d68e5d 100644 --- a/Published/CORE-000703/rule.yml +++ b/Published/CORE-000703/rule.yml @@ -1,33 +1,33 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must refer to at least one element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00067' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must refer to at least one element.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00067' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'StudyCell' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: elementIds + operator: not_exists + - name: elementIds + operator: empty + - name: elementIds operator: equal_to - value: 'StudyCell' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: elementIds - operator: not_exists - - name: elementIds - operator: empty - - name: elementIds - operator: equal_to - value: false + value: false Core: Id: 'CORE-000703' Status: Published @@ -37,14 +37,14 @@ Executability: Fully Executable Outcome: Message: 'The study cell does not refer to any elements.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - elementIds + - parent_entity + - parent_id + - parent_rel + - id + - elementIds Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - 'StudyCell' Sensitivity: Record diff --git a/Published/CORE-000704/rule.yml b/Published/CORE-000704/rule.yml index 67ae6f4fc..9f74498cb 100644 --- a/Published/CORE-000704/rule.yml +++ b/Published/CORE-000704/rule.yml @@ -2,54 +2,54 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: 'TIG 1.0' + Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' + Section: '2.8.8.2' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0016' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMAX - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: greater_than - value: --VALMAX + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMAX + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: greater_than + value: --VALMAX Core: + Id: CORE-000704 Status: Published Version: '1' - Id: CORE-000704 -Description: Part B - Raise an error when --VALTRG is a number and is greater - than the specified --VALMAX value. +Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified + --VALMAX value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or less than the --VALMAX value. Output Variables: - - SPTOBID - - --VALTRG - - --VALMAX - - PDPARMCD + - SPTOBID + - --VALTRG + - --VALMAX + - PDPARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - PD + - PD Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000707/rule.yml b/Published/CORE-000707/rule.yml index d9eb0eeff..13b778f57 100644 --- a/Published/CORE-000707/rule.yml +++ b/Published/CORE-000707/rule.yml @@ -2,179 +2,169 @@ # Condition: --DY ^= Null and --ENDY ^= Null # Rule: --DY <= --ENDY Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DY - operator: exists - - name: --ENDY - operator: exists - - name: --DY - operator: non_empty - - name: --ENDY - operator: non_empty - - name: --DY - operator: greater_than - value: --ENDY + - name: --DY + operator: exists + - name: --ENDY + operator: exists + - name: --DY + operator: non_empty + - name: --ENDY + operator: non_empty + - name: --DY + operator: greater_than + value: --ENDY Core: Id: CORE-000707 Status: Published Version: '1' -Description: Study Day of Visit/Collection/Exam (--DY) should be less than or - equal to Study Day of End of Observation (--ENDY). +Description: Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of + End of Observation (--ENDY). Executability: Fully Executable Outcome: Message: --DY is greater than --ENDY. Output Variables: - - --DY - - --ENDY + - --DY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000708/rule.yml b/Published/CORE-000708/rule.yml index f9fb04a4c..7411c3d36 100644 --- a/Published/CORE-000708/rule.yml +++ b/Published/CORE-000708/rule.yml @@ -2,178 +2,167 @@ # Condition: --STDY ^= Null and --ENDY ^= Null # Rule: --STDY <= --ENDY Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STDY - operator: non_empty - - name: --ENDY - operator: non_empty - - name: --STDY - operator: greater_than - value: --ENDY + - name: --STDY + operator: non_empty + - name: --ENDY + operator: non_empty + - name: --STDY + operator: greater_than + value: --ENDY Core: Id: CORE-000708 Status: Published Version: '1' -Description: When Study Day of End of Observation (--ENDY) is present in the - dataset, then the End Date/Time of Observation (--ENDTC) should also be - present in the dataset. +Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End + Date/Time of Observation (--ENDTC) should also be present in the dataset. Executability: Fully Executable Outcome: Message: --STDY is greater than --ENDY. Output Variables: - - --STDY - - --ENDY + - --STDY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000710/rule.yml b/Published/CORE-000710/rule.yml index 53c96e768..55ce161b9 100644 --- a/Published/CORE-000710/rule.yml +++ b/Published/CORE-000710/rule.yml @@ -1,130 +1,116 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start BEFORE - the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be - known (U) when it started. End values: an observation can end - BEFORE the reference point, can end COINCIDENT with the - reference point, can end AFTER the reference point, can be - known that it didn't end but was ONGOING, or it is unknown (U) - when it ended or if it was ongoing." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'If the reference time point is prior to the date of collection - or assessment: Start values: an observation can start - BEFORE the reference point, can start COINCIDENT with the - reference point, can start AFTER the reference point, or it - may not be known (U) when it started. End values: an - observation can end BEFORE the reference point, can end - COINCIDENT with the reference point, can end AFTER the - reference point, can be known that it didn''t end but was - ONGOING, or it is unknown (U) when it ended or if it was - ongoing.' - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0442 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: 'If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT + with the reference point, can start AFTER the reference point, or it may not be known (U) when + it started. End values: an observation can end BEFORE the reference point, can end COINCIDENT + with the reference point, can end AFTER the reference point, can be known that it didn''t end + but was ONGOING, or it is unknown (U) when it ended or if it was ongoing.' + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0442 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --STRTPT # Condition: --STTPT is prior to the date of collection or assessment. # Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') Check: all: - - name: --STTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --STTPT - operator: date_less_than - value: --DTC - - name: --STRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - AFTER - - UNKNOWN + - name: --STTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --STTPT + operator: date_less_than + value: --DTC + - name: --STRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - AFTER + - UNKNOWN Core: Id: CORE-000710 Status: Published Version: '1' -Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', - 'AFTER', 'UNKNOWN') and --STTPT is prior to the date of collection or - assessment. +Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and + --STTPT is prior to the date of collection or assessment. Executability: Partially Executable Outcome: Message: --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') Output Variables: - - --STTPT - - --STRTPT - - --DTC + - --STTPT + - --STRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000711/rule.yml b/Published/CORE-000711/rule.yml index 10792afe4..62d1fb341 100644 --- a/Published/CORE-000711/rule.yml +++ b/Published/CORE-000711/rule.yml @@ -2,165 +2,155 @@ # Condition: DM.RFSTDTC ^= Null and DM.RFENDTC ^= Null # Rule: DM.RFSTDTC <= DM.RFENDTC (Note: When comparing values that contain missing date/time components, the comparison is based on the most detailed level of specificity shared by both values. If components such as day, month, or time are missing in either value, these components are excluded from the comparison. Interval components are not included in the comparison.) Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: RFSTDTC - operator: non_empty - - name: RFENDTC - operator: non_empty - - name: RFSTDTC - operator: date_greater_than - value: RFENDTC + - name: RFSTDTC + operator: non_empty + - name: RFENDTC + operator: non_empty + - name: RFSTDTC + operator: date_greater_than + value: RFENDTC Core: Id: CORE-000711 Status: Published Version: '1' -Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or - equal to the Subject Reference End Date/Time (RFENDTC). +Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject + Reference End Date/Time (RFENDTC). Executability: Fully Executable Outcome: Message: RFSTDTC falls after RFENDTC. Output Variables: - - RFSTDTC - - RFENDTC + - RFSTDTC + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000712/rule.yml b/Published/CORE-000712/rule.yml index 573901c16..0597dec05 100644 --- a/Published/CORE-000712/rule.yml +++ b/Published/CORE-000712/rule.yml @@ -2,128 +2,124 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000712 Status: Published Version: '1' -Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with - a valid variable from the dataset referenced in RDOMAIN. +Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable + from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: SUPP-- +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: SUPP-- Operations: - - domain: SUPP-- - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true +- domain: SUPP-- + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in SUPP-- does not represent a variable present in the - dataset referenced in RDOMAIN. + Message: Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced + in RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000714/rule.yml b/Published/CORE-000714/rule.yml index 2e01127b5..c939491c4 100644 --- a/Published/CORE-000714/rule.yml +++ b/Published/CORE-000714/rule.yml @@ -2,152 +2,143 @@ # Condition: DM.RFXSTDTC ^= Null and DM.RFXENDTC ^= Null # Rule: DM.RFXSTDTC <= DM.RFXENDTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: RFXSTDTC - operator: non_empty - - name: RFXENDTC - operator: non_empty - - name: RFXSTDTC - operator: date_greater_than - value: RFXENDTC + - name: RFXSTDTC + operator: non_empty + - name: RFXENDTC + operator: non_empty + - name: RFXSTDTC + operator: date_greater_than + value: RFXENDTC Core: Id: CORE-000714 Status: Published Version: '1' -Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should - be prior or equal to the Date/Time of Last Study Treatment (RFXENDTC). +Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal + to the Date/Time of Last Study Treatment (RFXENDTC). Executability: Fully Executable Outcome: Message: RFXSTDTC falls after RFXENDTC. Output Variables: - - RFXSTDTC - - RFXENDTC + - RFXSTDTC + - RFXENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000715/rule.yml b/Published/CORE-000715/rule.yml index b9d4c6c6e..69c192759 100644 --- a/Published/CORE-000715/rule.yml +++ b/Published/CORE-000715/rule.yml @@ -1,111 +1,111 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.0 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. - Should be null if a result exists in BWORRES. - Document: TIG v1.0 - Item: BWSTAT CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0080 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.0 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: TIG v1.0 + Item: BWSTAT CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0080 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --ORRES - operator: empty - - name: --STAT - operator: empty + - name: --ORRES + operator: empty + - name: --STAT + operator: empty Core: Id: CORE-000715 Status: Published @@ -118,9 +118,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000718/rule.yml b/Published/CORE-000718/rule.yml index 47dfd0ca0..24aaee728 100644 --- a/Published/CORE-000718/rule.yml +++ b/Published/CORE-000718/rule.yml @@ -2,177 +2,167 @@ # Condition: --STDTC ^= Null and --ENDTC ^= Null # Rule: --STDTC <= --ENDTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STDTC - operator: non_empty - - name: --ENDTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: --ENDTC + - name: --STDTC + operator: non_empty + - name: --ENDTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: --ENDTC Core: Id: CORE-000718 Status: Published Version: '1' -Description: Start Date/Time of Observation (--STDTC) should be prior or equal - to the End Date/Time of Observation (--ENDTC). +Description: Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time + of Observation (--ENDTC). Executability: Fully Executable Outcome: Message: --STDTC falls after --ENDTC. Output Variables: - - --STDTC - - --ENDTC + - --STDTC + - --ENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Exclude: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000721/rule.yml b/Published/CORE-000721/rule.yml index 6b208e86b..da0368085 100644 --- a/Published/CORE-000721/rule.yml +++ b/Published/CORE-000721/rule.yml @@ -2,51 +2,51 @@ # Condition: # Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Product Exposure', 'Not Exposed to Product') Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: The trial arms table describes each planned arm in the trial. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.6.1|2.8.10.27|2.8.9.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0654 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: The trial arms table describes each planned arm in the trial. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.6.1|2.8.10.27|2.8.9.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0654 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARM - operator: is_contained_by_case_insensitive - value: - - Screen Failure - - Not Assigned - - Not Exposed to Product - - Unplanned Product Exposure + - name: ARM + operator: is_contained_by_case_insensitive + value: + - Screen Failure + - Not Assigned + - Not Exposed to Product + - Unplanned Product Exposure Core: Id: "CORE-000721" Status: Published Version: '1' -Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', - 'Unplanned Product Exposure', or 'Not Exposed to Product' +Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product + Exposure', or 'Not Exposed to Product' Executability: Fully Executable Outcome: - Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned - Product Exposure' or 'Not Exposed to Product'. + Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or + 'Not Exposed to Product'. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - DM - - TA - - TV + - DM + - TA + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000722/rule.yml b/Published/CORE-000722/rule.yml index ee2835fb0..255d8262c 100644 --- a/Published/CORE-000722/rule.yml +++ b/Published/CORE-000722/rule.yml @@ -1,117 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.0 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of - Quantification (LLQ), then PCSTRESN should be null and not - populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.0 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # Attention: -ORRES is "char", -STRESN is "num" - - name: PCORRES - operator: less_than - value: PCLLOQ - - name: PCSTRESN - operator: non_empty + - name: PCORRES + operator: less_than + value: PCLLOQ + - name: PCSTRESN + operator: non_empty Core: Id: CORE-000722 Status: Published Version: '1' -Description: If the PCORRES result is less than the Lower Limit of - Quantification, then PCSTRESN should be null and not populated with the value - of zero (0). +Description: If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN + should be null and not populated with the value of zero (0). Executability: Fully Executable Outcome: Message: PCSTRESN may not be populated as PCORRES is less than PCLLOQ Output Variables: - - PCORRES - - PCSTRESN + - PCORRES + - PCSTRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000727/rule.yml b/Published/CORE-000727/rule.yml index 10bd75230..1821433f0 100644 --- a/Published/CORE-000727/rule.yml +++ b/Published/CORE-000727/rule.yml @@ -2,65 +2,63 @@ # Condition: IQCAT = NON-TOBACCO INGREDIENT # Rule: IGDCMPID in IN.IGDCMPID Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IGDCMPID represents the unique ingredient name established in - either the Tobacco Ingredients (IT) domain or the Non-Tobacco - Ingredients (IN) domain. Therefore, every value of IDGCMPID in - the IQ domain must have an exact match in either IT or IN - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0014' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: IGDCMPID represents the unique ingredient name established in either the + Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, + every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN + Document: 'TIG 1.0' + Item: 'assumption 2' + Section: '2.8.8.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0014' + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IQCAT - operator: equal_to - value: NON-TOBACCO INGREDIENT - value_is_literal: true - - name: IGDCMPID - operator: is_not_contained_by - value: $in_igdcmpid - within: SPTOBID + - name: IQCAT + operator: equal_to + value: NON-TOBACCO INGREDIENT + value_is_literal: true + - name: IGDCMPID + operator: is_not_contained_by + value: $in_igdcmpid + within: SPTOBID Core: + Id: CORE-000727 Status: Published Version: '1' - Id: CORE-000727 -Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ - dataset (IQCAT = NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per - SPTOBID in the IN dataset. +Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT = + NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IN dataset. Executability: Fully Executable Operations: - - domain: IN - group: - - SPTOBID - id: $in_igdcmpid - name: IGDCMPID - operator: distinct +- domain: IN + group: + - SPTOBID + id: $in_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not - have a matching IGDCMPID per SPTOBID in IN. + Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching + IGDCMPID per SPTOBID in IN. Output Variables: - - SPTOBID - - IGDCMPID - - IQCAT - - $in_igdcmpid + - SPTOBID + - IGDCMPID + - IQCAT + - $in_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000732/rule.yml b/Published/CORE-000732/rule.yml index 60b96ca65..543890f53 100644 --- a/Published/CORE-000732/rule.yml +++ b/Published/CORE-000732/rule.yml @@ -2,147 +2,137 @@ # Condition: # Rule: --STRESC is not populated with a numeric value, but --STRESN is not empty Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3103' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STRESC - operator: non_empty - - name: --STRESC - operator: not_matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --STRESN - operator: non_empty + - name: --STRESC + operator: non_empty + - name: --STRESC + operator: not_matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --STRESN + operator: non_empty Core: Id: CORE-000732 Status: Published @@ -152,14 +142,14 @@ Executability: Fully Executable Outcome: Message: '--STRESC is not numeric but --STRESN is not empty' Output Variables: - - --STRESC - - --STRESN + - --STRESC + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000736/rule.yml b/Published/CORE-000736/rule.yml index b31304f20..045fd4dca 100644 --- a/Published/CORE-000736/rule.yml +++ b/Published/CORE-000736/rule.yml @@ -2,167 +2,166 @@ # Condition: # Rule: Either 'AGE' or 'AGETXT' is in the list of TSPARAMCDs with TSVAL populated, not both. Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '3.4' # SEND-IGs added Jozef - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1116' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - any: - - name: TSPARMCD - operator: equal_to - value: AGE - - name: TSPARMCD - operator: equal_to - value: AGETXT - - name: $age_count - operator: greater_than_or_equal_to - value: 1 - - name: $agetxt_count - operator: greater_than_or_equal_to - value: 1 - - name: TSVAL - operator: non_empty + - any: + - name: TSPARMCD + operator: equal_to + value: AGE + - name: TSPARMCD + operator: equal_to + value: AGETXT + - name: $age_count + operator: greater_than_or_equal_to + value: 1 + - name: $agetxt_count + operator: greater_than_or_equal_to + value: 1 + - name: TSVAL + operator: non_empty Core: Id: CORE-000736 Status: Published Version: '1' -Description: 'Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL - populated, not both.' +Description: 'Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL populated, not both.' Executability: Fully Executable Operations: - - domain: TS - filter: - TSPARMCD: AGE - id: $age_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: AGETXT - id: $agetxt_count - name: TSPARMCD - operator: record_count +- domain: TS + filter: + TSPARMCD: AGE + id: $age_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: AGETXT + id: $agetxt_count + name: TSPARMCD + operator: record_count Outcome: Message: 'AGE and AGETXT are in the list of TSPARAMCDs with TSVAL populated.' Output Variables: - - TSPARMCD - - TSVAL - - $age_count - - $agetxt_count + - TSPARMCD + - TSVAL + - $age_count + - $agetxt_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000744/rule.yml b/Published/CORE-000744/rule.yml index c67a8d391..cbea1fd92 100644 --- a/Published/CORE-000744/rule.yml +++ b/Published/CORE-000744/rule.yml @@ -2,109 +2,102 @@ # Condition: Related record present in parent domain dataset # Rule: FAOBJ in (--TERM, --TRT, --DECOD) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If an FA record does have a parent record, the value in FAOBJ - should match the value in --TERM or --TRT, unless the parent - domain is dictionary coded or subject to controlled - terminology, in which case FAOBJ should match the value in - --DECOD. - Document: IG v3.4 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM - or --TRT, unless the parent domain is dictionary coded or - subject to controlled terminology, in which case FAOBJ should - then match the value in --DECOD. - Document: IG v3.3 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM - or --TRT, unless the parent domain is dictionary coded or - subject to controlled terminology, in which case FAOBJ should - then match the value in --DECOD. - Document: IG v3.2 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A record in FA may or may not have a parent record in an events - or interventions domain. If an FA record does have a parent - record, the value in FAOBJ should match the value in --TERM or - --TRT, unless the parent domain is dictionary coded or subject - to controlled terminology. In such cases, the value - represented in FAOBJ will match the value represented in - --DECOD. - Document: TIG 1.0 - Section: 2.8.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0403 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If an FA record does have a parent record, the value in FAOBJ should match + the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to + controlled terminology, in which case FAOBJ should match the value in --DECOD. + Document: IG v3.4 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM or --TRT, + unless the parent domain is dictionary coded or subject to controlled terminology, in + which case FAOBJ should then match the value in --DECOD. + Document: IG v3.3 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM or --TRT, + unless the parent domain is dictionary coded or subject to controlled terminology, in + which case FAOBJ should then match the value in --DECOD. + Document: IG v3.2 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: A record in FA may or may not have a parent record in an events or + interventions domain. If an FA record does have a parent record, the value in FAOBJ should + match the value in --TERM or --TRT, unless the parent domain is dictionary coded or + subject to controlled terminology. In such cases, the value represented in FAOBJ will + match the value represented in --DECOD. + Document: TIG 1.0 + Section: 2.8.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0403 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: FAOBJ - operator: not_equal_to - value: RELREC.**TERM - - name: FAOBJ - operator: not_equal_to - value: RELREC.**TRT - - name: FAOBJ - operator: not_equal_to_case_insensitive - value: RELREC.**DECOD + - name: FAOBJ + operator: not_equal_to + value: RELREC.**TERM + - name: FAOBJ + operator: not_equal_to + value: RELREC.**TRT + - name: FAOBJ + operator: not_equal_to_case_insensitive + value: RELREC.**DECOD Core: Id: CORE-000744 Status: Published Version: '1' -Description: Raise an error when a related record is present in the parent - domain dataset but FAOBJ is not equal to the --TERM, --TRT or --DECOD of the - parent domain. +Description: Raise an error when a related record is present in the parent domain dataset but FAOBJ + is not equal to the --TERM, --TRT or --DECOD of the parent domain. Executability: Fully Executable Match Datasets: - - Name: RELREC +- Name: RELREC Outcome: - Message: Related record is present in the parent domain dataset but FAOBJ is not - equal to the "TERM", "TRT" or "DECOD" of the parent domain. + Message: Related record is present in the parent domain dataset but FAOBJ is not equal to the + "TERM", "TRT" or "DECOD" of the parent domain. Output Variables: - - FAOBJ - - RELREC.**TERM - - RELREC.**TRT - - RELREC.**DECOD + - FAOBJ + - RELREC.**TERM + - RELREC.**TRT + - RELREC.**DECOD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - FA + - FA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000749/rule.yml b/Published/CORE-000749/rule.yml index 857b59cad..2cb47fc4d 100644 --- a/Published/CORE-000749/rule.yml +++ b/Published/CORE-000749/rule.yml @@ -1,110 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.0 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial - Summary parameter value, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0166 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.0 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0166 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: TSVAL - operator: is_not_unique_set - value: TSPARMCD + - name: TSVAL + operator: is_not_unique_set + value: TSPARMCD Core: Id: CORE-000749 Status: Published @@ -114,15 +114,15 @@ Executability: Fully Executable Outcome: Message: The value of TSVAL is not unique within the value for TSPARMCD Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000750/rule.yml b/Published/CORE-000750/rule.yml index f7522d1d4..8ef2c6e6c 100644 --- a/Published/CORE-000750/rule.yml +++ b/Published/CORE-000750/rule.yml @@ -2,69 +2,68 @@ # Condition: Variable is not TS.TSSEQ # Rule: --SEQ is a unique number per USUBJID per domain, or a unique number per POOLID per domain, including when the domain is split into multiple files Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within - a domain. The Trial Summary domain does not contain subject - data, and TSSEQ is a sequence number to ensure uniqueness - within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: '3.1.4 Identifiers for All Classes' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - POOLID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - POOLID Core: Id: "CORE-000750" Status: Published Version: '1' -Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a - unique number per USUBJID per domain, or not a unique number per POOLID per - domain, including when the domain is split into multiple files. +Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per + USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is + split into multiple files. Executability: Fully Executable Outcome: - Message: --SEQ is not a unique number per one of the following identifier - variables, per domain; USUBJID or POOLID. + Message: --SEQ is not a unique number per one of the following identifier variables, per domain; + USUBJID or POOLID. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TS - - EM - - DU - - DO - - DI + - TS + - EM + - DU + - DO + - DI Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000751/rule.yml b/Published/CORE-000751/rule.yml index f27ccfc4a..23c2da7f6 100644 --- a/Published/CORE-000751/rule.yml +++ b/Published/CORE-000751/rule.yml @@ -1,78 +1,77 @@ Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within - a domain. The Trial Summary domain does not contain subject - data, and TSSEQ is a sequence number to ensure uniqueness - within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: '3.1.4 Identifiers for All Classes' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: any: - - all: - - name: SPDEVID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPDEVID - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - POOLID + - all: + - name: SPDEVID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPDEVID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - POOLID Core: Id: CORE-000751 Status: Published Version: '1' -Description: Part B - Raise an error when --SEQ is not a unique number per one - of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID. +Description: Part B - Raise an error when --SEQ is not a unique number per one of the following + identifier variables, per domain; USUBJID, POOLID or SPDEVID. Executability: Fully Executable Outcome: - Message: --SEQ is not a unique number per one of the following identifier - variables, per domain; USUBJID, POOLID or SPDEVID. + Message: --SEQ is not a unique number per one of the following identifier variables, per domain; + USUBJID, POOLID or SPDEVID. Output Variables: - - SPDEVID - - USUBJID - - POOLID + - SPDEVID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - DU - - DI - - DO + - DU + - DI + - DO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000752/rule.yml b/Published/CORE-000752/rule.yml index c95f761b7..0dc032417 100644 --- a/Published/CORE-000752/rule.yml +++ b/Published/CORE-000752/rule.yml @@ -1,52 +1,51 @@ Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within - a domain. The Trial Summary domain does not contain subject - data, and TSSEQ is a sequence number to ensure uniqueness - within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: '3.1.4 Identifiers for All Classes' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SPTOBID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPTOBID + - name: SPTOBID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPTOBID Core: Id: CORE-000752 Status: Published Version: '1' -Description: Part C - Raise an error when --SEQ is not a unique number per one - of the following identifier variables, per domain; SPTOBID. +Description: Part C - Raise an error when --SEQ is not a unique number per one of the following + identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per SPTOBID per domain. Output Variables: - - SPTOBID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - EM + - EM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000753/rule.yml b/Published/CORE-000753/rule.yml index 678687669..f4111bc67 100644 --- a/Published/CORE-000753/rule.yml +++ b/Published/CORE-000753/rule.yml @@ -1,52 +1,51 @@ Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within - a domain. The Trial Summary domain does not contain subject - data, and TSSEQ is a sequence number to ensure uniqueness - within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: '3.1.4 Identifiers for All Classes' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: SPTOBID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPTOBID + - name: SPTOBID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPTOBID Core: Id: CORE-000753 Status: Published Version: '1' -Description: Part D - Raise an error when --SEQ is not a unique number per one - of the following identifier variables, per domain; SPTOBID. +Description: Part D - Raise an error when --SEQ is not a unique number per one of the following + identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per SPTOBID per domain. Output Variables: - - SPTOBID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - ES + - ES Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000754/rule.yml b/Published/CORE-000754/rule.yml index ca5b378e2..161c97368 100644 --- a/Published/CORE-000754/rule.yml +++ b/Published/CORE-000754/rule.yml @@ -1,52 +1,51 @@ Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within - a domain. The Trial Summary domain does not contain subject - data, and TSSEQ is a sequence number to ensure uniqueness - within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: '3.1.4 Identifiers for All Classes' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: STOCONID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - STOCONID + - name: STOCONID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - STOCONID Core: Id: CORE-000754 Status: Published Version: '1' -Description: Part E - Raise an error when --SEQ is not a unique number per one - of the following identifier variables, per domain; SPTOBID. +Description: Part E - Raise an error when --SEQ is not a unique number per one of the following + identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per STOCONID per domain. Output Variables: - - STOCONID + - STOCONID Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - ES + - ES Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000755/rule.yml b/Published/CORE-000755/rule.yml index d7ccff759..89f25a16d 100644 --- a/Published/CORE-000755/rule.yml +++ b/Published/CORE-000755/rule.yml @@ -2,36 +2,35 @@ # Condition: # Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on - one of the 3 general observation classes. Each general class - domain must also include at least one of the following subject - identifiers - SUBJID, SPDEVID, or POOLID. - Document: SDTM v2.1 - Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all - AP datasets, and will identify records as AP data. - Document: SDTM v2.1 - Section: Section 4.0 Associated Persons Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0642 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers - SUBJID, SPDEVID, or POOLID. + Document: SDTM v2.1 + Section: Section 3.1.4 Identifiers For All Classes + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data. + Document: SDTM v2.1 + Section: Section 4.0 Associated Persons Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0642 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: DOMAIN - operator: exists - - name: STUDYID - operator: exists - - name: SPTOBID - operator: not_exists + - name: DOMAIN + operator: exists + - name: STUDYID + operator: exists + - name: SPTOBID + operator: not_exists Core: Id: "CORE-000755" Status: Published @@ -44,11 +43,11 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN - - IQ - - IT + - IN + - IQ + - IT Use Case: PROD Sensitivity: Dataset diff --git a/Published/CORE-000756/rule.yml b/Published/CORE-000756/rule.yml index a24cf8deb..824cefec4 100644 --- a/Published/CORE-000756/rule.yml +++ b/Published/CORE-000756/rule.yml @@ -1,161 +1,146 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected - with characters attached that cause the character-to numeric - conversion to fail. For example, numeric cell counts in the - source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values - should have a null result in the --STRESN column since only - numeric values can be represented in the --STRESN field. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0281 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0281 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: --ORRES - operator: not_matches_regex - value: ^(?:[+-]?(\d+(\.\d+)?|\.\d+)|[a-zA-Z]+|[^\d\s\w]+)$ - - name: --STRESN - operator: non_empty + - name: --ORRES + operator: not_matches_regex + value: ^(?:[+-]?(\d+(\.\d+)?|\.\d+)|[a-zA-Z]+|[^\d\s\w]+)$ + - name: --STRESN + operator: non_empty Core: Id: CORE-000756 Status: Published Version: '1' -Description: When --ORRES is representing numeric data with special characters - like '<' and '>', , --STRESN may not be populated. +Description: When --ORRES is representing numeric data with special characters like '<' and '>', , + --STRESN may not be populated. Executability: Partially Executable # See JIRA Outcome: - Message: --STRESN may not be populated as --ORRES does not represent a pure - numeric value. + Message: --STRESN may not be populated as --ORRES does not represent a pure numeric value. Output Variables: - - --ORRES - - --STRESN + - --ORRES + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000757/rule.yml b/Published/CORE-000757/rule.yml index 235e5be50..217534300 100644 --- a/Published/CORE-000757/rule.yml +++ b/Published/CORE-000757/rule.yml @@ -1,73 +1,69 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and - the name of the event or intervention is collected in an - "Other, specify" CRF field, the value in --OBJ variable - depends on whether the FA record has a parent record and - whether the "Other, specify" value was coded. - Document: IG v3.4 - Section: '4.2.7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0602 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and - the name of the event or intervention is collected in an - "Other, specify" CRF field, the value in --OBJ variable - depends on whether the FA record has a parent record and - whether the "Other, specify" value was coded. - Document: TIG 1.0 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0656 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: '4.2.7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0602 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: TIG 1.0 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0656 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: --DECOD - operator: empty - - name: RELREC.FAOBJ - operator: non_empty - - name: --TRT - operator: not_equal_to - value: RELREC.FAOBJ + - name: --DECOD + operator: empty + - name: RELREC.FAOBJ + operator: non_empty + - name: --TRT + operator: not_equal_to + value: RELREC.FAOBJ Core: Id: CORE-000757 Status: Published Version: '1' -Description: When findings are collected about an intervention, and the - interventions parent record exists and --DECOD = null, FAOBJ should be equal - to --TRT. +Description: When findings are collected about an intervention, and the interventions parent record + exists and --DECOD = null, FAOBJ should be equal to --TRT. Executability: Fully Executable Match Datasets: - - Name: RELREC - Wildcard: FA +- Name: RELREC + Wildcard: FA Outcome: - Message: Interventions parent record exists and --DECOD = null, but FAOBJ is not - equal to --TRT. + Message: Interventions parent record exists and --DECOD = null, but FAOBJ is not equal to --TRT. Output Variables: - - RELREC.FAOBJ - - --TRT - - --DECOD + - RELREC.FAOBJ + - --TRT + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000758/rule.yml b/Published/CORE-000758/rule.yml index 1eeb7995e..757352eed 100644 --- a/Published/CORE-000758/rule.yml +++ b/Published/CORE-000758/rule.yml @@ -2,141 +2,123 @@ # Condition: Milestone associated with RFSTDTC is start of treatment and ARMNRS ^=null and ARMNRS ^='UNPLANNED TREATMENT'. # Rule: RFSTDTC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character - format. Usually equivalent to date/time when subject was first - exposed to study treatment. See Assumption 9 for additional - detail on when RFSTDTC may be null. - Document: IG v3.3 - Item: Specification - Section: '5.2' - - Cited Guidance: ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should - be populated with a description of the unplanned treatment - received. - Document: IG v3.3 - Item: Assumption 4.a.4 - Section: '5.2' - - Cited Guidance: As described in Section 4.1.4, Order of the Variables, RFSTDTC - is used to calculate study day variables. RFSTDTC is usually - defined as the date/time when a subject was first exposed to - study drug. This definition applies for most interventional - studies, when the start of treatment is the natural and - preferred starting point for study day variables and thus the - logical value for RFSTDTC. In such studies, when data are - submitted for subjects who are ineligible for treatment (e.g., - screen failures with ARMNRS = "SCREEN FAILURE"), subjects who - were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT - ASSIGNED"), or subjects who were randomized but not treated - (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For - studies with designs that include a substantial portion of - subjects who are not expected to be treated, a different - protocol milestone may be chosen as the starting point for - study day variables. Some examples include non-interventional - or observational studies, studies with a no-treatment arm, or - studies where there is a delay between randomization and - treatment. - Document: IG v3.3 - Item: Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0534 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character - format. Usually equivalent to date/time when subject was first - exposed to study treatment. See Assumption 9 for additional - detail on when RFSTDTC may be null. - Document: IG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: RFSTDTC is used to calculate study day variables. RFSTDTC is - usually defined as the date/time when a subject was first - exposed to study drug. This definition applies for most - interventional studies, when the start of treatment is the - natural and preferred starting point for study day variables - and thus the logical value for RFSTDTC. In such studies, when - data are submitted for subjects who are ineligible for - treatment (e.g., screen failures with ARMNRS = "SCREEN - FAILURE"), subjects who were enrolled but not assigned to an - arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were - randomized but not treated (e.g., ARMNRS = "NOT TREATED"), - RFSTDTC will be null. For studies with designs that include a - substantial portion of subjects who are not expected to be - treated, a different protocol milestone may be chosen as the - starting point for study day variables. Some examples include - non-interventional or observational studies, studies with a - no-treatment Arm, or studies where there is a delay between - randomization and treatment. - Document: IG v3.4 - Item: Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0534 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: RFSTDTC Reference start date/time for the subject in ISO 8601 - character format. Usually equivalent to date/time when subject - was first exposed to study product - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - - Cited Guidance: RFSTDTC is used to calculate study day variables - Document: TIG 1.0 - Item: Assumption 9 - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0627 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character format. + Usually equivalent to date/time when subject was first exposed to study treatment. See + Assumption 9 for additional detail on when RFSTDTC may be null. + Document: IG v3.3 + Item: Specification + Section: '5.2' + - Cited Guidance: ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should be populated + with a description of the unplanned treatment received. + Document: IG v3.3 + Item: Assumption 4.a.4 + Section: '5.2' + - Cited Guidance: As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to + calculate study day variables. RFSTDTC is usually defined as the date/time when a subject + was first exposed to study drug. This definition applies for most interventional studies, + when the start of treatment is the natural and preferred starting point for study day + variables and thus the logical value for RFSTDTC. In such studies, when data are submitted + for subjects who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN + FAILURE"), subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT + ASSIGNED"), or subjects who were randomized but not treated (e.g., ARMNRS = "NOT + TREATED"), RFSTDTC will be null. For studies with designs that include a substantial + portion of subjects who are not expected to be treated, a different protocol milestone may + be chosen as the starting point for study day variables. Some examples include + non-interventional or observational studies, studies with a no-treatment arm, or studies + where there is a delay between randomization and treatment. + Document: IG v3.3 + Item: Assumption 9 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0534 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character format. + Usually equivalent to date/time when subject was first exposed to study treatment. See + Assumption 9 for additional detail on when RFSTDTC may be null. + Document: IG v3.4 + Item: Specification + Section: '5.2' + - Cited Guidance: RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined + as the date/time when a subject was first exposed to study drug. This definition applies + for most interventional studies, when the start of treatment is the natural and preferred + starting point for study day variables and thus the logical value for RFSTDTC. In such + studies, when data are submitted for subjects who are ineligible for treatment (e.g., + screen failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not + assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but + not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs + that include a substantial portion of subjects who are not expected to be treated, a + different protocol milestone may be chosen as the starting point for study day variables. + Some examples include non-interventional or observational studies, studies with a + no-treatment Arm, or studies where there is a delay between randomization and treatment. + Document: IG v3.4 + Item: Assumption 9 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0534 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: RFSTDTC Reference start date/time for the subject in ISO 8601 character + format. Usually equivalent to date/time when subject was first exposed to study product + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + - Cited Guidance: RFSTDTC is used to calculate study day variables + Document: TIG 1.0 + Item: Assumption 9 + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0627 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: ARMNRS - operator: non_empty - - name: ARMNRS - operator: not_equal_to - value: 'UNPLANNED TREATMENT' - value_is_literal: true - - name: RFSTDTC - operator: non_empty + - name: ARMNRS + operator: non_empty + - name: ARMNRS + operator: not_equal_to + value: 'UNPLANNED TREATMENT' + value_is_literal: true + - name: RFSTDTC + operator: non_empty Core: Id: 'CORE-000758' Status: Published Version: '1' -Description: 'Raise an error when milestone associated with RFSTDTC is start of - treatment and ARMNRS is not null and different from ''UNPLANNED TREATMENT'', - but RFSTDTC is not null.' +Description: 'Raise an error when milestone associated with RFSTDTC is start of treatment and ARMNRS is + not null and different from ''UNPLANNED TREATMENT'', but RFSTDTC is not null.' Executability: Partially Executable Outcome: - Message: 'Milestone associated with RFSTDTC is start of treatment and ARMNRS is - not null and different from ''UNPLANNED TREATMENT'', but RFSTDTC is not - empty.' + Message: 'Milestone associated with RFSTDTC is start of treatment and ARMNRS is not null and different + from ''UNPLANNED TREATMENT'', but RFSTDTC is not empty.' Output Variables: - - ARMNRS - - RFSTDTC + - ARMNRS + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000760/rule.yml b/Published/CORE-000760/rule.yml index 915bc4700..d8d28ec90 100644 --- a/Published/CORE-000760/rule.yml +++ b/Published/CORE-000760/rule.yml @@ -2,61 +2,59 @@ # Condition: DM.RFCSTDTC ^= Null and DM.RFCENDTC ^= Null # Rule: DM.RFCSTDTC <= DM.RFCENDTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3413 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3413 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3413 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3413 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: RFCSTDTC - operator: non_empty - - name: RFCENDTC - operator: non_empty - - name: RFCSTDTC - operator: date_greater_than - value: RFCENDTC + - name: RFCSTDTC + operator: non_empty + - name: RFCENDTC + operator: non_empty + - name: RFCSTDTC + operator: date_greater_than + value: RFCENDTC Core: Id: CORE-000760 Status: Published Version: '1' -Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior - or equal to the Date/Time of Last Challenge Agent Admin (RFCENDTC). +Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the + Date/Time of Last Challenge Agent Admin (RFCENDTC). Executability: Fully Executable Outcome: Message: RFCSTDTC falls after RFCENDTC. Output Variables: - - RFCSTDTC - - RFCENDTC + - RFCSTDTC + - RFCENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000762/rule.yml b/Published/CORE-000762/rule.yml index bd6986d2d..ee7aa8eeb 100644 --- a/Published/CORE-000762/rule.yml +++ b/Published/CORE-000762/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.2" - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be - included in nonclinical data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: "--HLGTCD" - operator: exists + - name: "--HLGTCD" + operator: exists Core: Id: "CORE-000762" Status: Published @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000763/rule.yml b/Published/CORE-000763/rule.yml index 598014f03..9a7844959 100644 --- a/Published/CORE-000763/rule.yml +++ b/Published/CORE-000763/rule.yml @@ -1,112 +1,97 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when - it ended or if it was ongoing. AFTER is not a valid value in - this case because it would represent an event after the date - of collection." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of - collection or assessment: Start values: an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the reference time point corresponds to the date of - collection or assessment; Start values; an observation can - start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values; - an observation can end BEFORE that time point, can end - COINCIDENT with that time point, can be known that it didn't - end but was ONGOING, or it is unknown (U) at all when it ended - or if it was ongoing. AFTER is not a valid value in this case - because it would represent an event after the date of - collection. - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0441 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not + a valid value in this case because it would represent an event after the date of collection." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If the reference time point corresponds to the date of collection or + assessment; Start values; an observation can start BEFORE that time point, can start + COINCIDENT with that time point, or it is unknown (U) when it started. End values; an + observation can end BEFORE that time point, can end COINCIDENT with that time point, can + be known that it didn't end but was ONGOING, or it is unknown (U) at all when it ended or + if it was ongoing. AFTER is not a valid value in this case because it would represent an + event after the date of collection. + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0441 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' # Variable: --STRTPT # Condition: --STTPT corresponds to the date of collection or assessment. # Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'UNKNOWN') Check: all: - - name: --STTPT - operator: non_empty - - name: --STTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --STTPT - operator: date_equal_to - value: --DTC - - name: --STRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - UNKNOWN + - name: --STTPT + operator: non_empty + - name: --STTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --STTPT + operator: date_equal_to + value: --DTC + - name: --STRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - UNKNOWN Core: Id: CORE-000763 Status: Published @@ -114,15 +99,15 @@ Core: Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN') Executability: Partially Executable Outcome: - Message: --STTPT is equal to the date of collection or assessment but --STRTPT - is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN'). + Message: --STTPT is equal to the date of collection or assessment but --STRTPT is not in + ('BEFORE', 'COINCIDENT', 'UNKNOWN'). Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000764/rule.yml b/Published/CORE-000764/rule.yml index c022a3b25..4db492f76 100644 --- a/Published/CORE-000764/rule.yml +++ b/Published/CORE-000764/rule.yml @@ -1,69 +1,68 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a - single product|2.b.iii If a study has multiple products, then - DSSCAT should name the individual product. - Document: TIG v1.0 - Item: 2.b.ii - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0632 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single + product|2.b.iii If a study has multiple products, then DSSCAT should name the individual + product. + Document: TIG v1.0 + Item: 2.b.ii + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0632 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: $disposition_event_count - operator: greater_than - value: 1 - - name: DSSCAT - operator: equal_to - value: PRODUCT EXPOSURE - value_is_literal: true - - name: DSSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH + - name: $disposition_event_count + operator: greater_than + value: 1 + - name: DSSCAT + operator: equal_to + value: PRODUCT EXPOSURE + value_is_literal: true + - name: DSSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH Core: + Id: CORE-000764 Status: Published Version: '1' - Id: CORE-000764 -Description: Trigger error when subject has more than one record per Epoch with - DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = PRODUCT - EXPOSURE' +Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION + EVENT' and more than one record where DSSCAT = PRODUCT EXPOSURE' Executability: Fully Executable Operations: - - domain: DS - filter: - DSCAT: DISPOSITION EVENT - group: - - USUBJID - - EPOCH - id: $disposition_event_count - name: DSCAT - operator: record_count +- domain: DS + filter: + DSCAT: DISPOSITION EVENT + group: + - USUBJID + - EPOCH + id: $disposition_event_count + name: DSCAT + operator: record_count Outcome: - Message: More than 1 record exists per subject per EPOCH with DSCAT = - 'DISPOSITION EVENT' and DSSCAT = 'PRODUCT EXPOSURE'. + Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + DSSCAT = 'PRODUCT EXPOSURE'. Output Variables: - - USUBJID - - DSCAT - - DSSCAT - - EPOCH + - USUBJID + - DSCAT + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000765/rule.yml b/Published/CORE-000765/rule.yml index 0a209e7b8..c951cf9e6 100644 --- a/Published/CORE-000765/rule.yml +++ b/Published/CORE-000765/rule.yml @@ -2,143 +2,143 @@ # Condition: # Rule: dataset_size is not greater than 5GB Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger - than 5 GB in size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: $dataset_size - operator: greater_than - value: 5368709120 + - name: $dataset_size + operator: greater_than + value: 5368709120 Core: Id: CORE-000765 Status: Published @@ -146,19 +146,19 @@ Core: Description: The submitted dataset is larger than 5 GB Executability: Fully Executable Operations: - - id: $dataset_size - name: dataset_size - operator: extract_metadata +- id: $dataset_size + name: dataset_size + operator: extract_metadata Outcome: Message: The submitted dataset is larger than 5 GB Output Variables: - - $dataset_size + - $dataset_size Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000768/rule.yml b/Published/CORE-000768/rule.yml index e7f2524a9..e8279dd11 100644 --- a/Published/CORE-000768/rule.yml +++ b/Published/CORE-000768/rule.yml @@ -1,91 +1,91 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # There may be only 1 record for TXPARMCD=ARMCD per group of SETCD values # REMARK: 2025-03-13: works, but currently only the first violation is reported, the following ones are not - - name: $armcd_count - operator: not_equal_to - value: 1 + - name: $armcd_count + operator: not_equal_to + value: 1 Core: Id: CORE-000768 Status: Published @@ -93,30 +93,30 @@ Core: Description: Every Trial Set should have only one ARMCD. Executability: Fully Executable Operations: - - domain: TX +- domain: TX # only keep the records with TXPARMCD=ARMCD - filter: - TXPARMCD: ARMCD + filter: + TXPARMCD: ARMCD # group the records by value of TXSETCD - group: - - SETCD + group: + - SETCD # within the filtered and grouped records, count the number of TXVAL records - id: $armcd_count - name: TXVAL - operator: record_count + id: $armcd_count + name: TXVAL + operator: record_count Outcome: Message: There may be only 1 record for TXPARMCD=ARMCD per group of SETCD values Output Variables: - - SETCD - - $armcd_count + - SETCD + - $armcd_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When Sensitivity is set to Dataset, only the first set that violates the rule is reported # When Sensitivity is set to Record, a violation is reported for EACH record in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000769/rule.yml b/Published/CORE-000769/rule.yml index fe17458b3..25b118246 100644 --- a/Published/CORE-000769/rule.yml +++ b/Published/CORE-000769/rule.yml @@ -1,92 +1,86 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number - format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' + Document: 'FDA' + Section: 'FDAB053' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB5302' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TSPARMCD - operator: equal_to - value: 'AGETXT' - - name: TSVAL - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: TSPARMCD + operator: equal_to + value: 'AGETXT' + - name: TSVAL + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000769 Status: Published @@ -99,8 +93,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000770/rule.yml b/Published/CORE-000770/rule.yml index 4afd8034f..7f7dad5c6 100644 --- a/Published/CORE-000770/rule.yml +++ b/Published/CORE-000770/rule.yml @@ -1,217 +1,211 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD value assigned in TXPARMCD. - Document: IG v3.0 - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with - corresponding parameter value under TXVAL. - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0162 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD value assigned in TXPARMCD. + Document: IG v3.0 + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: TIG + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0162 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # FDA rule FB4602 added (SEND-only) - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable to SENDIG as of version 3.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: # 2025-03-13: REMARK that only the first violation is reported when Sensitivity is set to "Dataset" # See Github issue https://github.com/cdisc-org/cdisc-rules-engine/issues/831 - - name: '$txgroupsbysetcd' - operator: 'does_not_contain' - value: 'SPGRPCD' + - name: '$txgroupsbysetcd' + operator: 'does_not_contain' + value: 'SPGRPCD' # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule Core: Id: CORE-000770 Status: Published Version: '1' -Description: 'For each Trial Set (SETCD) in the TX dataset exactly one - Sponsor-Defined Group Code (SPGRPCD) record should be included.' +Description: 'For each Trial Set (SETCD) in the TX dataset exactly one Sponsor-Defined Group Code (SPGRPCD) + record should be included.' Executability: Fully Executable Operations: - - domain: TX - group: - - SETCD - id: $txgroupsbysetcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txgroupsbysetcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'SPGRPCD' record per SETCD. Output Variables: - - SETCD - - TXPARMCD - - $txgroupsbysetcd + - SETCD + - TXPARMCD + - $txgroupsbysetcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN # CAVEAT: When Sensitivity set to "Dataset" only the an issue is reported for the FIRST "set" for which the rule is violate # When Sensitivity is set to "Record", an issue is reported for EACH record in the set that violates the rule diff --git a/Published/CORE-000771/rule.yml b/Published/CORE-000771/rule.yml index 88e6c9c4a..e9b8bfa29 100644 --- a/Published/CORE-000771/rule.yml +++ b/Published/CORE-000771/rule.yml @@ -1,124 +1,122 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.0 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.0 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: CLDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: CLORRES - operator: is_not_unique_set - value: - - USUBJID - - CLDTC - - all: - - name: CLDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: CLORRES - operator: is_not_unique_set - value: - - POOLID - - CLDTC + - all: + - name: CLDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: CLORRES + operator: is_not_unique_set + value: + - USUBJID + - CLDTC + - all: + - name: CLDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: CLORRES + operator: is_not_unique_set + value: + - POOLID + - CLDTC Core: Id: CORE-000771 Status: Published Version: '1' -Description: Raise an error when there is more than one record present for any - particular Result or Findings as Collected, in the CL Domain, for a subject or - pool on a particular date. +Description: Raise an error when there is more than one record present for any particular Result or + Findings as Collected, in the CL Domain, for a subject or pool on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where CLDTC is null Outcome: - Message: The Clinical Observation test result is not unique for this subject and - date/time. + Message: The Clinical Observation test result is not unique for this subject and date/time. Output Variables: - - USUBJID - - POOLID - - CLTESTCD - - CLORRES - - CLDTC + - USUBJID + - POOLID + - CLTESTCD + - CLORRES + - CLDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL + - CL Sensitivity: Record diff --git a/Published/CORE-000772/rule.yml b/Published/CORE-000772/rule.yml index 88383f139..69c4d7062 100644 --- a/Published/CORE-000772/rule.yml +++ b/Published/CORE-000772/rule.yml @@ -1,130 +1,124 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set - with a Trial Arm as defined in the Trial Arms table. Each - Trial Set should only have one ARMCD parameter, but more than - one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: TXPARMCD - operator: equal_to - value: ARMCD - value_is_literal: true - - name: TXVAL - operator: is_not_contained_by - value: $ta_armcd + - name: TXPARMCD + operator: equal_to + value: ARMCD + value_is_literal: true + - name: TXVAL + operator: is_not_contained_by + value: $ta_armcd Core: + Id: CORE-000772 Status: Published Version: '1' - Id: CORE-000772 Description: '' Executability: Fully Executable Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: 'The value of TXVAL for TXPARMCD=ARMCD cannot be found in the TA dataset' Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000773/rule.yml b/Published/CORE-000773/rule.yml index 0a8436c87..9e2314b1c 100644 --- a/Published/CORE-000773/rule.yml +++ b/Published/CORE-000773/rule.yml @@ -1,78 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the - date/time of subject disposition in ISO 8601 format - Document: IG v3.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the - date/time of subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the - date/time of subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the - date/time of subject disposition in ISO 8601 format - Document: IG v3.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the - date/time of subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND320' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND320' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND320' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND320' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND320' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: date_greater_than - value: $dsstdtc + - name: --DTC + operator: non_empty + - name: --DTC + operator: date_greater_than + value: $dsstdtc Core: Id: CORE-000773 Status: Published @@ -81,25 +81,25 @@ Description: --DTC may not be later than DS.DSSTDTC Executability: Fully Executable Operations: # Though there should be only one record per subject in DS - - domain: DS - group: - - USUBJID - id: $dsstdtc - name: DSSTDTC - operator: max_date +- domain: DS + group: + - USUBJID + id: $dsstdtc + name: DSSTDTC + operator: max_date Outcome: Message: --DTC may not be later than DS.DSSTDTC (date/time of death) Output Variables: - - --DTC - - $dsstdtc + - --DTC + - $dsstdtc Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI - - MA - - TF + - MI + - MA + - TF Sensitivity: Record diff --git a/Published/CORE-000774/rule.yml b/Published/CORE-000774/rule.yml index d6252cca8..9120c122b 100644 --- a/Published/CORE-000774/rule.yml +++ b/Published/CORE-000774/rule.yml @@ -1,177 +1,167 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be - populated, and the reason not done should be provided in the - appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - value_is_literal: true - - any: - - name: --REASND - operator: empty - - name: --REASND - operator: not_exists + - name: --STAT + operator: equal_to + value: NOT DONE + value_is_literal: true + - any: + - name: --REASND + operator: empty + - name: --REASND + operator: not_exists Core: Id: CORE-000774 Status: Published Version: '1' -Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done - (--REASND) should be populated. +Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be + populated. Executability: Partially Executable - Possible Overreporting Outcome: Message: --STAT = NOT DONE, but --REASND is missing. Output Variables: - - --TESTCD - - --STAT - - --REASND + - --TESTCD + - --STAT + - --REASND Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000775/rule.yml b/Published/CORE-000775/rule.yml index 3958e5c5d..fc3007ab0 100644 --- a/Published/CORE-000775/rule.yml +++ b/Published/CORE-000775/rule.yml @@ -1,144 +1,143 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "TRTDOSU: For more complex dosing regimens, sponsor should enter - 'SEE PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE - PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE - PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE - PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE - PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE - PROTOCOL' to match the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "TRTDOSU: For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' + to match the associated TRTDOS value." + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: # With thanks to Richard Marshall 2025-03-16 all: - - name: TXPARMCD - operator: is_contained_by - value: - - TRTDOS - - TRTDOSU - - name: $num_trtdos_see_protocol - operator: equal_to - value: 1 - - name: $num_trtdosu_see_protocol - operator: not_equal_to - value: 1 + - name: TXPARMCD + operator: is_contained_by + value: + - TRTDOS + - TRTDOSU + - name: $num_trtdos_see_protocol + operator: equal_to + value: 1 + - name: $num_trtdosu_see_protocol + operator: not_equal_to + value: 1 Core: + Id: CORE-000775 Status: Published Version: '1' - Id: CORE-000775 Description: '' Executability: Fully Executable # Group by value of SETCD Operations: # With thanks to Richard Marshall 2025-03-16 # counts the records with TRTDOS='SEE PROTOCOL' within the group - - filter: - TXPARMCD: TRTDOS - TXVAL: 'SEE PROTOCOL' - group: - - SETCD - id: $num_trtdos_see_protocol - operator: record_count +- filter: + TXPARMCD: TRTDOS + TXVAL: 'SEE PROTOCOL' + group: + - SETCD + id: $num_trtdos_see_protocol + operator: record_count # counts the records with TRTDOSU='SEE PROTOCOL' within the group - - filter: - TXPARMCD: TRTDOSU - TXVAL: 'SEE PROTOCOL' - group: - - SETCD - id: $num_trtdosu_see_protocol - operator: record_count +- filter: + TXPARMCD: TRTDOSU + TXVAL: 'SEE PROTOCOL' + group: + - SETCD + id: $num_trtdosu_see_protocol + operator: record_count Outcome: - Message: "Within a single set, when TXPARMCD='TRTDOS' with the value for - TXVAL='SEE PROTOCOL', then for the record with TXPARMCD=TRTDOSU in the same - set, the value for TXVAL must also be 'SEE PROTOCOL'" + Message: "Within a single set, when TXPARMCD='TRTDOS' with the value for TXVAL='SEE PROTOCOL', then + for the record with TXPARMCD=TRTDOSU in the same set, the value for TXVAL must also be 'SEE PROTOCOL'" Output Variables: - - STUDYID - - $num_trtdos_see_protocol - - $num_trtdosu_see_protocol + - STUDYID + - $num_trtdos_see_protocol + - $num_trtdosu_see_protocol Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # Keeping Sensitivity to "Record" as otherwise only the first violation is reported Sensitivity: Record diff --git a/Published/CORE-000776/rule.yml b/Published/CORE-000776/rule.yml index ea6039bd2..d14bfb474 100644 --- a/Published/CORE-000776/rule.yml +++ b/Published/CORE-000776/rule.yml @@ -1,173 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --ENDY - operator: not_exists - - name: --ENDTC - operator: exists + - name: --ENDY + operator: not_exists + - name: --ENDTC + operator: exists Core: Id: CORE-000776 Status: Published Version: '1' -Description: When End Date/Time of Observation (--ENDTC) is present in the - dataset, then the Study Day of End of Observation (--ENDY) should also be - present in the dataset +Description: When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study + Day of End of Observation (--ENDY) should also be present in the dataset Executability: Fully Executable Outcome: - Message: Study Day of End of Observation (--ENDY) variable is missing when End - Date/Time of Observation (--ENDTC) is present. + Message: Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of + Observation (--ENDTC) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000780/rule.yml b/Published/CORE-000780/rule.yml index 3b63d5396..61163a7ed 100644 --- a/Published/CORE-000780/rule.yml +++ b/Published/CORE-000780/rule.yml @@ -1,96 +1,96 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.0' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first - 200 characters of the comment will be in COVAL, the next 200 - in COVAL1, and additional text stored as needed to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.0' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.1' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.1.1' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.1.1' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.1' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn.' + Document: 'IG v.3.1.1' + Item: 'Specification' + Section: '5.2.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND119' + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: #- all: @@ -100,9 +100,9 @@ Check: # operator: non_empty # - name: COVAL # operator: empty - - all: - - name: --VAL - operator: inconsistent_enumerated_columns + - all: + - name: --VAL + operator: inconsistent_enumerated_columns Core: Id: CORE-000780 Status: Published @@ -110,14 +110,13 @@ Core: Description: 'Correct order of population in COVALn variables check' Executability: Partially Executable - Possible Underreporting Outcome: - Message: 'Correct order of population in COVAL variables must be COVAL, COVAL1, - COVAL2 ...' + Message: 'Correct order of population in COVAL variables must be COVAL, COVAL1, COVAL2 ...' Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000781/rule.yml b/Published/CORE-000781/rule.yml index c3854fed0..0ecdb3491 100644 --- a/Published/CORE-000781/rule.yml +++ b/Published/CORE-000781/rule.yml @@ -2,108 +2,107 @@ # Condition: TXPARMCD = SPECIES # Rule: One Trail Set cannot contain more than one species Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND307' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND307' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND307' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND307' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND307' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: $species_count - operator: greater_than - value: 1 + - name: $species_count + operator: greater_than + value: 1 Core: + Id: CORE-000781 Status: Published Version: '1' - Id: CORE-000781 -Description: 'Trial Sets (TX) can have multiple species and/or strains if they - are different by set.' +Description: 'Trial Sets (TX) can have multiple species and/or strains if they are different by set.' Executability: Fully Executable Operations: - - domain: TX +- domain: TX # only keep the records with TXPARMCD=SPECIES - filter: - TXPARMCD: SPECIES + filter: + TXPARMCD: SPECIES # group the records by value of TXSETCD - group: - - SETCD + group: + - SETCD # within the filtered and grouped records, count the number of records - id: $species_count - operator: record_count + id: $species_count + operator: record_count Outcome: Message: 'One Trial Set cannot contain more than one species for the same SETCD.' Output Variables: - - SETCD - - $species_count - - TXPARMCD + - SETCD + - $species_count + - TXPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000782/rule.yml b/Published/CORE-000782/rule.yml index 09f9372a0..40e76d479 100644 --- a/Published/CORE-000782/rule.yml +++ b/Published/CORE-000782/rule.yml @@ -2,108 +2,107 @@ # Condition: TXPARMCD = STRAIN # Rule: One Trail Set cannot contain more than one strain Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND308' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND308' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND308' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND308' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND308' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: $strain_count - operator: greater_than - value: 1 + - name: $strain_count + operator: greater_than + value: 1 Core: + Id: CORE-000782 Status: Published Version: '1' - Id: CORE-000782 -Description: 'Trial Sets (TX) can have multiple species and/or strains if they - are different by set.' +Description: 'Trial Sets (TX) can have multiple species and/or strains if they are different by set.' Executability: Fully Executable Operations: - - domain: TX +- domain: TX # only keep the records with TXPARMCD=STRAIN - filter: - TXPARMCD: STRAIN + filter: + TXPARMCD: STRAIN # group the records by value of TXSETCD - group: - - SETCD + group: + - SETCD # within the filtered and grouped records, count the number of records - id: $strain_count - operator: record_count + id: $strain_count + operator: record_count Outcome: Message: 'One Trial Set cannot contain more than one strain.' Output Variables: - - SETCD - - $strain_count - - TXPARMCD + - SETCD + - $strain_count + - TXPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000783/rule.yml b/Published/CORE-000783/rule.yml index 441609e51..a2ec34c2a 100644 --- a/Published/CORE-000783/rule.yml +++ b/Published/CORE-000783/rule.yml @@ -1,170 +1,166 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM - variables using the Supplemental Qualifiers special-purpose - dataset structure - Document: IG v3.4 - Item: NA - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The SDTM allows for the inclusion of the sponsors non-SDTM - variables using the Supplemental Qualifiers special-purpose - dataset structure, described in Section 8; 8.4, Relating - Non-Standard Variables Values To A Parent Domain.' - Document: IG v3.2 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM - variables using the Supplemental Qualifiers special purpose - dataset structure, described in Section 8.4, Relating - Non-Standard Variables Values to a Parent Domain. - Document: IG v3.3 - Section: '2.5' - - Cited Guidance: New sponsor-defined variables must not be added, and existing - variables must not be renamed or modified for novel usage. - Document: Model v1.7 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.0 - Item: QNAM CDISC Notes - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name - defined in another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM variables using + the Supplemental Qualifiers special-purpose dataset structure + Document: IG v3.4 + Item: NA + Section: '2.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The SDTM allows for the inclusion of the sponsors non-SDTM variables using the + Supplemental Qualifiers special-purpose dataset structure, described in Section 8; 8.4, Relating + Non-Standard Variables Values To A Parent Domain.' + Document: IG v3.2 + Section: '2.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM variables using + the Supplemental Qualifiers special purpose dataset structure, described in Section 8.4, + Relating Non-Standard Variables Values to a Parent Domain. + Document: IG v3.3 + Section: '2.5' + - Cited Guidance: New sponsor-defined variables must not be added, and existing variables must + not be renamed or modified for novel usage. + Document: Model v1.7 + Section: '2.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.0 + Item: QNAM CDISC Notes + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1 + Item: QNAM CDISC Notes + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1 + Item: QNAM CDISC Notes + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: '8.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: '1' + Version: '5.0' + Version: '1.2' # Variable: QNAM # Condition: SUPP--.QNAM present in dataset # Rule: Value of SUPP--.QNAM ^= any variable name defined in the corresponding SDTM version Check: all: - - name: QNAM - operator: is_contained_by - value: $model_variables + - name: QNAM + operator: is_contained_by + value: $model_variables Core: Id: CORE-000783 Status: Published Version: '1' -Description: Raise an error when SUPP--.QNAM is present in dataset, but value of - SUPP--.QNAM is equal to a variable name defined in the corresponding SDTM - version. +Description: Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is + equal to a variable name defined in the corresponding SDTM version. Executability: Fully Executable Operations: - - id: $model_variables - operator: get_parent_model_column_order +- id: $model_variables + operator: get_parent_model_column_order Outcome: - Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM - equals a variable name defined in the corresponding SDTM version. + Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable + name defined in the corresponding SDTM version. Output Variables: - - QNAM - - $model_variables + - QNAM + - $model_variables Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000784/rule.yml b/Published/CORE-000784/rule.yml index d8fbde9a4..6c98afd5a 100644 --- a/Published/CORE-000784/rule.yml +++ b/Published/CORE-000784/rule.yml @@ -2,111 +2,109 @@ # Condition: TAETORD present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC # Rule: TAETORD = SE.TAETORD Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: IG v3.4 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.2 - Item: Assumption 11 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit.It would be inappropriate to add the - variables that support time points (--TPT, --TPTNUM, --ELTM, - --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.3 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those - at the start of the visit. - Document: TIG 1.0 - Item: Assumption 11 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0431 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: IG v3.4 + Item: Assumption 11 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.2 + Item: Assumption 11 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.3 + Item: Assumption 11 + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: TIG 1.0 + Item: Assumption 11 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0431 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: TAETORD - operator: exists - - name: SVSTDTC - operator: date_greater_than_or_equal_to - value: SESTDTC - - name: SVSTDTC - operator: date_less_than_or_equal_to - value: SEENDTC - - name: TAETORD - operator: not_equal_to - value: SE.TAETORD + - name: TAETORD + operator: exists + - name: SVSTDTC + operator: date_greater_than_or_equal_to + value: SESTDTC + - name: SVSTDTC + operator: date_less_than_or_equal_to + value: SEENDTC + - name: TAETORD + operator: not_equal_to + value: SE.TAETORD Core: Id: CORE-000784 Status: Published Version: '1' -Description: Raise an error when variable TAETORD values don't match between - Subject Visits (SV) and Subject Elements (SE) datasets. +Description: Raise an error when variable TAETORD values don't match between Subject Visits (SV) and + Subject Elements (SE) datasets. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: SE +- Keys: + - USUBJID + Name: SE Outcome: - Message: TAETORD values don't match between Subject Visits (SV) and Subject - Elements (SE) datasets. + Message: TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) + datasets. Output Variables: - - SESTDTC - - SEENDTC - - SVSTDTC - - TAETORD - - SE.TAETORD + - SESTDTC + - SEENDTC + - SVSTDTC + - TAETORD + - SE.TAETORD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000785/rule.yml b/Published/CORE-000785/rule.yml index 97f2399ff..5c07c47a8 100644 --- a/Published/CORE-000785/rule.yml +++ b/Published/CORE-000785/rule.yml @@ -2,94 +2,85 @@ # Condition: --SCAT ^= null # Rule: --CAT ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further - categorization of --CAT values.]|2.2.2[Table 3.2.2 - --SCAT][Used to define a further categorization of --CAT - values.]|2.2.3[Table 3.2.3 --SCAT][Used to define a further - categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: - --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Interventions[A further grouping or classification of the - category for the topic of the finding, event, or intervention. - The category is in --CAT.]|Events[A further grouping or - classification of the category for the topic of the finding, - event, or intervention. The category is in --CAT.]|Findings[A - further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT.] - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The - Events Observation Class Section|3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0583 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table + 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used + to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Interventions[A further grouping or classification of the category for the + topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further + grouping or classification of the category for the topic of the finding, event, or + intervention. The category is in --CAT.]|Findings[A further grouping or classification of + the category for the topic of the finding, event, or intervention. The category is in + --CAT.] + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Observation Class Section|3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0583 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IESCAT - operator: non_empty - - name: IECAT - operator: empty + - name: IESCAT + operator: non_empty + - name: IECAT + operator: empty Core: Id: CORE-000785 Status: Published @@ -99,15 +90,15 @@ Executability: Fully Executable Outcome: Message: IECAT should not be null when IESCAT is populated Output Variables: - - IECAT - - IESCAT + - IECAT + - IESCAT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000786/rule.yml b/Published/CORE-000786/rule.yml index 2cc0f8944..14d6a20ef 100644 --- a/Published/CORE-000786/rule.yml +++ b/Published/CORE-000786/rule.yml @@ -2,114 +2,106 @@ # Condition: --SCAT present in dataset # Rule: --CAT present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: - --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.2 The Events Observation Class Section - - Cited Guidance: A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is - in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0584 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.2 The Events Observation Class Section + - Cited Guidance: A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0584 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: IESCAT - operator: exists - - name: IECAT - operator: not_exists + - name: IESCAT + operator: exists + - name: IECAT + operator: not_exists Core: Id: CORE-000786 Status: Published Version: '1' -Description: Part B - Raise an error when IESCAT exists in a dataset, but IECAT - does not exist. +Description: Part B - Raise an error when IESCAT exists in a dataset, but IECAT does not exist. Executability: Fully Executable Outcome: Message: IESCAT exists in a dataset, but IECAT does not exist. Output Variables: - - IECAT - - IESCAT + - IECAT + - IESCAT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000788/rule.yml b/Published/CORE-000788/rule.yml index 9e4970fa7..b37e62ead 100644 --- a/Published/CORE-000788/rule.yml +++ b/Published/CORE-000788/rule.yml @@ -1,117 +1,116 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'TSVCDREF' - operator: exists + - name: 'TSVCDREF' + operator: exists Core: + Id: CORE-000788 Status: Published Version: '1' - Id: CORE-000788 Description: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset' Executability: Fully Executable Outcome: - Message: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND - dataset' + Message: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset' Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Published/CORE-000789/rule.yml b/Published/CORE-000789/rule.yml index 6540a2064..479403afc 100644 --- a/Published/CORE-000789/rule.yml +++ b/Published/CORE-000789/rule.yml @@ -1,108 +1,107 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'TSVCDVER' - operator: exists + - name: 'TSVCDVER' + operator: exists Core: + Id: CORE-000789 Status: Published Version: '1' - Id: CORE-000789 -Description: 'TSVCDVER (Version of the Reference Terminology) must not be - present in SEND dataset' +Description: 'TSVCDVER (Version of the Reference Terminology) must not be present in SEND dataset' Executability: Fully Executable Outcome: Message: 'TSVCDVER must not be present in SEND dataset' @@ -110,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Published/CORE-000791/rule.yml b/Published/CORE-000791/rule.yml index dfa375c09..a532f82f7 100644 --- a/Published/CORE-000791/rule.yml +++ b/Published/CORE-000791/rule.yml @@ -1,161 +1,151 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. - Examples include short name and name of test; parameter name - and parameter code or number; variable name and variable - label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: ACTARM - operator: is_not_unique_relationship - value: ACTARMCD + - name: ACTARM + operator: is_not_unique_relationship + value: ACTARMCD Core: Id: CORE-000791 Status: Published @@ -165,14 +155,14 @@ Executability: Fully Executable Outcome: Message: ACTARMCD and ACTARM do not have a one-to-one relationship. Output Variables: - - ACTARM - - ACTARMCD + - ACTARM + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000793/rule.yml b/Published/CORE-000793/rule.yml index 4f96a78eb..89937405b 100644 --- a/Published/CORE-000793/rule.yml +++ b/Published/CORE-000793/rule.yml @@ -1,160 +1,158 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: --DY - operator: not_exists + - name: --DTC + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: --DY + operator: not_exists Core: Id: CORE-000793 Status: Published Version: '1' -Description: 'Collection study day (--DY) should be present when date/time of - collection (--DTC) is populated' +Description: 'Collection study day (--DY) should be present when date/time of collection (--DTC) is populated' Executability: Fully Executable Outcome: - Message: Collection study day (--DY) is missing when date/time of collection - (--DTC) is populated. + Message: Collection study day (--DY) is missing when date/time of collection (--DTC) is populated. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000794/rule.yml b/Published/CORE-000794/rule.yml index 7f2b852fc..846111317 100644 --- a/Published/CORE-000794/rule.yml +++ b/Published/CORE-000794/rule.yml @@ -1,106 +1,106 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--PTCD' - operator: exists + - name: '--PTCD' + operator: exists Core: + Id: CORE-000794 Status: Published Version: '1' - Id: CORE-000794 Description: '--PTCD (Preferred Term Code) must not be in SEND dataset' Executability: Fully Executable Outcome: @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000796/rule.yml b/Published/CORE-000796/rule.yml index 3ca371318..6de3f0a2e 100644 --- a/Published/CORE-000796/rule.yml +++ b/Published/CORE-000796/rule.yml @@ -1,52 +1,49 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A specified condition for assessments must apply to at least to - a procedure, biomedical concept, biomedical concept surrogate, - biomedical concept category or a whole activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00016' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A specified condition for assessments must apply to at least to a procedure, + biomedical concept, biomedical concept surrogate, biomedical concept category or a whole activity.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00016' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Condition' - - any: - - name: appliesToIds - operator: not_exists - - name: appliesToIds - operator: not_equal_to - value: true + - name: instanceType + operator: equal_to + value: 'Condition' + - any: + - name: appliesToIds + operator: not_exists + - name: appliesToIds + operator: not_equal_to + value: true Core: Id: 'CORE-000796' Status: Published Version: '1' -Description: 'A specified condition for assessments must apply to at least to a - procedure, biomedical concept, biomedical concept surrogate, biomedical - concept category or a whole activity.' +Description: 'A specified condition for assessments must apply to at least to a procedure, biomedical + concept, biomedical concept surrogate, biomedical concept category or a whole activity.' Executability: Fully Executable Outcome: - Message: 'The condition does not apply to a procedure, biomedical concept, - biomedical concept surrogate, biomedical concept category or a whole - activity.' + Message: 'The condition does not apply to a procedure, biomedical concept, biomedical concept surrogate, + biomedical concept category or a whole activity.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - appliesToIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - appliesToIds Rule Type: Record Data Scope: Entities: Include: - - Condition + - Condition Sensitivity: Record diff --git a/Published/CORE-000797/rule.yml b/Published/CORE-000797/rule.yml index 5415b57e6..04470c2ca 100644 --- a/Published/CORE-000797/rule.yml +++ b/Published/CORE-000797/rule.yml @@ -1,52 +1,52 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each StudyArm must have one StudyCell for each StudyEpoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00068' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each StudyArm must have one StudyCell for each StudyEpoch.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00068' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyArm' - - name: id.StudyEpoch - operator: is_unique_set - value: id - - any: - - all: - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'arms' - - name: parent_rel.StudyEpoch - operator: equal_to - value: 'epochs' - - all: - - name: parent_entity - operator: equal_to - value: 'StudyCell' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'armId' - - name: parent_rel.StudyEpoch - operator: equal_to - value: 'epochId' + - name: instanceType + operator: equal_to + value: 'StudyArm' + - name: id.StudyEpoch + operator: is_unique_set + value: id + - any: + - all: + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_rel + operator: equal_to + value: 'arms' + - name: parent_rel.StudyEpoch + operator: equal_to + value: 'epochs' + - all: + - name: parent_entity + operator: equal_to + value: 'StudyCell' + - name: rel_type + operator: equal_to + value: 'reference' + - name: parent_rel + operator: equal_to + value: 'armId' + - name: parent_rel.StudyEpoch + operator: equal_to + value: 'epochId' Core: Id: 'CORE-000797' Status: Published @@ -54,25 +54,25 @@ Core: Description: 'Each StudyArm must have one StudyCell for each StudyEpoch.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - parent_entity - - parent_id - - rel_type - Name: StudyEpoch +- Join Type: left + Keys: + - parent_entity + - parent_id + - rel_type + Name: StudyEpoch Outcome: Message: 'The StudyArm does not have a StudyCell for the StudyEpoch.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - id.StudyEpoch - - name.StudyEpoch + - parent_entity + - parent_id + - parent_rel + - id + - name + - id.StudyEpoch + - name.StudyEpoch Rule Type: Record Data Scope: Entities: Include: - - 'StudyArm' + - 'StudyArm' Sensitivity: Record diff --git a/Published/CORE-000798/rule.yml b/Published/CORE-000798/rule.yml index 2f15c9a4c..85051a005 100644 --- a/Published/CORE-000798/rule.yml +++ b/Published/CORE-000798/rule.yml @@ -1,72 +1,68 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A procedure must only reference a study intervention that is - defined within the same study design as the activity within - which the procedure is defined.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00048' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A procedure must only reference a study intervention that is defined within the + same study design as the activity within which the procedure is defined.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00048' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Procedure' - - name: rel_type - operator: equal_to - value: 'definition' - - name: rel_type.StudyIntervention - operator: equal_to - value: 'definition' - - name: rel_type.Activity - operator: equal_to - value: 'definition' - - name: parent_id.StudyIntervention - operator: not_equal_to - value: parent_id.Activity + - name: instanceType + operator: equal_to + value: 'Procedure' + - name: rel_type + operator: equal_to + value: 'definition' + - name: rel_type.StudyIntervention + operator: equal_to + value: 'definition' + - name: rel_type.Activity + operator: equal_to + value: 'definition' + - name: parent_id.StudyIntervention + operator: not_equal_to + value: parent_id.Activity Core: Id: 'CORE-000798' Status: Published Version: '1' -Description: 'A procedure must only reference a study intervention that is - defined within the same study design as the activity within which the - procedure is defined.' +Description: 'A procedure must only reference a study intervention that is defined within the same study + design as the activity within which the procedure is defined.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: studyInterventionId - Right: id - Name: StudyIntervention - - Join Type: left - Keys: - - Left: parent_id - Right: id - Name: Activity +- Join Type: left + Keys: + - Left: studyInterventionId + Right: id + Name: StudyIntervention +- Join Type: left + Keys: + - Left: parent_id + Right: id + Name: Activity Outcome: - Message: 'The procedure references a study intervention that is not defined - within the same study design as the activity within which the procedure is - defined: the parent_id of the study intervention - (parent_id.StudyIntervention) is not the same as the parent_id of the - activity (parent_id.Activity).' + Message: 'The procedure references a study intervention that is not defined within the same study design + as the activity within which the procedure is defined: the parent_id of the study intervention (parent_id.StudyIntervention) + is not the same as the parent_id of the activity (parent_id.Activity).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyIntervention - - parent_id.Activity + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyIntervention + - parent_id.Activity Rule Type: Record Data Scope: Entities: Include: - - Procedure + - Procedure Sensitivity: Record diff --git a/Published/CORE-000799/rule.yml b/Published/CORE-000799/rule.yml index 2b4cd2942..8e708b1aa 100644 --- a/Published/CORE-000799/rule.yml +++ b/Published/CORE-000799/rule.yml @@ -1,74 +1,73 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference populations that are defined - within the same study design as the study arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00049' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study arm must only reference populations that are defined within the same + study design as the study arm.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00049' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'populationIds' - value_is_literal: true - - name: rel_type.StudyArm - operator: equal_to - value: 'definition' - - name: parent_id.StudyArm - operator: is_not_contained_by - value: $parent_of_population + - name: instanceType + operator: equal_to + value: 'StudyDesignPopulation' + - name: rel_type + operator: equal_to + value: 'reference' + - name: parent_rel + operator: equal_to + value: 'populationIds' + value_is_literal: true + - name: rel_type.StudyArm + operator: equal_to + value: 'definition' + - name: parent_id.StudyArm + operator: is_not_contained_by + value: $parent_of_population Core: Id: 'CORE-000799' Status: Published Version: '1' -Description: 'A study arm must only reference populations that are defined - within the same study design as the study arm.' +Description: 'A study arm must only reference populations that are defined within the same study design + as the study arm.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - Name: StudyArm +- Keys: + - Left: parent_id + Right: id + Name: StudyArm Operations: - - group: - - id - - rel_type - group_aliases: - - id - - rel_type.StudyArm - id: $parent_of_population - name: parent_id - operator: distinct +- group: + - id + - rel_type + group_aliases: + - id + - rel_type.StudyArm + id: $parent_of_population + name: parent_id + operator: distinct Outcome: - Message: 'The study population is referenced by a study arm but was not defined - within the same study design as the study arm: the parent_id of the study - population ($parent_of_population) is not the same as parent_id of the study - arm (parent_id.StudyArm).' + Message: 'The study population is referenced by a study arm but was not defined within the same study + design as the study arm: the parent_id of the study population ($parent_of_population) is not the + same as parent_id of the study arm (parent_id.StudyArm).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyArm - - $parent_of_population + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyArm + - $parent_of_population Rule Type: Record Data Scope: Entities: Include: - - StudyDesignPopulation + - StudyDesignPopulation Sensitivity: Record diff --git a/Published/CORE-000800/rule.yml b/Published/CORE-000800/rule.yml index 9906479ab..f22c6bb23 100644 --- a/Published/CORE-000800/rule.yml +++ b/Published/CORE-000800/rule.yml @@ -1,75 +1,73 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then no codes are expected - to specify the specific area within scope while if it is not - global then at least one code is expected to specify the - specific area within scope.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00077' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If geographic scope type is global then no codes are expected to specify the + specific area within scope while if it is not global then at least one code is expected to specify + the specific area within scope.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00077' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: type.code - operator: equal_to - value: 'C68846' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - all: - - name: type.code - operator: not_equal_to - value: 'C68846' - - any: - - name: code - operator: not_exists - - name: code - operator: empty - - name: code - operator: equal_to - value: false + - name: instanceType + operator: equal_to + value: 'GeographicScope' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: type.code + operator: equal_to + value: 'C68846' + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - all: + - name: type.code + operator: not_equal_to + value: 'C68846' + - any: + - name: code + operator: not_exists + - name: code + operator: empty + - name: code + operator: equal_to + value: false Core: Id: 'CORE-000800' Status: Published Version: '1' -Description: 'If geographic scope type is global then no codes are expected to - specify the specific area within scope while if it is not global then at least - one code is expected to specify the specific area within scope.' +Description: 'If geographic scope type is global then no codes are expected to specify the specific area + within scope while if it is not global then at least one code is expected to specify the specific area + within scope.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The geographic scope is global (type.code = C68846) and a code has - been specified or the geographic scope is not global (type.code is not - C68846) and no code has been specified.' + Message: 'The geographic scope is global (type.code = C68846) and a code has been specified or the geographic + scope is not global (type.code is not C68846) and no code has been specified.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - type.code - - type.decode - - code - - code.standardCode.code - - code.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - type.code + - type.decode + - code + - code.standardCode.code + - code.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - 'GeographicScope' Sensitivity: Record diff --git a/Published/CORE-000801/rule.yml b/Published/CORE-000801/rule.yml index 40702561a..861235a83 100644 --- a/Published/CORE-000801/rule.yml +++ b/Published/CORE-000801/rule.yml @@ -1,94 +1,91 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study protocol document version, if a date of a - specific type exists with a global geographic scope then no - other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00095' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study protocol document version, if a date of a specific type exists + with a global geographic scope then no other dates are expected with the same type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00095' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'GeographicScope' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: type.code operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code - operator: equal_to - value: 'C68846' - - name: type.decode - operator: equal_to_case_insensitive - value: 'Global' - - any: - - name: $num_geographic_scopes_for_this_date - operator: greater_than - value: 1 - - name: $num_dates_of_this_type - operator: greater_than - value: 1 + value: 'C68846' + - name: type.decode + operator: equal_to_case_insensitive + value: 'Global' + - any: + - name: $num_geographic_scopes_for_this_date + operator: greater_than + value: 1 + - name: $num_dates_of_this_type + operator: greater_than + value: 1 Core: Id: 'CORE-000801' Status: Published Version: '1' -Description: 'Within a study protocol document version, if a date of a specific - type exists with a global geographic scope then no other dates are expected - with the same type.' +Description: 'Within a study protocol document version, if a date of a specific type exists with a global + geographic scope then no other dates are expected with the same type.' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: GovernanceDate - - Keys: - - Left: parent_id.GovernanceDate - Right: id - - rel_type - Name: StudyProtocolDocumentVersion +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: GovernanceDate +- Keys: + - Left: parent_id.GovernanceDate + Right: id + - rel_type + Name: StudyProtocolDocumentVersion Operations: - - group: - - parent_id - id: $num_geographic_scopes_for_this_date - operator: record_count - - domain: GovernanceDate - group: - - parent_id - - type.code - group_aliases: - - id.StudyProtocolDocumentVersion - - type.code.GovernanceDate - id: $num_dates_of_this_type - operator: record_count +- group: + - parent_id + id: $num_geographic_scopes_for_this_date + operator: record_count +- domain: GovernanceDate + group: + - parent_id + - type.code + group_aliases: + - id.StudyProtocolDocumentVersion + - type.code.GovernanceDate + id: $num_dates_of_this_type + operator: record_count Outcome: - Message: 'The study protocol document version has a type of governance date with - a global geographic scope and either another date of the same type or - additional geographic scope(s) defined for the date.' + Message: 'The study protocol document version has a type of governance date with a global geographic + scope and either another date of the same type or additional geographic scope(s) defined for the date.' Output Variables: - - parent_entity.StudyProtocolDocumentVersion - - parent_id.StudyProtocolDocumentVersion - - parent_rel.StudyProtocolDocumentVersion - - id.StudyProtocolDocumentVersion - - protocolVersion - - type.code.GovernanceDate - - type.decode.GovernanceDate - - dateValue - - type.code - - type.decode - - $num_dates_of_this_type - - $num_geographic_scopes_for_this_date + - parent_entity.StudyProtocolDocumentVersion + - parent_id.StudyProtocolDocumentVersion + - parent_rel.StudyProtocolDocumentVersion + - id.StudyProtocolDocumentVersion + - protocolVersion + - type.code.GovernanceDate + - type.decode.GovernanceDate + - dateValue + - type.code + - type.decode + - $num_dates_of_this_type + - $num_geographic_scopes_for_this_date Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - 'GeographicScope' Sensitivity: Record diff --git a/Published/CORE-000802/rule.yml b/Published/CORE-000802/rule.yml index 2d12793a5..dfe017721 100644 --- a/Published/CORE-000802/rule.yml +++ b/Published/CORE-000802/rule.yml @@ -1,72 +1,72 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the duration of an administration will vary, a quantity is - not expected for the administration duration and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00003' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If the duration of an administration will vary, a quantity is not expected for + the administration duration and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00003' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'AdministrationDuration' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: durationWillVary - operator: equal_to - value: true - - not: - any: - - name: quantity - operator: not_exists - - name: quantity - operator: equal_to - value: false - - all: - - name: durationWillVary - operator: equal_to - value: false - - any: - - name: quantity - operator: not_exists - - name: quantity - operator: equal_to - value: false + - name: instanceType + operator: equal_to + value: 'AdministrationDuration' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: durationWillVary + operator: equal_to + value: true + - not: + any: + - name: quantity + operator: not_exists + - name: quantity + operator: equal_to + value: false + - all: + - name: durationWillVary + operator: equal_to + value: false + - any: + - name: quantity + operator: not_exists + - name: quantity + operator: equal_to + value: false Core: Id: 'CORE-000802' Status: Published Version: '1' -Description: 'If the duration of an administration will vary, a quantity is not - expected for the administration duration and vice versa.' +Description: 'If the duration of an administration will vary, a quantity is not expected for the administration + duration and vice versa.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A duration quantity has been specified when the duration will vary, or - a duration quantity has not been specified when the duration will not vary.' + Message: 'A duration quantity has been specified when the duration will vary, or a duration quantity + has not been specified when the duration will not vary.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - durationWillVary - - quantity - - quantity.id - - quantity.value - - quantity.unit.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - description + - durationWillVary + - quantity + - quantity.id + - quantity.value + - quantity.unit.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - AdministrationDuration + - AdministrationDuration Sensitivity: Record diff --git a/Published/CORE-000803/rule.yml b/Published/CORE-000803/rule.yml index 4bd272530..5f7b3a92b 100644 --- a/Published/CORE-000803/rule.yml +++ b/Published/CORE-000803/rule.yml @@ -1,60 +1,59 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a synonym is specified then it is not expected to be equal - to the name of the biomedical concept (case insensitive).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00079' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a synonym is specified then it is not expected to be equal to the name of + the biomedical concept (case insensitive).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00079' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConcept' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel.string - operator: equal_to - value: 'synonyms' - value_is_literal: true - - name: value - operator: equal_to_case_insensitive - value: name + - name: instanceType + operator: equal_to + value: 'BiomedicalConcept' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_rel.string + operator: equal_to + value: 'synonyms' + value_is_literal: true + - name: value + operator: equal_to_case_insensitive + value: name Core: Id: 'CORE-000803' Status: Published Version: '1' -Description: 'If a synonym is specified then it is not expected to be equal to - the name of the biomedical concept (case insensitive).' +Description: 'If a synonym is specified then it is not expected to be equal to the name of the biomedical + concept (case insensitive).' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - Left: id - Right: parent_id - - rel_type - Name: string +- Keys: + - Left: id + Right: parent_id + - rel_type + Name: string Outcome: - Message: 'The biomedical concept synonym value is the same as the biomedical - concept name (case insensitive).' + Message: 'The biomedical concept synonym value is the same as the biomedical concept name (case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_rel.string - - value + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_rel.string + - value Rule Type: Record Data Scope: Entities: Include: - - 'BiomedicalConcept' + - 'BiomedicalConcept' Sensitivity: Record diff --git a/Published/CORE-000804/rule.yml b/Published/CORE-000804/rule.yml index 3afeb9e1b..9fbfdc88d 100644 --- a/Published/CORE-000804/rule.yml +++ b/Published/CORE-000804/rule.yml @@ -1,99 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing must only be specified as being relative to/from a - scheduled activity/decision instance that is defined within - the same timeline as the timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00046' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing must only be specified as being relative to/from a - scheduled activity/decision instance that is defined within - the same timeline as the timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00046' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00046' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00046' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - any: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type + - any: + - name: instanceType operator: equal_to - value: 'reference' - - any: - - name: parent_rel - operator: equal_to - value: 'relativeToScheduledInstanceId' - value_is_literal: true - - name: parent_rel - operator: equal_to - value: 'relativeFromScheduledInstanceId' - value_is_literal: true - - name: rel_type.Timing + value: 'ScheduledActivityInstance' + - name: instanceType operator: equal_to - value: 'definition' - - name: parent_id.Timing - operator: is_not_contained_by - value: $parent_of_scheduled_instance + value: 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'reference' + - any: + - name: parent_rel + operator: equal_to + value: 'relativeToScheduledInstanceId' + value_is_literal: true + - name: parent_rel + operator: equal_to + value: 'relativeFromScheduledInstanceId' + value_is_literal: true + - name: rel_type.Timing + operator: equal_to + value: 'definition' + - name: parent_id.Timing + operator: is_not_contained_by + value: $parent_of_scheduled_instance Core: Id: 'CORE-000804' Status: Published Version: '1' -Description: 'A timing must only be specified as being relative to/from a - scheduled activity/decision instance that is defined within the same timeline - as the timing.' +Description: 'A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - Name: Timing +- Keys: + - Left: parent_id + Right: id + Name: Timing Operations: - - group: - - id - - rel_type - group_aliases: - - id - - rel_type.Timing - id: $parent_of_scheduled_instance - name: parent_id - operator: distinct +- group: + - id + - rel_type + group_aliases: + - id + - rel_type.Timing + id: $parent_of_scheduled_instance + name: parent_id + operator: distinct Outcome: - Message: 'The relative to/from scheduled instance of a timing was not defined - within the same timeline as the timing: the parent_id of the scheduled - instance ($parent_of_scheduled_instance) is not the same as parent_id of the - timing (parent_id.Timing).' + Message: 'The relative to/from scheduled instance of a timing was not defined within the same timeline + as the timing: the parent_id of the scheduled instance ($parent_of_scheduled_instance) is not the + same as parent_id of the timing (parent_id.Timing).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.Timing - - $parent_of_scheduled_instance + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.Timing + - $parent_of_scheduled_instance Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' + - 'ScheduledActivityInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-000805/rule.yml b/Published/CORE-000805/rule.yml index 91a461ec2..79faa51dc 100644 --- a/Published/CORE-000805/rule.yml +++ b/Published/CORE-000805/rule.yml @@ -1,44 +1,42 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The range specified for a planned age is not expected to be - approximate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00042' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The range specified for a planned age is not expected to be - approximate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00042' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The range specified for a planned age is not expected to be approximate.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00042' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The range specified for a planned age is not expected to be approximate.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00042' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'plannedAge' - - name: isApproximate - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: 'Range' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_rel + operator: equal_to + value: 'plannedAge' + - name: isApproximate + operator: equal_to + value: true Core: Id: 'CORE-000805' Status: Published @@ -48,15 +46,15 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The planned age range is marked as approximate, which is not expected.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - isApproximate + - parent_entity + - parent_id + - parent_rel + - id + - name + - isApproximate Rule Type: Record Data Scope: Entities: Include: - - Range + - Range Sensitivity: Record diff --git a/Published/CORE-000806/rule.yml b/Published/CORE-000806/rule.yml index c697bb66c..457fd0477 100644 --- a/Published/CORE-000806/rule.yml +++ b/Published/CORE-000806/rule.yml @@ -1,85 +1,85 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a - percentage (i.e. the unit must be empty or %).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00017' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a - percentage (i.e. the unit must be empty or %).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00017' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. + the unit must be empty or %).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00017' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. + the unit must be empty or %).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00017' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Quantity' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_entity - operator: equal_to - value: 'SubjectEnrollment' - - name: parent_rel - operator: equal_to - value: 'quantity' - - not: - any: - - name: unit - operator: equal_to - value: false - - name: unit - operator: not_exists - - name: unit - operator: empty - - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.code - operator: equal_to - value: 'C25613' - - name: unit.standardCode.decode - operator: equal_to - value: '%' + - name: instanceType + operator: equal_to + value: 'Quantity' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_entity + operator: equal_to + value: 'SubjectEnrollment' + - name: parent_rel + operator: equal_to + value: 'quantity' + - not: + any: + - name: unit + operator: equal_to + value: false + - name: unit + operator: not_exists + - name: unit + operator: empty + - all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: unit.standardCode.code + operator: equal_to + value: 'C25613' + - name: unit.standardCode.decode + operator: equal_to + value: '%' Core: Id: 'CORE-000806' Status: Published Version: '1' -Description: 'Within subject enrollment, the quantity must be a number or a - percentage (i.e. the unit must be empty or %).' +Description: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. the unit + must be empty or %).' Executability: Fully Executable Outcome: - Message: 'The unit for a subject enrollement quantity is not empty or coded as % - (codeSystem = http://www.cdisc.org, code = C25613 and decode = %).' + Message: 'The unit for a subject enrollement quantity is not empty or coded as % (codeSystem = http://www.cdisc.org, + code = C25613 and decode = %).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - unit.standardCode.codeSystem - - unit.standardCode.code - - unit.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - value + - unit.standardCode.codeSystem + - unit.standardCode.code + - unit.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - Quantity + - Quantity Sensitivity: Record diff --git a/Published/CORE-000807/rule.yml b/Published/CORE-000807/rule.yml index 4b7aafa87..2712cfd5e 100644 --- a/Published/CORE-000807/rule.yml +++ b/Published/CORE-000807/rule.yml @@ -1,68 +1,67 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one scheduled activity instance within a timeline must - point to a timeline exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00037' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one scheduled activity instance within a timeline must - point to a timeline exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00037' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least one scheduled activity instance within a timeline must point to a timeline + exit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: USDM Conformance Rules + Rule Identifier: + Id: 'DDF00037' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least one scheduled activity instance within a timeline must point to a timeline + exit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: USDM Conformance Rules + Rule Identifier: + Id: 'DDF00037' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $timeline_exits - operator: empty + - name: instanceType + operator: equal_to + value: 'ScheduleTimeline' + - name: rel_type + operator: equal_to + value: 'definition' + - name: $timeline_exits + operator: empty Core: + Id: CORE-000807 Status: Published Version: '1' - Id: CORE-000807 -Description: 'At least one scheduled activity instance within a timeline must - point to a timeline exit.' +Description: 'At least one scheduled activity instance within a timeline must point to a timeline exit.' Executability: Fully Executable Operations: - - domain: ScheduledActivityInstance - group: - - parent_id - group_aliases: - - id - id: $timeline_exits - name: timelineExitId - operator: distinct +- domain: ScheduledActivityInstance + group: + - parent_id + group_aliases: + - id + id: $timeline_exits + name: timelineExitId + operator: distinct Outcome: - Message: 'The schedule timeline does not have a defined exit: none of its - scheduled activity instances has a timeline exit.' + Message: 'The schedule timeline does not have a defined exit: none of its scheduled activity instances + has a timeline exit.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - ScheduleTimeline + - ScheduleTimeline Sensitivity: Record diff --git a/Published/CORE-000808/rule.yml b/Published/CORE-000808/rule.yml index 9cf5434cb..ec3c111b7 100644 --- a/Published/CORE-000808/rule.yml +++ b/Published/CORE-000808/rule.yml @@ -1,80 +1,77 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Only one version of any code system is expected to be used - within a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00073' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Only one version of any code system is expected to be used - within a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00073' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Only one version of any code system is expected to be used within a study version.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00073' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Only one version of any code system is expected to be used within a study version.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00073' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $min_codeSystemVersion - operator: not_equal_to - value: $max_codeSystemVersion - - name: id - operator: equal_to - value: $min_id_for_codeSystemVersion + - name: rel_type + operator: equal_to + value: 'definition' + - name: $min_codeSystemVersion + operator: not_equal_to + value: $max_codeSystemVersion + - name: id + operator: equal_to + value: $min_id_for_codeSystemVersion Core: Id: 'CORE-000808' Status: Published Version: '1' -Description: 'Only one version of any code system is expected to be used within - a study version.' +Description: 'Only one version of any code system is expected to be used within a study version.' Executability: Partially Executable - Possible Overreporting Operations: - - group: - - codeSystem - id: $min_codeSystemVersion - name: codeSystemVersion - operator: min - - group: - - codeSystem - id: $max_codeSystemVersion - name: codeSystemVersion - operator: max - - group: - - codeSystem - - codeSystemVersion - id: $min_id_for_codeSystemVersion - name: id - operator: min - - group: - - codeSystem - - codeSystemVersion - id: $record_count - name: codeSystemVersion - operator: record_count +- group: + - codeSystem + id: $min_codeSystemVersion + name: codeSystemVersion + operator: min +- group: + - codeSystem + id: $max_codeSystemVersion + name: codeSystemVersion + operator: max +- group: + - codeSystem + - codeSystemVersion + id: $min_id_for_codeSystemVersion + name: id + operator: min +- group: + - codeSystem + - codeSystemVersion + id: $record_count + name: codeSystemVersion + operator: record_count Outcome: Message: 'More than one code system version is used for the code system.' Output Variables: - - codeSystem - - codeSystemVersion - - $record_count + - codeSystem + - codeSystemVersion + - $record_count Rule Type: Record Data Scope: Entities: Include: - - 'Code' + - 'Code' Sensitivity: Record diff --git a/Published/CORE-000809/rule.yml b/Published/CORE-000809/rule.yml index b4040a616..64c28e888 100644 --- a/Published/CORE-000809/rule.yml +++ b/Published/CORE-000809/rule.yml @@ -1,86 +1,85 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference elements that are defined - within the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00047' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference elements that are defined - within the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00047' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference elements that are defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00047' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference elements that are defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00047' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyElement' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'elementIds' - value_is_literal: true - - name: rel_type.StudyCell - operator: equal_to - value: 'definition' - - name: parent_id.StudyCell - operator: is_not_contained_by - value: $parent_of_study_element + - name: instanceType + operator: equal_to + value: 'StudyElement' + - name: rel_type + operator: equal_to + value: 'reference' + - name: parent_rel + operator: equal_to + value: 'elementIds' + value_is_literal: true + - name: rel_type.StudyCell + operator: equal_to + value: 'definition' + - name: parent_id.StudyCell + operator: is_not_contained_by + value: $parent_of_study_element Core: Id: 'CORE-000809' Status: Published Version: '1' -Description: 'A study cell must only reference elements that are defined within - the same study design as the study cell.' +Description: 'A study cell must only reference elements that are defined within the same study design + as the study cell.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - Name: StudyCell +- Keys: + - Left: parent_id + Right: id + Name: StudyCell Operations: - - group: - - id - - rel_type - group_aliases: - - id - - rel_type.StudyCell - id: $parent_of_study_element - name: parent_id - operator: distinct +- group: + - id + - rel_type + group_aliases: + - id + - rel_type.StudyCell + id: $parent_of_study_element + name: parent_id + operator: distinct Outcome: - Message: 'The study element is referenced by a study cell but was not defined - within the same study design as the study cell: the parent_id of the study - element ($parent_of_study_element) is not the same as parent_id of the study - cell (parent_id.StudyCell).' + Message: 'The study element is referenced by a study cell but was not defined within the same study + design as the study cell: the parent_id of the study element ($parent_of_study_element) is not the + same as parent_id of the study cell (parent_id.StudyCell).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyCell - - $parent_of_study_element + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyCell + - $parent_of_study_element Rule Type: Record Data Scope: Entities: Include: - - StudyElement + - StudyElement Sensitivity: Record diff --git a/Published/CORE-000810/rule.yml b/Published/CORE-000810/rule.yml index 69a8b17f2..e21c21ee6 100644 --- a/Published/CORE-000810/rule.yml +++ b/Published/CORE-000810/rule.yml @@ -1,83 +1,81 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity is expected to refer to at least one procedure, - biomedical concept, biomedical concept category or biomedical - concept surrogate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00075' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity is expected to refer to at least one procedure, biomedical concept, + biomedical concept category or biomedical concept surrogate.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00075' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'Activity' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: definedProcedures + operator: not_exists + - name: definedProcedures + operator: empty + - name: definedProcedures operator: equal_to - value: 'Activity' - - name: rel_type + value: false + - any: + - name: biomedicalConceptIds + operator: not_exists + - name: biomedicalConceptIds + operator: empty + - name: biomedicalConceptIds operator: equal_to - value: 'definition' - - any: - - name: definedProcedures - operator: not_exists - - name: definedProcedures - operator: empty - - name: definedProcedures - operator: equal_to - value: false - - any: - - name: biomedicalConceptIds - operator: not_exists - - name: biomedicalConceptIds - operator: empty - - name: biomedicalConceptIds - operator: equal_to - value: false - - any: - - name: bcCategoryIds - operator: not_exists - - name: bcCategoryIds - operator: empty - - name: bcCategoryIds - operator: equal_to - value: false - - any: - - name: bcSurrogateIds - operator: not_exists - - name: bcSurrogateIds - operator: empty - - name: bcSurrogateIds - operator: equal_to - value: false + value: false + - any: + - name: bcCategoryIds + operator: not_exists + - name: bcCategoryIds + operator: empty + - name: bcCategoryIds + operator: equal_to + value: false + - any: + - name: bcSurrogateIds + operator: not_exists + - name: bcSurrogateIds + operator: empty + - name: bcSurrogateIds + operator: equal_to + value: false Core: Id: 'CORE-000810' Status: Published Version: '1' -Description: 'An activity is expected to refer to at least one procedure, - biomedical concept, biomedical concept category or biomedical concept - surrogate.' +Description: 'An activity is expected to refer to at least one procedure, biomedical concept, biomedical + concept category or biomedical concept surrogate.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity does not refer to any procedure, biomedical concept, - biomedical concept category or biomedical concept surrogate.' + Message: 'The activity does not refer to any procedure, biomedical concept, biomedical concept category + or biomedical concept surrogate.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - definedProcedures - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - definedProcedures + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-000811/rule.yml b/Published/CORE-000811/rule.yml index 283d42abe..1df2b7492 100644 --- a/Published/CORE-000811/rule.yml +++ b/Published/CORE-000811/rule.yml @@ -1,82 +1,81 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same Biomedical Concept Category must not be referenced - more than once from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00090' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same Biomedical Concept Category must not be referenced - more than once from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00090' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The same Biomedical Concept Category must not be referenced more than once from + the same activity.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00090' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The same Biomedical Concept Category must not be referenced more than once from + the same activity.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00090' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptCategory' - - name: rel_type - operator: equal_to - value: 'reference' - - name: rel_type.Activity - operator: equal_to - value: 'definition' - - name: parent_entity - operator: equal_to - value: 'Activity' - - name: parent_rel - operator: equal_to - value: 'bcCategoryIds' - value_is_literal: true - - name: id - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - rel_type.Activity + - name: instanceType + operator: equal_to + value: 'BiomedicalConceptCategory' + - name: rel_type + operator: equal_to + value: 'reference' + - name: rel_type.Activity + operator: equal_to + value: 'definition' + - name: parent_entity + operator: equal_to + value: 'Activity' + - name: parent_rel + operator: equal_to + value: 'bcCategoryIds' + value_is_literal: true + - name: id + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - rel_type.Activity Core: Id: 'CORE-000811' Status: Published Version: '1' -Description: 'The same Biomedical Concept Category must not be referenced more - than once from the same activity.' +Description: 'The same Biomedical Concept Category must not be referenced more than once from the same + activity.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - Left: parent_entity - Right: instanceType - Name: Activity +- Keys: + - Left: parent_id + Right: id + - Left: parent_entity + Right: instanceType + Name: Activity Outcome: - Message: 'The biomedical concept category is referenced more than once from the - same activity.' + Message: 'The biomedical concept category is referenced more than once from the same activity.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - name.Activity + - parent_entity + - parent_id + - parent_rel + - id + - name + - name.Activity Rule Type: Record Data Scope: Entities: Include: - - 'BiomedicalConceptCategory' + - 'BiomedicalConceptCategory' Sensitivity: Record diff --git a/Published/CORE-000812/rule.yml b/Published/CORE-000812/rule.yml index 3704552b1..fea3f77fb 100644 --- a/Published/CORE-000812/rule.yml +++ b/Published/CORE-000812/rule.yml @@ -1,78 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A biomedical concept category is expected to have at least a - member or a child.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00014' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A biomedical concept category is expected to have at least a - member or a child.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00014' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A biomedical concept category is expected to have at least a member or a child.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00014' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A biomedical concept category is expected to have at least a member or a child.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00014' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptCategory' - - name: rel_type - operator: equal_to - value: 'definition' - - any: + - name: instanceType + operator: equal_to + value: 'BiomedicalConceptCategory' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: memberIds + operator: not_exists + - name: childIds + operator: not_exists + - not: + any: - all: - - name: memberIds - operator: not_exists - - name: childIds - operator: not_exists - - not: - any: - - all: - - name: memberIds - operator: exists - - name: memberIds - operator: equal_to - value: true - - all: - - name: childIds - operator: exists - - name: childIds - operator: equal_to - value: true + - name: memberIds + operator: exists + - name: memberIds + operator: equal_to + value: true + - all: + - name: childIds + operator: exists + - name: childIds + operator: equal_to + value: true Core: Id: 'CORE-000812' Status: Published Version: '1' -Description: 'A biomedical concept category is expected to have at least a - member or a child.' +Description: 'A biomedical concept category is expected to have at least a member or a child.' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The biomedical concept category does not have any members or children.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - memberIds - - childIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - memberIds + - childIds Rule Type: Record Data Scope: Entities: Include: - - BiomedicalConceptCategory + - BiomedicalConceptCategory Sensitivity: Record diff --git a/Published/CORE-000813/rule.yml b/Published/CORE-000813/rule.yml index 04efe7061..549935b22 100644 --- a/Published/CORE-000813/rule.yml +++ b/Published/CORE-000813/rule.yml @@ -1,81 +1,80 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All standard code aliases referenced by an instance of the - alias code class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00052' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All standard code aliases referenced by an instance of the - alias code class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00052' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All standard code aliases referenced by an instance of the alias code class must + be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00052' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All standard code aliases referenced by an instance of the alias code class must + be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00052' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'AliasCode' - - name: parent_rel - operator: equal_to - value: 'standardCodeAliases' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'AliasCode' + - name: parent_rel + operator: equal_to + value: 'standardCodeAliases' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000813" Status: Published Version: '1' -Description: 'All standard code aliases referenced by an instance of the alias - code class must be unique.' +Description: 'All standard code aliases referenced by an instance of the alias code class must be unique.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - Name: AliasCode +- Keys: + - Left: parent_id + Right: id + Name: AliasCode Outcome: - Message: 'The standard code aliases of the alias code are not unique - the same - code is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The standard code aliases of the alias code are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion.' Output Variables: - - parent_entity.AliasCode - - parent_id.AliasCode - - parent_rel.AliasCode - - id.AliasCode - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity.AliasCode + - parent_id.AliasCode + - parent_rel.AliasCode + - id.AliasCode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000814/rule.yml b/Published/CORE-000814/rule.yml index e35532af1..57a0c8d46 100644 --- a/Published/CORE-000814/rule.yml +++ b/Published/CORE-000814/rule.yml @@ -1,106 +1,103 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if a date of a specific type exists - with a global geographic scope then no other dates are - expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00094' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if a date of a specific type exists - with a global geographic scope then no other dates are - expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00094' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, if a date of a specific type exists with a global geographic + scope then no other dates are expected with the same type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00094' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, if a date of a specific type exists with a global geographic + scope then no other dates are expected with the same type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00094' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'GeographicScope' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: type.code operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code - operator: equal_to - value: 'C68846' - - name: type.decode - operator: equal_to_case_insensitive - value: 'Global' - - any: - - name: $num_geographic_scopes_for_this_date - operator: greater_than - value: 1 - - name: $num_dates_of_this_type - operator: greater_than - value: 1 + value: 'C68846' + - name: type.decode + operator: equal_to_case_insensitive + value: 'Global' + - any: + - name: $num_geographic_scopes_for_this_date + operator: greater_than + value: 1 + - name: $num_dates_of_this_type + operator: greater_than + value: 1 Core: Id: 'CORE-000814' Status: Published Version: '1' -Description: 'Within a study version, if a date of a specific type exists with a - global geographic scope then no other dates are expected with the same type.' +Description: 'Within a study version, if a date of a specific type exists with a global geographic scope + then no other dates are expected with the same type.' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: GovernanceDate - - Keys: - - Left: parent_id.GovernanceDate - Right: id - - rel_type - Name: StudyVersion +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: GovernanceDate +- Keys: + - Left: parent_id.GovernanceDate + Right: id + - rel_type + Name: StudyVersion Operations: - - group: - - parent_id - id: $num_geographic_scopes_for_this_date - operator: record_count - - domain: GovernanceDate - group: - - parent_id - - type.code - group_aliases: - - id.StudyVersion - - type.code.GovernanceDate - id: $num_dates_of_this_type - operator: record_count +- group: + - parent_id + id: $num_geographic_scopes_for_this_date + operator: record_count +- domain: GovernanceDate + group: + - parent_id + - type.code + group_aliases: + - id.StudyVersion + - type.code.GovernanceDate + id: $num_dates_of_this_type + operator: record_count Outcome: - Message: 'The study version has a type of governance date with a global - geographic scope and either another date of the same type or additional - geographic scope(s) defined for the date.' + Message: 'The study version has a type of governance date with a global geographic scope and either + another date of the same type or additional geographic scope(s) defined for the date.' Output Variables: - - parent_entity.StudyVersion - - parent_id.StudyVersion - - parent_rel.StudyVersion - - id.StudyVersion - - versionIdentifier - - type.code.GovernanceDate - - type.decode.GovernanceDate - - dateValue - - type.code - - type.decode - - $num_dates_of_this_type - - $num_geographic_scopes_for_this_date + - parent_entity.StudyVersion + - parent_id.StudyVersion + - parent_rel.StudyVersion + - id.StudyVersion + - versionIdentifier + - type.code.GovernanceDate + - type.decode.GovernanceDate + - dateValue + - type.code + - type.decode + - $num_dates_of_this_type + - $num_geographic_scopes_for_this_date Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - 'GeographicScope' Sensitivity: Record diff --git a/Published/CORE-000815/rule.yml b/Published/CORE-000815/rule.yml index 541903263..017d56d3b 100644 --- a/Published/CORE-000815/rule.yml +++ b/Published/CORE-000815/rule.yml @@ -1,101 +1,101 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned age range must be specified - either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00097' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned age range must be specified - either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00097' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, the planned age range must be specified either in the + study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00097' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, the planned age range must be specified either in the + study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00097' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - any: - - name: plannedAge - operator: not_exists - - name: plannedAge - operator: empty - - name: plannedAge - operator: equal_to - value: false - - any: - - name: plannedAge.StudyCohort - operator: not_exists - - name: plannedAge.StudyCohort - operator: empty - - name: plannedAge.StudyCohort - operator: equal_to - value: false - - all: - - name: plannedAge - operator: equal_to - value: true - - name: plannedAge.StudyCohort - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: 'StudyDesignPopulation' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - any: + - name: plannedAge + operator: not_exists + - name: plannedAge + operator: empty + - name: plannedAge + operator: equal_to + value: false + - any: + - name: plannedAge.StudyCohort + operator: not_exists + - name: plannedAge.StudyCohort + operator: empty + - name: plannedAge.StudyCohort + operator: equal_to + value: false + - all: + - name: plannedAge + operator: equal_to + value: true + - name: plannedAge.StudyCohort + operator: equal_to + value: true Core: Id: 'CORE-000815' Status: Published Version: '1' -Description: 'Within a study design, the planned age range must be specified - either in the study population or in all cohorts.' +Description: 'Within a study design, the planned age range must be specified either in the study population + or in all cohorts.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - - rel_type - Name: StudyCohort +- Join Type: left + Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + - rel_type + Name: StudyCohort Outcome: - Message: 'Planned age has not been specified for either the study population or - the cohort, or it has been specified for both.' + Message: 'Planned age has not been specified for either the study population or the cohort, or it has + been specified for both.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - plannedAge - - plannedAge.minValue - - plannedAge.maxValue - - plannedAge.unit.decode - - id.StudyCohort - - name.StudyCohort - - plannedAge.StudyCohort - - plannedAge.minValue.StudyCohort - - plannedAge.maxValue.StudyCohort - - plannedAge.unit.decode.StudyCohort + - parent_entity + - parent_id + - parent_rel + - id + - name + - plannedAge + - plannedAge.minValue + - plannedAge.maxValue + - plannedAge.unit.decode + - id.StudyCohort + - name.StudyCohort + - plannedAge.StudyCohort + - plannedAge.minValue.StudyCohort + - plannedAge.maxValue.StudyCohort + - plannedAge.unit.decode.StudyCohort Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000816/rule.yml b/Published/CORE-000816/rule.yml index 83a294ad2..a3d28024d 100644 --- a/Published/CORE-000816/rule.yml +++ b/Published/CORE-000816/rule.yml @@ -1,43 +1,41 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All epochs are expected to be referred to from a scheduled - Activity Instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00099' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All epochs are expected to be referred to from a scheduled - Activity Instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00099' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All epochs are expected to be referred to from a scheduled Activity Instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00099' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All epochs are expected to be referred to from a scheduled Activity Instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00099' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyEpoch' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: epochId - operator: not_exists - - name: epochId - operator: empty + - name: instanceType + operator: equal_to + value: 'StudyEpoch' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: epochId + operator: not_exists + - name: epochId + operator: empty Core: Id: 'CORE-000816' Status: Published @@ -45,23 +43,23 @@ Core: Description: 'All epochs are expected to be referred to from a scheduled Activity Instance.' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Join Type: left - Keys: - - Left: id - Right: epochId - - rel_type - Name: ScheduledActivityInstance +- Join Type: left + Keys: + - Left: id + Right: epochId + - rel_type + Name: ScheduledActivityInstance Outcome: Message: 'The epoch is not referenced by any scheduled activity instances.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - 'StudyEpoch' + - 'StudyEpoch' Sensitivity: Record diff --git a/Published/CORE-000817/rule.yml b/Published/CORE-000817/rule.yml index 5f0de85d6..8939c7089 100644 --- a/Published/CORE-000817/rule.yml +++ b/Published/CORE-000817/rule.yml @@ -1,47 +1,45 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, there must be no more than one title of - each type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00100' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, there must be no more than one title of - each type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00100' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, there must be no more than one title of each type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00100' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, there must be no more than one title of each type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00100' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyTitle' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code - operator: is_not_unique_set - value: - - parent_id - - name: type.decode - operator: is_not_unique_set - value: - - parent_id + - name: instanceType + operator: equal_to + value: 'StudyTitle' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: type.code + operator: is_not_unique_set + value: + - parent_id + - name: type.decode + operator: is_not_unique_set + value: + - parent_id Core: Id: 'CORE-000817' Status: Published @@ -51,16 +49,16 @@ Executability: Fully Executable Outcome: Message: 'There is more than one title of the same type code or decode.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - type.code - - type.decode + - parent_entity + - parent_id + - parent_rel + - id + - text + - type.code + - type.decode Rule Type: Record Data Scope: Entities: Include: - - StudyTitle + - StudyTitle Sensitivity: Record diff --git a/Published/CORE-000818/rule.yml b/Published/CORE-000818/rule.yml index 733afe3a2..aad1163ee 100644 --- a/Published/CORE-000818/rule.yml +++ b/Published/CORE-000818/rule.yml @@ -1,66 +1,63 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must not point (via the - "timeline" relationship) to the timeline in which it is - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00026' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must not point (via the - "timeline" relationship) to the timeline in which it is - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00026' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must not point (via the "timeline" relationship) + to the timeline in which it is specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00026' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must not point (via the "timeline" relationship) + to the timeline in which it is specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00026' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'instances' - - name: timelineId - operator: equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: 'ScheduledActivityInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_rel + operator: equal_to + value: 'instances' + - name: timelineId + operator: equal_to + value: parent_id Core: Id: CORE-000818 Status: Published Version: '1' -Description: 'A scheduled activity instance must not point (via the "timeline" - relationship) to the timeline in which it is specified.' +Description: 'A scheduled activity instance must not point (via the "timeline" relationship) to the timeline + in which it is specified.' Executability: Fully Executable Outcome: - Message: 'The scheduled activity instance is referencing its parent timeline as - its sub-timeline.' + Message: 'The scheduled activity instance is referencing its parent timeline as its sub-timeline.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance + - ScheduledActivityInstance Sensitivity: Record diff --git a/Published/CORE-000819/rule.yml b/Published/CORE-000819/rule.yml index 7d7f90278..4a2ade78b 100644 --- a/Published/CORE-000819/rule.yml +++ b/Published/CORE-000819/rule.yml @@ -1,74 +1,70 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference a timeline - exit that is defined within the same schedule timeline as the - scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00102' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference a timeline - exit that is defined within the same schedule timeline as the - scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00102' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only reference a timeline exit that is defined + within the same schedule timeline as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00102' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only reference a timeline exit that is defined + within the same schedule timeline as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00102' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineExitId - operator: non_empty - - name: parent_id.ScheduleTimelineExit - operator: not_equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: 'ScheduledActivityInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - name: timelineExitId + operator: non_empty + - name: parent_id.ScheduleTimelineExit + operator: not_equal_to + value: parent_id Core: Id: 'CORE-000819' Status: Published Version: '1' -Description: 'A scheduled activity instance must only reference a timeline exit - that is defined within the same schedule timeline as the scheduled activity - instance.' +Description: 'A scheduled activity instance must only reference a timeline exit that is defined within + the same schedule timeline as the scheduled activity instance.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: timelineExitId - Right: id - - rel_type - Name: ScheduleTimelineExit +- Keys: + - Left: timelineExitId + Right: id + - rel_type + Name: ScheduleTimelineExit Outcome: - Message: 'The scheduled activity instance references a timeline exit that is not - defined within the same schedule timeline as the scheduled activity - instance.' + Message: 'The scheduled activity instance references a timeline exit that is not defined within the + same schedule timeline as the scheduled activity instance.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineExitId - - parent_id.ScheduleTimelineExit + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineExitId + - parent_id.ScheduleTimelineExit Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - 'ScheduledActivityInstance' Sensitivity: Record diff --git a/Published/CORE-000820/rule.yml b/Published/CORE-000820/rule.yml index c5e905d4f..c78c2e7c3 100644 --- a/Published/CORE-000820/rule.yml +++ b/Published/CORE-000820/rule.yml @@ -1,66 +1,64 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The value for each timing must be a non-negative duration - specified in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00060' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The value for each timing must be a non-negative duration - specified in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00060' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The value for each timing must be a non-negative duration specified in ISO 8601 + format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00060' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The value for each timing must be a non-negative duration specified in ISO 8601 + format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00060' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: value - operator: exists - - name: value - operator: non_empty - - name: value - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: 'Timing' + - name: rel_type + operator: equal_to + value: 'definition' + - name: value + operator: exists + - name: value + operator: non_empty + - name: value + negative: false + operator: invalid_duration Core: Id: 'CORE-000820' Status: Published Version: '1' -Description: 'The value for each timing must be a non-negative duration - specified in ISO 8601 format.' +Description: 'The value for each timing must be a non-negative duration specified in ISO 8601 format.' Executability: Fully Executable Outcome: - Message: 'The value attribute of the timing is not a non-negative duration in - ISO 8601 format.' + Message: 'The value attribute of the timing is not a non-negative duration in ISO 8601 format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - value - - valueLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - value + - valueLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000821/rule.yml b/Published/CORE-000821/rule.yml index 7238d6ab3..14d13d315 100644 --- a/Published/CORE-000821/rule.yml +++ b/Published/CORE-000821/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The target for a condition must not be equal to its parent.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00044' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The target for a condition must not be equal to its parent.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00044' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The target for a condition must not be equal to its parent.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00044' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The target for a condition must not be equal to its parent.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00044' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ConditionAssignment' - - name: 'rel_type' - operator: equal_to - value: 'definition' - - name: conditionTargetId - operator: equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: 'ConditionAssignment' + - name: 'rel_type' + operator: equal_to + value: 'definition' + - name: conditionTargetId + operator: equal_to + value: parent_id Core: Id: 'CORE-000821' Status: Published @@ -43,14 +43,14 @@ Executability: Fully Executable Outcome: Message: "The condition assignment's target is the same as its parent." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - conditionTargetId + - parent_entity + - parent_id + - parent_rel + - id + - conditionTargetId Rule Type: Record Data Scope: Entities: Include: - - ConditionAssignment + - ConditionAssignment Sensitivity: Record diff --git a/Published/CORE-000822/rule.yml b/Published/CORE-000822/rule.yml index 2314ee9b7..d045465a6 100644 --- a/Published/CORE-000822/rule.yml +++ b/Published/CORE-000822/rule.yml @@ -1,68 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "There must be at least one exit defined for each timeline - (i.e., at least one instance of StudyTimelineExit linked via - the 'exits' relationship)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00108' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "There must be at least one exit defined for each timeline - (i.e., at least one instance of StudyTimelineExit linked via - the 'exits' relationship)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00108' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "There must be at least one exit defined for each timeline (i.e., at least one + instance of StudyTimelineExit linked via the 'exits' relationship)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00108' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "There must be at least one exit defined for each timeline (i.e., at least one + instance of StudyTimelineExit linked via the 'exits' relationship)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00108' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType + - name: instanceType + operator: equal_to + value: 'ScheduleTimeline' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: exits + operator: not_exists + - name: exits + operator: empty + - name: exits operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: exits - operator: not_exists - - name: exits - operator: empty - - name: exits - operator: equal_to - value: false + value: false Core: Id: 'CORE-000822' Status: Published Version: '1' -Description: "There must be at least one exit defined for each timeline (i.e., - at least one instance of StudyTimelineExit linked via the 'exits' - relationship)." +Description: "There must be at least one exit defined for each timeline (i.e., at least one instance of + StudyTimelineExit linked via the 'exits' relationship)." Executability: Fully Executable Outcome: Message: 'There is no exit defined for the timeline.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - exits + - parent_entity + - parent_id + - parent_rel + - id + - name + - exits Rule Type: Record Data Scope: Entities: Include: - - 'ScheduleTimeline' + - 'ScheduleTimeline' Sensitivity: Record diff --git a/Published/CORE-000823/rule.yml b/Published/CORE-000823/rule.yml index 07105a5b5..8afa3c39b 100644 --- a/Published/CORE-000823/rule.yml +++ b/Published/CORE-000823/rule.yml @@ -1,44 +1,42 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have a title of type "Official Study - Title".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00115' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have a title of type "Official Study - Title".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00115' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00115' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00115' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $study_title_type_codes - operator: does_not_contain_case_insensitive - value: 'C207616' - - name: $study_title_type_decodes - operator: does_not_contain_case_insensitive - value: 'Official Study Title' + - name: instanceType + operator: equal_to + value: 'StudyVersion' + - name: rel_type + operator: equal_to + value: 'definition' + - name: $study_title_type_codes + operator: does_not_contain_case_insensitive + value: 'C207616' + - name: $study_title_type_decodes + operator: does_not_contain_case_insensitive + value: 'Official Study Title' Core: Id: 'CORE-000823' Status: Published @@ -46,43 +44,42 @@ Core: Description: 'Every study version must have a title of type "Official Study Title".' Executability: Fully Executable Operations: - - domain: StudyTitle - group: - - parent_entity - - parent_id - - rel_type - group_aliases: - - instanceType - - id - id: $study_title_type_codes - name: type.code - operator: distinct - - domain: StudyTitle - group: - - parent_entity - - parent_id - - rel_type - group_aliases: - - instanceType - - id - id: $study_title_type_decodes - name: type.decode - operator: distinct +- domain: StudyTitle + group: + - parent_entity + - parent_id + - rel_type + group_aliases: + - instanceType + - id + id: $study_title_type_codes + name: type.code + operator: distinct +- domain: StudyTitle + group: + - parent_entity + - parent_id + - rel_type + group_aliases: + - instanceType + - id + id: $study_title_type_decodes + name: type.decode + operator: distinct Outcome: - Message: 'The study version does not have a title of type "Official Study Title" - (type.code = C207616 or type.decode = "Official Study Title", both case - insensitive).' + Message: 'The study version does not have a title of type "Official Study Title" (type.code = C207616 + or type.decode = "Official Study Title", both case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $study_title_type_codes - - $study_title_type_decodes + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $study_title_type_codes + - $study_title_type_decodes Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-000824/rule.yml b/Published/CORE-000824/rule.yml index 183c2b68d..7ba72c6d3 100644 --- a/Published/CORE-000824/rule.yml +++ b/Published/CORE-000824/rule.yml @@ -1,64 +1,62 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself - as its default condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00019' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself - as its default condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00019' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself as its default + condition.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00019' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself as its default + condition.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00019' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: is_contained_by - value: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: defaultConditionId - operator: equal_to - value: id + - name: instanceType + operator: is_contained_by + value: + - 'ScheduledActivityInstance' + - 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - name: defaultConditionId + operator: equal_to + value: id Core: Id: CORE-000824 Status: Published Version: '1' -Description: 'A scheduled activity/decision instance must not refer to itself as - its default condition.' +Description: 'A scheduled activity/decision instance must not refer to itself as its default condition.' Executability: Fully Executable Outcome: - Message: 'A scheduled activity/decision instance is referencing itself as its - default condition.' + Message: 'A scheduled activity/decision instance is referencing itself as its default condition.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance - - ScheduledDecisionInstance + - ScheduledActivityInstance + - ScheduledDecisionInstance Sensitivity: Record diff --git a/Published/CORE-000825/rule.yml b/Published/CORE-000825/rule.yml index 14531bac9..ad8da097f 100644 --- a/Published/CORE-000825/rule.yml +++ b/Published/CORE-000825/rule.yml @@ -1,66 +1,66 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the lower limit of a timing window must be a - non-negative duration in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00061' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the lower limit of a timing window must be a - non-negative duration in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00061' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When specified, the lower limit of a timing window must be a non-negative duration + in ISO 8601 format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00061' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When specified, the lower limit of a timing window must be a non-negative duration + in ISO 8601 format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00061' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: windowLower - operator: exists - - name: windowLower - operator: non_empty - - name: windowLower - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: 'Timing' + - name: rel_type + operator: equal_to + value: 'definition' + - name: windowLower + operator: exists + - name: windowLower + operator: non_empty + - name: windowLower + negative: false + operator: invalid_duration Core: Id: 'CORE-000825' Status: Published Version: '1' -Description: 'When specified, the lower limit of a timing window must be a - non-negative duration in ISO 8601 format.' +Description: 'When specified, the lower limit of a timing window must be a non-negative duration in ISO + 8601 format.' Executability: Fully Executable Outcome: - Message: 'The lower limit of the timing window (windowLower) is not a - non-negative duration in ISO 8601 format.' + Message: 'The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601 + format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - windowLower - - windowLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - windowLower + - windowLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000826/rule.yml b/Published/CORE-000826/rule.yml index 3946e3b5d..a857a65df 100644 --- a/Published/CORE-000826/rule.yml +++ b/Published/CORE-000826/rule.yml @@ -1,66 +1,66 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the upper limit of a timing window must be a - non-negative duration in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00062' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the upper limit of a timing window must be a - non-negative duration in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00062' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When specified, the upper limit of a timing window must be a non-negative duration + in ISO 8601 format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00062' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When specified, the upper limit of a timing window must be a non-negative duration + in ISO 8601 format.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00062' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: windowUpper - operator: exists - - name: windowUpper - operator: non_empty - - name: windowUpper - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: 'Timing' + - name: rel_type + operator: equal_to + value: 'definition' + - name: windowUpper + operator: exists + - name: windowUpper + operator: non_empty + - name: windowUpper + negative: false + operator: invalid_duration Core: Id: 'CORE-000826' Status: Published Version: '1' -Description: 'When specified, the upper limit of a timing window must be a - non-negative duration in ISO 8601 format.' +Description: 'When specified, the upper limit of a timing window must be a non-negative duration in ISO + 8601 format.' Executability: Fully Executable Outcome: - Message: 'The upper limit of the timing window (windowUpper) is not a - non-negative duration in ISO 8601 format.' + Message: 'The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601 + format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - windowUpper - - windowLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - windowUpper + - windowLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000827/rule.yml b/Published/CORE-000827/rule.yml index 17e9c4fc4..c00de5861 100644 --- a/Published/CORE-000827/rule.yml +++ b/Published/CORE-000827/rule.yml @@ -1,80 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined - within the same study design as the encounter.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00127' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined - within the same study design as the encounter.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00127' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined within the same + study design as the encounter.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00127' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined within the same + study design as the encounter.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00127' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Encounter' - - name: rel_type - operator: equal_to - value: 'definition' - - name: scheduledAtId - operator: non_empty - - name: parent_id - operator: not_equal_to - value: parent_id.ScheduleTimeline + - name: instanceType + operator: equal_to + value: 'Encounter' + - name: rel_type + operator: equal_to + value: 'definition' + - name: scheduledAtId + operator: non_empty + - name: parent_id + operator: not_equal_to + value: parent_id.ScheduleTimeline Core: Id: 'CORE-000827' Status: Published Version: '1' -Description: 'An encounter must only be scheduled at a timing that is defined - within the same study design as the encounter.' +Description: 'An encounter must only be scheduled at a timing that is defined within the same study design + as the encounter.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: scheduledAtId - Right: id - - rel_type - Name: Timing - - Join Type: left - Keys: - - Left: parent_id.Timing - Right: id - - rel_type - Name: ScheduleTimeline +- Join Type: left + Keys: + - Left: scheduledAtId + Right: id + - rel_type + Name: Timing +- Join Type: left + Keys: + - Left: parent_id.Timing + Right: id + - rel_type + Name: ScheduleTimeline Outcome: - Message: 'The encounter is scheduled at a timing that either is not defined in - the same study design (the parent_id of the timing''s parent schedule - timeline does not match the parent_id of the encounter) or is invalid - (schedulateAtId does not match the id of any timing).' + Message: 'The encounter is scheduled at a timing that either is not defined in the same study design + (the parent_id of the timing''s parent schedule timeline does not match the parent_id of the encounter) + or is invalid (schedulateAtId does not match the id of any timing).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - scheduledAtId - - name.Timing - - parent_id.ScheduleTimeline + - parent_entity + - parent_id + - parent_rel + - id + - name + - scheduledAtId + - name.Timing + - parent_id.ScheduleTimeline Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000828/rule.yml b/Published/CORE-000828/rule.yml index 582bea199..f3f766a25 100644 --- a/Published/CORE-000828/rule.yml +++ b/Published/CORE-000828/rule.yml @@ -1,90 +1,86 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A standard code alias is not expected to be equal to the - standard code (e.g. no equal code or decode for the same - coding system version is expected).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00063' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A standard code alias is not expected to be equal to the - standard code (e.g. no equal code or decode for the same - coding system version is expected).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00063' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A standard code alias is not expected to be equal to the standard code (e.g. + no equal code or decode for the same coding system version is expected).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00063' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A standard code alias is not expected to be equal to the standard code (e.g. + no equal code or decode for the same coding system version is expected).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00063' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'AliasCode' - - name: parent_rel.Code - operator: equal_to - value: 'standardCodeAliases' - value_is_literal: true - - name: standardCode.codeSystem + - name: instanceType + operator: equal_to + value: 'AliasCode' + - name: parent_rel.Code + operator: equal_to + value: 'standardCodeAliases' + value_is_literal: true + - name: standardCode.codeSystem + operator: equal_to_case_insensitive + value: codeSystem + - name: standardCode.codeSystemVersion + operator: equal_to_case_insensitive + value: codeSystemVersion + - any: + - name: standardCode.code operator: equal_to_case_insensitive - value: codeSystem - - name: standardCode.codeSystemVersion + value: code + - name: standardCode.decode operator: equal_to_case_insensitive - value: codeSystemVersion - - any: - - name: standardCode.code - operator: equal_to_case_insensitive - value: code - - name: standardCode.decode - operator: equal_to_case_insensitive - value: decode + value: decode Core: Id: 'CORE-000828' Status: Published Version: '1' -Description: 'A standard code alias is not expected to be equal to the standard - code (e.g. no equal code or decode for the same coding system version is - expected).' +Description: 'A standard code alias is not expected to be equal to the standard code (e.g. no equal code + or decode for the same coding system version is expected).' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - Name: Code +- Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + Name: Code Outcome: - Message: 'The standard code alias is the same as the standard code - the same - combination of code system, code system version and either code or decode is - used for both the standard code and the standard code alias (case - insensitive).' + Message: 'The standard code alias is the same as the standard code - the same combination of code system, + code system version and either code or decode is used for both the standard code and the standard + code alias (case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - standardCode.codeSystem - - standardCode.codeSystemVersion - - standardCode.code - - standardCode.decode - - codeSystem - - codeSystemVersion - - code - - decode + - parent_entity + - parent_id + - parent_rel + - id + - standardCode.codeSystem + - standardCode.codeSystemVersion + - standardCode.code + - standardCode.decode + - codeSystem + - codeSystemVersion + - code + - decode Rule Type: Record Data Scope: Entities: Include: - - 'AliasCode' + - 'AliasCode' Sensitivity: Record diff --git a/Published/CORE-000829/rule.yml b/Published/CORE-000829/rule.yml index 921102a98..5916afb77 100644 --- a/Published/CORE-000829/rule.yml +++ b/Published/CORE-000829/rule.yml @@ -1,48 +1,48 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00054' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00054' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00054' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00054' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'contactModes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'Encounter' + - name: parent_rel + operator: equal_to + value: 'contactModes' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000829" Status: Published @@ -50,27 +50,27 @@ Core: Description: 'Within an encounter there must be no duplicate contact modes.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The contact modes of the encounter are not unique - the same code is - used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The contact modes of the encounter are not unique - the same code is used more than once with + the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000830/rule.yml b/Published/CORE-000830/rule.yml index b994a2942..bae7574d0 100644 --- a/Published/CORE-000830/rule.yml +++ b/Published/CORE-000830/rule.yml @@ -1,82 +1,77 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related - to a scheduled activity instance via a - relativeFromScheduledInstance relationship.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00011' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related - to a scheduled activity instance via a - relativeFromScheduledInstance relationship.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00011' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled + activity instance via a relativeFromScheduledInstance relationship.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00011' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled + activity instance via a relativeFromScheduledInstance relationship.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00011' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: relativeFromScheduledInstanceId - operator: empty - - name: id.ScheduledActivityInstance - operator: not_exists - - name: id.ScheduledActivityInstance - operator: empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: type.code + operator: equal_to + value: 'C201358' + - any: + - name: relativeFromScheduledInstanceId + operator: empty + - name: id.ScheduledActivityInstance + operator: not_exists + - name: id.ScheduledActivityInstance + operator: empty Core: Id: 'CORE-000830' Status: Published Version: '1' -Description: 'Anchor timings (e.g. type is "Fixed Reference") must be related to - a scheduled activity instance via a relativeFromScheduledInstance - relationship.' +Description: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled activity + instance via a relativeFromScheduledInstance relationship.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: relativeFromScheduledInstanceId - Right: id - - Left: instanceType - Right: parent_entity - Name: ScheduledActivityInstance +- Join Type: left + Keys: + - Left: relativeFromScheduledInstanceId + Right: id + - Left: instanceType + Right: parent_entity + Name: ScheduledActivityInstance Outcome: - Message: 'The timing has a type of "Fixed Reference" (type.code=C201358) but it - is not related to a scheduled activity instance via a - relativeFromScheduledInstance relationship - the value of - relativeFromScheduledInstanceId is missing or it does not match the id value - of a ScheduledActivityInstance.' + Message: 'The timing has a type of "Fixed Reference" (type.code=C201358) but it is not related to a + scheduled activity instance via a relativeFromScheduledInstance relationship - the value of relativeFromScheduledInstanceId + is missing or it does not match the id value of a ScheduledActivityInstance.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - id.ScheduledActivityInstance + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - id.ScheduledActivityInstance Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000831/rule.yml b/Published/CORE-000831/rule.yml index 1e51e4e30..91fdef463 100644 --- a/Published/CORE-000831/rule.yml +++ b/Published/CORE-000831/rule.yml @@ -1,79 +1,76 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an indication, if more indication codes are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00058' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an indication, if more indication codes are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00058' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an indication, if more indication codes are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00058' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an indication, if more indication codes are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00058' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Indication' - - name: parent_rel - operator: equal_to - value: 'codes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'Indication' + - name: parent_rel + operator: equal_to + value: 'codes' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000831" Status: Published Version: '1' -Description: 'Within an indication, if more indication codes are defined, they - must be distinct.' +Description: 'Within an indication, if more indication codes are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Indication +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: Indication Outcome: - Message: 'The codes of the indication are not unique - the same code is used - more than once with the same codeSystem and codeSystemVersion.' + Message: 'The codes of the indication are not unique - the same code is used more than once with the + same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000832/rule.yml b/Published/CORE-000832/rule.yml index 02d6ef57f..0b8d9d895 100644 --- a/Published/CORE-000832/rule.yml +++ b/Published/CORE-000832/rule.yml @@ -1,79 +1,78 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study intervention, if more intervention codes are - defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00059' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study intervention, if more intervention codes are - defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00059' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study intervention, if more intervention codes are defined, they must + be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00059' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study intervention, if more intervention codes are defined, they must + be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00059' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyIntervention' - - name: parent_rel - operator: equal_to - value: 'codes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'StudyIntervention' + - name: parent_rel + operator: equal_to + value: 'codes' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000832" Status: Published Version: '1' -Description: 'Within a study intervention, if more intervention codes are - defined, they must be distinct.' +Description: 'Within a study intervention, if more intervention codes are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyIntervention +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyIntervention Outcome: - Message: 'The codes of the study intervention are not unique - the same code is - used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The codes of the study intervention are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000833/rule.yml b/Published/CORE-000833/rule.yml index d96bfcb49..1d5501b66 100644 --- a/Published/CORE-000833/rule.yml +++ b/Published/CORE-000833/rule.yml @@ -1,60 +1,58 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: >- - References must be a fixed value or a reference to items - stored elsewhere in the data model which must be specified in - the correct format. They must start with '' or '>', and must contain - 'klass="klassName"', 'id="idValue"', and - 'attribute="attributeName"/>' in any order (where "klassName" - and "attributeName" contain only letters in upper or lower - case). - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00137' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: >- - References must be a fixed value or a reference to items - stored elsewhere in the data model which must be specified in - the correct format. They must start with '' or '>', and must contain - 'klass="klassName"', 'id="idValue"', and - 'attribute="attributeName"/>' in any order (where "klassName" - and "attributeName" contain only letters in upper or lower - case). - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00137' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: >- + References must be a fixed value or a reference to items + stored elsewhere in the data model which must be specified in + the correct format. They must start with '' or '>', and must contain + 'klass="klassName"', 'id="idValue"', and + 'attribute="attributeName"/>' in any order (where "klassName" + and "attributeName" contain only letters in upper or lower + case). + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00137' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: >- + References must be a fixed value or a reference to items + stored elsewhere in the data model which must be specified in + the correct format. They must start with '' or '>', and must contain + 'klass="klassName"', 'id="idValue"', and + 'attribute="attributeName"/>' in any order (where "klassName" + and "attributeName" contain only letters in upper or lower + case). + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00137' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ParameterMap' - - name: rel_type - operator: equal_to - value: definition - - name: reference - operator: contains - value: 'usdm:ref' - - name: reference - operator: not_matches_regex - value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]* - id=\"([^\"]+)\")(?=[^>]* - attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$' + - name: instanceType + operator: equal_to + value: 'ParameterMap' + - name: rel_type + operator: equal_to + value: definition + - name: reference + operator: contains + value: 'usdm:ref' + - name: reference + operator: not_matches_regex + value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]* id=\"([^\"]+)\")(?=[^>]* attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$' Core: Id: 'CORE-000833' Status: Published @@ -68,18 +66,18 @@ Description: >- lower case). Executability: Fully Executable Outcome: - Message: 'The reference is not a fixed value (it contains "usdm:ref") but it is - not specified in the correct format.' + Message: 'The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the + correct format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - tag - - reference + - parent_entity + - parent_id + - parent_rel + - id + - tag + - reference Rule Type: Record Data Scope: Entities: Include: - - 'ParameterMap' + - 'ParameterMap' Sensitivity: Record diff --git a/Published/CORE-000834/rule.yml b/Published/CORE-000834/rule.yml index 2ce2f93e0..50b277ca2 100644 --- a/Published/CORE-000834/rule.yml +++ b/Published/CORE-000834/rule.yml @@ -1,99 +1,97 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then there must be only one - geographic scope specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00151' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then there must be only one - geographic scope specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00151' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If geographic scope type is global then there must be only one geographic scope + specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00151' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If geographic scope type is global then there must be only one geographic scope + specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00151' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'GovernanceDate' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $num_of_geographic_scopes - operator: greater_than - value: 1 - - any: - - name: $geographic_scope_type_codes - operator: contains_case_insensitive - value: 'C68846' - - name: $geographic_scope_type_decodes - operator: contains_case_insensitive - value: 'Global' + - name: instanceType + operator: equal_to + value: 'GovernanceDate' + - name: rel_type + operator: equal_to + value: 'definition' + - name: $num_of_geographic_scopes + operator: greater_than + value: 1 + - any: + - name: $geographic_scope_type_codes + operator: contains_case_insensitive + value: 'C68846' + - name: $geographic_scope_type_decodes + operator: contains_case_insensitive + value: 'Global' Core: Id: 'CORE-000834' Status: Published Version: '1' -Description: 'If geographic scope type is global then there must be only one - geographic scope specified.' +Description: 'If geographic scope type is global then there must be only one geographic scope specified.' Executability: Fully Executable Operations: - - domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $num_of_geographic_scopes - operator: record_count - - domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $geographic_scope_type_codes - name: type.code - operator: distinct - - domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $geographic_scope_type_decodes - name: type.decode - operator: distinct +- domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $num_of_geographic_scopes + operator: record_count +- domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $geographic_scope_type_codes + name: type.code + operator: distinct +- domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $geographic_scope_type_decodes + name: type.decode + operator: distinct Outcome: - Message: 'The governance date has more than one geographic scope defined, at - least one of which has type of "Global" (type.code = C68846 or type.decode = - "Global", both case insensitive).' + Message: 'The governance date has more than one geographic scope defined, at least one of which has + type of "Global" (type.code = C68846 or type.decode = "Global", both case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - dateValue - - $num_of_geographic_scopes - - $geographic_scope_type_codes - - $geographic_scope_type_decodes + - parent_entity + - parent_id + - parent_rel + - id + - name + - dateValue + - $num_of_geographic_scopes + - $geographic_scope_type_codes + - $geographic_scope_type_decodes Rule Type: Record Data Scope: Entities: Include: - - 'GovernanceDate' + - 'GovernanceDate' Sensitivity: Record diff --git a/Published/CORE-000835/rule.yml b/Published/CORE-000835/rule.yml index bd4001165..2f299d327 100644 --- a/Published/CORE-000835/rule.yml +++ b/Published/CORE-000835/rule.yml @@ -1,71 +1,71 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an arm that is defined within - the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00071' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an arm that is defined within - the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00071' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference an arm that is defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00071' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference an arm that is defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00071' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyCell' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_id - operator: not_equal_to - value: parent_id.StudyArm + - name: instanceType + operator: equal_to + value: 'StudyCell' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_id + operator: not_equal_to + value: parent_id.StudyArm Core: Id: 'CORE-000835' Status: Published Version: '1' -Description: 'A study cell must only reference an arm that is defined within the - same study design as the study cell.' +Description: 'A study cell must only reference an arm that is defined within the same study design as + the study cell.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: armId - Right: id - - parent_entity - - rel_type - Name: StudyArm +- Keys: + - Left: armId + Right: id + - parent_entity + - rel_type + Name: StudyArm Outcome: - Message: 'The study cell references an arm that is not defined within the same - study design as the study cell.' + Message: 'The study cell references an arm that is not defined within the same study design as the study + cell.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - armId - - parent_id.StudyArm + - parent_entity + - parent_id + - parent_rel + - id + - armId + - parent_id.StudyArm Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - 'StudyCell' Sensitivity: Record diff --git a/Published/CORE-000836/rule.yml b/Published/CORE-000836/rule.yml index c380e1b40..5cbe526ad 100644 --- a/Published/CORE-000836/rule.yml +++ b/Published/CORE-000836/rule.yml @@ -1,71 +1,71 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an epoch that is defined - within the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00072' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an epoch that is defined - within the same study design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00072' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference an epoch that is defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00072' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cell must only reference an epoch that is defined within the same study + design as the study cell.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00072' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyCell' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_id - operator: not_equal_to - value: parent_id.StudyEpoch + - name: instanceType + operator: equal_to + value: 'StudyCell' + - name: parent_entity + operator: equal_to + value: 'StudyDesign' + - name: rel_type + operator: equal_to + value: 'definition' + - name: parent_id + operator: not_equal_to + value: parent_id.StudyEpoch Core: Id: 'CORE-000836' Status: Published Version: '1' -Description: 'A study cell must only reference an epoch that is defined within - the same study design as the study cell.' +Description: 'A study cell must only reference an epoch that is defined within the same study design as + the study cell.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: epochId - Right: id - - parent_entity - - rel_type - Name: StudyEpoch +- Keys: + - Left: epochId + Right: id + - parent_entity + - rel_type + Name: StudyEpoch Outcome: - Message: 'The study cell references an epoch that is not defined within the same - study design as the study cell.' + Message: 'The study cell references an epoch that is not defined within the same study design as the + study cell.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - epochId - - parent_id.StudyEpoch + - parent_entity + - parent_id + - parent_rel + - id + - epochId + - parent_id.StudyEpoch Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - 'StudyCell' Sensitivity: Record diff --git a/Published/CORE-000837/rule.yml b/Published/CORE-000837/rule.yml index 279fe2e2e..1f27b1e96 100644 --- a/Published/CORE-000837/rule.yml +++ b/Published/CORE-000837/rule.yml @@ -1,84 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference activities that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00028' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference activities that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00028' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity must only reference activities that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00028' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity must only reference activities that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00028' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Activity' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $activity_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $activity_ids_for_study_design + - name: instanceType + operator: equal_to + value: 'Activity' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $activity_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $activity_ids_for_study_design Core: Id: 'CORE-000837' Status: Published Version: '1' -Description: 'An activity must only reference activities that are specified - within the same study design.' +Description: 'An activity must only reference activities that are specified within the same study design.' Executability: Fully Executable Operations: - - group: - - parent_id - - rel_type - id: $activity_ids_for_study_design - name: id - operator: distinct +- group: + - parent_id + - rel_type + id: $activity_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The activity references a previous or next activity that is not - specified within the same study design.' + Message: 'The activity references a previous or next activity that is not specified within the same + study design.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $activity_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $activity_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-000838/rule.yml b/Published/CORE-000838/rule.yml index cff43fe7a..da0c95a5b 100644 --- a/Published/CORE-000838/rule.yml +++ b/Published/CORE-000838/rule.yml @@ -1,84 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only reference encounters that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00029' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only reference encounters that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00029' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An encounter must only reference encounters that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00029' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An encounter must only reference encounters that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00029' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Encounter' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $encounter_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $encounter_ids_for_study_design + - name: instanceType + operator: equal_to + value: 'Encounter' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $encounter_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $encounter_ids_for_study_design Core: Id: 'CORE-000838' Status: Published Version: '1' -Description: 'An encounter must only reference encounters that are specified - within the same study design.' +Description: 'An encounter must only reference encounters that are specified within the same study design.' Executability: Fully Executable Operations: - - group: - - parent_id - - rel_type - id: $encounter_ids_for_study_design - name: id - operator: distinct +- group: + - parent_id + - rel_type + id: $encounter_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The encounter references a previous or next encounter that is not - specified within the same study design.' + Message: 'The encounter references a previous or next encounter that is not specified within the same + study design.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $encounter_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $encounter_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000839/rule.yml b/Published/CORE-000839/rule.yml index 963df33b6..cdd078416 100644 --- a/Published/CORE-000839/rule.yml +++ b/Published/CORE-000839/rule.yml @@ -1,84 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An epoch must only reference epochs that are specified within - the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00024' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An epoch must only reference epochs that are specified within - the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00024' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An epoch must only reference epochs that are specified within the same study + design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00024' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An epoch must only reference epochs that are specified within the same study + design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00024' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyEpoch' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $epoch_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $epoch_ids_for_study_design + - name: instanceType + operator: equal_to + value: 'StudyEpoch' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $epoch_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $epoch_ids_for_study_design Core: Id: 'CORE-000839' Status: Published Version: '1' -Description: 'An epoch must only reference epochs that are specified within the - same study design.' +Description: 'An epoch must only reference epochs that are specified within the same study design.' Executability: Fully Executable Operations: - - group: - - parent_id - - rel_type - id: $epoch_ids_for_study_design - name: id - operator: distinct +- group: + - parent_id + - rel_type + id: $epoch_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The epoch references a previous or next epoch that is not specified - within the same study design.' + Message: 'The epoch references a previous or next epoch that is not specified within the same study + design.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $epoch_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $epoch_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'StudyEpoch' + - 'StudyEpoch' Sensitivity: Record diff --git a/Published/CORE-000840/rule.yml b/Published/CORE-000840/rule.yml index 5c5e391d4..82cf491cb 100644 --- a/Published/CORE-000840/rule.yml +++ b/Published/CORE-000840/rule.yml @@ -1,74 +1,72 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference timelines that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00152' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference timelines that are specified - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00152' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity must only reference timelines that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00152' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity must only reference timelines that are specified within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00152' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Activity' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineId - operator: exists - - name: timelineId - operator: non_empty - - name: timelineId - operator: is_not_contained_by - value: $timeline_ids_for_study_design + - name: instanceType + operator: equal_to + value: 'Activity' + - name: rel_type + operator: equal_to + value: 'definition' + - name: timelineId + operator: exists + - name: timelineId + operator: non_empty + - name: timelineId + operator: is_not_contained_by + value: $timeline_ids_for_study_design Core: Id: 'CORE-000840' Status: Published Version: '1' -Description: 'An activity must only reference timelines that are specified - within the same study design.' +Description: 'An activity must only reference timelines that are specified within the same study design.' Executability: Fully Executable Operations: - - domain: ScheduleTimeline - group: - - parent_id - - rel_type - id: $timeline_ids_for_study_design - name: id - operator: distinct +- domain: ScheduleTimeline + group: + - parent_id + - rel_type + id: $timeline_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The activity references a timeline that is not specified within the - same study design.' + Message: 'The activity references a timeline that is not specified within the same study design.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId - - $timeline_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId + - $timeline_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-000847/rule.yml b/Published/CORE-000847/rule.yml index a6b6ec014..a0c2fce17 100644 --- a/Published/CORE-000847/rule.yml +++ b/Published/CORE-000847/rule.yml @@ -1,106 +1,106 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SCAN' - operator: exists + - name: '--SCAN' + operator: exists Core: + Id: CORE-000847 Status: Published Version: '1' - Id: CORE-000847 Description: '--SCAN must not be present in SEND dataset' Executability: Fully Executable Outcome: @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000848/rule.yml b/Published/CORE-000848/rule.yml index 676fd6f48..b8ed63f9e 100644 --- a/Published/CORE-000848/rule.yml +++ b/Published/CORE-000848/rule.yml @@ -1,106 +1,106 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '--SCONG' - operator: exists + - name: '--SCONG' + operator: exists Core: + Id: CORE-000848 Status: Published Version: '1' - Id: CORE-000848 Description: '--SCONG (Congenital Anomaly or Birth Defect) must not be in SEND dataset' Executability: Fully Executable Outcome: @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000849/rule.yml b/Published/CORE-000849/rule.yml index 4cfd82434..df520d2d4 100644 --- a/Published/CORE-000849/rule.yml +++ b/Published/CORE-000849/rule.yml @@ -1,40 +1,38 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its next - instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00022' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its next - instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00022' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not refer to itself as its next instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00022' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not refer to itself as its next instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00022' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: nextId - operator: exists - - name: nextId - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: 'definition' + - name: nextId + operator: exists + - name: nextId + operator: equal_to + value: id Core: Id: CORE-000849 Status: Published @@ -44,15 +42,15 @@ Executability: Fully Executable Outcome: Message: 'An instance of a class is referencing itself as its next instance.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - nextId + - parent_entity + - parent_id + - parent_rel + - id + - name + - nextId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000850/rule.yml b/Published/CORE-000850/rule.yml index 1edb5281e..40548bd8a 100644 --- a/Published/CORE-000850/rule.yml +++ b/Published/CORE-000850/rule.yml @@ -1,87 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a transition start rule is defined then an end rule is - expected and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00078' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a transition start rule is defined then an end rule is expected and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00078' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: is_contained_by - value: - - 'Encounter' - - 'StudyElement' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: transitionStartRule - operator: exists - - name: transitionStartRule - operator: non_empty - - name: transitionStartRule - operator: equal_to - value: true - - any: - - name: transitionEndRule - operator: not_exists - - name: transitionEndRule - operator: empty - - name: transitionEndRule - operator: equal_to - value: false - - all: - - name: transitionEndRule - operator: exists - - name: transitionEndRule - operator: non_empty - - name: transitionEndRule - operator: equal_to - value: true - - any: - - name: transitionStartRule - operator: not_exists - - name: transitionStartRule - operator: empty - - name: transitionStartRule - operator: equal_to - value: false + - name: instanceType + operator: is_contained_by + value: + - 'Encounter' + - 'StudyElement' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: transitionStartRule + operator: exists + - name: transitionStartRule + operator: non_empty + - name: transitionStartRule + operator: equal_to + value: true + - any: + - name: transitionEndRule + operator: not_exists + - name: transitionEndRule + operator: empty + - name: transitionEndRule + operator: equal_to + value: false + - all: + - name: transitionEndRule + operator: exists + - name: transitionEndRule + operator: non_empty + - name: transitionEndRule + operator: equal_to + value: true + - any: + - name: transitionStartRule + operator: not_exists + - name: transitionStartRule + operator: empty + - name: transitionStartRule + operator: equal_to + value: false Core: Id: 'CORE-000850' Status: Published Version: '1' -Description: 'If a transition start rule is defined then an end rule is expected - and vice versa.' +Description: 'If a transition start rule is defined then an end rule is expected and vice versa.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A transition start rule is defined but an end rule is missing, or vice - versa.' + Message: 'A transition start rule is defined but an end rule is missing, or vice versa.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - transitionStartRule - - transitionStartRule.id - - transitionStartRule.name - - transitionEndRule - - transitionEndRule.id - - transitionEndRule.name + - parent_entity + - parent_id + - parent_rel + - id + - name + - transitionStartRule + - transitionStartRule.id + - transitionStartRule.name + - transitionEndRule + - transitionEndRule.id + - transitionEndRule.name Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' - - 'StudyElement' + - 'Encounter' + - 'StudyElement' Sensitivity: Record diff --git a/Published/CORE-000851/rule.yml b/Published/CORE-000851/rule.yml index ff0a4222a..4384ef1d4 100644 --- a/Published/CORE-000851/rule.yml +++ b/Published/CORE-000851/rule.yml @@ -1,44 +1,42 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not reference itself as one of its - own children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00018' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not reference itself as one of its - own children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00018' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not reference itself as one of its own children.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00018' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An instance of a class must not reference itself as one of its own children.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00018' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'reference' - - name: childIds - operator: exists - - name: parent_rel - operator: equal_to - value: 'childIds' - value_is_literal: true - - name: parent_id - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: 'reference' + - name: childIds + operator: exists + - name: parent_rel + operator: equal_to + value: 'childIds' + value_is_literal: true + - name: parent_id + operator: equal_to + value: id Core: Id: CORE-000851 Status: Published @@ -48,14 +46,14 @@ Executability: Fully Executable Outcome: Message: 'An instance of a class is being referenced as one of its own children.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000852/rule.yml b/Published/CORE-000852/rule.yml index 724cc0be2..e818ca96f 100644 --- a/Published/CORE-000852/rule.yml +++ b/Published/CORE-000852/rule.yml @@ -2,206 +2,181 @@ # Condition: # Rule: Variables are ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables are ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.3.1, 2.2.4, and 2.2.5 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Variables for the three general observation classes must be - ordered with Identifiers first; followed by the Topic; - Qualifier; and Timing variables. Within each role; variables - must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; - 2.2.3.1; 2.2.4; and 2.2.5' - Document: IG v3.2 - Section: 4.1.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0330 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Variables for the three general observation classes must be - ordered with Identifiers first; followed by the Topic; - Qualifier; and Timing variables. Within each role; variables - must be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; - 2.2.3.1; 2.2.4; and 2.2.5' - Document: IG v3.3 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0330 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variables for the 3 general observation classes must be ordered - with Identifiers variables first, followed by Topic, - Qualifier, and Timing variables. Within each role, variables - must be ordered as shown in SDTM Sections 3.1.1, The - Interventions Observation Class; 3.1.2, The Events Observation - Class; 3.1.3, The Findings Observation Class; 3.1.3.1, - Findings About Events or Interventions; 3.1.4, Identifiers for - All Classes; and 3.1.5, Timing Variables for All Classes. - Document: IG v3.4 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0664 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Dataset variables will be ordered per guidance in the SDTM Model - v1.2. Variable order in TIG Domain Specifications aligns with - variable order in the SDTM. - Document: TIG 1.0 - Item: Tabulation Datasets Num 3 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0698 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should - reflect the order of variables in the dataset. The order of - variables in the SDTM domain models has been chosen to - facilitate the review of the models and application of the - models. Variables for the three general observation classes - should be ordered with Identifiers first, followed by the - Topic Qualifier, and Timing variables. Within each role, - variables are ordered as shown in Tables 2.2.1-2.2.5 of the - SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Variables for the three general observation classes must be ordered with Identifiers + first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must + be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5' + Document: IG v3.2 + Section: 4.1.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0330 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Variables for the three general observation classes must be ordered with Identifiers + first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must + be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5' + Document: IG v3.3 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0330 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variables for the 3 general observation classes must be ordered with + Identifiers variables first, followed by Topic, Qualifier, and Timing variables. Within + each role, variables must be ordered as shown in SDTM Sections 3.1.1, The Interventions + Observation Class; 3.1.2, The Events Observation Class; 3.1.3, The Findings Observation + Class; 3.1.3.1, Findings About Events or Interventions; 3.1.4, Identifiers for All + Classes; and 3.1.5, Timing Variables for All Classes. + Document: IG v3.4 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0664 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: TIG + References: + - Citations: + - Cited Guidance: Dataset variables will be ordered per guidance in the SDTM Model v1.2. + Variable order in TIG Domain Specifications aligns with variable order in the SDTM. + Document: TIG 1.0 + Item: Tabulation Datasets Num 3 + Section: '2.6' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0698 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: $column_order_from_dataset - operator: is_not_ordered_subset_of - value: $column_order_from_library + - name: $column_order_from_dataset + operator: is_not_ordered_subset_of + value: $column_order_from_library Core: Id: CORE-000852 Status: Published @@ -210,23 +185,22 @@ Description: 'Raise an error when variables are not in the specified order' Executability: Fully Executable Operations: # variable order in CDISC-Library - - id: $column_order_from_library - operator: get_column_order_from_library +- id: $column_order_from_library + operator: get_column_order_from_library # variable order in dataset - - id: $column_order_from_dataset - operator: get_column_order_from_dataset +- id: $column_order_from_dataset + operator: get_column_order_from_dataset Outcome: - Message: Variables are not in the correct order as shown in SDTM for the - observation class. + Message: Variables are not in the correct order as shown in SDTM for the observation class. Output Variables: - - $column_order_from_dataset - - $column_order_from_library + - $column_order_from_dataset + - $column_order_from_library Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000853/rule.yml b/Published/CORE-000853/rule.yml index ac2f65927..145a0077f 100644 --- a/Published/CORE-000853/rule.yml +++ b/Published/CORE-000853/rule.yml @@ -1,168 +1,168 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of - collection is available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: non_empty - - name: RFSTDTC - operator: is_complete_date - - name: --DY - operator: empty + - name: --DTC + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: non_empty + - name: RFSTDTC + operator: is_complete_date + - name: --DY + operator: empty Core: Id: "CORE-000853" Status: Published Version: '1' -Description: Collection study day (--DY) should be populated when date/time of - collection (--DTC) is populated +Description: Collection study day (--DY) should be populated when date/time of collection (--DTC) is + populated Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: - Message: Collection study day (--DY) is not populated when date/time of - collection (--DTC) is populated. + Message: Collection study day (--DY) is not populated when date/time of collection (--DTC) is + populated. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000854/rule.yml b/Published/CORE-000854/rule.yml index 02016ee23..6ec5a2bb1 100644 --- a/Published/CORE-000854/rule.yml +++ b/Published/CORE-000854/rule.yml @@ -1,159 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion''s category must be specified using - the Category of Inclusion/Exclusion (C66797) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00110' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion''s category must be specified using - the Category of Inclusion/Exclusion (C66797) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00110' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An eligibility criterion''s category must be specified using the Category of + Inclusion/Exclusion (C66797) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00110' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An eligibility criterion''s category must be specified using the Category of + Inclusion/Exclusion (C66797) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00110' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: category - operator: equal_to - value: true - - not: - all: - - name: category.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: category.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: category + operator: equal_to + value: true + - not: + all: + - name: category.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: category.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: category.code - operator: equal_to - value: $code_for_decode_pref_term - - name: category.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: category.decode - operator: equal_to - value: $pref_term_for_code - - name: category.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: category.code + operator: equal_to + value: $code_for_decode_pref_term + - name: category.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: category.decode + operator: equal_to + value: $pref_term_for_code + - name: category.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000854' Status: Published Version: '1' -Description: 'An eligibility criterion''s category must be specified using the - Category of Inclusion/Exclusion (C66797) SDTM codelist.' +Description: 'An eligibility criterion''s category must be specified using the Category of Inclusion/Exclusion + (C66797) SDTM codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66797 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: category.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: category.code - version: category.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: category.code - version: category.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: category.decode - version: category.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: category.decode - version: category.codeSystemVersion +- id: $codelist_code + map: + - output: C66797 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: category.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: category.code + version: category.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: category.code + version: category.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: category.decode + version: category.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: category.decode + version: category.codeSystemVersion Outcome: - Message: 'The eligibility criterion''s category is not specified using the - Category of Inclusion/Exclusion (C66797) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The eligibility criterion''s category is not specified using the Category of Inclusion/Exclusion + (C66797) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, the code or decode (either as preferred term or as submission value) is + found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - category.code - - $code_for_decode_value - - $code_for_decode_pref_term - - category.codeSystem - - category.codeSystemVersion - - category.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - category.code + - $code_for_decode_value + - $code_for_decode_pref_term + - category.codeSystem + - category.codeSystemVersion + - category.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'EligibilityCriterion' + - 'EligibilityCriterion' Sensitivity: Record diff --git a/Published/CORE-000855/rule.yml b/Published/CORE-000855/rule.yml index 58c2240cd..3e33b4d89 100644 --- a/Published/CORE-000855/rule.yml +++ b/Published/CORE-000855/rule.yml @@ -1,159 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s type must be specified using the - Intervention Type Response (C99078) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00128' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s type must be specified using the - Intervention Type Response (C99078) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00128' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study intervention''s type must be specified using the Intervention Type Response + (C99078) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00128' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study intervention''s type must be specified using the Intervention Type Response + (C99078) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00128' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000855' Status: Published Version: '1' -Description: 'A study intervention''s type must be specified using the - Intervention Type Response (C99078) SDTM codelist.' +Description: 'A study intervention''s type must be specified using the Intervention Type Response (C99078) + SDTM codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C99078 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C99078 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study intervention''s type is not specified using the Intervention - Type Response (C99078) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The study intervention''s type is not specified using the Intervention Type Response (C99078) + SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - 'StudyIntervention' Sensitivity: Record diff --git a/Published/CORE-000856/rule.yml b/Published/CORE-000856/rule.yml index 5079e885d..3ae5efa1a 100644 --- a/Published/CORE-000856/rule.yml +++ b/Published/CORE-000856/rule.yml @@ -1,180 +1,175 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's contact modes must be specified according to the - extensible Mode of Subject Contact (C171445) SDTM codelist - (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00136' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's contact modes must be specified according to the - extensible Mode of Subject Contact (C171445) SDTM codelist - (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00136' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter's contact modes must be specified according to the extensible Mode + of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the + codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00136' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter's contact modes must be specified according to the extensible Mode + of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the + codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00136' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: contactModes - operator: exists - - name: contactModes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'contactModes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: contactModes + operator: exists + - name: contactModes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'contactModes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000856' Status: Published Version: '1' -Description: "An encounter's contact modes must be specified according to the - extensible Mode of Subject Contact (C171445) SDTM codelist (e.g. an entry with - a code or decode used from the codelist should be consistent with the full - entry in the codelist)." +Description: "An encounter's contact modes must be specified according to the extensible Mode of Subject + Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C171445 - parent_rel.Code: 'contactModes' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C171445 + parent_rel.Code: 'contactModes' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s contact mode is not specified according to the - extensible Mode of Subject Contact (C171445) SDTM codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The encounter''s contact mode is not specified according to the extensible Mode of Subject + Contact (C171445) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000857/rule.yml b/Published/CORE-000857/rule.yml index 46991f33b..7e81856fe 100644 --- a/Published/CORE-000857/rule.yml +++ b/Published/CORE-000857/rule.yml @@ -1,173 +1,168 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must be specified using the Sex of Participants - (C66732) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00141' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must be specified using the Sex of Participants - (C66732) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00141' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00141' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00141' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: plannedSex - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'plannedSex' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: plannedSex + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'plannedSex' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000857' Status: Published Version: '1' -Description: 'A planned sex must be specified using the Sex of Participants - (C66732) SDTM codelist.' +Description: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C66732 - parent_rel.Code: 'plannedSex' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C66732 + parent_rel.Code: 'plannedSex' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The planned sex is not specified using the Sex of Participants - (C66732) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The planned sex is not specified using the Sex of Participants (C66732) SDTM codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code + or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither + code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' - - 'StudyCohort' + - 'StudyDesignPopulation' + - 'StudyCohort' Sensitivity: Record diff --git a/Published/CORE-000858/rule.yml b/Published/CORE-000858/rule.yml index a20c45af9..079915503 100644 --- a/Published/CORE-000858/rule.yml +++ b/Published/CORE-000858/rule.yml @@ -1,166 +1,161 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's environmental settings must be specified - according to the extensible Environmental Setting (C127262) - SDTM codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00157' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter's environmental settings must be specified according to the extensible + Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00157' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: environmentalSettings - operator: exists - - name: environmentalSettings - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'environmentalSettings' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: environmentalSettings + operator: exists + - name: environmentalSettings + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'environmentalSettings' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000858' Status: Published Version: '1' -Description: "An encounter's environmental settings must be specified according - to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the - full entry in the codelist)." +Description: "An encounter's environmental settings must be specified according to the extensible Environmental + Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C127262 - parent_rel.Code: 'environmentalSettings' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C127262 + parent_rel.Code: 'environmentalSettings' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s environmental setting is not specified according to - the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The encounter''s environmental setting is not specified according to the extensible Environmental + Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000859/rule.yml b/Published/CORE-000859/rule.yml index c2438b434..86d7709cb 100644 --- a/Published/CORE-000859/rule.yml +++ b/Published/CORE-000859/rule.yml @@ -1,152 +1,148 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administration's frequency must be specified according to - the extensible Frequency (C71113) SDTM codelist (e.g. an entry - with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00175' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An administration's frequency must be specified according to the extensible Frequency + (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00175' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: frequency.standardCode - operator: exists - - name: frequency.standardCode - operator: equal_to - value: true - - not: - all: - - name: frequency.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: frequency.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: frequency.standardCode + operator: exists + - name: frequency.standardCode + operator: equal_to + value: true + - not: + all: + - name: frequency.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: frequency.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: frequency.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: frequency.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: frequency.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: frequency.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000859' Status: Published Version: '1' -Description: "An administration's frequency must be specified according to the - extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or - decode used from the codelist should be consistent with the full entry in the - codelist)." +Description: "An administration's frequency must be specified according to the extensible Frequency (C71113) + SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with + the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C71113 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C71113 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion Outcome: - Message: 'The administration''s frequency is not specified according to the - extensible Frequency (C71113) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode is found in the codelist (case insensitive) - but the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The administration''s frequency is not specified according to the extensible Frequency (C71113) + SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding + decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - frequency.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - frequency.standardCode.codeSystem - - frequency.standardCode.codeSystemVersion - - frequency.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - frequency.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - frequency.standardCode.codeSystem + - frequency.standardCode.codeSystemVersion + - frequency.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000860/rule.yml b/Published/CORE-000860/rule.yml index bfd87b9d5..8a2913d40 100644 --- a/Published/CORE-000860/rule.yml +++ b/Published/CORE-000860/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administration's route must be specified according to the - extensible Route of Administration Response (C66729) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00176' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An administration's route must be specified according to the extensible Route + of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00176' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: route.standardCode - operator: exists - - name: route.standardCode - operator: equal_to - value: true - - not: - all: - - name: route.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: route.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: route.standardCode + operator: exists + - name: route.standardCode + operator: equal_to + value: true + - not: + all: + - name: route.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: route.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: route.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: route.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: route.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: route.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000860' Status: Published Version: '1' -Description: "An administration's route must be specified according to the - extensible Route of Administration Response (C66729) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "An administration's route must be specified according to the extensible Route of Administration + Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66729 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: route.standardCode.decode - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: route.standardCode.decode - version: route.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66729 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: route.standardCode.decode + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: route.standardCode.decode + version: route.standardCode.codeSystemVersion Outcome: - Message: 'The administration''s route is not specified according to the - extensible Route of Administration Response (C66729) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The administration''s route is not specified according to the extensible Route of Administration + Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - route.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - route.standardCode.codeSystem - - route.standardCode.codeSystemVersion - - route.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - route.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - route.standardCode.codeSystem + - route.standardCode.codeSystemVersion + - route.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000861/rule.yml b/Published/CORE-000861/rule.yml index 663fbabeb..4c08f10ac 100644 --- a/Published/CORE-000861/rule.yml +++ b/Published/CORE-000861/rule.yml @@ -1,154 +1,150 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable dose form must be specified according to the - extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00179' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An administrable dose form must be specified according to the extensible Pharmaceutical + Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00179' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: administrableDoseForm.standardCode - operator: exists - - name: administrableDoseForm.standardCode - operator: equal_to - value: true - - not: - all: - - name: administrableDoseForm.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: administrableDoseForm.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: administrableDoseForm.standardCode + operator: exists + - name: administrableDoseForm.standardCode + operator: equal_to + value: true + - not: + all: + - name: administrableDoseForm.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: administrableDoseForm.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: administrableDoseForm.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: administrableDoseForm.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: administrableDoseForm.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: administrableDoseForm.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: administrableDoseForm.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: administrableDoseForm.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: administrableDoseForm.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: administrableDoseForm.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000861' Status: Published Version: '1' -Description: "An administrable dose form must be specified according to the - extensible Pharmaceutical Dosage Form (C66726) SDTM codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the - full entry in the codelist)." +Description: "An administrable dose form must be specified according to the extensible Pharmaceutical + Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66726 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: administrableDoseForm.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: administrableDoseForm.standardCode.code - version: administrableDoseForm.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: administrableDoseForm.standardCode.code - version: administrableDoseForm.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: administrableDoseForm.standardCode.decode - version: administrableDoseForm.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: administrableDoseForm.standardCode.decode - version: administrableDoseForm.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66726 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: administrableDoseForm.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: administrableDoseForm.standardCode.code + version: administrableDoseForm.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: administrableDoseForm.standardCode.code + version: administrableDoseForm.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: administrableDoseForm.standardCode.decode + version: administrableDoseForm.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: administrableDoseForm.standardCode.decode + version: administrableDoseForm.standardCode.codeSystemVersion Outcome: - Message: 'The administrable dose form is not specified according to the - extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The administrable dose form is not specified according to the extensible Pharmaceutical Dosage + Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a + valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - administrableDoseForm.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - administrableDoseForm.standardCode.codeSystem - - administrableDoseForm.standardCode.codeSystemVersion - - administrableDoseForm.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - administrableDoseForm.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - administrableDoseForm.standardCode.codeSystem + - administrableDoseForm.standardCode.codeSystemVersion + - administrableDoseForm.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - 'AdministrableProduct' Sensitivity: Record diff --git a/Published/CORE-000862/rule.yml b/Published/CORE-000862/rule.yml index 9b0bf4211..d4a0920d8 100644 --- a/Published/CORE-000862/rule.yml +++ b/Published/CORE-000862/rule.yml @@ -1,173 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STDY - operator: exists - - name: --STDTC - operator: not_exists + - name: --STDY + operator: exists + - name: --STDTC + operator: not_exists Core: Id: CORE-000862 Status: Published Version: '1' -Description: When Study Day of Start of Observation (--STDY) is present in the - dataset, then the Start Date/Time of Observation (--STDTC) is also present in - the dataset. +Description: When Study Day of Start of Observation (--STDY) is present in the dataset, then the + Start Date/Time of Observation (--STDTC) is also present in the dataset. Executability: Fully Executable Outcome: - Message: Start Date/Time of Observation (--STDTC) variable is missing when Study - Day of Start of Observation (--STDY) is present. + Message: Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of + Observation (--STDY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000863/rule.yml b/Published/CORE-000863/rule.yml index c93178476..bcf106784 100644 --- a/Published/CORE-000863/rule.yml +++ b/Published/CORE-000863/rule.yml @@ -1,145 +1,135 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated - whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' + Document: 'FDA' + Section: 'FDAB031' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3101' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STRESC - operator: non_empty - - name: --STRESC - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --STRESN - operator: empty + - name: --STRESC + operator: non_empty + - name: --STRESC + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --STRESN + operator: empty Core: Id: CORE-000863 Status: Published @@ -149,14 +139,14 @@ Executability: Fully Executable Outcome: Message: --STRESC is populated with a numeric value, but --STRESN is not populated. Output Variables: - - --STRESC - - --STRESN + - --STRESC + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000864/rule.yml b/Published/CORE-000864/rule.yml index 9458f858d..b1824bbaf 100644 --- a/Published/CORE-000864/rule.yml +++ b/Published/CORE-000864/rule.yml @@ -1,173 +1,162 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --ENDY - operator: exists - - name: --ENDTC - operator: not_exists + - name: --ENDY + operator: exists + - name: --ENDTC + operator: not_exists Core: Id: CORE-000864 Status: Published Version: '1' -Description: When Study Day of End of Observation (--ENDY) is present in the - dataset, then the End Date/Time of Observation (--ENDTC) is also present in - the dataset +Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End + Date/Time of Observation (--ENDTC) is also present in the dataset Executability: Fully Executable Outcome: - Message: End Date/Time of Observation (--ENDTC) variable is missing when Study - Day of End of Observation (--ENDY) is present. + Message: End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of + Observation (--ENDY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000865/rule.yml b/Published/CORE-000865/rule.yml index 27a67e54a..a90580dc6 100644 --- a/Published/CORE-000865/rule.yml +++ b/Published/CORE-000865/rule.yml @@ -1,159 +1,159 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular - timepoint, the timepoint should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated.' + Document: 'FDA' + Section: 'FDAB044' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4405' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # REMARK: --TPTNUM and --ELTM both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--ELTM' - operator: exists + - name: '--TPTREF' + operator: exists + - name: '--ELTM' + operator: exists #- name: '--TPTREF' # operator: 'non_empty' #- name: '--ELTM' # operator: 'empty' # Correction 2025-09-05 - - name: '--ELTM' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: '--ELTM' + operator: 'non_empty' + - name: '--TPTREF' + operator: 'empty' Core: Id: CORE-000865 Status: Published Version: '1' -Description: 'When Planned Elapsed Time from Time Point Ref (--ELTM) is - populated, Time Point Reference (--TPTREF) should also be populated.' +Description: 'When Planned Elapsed Time from Time Point Ref (--ELTM) is populated, Time Point Reference + (--TPTREF) should also be populated.' Executability: Fully Executable Outcome: Message: --ELTM is populated, but --TPTREF is missing. @@ -161,10 +161,10 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - EVENTS - - INTERVENTIONS + - FINDINGS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000866/rule.yml b/Published/CORE-000866/rule.yml index 783743a43..a49c66cf8 100644 --- a/Published/CORE-000866/rule.yml +++ b/Published/CORE-000866/rule.yml @@ -2,189 +2,169 @@ # Condition: --DTC ^= Null and --ENDTC ^= Null # Rule: --DTC <= --ENDTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: - Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --DTC - operator: exists - - name: --ENDTC - operator: exists - - name: --DTC - operator: non_empty - - name: --ENDTC - operator: non_empty - - name: --DTC - operator: date_greater_than_or_equal_to - value: --ENDTC + - name: --DTC + operator: exists + - name: --ENDTC + operator: exists + - name: --DTC + operator: non_empty + - name: --ENDTC + operator: non_empty + - name: --DTC + operator: date_greater_than_or_equal_to + value: --ENDTC Core: Id: CORE-000866 Status: Published Version: '1' -Description: Date/Time of Collection (--DTC) should be prior or equal to the End - Date/Time of Observation (--ENDTC) +Description: Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of + Observation (--ENDTC) Executability: Fully Executable Outcome: Message: --DTC falls after --ENDTC. Output Variables: - - --DTC - - --ENDTC + - --DTC + - --ENDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000867/rule.yml b/Published/CORE-000867/rule.yml index 9b9b69cff..c00b58435 100644 --- a/Published/CORE-000867/rule.yml +++ b/Published/CORE-000867/rule.yml @@ -1,144 +1,134 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1501' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: matches_regex - value: ^\s # leading spaces + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: matches_regex + value: ^\s # leading spaces Core: Id: CORE-000867 Status: Published @@ -148,14 +138,14 @@ Executability: Fully Executable Outcome: Message: Text variable contains leading spaces. Output Variables: - - variable_value - - variable_name + - variable_value + - variable_name Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000868/rule.yml b/Published/CORE-000868/rule.yml index ed27dfc55..f26910e4f 100644 --- a/Published/CORE-000868/rule.yml +++ b/Published/CORE-000868/rule.yml @@ -1,92 +1,89 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed - time) - i.e., at least one scheduled activity instance that is - referenced by a Fixed Reference timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00009' - Version: '1' - Version: '1.0' - Version: '3.0' - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed - time) - i.e., at least one scheduled activity instance that is - referenced by a Fixed Reference timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00009' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., + at least one scheduled activity instance that is referenced by a Fixed Reference timing.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00009' + Version: '1' + Version: '1.0' + Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., + at least one scheduled activity instance that is referenced by a Fixed Reference timing.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00009' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $fixed_ref_sched_ins - operator: empty - - name: $instances - operator: empty - - name: $fixed_ref_sched_ins - operator: shares_no_elements_with - value: $instances + - name: instanceType + operator: equal_to + value: 'ScheduleTimeline' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: $fixed_ref_sched_ins + operator: empty + - name: $instances + operator: empty + - name: $fixed_ref_sched_ins + operator: shares_no_elements_with + value: $instances Core: Id: 'CORE-000868' Status: Published Version: '1' -Description: 'Each schedule timeline must contain at least one anchor (fixed - time) - i.e., at least one scheduled activity instance that is referenced by a - Fixed Reference timing.' +Description: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., at least one + scheduled activity instance that is referenced by a Fixed Reference timing.' Executability: Fully Executable Operations: - - domain: Timing - filter: - rel_type: 'definition' - type.code: 'C201358' - group: - - parent_id - group_aliases: - - id - id: $fixed_ref_sched_ins - name: relativeFromScheduledInstanceId - operator: distinct - - domain: ScheduledActivityInstance - filter: - rel_type: 'definition' - group: - - parent_id - group_aliases: - - id - id: $instances - name: id - operator: distinct +- domain: Timing + filter: + rel_type: 'definition' + type.code: 'C201358' + group: + - parent_id + group_aliases: + - id + id: $fixed_ref_sched_ins + name: relativeFromScheduledInstanceId + operator: distinct +- domain: ScheduledActivityInstance + filter: + rel_type: 'definition' + group: + - parent_id + group_aliases: + - id + id: $instances + name: id + operator: distinct Outcome: - Message: 'The schedule timeline does not contain an anchor (i.e., a scheduled - activity instance that is referenced by a Fixed Reference timing).' + Message: 'The schedule timeline does not contain an anchor (i.e., a scheduled activity instance that + is referenced by a Fixed Reference timing).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - 'ScheduleTimeline' + - 'ScheduleTimeline' Sensitivity: Record diff --git a/Published/CORE-000869/rule.yml b/Published/CORE-000869/rule.yml index 237a44a4a..a4fe8e5d6 100644 --- a/Published/CORE-000869/rule.yml +++ b/Published/CORE-000869/rule.yml @@ -1,63 +1,62 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then - a reason (attribute reasonDurationWillVary) must be given and - vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00034' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute + reasonDurationWillVary) must be given and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00034' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Duration' - - any: - - name: durationWillVary - operator: not_equal_to - value: false - - all: - - name: reasonDurationWillVary - operator: exists - - name: reasonDurationWillVary - operator: non_empty - - any: - - name: durationWillVary - operator: not_equal_to - value: true - - name: reasonDurationWillVary - operator: not_exists - - name: reasonDurationWillVary - operator: empty + - name: instanceType + operator: equal_to + value: 'Duration' + - any: + - name: durationWillVary + operator: not_equal_to + value: false + - all: + - name: reasonDurationWillVary + operator: exists + - name: reasonDurationWillVary + operator: non_empty + - any: + - name: durationWillVary + operator: not_equal_to + value: true + - name: reasonDurationWillVary + operator: not_exists + - name: reasonDurationWillVary + operator: empty Core: Id: 'CORE-000869' Status: Published Version: '1' -Description: 'If duration will vary (attribute durationWillVary is True) then a - reason (attribute reasonDurationWillVary) must be given and vice versa.' +Description: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) + must be given and vice versa.' Executability: Fully Executable Outcome: - Message: The duration will vary (durationWillVary is not 'false' or - reasonDurationWillVary is populated), but it is not fully defined - (durationWillVary is not 'true' or reasonDurationWillVary is missing). + Message: The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is + populated), but it is not fully defined (durationWillVary is not 'true' or + reasonDurationWillVary is missing). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - durationWillVary - - reasonDurationWillVary + - parent_entity + - parent_id + - parent_rel + - id + - text + - durationWillVary + - reasonDurationWillVary Rule Type: Record Data Scope: Entities: Include: - - Duration + - Duration Sensitivity: Record diff --git a/Published/CORE-000870/rule.yml b/Published/CORE-000870/rule.yml index 14712162d..4c748568b 100644 --- a/Published/CORE-000870/rule.yml +++ b/Published/CORE-000870/rule.yml @@ -1,72 +1,70 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All scheduled activity instances in the main timeline are - expected to refer to an epoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00080' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All scheduled activity instances in the main timeline are - expected to refer to an epoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00080' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All scheduled activity instances in the main timeline are expected to refer to + an epoch.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00080' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All scheduled activity instances in the main timeline are expected to refer to + an epoch.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00080' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: mainTimeline - operator: equal_to - value: true - - any: - - name: epochId - operator: not_exists - - name: epochId - operator: empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: mainTimeline + operator: equal_to + value: true + - any: + - name: epochId + operator: not_exists + - name: epochId + operator: empty Core: Id: 'CORE-000870' Status: Published Version: '1' -Description: 'All scheduled activity instances in the main timeline are expected - to refer to an epoch.' +Description: 'All scheduled activity instances in the main timeline are expected to refer to an epoch.' Executability: Partially Executable - Possible Overreporting Match Datasets: - - Keys: - - Left: parent_entity - Right: instanceType - - Left: parent_id - Right: id - - rel_type - Name: ScheduleTimeline +- Keys: + - Left: parent_entity + Right: instanceType + - Left: parent_id + Right: id + - rel_type + Name: ScheduleTimeline Outcome: - Message: 'The scheduled activity instance is in the main timeline but does not - refer to an epoch.' + Message: 'The scheduled activity instance is in the main timeline but does not refer to an epoch.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - mainTimeline - - id - - name - - epochId + - parent_entity + - parent_id + - parent_rel + - mainTimeline + - id + - name + - epochId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - 'ScheduledActivityInstance' Sensitivity: Record diff --git a/Published/CORE-000871/rule.yml b/Published/CORE-000871/rule.yml index 18c778d5b..340f98a6b 100644 --- a/Published/CORE-000871/rule.yml +++ b/Published/CORE-000871/rule.yml @@ -1,89 +1,88 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design there is expected to be exactly one - objective with level 'Primary Objective'." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00084' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design there is expected to be exactly one - objective with level 'Primary Objective'." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00084' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design there is expected to be exactly one objective with level + 'Primary Objective'." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00084' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design there is expected to be exactly one objective with level + 'Primary Objective'." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00084' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - not: - all: - - name: $num_primary_obj - operator: non_empty - - name: $num_primary_obj - operator: equal_to - value: 1 + - name: rel_type + operator: equal_to + value: 'definition' + - not: + all: + - name: $num_primary_obj + operator: non_empty + - name: $num_primary_obj + operator: equal_to + value: 1 Core: Id: 'CORE-000871' Status: Published Version: '1' -Description: "Within a study design there is expected to be exactly one - objective with level 'Primary Objective'." +Description: "Within a study design there is expected to be exactly one objective with level 'Primary + Objective'." Executability: Partially Executable - Possible Overreporting Operations: - - domain: Objective - filter: - level.code: 'C85826' - rel_type: 'definition' - group: - - parent_id - - rel_type - group_aliases: - - id - id: $num_primary_obj - operator: record_count - - domain: Objective - filter: - level.code: 'C85826' - rel_type: 'definition' - group: - - parent_id - - rel_type - group_aliases: - - id - id: $primary_objectives - name: text - operator: distinct +- domain: Objective + filter: + level.code: 'C85826' + rel_type: 'definition' + group: + - parent_id + - rel_type + group_aliases: + - id + id: $num_primary_obj + operator: record_count +- domain: Objective + filter: + level.code: 'C85826' + rel_type: 'definition' + group: + - parent_id + - rel_type + group_aliases: + - id + id: $primary_objectives + name: text + operator: distinct Outcome: - Message: "There is not exactly one objective with a level of 'Primary Objective' - within the study design." + Message: "There is not exactly one objective with a level of 'Primary Objective' within the study design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $num_primary_obj - - $primary_objectives + - parent_entity + - parent_id + - parent_rel + - id + - name + - $num_primary_obj + - $primary_objectives Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000872/rule.yml b/Published/CORE-000872/rule.yml index 21b8fffde..fdf0c2db1 100644 --- a/Published/CORE-000872/rule.yml +++ b/Published/CORE-000872/rule.yml @@ -1,85 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study protocol document version - must be unique regarding the combination of type and - geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00092' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Date values associated to a study protocol document version must be unique regarding + the combination of type and geographic scopes of the date.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00092' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyProtocolDocumentVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: 'StudyProtocolDocumentVersion' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: Id: 'CORE-000872' Status: Published Version: '1' -Description: 'Date values associated to a study protocol document version must - be unique regarding the combination of type and geographic scopes of the - date.' +Description: 'Date values associated to a study protocol document version must be unique regarding the + combination of type and geographic scopes of the date.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate - - Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope +- Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate +- Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study protocol document version has more than one governance date - with the same type and geographic scope.' + Message: 'The study protocol document version has more than one governance date with the same type and + geographic scope.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - protocolVersion - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - protocolVersion + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyProtocolDocumentVersion' + - 'StudyProtocolDocumentVersion' Sensitivity: Record diff --git a/Published/CORE-000873/rule.yml b/Published/CORE-000873/rule.yml index be4b9afe4..886f9d24b 100644 --- a/Published/CORE-000873/rule.yml +++ b/Published/CORE-000873/rule.yml @@ -1,97 +1,94 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study version must be unique - regarding the combination of type and geographic scopes of the - date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00093' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study version must be unique - regarding the combination of type and geographic scopes of the - date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00093' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Date values associated to a study version must be unique regarding the combination + of type and geographic scopes of the date.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00093' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Date values associated to a study version must be unique regarding the combination + of type and geographic scopes of the date.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00093' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: 'StudyVersion' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: Id: 'CORE-000873' Status: Published Version: '1' -Description: 'Date values associated to a study version must be unique regarding - the combination of type and geographic scopes of the date.' +Description: 'Date values associated to a study version must be unique regarding the combination of type + and geographic scopes of the date.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate - - Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope +- Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate +- Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study version has more than one governance date with the same type - and geographic scope.' + Message: 'The study version has more than one governance date with the same type and geographic scope.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-000874/rule.yml b/Published/CORE-000874/rule.yml index 07a18aecc..cdcecf94c 100644 --- a/Published/CORE-000874/rule.yml +++ b/Published/CORE-000874/rule.yml @@ -1,41 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All primary endpoints must be referenced by a primary - objective.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00096' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All primary endpoints must be referenced by a primary - objective.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00096' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All primary endpoints must be referenced by a primary objective.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00096' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All primary endpoints must be referenced by a primary objective.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00096' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level.code - operator: equal_to - value: 'C94496' - - name: level.code.Objective - operator: not_equal_to - value: 'C85826' + - name: rel_type + operator: equal_to + value: 'definition' + - name: level.code + operator: equal_to + value: 'C94496' + - name: level.code.Objective + operator: not_equal_to + value: 'C85826' Core: Id: 'CORE-000874' Status: Published @@ -43,29 +41,29 @@ Core: Description: 'All primary endpoints must be referenced by a primary objective.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Objective +- Join Type: left + Keys: + - Left: parent_id + Right: id + - rel_type + Name: Objective Outcome: - Message: 'The primary endpoint (level.code = C94496) is not referenced by a - primary objective (level.code.Objective = C85826).' + Message: 'The primary endpoint (level.code = C94496) is not referenced by a primary objective (level.code.Objective + = C85826).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - level.code - - level.decode - - name.Objective - - level.code.Objective - - level.decode.Objective + - parent_entity + - parent_id + - parent_rel + - id + - name + - level.code + - level.decode + - name.Objective + - level.code.Objective + - level.decode.Objective Rule Type: Record Data Scope: Entities: Include: - - 'Endpoint' + - 'Endpoint' Sensitivity: Record diff --git a/Published/CORE-000875/rule.yml b/Published/CORE-000875/rule.yml index 4b6519c80..99fc8be24 100644 --- a/Published/CORE-000875/rule.yml +++ b/Published/CORE-000875/rule.yml @@ -1,97 +1,97 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned sex must be specified either - in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00098' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned sex must be specified either - in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00098' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, the planned sex must be specified either in the study + population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00098' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, the planned sex must be specified either in the study + population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00098' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - any: - - name: plannedSex - operator: not_exists - - name: plannedSex - operator: empty - - name: plannedSex - operator: equal_to - value: false - - any: - - name: plannedSex.StudyCohort - operator: not_exists - - name: plannedSex.StudyCohort - operator: empty - - name: plannedSex.StudyCohort - operator: equal_to - value: false - - all: - - name: plannedSex - operator: equal_to - value: true - - name: plannedSex.StudyCohort - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: 'StudyDesignPopulation' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - any: + - name: plannedSex + operator: not_exists + - name: plannedSex + operator: empty + - name: plannedSex + operator: equal_to + value: false + - any: + - name: plannedSex.StudyCohort + operator: not_exists + - name: plannedSex.StudyCohort + operator: empty + - name: plannedSex.StudyCohort + operator: equal_to + value: false + - all: + - name: plannedSex + operator: equal_to + value: true + - name: plannedSex.StudyCohort + operator: equal_to + value: true Core: Id: 'CORE-000875' Status: Published Version: '1' -Description: 'Within a study design, the planned sex must be specified either in - the study population or in all cohorts.' +Description: 'Within a study design, the planned sex must be specified either in the study population + or in all cohorts.' Executability: Fully Executable Match Datasets: - - Join Type: left - Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - - rel_type - Name: StudyCohort +- Join Type: left + Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + - rel_type + Name: StudyCohort Outcome: - Message: 'Planned sex has not been specified for either the study population or - the cohort, or it has been specified for both.' + Message: 'Planned sex has not been specified for either the study population or the cohort, or it has + been specified for both.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - plannedSex - - plannedSex.decode - - id.StudyCohort - - name.StudyCohort - - plannedSex.StudyCohort - - plannedSex.decode.StudyCohort + - parent_entity + - parent_id + - parent_rel + - id + - name + - plannedSex + - plannedSex.decode + - id.StudyCohort + - name.StudyCohort + - plannedSex.StudyCohort + - plannedSex.decode.StudyCohort Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000876/rule.yml b/Published/CORE-000876/rule.yml index 47343c21a..ad9e77efc 100644 --- a/Published/CORE-000876/rule.yml +++ b/Published/CORE-000876/rule.yml @@ -1,65 +1,64 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a document version, the specified section numbers for - narrative content must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00103' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a document version, the specified section numbers for narrative content + must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00103' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: instanceType - operator: equal_to - value: 'NarrativeContent' - - name: rel_type - operator: equal_to - value: 'definition' - - name: sectionNumber - operator: non_empty - - name: sectionNumber - operator: is_not_unique_set - value: - - parent_entity - - parent_id + - name: instanceType + operator: equal_to + value: 'NarrativeContent' + - name: rel_type + operator: equal_to + value: 'definition' + - name: sectionNumber + operator: non_empty + - name: sectionNumber + operator: is_not_unique_set + value: + - parent_entity + - parent_id Core: Id: 'CORE-000876' Status: Published Version: '1' -Description: 'Within a document version, the specified section numbers for - narrative content must be unique.' +Description: 'Within a document version, the specified section numbers for narrative content must be unique.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyProtocolDocumentVersion - - Keys: - - Left: parent_id.StudyProtocolDocumentVersion - Right: id - - rel_type - Name: StudyProtocolDocument +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyProtocolDocumentVersion +- Keys: + - Left: parent_id.StudyProtocolDocumentVersion + Right: id + - rel_type + Name: StudyProtocolDocument Outcome: Message: 'The section number is not unique within the document version.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - sectionNumber - - name.StudyProtocolDocument - - protocolVersion + - parent_entity + - parent_id + - parent_rel + - id + - name + - sectionNumber + - name.StudyProtocolDocument + - protocolVersion Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-000877/rule.yml b/Published/CORE-000877/rule.yml index bedbda514..006fe924f 100644 --- a/Published/CORE-000877/rule.yml +++ b/Published/CORE-000877/rule.yml @@ -1,86 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline - that is defined within the same study design as the scheduled - activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00107' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline - that is defined within the same study design as the scheduled - activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00107' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline that is defined within + the same study design as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00107' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline that is defined within + the same study design as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00107' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineId - operator: non_empty - - name: $study_design_id_for_subtimeline - operator: not_equal_to - value: $study_design_id_for_scheduled_instance + - name: instanceType + operator: equal_to + value: 'ScheduledActivityInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - name: timelineId + operator: non_empty + - name: $study_design_id_for_subtimeline + operator: not_equal_to + value: $study_design_id_for_scheduled_instance Core: Id: 'CORE-000877' Status: Published Version: '1' -Description: 'A scheduled activity instance must only have a sub-timeline that - is defined within the same study design as the scheduled activity instance.' +Description: 'A scheduled activity instance must only have a sub-timeline that is defined within the same + study design as the scheduled activity instance.' Executability: Fully Executable Operations: - - domain: ScheduleTimeline - group: - - id - - rel_type - group_aliases: - - parent_id - id: $study_design_id_for_scheduled_instance - name: parent_id - operator: distinct - - domain: ScheduleTimeline - group: - - id - - rel_type - group_aliases: - - timelineId - id: $study_design_id_for_subtimeline - name: parent_id - operator: distinct +- domain: ScheduleTimeline + group: + - id + - rel_type + group_aliases: + - parent_id + id: $study_design_id_for_scheduled_instance + name: parent_id + operator: distinct +- domain: ScheduleTimeline + group: + - id + - rel_type + group_aliases: + - timelineId + id: $study_design_id_for_subtimeline + name: parent_id + operator: distinct Outcome: - Message: 'The scheduled activity instance has a sub-timeline that is not defined - within the same study design.' + Message: 'The scheduled activity instance has a sub-timeline that is not defined within the same study + design.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId - - $study_design_id_for_scheduled_instance - - $study_design_id_for_subtimeline + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId + - $study_design_id_for_scheduled_instance + - $study_design_id_for_subtimeline Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - 'ScheduledActivityInstance' Sensitivity: Record diff --git a/Published/CORE-000878/rule.yml b/Published/CORE-000878/rule.yml index 45b92428e..0e39ba907 100644 --- a/Published/CORE-000878/rule.yml +++ b/Published/CORE-000878/rule.yml @@ -1,154 +1,150 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If specified, the context of a condition must point to a valid - instance in the activity or scheduled activity instance - class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00114' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If specified, the context of a condition must point to a valid - instance in the activity or scheduled activity instance - class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00114' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If specified, the context of a condition must point to a valid instance in the + activity or scheduled activity instance class.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00114' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If specified, the context of a condition must point to a valid instance in the + activity or scheduled activity instance class.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00114' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: parent_rel - operator: equal_to - value: 'contextIds' - value_is_literal: true - - name: $condition_count - operator: non_empty + - name: parent_rel + operator: equal_to + value: 'contextIds' + value_is_literal: true + - name: $condition_count + operator: non_empty Core: Id: 'CORE-000878' Status: Published Version: '1' -Description: 'If specified, the context of a condition must point to a valid - instance in the activity or scheduled activity instance class.' +Description: 'If specified, the context of a condition must point to a valid instance in the activity + or scheduled activity instance class.' Executability: Fully Executable Operations: - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_count - operator: record_count - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_entity - name: parent_entity - operator: distinct - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_id - name: parent_id - operator: distinct - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_rel - name: parent_rel - operator: distinct - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_rel_type - name: rel_type - operator: distinct - - domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_name - name: name - operator: distinct - - id: $error_type - map: - - output: The id value references an invalid instance type. - parent_entity: Condition - rel_type: reference - - output: The referenced id value is not valid. - parent_entity: Condition - rel_type: definition - operator: map +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_count + operator: record_count +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_entity + name: parent_entity + operator: distinct +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_id + name: parent_id + operator: distinct +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_rel + name: parent_rel + operator: distinct +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_rel_type + name: rel_type + operator: distinct +- domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_name + name: name + operator: distinct +- id: $error_type + map: + - output: The id value references an invalid instance type. + parent_entity: Condition + rel_type: reference + - output: The referenced id value is not valid. + parent_entity: Condition + rel_type: definition + operator: map Outcome: - Message: 'The specified context of the condition is not a valid instance of - either the Activity or ScheduledActivityInstance class (the value of the - condition''s contextIds attribute either matches the id of an instance that - is not an Activity or ScheduledActivityInstance, or it does not match the id - of any class instance).' + Message: 'The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance + class (the value of the condition''s contextIds attribute either matches the id of an instance that + is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance).' Output Variables: - - $condition_parent_entity - - $condition_parent_id - - $condition_parent_rel - - $condition_rel_type - - $condition_name - - id - - name - - parent_id - - parent_rel - - rel_type - - instanceType - - value - - $error_type + - $condition_parent_entity + - $condition_parent_id + - $condition_parent_rel + - $condition_rel_type + - $condition_name + - id + - name + - parent_id + - parent_rel + - rel_type + - instanceType + - value + - $error_type Rule Type: Record Data Scope: Entities: Exclude: - - 'Activity' - - 'ScheduledActivityInstance' + - 'Activity' + - 'ScheduledActivityInstance' Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000879/rule.yml b/Published/CORE-000879/rule.yml index 72f26c1f2..6de746ff2 100644 --- a/Published/CORE-000879/rule.yml +++ b/Published/CORE-000879/rule.yml @@ -1,70 +1,67 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "For CDISC codelist references (where the code system is - 'http://www.cdisc.org'), the code system version must be a - valid CDISC terminology release date in ISO 8601 date format." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00155' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "For CDISC codelist references (where the code system is - 'http://www.cdisc.org'), the code system version must be a - valid CDISC terminology release date in ISO 8601 date format." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00155' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), + the code system version must be a valid CDISC terminology release date in ISO 8601 date format." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00155' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), + the code system version must be a valid CDISC terminology release date in ISO 8601 date format." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00155' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_not_contained_by - value: $valid_versions + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_not_contained_by + value: $valid_versions Core: Id: 'CORE-000879' Status: Published Version: '1' -Description: "For CDISC codelist references (where the code system is - 'http://www.cdisc.org'), the code system version must be a valid CDISC - terminology release date in ISO 8601 date format." +Description: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), the code + system version must be a valid CDISC terminology release date in ISO 8601 date format." Executability: Fully Executable Operations: - - ct_package_types: - - DDF - - SDTM - - PROTOCOL - id: $valid_versions - operator: valid_codelist_dates +- ct_package_types: + - DDF + - SDTM + - PROTOCOL + id: $valid_versions + operator: valid_codelist_dates Outcome: - Message: 'The code system is "http://www.cdisc.org" but the code system version - is not a valid CDISC terminology release date in ISO 8601 date format.' + Message: 'The code system is "http://www.cdisc.org" but the code system version is not a valid CDISC + terminology release date in ISO 8601 date format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - 'Code' + - 'Code' Sensitivity: Record diff --git a/Published/CORE-000881/rule.yml b/Published/CORE-000881/rule.yml index 11d2fd5a8..f14cad614 100644 --- a/Published/CORE-000881/rule.yml +++ b/Published/CORE-000881/rule.yml @@ -1,57 +1,54 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable to SENDIG version 3.1 and 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on - which group summaries (group means and incidences) are - calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on - which group summaries (group means and incidences) are - calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4701 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data.' + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4701 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data.' + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4701 + Version: '1' + Version: '1.5' + Version: '3.1.1' Check: all: # - name: DSTERM - - name: DSDECOD - operator: is_contained_by - value: - - "INTERIM SACRIFICE" - - "RECOVERY SACRIFICE" - - "REMOVED FROM STUDY ALIVE" - - "TERMINAL SACRIFICE" - - name: VISITDY - operator: 'empty' - - name: DSNOMDY - operator: 'empty' + - name: DSDECOD + operator: is_contained_by + value: + - "INTERIM SACRIFICE" + - "RECOVERY SACRIFICE" + - "REMOVED FROM STUDY ALIVE" + - "TERMINAL SACRIFICE" + - name: VISITDY + operator: 'empty' + - name: DSNOMDY + operator: 'empty' Core: Id: CORE-000881 Status: Published Version: '1' -Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled - disposition records as these are required timing variables for identification - of the day on which group summaries (Group Means and Incidences) are - calculated for post mortem data. +Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as + these are required timing variables for identification of the day on which group summaries (Group + Means and Incidences) are calculated for post mortem data. Executability: Fully Executable Outcome: Message: Missing VISITDY or DSNOMDY values for scheduled disposition record. @@ -59,8 +56,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000882/rule.yml b/Published/CORE-000882/rule.yml index 3dddbce1a..3ea0c13e6 100644 --- a/Published/CORE-000882/rule.yml +++ b/Published/CORE-000882/rule.yml @@ -1,46 +1,44 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable to SENDIG version 3.0, not to SENDIG 3.1 and 3.1.1 # Very similar to FB4701, but without DSNOMDY, only with VISITDY - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on - which group summaries (group means and incidences) are - calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4703 - Version: '1' - Version: '1.5' - Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data.' + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4703 + Version: '1' + Version: '1.5' + Version: '3.0' Check: all: # - name: DSTERM # "DSTERM" changed in "DSDECOD" - see comment Keith Moseley # https://jira.cdisc.org/browse/CORERULES-9244 - - name: DSDECOD - operator: is_contained_by - value: - - "INTERIM SACRIFICE" - - "RECOVERY SACRIFICE" - - "REMOVED FROM STUDY ALIVE" - - "TERMINAL SACRIFICE" - - name: VISITDY - operator: 'empty' + - name: DSDECOD + operator: is_contained_by + value: + - "INTERIM SACRIFICE" + - "RECOVERY SACRIFICE" + - "REMOVED FROM STUDY ALIVE" + - "TERMINAL SACRIFICE" + - name: VISITDY + operator: 'empty' Core: Id: CORE-000882 Status: Published Version: '1' -Description: VISITDY should be populated in the DS dataset for disposition - records where DSTERM has been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY - SACRIFICE', 'REMOVED FROM STUDY ALIVE', or 'TERMINAL SACRIFICE', as these are - required timing variables for identification of the day on which group - summaries (Group Means and Incidences) are calculated for post mortem data. +Description: VISITDY should be populated in the DS dataset for disposition records where DSTERM has + been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY SACRIFICE', 'REMOVED FROM STUDY ALIVE', or + 'TERMINAL SACRIFICE', as these are required timing variables for identification of the day on + which group summaries (Group Means and Incidences) are calculated for post mortem data. Executability: Fully Executable Outcome: Message: Missing VISITDY value for scheduled disposition record. @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000883/rule.yml b/Published/CORE-000883/rule.yml index cb923a31c..23cd01601 100644 --- a/Published/CORE-000883/rule.yml +++ b/Published/CORE-000883/rule.yml @@ -1,117 +1,117 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # PART 1 for DM, as in TS, AGE, AGETXT and AGEU are parameters - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: # For DM: AGE, AGETXT and AGEU are variables - - all: + - all: #- name: DOMAIN # operator: equal_to # value: DM - - name: AGEU - operator: empty - - any: - - name: AGETXT - operator: non_empty - - name: AGE - operator: non_empty + - name: AGEU + operator: empty + - any: + - name: AGETXT + operator: non_empty + - name: AGE + operator: non_empty Core: Id: CORE-000883 Status: Published Version: '1' -Description: AGEU is the unit associated with AGE or AGETXT. If either of those - variables is populated, AGEU should be populated. This applies to both DM (as - variables) as to TS (as parameters) +Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is + populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as + parameters) Executability: Fully Executable Outcome: Message: AGE or AGETXT is populated, but AGEU is not populated Output Variables: - - USUBJID - - AGETXT - - AGE - - AGEU + - USUBJID + - AGETXT + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000884/rule.yml b/Published/CORE-000884/rule.yml index 33d3d8bc8..82471d9f6 100644 --- a/Published/CORE-000884/rule.yml +++ b/Published/CORE-000884/rule.yml @@ -1,129 +1,129 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: '1' + Version: '5.0' + Version: '1.0' Check: any: # For DM: AGE, AGETXT and AGEU are variables - - all: - - name: DOMAIN - operator: equal_to - value: DM - - name: AGEU - operator: empty - - any: - - name: AGETXT - operator: non_empty - - name: AGE - operator: non_empty + - all: + - name: DOMAIN + operator: equal_to + value: DM + - name: AGEU + operator: empty + - any: + - name: AGETXT + operator: non_empty + - name: AGE + operator: non_empty # for TS, they are parameters (values in TSPARMCD) - - all: - - name: DOMAIN - operator: equal_to - value: TS - - name: $ageu_count - operator: equal_to - value: 0 + - all: + - name: DOMAIN + operator: equal_to + value: TS + - name: $ageu_count + operator: equal_to + value: 0 Core: Id: CORE-000884 Status: Published Version: '1' -Description: AGEU is the unit associated with AGE or AGETXT. If either of those - variables is populated, AGEU should be populated. This applies to both DM (as - variables) as to TS (as parameters) +Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is + populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as + parameters) Executability: Fully Executable Operations: - - domain: TS +- domain: TS # only keep the records with TSPARMCD=AGEU - filter: - TSPARMCD: AGEU + filter: + TSPARMCD: AGEU # group the records by value of TXSETCD #group: # - SETCD # within the filtered and grouped records, count the number of TXVAL records - id: $ageu_count - name: TSVAL - operator: record_count + id: $ageu_count + name: TSVAL + operator: record_count Outcome: Message: AGE or AGETXT is populated, but AGEU is not populated Output Variables: - - DOMAIN - - $ageu_count + - DOMAIN + - $ageu_count #- USUBJID #- AGETXT #- AGE @@ -132,10 +132,10 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TS + - DM + - TS Sensitivity: Record diff --git a/Published/CORE-000888/rule.yml b/Published/CORE-000888/rule.yml index 14bc4df89..c108ba78b 100644 --- a/Published/CORE-000888/rule.yml +++ b/Published/CORE-000888/rule.yml @@ -1,132 +1,125 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4608' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'PLANFSUB' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'PLANFSUB' Core: Id: CORE-000888 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned - Number of Female Subjects (PLANFSUB) record should be included. +Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female + Subjects (PLANFSUB) record should be included. Executability: Fully Executable Grouping_Variables: - - SETCD +- SETCD # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'PLANFSUB' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule # Sensitivity: Record diff --git a/Published/CORE-000889/rule.yml b/Published/CORE-000889/rule.yml index fa161bd65..a07f82e6f 100644 --- a/Published/CORE-000889/rule.yml +++ b/Published/CORE-000889/rule.yml @@ -1,170 +1,170 @@ Authorities: - - Organization: FDA - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower - limit, whenever both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: 'FDA' + Section: 'FDAB039' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3902' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --ORNRLO - operator: non_empty - - name: --ORNRLO - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --ORNRHI - operator: non_empty - - name: --ORNRHI - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --ORNRHI - operator: less_than_or_equal_to - value: --ORNRLO + - name: --ORNRLO + operator: non_empty + - name: --ORNRLO + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --ORNRHI + operator: non_empty + - name: --ORNRHI + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --ORNRHI + operator: less_than_or_equal_to + value: --ORNRLO Core: Id: CORE-000889 Status: Published Version: '1' -Description: 'Normal Range Upper Limit-Original Units (--ORNRHI) is greater than - the Normal Range Lower Limit-Original Units (--ORNRLO).' +Description: 'Normal Range Upper Limit-Original Units (--ORNRHI) is greater than the Normal Range Lower + Limit-Original Units (--ORNRLO).' Executability: Partially Executable - Possible Underreporting Outcome: Message: --ORNRHI is less than or equal to --ORNRLO. Output Variables: - - --TESTCD - - --ORNRHI - - --ORNRLO + - --TESTCD + - --ORNRHI + - --ORNRLO Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000890/rule.yml b/Published/CORE-000890/rule.yml index bc7767cd3..991f17e27 100644 --- a/Published/CORE-000890/rule.yml +++ b/Published/CORE-000890/rule.yml @@ -1,147 +1,137 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a - period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' + Document: 'FDA' + Section: 'FDAB015' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB1502' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: non_empty - - name: variable_value - operator: equal_to - value: '.' - value_is_literal: true + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: non_empty + - name: variable_value + operator: equal_to + value: '.' + value_is_literal: true Core: Id: CORE-000890 Status: Published @@ -151,14 +141,14 @@ Executability: Fully Executable Outcome: Message: Text variable contains '.' as an entire value. Output Variables: - - variable_value - - variable_name + - variable_value + - variable_name Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000891/rule.yml b/Published/CORE-000891/rule.yml index 5dd15561a..2f1d545c1 100644 --- a/Published/CORE-000891/rule.yml +++ b/Published/CORE-000891/rule.yml @@ -1,129 +1,122 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4603' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'ARMCD' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'ARMCD' Core: Id: CORE-000891 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) - record should be included. +Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be + included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include a TXPARMCD = 'ARMCD' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000892/rule.yml b/Published/CORE-000892/rule.yml index 7ae0d8ace..33465df58 100644 --- a/Published/CORE-000892/rule.yml +++ b/Published/CORE-000892/rule.yml @@ -1,233 +1,233 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint - should also be provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be + provided.' + Document: 'FDA' + Section: 'FDAB041' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB4301' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # TODO: FAILS when e.g. --ENRF and --STDTC columns are absent all: - - any: + - any: # Case ENDTC populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENDTC - operator: non_empty + - all: + - name: --ENDTC + operator: non_empty # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: empty # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: empty # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENRF - operator: non_empty + - all: + - name: --ENRF + operator: non_empty # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: empty # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: empty # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENRTPT - operator: non_empty + - all: + - name: --ENRTPT + operator: non_empty # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: empty # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: empty # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty Core: Id: CORE-000892 Status: Published Version: '1' -Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, - related start timepoint (--STDTC, --STRF or --STRTPT should also be populated. +Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint + (--STDTC, --STRF or --STRTPT should also be populated. Executability: Fully Executable Outcome: Message: End timepoint is populated but start timepoint is missing. Output Variables: - - --STDTC - - --STRF - - --STRTPT - - --ENDTC - - --ENRF - - --ENRTPT + - --STDTC + - --STRF + - --STRTPT + - --ENDTC + - --ENRF + - --ENRTPT Rule Type: Record Data Scope: Classes: # Only applicable to EVENTS and INTERVENTIONS and Findings Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Exclude: - - NONE + - NONE Sensitivity: Record diff --git a/Published/CORE-000893/rule.yml b/Published/CORE-000893/rule.yml index 0e879ef10..f4da1f5c4 100644 --- a/Published/CORE-000893/rule.yml +++ b/Published/CORE-000893/rule.yml @@ -1,127 +1,120 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4604' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'GRPLBL' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'GRPLBL' Core: Id: CORE-000893 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Group - Label (GRPLBL) record should be included. +Description: For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record + should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = GRPLBL record per SETCD. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000894/rule.yml b/Published/CORE-000894/rule.yml index 915ebb4aa..4b2e75ae9 100644 --- a/Published/CORE-000894/rule.yml +++ b/Published/CORE-000894/rule.yml @@ -1,127 +1,120 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4605' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'TRTDOS' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'TRTDOS' Core: Id: CORE-000894 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) - record should be included. +Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be + included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: 'TX dataset should include a TXPARMCD = TRTDOS record per SETCD.' Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000895/rule.yml b/Published/CORE-000895/rule.yml index ccf5f90a8..ffe19e445 100644 --- a/Published/CORE-000895/rule.yml +++ b/Published/CORE-000895/rule.yml @@ -1,127 +1,120 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4606' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'TRTDOSU' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'TRTDOSU' Core: Id: CORE-000895 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) - record should be included. +Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be + included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include a TXPARMCD = TRTDOSU record per SETCD. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000896/rule.yml b/Published/CORE-000896/rule.yml index c611a2cf6..5e6aa282d 100644 --- a/Published/CORE-000896/rule.yml +++ b/Published/CORE-000896/rule.yml @@ -1,120 +1,119 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: POOLID - operator: non_empty - - name: POOLID - operator: is_not_contained_by - value: $pooldef_poolid + - name: POOLID + operator: non_empty + - name: POOLID + operator: is_not_contained_by + value: $pooldef_poolid Core: Id: CORE-000896 Status: Published Version: '1' -Description: 'POOLID value in the dataset should match one of the POOLID values - in the POOLDEF dataset' +Description: 'POOLID value in the dataset should match one of the POOLID values in the POOLDEF dataset' Executability: Fully Executable Operations: - - domain: POOLDEF - id: $pooldef_poolid - name: POOLID - operator: distinct +- domain: POOLDEF + id: $pooldef_poolid + name: POOLID + operator: distinct Outcome: Message: 'POOLID value does not match a POOLID value in the POOLDEF dataset.' Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - RELATIONSHIP + - INTERVENTIONS + - FINDINGS + - RELATIONSHIP Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000897/rule.yml b/Published/CORE-000897/rule.yml index ce6e1f2e7..e7a7554bd 100644 --- a/Published/CORE-000897/rule.yml +++ b/Published/CORE-000897/rule.yml @@ -1,152 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study version's study phase must be specified according to - the extensible Trial Phase Response (C66737) SDTM codelist - (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00015' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study version's study phase must be specified according to the extensible Trial + Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00015' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyPhase.standardCode - operator: exists - - name: studyPhase.standardCode - operator: equal_to - value: true - - not: - all: - - name: studyPhase.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyPhase.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyPhase.standardCode + operator: exists + - name: studyPhase.standardCode + operator: equal_to + value: true + - not: + all: + - name: studyPhase.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: studyPhase.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyPhase.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: studyPhase.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyPhase.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: studyPhase.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000897' Status: Published Version: '1' -Description: "A study version's study phase must be specified according to the - extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a - code or decode used from the codelist should be consistent with the full entry - in the codelist)." +Description: "A study version's study phase must be specified according to the extensible Trial Phase + Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66737 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66737 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion Outcome: - Message: 'The study version''s study phase is not specified according to the - extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The study version''s study phase is not specified according to the extensible Trial Phase + Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $codelist_code - - $codelist_extensible - - studyPhase.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyPhase.standardCode.codeSystem - - studyPhase.standardCode.codeSystemVersion - - studyPhase.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $codelist_code + - $codelist_extensible + - studyPhase.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyPhase.standardCode.codeSystem + - studyPhase.standardCode.codeSystemVersion + - studyPhase.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-000898/rule.yml b/Published/CORE-000898/rule.yml index 81b82251c..3e8bdc9fd 100644 --- a/Published/CORE-000898/rule.yml +++ b/Published/CORE-000898/rule.yml @@ -1,45 +1,44 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per implantation site per fetus per subject. - Document: IG-DART v1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND355 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per implantation site per fetus per subject. - Document: IG-DART v1.2 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND355 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per implantation site per fetus per subject. + Document: IG-DART v1.1 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND355 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per implantation site per fetus per subject. + Document: IG-DART v1.2 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND355 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: ICIMPLBL - operator: is_not_unique_set - value: - - FETUSID - - USUBJID + - name: ICIMPLBL + operator: is_not_unique_set + value: + - FETUSID + - USUBJID Core: Id: CORE-000898 Status: Published Version: '1' -Description: Raise an error when the combination of USUBJID, ICIMPLBL and - FETUSID in not unique +Description: Raise an error when the combination of USUBJID, ICIMPLBL and FETUSID in not unique Executability: Fully Executable Outcome: Message: The value of ICIMPLBL is not unique within FETUSID and USUBJID @@ -47,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - IC + - IC Sensitivity: Record diff --git a/Published/CORE-000899/rule.yml b/Published/CORE-000899/rule.yml index d366145d2..a440e66ed 100644 --- a/Published/CORE-000899/rule.yml +++ b/Published/CORE-000899/rule.yml @@ -1,79 +1,74 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each - implantation site. In the situation where the implantations - were not evaluated (ICSTAT = NOT DONE) per protocol, the - artificial label, ALL, is used to represent missing results - (see Example 5). - Document: DART-IG v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND363 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each - implantation site. In the situation where the implantations - were not evaluated (ICSTAT = NOT DONE) per protocol, the - artificial label, ALL, is used to represent missing results - (see Example 5). - Document: DART-IG v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND363 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each implantation + site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per + protocol, the artificial label, ALL, is used to represent missing results (see Example 5). + Document: DART-IG v1.1 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND363 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each implantation + site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per + protocol, the artificial label, ALL, is used to represent missing results (see Example 5). + Document: DART-IG v1.2 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND363 + Version: '1' + Version: '5.0' + Version: '1.2' Check: # Rule has 2 parts: # a) number of records for this subject = 1 # b) when ICSTAT='NOT DONE', ICIMPLBL = "ALL" all: - - name: $record_count_USUBJID - operator: equal_to - value: 1 - - name: ICSTAT - operator: equal_to - value: 'NOT DONE' + - name: $record_count_USUBJID + operator: equal_to + value: 1 + - name: ICSTAT + operator: equal_to + value: 'NOT DONE' # Raise issue when ICIMPLBL is not "ALL" - - name: ICIMPLBL - operator: not_equal_to - value: ALL + - name: ICIMPLBL + operator: not_equal_to + value: ALL Core: Id: CORE-000899 Status: Published Version: '1' -Description: "Raise an issue when there is only one record for this subject in - IC, LBSTAT='NOT DONE', and ICIMPLBL is not 'ALL'" +Description: "Raise an issue when there is only one record for this subject in IC, LBSTAT='NOT DONE', + and ICIMPLBL is not 'ALL'" Executability: Fully Executable Operations: # This counts the number of records for the current USUBJID - - group: - - USUBJID - id: $record_count_USUBJID - operator: record_count +- group: + - USUBJID + id: $record_count_USUBJID + operator: record_count Outcome: - Message: "ICIMPLBL must be 'ALL' when there is only one record for the subject - and ICSTAT is 'NOT DONE'" + Message: "ICIMPLBL must be 'ALL' when there is only one record for the subject and ICSTAT is 'NOT DONE'" Output Variables: - - $record_count_USUBJID - - ICSTAT - - ICIMPLBL + - $record_count_USUBJID + - ICSTAT + - ICIMPLBL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IC + - IC Sensitivity: Record diff --git a/Published/CORE-000900/rule.yml b/Published/CORE-000900/rule.yml index 33a71b799..d76318370 100644 --- a/Published/CORE-000900/rule.yml +++ b/Published/CORE-000900/rule.yml @@ -1,67 +1,66 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter, if more environmental settings are - defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00156' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within an encounter, if more environmental settings are defined, they must be + distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00156' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'environmentalSettings' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: 'Code' + - name: parent_entity + operator: equal_to + value: 'Encounter' + - name: parent_rel + operator: equal_to + value: 'environmentalSettings' + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: 'CORE-000900' Status: Published Version: '1' -Description: 'Within an encounter, if more environmental settings are defined, - they must be distinct.' +Description: 'Within an encounter, if more environmental settings are defined, they must be distinct.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter +- Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The environmental settings of the encounter are not unique - the same - code is used more than once with the same codeSystem and codeSystemVersion.' + Message: 'The environmental settings of the encounter are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion.' Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000901/rule.yml b/Published/CORE-000901/rule.yml index 60e2b6840..46a7f9013 100644 --- a/Published/CORE-000901/rule.yml +++ b/Published/CORE-000901/rule.yml @@ -1,171 +1,171 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be - consistent with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: PPCAT - operator: non_empty - - name: RELREC.PCRFTDTC - operator: non_empty - - name: PPRFTDTC - operator: equal_to - value: RELREC.PCRFTDTC - - name: PPCAT - operator: not_equal_to - value: RELREC.PCTEST + - name: PPCAT + operator: non_empty + - name: RELREC.PCRFTDTC + operator: non_empty + - name: PPRFTDTC + operator: equal_to + value: RELREC.PCRFTDTC + - name: PPCAT + operator: not_equal_to + value: RELREC.PCTEST Core: + Id: CORE-000901 Status: Published Version: '1' - Id: CORE-000901 Description: 'The values of PPCAT and PCTEST do not match at the same reference timepoint' Executability: Partially Executable Match Datasets: - - Name: RELREC - Wildcard: PC +- Name: RELREC + Wildcard: PC Outcome: Message: 'The values of PPCAT and PCTEST do not match at the same reference timepoint' Output Variables: - - PPCAT - - PPRFTDTC - - PPCAT - - RELREC.PCRFTDTC - - RELREC.PCTEST + - PPCAT + - PPRFTDTC + - PPCAT + - RELREC.PCRFTDTC + - RELREC.PCTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000902/rule.yml b/Published/CORE-000902/rule.yml index c7e8f6e15..fe30f56b8 100644 --- a/Published/CORE-000902/rule.yml +++ b/Published/CORE-000902/rule.yml @@ -1,253 +1,235 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # This rule is for SEND268/268.1 as well as for SEND269/269.1 # Part 1: SEND268/268.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.0 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table - 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier - variables from the same general observation class (described - in SDTM Tables 2.2.1-2.2.3). The addition of non-standard - variables will compromise the ability to use the datasets - (e.g., to populate a data repository and/or use standard - tools). See Appendix E for a list of SDTM variables that - should never be used in SEND. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table - 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier - variables from the same general observation class (described - in SDTM Tables 2.2.1-2.2.3). The addition of non-standard - variables will compromise the ability to use the datasets - (e.g., to populate a data repository and/or use standard - tools). See Appendix E for a list of SDTM variables that - should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table - 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier - variables from the same general observation class (described - in SDTM Tables 2.2.1-2.2.3). The addition of non-standard - variables will compromise the ability to use the datasets - (e.g., to populate a data repository and/or use standard - tools). See Appendix E for a list of SDTM variables that - should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table - 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier - variables from the same general observation class (described - in SDTM Tables 2.2.1-2.2.3). The addition of non-standard - variables will compromise the ability to use the datasets - (e.g., to populate a data repository and/or use standard - tools). See Appendix E for a list of SDTM variables that - should never be used in SEND. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (SDTM (http://www.cdisc.org/sdtm) Table - 2.2.4), Timing variables (SDTM Table 2.2.5), or Qualifier - variables from the same general observation class (described - in SDTM Tables 2.2.1-2.2.3). The addition of non-standard - variables will compromise the ability to use the datasets - (e.g., to populate a data repository and/or use standard - tools). See Appendix E for a list of SDTM variables that - should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: New variables (other than that are from the same general observation class) + must not be added, and existing variables must not be renamed or modified for novel usage. + Document: IG v3.0 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: '1' + Version: '5.0' + Version: '1.2' # Part 2: SEND269/269.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.0 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.0 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: '1' + Version: '5.0' + Version: '1.2' # The code is the same as for CG0013, but the scope is slightly different # (for SEND, the scope is limited to Interventions, Events and Findings) Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CORE-000902 Status: Published Version: '1' -Description: 'Trigger error when variable is not an allowed variable for the - underlying Observation Class' +Description: 'Trigger error when variable is not an allowed variable for the underlying Observation Class' Executability: Fully Executable Operations: - - id: $allowed_variables - operator: get_model_column_order +- id: $allowed_variables + operator: get_model_column_order Outcome: - Message: 'The variable is not an allowed variable for the underlying Observation - Class' + Message: 'The variable is not an allowed variable for the underlying Observation Class' Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000903/rule.yml b/Published/CORE-000903/rule.yml index ef83668f4..685c7d79e 100644 --- a/Published/CORE-000903/rule.yml +++ b/Published/CORE-000903/rule.yml @@ -1,70 +1,67 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure; ..Demographics (DM), Comments - (CO), and Subject Elements (SE) include study data that do not - conform to one of the three general observation classes. These - are described in Section 5" - Document: SENDIG v3.1 - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND297 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure; ..Demographics (DM), Comments - (CO), and Subject Elements (SE) include study data that do not - conform to one of the three general observation classes. These - are described in Section 5" - Document: SENDIG v3.1 - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND297 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study + data that do not conform to one of the three general observation classes. These are described + in Section 5" + Document: SENDIG v3.1 + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND297 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study + data that do not conform to one of the three general observation classes. These are described + in Section 5" + Document: SENDIG v3.1 + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND297 + Version: '1' + Version: '5.0' + Version: '1.1' # P.S. Not applicable to SENDIG-3.1.1, DART-1.2 and GENETOX Check: all: # select variable (is present) in dataset - - name: variable_name - operator: exists + - name: variable_name + operator: exists # check whether the variable is known in the CDISC Library - - name: variable_name - operator: not_equal_to - value: library_variable_name + - name: variable_name + operator: not_equal_to + value: library_variable_name Core: Id: CORE-000903 Status: Published Version: '1' -Description: "Additional variables not specified in the SENDIG description of - the domain (including both the domain table and assumptions) may not be added - to DM, CO, or SE" +Description: "Additional variables not specified in the SENDIG description of the domain (including both + the domain table and assumptions) may not be added to DM, CO, or SE" Executability: Fully Executable Outcome: - Message: The variable is not allowed in this domain as it is not specified in - the SENDIG for the specific domain + Message: The variable is not allowed in this domain as it is not specified in the SENDIG for the + specific domain Output Variables: - - variable_name + - variable_name # - library_variable_name Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM - - SE - - CO + - DM + - SE + - CO Sensitivity: Dataset diff --git a/Published/CORE-000904/rule.yml b/Published/CORE-000904/rule.yml index 9214aa1a4..8a863fd50 100644 --- a/Published/CORE-000904/rule.yml +++ b/Published/CORE-000904/rule.yml @@ -1,159 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value - Set Terminology (C201264) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00051' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value - Set Terminology (C201264) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00051' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value Set Terminology + (C201264) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00051' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value Set Terminology + (C201264) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00051' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000904' Status: Published Version: '1' -Description: 'A timing''s type must be specified using the Timing Type Value Set - Terminology (C201264) DDF codelist.' +Description: 'A timing''s type must be specified using the Timing Type Value Set Terminology (C201264) + DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C201264 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C201264 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The timing''s type is not specified using the Timing Type Value Set - Terminology (C201264) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The timing''s type is not specified using the Timing Type Value Set Terminology (C201264) + DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000905/rule.yml b/Published/CORE-000905/rule.yml index 3e2d575a3..403a9994f 100644 --- a/Published/CORE-000905/rule.yml +++ b/Published/CORE-000905/rule.yml @@ -1,161 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s relative to/from property must be specified using - the Timing Relative To From Value Set Terminology (C201265) - DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00104' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s relative to/from property must be specified using - the Timing Relative To From Value Set Terminology (C201265) - DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00104' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing''s relative to/from property must be specified using the Timing Relative + To From Value Set Terminology (C201265) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00104' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A timing''s relative to/from property must be specified using the Timing Relative + To From Value Set Terminology (C201265) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00104' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: relativeToFrom - operator: equal_to - value: true - - not: - all: - - name: relativeToFrom.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: relativeToFrom.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: relativeToFrom + operator: equal_to + value: true + - not: + all: + - name: relativeToFrom.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: relativeToFrom.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: relativeToFrom.code - operator: equal_to - value: $code_for_decode_pref_term - - name: relativeToFrom.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: relativeToFrom.decode - operator: equal_to - value: $pref_term_for_code - - name: relativeToFrom.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: relativeToFrom.code + operator: equal_to + value: $code_for_decode_pref_term + - name: relativeToFrom.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: relativeToFrom.decode + operator: equal_to + value: $pref_term_for_code + - name: relativeToFrom.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000905' Status: Published Version: '1' -Description: 'A timing''s relative to/from property must be specified using the - Timing Relative To From Value Set Terminology (C201265) DDF codelist.' +Description: 'A timing''s relative to/from property must be specified using the Timing Relative To From + Value Set Terminology (C201265) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C201265 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: relativeToFrom.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: relativeToFrom.code - version: relativeToFrom.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: relativeToFrom.code - version: relativeToFrom.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: relativeToFrom.decode - version: relativeToFrom.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: relativeToFrom.decode - version: relativeToFrom.codeSystemVersion +- id: $codelist_code + map: + - output: C201265 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: relativeToFrom.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: relativeToFrom.code + version: relativeToFrom.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: relativeToFrom.code + version: relativeToFrom.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: relativeToFrom.decode + version: relativeToFrom.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: relativeToFrom.decode + version: relativeToFrom.codeSystemVersion Outcome: - Message: 'The timing''s relative to/from property is not specified using the - Timing Relative To From Value Set Terminology (C201265) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive), and/or neither code nor decode is found in the codelist.' + Message: 'The timing''s relative to/from property is not specified using the Timing Relative To From + Value Set Terminology (C201265) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - relativeToFrom.code - - $code_for_decode_value - - $code_for_decode_pref_term - - relativeToFrom.codeSystem - - relativeToFrom.codeSystemVersion - - relativeToFrom.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - relativeToFrom.code + - $code_for_decode_value + - $code_for_decode_pref_term + - relativeToFrom.codeSystem + - relativeToFrom.codeSystemVersion + - relativeToFrom.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - 'Timing' Sensitivity: Record diff --git a/Published/CORE-000906/rule.yml b/Published/CORE-000906/rule.yml index 12cf02aa4..cdc01cba5 100644 --- a/Published/CORE-000906/rule.yml +++ b/Published/CORE-000906/rule.yml @@ -1,148 +1,146 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "The unit of a planned age is expected to be specified using - terms from the Age Unit (C66781) SDTM codelist." - Document: "USDM_CORE_Rules.xlsx" - Origin: "USDM Conformance Rules" - Rule Identifier: - Id: "DDF00111" - Version: "1" - Version: "1.0" - Version: "3.0" +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The unit of a planned age is expected to be specified using terms from the Age + Unit (C66781) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00111" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: "definition" - - name: plannedAge.unit - operator: equal_to - value: true - - not: - all: - - name: plannedAge.unit.codeSystem - operator: equal_to - value: "http://www.cdisc.org" - - name: plannedAge.unit.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: "definition" + - name: plannedAge.unit + operator: equal_to + value: true + - not: + all: + - name: plannedAge.unit.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: plannedAge.unit.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: plannedAge.unit.code - operator: equal_to - value: $code_for_decode_pref_term - - name: plannedAge.unit.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: plannedAge.unit.decode - operator: equal_to - value: $pref_term_for_code - - name: plannedAge.unit.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: plannedAge.unit.code + operator: equal_to + value: $code_for_decode_pref_term + - name: plannedAge.unit.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: plannedAge.unit.decode + operator: equal_to + value: $pref_term_for_code + - name: plannedAge.unit.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: "CORE-000906" Status: Published Version: "1" -Description: "The unit of a planned age is expected to be specified using terms - from the Age Unit (C66781) SDTM codelist." +Description: "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) + SDTM codelist." Executability: Partially Executable - Possible Overreporting Operations: - - id: $codelist_code - map: - - output: C66781 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: plannedAge.unit.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: plannedAge.unit.code - version: plannedAge.unit.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: plannedAge.unit.code - version: plannedAge.unit.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: plannedAge.unit.decode - version: plannedAge.unit.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: plannedAge.unit.decode - version: plannedAge.unit.codeSystemVersion +- id: $codelist_code + map: + - output: C66781 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: plannedAge.unit.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: plannedAge.unit.code + version: plannedAge.unit.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: plannedAge.unit.code + version: plannedAge.unit.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: plannedAge.unit.decode + version: plannedAge.unit.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: plannedAge.unit.decode + version: plannedAge.unit.codeSystemVersion Outcome: - Message: 'The unit of the planned age is not specified using the Age Unit - (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code + or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither + code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - plannedAge.unit.code - - $code_for_decode_value - - $code_for_decode_pref_term - - plannedAge.unit.codeSystem - - plannedAge.unit.codeSystemVersion - - plannedAge.unit.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - plannedAge.unit.code + - $code_for_decode_value + - $code_for_decode_pref_term + - plannedAge.unit.codeSystem + - plannedAge.unit.codeSystemVersion + - plannedAge.unit.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - "StudyDesignPopulation" - - "StudyCohort" + - "StudyDesignPopulation" + - "StudyCohort" Sensitivity: Record diff --git a/Published/CORE-000907/rule.yml b/Published/CORE-000907/rule.yml index f0a1594a3..5e8424aa6 100644 --- a/Published/CORE-000907/rule.yml +++ b/Published/CORE-000907/rule.yml @@ -1,159 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s role must be specified using the study - intervention role (C207417) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00112' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s role must be specified using the study - intervention role (C207417) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00112' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study intervention''s role must be specified using the study intervention role + (C207417) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00112' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study intervention''s role must be specified using the study intervention role + (C207417) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00112' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: role - operator: equal_to - value: true - - not: - all: - - name: role.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: role.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: role + operator: equal_to + value: true + - not: + all: + - name: role.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: role.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: role.code - operator: equal_to - value: $code_for_decode_pref_term - - name: role.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: role.decode - operator: equal_to - value: $pref_term_for_code - - name: role.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: role.code + operator: equal_to + value: $code_for_decode_pref_term + - name: role.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: role.decode + operator: equal_to + value: $pref_term_for_code + - name: role.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000907' Status: Published Version: '1' -Description: 'A study intervention''s role must be specified using the study - intervention role (C207417) DDF codelist.' +Description: 'A study intervention''s role must be specified using the study intervention role (C207417) + DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207417 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: role.code - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: role.code - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: role.decode - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: role.decode - version: role.codeSystemVersion +- id: $codelist_code + map: + - output: C207417 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: role.code + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: role.code + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: role.decode + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: role.decode + version: role.codeSystemVersion Outcome: - Message: 'The study intervention''s role is not specified using the study - intervention role (C207417) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The study intervention''s role is not specified using the study intervention role (C207417) + DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - role.code - - $code_for_decode_value - - $code_for_decode_pref_term - - role.codeSystem - - role.codeSystemVersion - - role.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - role.code + - $code_for_decode_value + - $code_for_decode_pref_term + - role.codeSystem + - role.codeSystemVersion + - role.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - 'StudyIntervention' Sensitivity: Record diff --git a/Published/CORE-000908/rule.yml b/Published/CORE-000908/rule.yml index 6f6729920..46767dd23 100644 --- a/Published/CORE-000908/rule.yml +++ b/Published/CORE-000908/rule.yml @@ -1,152 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An agent administration's frequency must be specified according - to the extensible Frequency (C71113) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00113' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An agent administration's frequency must be specified according to the extensible + Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00113' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: frequency.standardCode - operator: exists - - name: frequency.standardCode - operator: equal_to - value: true - - not: - all: - - name: frequency.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: frequency.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: frequency.standardCode + operator: exists + - name: frequency.standardCode + operator: equal_to + value: true + - not: + all: + - name: frequency.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: frequency.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: frequency.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: frequency.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: frequency.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: frequency.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000908' Status: Published Version: '1' -Description: "An agent administration's frequency must be specified according to - the extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or - decode used from the codelist should be consistent with the full entry in the - codelist)." +Description: "An agent administration's frequency must be specified according to the extensible Frequency + (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C71113 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C71113 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion Outcome: - Message: 'The agent administration''s frequency is not specified according to - the extensible Frequency (C71113) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The agent administration''s frequency is not specified according to the extensible Frequency + (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - frequency.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - frequency.standardCode.codeSystem - - frequency.standardCode.codeSystemVersion - - frequency.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - frequency.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - frequency.standardCode.codeSystem + - frequency.standardCode.codeSystemVersion + - frequency.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AgentAdministration' + - 'AgentAdministration' Sensitivity: Record diff --git a/Published/CORE-000909/rule.yml b/Published/CORE-000909/rule.yml index 256493068..c315cf1ed 100644 --- a/Published/CORE-000909/rule.yml +++ b/Published/CORE-000909/rule.yml @@ -1,147 +1,145 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study version''s study type must be specified using the Study - Type Response (C99077) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00116' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study version''s study type must be specified using the Study Type Response + (C99077) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00116' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyType - operator: equal_to - value: true - - not: - all: - - name: studyType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyType.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyType + operator: equal_to + value: true + - not: + all: + - name: studyType.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: studyType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyType.decode - operator: equal_to - value: $pref_term_for_code - - name: studyType.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: studyType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyType.decode + operator: equal_to + value: $pref_term_for_code + - name: studyType.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000909' Status: Published Version: '1' -Description: 'A study version''s study type must be specified using the Study - Type Response (C99077) SDTM codelist.' +Description: 'A study version''s study type must be specified using the Study Type Response (C99077) SDTM + codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C99077 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyType.code - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyType.code - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyType.decode - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyType.decode - version: studyType.codeSystemVersion +- id: $codelist_code + map: + - output: C99077 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyType.code + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyType.code + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyType.decode + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyType.decode + version: studyType.codeSystemVersion Outcome: - Message: 'The study version''s study type is not specified using the Study Type - Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The study version''s study type is not specified using the Study Type Response (C99077) SDTM + codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $codelist_code - - $codelist_extensible - - studyType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyType.codeSystem - - studyType.codeSystemVersion - - studyType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $codelist_code + - $codelist_extensible + - studyType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyType.codeSystem + - studyType.codeSystemVersion + - studyType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-000910/rule.yml b/Published/CORE-000910/rule.yml index 6bd837cf3..97d6830fd 100644 --- a/Published/CORE-000910/rule.yml +++ b/Published/CORE-000910/rule.yml @@ -1,150 +1,145 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study protocol document version''s protocol status must be - specified using the Protocol Status Value Set Terminology - (C188723) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00117' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study protocol document version''s protocol status must be specified using + the Protocol Status Value Set Terminology (C188723) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00117' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: protocolStatus - operator: equal_to - value: true - - not: - all: - - name: protocolStatus.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: protocolStatus.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: protocolStatus + operator: equal_to + value: true + - not: + all: + - name: protocolStatus.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: protocolStatus.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: protocolStatus.code - operator: equal_to - value: $code_for_decode_pref_term - - name: protocolStatus.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: protocolStatus.decode - operator: equal_to - value: $pref_term_for_code - - name: protocolStatus.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: protocolStatus.code + operator: equal_to + value: $code_for_decode_pref_term + - name: protocolStatus.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: protocolStatus.decode + operator: equal_to + value: $pref_term_for_code + - name: protocolStatus.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000910' Status: Published Version: '1' -Description: 'A study protocol document version''s protocol status must be - specified using the Protocol Status Value Set Terminology (C188723) DDF - codelist.' +Description: 'A study protocol document version''s protocol status must be specified using the Protocol + Status Value Set Terminology (C188723) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188723 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: protocolStatus.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: protocolStatus.code - version: protocolStatus.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: protocolStatus.code - version: protocolStatus.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: protocolStatus.decode - version: protocolStatus.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: protocolStatus.decode - version: protocolStatus.codeSystemVersion +- id: $codelist_code + map: + - output: C188723 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: protocolStatus.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: protocolStatus.code + version: protocolStatus.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: protocolStatus.code + version: protocolStatus.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: protocolStatus.decode + version: protocolStatus.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: protocolStatus.decode + version: protocolStatus.codeSystemVersion Outcome: - Message: 'The study protocol document version''s protocol status is not - specified using the Protocol Status Value Set Terminology (C188723) DDF - codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is - not a valid terminology package date, the code or decode (either as - preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive), and/or neither code nor decode is found in - the codelist.' + Message: 'The study protocol document version''s protocol status is not specified using the Protocol + Status Value Set Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - protocolVersion - - $codelist_code - - $codelist_extensible - - protocolStatus.code - - $code_for_decode_value - - $code_for_decode_pref_term - - protocolStatus.codeSystem - - protocolStatus.codeSystemVersion - - protocolStatus.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - protocolVersion + - $codelist_code + - $codelist_extensible + - protocolStatus.code + - $code_for_decode_value + - $code_for_decode_pref_term + - protocolStatus.codeSystem + - protocolStatus.codeSystemVersion + - protocolStatus.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyProtocolDocumentVersion' + - 'StudyProtocolDocumentVersion' Sensitivity: Record diff --git a/Published/CORE-000911/rule.yml b/Published/CORE-000911/rule.yml index cbd087e52..39b010b4e 100644 --- a/Published/CORE-000911/rule.yml +++ b/Published/CORE-000911/rule.yml @@ -1,167 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's trial intent types must be specified according - to the extensible Trial Intent Type Response (C66736) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00118' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's trial intent types must be specified according to the extensible + Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00118' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: trialIntentTypes - operator: exists - - name: trialIntentTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'trialIntentTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: trialIntentTypes + operator: exists + - name: trialIntentTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'trialIntentTypes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000911' Status: Published Version: '1' -Description: "A study design's trial intent types must be specified according to - the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's trial intent types must be specified according to the extensible Trial + Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C66736 - parent_rel.Code: 'trialIntentTypes' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C66736 + parent_rel.Code: 'trialIntentTypes' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s trial intent type is not specified according to - the extensible Trial Intent Type Response (C66736) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s trial intent type is not specified according to the extensible Trial Intent + Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-000912/rule.yml b/Published/CORE-000912/rule.yml index 4ffdd9c48..88a9caf5c 100644 --- a/Published/CORE-000912/rule.yml +++ b/Published/CORE-000912/rule.yml @@ -1,165 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's trial types must be specified according to the - extensible Trial Type Response (C66739) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00119' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's trial types must be specified according to the extensible Trial + Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00119' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: trialTypes - operator: exists - - name: trialTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'trialTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: trialTypes + operator: exists + - name: trialTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'trialTypes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000912' Status: Published Version: '1' -Description: "A study design's trial types must be specified according to the - extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a - code or decode used from the codelist should be consistent with the full entry - in the codelist)." +Description: "A study design's trial types must be specified according to the extensible Trial Type Response + (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C66739 - parent_rel.Code: 'trialTypes' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C66739 + parent_rel.Code: 'trialTypes' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s trial type is not specified according to the - extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The study design''s trial type is not specified according to the extensible Trial Type Response + (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-000914/rule.yml b/Published/CORE-000914/rule.yml index 2edd77f52..90037047b 100644 --- a/Published/CORE-000914/rule.yml +++ b/Published/CORE-000914/rule.yml @@ -2,178 +2,177 @@ # Condition: --BLFL="Y" and '--STRESC ^= Null # Rule: 'Only one --BLFL per record having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding - standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: 'FDA' + Section: 'FDAB026' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB2603' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STRESC - operator: non_empty - - name: --BLFL - operator: equal_to - value: 'Y' - value_is_literal: true - - name: --BLFL - operator: is_not_unique_set - value: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - USUBJID + - name: --STRESC + operator: non_empty + - name: --BLFL + operator: equal_to + value: 'Y' + value_is_literal: true + - name: --BLFL + operator: is_not_unique_set + value: + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - USUBJID Core: + Id: CORE-000914 Status: Published Version: '1' - Id: CORE-000914 -Description: There should be only one record with a baseline flag and non - missing character standard result value having the same --TESTCD, --CAT, - --SCAT, --SPEC, --METHOD values. +Description: There should be only one record with a baseline flag and non missing character standard + result value having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values. Executability: Fully Executable Outcome: Message: There are multiple records per assigned baseline flag (--BLFL). Output Variables: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --BLFL + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --BLFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000916/rule.yml b/Published/CORE-000916/rule.yml index 1c55e84af..872b2d890 100644 --- a/Published/CORE-000916/rule.yml +++ b/Published/CORE-000916/rule.yml @@ -2,128 +2,124 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000916 Status: Published Version: '1' -Description: Part B - Raise and error when IDVAR in RELREC is not populated with - a valid variable from the dataset referenced in RDOMAIN. +Description: Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable + from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: RELREC +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: RELREC Operations: - - domain: RELREC - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true +- domain: RELREC + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in RELREC does not represent a variable present in the - dataset referenced in RDOMAIN. + Message: Value for IDVAR in RELREC does not represent a variable present in the dataset referenced + in RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000917/rule.yml b/Published/CORE-000917/rule.yml index f03836d2f..0629b762b 100644 --- a/Published/CORE-000917/rule.yml +++ b/Published/CORE-000917/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's intervention model must be specified according - to the extensible Intervention Model Response (C99076) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00120' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's intervention model must be specified according to the extensible + Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00120' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: interventionModel - operator: exists - - name: interventionModel - operator: equal_to - value: true - - not: - all: - - name: interventionModel.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: interventionModel.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: interventionModel + operator: exists + - name: interventionModel + operator: equal_to + value: true + - not: + all: + - name: interventionModel.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: interventionModel.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: interventionModel.code - operator: equal_to - value: $code_for_decode_pref_term - - name: interventionModel.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: interventionModel.decode - operator: equal_to - value: $pref_term_for_code - - name: interventionModel.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: interventionModel.code + operator: equal_to + value: $code_for_decode_pref_term + - name: interventionModel.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: interventionModel.decode + operator: equal_to + value: $pref_term_for_code + - name: interventionModel.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000917' Status: Published Version: '1' -Description: "A study design's intervention model must be specified according to - the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's intervention model must be specified according to the extensible Intervention + Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C99076 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: interventionModel.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: interventionModel.code - version: interventionModel.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: interventionModel.code - version: interventionModel.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: interventionModel.decode - version: interventionModel.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: interventionModel.decode - version: interventionModel.codeSystemVersion +- id: $codelist_code + map: + - output: C99076 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: interventionModel.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: interventionModel.code + version: interventionModel.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: interventionModel.code + version: interventionModel.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: interventionModel.decode + version: interventionModel.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: interventionModel.decode + version: interventionModel.codeSystemVersion Outcome: - Message: 'The study design''s intervention model is not specified according to - the extensible Intervention Model Response (C99076) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s intervention model is not specified according to the extensible Intervention + Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - interventionModel.code - - $code_for_decode_value - - $code_for_decode_pref_term - - interventionModel.codeSystem - - interventionModel.codeSystemVersion - - interventionModel.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - interventionModel.code + - $code_for_decode_value + - $code_for_decode_pref_term + - interventionModel.codeSystem + - interventionModel.codeSystemVersion + - interventionModel.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-000918/rule.yml b/Published/CORE-000918/rule.yml index 33e3a786f..650e25ea9 100644 --- a/Published/CORE-000918/rule.yml +++ b/Published/CORE-000918/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's blinding schema must be specified according to - the extensible Trial Blinding Schema Response (C66735) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00121' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's blinding schema must be specified according to the extensible + Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00121' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: blindingSchema - operator: exists - - name: blindingSchema - operator: equal_to - value: true - - not: - all: - - name: blindingSchema.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: blindingSchema.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: blindingSchema + operator: exists + - name: blindingSchema + operator: equal_to + value: true + - not: + all: + - name: blindingSchema.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: blindingSchema.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: blindingSchema.code - operator: equal_to - value: $code_for_decode_pref_term - - name: blindingSchema.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: blindingSchema.decode - operator: equal_to - value: $pref_term_for_code - - name: blindingSchema.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: blindingSchema.code + operator: equal_to + value: $code_for_decode_pref_term + - name: blindingSchema.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: blindingSchema.decode + operator: equal_to + value: $pref_term_for_code + - name: blindingSchema.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000918' Status: Published Version: '1' -Description: "A study design's blinding schema must be specified according to - the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's blinding schema must be specified according to the extensible Trial Blinding + Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66735 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: blindingSchema.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: blindingSchema.code - version: blindingSchema.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: blindingSchema.code - version: blindingSchema.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: blindingSchema.decode - version: blindingSchema.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: blindingSchema.decode - version: blindingSchema.codeSystemVersion +- id: $codelist_code + map: + - output: C66735 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: blindingSchema.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: blindingSchema.code + version: blindingSchema.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: blindingSchema.code + version: blindingSchema.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: blindingSchema.decode + version: blindingSchema.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: blindingSchema.decode + version: blindingSchema.codeSystemVersion Outcome: - Message: 'The study design''s blinding schema is not specified according to the - extensible Trial Blinding Schema Response (C66735) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s blinding schema is not specified according to the extensible Trial Blinding + Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - blindingSchema.code - - $code_for_decode_value - - $code_for_decode_pref_term - - blindingSchema.codeSystem - - blindingSchema.codeSystemVersion - - blindingSchema.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - blindingSchema.code + - $code_for_decode_value + - $code_for_decode_pref_term + - blindingSchema.codeSystem + - blindingSchema.codeSystemVersion + - blindingSchema.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-000919/rule.yml b/Published/CORE-000919/rule.yml index ce577545c..d22a449a5 100644 --- a/Published/CORE-000919/rule.yml +++ b/Published/CORE-000919/rule.yml @@ -1,167 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's characteristics must be specified according to - the extensible Study Design Characteristics Value Set - Terminology (C207416) DDF codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the - full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00122' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's characteristics must be specified according to the extensible + Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with + a code or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00122' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: characteristics - operator: exists - - name: characteristics - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'characteristics' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: characteristics + operator: exists + - name: characteristics + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'characteristics' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000919' Status: Published Version: '1' -Description: "A study design's characteristics must be specified according to - the extensible Study Design Characteristics Value Set Terminology (C207416) - DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." +Description: "A study design's characteristics must be specified according to the extensible Study Design + Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C207416 - parent_rel.Code: 'characteristics' - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C207416 + parent_rel.Code: 'characteristics' + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s characteristic is not specified according to the - extensible Study Design Characteristics Value Set Terminology (C207416) DDF - codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is - not a valid terminology package date, and/or the code or decode (either as - preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The study design''s characteristic is not specified according to the extensible Study Design + Characteristics Value Set Terminology (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", + codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred + term or as submission value) is found in the codelist (case insensitive) but the corresponding decode + or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-000920/rule.yml b/Published/CORE-000920/rule.yml index 7f1407f85..d1d876b79 100644 --- a/Published/CORE-000920/rule.yml +++ b/Published/CORE-000920/rule.yml @@ -1,151 +1,148 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A masking role must be specified according to the extensible - masking role (C207414) DDF codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the - full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00123' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A masking role must be specified according to the extensible masking role (C207414) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00123' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: role - operator: exists - - name: role - operator: equal_to - value: true - - not: - all: - - name: role.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: role.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: role + operator: exists + - name: role + operator: equal_to + value: true + - not: + all: + - name: role.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: role.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: role.code - operator: equal_to - value: $code_for_decode_pref_term - - name: role.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: role.decode - operator: equal_to - value: $pref_term_for_code - - name: role.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: role.code + operator: equal_to + value: $code_for_decode_pref_term + - name: role.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: role.decode + operator: equal_to + value: $pref_term_for_code + - name: role.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000920' Status: Published Version: '1' -Description: "A masking role must be specified according to the extensible - masking role (C207414) DDF codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." +Description: "A masking role must be specified according to the extensible masking role (C207414) DDF + codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full + entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207414 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: role.code - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: role.code - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: role.decode - version: role.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: role.decode - version: role.codeSystemVersion +- id: $codelist_code + map: + - output: C207414 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: role.code + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: role.code + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: role.decode + version: role.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: role.decode + version: role.codeSystemVersion Outcome: - Message: 'The masking role is not specified according to the extensible masking - role (C207414) DDF codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, and/or the code - or decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive).' + Message: 'The masking role is not specified according to the extensible masking role (C207414) DDF codelist + - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, + and/or the code or decode (either as preferred term or as submission value) is found in the codelist + (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - role.code - - $code_for_decode_value - - $code_for_decode_pref_term - - role.codeSystem - - role.codeSystemVersion - - role.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - role.code + - $code_for_decode_value + - $code_for_decode_pref_term + - role.codeSystem + - role.codeSystemVersion + - role.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Masking' + - 'Masking' Sensitivity: Record diff --git a/Published/CORE-000921/rule.yml b/Published/CORE-000921/rule.yml index dac59959c..5577107ae 100644 --- a/Published/CORE-000921/rule.yml +++ b/Published/CORE-000921/rule.yml @@ -1,147 +1,145 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s product designation must be specified - using the product designation (C207418) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00129' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study intervention''s product designation must be specified using the product + designation (C207418) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00129' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: productDesignation - operator: equal_to - value: true - - not: - all: - - name: productDesignation.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: productDesignation.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: productDesignation + operator: equal_to + value: true + - not: + all: + - name: productDesignation.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: productDesignation.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_pref_term - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: productDesignation.decode - operator: equal_to - value: $pref_term_for_code - - name: productDesignation.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_pref_term + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: productDesignation.decode + operator: equal_to + value: $pref_term_for_code + - name: productDesignation.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000921' Status: Published Version: '1' -Description: 'A study intervention''s product designation must be specified - using the product designation (C207418) DDF codelist.' +Description: 'A study intervention''s product designation must be specified using the product designation + (C207418) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207418 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: productDesignation.code - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: productDesignation.code - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: productDesignation.decode - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: productDesignation.decode - version: productDesignation.codeSystemVersion +- id: $codelist_code + map: + - output: C207418 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: productDesignation.code + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: productDesignation.code + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: productDesignation.decode + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: productDesignation.decode + version: productDesignation.codeSystemVersion Outcome: - Message: 'The study intervention''s product designation is not specified using - the product designation (C207418) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The study intervention''s product designation is not specified using the product designation + (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, the code or decode (either as preferred term or as submission value) is + found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - productDesignation.code - - $code_for_decode_value - - $code_for_decode_pref_term - - productDesignation.codeSystem - - productDesignation.codeSystemVersion - - productDesignation.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - productDesignation.code + - $code_for_decode_value + - $code_for_decode_pref_term + - productDesignation.codeSystem + - productDesignation.codeSystemVersion + - productDesignation.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - 'StudyIntervention' Sensitivity: Record diff --git a/Published/CORE-000922/rule.yml b/Published/CORE-000922/rule.yml index c9485dd64..2238cfcb5 100644 --- a/Published/CORE-000922/rule.yml +++ b/Published/CORE-000922/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An agent administration's route must be specified according to - the extensible Route of Administration Response (C66729) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00130' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An agent administration's route must be specified according to the extensible + Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode + used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00130' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: route.standardCode - operator: exists - - name: route.standardCode - operator: equal_to - value: true - - not: - all: - - name: route.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: route.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: route.standardCode + operator: exists + - name: route.standardCode + operator: equal_to + value: true + - not: + all: + - name: route.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: route.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: route.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: route.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: route.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: route.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000922' Status: Published Version: '1' -Description: "An agent administration's route must be specified according to the - extensible Route of Administration Response (C66729) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "An agent administration's route must be specified according to the extensible Route of Administration + Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66729 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: route.standardCode.decode - version: route.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: route.standardCode.decode - version: route.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66729 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: route.standardCode.decode + version: route.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: route.standardCode.decode + version: route.standardCode.codeSystemVersion Outcome: - Message: 'The agent administration''s route is not specified according to the - extensible Route of Administration Response (C66729) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The agent administration''s route is not specified according to the extensible Route of Administration + Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - route.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - route.standardCode.codeSystem - - route.standardCode.codeSystemVersion - - route.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - route.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - route.standardCode.codeSystem + - route.standardCode.codeSystemVersion + - route.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AgentAdministration' + - 'AgentAdministration' Sensitivity: Record diff --git a/Published/CORE-000923/rule.yml b/Published/CORE-000923/rule.yml index 19a7b0b49..e6ea2952d 100644 --- a/Published/CORE-000923/rule.yml +++ b/Published/CORE-000923/rule.yml @@ -1,167 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's environmental setting must be specified - according to the extensible Environmental Setting (C127262) - SDTM codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00135' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter's environmental setting must be specified according to the extensible + Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00135' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: environmentalSetting - operator: exists - - name: environmentalSetting - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'environmentalSetting' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: environmentalSetting + operator: exists + - name: environmentalSetting + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'environmentalSetting' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000923' Status: Published Version: '1' -Description: "An encounter's environmental setting must be specified according - to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the - full entry in the codelist)." +Description: "An encounter's environmental setting must be specified according to the extensible Environmental + Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C127262 - parent_rel.Code: 'environmentalSetting' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C127262 + parent_rel.Code: 'environmentalSetting' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s environmental setting is not specified according to - the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The encounter''s environmental setting is not specified according to the extensible Environmental + Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not + a valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000924/rule.yml b/Published/CORE-000924/rule.yml index 5c0d293ba..8d7d1cc16 100644 --- a/Published/CORE-000924/rule.yml +++ b/Published/CORE-000924/rule.yml @@ -1,177 +1,174 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An organization type must be specified according to the - extensible organization type (C188724) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00140' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An organization type must be specified according to the extensible organization + type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00140' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: organizationType - operator: exists - - name: organizationType - operator: equal_to - value: true - - not: - all: - - name: organizationType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: organizationType.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: organizationType + operator: exists + - name: organizationType + operator: equal_to + value: true + - not: + all: + - name: organizationType.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: organizationType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: 'Y' + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: organizationType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: organizationType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: organizationType.decode - operator: equal_to - value: $pref_term_for_code - - name: organizationType.decode - operator: equal_to - value: $value_for_code + - name: organizationType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: organizationType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: organizationType.decode + operator: equal_to + value: $pref_term_for_code + - name: organizationType.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000924' Status: Published Version: '1' -Description: "An organization type must be specified according to the extensible - organization type (C188724) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the - codelist)." +Description: "An organization type must be specified according to the extensible organization type (C188724) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the + full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188724 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: organizationType.codeSystemVersion +- id: $codelist_code + map: + - output: C188724 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: organizationType.codeSystemVersion # DDF codelist extensibility was not defined in earlier CT packages and # defaults to false, so assigning an override: - - id: $codelist_extensible_override - map: - - organizationType.codeSystemVersion: '2022-09-30' - output: "Y" - - organizationType.codeSystemVersion: '2022-12-16' - output: "Y" - - organizationType.codeSystemVersion: '2023-03-31' - output: "Y" - - organizationType.codeSystemVersion: '2023-06-30' - output: "Y" - - organizationType.codeSystemVersion: '2023-09-29' - output: "Y" - - organizationType.codeSystemVersion: '2023-12-15' - output: "Y" - - organizationType.codeSystemVersion: '2024-03-29' - output: "Y" - operator: map - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: organizationType.code - version: organizationType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: organizationType.code - version: organizationType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: organizationType.decode - version: organizationType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: organizationType.decode - version: organizationType.codeSystemVersion +- id: $codelist_extensible_override + map: + - organizationType.codeSystemVersion: '2022-09-30' + output: "Y" + - organizationType.codeSystemVersion: '2022-12-16' + output: "Y" + - organizationType.codeSystemVersion: '2023-03-31' + output: "Y" + - organizationType.codeSystemVersion: '2023-06-30' + output: "Y" + - organizationType.codeSystemVersion: '2023-09-29' + output: "Y" + - organizationType.codeSystemVersion: '2023-12-15' + output: "Y" + - organizationType.codeSystemVersion: '2024-03-29' + output: "Y" + operator: map +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: organizationType.code + version: organizationType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: organizationType.code + version: organizationType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: organizationType.decode + version: organizationType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: organizationType.decode + version: organizationType.codeSystemVersion Outcome: - Message: 'The organization type is not specified according to the extensible - organization type (C188724) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The organization type is not specified according to the extensible organization type (C188724) + DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, and/or the code or decode (either as preferred term or as submission value) is found + in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - organizationType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - organizationType.codeSystem - - organizationType.codeSystemVersion - - organizationType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - organizationType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - organizationType.codeSystem + - organizationType.codeSystemVersion + - organizationType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Organization' - - 'ResearchOrganization' + - 'Organization' + - 'ResearchOrganization' Sensitivity: Record diff --git a/Published/CORE-000925/rule.yml b/Published/CORE-000925/rule.yml index bebdada45..9b10ac61e 100644 --- a/Published/CORE-000925/rule.yml +++ b/Published/CORE-000925/rule.yml @@ -1,166 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A governance date type must be specified according to the - extensible governance date type (C207413) DDF codelist (e.g. - an entry with a code or decode used from the codelist should - be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00142' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A governance date type must be specified according to the - extensible governance date type (C207413) DDF codelist (e.g. - an entry with a code or decode used from the codelist should - be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00142' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A governance date type must be specified according to the extensible governance + date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00142' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "A governance date type must be specified according to the extensible governance + date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00142' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000925' Status: Published Version: '1' -Description: "A governance date type must be specified according to the - extensible governance date type (C207413) DDF codelist (e.g. an entry with a - code or decode used from the codelist should be consistent with the full entry - in the codelist)." +Description: "A governance date type must be specified according to the extensible governance date type + (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207413 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C207413 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The governance date type is not specified according to the extensible - governance date type (C207413) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The governance date type is not specified according to the extensible governance date type + (C207413) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'GovernanceDate' + - 'GovernanceDate' Sensitivity: Record diff --git a/Published/CORE-000926/rule.yml b/Published/CORE-000926/rule.yml index 31259ada4..419b94167 100644 --- a/Published/CORE-000926/rule.yml +++ b/Published/CORE-000926/rule.yml @@ -1,29 +1,29 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In Vivo Micronucleus is represented at the subject level, not - the slide level. - Document: SENDIG-GENETOX - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND409 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: In Vivo Micronucleus is represented at the subject level, not the slide + level. + Document: SENDIG-GENETOX + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND409 + Version: '1' + Version: '5.0' + Version: '1.0' # In Vivo Micronucleus is represented at the subject level, not the slide level. # i.e. when GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not POOLID # REMARK: but USUBJID = "required" anyway Check: all: - - name: 'GVCAT' - operator: equal_to - value: 'IN VIVO MICRONUCLEUS' - - name: 'USUBJID' - operator: empty + - name: 'GVCAT' + operator: equal_to + value: 'IN VIVO MICRONUCLEUS' + - name: 'USUBJID' + operator: empty Core: Id: CORE-000926 Status: Published @@ -31,14 +31,13 @@ Core: Description: In Vivo Micronucleus is represented at the subject level, not the slide level. Executability: Fully Executable Outcome: - Message: When GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not - POOLID + Message: When GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not POOLID Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Published/CORE-000929/rule.yml b/Published/CORE-000929/rule.yml index 45e8ffb11..a35025617 100644 --- a/Published/CORE-000929/rule.yml +++ b/Published/CORE-000929/rule.yml @@ -1,211 +1,203 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard domain names and prefixes where - applicable. - Document: SDTMIG v3.4 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C - - Controlled Terminology] for reserved two-character domain - identifiers or abbreviations. If one has not been assigned by - CDISC, then the sponsor may select the unique two-character - domain code to be used consistently throughout the submission. - Document: IG v3.2 - Item: 3.d - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Determine the domain code, one that is not a domain code in the - CDISC Controlled Terminology codelist "SDTM Domain - Abbreviations" available at - http://www.cancer.gov/research/resources/terminology/cdisc. If - it desired to have this domain code as part of CDISC - controlled terminology, then submit a request to - https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. - The sponsor-selected, two-character domain code should be used - consistently throughout the submission. - Document: IG v3.3 - Item: 3.e - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A dataset is created using a domain specification in this guide - when the scientific nature or role of the data is within the - scope of a domain. Domains are extended or custom domain - specifications are only used when data are different in nature - and are not in scope for domains in this guide. - Document: TIG 1.0 - Item: Table 2 Num 2 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0289 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.0 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: To support implementation of standards, controlled terminology - will be used to name domain datasets and variables in datasets - when applicable. - Document: TIG v1.0 - Item: Standards for Tabulation - Section: 2.3. - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0090 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard domain names and prefixes where applicable. + Document: SDTMIG v3.4 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C - Controlled + Terminology] for reserved two-character domain identifiers or abbreviations. If one has + not been assigned by CDISC, then the sponsor may select the unique two-character domain + code to be used consistently throughout the submission. + Document: IG v3.2 + Item: 3.d + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Determine the domain code, one that is not a domain code in the CDISC + Controlled Terminology codelist "SDTM Domain Abbreviations" available at + http://www.cancer.gov/research/resources/terminology/cdisc. If it desired to have this + domain code as part of CDISC controlled terminology, then submit a request to + https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The sponsor-selected, + two-character domain code should be used consistently throughout the submission. + Document: IG v3.3 + Item: 3.e + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A dataset is created using a domain specification in this guide when the + scientific nature or role of the data is within the scope of a domain. Domains are + extended or custom domain specifications are only used when data are different in nature + and are not in scope for domains in this guide. + Document: TIG 1.0 + Item: Table 2 Num 2 + Section: '2.5' + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0289 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.0 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: TIG + References: + - Citations: + - Cited Guidance: To support implementation of standards, controlled terminology will be used + to name domain datasets and variables in datasets when applicable. + Document: TIG v1.0 + Item: Standards for Tabulation + Section: 2.3. + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0090 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' # Variable: DOMAIN # Condition: Not custom domain # Rule: DOMAIN = valid Domain Code published by CDISC Check: all: - - name: $domain_is_custom - operator: equal_to - value: false - - name: define_variable_ccode - operator: equal_to - value: C66734 - - name: define_variable_codelist_coded_codes - operator: is_not_contained_by - value: $domain_lib_ccode + - name: $domain_is_custom + operator: equal_to + value: false + - name: define_variable_ccode + operator: equal_to + value: C66734 + - name: define_variable_codelist_coded_codes + operator: is_not_contained_by + value: $domain_lib_ccode Core: Id: CORE-000929 Status: Published Version: '1' -Description: Raise and error when the DOMAIN Code is not a valid Domain Code - published by CDISC. +Description: Raise and error when the DOMAIN Code is not a valid Domain Code published by CDISC. Executability: Fully Executable Operations: - - id: $domain_is_custom - operator: domain_is_custom - - codelists: - - DOMAIN - id: $domain_lib_ccode - level: term - operator: codelist_terms - returntype: code +- id: $domain_is_custom + operator: domain_is_custom +- codelists: + - DOMAIN + id: $domain_lib_ccode + level: term + operator: codelist_terms + returntype: code Outcome: Message: DOMAIN Code is not a published DOMAIN Code in CDISC Controlled Terminology. Output Variables: - - $domain_lib_ccode - - define_variable_codelist_coded_codes + - $domain_lib_ccode + - define_variable_codelist_coded_codes Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000930/rule.yml b/Published/CORE-000930/rule.yml index 17c966f30..2622ddddc 100644 --- a/Published/CORE-000930/rule.yml +++ b/Published/CORE-000930/rule.yml @@ -1,160 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment reason must be coded using the study - amendment reason (C207415) DDF codelist." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00143' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment reason must be coded using the study - amendment reason (C207415) DDF codelist." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00143' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study amendment reason must be coded using the study amendment reason (C207415) + DDF codelist." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00143' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study amendment reason must be coded using the study amendment reason (C207415) + DDF codelist." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00143' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - not: - all: - - name: code.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: code.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - not: + all: + - name: code.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: code.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code.code - operator: equal_to - value: $code_for_decode_pref_term - - name: code.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: code.decode - operator: equal_to - value: $pref_term_for_code - - name: code.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: code.code + operator: equal_to + value: $code_for_decode_pref_term + - name: code.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: code.decode + operator: equal_to + value: $pref_term_for_code + - name: code.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000930' Status: Published Version: '1' -Description: "A study amendment reason must be coded using the study amendment - reason (C207415) DDF codelist." +Description: "A study amendment reason must be coded using the study amendment reason (C207415) DDF codelist." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207415 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code.code - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code.code - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: code.decode - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: code.decode - version: code.codeSystemVersion +- id: $codelist_code + map: + - output: C207415 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code.code + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code.code + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: code.decode + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: code.decode + version: code.codeSystemVersion Outcome: - Message: 'The study amendment reason is not coded using the study amendment - reason (C207415) DDF codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, and/or the code - or decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive).' + Message: 'The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist + - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, + and/or the code or decode (either as preferred term or as submission value) is found in the codelist + (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - code.code - - $code_for_decode_value - - $code_for_decode_pref_term - - code.codeSystem - - code.codeSystemVersion - - code.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - code.code + - $code_for_decode_value + - $code_for_decode_pref_term + - code.codeSystem + - code.codeSystemVersion + - code.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyAmendmentReason' + - 'StudyAmendmentReason' Sensitivity: Record diff --git a/Published/CORE-000931/rule.yml b/Published/CORE-000931/rule.yml index 65a3bc828..3850d803a 100644 --- a/Published/CORE-000931/rule.yml +++ b/Published/CORE-000931/rule.yml @@ -1,158 +1,156 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study geographic scope type must be specified using the - geographic scope type (C207412) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00144' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study geographic scope type must be specified using the - geographic scope type (C207412) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00144' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study geographic scope type must be specified using the geographic scope type + (C207412) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00144' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study geographic scope type must be specified using the geographic scope type + (C207412) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00144' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000931' Status: Published Version: '1' -Description: 'A study geographic scope type must be specified using the - geographic scope type (C207412) DDF codelist.' +Description: 'A study geographic scope type must be specified using the geographic scope type (C207412) + DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207412 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C207412 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study geographic scope type is not specified using the geographic - scope type (C207412) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The study geographic scope type is not specified using the geographic scope type (C207412) + DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - 'GeographicScope' Sensitivity: Record diff --git a/Published/CORE-000932/rule.yml b/Published/CORE-000932/rule.yml index e6dbf5c1c..9a2ce63dc 100644 --- a/Published/CORE-000932/rule.yml +++ b/Published/CORE-000932/rule.yml @@ -1,152 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A quantity's unit must be coded according to the extensible - unit (C71620) SDTM codelist (e.g. an entry with a code or - decode used from the codelist should be consistent with the - full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00145' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A quantity's unit must be coded according to the extensible unit (C71620) SDTM + codelist (e.g. an entry with a code or decode used from the codelist should be consistent with + the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00145' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: unit - operator: exists - - name: unit - operator: equal_to - value: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: unit + operator: exists + - name: unit + operator: equal_to + value: true + - not: + all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000932' Status: Published Version: '1' -Description: "A quantity's unit must be coded according to the extensible unit - (C71620) SDTM codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the codelist)." +Description: "A quantity's unit must be coded according to the extensible unit (C71620) SDTM codelist + (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry + in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C71620 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C71620 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion Outcome: - Message: 'The quantity''s unit is not specified according to the extensible unit - (C71620) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, and/or the code - or decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive).' + Message: 'The quantity''s unit is not specified according to the extensible unit (C71620) SDTM codelist + - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, + and/or the code or decode (either as preferred term or as submission value) is found in the codelist + (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - value + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Quantity' + - 'Quantity' Sensitivity: Record diff --git a/Published/CORE-000933/rule.yml b/Published/CORE-000933/rule.yml index 504e1c45c..ddfa216fb 100644 --- a/Published/CORE-000933/rule.yml +++ b/Published/CORE-000933/rule.yml @@ -1,159 +1,156 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study title type must be specified using the study title type - (C207419) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00146' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study title type must be specified using the study title type - (C207419) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00146' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study title type must be specified using the study title type (C207419) DDF + codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00146' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study title type must be specified using the study title type (C207419) DDF + codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00146' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000933' Status: Published Version: '1' -Description: 'A study title type must be specified using the study title type - (C207419) DDF codelist.' +Description: 'A study title type must be specified using the study title type (C207419) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207419 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C207419 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study title type is not specified using the study title type - (C207419) DDF codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The study title type is not specified using the study title type (C207419) DDF codelist - + codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, + the code or decode (either as preferred term or as submission value) is found in the codelist (case + insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), + and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyTitle' + - 'StudyTitle' Sensitivity: Record diff --git a/Published/CORE-000934/rule.yml b/Published/CORE-000934/rule.yml index d80554ced..c5b1004ae 100644 --- a/Published/CORE-000934/rule.yml +++ b/Published/CORE-000934/rule.yml @@ -1,91 +1,81 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: - SERUM, PLASMA, URINE. If multiple specimen types are used for - a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how - to populate." - Document: IG v3.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: - SERUM, PLASMA, URINE. If multiple specimen types are used for - a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how - to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: - SERUM, PLASMA, URINE. If multiple specimen types are used for - a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how - to populate." - Document: IG v3.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: - SERUM, PLASMA, URINE. If multiple specimen types are used for - a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how - to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: - SERUM, PLASMA, URINE. If multiple specimen types are used for - a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how - to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.0" Check: # 2022-09-29: Currently it is only checked whether the semicolon is correctly used as the separator # TODO: values must be checked against [SPEC] codelist, which requires use of the CDISC-Library API @@ -99,52 +89,51 @@ Check: # value: ^[A-Za-z\s,]+(;[A-Za-z\s,]+)*$ # PPSPEC value contains a semicolon # TODO: check whether each "splitted part follows the CT for "SPEC" (codelist) - - name: PPSPEC - operator: contains - value: ';' + - name: PPSPEC + operator: contains + value: ';' # 2025-11-19: part that iterates of the "splitted parts" and checks each of them #- name: $ppspec_value # operator: not_contains_all # value: $ppspec_codelist # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY - - name: $ppspec_codelist - operator: not_contains_all - value: $ppspec_value + - name: $ppspec_codelist + operator: not_contains_all + value: $ppspec_value # operator: not_equal_to # value: 'TEST' Core: Id: CORE-000934 Status: Published Version: "1" -Description: If multiple specimen types are used for a calculation (e.g., serum - and urine for creatinine clearance), then this field should be populated with - values from the (SPEC) Controlled Terminology codelist delimited by a - semicolon. +Description: If multiple specimen types are used for a calculation (e.g., serum and urine for + creatinine clearance), then this field should be populated with values from the (SPEC) Controlled + Terminology codelist delimited by a semicolon. Executability: Fully Executable Operations: - - delimiter: ';' - id: $ppspec_value - name: PPSPEC - operator: split_by - - codelists: - - SPEC - ct_package_type: SEND - id: $ppspec_codelist - level: term - operator: codelist_terms - returntype: value +- delimiter: ';' + id: $ppspec_value + name: PPSPEC + operator: split_by +- codelists: + - SPEC + ct_package_type: SEND + id: $ppspec_codelist + level: term + operator: codelist_terms + returntype: value Outcome: Message: The multiple specimens are not correctly separated by a semicolon Output Variables: - - PPSPEC - - $ppspec_value - - $ppspec_codelist + - PPSPEC + - $ppspec_value + - $ppspec_codelist Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000935/rule.yml b/Published/CORE-000935/rule.yml index 45d20a150..3c61a7919 100644 --- a/Published/CORE-000935/rule.yml +++ b/Published/CORE-000935/rule.yml @@ -1,50 +1,50 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform - with the USDM schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00082' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform - with the USDM schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00082' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform with the USDM + schema based on the API specification.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00082' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform with the USDM + schema based on the API specification.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00082' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: validator - operator: equal_to - value: 'type' + - name: validator + operator: equal_to + value: 'type' Core: Id: 'CORE-000935' Status: Published Version: '1' -Description: 'Data types of attributes (string, number, boolean) must conform - with the USDM schema based on the API specification.' +Description: 'Data types of attributes (string, number, boolean) must conform with the USDM schema based + on the API specification.' Executability: Fully Executable Outcome: Message: 'The datatype of the attribute does not conform with the USDM schema.' Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Published/CORE-000936/rule.yml b/Published/CORE-000936/rule.yml index 03ba90218..f86b274e8 100644 --- a/Published/CORE-000936/rule.yml +++ b/Published/CORE-000936/rule.yml @@ -1,24 +1,24 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00086' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00086' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: $xhtml_errors + operator: non_empty Core: Id: 'CORE-000936' Status: Published @@ -26,25 +26,25 @@ Core: Description: 'Syntax template text is expected to be HTML formatted.' Executability: Partially Executable - Possible Overreporting Operations: - - id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors +- id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: Message: 'The text attribute contains non-conformant XHTML.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'Characteristic' - - 'Condition' - - 'EligibilityCriterion' - - 'Endpoint' - - 'Objective' + - 'Characteristic' + - 'Condition' + - 'EligibilityCriterion' + - 'Endpoint' + - 'Objective' Sensitivity: Record diff --git a/Published/CORE-000937/rule.yml b/Published/CORE-000937/rule.yml index 00c375b2f..0ec12e495 100644 --- a/Published/CORE-000937/rule.yml +++ b/Published/CORE-000937/rule.yml @@ -1,55 +1,52 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Attributes must be included as defined in the USDM schema based - on the API specification (i.e., all required properties are - present and no additional attributes are present).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00125' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Attributes must be included as defined in the USDM schema based - on the API specification (i.e., all required properties are - present and no additional attributes are present).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00125' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00125' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00125' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: validator - operator: is_contained_by - value: - - 'required' - - 'additionalProperties' + - name: validator + operator: is_contained_by + value: + - 'required' + - 'additionalProperties' Core: Id: 'CORE-000937' Status: Published Version: '1' -Description: 'Attributes must be included as defined in the USDM schema based on - the API specification (i.e., all required properties are present and no - additional attributes are present).' +Description: 'Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present).' Executability: Fully Executable Outcome: - Message: 'Attributes are not included as defined in the USDM schema - required - properties are missing or additional properties are present.' + Message: 'Attributes are not included as defined in the USDM schema - required properties are missing + or additional properties are present.' Output Variables: - - message + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Published/CORE-000938/rule.yml b/Published/CORE-000938/rule.yml index 152dbc3e2..b5d3c3c7e 100644 --- a/Published/CORE-000938/rule.yml +++ b/Published/CORE-000938/rule.yml @@ -1,59 +1,55 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on - the API specification (i.e., required properties have at least - one value and single-value properties are not lists).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00126' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on - the API specification (i.e., required properties have at least - one value and single-value properties are not lists).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00126' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on the API specification + (i.e., required properties have at least one value and single-value properties are not lists).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00126' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on the API specification + (i.e., required properties have at least one value and single-value properties are not lists).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00126' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: validator - operator: is_contained_by - value: - - 'minLength' - - 'minItems' - - 'maxItems' + - name: validator + operator: is_contained_by + value: + - 'minLength' + - 'minItems' + - 'maxItems' Core: Id: 'CORE-000938' Status: Published Version: '1' -Description: 'Cardinalities must be as defined in the USDM schema based on the - API specification (i.e., required properties have at least one value and - single-value properties are not lists).' +Description: 'Cardinalities must be as defined in the USDM schema based on the API specification (i.e., + required properties have at least one value and single-value properties are not lists).' Executability: Fully Executable Outcome: - Message: 'The cardinality of the attribute is not as defined in the USDM schema - - the attribute is required but does not have a value (the value is too - short), or the attribute is a list and has either too few entries (the list - is too short) or too many entries (the list is too long).' + Message: 'The cardinality of the attribute is not as defined in the USDM schema - the attribute is required + but does not have a value (the value is too short), or the attribute is a list and has either too + few entries (the list is too short) or too many entries (the list is too long).' Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Published/CORE-000939/rule.yml b/Published/CORE-000939/rule.yml index 01e20b7fd..5e085e867 100644 --- a/Published/CORE-000939/rule.yml +++ b/Published/CORE-000939/rule.yml @@ -1,159 +1,156 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An objective level must be specified using the objective level - (C188725) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00147' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An objective level must be specified using the objective level - (C188725) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00147' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An objective level must be specified using the objective level (C188725) DDF + codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00147' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An objective level must be specified using the objective level (C188725) DDF + codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00147' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level - operator: equal_to - value: true - - not: - all: - - name: level.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: level.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: level + operator: equal_to + value: true + - not: + all: + - name: level.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: level.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: level.code - operator: equal_to - value: $code_for_decode_pref_term - - name: level.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: level.decode - operator: equal_to - value: $pref_term_for_code - - name: level.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: level.code + operator: equal_to + value: $code_for_decode_pref_term + - name: level.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: level.decode + operator: equal_to + value: $pref_term_for_code + - name: level.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000939' Status: Published Version: '1' -Description: 'An objective level must be specified using the objective level - (C188725) DDF codelist.' +Description: 'An objective level must be specified using the objective level (C188725) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188725 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: level.code - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: level.code - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: level.decode - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: level.decode - version: level.codeSystemVersion +- id: $codelist_code + map: + - output: C188725 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: level.code + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: level.code + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: level.decode + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: level.decode + version: level.codeSystemVersion Outcome: - Message: 'The objective level is not specified using the objective level - (C188725) DDF codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The objective level is not specified using the objective level (C188725) DDF codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code + or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither + code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - level.code - - $code_for_decode_value - - $code_for_decode_pref_term - - level.codeSystem - - level.codeSystemVersion - - level.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - level.code + - $code_for_decode_value + - $code_for_decode_pref_term + - level.codeSystem + - level.codeSystemVersion + - level.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Objective' + - 'Objective' Sensitivity: Record diff --git a/Published/CORE-000940/rule.yml b/Published/CORE-000940/rule.yml index 210645ce4..ab6e43ff0 100644 --- a/Published/CORE-000940/rule.yml +++ b/Published/CORE-000940/rule.yml @@ -1,159 +1,154 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An endpoint level must be specified using the endpoint level - (C188726) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00148' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An endpoint level must be specified using the endpoint level - (C188726) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00148' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00148' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00148' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level - operator: equal_to - value: true - - not: - all: - - name: level.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: level.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: level + operator: equal_to + value: true + - not: + all: + - name: level.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: level.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: level.code - operator: equal_to - value: $code_for_decode_pref_term - - name: level.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: level.decode - operator: equal_to - value: $pref_term_for_code - - name: level.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: level.code + operator: equal_to + value: $code_for_decode_pref_term + - name: level.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: level.decode + operator: equal_to + value: $pref_term_for_code + - name: level.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000940' Status: Published Version: '1' -Description: 'An endpoint level must be specified using the endpoint level - (C188726) DDF codelist.' +Description: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188726 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: level.code - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: level.code - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: level.decode - version: level.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: level.decode - version: level.codeSystemVersion +- id: $codelist_code + map: + - output: C188726 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: level.code + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: level.code + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: level.decode + version: level.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: level.decode + version: level.codeSystemVersion Outcome: - Message: 'The endpoint level is not specified using the endpoint level (C188726) - DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion - is not a valid terminology package date, the code or decode (either as - preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive), and/or neither code nor decode is found in - the codelist.' + Message: 'The endpoint level is not specified using the endpoint level (C188726) DDF codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code + or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither + code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - level.code - - $code_for_decode_value - - $code_for_decode_pref_term - - level.codeSystem - - level.codeSystemVersion - - level.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - level.code + - $code_for_decode_value + - $code_for_decode_pref_term + - level.codeSystem + - level.codeSystemVersion + - level.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Endpoint' + - 'Endpoint' Sensitivity: Record diff --git a/Published/CORE-000941/rule.yml b/Published/CORE-000941/rule.yml index 16329e83c..0b1288f5c 100644 --- a/Published/CORE-000941/rule.yml +++ b/Published/CORE-000941/rule.yml @@ -1,190 +1,186 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study arm data origin type must be specified according to the - extensible data origin type (C188727) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00149' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study arm data origin type must be specified according to the - extensible data origin type (C188727) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00149' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study arm data origin type must be specified according to the extensible data + origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00149' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study arm data origin type must be specified according to the extensible data + origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00149' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: dataOriginType - operator: exists - - name: dataOriginType - operator: equal_to - value: true - - not: - all: - - name: dataOriginType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: dataOriginType.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: dataOriginType + operator: exists + - name: dataOriginType + operator: equal_to + value: true + - not: + all: + - name: dataOriginType.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: dataOriginType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: 'Y' + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: dataOriginType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: dataOriginType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: dataOriginType.decode - operator: equal_to - value: $pref_term_for_code - - name: dataOriginType.decode - operator: equal_to - value: $value_for_code + - name: dataOriginType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: dataOriginType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: dataOriginType.decode + operator: equal_to + value: $pref_term_for_code + - name: dataOriginType.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000941' Status: Published Version: '1' -Description: "A study arm data origin type must be specified according to the - extensible data origin type (C188727) DDF codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the full entry in - the codelist)." +Description: "A study arm data origin type must be specified according to the extensible data origin type + (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188727 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: dataOriginType.codeSystemVersion +- id: $codelist_code + map: + - output: C188727 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: dataOriginType.codeSystemVersion # DDF codelist extensibility was not defined in earlier CT packages and # defaults to false, so assigning an override: - - id: $codelist_extensible_override - map: - - dataOriginType.codeSystemVersion: '2022-09-30' - output: "Y" - - dataOriginType.codeSystemVersion: '2022-12-16' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-03-31' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-06-30' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-09-29' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-12-15' - output: "Y" - - dataOriginType.codeSystemVersion: '2024-03-29' - output: "Y" - operator: map - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: dataOriginType.code - version: dataOriginType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: dataOriginType.code - version: dataOriginType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: dataOriginType.decode - version: dataOriginType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: dataOriginType.decode - version: dataOriginType.codeSystemVersion +- id: $codelist_extensible_override + map: + - dataOriginType.codeSystemVersion: '2022-09-30' + output: "Y" + - dataOriginType.codeSystemVersion: '2022-12-16' + output: "Y" + - dataOriginType.codeSystemVersion: '2023-03-31' + output: "Y" + - dataOriginType.codeSystemVersion: '2023-06-30' + output: "Y" + - dataOriginType.codeSystemVersion: '2023-09-29' + output: "Y" + - dataOriginType.codeSystemVersion: '2023-12-15' + output: "Y" + - dataOriginType.codeSystemVersion: '2024-03-29' + output: "Y" + operator: map +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: dataOriginType.code + version: dataOriginType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: dataOriginType.code + version: dataOriginType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: dataOriginType.decode + version: dataOriginType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: dataOriginType.decode + version: dataOriginType.codeSystemVersion Outcome: - Message: 'The study arm data origin type is not specified according to the - extensible data origin type (C188727) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The study arm data origin type is not specified according to the extensible data origin type + (C188727) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - dataOriginType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - dataOriginType.codeSystem - - dataOriginType.codeSystemVersion - - dataOriginType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - dataOriginType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - dataOriginType.codeSystem + - dataOriginType.codeSystemVersion + - dataOriginType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyArm' + - 'StudyArm' Sensitivity: Record diff --git a/Published/CORE-000942/rule.yml b/Published/CORE-000942/rule.yml index 146f9695b..ceb8223f4 100644 --- a/Published/CORE-000942/rule.yml +++ b/Published/CORE-000942/rule.yml @@ -1,190 +1,186 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter type must be specified according to the extensible - encounter type (C188728) DDF codelist (e.g. an entry with a - code or decode used from the codelist should be consistent - with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00150' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter type must be specified according to the extensible - encounter type (C188728) DDF codelist (e.g. an entry with a - code or decode used from the codelist should be consistent - with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00150' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter type must be specified according to the extensible encounter type + (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00150' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "An encounter type must be specified according to the extensible encounter type + (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00150' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: 'Y' + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000942' Status: Published Version: '1' -Description: "An encounter type must be specified according to the extensible - encounter type (C188728) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the - codelist)." +Description: "An encounter type must be specified according to the extensible encounter type (C188728) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the + full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188728 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C188728 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion # DDF codelist extensibility was not defined in earlier CT packages and # defaults to false, so assigning an override: - - id: $codelist_extensible_override - map: - - output: "Y" - type.codeSystemVersion: '2022-09-30' - - output: "Y" - type.codeSystemVersion: '2022-12-16' - - output: "Y" - type.codeSystemVersion: '2023-03-31' - - output: "Y" - type.codeSystemVersion: '2023-06-30' - - output: "Y" - type.codeSystemVersion: '2023-09-29' - - output: "Y" - type.codeSystemVersion: '2023-12-15' - - output: "Y" - type.codeSystemVersion: '2024-03-29' - operator: map - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_extensible_override + map: + - output: "Y" + type.codeSystemVersion: '2022-09-30' + - output: "Y" + type.codeSystemVersion: '2022-12-16' + - output: "Y" + type.codeSystemVersion: '2023-03-31' + - output: "Y" + type.codeSystemVersion: '2023-06-30' + - output: "Y" + type.codeSystemVersion: '2023-09-29' + - output: "Y" + type.codeSystemVersion: '2023-12-15' + - output: "Y" + type.codeSystemVersion: '2024-03-29' + operator: map +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The encounter type is not specified according to the extensible - encounter type (C188728) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The encounter type is not specified according to the extensible encounter type (C188728) DDF + codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, and/or the code or decode (either as preferred term or as submission value) is found + in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - 'Encounter' Sensitivity: Record diff --git a/Published/CORE-000943/rule.yml b/Published/CORE-000943/rule.yml index 3094b88ce..204c3e19d 100644 --- a/Published/CORE-000943/rule.yml +++ b/Published/CORE-000943/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study definition document type must be specified according to - the extensible study definition document type (C215477) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00166' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study definition document type must be specified according to the extensible + study definition document type (C215477) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00166' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000943' Status: Published Version: '1' -Description: "A study definition document type must be specified according to - the extensible study definition document type (C215477) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study definition document type must be specified according to the extensible study definition + document type (C215477) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215477 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C215477 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study definition document type is not specified according to the - extensible study definition document type (C215477) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study definition document type is not specified according to the extensible study definition + document type (C215477) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocument' + - 'StudyDefinitionDocument' Sensitivity: Record diff --git a/Published/CORE-000944/rule.yml b/Published/CORE-000944/rule.yml index 558e50f54..287eeb273 100644 --- a/Published/CORE-000944/rule.yml +++ b/Published/CORE-000944/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A piece of narrative content must only reference narrative - content items that have been defined within the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00168' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A piece of narrative content must only reference narrative content items that + have been defined within the study.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00168' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.study)@$s.$s.documentedBy@$sd. $sd.versions@$sv. @@ -43,23 +43,23 @@ Core: Id: 'CORE-000944' Status: Published Version: '1' -Description: 'A piece of narrative content must only reference narrative content - items that have been defined within the study.' +Description: 'A piece of narrative content must only reference narrative content items that have been + defined within the study.' Executability: Fully Executable Outcome: - Message: 'The reference to the narrative content item is not targetting a - narrative content item that has been defined within the study.' + Message: 'The reference to the narrative content item is not targetting a narrative content item that + has been defined within the study.' Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - contentItemId - - sectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - contentItemId + - sectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-000945/rule.yml b/Published/CORE-000945/rule.yml index 34955845b..34e8ec58a 100644 --- a/Published/CORE-000945/rule.yml +++ b/Published/CORE-000945/rule.yml @@ -1,24 +1,24 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00247' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00247' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: $xhtml_errors + operator: non_empty Core: Id: 'CORE-000945' Status: Published @@ -26,26 +26,26 @@ Core: Description: 'Syntax template text is expected to be HTML formatted.' Executability: Partially Executable - Possible Overreporting Operations: - - id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors +- id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: Message: 'The text attribute contains non-conformant XHTML.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'Characteristic' - - 'Condition' - - 'EligibilityCriterionItem' - - 'Endpoint' - - 'IntercurrentEvent' - - 'Objective' + - 'Characteristic' + - 'Condition' + - 'EligibilityCriterionItem' + - 'Endpoint' + - 'IntercurrentEvent' + - 'Objective' Sensitivity: Record diff --git a/Published/CORE-000946/rule.yml b/Published/CORE-000946/rule.yml index a1421bb77..7f78a10e2 100644 --- a/Published/CORE-000946/rule.yml +++ b/Published/CORE-000946/rule.yml @@ -1,77 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is - used - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND351 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is - used - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND351 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used + Document: IG-DART v1.1 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND351 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used + Document: IG-DART v1.2 + Section: '4.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND351 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # RPPLDY ^= null OR RPPLSTDY ^= null OR RPPLENDY ^= null OR --RPDY ^= null OR --RPSTDY ^= null OR --RPENDY ^= null - - any: - - all: - - name: RPPLDY - operator: exists - - name: RPPLDY - operator: non_empty - - all: - - name: RPPLSTDY - operator: exists - - name: RPPLSTDY - operator: non_empty - - all: - - name: RPPLENDY - operator: exists - - name: RPPLENDY - operator: non_empty - - all: - - name: --RPDY - operator: exists - - name: --RPDY - operator: non_empty - - all: - - name: --RPSTDY - operator: exists - - name: --RPSTDY - operator: non_empty - - all: - - name: --RPENDY - operator: exists - - name: --RPENDY - operator: non_empty + - any: + - all: + - name: RPPLDY + operator: exists + - name: RPPLDY + operator: non_empty + - all: + - name: RPPLSTDY + operator: exists + - name: RPPLSTDY + operator: non_empty + - all: + - name: RPPLENDY + operator: exists + - name: RPPLENDY + operator: non_empty + - all: + - name: --RPDY + operator: exists + - name: --RPDY + operator: non_empty + - all: + - name: --RPSTDY + operator: exists + - name: --RPSTDY + operator: non_empty + - all: + - name: --RPENDY + operator: exists + - name: --RPENDY + operator: non_empty # when one of the above is populated, RPHASE may not be empty - - name: RPHASE - operator: empty + - name: RPHASE + operator: empty Core: Id: CORE-000946 Status: Published Version: '1' -Description: Raise an error when one of the timing variables is populated and - RPHASE is not populated +Description: Raise an error when one of the timing variables is populated and RPHASE is not + populated Executability: Fully Executable Outcome: Message: RPHASE must be populated when one of the timing variables is populated @@ -79,10 +77,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000947/rule.yml b/Published/CORE-000947/rule.yml index 055c674d6..decc13b64 100644 --- a/Published/CORE-000947/rule.yml +++ b/Published/CORE-000947/rule.yml @@ -1,123 +1,116 @@ Authorities: # TODO in future? Possibly merge with CG0013, TIG0298 - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those that are from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.0 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general - observation class) must not be added, and existing variables - must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'New variables (other than those that are from the same general observation class) + must not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.0 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.1 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.1.1 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.1.1 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.1 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage.' + Document: IG v3.1.1 + Section: '2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # TODO in future?: add to rule implementation of rules CG0013, TIG0298 # Difference is that the current SEND rule is limited to Interventions, Findings, Events # Whereas CG0013, TIG0298 is for all classes - - name: 'variable_name' - operator: 'is_not_contained_by' - value: $allowed_variables + - name: 'variable_name' + operator: 'is_not_contained_by' + value: $allowed_variables Core: + Id: CORE-000947 Status: Published Version: '1' - Id: CORE-000947 -Description: 'Report a violation when the variable is not found in the - underlying SDTM model for the same observation class' +Description: 'Report a violation when the variable is not found in the underlying SDTM model for the same + observation class' # Set to "partially executable" as the second part "and use is consistent with SDTM v1.5 definition" # cannot be implemented as machine-executable Executability: Partially Executable Operations: - - id: $allowed_variables - operator: get_model_column_order +- id: $allowed_variables + operator: get_model_column_order Outcome: - Message: 'The variable is not found in the underlying SDTM model for the same - observation class' + Message: 'The variable is not found in the underlying SDTM model for the same observation class' # Rule Type: Variable Metadata Check against Library Metadata Rule Type: Variable Metadata Check Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000948/rule.yml b/Published/CORE-000948/rule.yml index d615c0b33..612dd4f45 100644 --- a/Published/CORE-000948/rule.yml +++ b/Published/CORE-000948/rule.yml @@ -1,30 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each combination of arm and epoch must occur no more than once - within a study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00069' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each combination of arm and epoch must occur no more than once - within a study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00069' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each combination of arm and epoch must occur no more than once within a study + design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00069' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each combination of arm and epoch must occur no more than once within a study + design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00069' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.versions.studyDesigns@$sd. $filter($sd.studyCells,function($v,$i,$a) @@ -55,22 +55,20 @@ Core: Id: 'CORE-000948' Status: Published Version: '1' -Description: 'Each combination of arm and epoch must occur no more than once - within a study design.' +Description: 'Each combination of arm and epoch must occur no more than once within a study design.' Executability: Fully Executable Outcome: - Message: 'The combination of arm and epoch occurs more than once within the - study design.' + Message: 'The combination of arm and epoch occurs more than once within the study design.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - armId - - StudyArm.name - - epochId - - StudyEpoch.name + - StudyDesign.id + - StudyDesign.name + - armId + - StudyArm.name + - epochId + - StudyEpoch.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyCell' + - 'StudyCell' Sensitivity: Record diff --git a/Published/CORE-000949/rule.yml b/Published/CORE-000949/rule.yml index 4cbcad824..4639e5d42 100644 --- a/Published/CORE-000949/rule.yml +++ b/Published/CORE-000949/rule.yml @@ -1,53 +1,50 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Class relationships must conform with the USDM schema based on - the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00081' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Class relationships must conform with the USDM schema based on - the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00081' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Class relationships must conform with the USDM schema based on the API specification.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00081' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Class relationships must conform with the USDM schema based on the API specification.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00081' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: validator - operator: equal_to - value: 'const' - - name: error_attribute - operator: equal_to - value: 'instanceType' + - name: validator + operator: equal_to + value: 'const' + - name: error_attribute + operator: equal_to + value: 'instanceType' Core: Id: 'CORE-000949' Status: Published Version: '1' -Description: 'Class relationships must conform with the USDM schema based on the - API specification.' +Description: 'Class relationships must conform with the USDM schema based on the API specification.' Executability: Fully Executable Outcome: Message: 'The class relationship does not conform with the USDM schema.' Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Published/CORE-000950/rule.yml b/Published/CORE-000950/rule.yml index 6d5e52c47..73e61ddb8 100644 --- a/Published/CORE-000950/rule.yml +++ b/Published/CORE-000950/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must only reference an - epoch that is defined within the same study design as the - scheduled activity/decision instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00105' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must only reference an - epoch that is defined within the same study design as the - scheduled activity/decision instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00105' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity/decision instance must only reference an epoch that is defined + within the same study design as the scheduled activity/decision instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00105' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity/decision instance must only reference an epoch that is defined + within the same study design as the scheduled activity/decision instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00105' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $lkp:=$merge($.**.studyDesigns.epochs.{id:%.id}); @@ -50,23 +48,22 @@ Core: Id: 'CORE-000950' Status: Published Version: '1' -Description: 'A scheduled activity/decision instance must only reference an - epoch that is defined within the same study design as the scheduled - activity/decision instance.' +Description: 'A scheduled activity/decision instance must only reference an epoch that is defined within + the same study design as the scheduled activity/decision instance.' Executability: Fully Executable Outcome: - Message: 'The scheduled activity/decision instance references an epoch that is - not defined within the same study design.' + Message: 'The scheduled activity/decision instance references an epoch that is not defined within the + same study design.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - epochId - - "Referenced epoch's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - epochId + - "Referenced epoch's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' + - 'ScheduledActivityInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-000951/rule.yml b/Published/CORE-000951/rule.yml index a8a952d3f..c97d8e875 100644 --- a/Published/CORE-000951/rule.yml +++ b/Published/CORE-000951/rule.yml @@ -1,148 +1,145 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version''s status must be specified - using the status Value Set Terminology (C188723) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00169' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study definition document version''s status must be specified using the status + Value Set Terminology (C188723) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00169' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: status - operator: equal_to - value: true - - not: - all: - - name: status.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: status.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: status + operator: equal_to + value: true + - not: + all: + - name: status.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: status.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: status.code - operator: equal_to - value: $code_for_decode_pref_term - - name: status.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: status.decode - operator: equal_to - value: $pref_term_for_code - - name: status.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: status.code + operator: equal_to + value: $code_for_decode_pref_term + - name: status.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: status.decode + operator: equal_to + value: $pref_term_for_code + - name: status.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000951' Status: Published Version: '1' -Description: 'A study definition document version''s status must be specified - using the status Value Set Terminology (C188723) DDF codelist.' +Description: 'A study definition document version''s status must be specified using the status Value Set + Terminology (C188723) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188723 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: status.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: status.code - version: status.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: status.code - version: status.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: status.decode - version: status.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: status.decode - version: status.codeSystemVersion +- id: $codelist_code + map: + - output: C188723 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: status.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: status.code + version: status.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: status.code + version: status.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: status.decode + version: status.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: status.decode + version: status.codeSystemVersion Outcome: - Message: 'The study definition document version''s status is not specified using - the status Value Set Terminology (C188723) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The study definition document version''s status is not specified using the status Value Set + Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is + not a valid terminology package date, the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - version - - $codelist_code - - $codelist_extensible - - status.code - - $code_for_decode_value - - $code_for_decode_pref_term - - status.codeSystem - - status.codeSystemVersion - - status.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - version + - $codelist_code + - $codelist_extensible + - status.code + - $code_for_decode_value + - $code_for_decode_pref_term + - status.codeSystem + - status.codeSystemVersion + - status.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - 'StudyDefinitionDocumentVersion' Sensitivity: Record diff --git a/Published/CORE-000953/rule.yml b/Published/CORE-000953/rule.yml index 81c622030..9ce7d1696 100644 --- a/Published/CORE-000953/rule.yml +++ b/Published/CORE-000953/rule.yml @@ -2,128 +2,124 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the - record(s) to which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the - general-observation-class dataset that identifies the related - record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000953 Status: Published Version: '1' -Description: Part C - Raise and error when IDVAR in CO is not populated with a - valid variable from the dataset referenced in RDOMAIN. +Description: Part C - Raise and error when IDVAR in CO is not populated with a valid variable from + the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: - - Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: CO +- Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: CO Operations: - - domain: CO - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true +- domain: CO + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in CO does not represent a variable present in the - dataset referenced in RDOMAIN. + Message: Value for IDVAR in CO does not represent a variable present in the dataset referenced in + RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000954/rule.yml b/Published/CORE-000954/rule.yml index d5ec78d72..548b2d4f0 100644 --- a/Published/CORE-000954/rule.yml +++ b/Published/CORE-000954/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity with children must not refer to a timeline, - procedure, biomedical concept, biomedical concept category or - biomedical concept surrogate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00160' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity with children must not refer to a timeline, procedure, biomedical + concept, biomedical concept category or biomedical concept surrogate.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00160' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.activities@$p. @@ -45,27 +44,25 @@ Core: Id: 'CORE-000954' Status: Published Version: '1' -Description: 'An activity with children must not refer to a timeline, procedure, - biomedical concept, biomedical concept category or biomedical concept - surrogate.' +Description: 'An activity with children must not refer to a timeline, procedure, biomedical concept, biomedical + concept category or biomedical concept surrogate.' Executability: Fully Executable Outcome: - Message: 'The activity has children but also refers to a timeline, procedure, - biomedical concept, biomedical concept category, or biomedical concept - surrogate as well.' + Message: 'The activity has children but also refers to a timeline, procedure, biomedical concept, biomedical + concept category, or biomedical concept surrogate as well.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - childIds - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds - - timelineId - - definedProcedures.id + - StudyDesign.id + - StudyDesign.name + - name + - childIds + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds + - timelineId + - definedProcedures.id Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-000955/rule.yml b/Published/CORE-000955/rule.yml index 72e4b69ca..7ed2865a1 100644 --- a/Published/CORE-000955/rule.yml +++ b/Published/CORE-000955/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every identifier must be unique within the scope of an - identified organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00173' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every identifier must be unique within the scope of an identified organization.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00173' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ( @@ -38,23 +37,21 @@ Core: Id: 'CORE-000955' Status: Published Version: '1' -Description: 'Every identifier must be unique within the scope of an identified - organization.' +Description: 'Every identifier must be unique within the scope of an identified organization.' Executability: Fully Executable Outcome: - Message: 'The identifier text is not unique within the scope of the identified - organization.' + Message: 'The identifier text is not unique within the scope of the identified organization.' Output Variables: - - text - - scopeId - - Organization.name - - type.decode + - text + - scopeId + - Organization.name + - type.decode Rule Type: JSONata Scope: Entities: Include: - - 'StudyIdentifier' - - 'ReferenceIdentifier' - - 'AdministrableProductIdentifier' - - 'MedicalDeviceIdentifier' + - 'StudyIdentifier' + - 'ReferenceIdentifier' + - 'AdministrableProductIdentifier' + - 'MedicalDeviceIdentifier' Sensitivity: Record diff --git a/Published/CORE-000956/rule.yml b/Published/CORE-000956/rule.yml index 99e5cfad2..72188e383 100644 --- a/Published/CORE-000956/rule.yml +++ b/Published/CORE-000956/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An identified organization is not expected to have more than 1 - identifier for the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00174' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An identified organization is not expected to have more than 1 identifier for + the study.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00174' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ( @@ -38,18 +38,17 @@ Core: Id: 'CORE-000956' Status: Published Version: '1' -Description: 'An identified organization is not expected to have more than 1 - identifier for the study.' +Description: 'An identified organization is not expected to have more than 1 identifier for the study.' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'More than 1 study identifier is specified for the same organization.' Output Variables: - - text - - scopeId - - Organization.name + - text + - scopeId + - Organization.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyIdentifier' + - 'StudyIdentifier' Sensitivity: Record diff --git a/Published/CORE-000957/rule.yml b/Published/CORE-000957/rule.yml index 473042377..523c269a7 100644 --- a/Published/CORE-000957/rule.yml +++ b/Published/CORE-000957/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable product property type must be specified - according to the extensible administrable product property - type (C215479) DDF codelist (e.g. an entry with a code or - decode used from the codelist should be consistent with the - full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00180' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An administrable product property type must be specified according to the extensible + administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode + used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00180' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000957' Status: Published Version: '1' -Description: "An administrable product property type must be specified according - to the extensible administrable product property type (C215479) DDF codelist - (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." +Description: "An administrable product property type must be specified according to the extensible administrable + product property type (C215479) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215479 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C215479 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The administrable product property type is not specified according to - the extensible administrable product property type (C215479) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The administrable product property type is not specified according to the extensible administrable + product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProductProperty' + - 'AdministrableProductProperty' Sensitivity: Record diff --git a/Published/CORE-000958/rule.yml b/Published/CORE-000958/rule.yml index 26bb5f77c..0b6c3e6ce 100644 --- a/Published/CORE-000958/rule.yml +++ b/Published/CORE-000958/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A reference identifier type must be specified according to the - extensible reference identifier type (C215478) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00183' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A reference identifier type must be specified according to the extensible reference + identifier type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00183' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000958' Status: Published Version: '1' -Description: "A reference identifier type must be specified according to the - extensible reference identifier type (C215478) DDF codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the - full entry in the codelist)." +Description: "A reference identifier type must be specified according to the extensible reference identifier + type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215478 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C215478 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The reference identifier type is not specified according to the - extensible reference identifier type (C215478) DDF codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The reference identifier type is not specified according to the extensible reference identifier + type (C215478) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a + valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ReferenceIdentifier' + - 'ReferenceIdentifier' Sensitivity: Record diff --git a/Published/CORE-000959/rule.yml b/Published/CORE-000959/rule.yml index b2177d26b..34f7cd8c5 100644 --- a/Published/CORE-000959/rule.yml +++ b/Published/CORE-000959/rule.yml @@ -1,153 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment impact type must be specified according to - the extensible study amendment impact type (C215481) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00199' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study amendment impact type must be specified according to the extensible study + amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00199' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000959' Status: Published Version: '1' -Description: "A study amendment impact type must be specified according to the - extensible study amendment impact type (C215481) DDF codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the - full entry in the codelist)." +Description: "A study amendment impact type must be specified according to the extensible study amendment + impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215481 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C215481 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study impact type is not specified according to the extensible - study amendment impact type (C215481) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The study impact type is not specified according to the extensible study amendment impact + type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a + valid terminology package date, and/or the code or decode (either as preferred term or as submission + value) is found in the codelist (case insensitive) but the corresponding decode or code does not match + the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyAmendmentImpact' + - 'StudyAmendmentImpact' Sensitivity: Record diff --git a/Published/CORE-000960/rule.yml b/Published/CORE-000960/rule.yml index 2b9bf9113..4c6aad6b0 100644 --- a/Published/CORE-000960/rule.yml +++ b/Published/CORE-000960/rule.yml @@ -1,24 +1,24 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00085' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Narrative content text is expected to be HTML formatted.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00085' + Version: '1' + Version: '1.0' + Version: '3.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: $xhtml_errors + operator: non_empty Core: Id: 'CORE-000960' Status: Published @@ -26,21 +26,21 @@ Core: Description: 'Narrative content text is expected to be HTML formatted.' Executability: Partially Executable - Possible Overreporting Operations: - - id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors +- id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: Message: 'The narrative content text contains non-conformant XHTML.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-000961/rule.yml b/Published/CORE-000961/rule.yml index c5a27087f..b4e4fdcfc 100644 --- a/Published/CORE-000961/rule.yml +++ b/Published/CORE-000961/rule.yml @@ -1,34 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Encounter ordering using previous and next attributes is - expected to be consistent with the order of corresponding - scheduled activity instances according to their specified - default conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00087' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Encounter ordering using previous and next attributes is - expected to be consistent with the order of corresponding - scheduled activity instances according to their specified - default conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00087' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Encounter ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00087' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Encounter ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00087' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd. @@ -56,27 +54,25 @@ Core: Id: 'CORE-000961' Status: Published Version: '1' -Description: 'Encounter ordering using previous and next attributes is expected - to be consistent with the order of corresponding scheduled activity instances - according to their specified default conditions.' +Description: 'Encounter ordering using previous and next attributes is expected to be consistent with + the order of corresponding scheduled activity instances according to their specified default conditions.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The order of the encounters in the study design (as defined by the - next attribute) does not match the order of encounters as referenced from - scheduled activity instances in the main timeline that are ordered by - default condition.' + Message: 'The order of the encounters in the study design (as defined by the next attribute) does not + match the order of encounters as referenced from scheduled activity instances in the main timeline + that are ordered by default condition.' Output Variables: - - name - - ScheduleTimeline.id - - ScheduleTimeline.name - - ScheduleTimeline.mainTimeline - - Encounter order by previous/next - - Encounter order by timeline refs + - name + - ScheduleTimeline.id + - ScheduleTimeline.name + - ScheduleTimeline.mainTimeline + - Encounter order by previous/next + - Encounter order by timeline refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000962/rule.yml b/Published/CORE-000962/rule.yml index 6f8ed654c..1c8973707 100644 --- a/Published/CORE-000962/rule.yml +++ b/Published/CORE-000962/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned completion number is - defined, it must be specified either in the study population - or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00132' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned completion number is - defined, it must be specified either in the study population - or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00132' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if a planned completion number is defined, it must be + specified either in the study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00132' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if a planned completion number is defined, it must be + specified either in the study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00132' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -70,25 +68,24 @@ Core: Id: 'CORE-000962' Status: Published Version: '1' -Description: 'Within a study design, if a planned completion number is defined, - it must be specified either in the study population or in all cohorts.' +Description: 'Within a study design, if a planned completion number is defined, it must be specified either + in the study population or in all cohorts.' Executability: Fully Executable Outcome: - Message: 'A planned completion number has been specified for both the study - population and one or more cohorts, or it has been specified for only a - subset of the cohorts.' + Message: 'A planned completion number has been specified for both the study population and one or more + cohorts, or it has been specified for only a subset of the cohorts.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedCompletionNumber.id - - plannedCompletionNumber(value/range) - - cohorts.name - - cohorts.plannedCompletionNumber.id - - cohorts.plannedCompletionNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedCompletionNumber.id + - plannedCompletionNumber(value/range) + - cohorts.name + - cohorts.plannedCompletionNumber.id + - cohorts.plannedCompletionNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000963/rule.yml b/Published/CORE-000963/rule.yml index a34c66444..039d913f2 100644 --- a/Published/CORE-000963/rule.yml +++ b/Published/CORE-000963/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned enrollment number is - defined, it must be specified either in the study population - or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00133' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned enrollment number is - defined, it must be specified either in the study population - or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00133' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if a planned enrollment number is defined, it must be + specified either in the study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00133' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if a planned enrollment number is defined, it must be + specified either in the study population or in all cohorts.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00133' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -70,25 +68,24 @@ Core: Id: 'CORE-000963' Status: Published Version: '1' -Description: 'Within a study design, if a planned enrollment number is defined, - it must be specified either in the study population or in all cohorts.' +Description: 'Within a study design, if a planned enrollment number is defined, it must be specified either + in the study population or in all cohorts.' Executability: Fully Executable Outcome: - Message: 'A planned enrollment number has been specified for both the study - population and the cohorts, or it has been specified for only a subset of - the cohorts.' + Message: 'A planned enrollment number has been specified for both the study population and the cohorts, + or it has been specified for only a subset of the cohorts.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedEnrollmentNumber.id - - plannedEnrollmentNumber(value/range) - - cohorts.name - - cohorts.plannedEnrollmentNumber.id - - cohorts.plannedEnrollmentNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedEnrollmentNumber.id + - plannedEnrollmentNumber(value/range) + - cohorts.name + - cohorts.plannedEnrollmentNumber.id + - cohorts.plannedEnrollmentNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000964/rule.yml b/Published/CORE-000964/rule.yml index 25a2dd6e6..f840d7e41 100644 --- a/Published/CORE-000964/rule.yml +++ b/Published/CORE-000964/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a section number is to be displayed then a number must be - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00164' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a section number is to be displayed then a number must be specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00164' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.documentedBy)@$db. $db.versions@$sv. @@ -48,19 +47,18 @@ Core: Description: 'If a section number is to be displayed then a number must be specified.' Executability: Fully Executable Outcome: - Message: 'A section number is indicated to be displayed - (displaySectionNumber=true) but not specified.' + Message: 'A section number is indicated to be displayed (displaySectionNumber=true) but not specified.' Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - displaySectionNumber - - sectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - displaySectionNumber + - sectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-000965/rule.yml b/Published/CORE-000965/rule.yml index f840cee75..299742683 100644 --- a/Published/CORE-000965/rule.yml +++ b/Published/CORE-000965/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a section title is to be displayed then a title must be - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00165' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a section title is to be displayed then a title must be specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00165' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.documentedBy)@$db. $db.versions@$sv. @@ -48,19 +47,18 @@ Core: Description: 'If a section title is to be displayed then a title must be specified.' Executability: Fully Executable Outcome: - Message: 'A section title is indicated to be displayed - (displaySectionTitle=true) but not specified.' + Message: 'A section title is indicated to be displayed (displaySectionTitle=true) but not specified.' Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - displaySectionTitle - - sectionTitle + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - displaySectionTitle + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-000966/rule.yml b/Published/CORE-000966/rule.yml index 3782eeb49..93959b122 100644 --- a/Published/CORE-000966/rule.yml +++ b/Published/CORE-000966/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If an administration''s dose is specified then a corresponding - route is expected and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00177' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If an administration''s dose is specified then a corresponding route is expected + and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00177' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.studyInterventions)@$si. $si.administrations@$sa. @@ -47,22 +47,22 @@ Core: Id: 'CORE-000966' Status: Published Version: '1' -Description: 'If an administration''s dose is specified then a corresponding - route is expected and vice versa.' +Description: 'If an administration''s dose is specified then a corresponding route is expected and vice + versa.' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The administration dose has been specified without a route or vice versa.' Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value) - - route.id - - route + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value) + - route.id + - route Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000967/rule.yml b/Published/CORE-000967/rule.yml index 22e7337ae..bc9039e91 100644 --- a/Published/CORE-000967/rule.yml +++ b/Published/CORE-000967/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a dose is specified then a corresponding frequency must also - be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00178' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a dose is specified then a corresponding frequency must also be specified.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00178' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.studyInterventions)@$si. $si.administrations@$sa. @@ -55,16 +54,16 @@ Executability: Fully Executable Outcome: Message: 'The administration dose has been specified without a frequency.' Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value/range) - - frequency.id - - frequency + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value/range) + - frequency.id + - frequency Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000968/rule.yml b/Published/CORE-000968/rule.yml index c21186297..29c3dbb06 100644 --- a/Published/CORE-000968/rule.yml +++ b/Published/CORE-000968/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study definition document version, if a date of a - specific type exists with a global geographic scope then no - other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00182' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study definition document version, if a date of a specific type exists + with a global geographic scope then no other dates are expected with the same type.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00182' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study@$s. $s.documentedBy@$sdd. @@ -41,25 +40,23 @@ Core: Id: 'CORE-000968' Status: Published Version: '1' -Description: 'Within a study definition document version, if a date of a - specific type exists with a global geographic scope then no other dates are - expected with the same type.' +Description: 'Within a study definition document version, if a date of a specific type exists with a global + geographic scope then no other dates are expected with the same type.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: "There is more than one date of this type for the study definition - document version, but at least one of the dates has a global geographic - scope." + Message: "There is more than one date of this type for the study definition document version, but at + least one of the dates has a global geographic scope." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - type - - dateValue - - geographicScopes.type + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - type + - dateValue + - geographicScopes.type Rule Type: JSONata Scope: Entities: Include: - - 'GovernanceDate' + - 'GovernanceDate' Sensitivity: Record diff --git a/Published/CORE-000969/rule.yml b/Published/CORE-000969/rule.yml index c88a4bb4b..f4fa42691 100644 --- a/Published/CORE-000969/rule.yml +++ b/Published/CORE-000969/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a dose is specified, then a corresponding administrable - product must also be specified either directly or embedded in - the medical device and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00185' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a dose is specified, then a corresponding administrable product must also + be specified either directly or embedded in the medical device and vice versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00185' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyInterventions@$si. @@ -56,28 +55,26 @@ Core: Id: 'CORE-000969' Status: Published Version: '1' -Description: 'If a dose is specified, then a corresponding administrable product - must also be specified either directly or embedded in the medical device and - vice versa.' +Description: 'If a dose is specified, then a corresponding administrable product must also be specified + either directly or embedded in the medical device and vice versa.' Executability: Fully Executable Outcome: - Message: 'The administration dose has been specified without an administrable - product (either as a direct administrable product or as an embedded product - via the related medical device) or vice versa.' + Message: 'The administration dose has been specified without an administrable product (either as a direct + administrable product or as an embedded product via the related medical device) or vice versa.' Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value/range) - - administrableProductId - - medicalDeviceId - - MedicalDevice.name - - MedicalDevice.embeddedProductId - - AdministrableProduct.name + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value/range) + - administrableProductId + - medicalDeviceId + - MedicalDevice.name + - MedicalDevice.embeddedProductId + - AdministrableProduct.name Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000970/rule.yml b/Published/CORE-000970/rule.yml index f2d77d7ef..0bb9a137a 100644 --- a/Published/CORE-000970/rule.yml +++ b/Published/CORE-000970/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study role must apply to either a study version or at - least one study design, but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00189' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study role must apply to either a study version or at least one study design, + but not both.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00189' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ($sv.roles @@ -40,23 +40,22 @@ Core: Id: 'CORE-000970' Status: Published Version: '1' -Description: 'Every study role must apply to either a study version or at least - one study design, but not both.' +Description: 'Every study role must apply to either a study version or at least one study design, but + not both.' Executability: Fully Executable Outcome: - Message: 'The study role does not only apply to the study version or at least - one study design - it does not apply to anything, it applies to both the - study version and at least one study design, or it applies to something that - is not a study version or a study design.' + Message: 'The study role does not only apply to the study version or at least one study design - it + does not apply to anything, it applies to both the study version and at least one study design, or + it applies to something that is not a study version or a study design.' Output Variables: - - name - - code - - appliesToIds - - StudyVersion.id - - StudyVersion.studyDesigns.id + - name + - code + - appliesToIds + - StudyVersion.id + - StudyVersion.studyDesigns.id Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-000971/rule.yml b/Published/CORE-000971/rule.yml index b8303089b..039d6d56c 100644 --- a/Published/CORE-000971/rule.yml +++ b/Published/CORE-000971/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one attribute must be specified for an address.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00194' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least one attribute must be specified for an address.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00194' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.organizations@$o. $o.legalAddress[$not(text or lines or city or district or state or postalCode or country)]. @@ -41,18 +41,18 @@ Executability: Fully Executable Outcome: Message: 'All attributes of the address are blank.' Output Variables: - - Organization.id - - Organization.name - - text - - lines - - district - - city - - postalCode - - state - - country + - Organization.id + - Organization.name + - text + - lines + - district + - city + - postalCode + - state + - country Rule Type: JSONata Scope: Entities: Include: - - Address + - Address Sensitivity: Record diff --git a/Published/CORE-000972/rule.yml b/Published/CORE-000972/rule.yml index b79a397df..47da24d1d 100644 --- a/Published/CORE-000972/rule.yml +++ b/Published/CORE-000972/rule.yml @@ -1,176 +1,173 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An organization type must be specified according to the - extensible organization type (C188724) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00200' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An organization type must be specified according to the extensible organization + type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00200' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: 'Y' + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000972' Status: Published Version: '1' -Description: "An organization type must be specified according to the extensible - organization type (C188724) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the - codelist)." +Description: "An organization type must be specified according to the extensible organization type (C188724) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the + full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C188724 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C188724 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion # DDF codelist extensibility was not defined in earlier CT packages and # defaults to false, so assigning an override: - - id: $codelist_extensible_override - map: - - output: "Y" - type.codeSystemVersion: '2022-09-30' - - output: "Y" - type.codeSystemVersion: '2022-12-16' - - output: "Y" - type.codeSystemVersion: '2023-03-31' - - output: "Y" - type.codeSystemVersion: '2023-06-30' - - output: "Y" - type.codeSystemVersion: '2023-09-29' - - output: "Y" - type.codeSystemVersion: '2023-12-15' - - output: "Y" - type.codeSystemVersion: '2024-03-29' - operator: map - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_extensible_override + map: + - output: "Y" + type.codeSystemVersion: '2022-09-30' + - output: "Y" + type.codeSystemVersion: '2022-12-16' + - output: "Y" + type.codeSystemVersion: '2023-03-31' + - output: "Y" + type.codeSystemVersion: '2023-06-30' + - output: "Y" + type.codeSystemVersion: '2023-09-29' + - output: "Y" + type.codeSystemVersion: '2023-12-15' + - output: "Y" + type.codeSystemVersion: '2024-03-29' + operator: map +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The organization type is not specified according to the extensible - organization type (C188724) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The organization type is not specified according to the extensible organization type (C188724) + DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, and/or the code or decode (either as preferred term or as submission value) is found + in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Organization' + - 'Organization' Sensitivity: Record diff --git a/Published/CORE-000973/rule.yml b/Published/CORE-000973/rule.yml index 9f45c8a3d..f44e9de05 100644 --- a/Published/CORE-000973/rule.yml +++ b/Published/CORE-000973/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be exactly one study role with a code of sponsor.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00201' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'There must be exactly one study role with a code of sponsor.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00201' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ( @@ -32,15 +32,14 @@ Core: Description: 'There must be exactly one study role with a code of sponsor.' Executability: Fully Executable Outcome: - Message: 'There is not exactly one study role with a code of sponsor (where - code.code is C70793).' + Message: 'There is not exactly one study role with a code of sponsor (where code.code is C70793).' Output Variables: - - versionIdentifier - - '# Sponsor Roles' - - 'Sponsor Roles' + - versionIdentifier + - '# Sponsor Roles' + - 'Sponsor Roles' Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-000974/rule.yml b/Published/CORE-000974/rule.yml index 7a87e5434..b40d4bdb9 100644 --- a/Published/CORE-000974/rule.yml +++ b/Published/CORE-000974/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The sponsor study role must be applicable to a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00203' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The sponsor study role must be applicable to a study version.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00203' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ($sv.roles[code.code = "C70793" and $not($sv.id in appliesToIds)])@$r. @@ -32,18 +32,17 @@ Core: Description: 'The sponsor study role must be applicable to a study version.' Executability: Fully Executable Outcome: - Message: "The study role is a sponsor role (code.code is C70793) but it is not - applicable to the study version (appliesToIds does not contain the id of the - study version)." + Message: "The study role is a sponsor role (code.code is C70793) but it is not applicable to the study + version (appliesToIds does not contain the id of the study version)." Output Variables: - - name - - code.code - - code.decode - - appliesToIds - - StudyVersion.id + - name + - code.code + - code.decode + - appliesToIds + - StudyVersion.id Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-000975/rule.yml b/Published/CORE-000975/rule.yml index ee62a3a97..d16659368 100644 --- a/Published/CORE-000975/rule.yml +++ b/Published/CORE-000975/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A medical device identifier type must be specified according to - the extensible medical device identifier type (C215484) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00207' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A medical device identifier type must be specified according to the extensible + medical device identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00207' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000975' Status: Published Version: '1' -Description: "A medical device identifier type must be specified according to - the extensible medical device identifier type (C215484) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A medical device identifier type must be specified according to the extensible medical device + identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215484 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion +- id: $codelist_code + map: + - output: C215484 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The medical device identifier type is not specified according to the - extensible medical device identifier type (C215484) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The medical device identifier type is not specified according to the extensible medical device + identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'MedicalDeviceIdentifier' + - 'MedicalDeviceIdentifier' Sensitivity: Record diff --git a/Published/CORE-000976/rule.yml b/Published/CORE-000976/rule.yml index 13cebf0b4..8f10bd455 100644 --- a/Published/CORE-000976/rule.yml +++ b/Published/CORE-000976/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable product sourcing must be specified using the - extensible administrable product sourcing (C215483) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00208' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An administrable product sourcing must be specified using the extensible administrable + product sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00208' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: sourcing - operator: exists - - name: sourcing - operator: equal_to - value: true - - not: - all: - - name: sourcing.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: sourcing.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: sourcing + operator: exists + - name: sourcing + operator: equal_to + value: true + - not: + all: + - name: sourcing.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: sourcing.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: sourcing.code - operator: equal_to - value: $code_for_decode_pref_term - - name: sourcing.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: sourcing.decode - operator: equal_to - value: $pref_term_for_code - - name: sourcing.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: sourcing.code + operator: equal_to + value: $code_for_decode_pref_term + - name: sourcing.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: sourcing.decode + operator: equal_to + value: $pref_term_for_code + - name: sourcing.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000976' Status: Published Version: '1' -Description: "An administrable product sourcing must be specified using the - extensible administrable product sourcing (C215483) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "An administrable product sourcing must be specified using the extensible administrable product + sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215483 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: sourcing.code - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: sourcing.code - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: sourcing.decode - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: sourcing.decode - version: sourcing.codeSystemVersion +- id: $codelist_code + map: + - output: C215483 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: sourcing.code + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: sourcing.code + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: sourcing.decode + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: sourcing.decode + version: sourcing.codeSystemVersion Outcome: - Message: 'The administrable product sourcing is not specified according to the - extensible administrable product sourcing (C215483) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The administrable product sourcing is not specified according to the extensible administrable + product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - sourcing.code - - $code_for_decode_value - - $code_for_decode_pref_term - - sourcing.codeSystem - - sourcing.codeSystemVersion - - sourcing.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - sourcing.code + - $code_for_decode_value + - $code_for_decode_pref_term + - sourcing.codeSystem + - sourcing.codeSystemVersion + - sourcing.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - 'AdministrableProduct' Sensitivity: Record diff --git a/Published/CORE-000977/rule.yml b/Published/CORE-000977/rule.yml index ecae528b8..f39a60f4a 100644 --- a/Published/CORE-000977/rule.yml +++ b/Published/CORE-000977/rule.yml @@ -1,153 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A medical device sourcing must be specified using the - extensible medical device sourcing (C215482) DDF codelist - (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00209' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A medical device sourcing must be specified using the extensible medical device + sourcing (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00209' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: sourcing - operator: exists - - name: sourcing - operator: equal_to - value: true - - not: - all: - - name: sourcing.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: sourcing.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: sourcing + operator: exists + - name: sourcing + operator: equal_to + value: true + - not: + all: + - name: sourcing.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: sourcing.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: sourcing.code - operator: equal_to - value: $code_for_decode_pref_term - - name: sourcing.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: sourcing.decode - operator: equal_to - value: $pref_term_for_code - - name: sourcing.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: sourcing.code + operator: equal_to + value: $code_for_decode_pref_term + - name: sourcing.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: sourcing.decode + operator: equal_to + value: $pref_term_for_code + - name: sourcing.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000977' Status: Published Version: '1' -Description: "A medical device sourcing must be specified using the extensible - medical device sourcing (C215482) DDF codelist (e.g. an entry with a code or - decode used from the codelist should be consistent with the full entry in the - codelist)." +Description: "A medical device sourcing must be specified using the extensible medical device sourcing + (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215482 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: sourcing.code - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: sourcing.code - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: sourcing.decode - version: sourcing.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: sourcing.decode - version: sourcing.codeSystemVersion +- id: $codelist_code + map: + - output: C215482 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: sourcing.code + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: sourcing.code + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: sourcing.decode + version: sourcing.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: sourcing.decode + version: sourcing.codeSystemVersion Outcome: - Message: 'The medical device sourcing is not specified according to the - extensible medical device sourcing (C215482) DDF codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The medical device sourcing is not specified according to the extensible medical device sourcing + (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - sourcing.code - - $code_for_decode_value - - $code_for_decode_pref_term - - sourcing.codeSystem - - sourcing.codeSystemVersion - - sourcing.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - sourcing.code + - $code_for_decode_value + - $code_for_decode_pref_term + - sourcing.codeSystem + - sourcing.codeSystemVersion + - sourcing.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'MedicalDevice' + - 'MedicalDevice' Sensitivity: Record diff --git a/Published/CORE-000978/rule.yml b/Published/CORE-000978/rule.yml index 034918930..99846500c 100644 --- a/Published/CORE-000978/rule.yml +++ b/Published/CORE-000978/rule.yml @@ -1,148 +1,145 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An administrable product''s product designation must be - specified using the product designation (C207418) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00210' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An administrable product''s product designation must be specified using the product + designation (C207418) DDF codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00210' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: productDesignation - operator: equal_to - value: true - - not: - all: - - name: productDesignation.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: productDesignation.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: productDesignation + operator: equal_to + value: true + - not: + all: + - name: productDesignation.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: productDesignation.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_pref_term - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: productDesignation.decode - operator: equal_to - value: $pref_term_for_code - - name: productDesignation.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_pref_term + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: productDesignation.decode + operator: equal_to + value: $pref_term_for_code + - name: productDesignation.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-000978' Status: Published Version: '1' -Description: 'An administrable product''s product designation must be specified - using the product designation (C207418) DDF codelist.' +Description: 'An administrable product''s product designation must be specified using the product designation + (C207418) DDF codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C207418 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: productDesignation.code - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: productDesignation.code - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: productDesignation.decode - version: productDesignation.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: productDesignation.decode - version: productDesignation.codeSystemVersion +- id: $codelist_code + map: + - output: C207418 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: productDesignation.code + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: productDesignation.code + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: productDesignation.decode + version: productDesignation.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: productDesignation.decode + version: productDesignation.codeSystemVersion Outcome: - Message: 'The administrable product''s product designation is not specified - using the product designation (C207418) DDF codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, the code or decode (either as preferred term or as submission value) - is found in the codelist (case insensitive) but the corresponding decode or - code does not match the codelist value (case sensitive), and/or neither code - nor decode is found in the codelist.' + Message: 'The administrable product''s product designation is not specified using the product designation + (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, the code or decode (either as preferred term or as submission value) is + found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - productDesignation.code - - $code_for_decode_value - - $code_for_decode_pref_term - - productDesignation.codeSystem - - productDesignation.codeSystemVersion - - productDesignation.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - productDesignation.code + - $code_for_decode_value + - $code_for_decode_pref_term + - productDesignation.codeSystem + - productDesignation.codeSystemVersion + - productDesignation.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - 'AdministrableProduct' Sensitivity: Record diff --git a/Published/CORE-000979/rule.yml b/Published/CORE-000979/rule.yml index 8a7aec16f..4e32e4815 100644 --- a/Published/CORE-000979/rule.yml +++ b/Published/CORE-000979/rule.yml @@ -1,167 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An interventional study design's intent types must be specified - according to the extensible Trial Intent Type Response - (C66736) SDTM codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full - entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00214' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An interventional study design's intent types must be specified according to + the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code + or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00214' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: intentTypes - operator: exists - - name: intentTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'intentTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: intentTypes + operator: exists + - name: intentTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'intentTypes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000979' Status: Published Version: '1' -Description: "An interventional study design's intent types must be specified - according to the extensible Trial Intent Type Response (C66736) SDTM codelist - (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." +Description: "An interventional study design's intent types must be specified according to the extensible + Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the + codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C66736 - parent_rel.Code: 'intentTypes' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C66736 + parent_rel.Code: 'intentTypes' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The interventional study design''s intent type is not specified - according to the extensible Trial Intent Type Response (C66736) SDTM - codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is - not a valid terminology package date, and/or the code or decode (either as - preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The interventional study design''s intent type is not specified according to the extensible + Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000980/rule.yml b/Published/CORE-000980/rule.yml index 3401cd8f9..5928cea75 100644 --- a/Published/CORE-000980/rule.yml +++ b/Published/CORE-000980/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more characteristics are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00219' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more characteristics are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00219' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns. ( @@ -36,19 +35,17 @@ Core: Id: 'CORE-000980' Status: Published Version: '1' -Description: 'Within a study design, if more characteristics are defined, they - must be distinct.' +Description: 'Within a study design, if more characteristics are defined, they must be distinct.' Executability: Fully Executable Outcome: - Message: 'The same characteristics code is used more than once within the study - design.' + Message: 'The same characteristics code is used more than once within the study design.' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000981/rule.yml b/Published/CORE-000981/rule.yml index 2cf6cd7dc..b50043ab3 100644 --- a/Published/CORE-000981/rule.yml +++ b/Published/CORE-000981/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned enrollment number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00234' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A unit must not be specified for a planned enrollment number.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00234' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -67,17 +67,17 @@ Executability: Fully Executable Outcome: Message: 'A unit has been specified for a planned enrollment number' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedEnrollmentNumber.id - - plannedEnrollmentNumber(value/range) - - cohorts.name - - cohorts.plannedEnrollmentNumber.id - - cohorts.plannedEnrollmentNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedEnrollmentNumber.id + - plannedEnrollmentNumber(value/range) + - cohorts.name + - cohorts.plannedEnrollmentNumber.id + - cohorts.plannedEnrollmentNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000982/rule.yml b/Published/CORE-000982/rule.yml index bdf2554dd..d9f7561d9 100644 --- a/Published/CORE-000982/rule.yml +++ b/Published/CORE-000982/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned completion number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00235' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A unit must not be specified for a planned completion number.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00235' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -67,17 +67,17 @@ Executability: Fully Executable Outcome: Message: 'A unit has been specified for a planned completion number' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedCompletionNumber.id - - plannedCompletionNumber(value/range) - - cohorts.name - - cohorts.plannedCompletionNumber.id - - cohorts.plannedCompletionNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedCompletionNumber.id + - plannedCompletionNumber(value/range) + - cohorts.name + - cohorts.plannedCompletionNumber.id + - cohorts.plannedCompletionNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000983/rule.yml b/Published/CORE-000983/rule.yml index e5dbbb4c4..56fa7d2ac 100644 --- a/Published/CORE-000983/rule.yml +++ b/Published/CORE-000983/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A procedure must only reference a study intervention that is - referenced by the same study design as the activity within - which the procedure is defined.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00240' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A procedure must only reference a study intervention that is referenced by the + same study design as the activity within which the procedure is defined.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00240' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -38,25 +37,24 @@ Core: Id: 'CORE-000983' Status: Published Version: '1' -Description: 'A procedure must only reference a study intervention that is - referenced by the same study design as the activity within which the procedure - is defined.' +Description: 'A procedure must only reference a study intervention that is referenced by the same study + design as the activity within which the procedure is defined.' Executability: Fully Executable Outcome: - Message: 'The reference to the intervention is not targetting an intervention - that has been referenced by the study design as a study intervention.' + Message: 'The reference to the intervention is not targetting an intervention that has been referenced + by the study design as a study intervention.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.studyInterventionIds - - Activity.id - - Activity.name - - name - - studyInterventionId - - StudyIntervention.name + - StudyDesign.id + - StudyDesign.name + - StudyDesign.studyInterventionIds + - Activity.id + - Activity.name + - name + - studyInterventionId + - StudyIntervention.name Rule Type: JSONata Scope: Entities: Include: - - 'Procedure' + - 'Procedure' Sensitivity: Record diff --git a/Published/CORE-000984/rule.yml b/Published/CORE-000984/rule.yml index 19783abc4..12c86f61a 100644 --- a/Published/CORE-000984/rule.yml +++ b/Published/CORE-000984/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study enrollment must apply to either a geographic scope, - a study site, or a study cohort.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00195' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each study enrollment must apply to either a geographic scope, a study site, + or a study cohort.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00195' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. $sv.amendments@$a. @@ -62,23 +62,23 @@ Core: Id: 'CORE-000984' Status: Published Version: '1' -Description: 'Each study enrollment must apply to either a geographic scope, a - study site, or a study cohort.' +Description: 'Each study enrollment must apply to either a geographic scope, a study site, or a study + cohort.' Executability: Fully Executable Outcome: - Message: 'The study enrollment does not apply to either a geographic scope, a - study site, or a study cohort - it does not apply to one and only one of - these, or the value for forStudySiteId or forStudyCohortId is invalid.' + Message: 'The study enrollment does not apply to either a geographic scope, a study site, or a study + cohort - it does not apply to one and only one of these, or the value for forStudySiteId or forStudyCohortId + is invalid.' Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - name - - forGeographicScope - - forStudySiteId - - forStudyCohortId + - StudyAmendment.id + - StudyAmendment.name + - name + - forGeographicScope + - forStudySiteId + - forStudyCohortId Rule Type: JSONata Scope: Entities: Include: - - SubjectEnrollment + - SubjectEnrollment Sensitivity: Record diff --git a/Published/CORE-000985/rule.yml b/Published/CORE-000985/rule.yml index db956421f..ce8bc2c91 100644 --- a/Published/CORE-000985/rule.yml +++ b/Published/CORE-000985/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be a one-to-one relationship between referenced - section number and title within any study definition document - affected by a study amendment.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00196' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'There must be a one-to-one relationship between referenced section number and + title within any study definition document affected by a study amendment.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00196' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study@$s. $s.versions@$sv. @@ -57,25 +56,23 @@ Core: Id: 'CORE-000985' Status: Published Version: '1' -Description: 'There must be a one-to-one relationship between referenced section - number and title within any study definition document affected by a study - amendment.' +Description: 'There must be a one-to-one relationship between referenced section number and title within + any study definition document affected by a study amendment.' Executability: Fully Executable Outcome: - Message: 'There is not a one-to-one relationship between the referenced section - number and title within the study definition document affected by the study - amendment.' + Message: 'There is not a one-to-one relationship between the referenced section number and title within + the study definition document affected by the study amendment.' Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - StudyChange.id - - StudyChange.name - - appliesToId - - sectionNumber - - sectionTitle + - StudyAmendment.id + - StudyAmendment.name + - StudyChange.id + - StudyChange.name + - appliesToId + - sectionNumber + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - DocumentContentReference + - DocumentContentReference Sensitivity: Record diff --git a/Published/CORE-000986/rule.yml b/Published/CORE-000986/rule.yml index 15725acdd..cdc655eed 100644 --- a/Published/CORE-000986/rule.yml +++ b/Published/CORE-000986/rule.yml @@ -1,20 +1,19 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An administrable product must not be referenced as both the - administrable product for an administration and the embedded - product of a medical device that is referenced by the same - administration.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00205' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An administrable product must not be referenced as both the administrable product + for an administration and the embedded product of a medical device that is referenced by the + same administration.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00205' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyInterventions@$si. @@ -38,25 +37,23 @@ Core: Id: 'CORE-000986' Status: Published Version: '1' -Description: 'An administrable product must not be referenced as both the - administrable product for an administration and the embedded product of a - medical device that is referenced by the same administration.' +Description: 'An administrable product must not be referenced as both the administrable product for an + administration and the embedded product of a medical device that is referenced by the same administration.' Executability: Fully Executable Outcome: - Message: 'The administrable product is referenced both as the administrable - product for an administration and as the embedded product of a medical - device that is referenced by the same administration.' + Message: 'The administrable product is referenced both as the administrable product for an administration + and as the embedded product of a medical device that is referenced by the same administration.' Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - administrableProductId - - AdministrableProduct.name - - medicalDeviceId - - MedicalDevice.name + - StudyIntervention.id + - StudyIntervention.name + - name + - administrableProductId + - AdministrableProduct.name + - medicalDeviceId + - MedicalDevice.name Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - 'Administration' Sensitivity: Record diff --git a/Published/CORE-000987/rule.yml b/Published/CORE-000987/rule.yml index b73120bb7..4c56f2dee 100644 --- a/Published/CORE-000987/rule.yml +++ b/Published/CORE-000987/rule.yml @@ -1,168 +1,163 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An interventional study design's sub types must be specified - according to the extensible Trial Type Response (C66739) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00215' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An interventional study design's sub types must be specified according to the + extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00215' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: subTypes - operator: exists - - name: subTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'subTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: subTypes + operator: exists + - name: subTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'subTypes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000987' Status: Published Version: '1' -Description: "An interventional study design's sub types must be specified - according to the extensible Trial Type Response (C66739) SDTM codelist (e.g. - an entry with a code or decode used from the codelist should be consistent - with the full entry in the codelist)." +Description: "An interventional study design's sub types must be specified according to the extensible + Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C66739 - parent_rel.Code: 'subTypes' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C66739 + parent_rel.Code: 'subTypes' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The interventional study design''s sub type is not specified according - to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is - not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The interventional study design''s sub type is not specified according to the extensible Trial + Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000988/rule.yml b/Published/CORE-000988/rule.yml index f41410334..2d339b7a4 100644 --- a/Published/CORE-000988/rule.yml +++ b/Published/CORE-000988/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's intervention model must be specified according - to the extensible Intervention Model Response (C99076) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00216' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's intervention model must be specified according to the extensible + Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00216' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: model - operator: exists - - name: model - operator: equal_to - value: true - - not: - all: - - name: model.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: model.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: model + operator: exists + - name: model + operator: equal_to + value: true + - not: + all: + - name: model.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: model.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: model.code - operator: equal_to - value: $code_for_decode_pref_term - - name: model.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: model.decode - operator: equal_to - value: $pref_term_for_code - - name: model.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: model.code + operator: equal_to + value: $code_for_decode_pref_term + - name: model.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: model.decode + operator: equal_to + value: $pref_term_for_code + - name: model.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000988' Status: Published Version: '1' -Description: "A study design's intervention model must be specified according to - the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's intervention model must be specified according to the extensible Intervention + Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C99076 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: model.code - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: model.code - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: model.decode - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: model.decode - version: model.codeSystemVersion +- id: $codelist_code + map: + - output: C99076 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: model.code + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: model.code + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: model.decode + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: model.decode + version: model.codeSystemVersion Outcome: - Message: 'The study design''s intervention model is not specified according to - the extensible Intervention Model Response (C99076) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s intervention model is not specified according to the extensible Intervention + Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - model.code - - $code_for_decode_value - - $code_for_decode_pref_term - - model.codeSystem - - model.codeSystemVersion - - model.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - model.code + - $code_for_decode_value + - $code_for_decode_pref_term + - model.codeSystem + - model.codeSystemVersion + - model.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000989/rule.yml b/Published/CORE-000989/rule.yml index efd5b8dd0..d0461114e 100644 --- a/Published/CORE-000989/rule.yml +++ b/Published/CORE-000989/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's blinding schema must be specified according to - the extensible Trial Blinding Schema Response (C66735) SDTM - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00217' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's blinding schema must be specified according to the extensible + Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00217' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: blindingSchema.standardCode - operator: exists - - name: blindingSchema.standardCode - operator: equal_to - value: true - - not: - all: - - name: blindingSchema.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: blindingSchema.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: blindingSchema.standardCode + operator: exists + - name: blindingSchema.standardCode + operator: equal_to + value: true + - not: + all: + - name: blindingSchema.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: blindingSchema.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: blindingSchema.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: blindingSchema.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: blindingSchema.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: blindingSchema.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: blindingSchema.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: blindingSchema.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: blindingSchema.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: blindingSchema.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000989' Status: Published Version: '1' -Description: "A study design's blinding schema must be specified according to - the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's blinding schema must be specified according to the extensible Trial Blinding + Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66735 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: blindingSchema.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: blindingSchema.standardCode.code - version: blindingSchema.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: blindingSchema.standardCode.code - version: blindingSchema.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: blindingSchema.standardCode.decode - version: blindingSchema.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: blindingSchema.standardCode.decode - version: blindingSchema.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66735 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: blindingSchema.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: blindingSchema.standardCode.code + version: blindingSchema.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: blindingSchema.standardCode.code + version: blindingSchema.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: blindingSchema.standardCode.decode + version: blindingSchema.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: blindingSchema.standardCode.decode + version: blindingSchema.standardCode.codeSystemVersion Outcome: - Message: 'The study design''s blinding schema is not specified according to the - extensible Trial Blinding Schema Response (C66735) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s blinding schema is not specified according to the extensible Trial Blinding + Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - blindingSchema.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - blindingSchema.standardCode.codeSystem - - blindingSchema.standardCode.codeSystemVersion - - blindingSchema.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - blindingSchema.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - blindingSchema.standardCode.codeSystem + - blindingSchema.standardCode.codeSystemVersion + - blindingSchema.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000990/rule.yml b/Published/CORE-000990/rule.yml index 2b9c733a9..7132d3ef1 100644 --- a/Published/CORE-000990/rule.yml +++ b/Published/CORE-000990/rule.yml @@ -1,168 +1,163 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's characteristics must be specified according to - the extensible study design characteristics (C207416) DDF - codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00218' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's characteristics must be specified according to the extensible + study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00218' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: characteristics - operator: exists - - name: characteristics - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'characteristics' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: characteristics + operator: exists + - name: characteristics + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'characteristics' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000990' Status: Published Version: '1' -Description: "A study design's characteristics must be specified according to - the extensible study design characteristics (C207416) DDF codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's characteristics must be specified according to the extensible study design + characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C207416 - parent_rel.Code: 'characteristics' - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C207416 + parent_rel.Code: 'characteristics' + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s characteristic is not specified according to the - extensible study design characteristics (C207416) DDF codelist - codeSystem - is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology - package date, and/or the code or decode (either as preferred term or as - submission value) is found in the codelist (case insensitive) but the - corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s characteristic is not specified according to the extensible study design + characteristics (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000991/rule.yml b/Published/CORE-000991/rule.yml index d86e5922f..0ea8520ac 100644 --- a/Published/CORE-000991/rule.yml +++ b/Published/CORE-000991/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's observational model must be specified - according to the extensible Observational Study Model - (C127259) SDTM codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full - entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00223' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's observational model must be specified according to the extensible + Observational Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00223' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: model - operator: exists - - name: model - operator: equal_to - value: true - - not: - all: - - name: model.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: model.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: model + operator: exists + - name: model + operator: equal_to + value: true + - not: + all: + - name: model.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: model.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: model.code - operator: equal_to - value: $code_for_decode_pref_term - - name: model.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: model.decode - operator: equal_to - value: $pref_term_for_code - - name: model.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: model.code + operator: equal_to + value: $code_for_decode_pref_term + - name: model.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: model.decode + operator: equal_to + value: $pref_term_for_code + - name: model.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000991' Status: Published Version: '1' -Description: "A study design's observational model must be specified according - to the extensible Observational Study Model (C127259) SDTM codelist (e.g. an - entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." +Description: "A study design's observational model must be specified according to the extensible Observational + Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C127259 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: model.code - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: model.code - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: model.decode - version: model.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: model.decode - version: model.codeSystemVersion +- id: $codelist_code + map: + - output: C127259 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: model.code + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: model.code + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: model.decode + version: model.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: model.decode + version: model.codeSystemVersion Outcome: - Message: 'The study design''s observational model is not specified according to - the extensible Observational Study Model (C127259) SDTM codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The study design''s observational model is not specified according to the extensible Observational + Study Model (C127259) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - model.code - - $code_for_decode_value - - $code_for_decode_pref_term - - model.codeSystem - - model.codeSystemVersion - - model.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - model.code + - $code_for_decode_value + - $code_for_decode_pref_term + - model.codeSystem + - model.codeSystemVersion + - model.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000992/rule.yml b/Published/CORE-000992/rule.yml index 47ca97248..736e2a731 100644 --- a/Published/CORE-000992/rule.yml +++ b/Published/CORE-000992/rule.yml @@ -1,154 +1,150 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's time perspective must be - specified according to the extensible Observational Study Time - Perspective (C127261) SDTM codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the - full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00224' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An observational study design's time perspective must be specified according + to the extensible Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry + with a code or decode used from the codelist should be consistent with the full entry in the + codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00224' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: timePerspective - operator: exists - - name: timePerspective - operator: equal_to - value: true - - not: - all: - - name: timePerspective.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: timePerspective.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: timePerspective + operator: exists + - name: timePerspective + operator: equal_to + value: true + - not: + all: + - name: timePerspective.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: timePerspective.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: timePerspective.code - operator: equal_to - value: $code_for_decode_pref_term - - name: timePerspective.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: timePerspective.decode - operator: equal_to - value: $pref_term_for_code - - name: timePerspective.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: timePerspective.code + operator: equal_to + value: $code_for_decode_pref_term + - name: timePerspective.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: timePerspective.decode + operator: equal_to + value: $pref_term_for_code + - name: timePerspective.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-000992' Status: Published Version: '1' -Description: "An observational study design's time perspective must be specified - according to the extensible Observational Study Time Perspective (C127261) - SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." +Description: "An observational study design's time perspective must be specified according to the extensible + Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C127261 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: timePerspective.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: timePerspective.code - version: timePerspective.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: timePerspective.code - version: timePerspective.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: timePerspective.decode - version: timePerspective.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: timePerspective.decode - version: timePerspective.codeSystemVersion +- id: $codelist_code + map: + - output: C127261 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: timePerspective.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: timePerspective.code + version: timePerspective.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: timePerspective.code + version: timePerspective.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: timePerspective.decode + version: timePerspective.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: timePerspective.decode + version: timePerspective.codeSystemVersion Outcome: - Message: 'The observational study design''s time perspective is not specified - according to the extensible Observational Study Time Perspective (C127261) - SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion - is not a valid terminology package date, and/or the code or decode (either - as preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The observational study design''s time perspective is not specified according to the extensible + Observational Study Time Perspective (C127261) SDTM codelist - codeSystem is not "http://www.cdisc.org", + codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred + term or as submission value) is found in the codelist (case insensitive) but the corresponding decode + or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - timePerspective.code - - $code_for_decode_value - - $code_for_decode_pref_term - - timePerspective.codeSystem - - timePerspective.codeSystemVersion - - timePerspective.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - timePerspective.code + - $code_for_decode_value + - $code_for_decode_pref_term + - timePerspective.codeSystem + - timePerspective.codeSystemVersion + - timePerspective.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000993/rule.yml b/Published/CORE-000993/rule.yml index 8b4184e1d..c145fd9c0 100644 --- a/Published/CORE-000993/rule.yml +++ b/Published/CORE-000993/rule.yml @@ -1,132 +1,125 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) - dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' + Document: 'FDA' + Section: 'FDAB046' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB4607' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'PLANMSUB' + - name: '$txparmcd' + operator: 'does_not_contain' + value: 'PLANMSUB' Core: Id: CORE-000993 Status: Published Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned - Number of Male Subjects (PLANMSUB) record should be included. +Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male + Subjects (PLANMSUB) record should be included. Executability: Fully Executable Grouping_Variables: - - SETCD +- SETCD # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: - - domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct +- domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'PLANMSUB' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule # Sensitivity: Record diff --git a/Published/CORE-000994/rule.yml b/Published/CORE-000994/rule.yml index c234b6426..8d36ca802 100644 --- a/Published/CORE-000994/rule.yml +++ b/Published/CORE-000994/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least the text or the quantity must be specified for a - duration.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00033' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least the text or the quantity must be specified for a duration.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00033' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**[instanceType="Duration"])@$d. $d.[{ @@ -32,11 +31,11 @@ Executability: Fully Executable Outcome: Message: 'The quantity and text are both missing for the specified duration.' Output Variables: - - text - - quantity + - text + - quantity Rule Type: JSONata Scope: Entities: Include: - - 'Duration' + - 'Duration' Sensitivity: Record diff --git a/Published/CORE-000995/rule.yml b/Published/CORE-000995/rule.yml index 377e4b4f8..8c783cee9 100644 --- a/Published/CORE-000995/rule.yml +++ b/Published/CORE-000995/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the duration will vary, a quantity is not expected for the - duration and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00039' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If the duration will vary, a quantity is not expected for the duration and vice + versa.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00039' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**[instanceType="Duration"])@$d. $d.[( @@ -42,18 +42,16 @@ Core: Id: 'CORE-000995' Status: Published Version: '1' -Description: 'If the duration will vary, a quantity is not expected for the - duration and vice versa.' +Description: 'If the duration will vary, a quantity is not expected for the duration and vice versa.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The duration quantity is specified while the duration is indicated to - vary or vice versa.' + Message: 'The duration quantity is specified while the duration is indicated to vary or vice versa.' Output Variables: - - quantity(value/range) - - durationWillVary + - quantity(value/range) + - durationWillVary Rule Type: JSONata Scope: Entities: Include: - - 'Duration' + - 'Duration' Sensitivity: Record diff --git a/Published/CORE-000996/rule.yml b/Published/CORE-000996/rule.yml index 121a8aff2..2242345f0 100644 --- a/Published/CORE-000996/rule.yml +++ b/Published/CORE-000996/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must either include a single entry of male or - female or both female and male as entries.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00188' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A planned sex must either include a single entry of male or female or both female + and male as entries.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00188' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**[plannedSex])@$p. $p.[{ @@ -27,19 +27,19 @@ Core: Id: 'CORE-000996' Status: Published Version: '1' -Description: 'A planned sex must either include a single entry of male or female - or both female and male as entries.' +Description: 'A planned sex must either include a single entry of male or female or both female and male + as entries.' Executability: Fully Executable Outcome: - Message: 'The planned sex includes more than a single entry of male and/or - female either by duplications or unexpected codes.' + Message: 'The planned sex includes more than a single entry of male and/or female either by duplications + or unexpected codes.' Output Variables: - - name - - plannedSex + - name + - plannedSex Rule Type: JSONata Scope: Entities: Include: - - 'StudyCohort' - - 'StudyDesignPopulation' + - 'StudyCohort' + - 'StudyDesignPopulation' Sensitivity: Record diff --git a/Published/CORE-000997/rule.yml b/Published/CORE-000997/rule.yml index d410f65ef..eca6323ff 100644 --- a/Published/CORE-000997/rule.yml +++ b/Published/CORE-000997/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study role must not reference both assigned persons and - organizations.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00190' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study role must not reference both assigned persons and organizations.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00190' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ($sv.roles[assignedPersons and organizationIds])@$r. @@ -32,16 +31,15 @@ Core: Description: 'A study role must not reference both assigned persons and organizations.' Executability: Fully Executable Outcome: - Message: 'The study role references both at least one assigned person and at - least one organization.' + Message: 'The study role references both at least one assigned person and at least one organization.' Output Variables: - - name - - code - - assignedPersons - - organizationIds + - name + - code + - assignedPersons + - organizationIds Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-000998/rule.yml b/Published/CORE-000998/rule.yml index 0cb4a3dbd..4d4b8f660 100644 --- a/Published/CORE-000998/rule.yml +++ b/Published/CORE-000998/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version must not be referenced more - than once by the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00197' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study definition document version must not be referenced more than once by + the same study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00197' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns. { @@ -27,19 +27,19 @@ Core: Id: 'CORE-000998' Status: Published Version: '1' -Description: 'A study definition document version must not be referenced more - than once by the same study design.' +Description: 'A study definition document version must not be referenced more than once by the same study + design.' Executability: Fully Executable Outcome: - Message: "The study design references the same study definition document version - more than once (there are duplicate id values in documentVersionIds)." + Message: "The study design references the same study definition document version more than once (there + are duplicate id values in documentVersionIds)." Output Variables: - - name - - "Duplicate documentVersionIds" + - name + - "Duplicate documentVersionIds" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-000999/rule.yml b/Published/CORE-000999/rule.yml index c5446e54b..b6b0b7247 100644 --- a/Published/CORE-000999/rule.yml +++ b/Published/CORE-000999/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study definition document version is expected to be - referenced by either a study version or a study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00198' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each study definition document version is expected to be referenced by either + a study version or a study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00198' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study@$s. $s.documentedBy@$sdd. @@ -29,19 +29,19 @@ Core: Id: 'CORE-000999' Status: Published Version: '1' -Description: 'Each study definition document version is expected to be - referenced by either a study version or a study design.' +Description: 'Each study definition document version is expected to be referenced by either a study version + or a study design.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: "The study definition document version is not referenced by either a - study version or a study design." + Message: "The study definition document version is not referenced by either a study version or a study + design." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - version + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - version Rule Type: JSONata Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - 'StudyDefinitionDocumentVersion' Sensitivity: Record diff --git a/Published/CORE-001000/rule.yml b/Published/CORE-001000/rule.yml index 074e20016..4acce42ec 100644 --- a/Published/CORE-001000/rule.yml +++ b/Published/CORE-001000/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The sponsor study role must point to exactly one organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00202' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The sponsor study role must point to exactly one organization.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00202' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ($sv.roles[code.code = "C70793"])@$r. @@ -33,17 +33,17 @@ Core: Description: 'The sponsor study role must point to exactly one organization.' Executability: Fully Executable Outcome: - Message: 'The study role is a sponsor role (code.code is C70793) but it does not - point to exactly one organization - it does not have exactly one value for - organizationIds that is a valid id value for an organization.' + Message: 'The study role is a sponsor role (code.code is C70793) but it does not point to exactly one + organization - it does not have exactly one value for organizationIds that is a valid id value for + an organization.' Output Variables: - - name - - code - - organizationIds - - '# Valid Organizations' + - name + - code + - organizationIds + - '# Valid Organizations' Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-001001/rule.yml b/Published/CORE-001001/rule.yml index 7a6a36740..84e8e0fd4 100644 --- a/Published/CORE-001001/rule.yml +++ b/Published/CORE-001001/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Sourcing must not be defined for an administrable product which - is only referenced as an embedded product for a medical - device.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00206' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Sourcing must not be defined for an administrable product which is only referenced + as an embedded product for a medical device.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00206' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -35,21 +34,21 @@ Core: Id: 'CORE-001001' Status: Published Version: '1' -Description: 'Sourcing must not be defined for an administrable product which is - only referenced as an embedded product for a medical device.' +Description: 'Sourcing must not be defined for an administrable product which is only referenced as an + embedded product for a medical device.' Executability: Fully Executable Outcome: - Message: 'The sourcing is defined while the administrable product is only - referenced to as an embedded product for a medical device.' + Message: 'The sourcing is defined while the administrable product is only referenced to as an embedded + product for a medical device.' Output Variables: - - name - - sourcing - - MedicalDevice.id - - MedicalDevice.name - - MedicalDevice.embeddedProductId + - name + - sourcing + - MedicalDevice.id + - MedicalDevice.name + - MedicalDevice.embeddedProductId Rule Type: JSONata Scope: Entities: Include: - - 'AdministrableProduct' + - 'AdministrableProduct' Sensitivity: Record diff --git a/Published/CORE-001002/rule.yml b/Published/CORE-001002/rule.yml index 182cd0724..a8fc57e2b 100644 --- a/Published/CORE-001002/rule.yml +++ b/Published/CORE-001002/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more sub types are defined, they must - be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00220' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more sub types are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00220' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns. ( @@ -41,12 +40,12 @@ Executability: Fully Executable Outcome: Message: 'The same sub types code is used more than once within the study design.' Output Variables: - - name - - subTypes + - name + - subTypes Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001003/rule.yml b/Published/CORE-001003/rule.yml index e4a519656..cac1d22e0 100644 --- a/Published/CORE-001003/rule.yml +++ b/Published/CORE-001003/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00221' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00221' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns@$sd.( $sd.therapeuticAreas. @@ -45,22 +44,20 @@ Core: Id: 'CORE-001003' Status: Published Version: '1' -Description: 'Within a study design, if more therapeutic areas are defined, they - must be distinct.' +Description: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' Executability: Fully Executable Outcome: - Message: 'The therapeutic areas of the study design are not unique - the same - code is used more than once within the same codeSystem and - codeSystemVersion.' + Message: 'The therapeutic areas of the study design are not unique - the same code is used more than + once within the same codeSystem and codeSystemVersion.' Output Variables: - - name - - therapeuticAreas.codeSystem - - therapeuticAreas.codeSystemVersion - - therapeuticAreas + - name + - therapeuticAreas.codeSystem + - therapeuticAreas.codeSystemVersion + - therapeuticAreas Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001004/rule.yml b/Published/CORE-001004/rule.yml index f93873368..f68f251b2 100644 --- a/Published/CORE-001004/rule.yml +++ b/Published/CORE-001004/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An observational study (including patient registries) must be - specified using the ObservationalStudyDesign class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00228' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An observational study (including patient registries) must be specified using + the ObservationalStudyDesign class.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00228' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -29,19 +29,19 @@ Core: Id: 'CORE-001004' Status: Published Version: '1' -Description: 'An observational study (including patient registries) must be - specified using the ObservationalStudyDesign class.' +Description: 'An observational study (including patient registries) must be specified using the ObservationalStudyDesign + class.' Executability: Fully Executable Outcome: - Message: 'The study type is observational (including patient registries) but is - not specified using the ObservationalStudyDesign class.' + Message: 'The study type is observational (including patient registries) but is not specified using + the ObservationalStudyDesign class.' Output Variables: - - name - - studyType + - name + - studyType Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001005/rule.yml b/Published/CORE-001005/rule.yml index 2255e2ab6..da6c0c7dd 100644 --- a/Published/CORE-001005/rule.yml +++ b/Published/CORE-001005/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a study phase is specified for an observational study - (including patient registries) it is expected to have a study - phase value indicating "Not Applicable".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00232' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a study phase is specified for an observational study (including patient registries) + it is expected to have a study phase value indicating "Not Applicable".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00232' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -32,21 +31,19 @@ Core: Id: 'CORE-001005' Status: Published Version: '1' -Description: 'If a study phase is specified for an observational study - (including patient registries) it is expected to have a study phase value - indicating "Not Applicable".' +Description: 'If a study phase is specified for an observational study (including patient registries) + it is expected to have a study phase value indicating "Not Applicable".' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study type is observational (including patient registries) as - coded by either "C16084" or "C129000" but the study phase is indicating a - phase which is not "Not Applicable".' + Message: 'The study type is observational (including patient registries) as coded by either "C16084" + or "C129000" but the study phase is indicating a phase which is not "Not Applicable".' Output Variables: - - name - - studyType - - studyPhase + - name + - studyType + - studyPhase Rule Type: JSONata Scope: Entities: Include: - - 'ObservationalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001006/rule.yml b/Published/CORE-001006/rule.yml index 5c8f8cdbe..9cb4cb520 100644 --- a/Published/CORE-001006/rule.yml +++ b/Published/CORE-001006/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a synonym is specified then it is not expected to be equal - to the label of the biomedical concept (case insensitive).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00236' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a synonym is specified then it is not expected to be equal to the label of + the biomedical concept (case insensitive).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00236' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.biomedicalConcepts)@$bc. $bc. @@ -30,18 +30,18 @@ Core: Id: 'CORE-001006' Status: Published Version: '1' -Description: 'If a synonym is specified then it is not expected to be equal to - the label of the biomedical concept (case insensitive).' +Description: 'If a synonym is specified then it is not expected to be equal to the label of the biomedical + concept (case insensitive).' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The synonym is equal to the label (case insensitive).' Output Variables: - - name - - label/synonym - - synonyms + - name + - label/synonym + - synonyms Rule Type: JSONata Scope: Entities: Include: - - 'BiomedicalConcept' + - 'BiomedicalConcept' Sensitivity: Record diff --git a/Published/CORE-001007/rule.yml b/Published/CORE-001007/rule.yml index 722d836b6..764ce3a02 100644 --- a/Published/CORE-001007/rule.yml +++ b/Published/CORE-001007/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength numerator quantity is specified, it must have a - unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00238' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a strength numerator quantity is specified, it must have a unit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00238' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -43,16 +42,16 @@ Executability: Fully Executable Outcome: Message: 'The strength numerator quantity is specified but it has no unit.' Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Substance.id - - Substance.name - - name - - numerator.value + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Substance.id + - Substance.name + - name + - numerator.value Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - 'Strength' Sensitivity: Record diff --git a/Published/CORE-001008/rule.yml b/Published/CORE-001008/rule.yml index a3b1cd112..b62829fc9 100644 --- a/Published/CORE-001008/rule.yml +++ b/Published/CORE-001008/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength numerator range is specified, both the minValue - and maxValue must have a unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00239' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a strength numerator range is specified, both the minValue and maxValue must + have a unit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00239' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -39,24 +39,23 @@ Core: Id: 'CORE-001008' Status: Published Version: '1' -Description: 'If a strength numerator range is specified, both the minValue and - maxValue must have a unit.' +Description: 'If a strength numerator range is specified, both the minValue and maxValue must have a unit.' Executability: Fully Executable Outcome: - Message: 'The strength numerator range is specified but the minValue and/or - maxValue does not have a unit.' + Message: 'The strength numerator range is specified but the minValue and/or maxValue does not have a + unit.' Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Substance.id - - Substance.name - - name - - numerator.minValue - - numerator.maxValue + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Substance.id + - Substance.name + - name + - numerator.minValue + - numerator.maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - 'Strength' Sensitivity: Record diff --git a/Published/CORE-001009/rule.yml b/Published/CORE-001009/rule.yml index 7406bad2f..65b4de3e4 100644 --- a/Published/CORE-001009/rule.yml +++ b/Published/CORE-001009/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the unit is the same (or missing) for both the minimum and - maximum value, then the minimum value must be less than the - maximum value.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00241' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If the unit is the same (or missing) for both the minimum and maximum value, + then the minimum value must be less than the maximum value.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00241' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.**[instanceType="Range"])@$rg. $rg. @@ -33,18 +32,18 @@ Core: Id: 'CORE-001009' Status: Published Version: '1' -Description: 'If the unit is the same (or missing) for both the minimum and - maximum value, then the minimum value must be less than the maximum value.' +Description: 'If the unit is the same (or missing) for both the minimum and maximum value, then the minimum + value must be less than the maximum value.' Executability: Fully Executable Outcome: - Message: 'The maximum value is less or equal to the minimum value while the unit - is the same (or missing) for both the minimum and maximum value.' + Message: 'The maximum value is less or equal to the minimum value while the unit is the same (or missing) + for both the minimum and maximum value.' Output Variables: - - minValue - - maxValue + - minValue + - maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Range' + - 'Range' Sensitivity: Record diff --git a/Published/CORE-001010/rule.yml b/Published/CORE-001010/rule.yml index 10491e720..07ed34de9 100644 --- a/Published/CORE-001010/rule.yml +++ b/Published/CORE-001010/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A reference substance must not have a reference substance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00253' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A reference substance must not have a reference substance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00253' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.administrableProducts)@$ap. $ap.ingredients@$in. @@ -40,21 +40,20 @@ Core: Description: 'A reference substance must not have a reference substance.' Executability: Fully Executable Outcome: - Message: 'A reference substance is specified for the substance, but the - substance is a reference substance for another substance (the parent - substance).' + Message: 'A reference substance is specified for the substance, but the substance is a reference substance + for another substance (the parent substance).' Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Parent Substance.id - - Parent Substance.name - - name - - referenceSubstance.id - - referenceSubstance.name + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Parent Substance.id + - Parent Substance.name + - name + - referenceSubstance.id + - referenceSubstance.name Rule Type: JSONata Scope: Entities: Include: - - 'Substance' + - 'Substance' Sensitivity: Record diff --git a/Published/CORE-001011/rule.yml b/Published/CORE-001011/rule.yml index adc31153e..fe0153ff9 100644 --- a/Published/CORE-001011/rule.yml +++ b/Published/CORE-001011/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A primary study amendment reason is not expected to be ''not - applicable''.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00255' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A primary study amendment reason is not expected to be ''not applicable''.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00255' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.amendments)@$am. $am.primaryReason@$pr. @@ -37,12 +36,12 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The primary study amendment reason is ''not applicable'' (code=C48660).' Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - code + - StudyAmendment.id + - StudyAmendment.name + - code Rule Type: JSONata Scope: Entities: Include: - - 'StudyAmendmentReason' + - 'StudyAmendmentReason' Sensitivity: Record diff --git a/Published/CORE-001012/rule.yml b/Published/CORE-001012/rule.yml index 78721fae0..8f0b2b802 100644 --- a/Published/CORE-001012/rule.yml +++ b/Published/CORE-001012/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'For each range, a unit must be specified either for both the - minimum and the maximum value, or for neither of them.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00242' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'For each range, a unit must be specified either for both the minimum and the + maximum value, or for neither of them.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00242' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.**[instanceType="Range"])@$rg. $rg. @@ -30,18 +30,17 @@ Core: Id: 'CORE-001012' Status: Published Version: '1' -Description: 'For each range, a unit must be specified either for both the - minimum and the maximum value, or for neither of them.' +Description: 'For each range, a unit must be specified either for both the minimum and the maximum value, + or for neither of them.' Executability: Fully Executable Outcome: - Message: 'The unit is specified either for the minimum or the maximum value but - not for both.' + Message: 'The unit is specified either for the minimum or the maximum value but not for both.' Output Variables: - - minValue - - maxValue + - minValue + - maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Range' + - 'Range' Sensitivity: Record diff --git a/Published/CORE-001013/rule.yml b/Published/CORE-001013/rule.yml index 5bf462fa8..1895c5824 100644 --- a/Published/CORE-001013/rule.yml +++ b/Published/CORE-001013/rule.yml @@ -1,28 +1,28 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The names of all instances of the same class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00010' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The names of all instances of the same class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00010' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The names of all instances of the same class must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00010' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The names of all instances of the same class must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00010' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- **.*[id and instanceType and name].$ { @@ -47,10 +47,10 @@ Executability: Fully Executable Outcome: Message: 'The same name has been used for more than one instance of the class.' Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-001014/rule.yml b/Published/CORE-001014/rule.yml index 966577f48..06a9fb482 100644 --- a/Published/CORE-001014/rule.yml +++ b/Published/CORE-001014/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least the text or the family name must be specified for a - person name.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00030' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'At least the text or the family name must be specified for a person name.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00030' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.**[instanceType="PersonName"])@$pn. $pn. @@ -34,11 +33,11 @@ Executability: Fully Executable Outcome: Message: 'Both the text and familyName are missing.' Output Variables: - - familyName - - text + - familyName + - text Rule Type: JSONata Scope: Entities: Include: - - 'PersonName' + - 'PersonName' Sensitivity: Record diff --git a/Published/CORE-001015/rule.yml b/Published/CORE-001015/rule.yml index a2be6c01f..88902ace1 100644 --- a/Published/CORE-001015/rule.yml +++ b/Published/CORE-001015/rule.yml @@ -1,28 +1,28 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, all id values must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00083' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, all id values must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00083' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, all id values must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00083' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study version, all id values must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00083' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( **.*[id and instanceType]. @@ -47,10 +47,10 @@ Executability: Fully Executable Outcome: Message: 'The id value is not unique.' Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-001016/rule.yml b/Published/CORE-001016/rule.yml index 1fc68c1e5..d2418e894 100644 --- a/Published/CORE-001016/rule.yml +++ b/Published/CORE-001016/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned duration is expected for the main timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00153' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A planned duration is expected for the main timeline.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00153' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.studyDesigns)@$sd. $sd.scheduleTimelines@$st. @@ -34,11 +34,11 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The planned duration is not specified for the main timeline.' Output Variables: - - name - - mainTimeline + - name + - mainTimeline Rule Type: JSONata Scope: Entities: Include: - - 'ScheduleTimeline' + - 'ScheduleTimeline' Sensitivity: Record diff --git a/Published/CORE-001017/rule.yml b/Published/CORE-001017/rule.yml index e4a09fb95..41730a7a2 100644 --- a/Published/CORE-001017/rule.yml +++ b/Published/CORE-001017/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design must not be characterized as both - "Single-Centre" and "Multicentre".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00154' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00154' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns["C217004" in characteristics.code and "C217005" in characteristics.code]. { @@ -26,19 +25,17 @@ Core: Id: 'CORE-001017' Status: Published Version: '1' -Description: 'A study design must not be characterized as both "Single-Centre" - and "Multicentre".' +Description: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".' Executability: Fully Executable Outcome: - Message: 'The study design is characterized as both "Single-Centre" and - "Multicentre".' + Message: 'The study design is characterized as both "Single-Centre" and "Multicentre".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001018/rule.yml b/Published/CORE-001018/rule.yml index 2bb34ec65..cd58c2631 100644 --- a/Published/CORE-001018/rule.yml +++ b/Published/CORE-001018/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each defined eligibility criterion must be used by at least one - study population or cohort within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00158' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Each defined eligibility criterion must be used by at least one study population + or cohort within the same study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00158' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$s. $s.eligibilityCriteria@$ec @@ -33,21 +33,21 @@ Core: Id: 'CORE-001018' Status: Published Version: '1' -Description: 'Each defined eligibility criterion must be used by at least one - study population or cohort within the same study design.' +Description: 'Each defined eligibility criterion must be used by at least one study population or cohort + within the same study design.' Executability: Fully Executable Outcome: - Message: "The eligibility criterion is not referenced by the study design's - population or any of its cohorts." + Message: "The eligibility criterion is not referenced by the study design's population or any of its + cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - category - - identifier + - StudyDesign.id + - StudyDesign.name + - name + - category + - identifier Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - 'EligibilityCriterion' Sensitivity: Record diff --git a/Published/CORE-001019/rule.yml b/Published/CORE-001019/rule.yml index bbb246be9..33c29b8ad 100644 --- a/Published/CORE-001019/rule.yml +++ b/Published/CORE-001019/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion must not be referenced by both a study - design population and any of the cohorts of the same study - design population.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00159' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An eligibility criterion must not be referenced by both a study design population + and any of the cohorts of the same study design population.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00159' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$s. $s.eligibilityCriteria@$ec @@ -36,22 +35,22 @@ Core: Id: 'CORE-001019' Status: Published Version: '1' -Description: 'An eligibility criterion must not be referenced by both a study - design population and any of the cohorts of the same study design population.' +Description: 'An eligibility criterion must not be referenced by both a study design population and any + of the cohorts of the same study design population.' Executability: Fully Executable Outcome: - Message: "The eligibility criterion is referenced by both the study design's - population and at least one of its cohorts." + Message: "The eligibility criterion is referenced by both the study design's population and at least + one of its cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - category - - identifier - - "Used in" + - StudyDesign.id + - StudyDesign.name + - name + - category + - identifier + - "Used in" Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - 'EligibilityCriterion' Sensitivity: Record diff --git a/Published/CORE-001020/rule.yml b/Published/CORE-001020/rule.yml index 48389bc9f..c6f494696 100644 --- a/Published/CORE-001020/rule.yml +++ b/Published/CORE-001020/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength denominator is specified, it must have a unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00186' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a strength denominator is specified, it must have a unit.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00186' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.administrableProducts)@$ap. $ap.ingredients@$in. @@ -41,15 +41,15 @@ Executability: Fully Executable Outcome: Message: 'The unit for the strength denominator is missing.' Output Variables: - - Ingredient.id - - Substance.id - - Substance.name - - name - - denominator.id - - denominator.value + - Ingredient.id + - Substance.id + - Substance.name + - name + - denominator.id + - denominator.value Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - 'Strength' Sensitivity: Record diff --git a/Published/CORE-001021/rule.yml b/Published/CORE-001021/rule.yml index f2e3465f7..68b13ea65 100644 --- a/Published/CORE-001021/rule.yml +++ b/Published/CORE-001021/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A product organization role is expected to apply to at least - one medical device or administrable product.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00211' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A product organization role is expected to apply to at least one medical device + or administrable product.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00211' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.productOrganizationRoles@$pr. @@ -31,18 +31,18 @@ Core: Id: 'CORE-001021' Status: Published Version: '1' -Description: 'A product organization role is expected to apply to at least one - medical device or administrable product.' +Description: 'A product organization role is expected to apply to at least one medical device or administrable + product.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The product organization role does not apply to at least one medical - device or administrable product.' + Message: 'The product organization role does not apply to at least one medical device or administrable + product.' Output Variables: - - name - - appliesToIds + - name + - appliesToIds Rule Type: JSONata Scope: Entities: Include: - - 'ProductOrganizationRole' + - 'ProductOrganizationRole' Sensitivity: Record diff --git a/Published/CORE-001022/rule.yml b/Published/CORE-001022/rule.yml index 19f045dff..ae2c70e6a 100644 --- a/Published/CORE-001022/rule.yml +++ b/Published/CORE-001022/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If ''appliesTo'' is specified for a product organization role, - then the product organization role must only apply to medical - devices or administrable products.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00212' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If ''appliesTo'' is specified for a product organization role, then the product + organization role must only apply to medical devices or administrable products.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00212' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.productOrganizationRoles@$pr. @@ -35,20 +34,19 @@ Core: Id: 'CORE-001022' Status: Published Version: '1' -Description: 'If ''appliesTo'' is specified for a product organization role, - then the product organization role must only apply to medical devices or - administrable products.' +Description: 'If ''appliesTo'' is specified for a product organization role, then the product organization + role must only apply to medical devices or administrable products.' Executability: Fully Executable Outcome: - Message: 'At least one of the ''appliesTo'' specifications does not apply to - medical devices or administrable products.' + Message: 'At least one of the ''appliesTo'' specifications does not apply to medical devices or administrable + products.' Output Variables: - - name - - appliesToIds - - appliesTo name + - name + - appliesToIds + - appliesTo name Rule Type: JSONata Scope: Entities: Include: - - 'ProductOrganizationRole' + - 'ProductOrganizationRole' Sensitivity: Record diff --git a/Published/CORE-001023/rule.yml b/Published/CORE-001023/rule.yml index d80132aa6..edcaeee66 100644 --- a/Published/CORE-001023/rule.yml +++ b/Published/CORE-001023/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more intent types are defined, they - must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00222' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if more intent types are defined, they must be distinct.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00222' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns. ( @@ -36,17 +35,16 @@ Core: Id: 'CORE-001023' Status: Published Version: '1' -Description: 'Within a study design, if more intent types are defined, they must - be distinct.' +Description: 'Within a study design, if more intent types are defined, they must be distinct.' Executability: Fully Executable Outcome: Message: 'The same intent types code is used more than once within the study design.' Output Variables: - - name - - intentTypes + - name + - intentTypes Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001024/rule.yml b/Published/CORE-001024/rule.yml index 3dc2bd381..e4a1581bc 100644 --- a/Published/CORE-001024/rule.yml +++ b/Published/CORE-001024/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An interventional study must be specified using the - InterventionalStudyDesign class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00227' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An interventional study must be specified using the InterventionalStudyDesign + class.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00227' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -29,19 +29,18 @@ Core: Id: 'CORE-001024' Status: Published Version: '1' -Description: 'An interventional study must be specified using the - InterventionalStudyDesign class.' +Description: 'An interventional study must be specified using the InterventionalStudyDesign class.' Executability: Fully Executable Outcome: - Message: 'The study type is interventional but is not specified using the - InterventionalStudyDesign class.' + Message: 'The study type is interventional but is not specified using the InterventionalStudyDesign + class.' Output Variables: - - name - - studyType + - name + - studyType Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001025/rule.yml b/Published/CORE-001025/rule.yml index 4185ddd2d..ef502ea63 100644 --- a/Published/CORE-001025/rule.yml +++ b/Published/CORE-001025/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biospecimen retention indicates that a type of biospecimen - is retained, then there must be an indication of whether the - type of biospecimen includes DNA.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00231' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a biospecimen retention indicates that a type of biospecimen is retained, + then there must be an indication of whether the type of biospecimen includes DNA.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00231' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -32,21 +31,20 @@ Core: Id: 'CORE-001025' Status: Published Version: '1' -Description: 'If a biospecimen retention indicates that a type of biospecimen is - retained, then there must be an indication of whether the type of biospecimen - includes DNA.' +Description: 'If a biospecimen retention indicates that a type of biospecimen is retained, then there + must be an indication of whether the type of biospecimen includes DNA.' Executability: Fully Executable Outcome: - Message: 'The biospecimen retention is indicated as retained (isRetained=true) - but information whether it includes DNA (includesDNA attribute) is missing.' + Message: 'The biospecimen retention is indicated as retained (isRetained=true) but information whether + it includes DNA (includesDNA attribute) is missing.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - isRetained + - StudyDesign.id + - StudyDesign.name + - name + - isRetained Rule Type: JSONata Scope: Entities: Include: - - 'BiospecimenRetention' + - 'BiospecimenRetention' Sensitivity: Record diff --git a/Published/CORE-001026/rule.yml b/Published/CORE-001026/rule.yml index 01f03af46..507012337 100644 --- a/Published/CORE-001026/rule.yml +++ b/Published/CORE-001026/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: Each StudyArm is expected to have one StudyCell for each - StudyEpoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00243' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: Each StudyArm is expected to have one StudyCell for each StudyEpoch.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00243' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns@$sd. $sd.arms@$sa.{ @@ -38,15 +37,15 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The StudyArm does not have one StudyCell for each StudyEpoch.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - StudyDesign.epochs - - Arm's StudyCell Epoch Refs - - Missing Epoch Refs + - StudyDesign.id + - StudyDesign.name + - name + - StudyDesign.epochs + - Arm's StudyCell Epoch Refs + - Missing Epoch Refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyArm' + - 'StudyArm' Sensitivity: Record diff --git a/Published/CORE-001027/rule.yml b/Published/CORE-001027/rule.yml index f68297409..8413287ef 100644 --- a/Published/CORE-001027/rule.yml +++ b/Published/CORE-001027/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion item must not be used more than once - within a study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00248' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An eligibility criterion item must not be used more than once within a study + design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00248' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns@$sd. ( @@ -35,20 +35,18 @@ Core: Id: 'CORE-001027' Status: Published Version: '1' -Description: 'An eligibility criterion item must not be used more than once - within a study design.' +Description: 'An eligibility criterion item must not be used more than once within a study design.' Executability: Fully Executable Outcome: - Message: "The eligibility criterion item is used more than once within the study - design." + Message: "The eligibility criterion item is used more than once within the study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - criterionItemId + - StudyDesign.id + - StudyDesign.name + - name + - criterionItemId Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - 'EligibilityCriterion' Sensitivity: Record diff --git a/Published/CORE-001028/rule.yml b/Published/CORE-001028/rule.yml index 7e0a76fe0..c01df1efc 100644 --- a/Published/CORE-001028/rule.yml +++ b/Published/CORE-001028/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion item is expected to be used in at - least one study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00249' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An eligibility criterion item is expected to be used in at least one study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00249' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. $sv.eligibilityCriterionItems @@ -31,18 +30,17 @@ Core: Id: 'CORE-001028' Status: Published Version: '1' -Description: 'An eligibility criterion item is expected to be used in at least - one study design.' +Description: 'An eligibility criterion item is expected to be used in at least one study design.' Executability: Partially Executable - Possible Overreporting Outcome: Message: "The eligibility criterion item is not used in at least one study design." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - name + - StudyVersion.id + - StudyVersion.versionIdentifier + - name Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterionItem' + - 'EligibilityCriterionItem' Sensitivity: Record diff --git a/Published/CORE-001029/rule.yml b/Published/CORE-001029/rule.yml index 1c78bf144..de68a1e68 100644 --- a/Published/CORE-001029/rule.yml +++ b/Published/CORE-001029/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cohort must only reference indications that are defined - within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00251' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study cohort must only reference indications that are defined within the same + study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00251' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$sd. $sd.population@$sp. @@ -33,23 +33,22 @@ Core: Id: 'CORE-001029' Status: Published Version: '1' -Description: 'A study cohort must only reference indications that are defined - within the same study design.' +Description: 'A study cohort must only reference indications that are defined within the same study design.' Executability: Fully Executable Outcome: - Message: 'The reference to the indication is not targetting an indication that - has been defined within the same study design.' + Message: 'The reference to the indication is not targetting an indication that has been defined within + the same study design.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.indications.id - - StudyDesignPopulation.id - - StudyDesignPopulation.name - - name - - Invalid indicationIds + - StudyDesign.id + - StudyDesign.name + - StudyDesign.indications.id + - StudyDesignPopulation.id + - StudyDesignPopulation.name + - name + - Invalid indicationIds Rule Type: JSONata Scope: Entities: Include: - - 'StudyCohort' + - 'StudyCohort' Sensitivity: Record diff --git a/Published/CORE-001030/rule.yml b/Published/CORE-001030/rule.yml index 353aeb830..8e816ab82 100644 --- a/Published/CORE-001030/rule.yml +++ b/Published/CORE-001030/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study element must only reference study interventions that - are referenced by the same study design as the study element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00252' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study element must only reference study interventions that are referenced by + the same study design as the study element.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00252' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.versions)@$sv. $sv.studyDesigns@$sd. @@ -32,22 +32,22 @@ Core: Id: 'CORE-001030' Status: Published Version: '1' -Description: 'A study element must only reference study interventions that are - referenced by the same study design as the study element.' +Description: 'A study element must only reference study interventions that are referenced by the same + study design as the study element.' Executability: Fully Executable Outcome: - Message: 'The reference to the intervention is not targetting an intervention - that has been referenced by the study design as a study intervention.' + Message: 'The reference to the intervention is not targetting an intervention that has been referenced + by the study design as a study intervention.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.studyInterventionIds - - name - - Invalid studyInterventionIds - - Invalid StudyIntervention.name + - StudyDesign.id + - StudyDesign.name + - StudyDesign.studyInterventionIds + - name + - Invalid studyInterventionIds + - Invalid StudyIntervention.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyElement' + - 'StudyElement' Sensitivity: Record diff --git a/Published/CORE-001031/rule.yml b/Published/CORE-001031/rule.yml index 8356897f1..d1450ce0f 100644 --- a/Published/CORE-001031/rule.yml +++ b/Published/CORE-001031/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same reason is not expected to be given as a primary and - secondary reason.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00256' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The same reason is not expected to be given as a primary and secondary reason.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00256' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (study.versions.amendments)@$am. $am.secondaryReasons@$sr. @@ -33,19 +32,18 @@ Core: Id: 'CORE-001031' Status: Published Version: '1' -Description: 'The same reason is not expected to be given as a primary and - secondary reason.' +Description: 'The same reason is not expected to be given as a primary and secondary reason.' Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The secondary reason code is equal to the primary reason code.' Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - code - - primaryReason.code + - StudyAmendment.id + - StudyAmendment.name + - code + - primaryReason.code Rule Type: JSONata Scope: Entities: Include: - - 'StudyAmendmentReason' + - 'StudyAmendmentReason' Sensitivity: Record diff --git a/Published/CORE-001032/rule.yml b/Published/CORE-001032/rule.yml index cf2488549..a28b98b51 100644 --- a/Published/CORE-001032/rule.yml +++ b/Published/CORE-001032/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design must not be characterized as both "Single - Country" and "Multiple Countries".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00257' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study design must not be characterized as both "Single Country" and "Multiple + Countries".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00257' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns["C217006" in characteristics.code and "C217007" in characteristics.code]. { @@ -26,19 +26,17 @@ Core: Id: 'CORE-001032' Status: Published Version: '1' -Description: 'A study design must not be characterized as both "Single Country" - and "Multiple Countries".' +Description: 'A study design must not be characterized as both "Single Country" and "Multiple Countries".' Executability: Fully Executable Outcome: - Message: 'The study design is characterized as both "Single Country" and - "Multiple Countries".' + Message: 'The study design is characterized as both "Single Country" and "Multiple Countries".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001033/rule.yml b/Published/CORE-001033/rule.yml index 008441ce3..884bb8bc8 100644 --- a/Published/CORE-001033/rule.yml +++ b/Published/CORE-001033/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design is not expected to have more than one of the - following characteristics: "Randomized", "Stratification", - "Stratified Randomisation".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00258' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study design is not expected to have more than one of the following characteristics: + "Randomized", "Stratification", "Stratified Randomisation".' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00258' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns[$count(characteristics[code in ["C46079","C25689","C147145"]])>1]. { @@ -27,20 +26,19 @@ Core: Id: 'CORE-001033' Status: Published Version: '1' -Description: 'A study design is not expected to have more than one of the - following characteristics: "Randomized", "Stratification", "Stratified - Randomisation".' +Description: 'A study design is not expected to have more than one of the following characteristics: "Randomized", + "Stratification", "Stratified Randomisation".' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has more than one of the following characteristics: - "Randomized", "Stratification", "Stratified Randomisation".' + Message: 'The study design has more than one of the following characteristics: "Randomized", "Stratification", + "Stratified Randomisation".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001034/rule.yml b/Published/CORE-001034/rule.yml index f1ae6b30b..1dd748608 100644 --- a/Published/CORE-001034/rule.yml +++ b/Published/CORE-001034/rule.yml @@ -2,108 +2,106 @@ # Condition: REPNUM is in the dataset, and the are multiple records for a subject for a test within the timeframe identified by the timing variables on the record # Rule: --REPNUM ^= null and unique per subject per test per the timing variables Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given - timeframe for the same test. The level of granularity can vary - (e.g., within a time point or within a visit). - Document: Model v2.0 - Item: --REPNUM - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0562 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given - timeframe for the same test. The level of granularity can vary - (e.g., within a time point or within a visit). For example, - multiple measurements of blood pressure or multiple analyses - of a sample. - Document: Model v1.7 - Item: --REPNUM - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0562 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given - timeframe for the same test. The level of granularity can vary - (e.g., within a time point or within a visit). - Document: SDTM v2.1 - Item: --REPNUM - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0648 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). + Document: Model v2.0 + Item: --REPNUM + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0562 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). For example, multiple measurements of blood pressure or multiple analyses of a + sample. + Document: Model v1.7 + Item: --REPNUM + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0562 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). + Document: SDTM v2.1 + Item: --REPNUM + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0648 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: + - name: --REPNUM + operator: exists + - name: $record_count_per_subject_test_timing + operator: greater_than + value: 1 + - any: - name: --REPNUM - operator: exists - - name: $record_count_per_subject_test_timing - operator: greater_than - value: 1 - - any: - - name: --REPNUM - operator: empty - - name: --REPNUM - operator: is_not_unique_set - regex: ^\d{4}-\d{2}-\d{2} - value: - - USUBJID - - --TESTCD - - $TIMING_VARIABLES + operator: empty + - name: --REPNUM + operator: is_not_unique_set + regex: ^\d{4}-\d{2}-\d{2} + value: + - USUBJID + - --TESTCD + - $TIMING_VARIABLES Core: Id: CORE-001034 Status: Published Version: '1' -Description: Raise an error when REPNUM is in the dataset and there are multiple - records for a subject for a test within the timeframe identified by the timing - variables on the record, and --REPNUM is null or not unique per subject per - test per timing variables. +Description: Raise an error when REPNUM is in the dataset and there are multiple records for a + subject for a test within the timeframe identified by the timing variables on the record, and + --REPNUM is null or not unique per subject per test per timing variables. Executability: Fully Executable Operations: - - id: $TIMING_VARIABLES - key_name: role - key_value: Timing - operator: get_dataset_filtered_variables - - group: - - USUBJID - - --TESTCD - - $TIMING_VARIABLES - id: $record_count_per_subject_test_timing - operator: record_count - regex: ^\d{4}-\d{2}-\d{2} +- id: $TIMING_VARIABLES + key_name: role + key_value: Timing + operator: get_dataset_filtered_variables +- group: + - USUBJID + - --TESTCD + - $TIMING_VARIABLES + id: $record_count_per_subject_test_timing + operator: record_count + regex: ^\d{4}-\d{2}-\d{2} Outcome: Message: --REPNUM is null or is not unique per subject per test per timing variables. Output Variables: - - USUBJID - - --TESTCD - - --REPNUM - - $TIMING_VARIABLES + - USUBJID + - --TESTCD + - --REPNUM + - $TIMING_VARIABLES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-001035/rule.yml b/Published/CORE-001035/rule.yml index a714a5a3e..c7766f91d 100644 --- a/Published/CORE-001035/rule.yml +++ b/Published/CORE-001035/rule.yml @@ -1,31 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance must refer to a default - condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00038' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled decision instance must refer to a default condition.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00038' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: defaultConditionId - operator: not_exists - - name: defaultConditionId - operator: empty + - name: instanceType + operator: equal_to + value: 'ScheduledDecisionInstance' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: defaultConditionId + operator: not_exists + - name: defaultConditionId + operator: empty Core: Id: 'CORE-001035' Status: Published @@ -35,15 +34,15 @@ Executability: Fully Executable Outcome: Message: 'The scheduled decision instance does not refer to a default condition.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - 'ScheduledDecisionInstance' Sensitivity: Record diff --git a/Published/CORE-001036/rule.yml b/Published/CORE-001036/rule.yml index 90653dcdd..2b8f951df 100644 --- a/Published/CORE-001036/rule.yml +++ b/Published/CORE-001036/rule.yml @@ -1,30 +1,28 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design, there must be at least one endpoint with - level primary." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00041' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design, there must be at least one endpoint with - level primary." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00041' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00041' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00041' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.versions.studyDesigns. { @@ -38,20 +36,18 @@ Core: Id: 'CORE-001036' Status: Published Version: '1' -Description: "Within a study design, there must be at least one endpoint with - level primary." +Description: "Within a study design, there must be at least one endpoint with level primary." Executability: Fully Executable Outcome: - Message: "There is not at least one endpoint with a level of primary within the - study design." + Message: "There is not at least one endpoint with a level of primary within the study design." Output Variables: - - name - - '# Primary endpoints' + - name + - '# Primary endpoints' Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001037/rule.yml b/Published/CORE-001037/rule.yml index 1be7d7cd1..2df2aa80a 100644 --- a/Published/CORE-001037/rule.yml +++ b/Published/CORE-001037/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Any parameter name referenced in a tag in the text should be - specified in the data dictionary parameter maps.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00089' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Any parameter name referenced in a tag in the text should be specified in the + data dictionary parameter maps.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00089' + Version: '1' + Version: '1.0' + Version: '3.0' Check: |- **.study.versions@$sv. ($sv.studyDesigns)@$sd.($sd.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st. @@ -48,28 +48,27 @@ Core: Id: 'CORE-001037' Status: Published Version: '1' -Description: 'Any parameter name referenced in a tag in the text should be - specified in the data dictionary parameter maps.' +Description: 'Any parameter name referenced in a tag in the text should be specified in the data dictionary + parameter maps.' Executability: Fully Executable Outcome: - Message: "The parameter name referenced in the text is not specified in the data - dictionary parameter map - the dictionaryId is missing or invalid, or the - parameter name does not match a tag in any of the dictionary's parameter - maps." + Message: "The parameter name referenced in the text is not specified in the data dictionary parameter + map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of + the dictionary's parameter maps." Output Variables: - - name - - Parameter reference - - Parameter name - - dictionaryId - - SyntaxTemplateDictionary.name - - Issue + - name + - Parameter reference + - Parameter name + - dictionaryId + - SyntaxTemplateDictionary.name + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' - - 'Characteristic' - - 'Condition' - - 'Objective' - - 'Endpoint' + - 'EligibilityCriterion' + - 'Characteristic' + - 'Condition' + - 'Objective' + - 'Endpoint' Sensitivity: Record diff --git a/Published/CORE-001038/rule.yml b/Published/CORE-001038/rule.yml index 6027002f5..94c7d546a 100644 --- a/Published/CORE-001038/rule.yml +++ b/Published/CORE-001038/rule.yml @@ -1,34 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical - concept, biomedical concept category, or biomedical concept - surrogate then an instance must be available in the - corresponding class with the specified id.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00091' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical - concept, biomedical concept category, or biomedical concept - surrogate then an instance must be available in the - corresponding class with the specified id.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00091' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical concept, biomedical + concept category, or biomedical concept surrogate then an instance must be available in the + corresponding class with the specified id.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00091' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical concept, biomedical + concept category, or biomedical concept surrogate then an instance must be available in the + corresponding class with the specified id.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00091' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $idityp:=$.study.versions.**[id]{id:instanceType}; @@ -57,23 +55,22 @@ Core: Id: 'CORE-001038' Status: Published Version: '1' -Description: 'When a condition applies to a procedure, activity, biomedical - concept, biomedical concept category, or biomedical concept surrogate then an - instance must be available in the corresponding class with the specified id.' +Description: 'When a condition applies to a procedure, activity, biomedical concept, biomedical concept + category, or biomedical concept surrogate then an instance must be available in the corresponding class + with the specified id.' Executability: Fully Executable Outcome: - Message: 'The id value specified to indicate what the condition applies to does - not reference a procedure, activity, biomedical concept, biomedical concept - category, or biomedical concept surrogate - either the specified id is not - an id for anything (it is invalid), or the instance identified by the id is + Message: 'The id value specified to indicate what the condition applies to does not reference a procedure, + activity, biomedical concept, biomedical concept category, or biomedical concept surrogate - either + the specified id is not an id for anything (it is invalid), or the instance identified by the id is not one of the expected classes.' Output Variables: - - name - - 'appliesTo id' - - 'appliesTo instanceType' + - name + - 'appliesTo id' + - 'appliesTo instanceType' Rule Type: JSONata Scope: Entities: Include: - - 'Condition' + - 'Condition' Sensitivity: Record diff --git a/Published/CORE-001039/rule.yml b/Published/CORE-001039/rule.yml index 128b59252..51cd58f08 100644 --- a/Published/CORE-001039/rule.yml +++ b/Published/CORE-001039/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference an encounter - that is defined within the same study design as the scheduled - activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00106' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference an encounter - that is defined within the same study design as the scheduled - activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00106' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only reference an encounter that is defined + within the same study design as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00106' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A scheduled activity instance must only reference an encounter that is defined + within the same study design as the scheduled activity instance.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00106' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $lkp:=$merge($.**.studyDesigns.encounters.{id:%.id}); @@ -54,22 +52,21 @@ Core: Id: 'CORE-001039' Status: Published Version: '1' -Description: 'A scheduled activity instance must only reference an encounter - that is defined within the same study design as the scheduled activity - instance.' +Description: 'A scheduled activity instance must only reference an encounter that is defined within the + same study design as the scheduled activity instance.' Executability: Fully Executable Outcome: - Message: 'The scheduled activity instance references an encounter that is not - defined within the same study design.' + Message: 'The scheduled activity instance references an encounter that is not defined within the same + study design.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - encounterId - - "Referenced encounter's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - encounterId + - "Referenced encounter's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'ScheduledActivityInstance' + - 'ScheduledActivityInstance' Sensitivity: Record diff --git a/Published/CORE-001040/rule.yml b/Published/CORE-001040/rule.yml index 47b2a89c9..fde1583be 100644 --- a/Published/CORE-001040/rule.yml +++ b/Published/CORE-001040/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study element must only reference study interventions that - are defined within the same study design as the study - element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00109' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study element must only reference study interventions that are defined within + the same study design as the study element.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00109' + Version: '1' + Version: '1.0' + Version: '3.0' Check: |- ( $lkp:=$merge($.**.studyDesigns.studyInterventions.{id:%.id}); @@ -39,21 +38,21 @@ Core: Id: 'CORE-001040' Status: Published Version: '1' -Description: 'A study element must only reference study interventions that are - defined within the same study design as the study element.' +Description: 'A study element must only reference study interventions that are defined within the same + study design as the study element.' Executability: Fully Executable Outcome: - Message: 'The study element references a study intervention that is not defined - within the same study design.' + Message: 'The study element references a study intervention that is not defined within the same study + design.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - "studyInterventionIds value" - - "Referenced intervention's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - "studyInterventionIds value" + - "Referenced intervention's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'StudyElement' + - 'StudyElement' Sensitivity: Record diff --git a/Published/CORE-001041/rule.yml b/Published/CORE-001041/rule.yml index 5cc17919d..a9184248a 100644 --- a/Published/CORE-001041/rule.yml +++ b/Published/CORE-001041/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: Within a document version, the specified displayed section - numbers for narrative content must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00245' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: Within a document version, the specified displayed section numbers for + narrative content must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00245' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -39,23 +39,22 @@ Core: Id: 'CORE-001041' Status: Published Version: '1' -Description: 'Within a document version, the specified displayed section numbers - for narrative content must be unique.' +Description: 'Within a document version, the specified displayed section numbers for narrative content + must be unique.' Executability: Fully Executable Outcome: - Message: 'The displayed section number is not unique within the study definition - document version.' + Message: 'The displayed section number is not unique within the study definition document version.' Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - displaySectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - displaySectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-001042/rule.yml b/Published/CORE-001042/rule.yml index 24b3a08b1..b9d09e5ce 100644 --- a/Published/CORE-001042/rule.yml +++ b/Published/CORE-001042/rule.yml @@ -1,20 +1,19 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a geographic scope type is global then no code is expected - to specify the specific area within scope while if it is not - global then a code is expected to specify the specific area - within scope.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00261' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a geographic scope type is global then no code is expected to specify the + specific area within scope while if it is not global then a code is expected to specify the + specific area within scope.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00261' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- **[instanceType="GeographicScope" and (type.code="C68846")=($exists(code) and code)]. { @@ -30,23 +29,21 @@ Core: Id: 'CORE-001042' Status: Published Version: '1' -Description: 'If a geographic scope type is global then no code is expected to - specify the specific area within scope while if it is not global then a code - is expected to specify the specific area within scope.' +Description: 'If a geographic scope type is global then no code is expected to specify the specific area + within scope while if it is not global then a code is expected to specify the specific area within scope.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The geographic scope is global (type.code = C68846) and a code has - been specified for the specific area or the geographic scope is not global - (type.code is not C68846) and no code has been specified for the specific - area.' + Message: 'The geographic scope is global (type.code = C68846) and a code has been specified for the + specific area or the geographic scope is not global (type.code is not C68846) and no code has been + specified for the specific area.' Output Variables: - - type.code - - type.decode - - code.standardCode.code - - code.standardCode.decode + - type.code + - type.decode + - code.standardCode.code + - code.standardCode.decode Rule Type: JSONata Scope: Entities: Include: - - 'GeographicScope' + - 'GeographicScope' Sensitivity: Record diff --git a/Published/CORE-001044/rule.yml b/Published/CORE-001044/rule.yml index 4ee6d6801..501a1afae 100644 --- a/Published/CORE-001044/rule.yml +++ b/Published/CORE-001044/rule.yml @@ -1,135 +1,128 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: "RFSTDTC" - operator: "date_not_equal_to" - value: "$ex_exstdtc" + - name: "RFSTDTC" + operator: "date_not_equal_to" + value: "$ex_exstdtc" Core: Id: CORE-001044 Status: Published Version: '1' -Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the - first Start Date/Time of Treatment (EXSDTC). +Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start + Date/Time of Treatment (EXSDTC). Executability: Fully Executable Operations: - - domain: "EX" - group: - - USUBJID - id: "$ex_exstdtc" - name: "EXSTDTC" - operator: "min_date" +- domain: "EX" + group: + - USUBJID + id: "$ex_exstdtc" + name: "EXSTDTC" + operator: "min_date" Outcome: Message: RFSTDTC is not equal to the first EXSTDTC. Output Variables: - - RFSTDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - SPECIAL PURPOSE + - INTERVENTIONS + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-001045/rule.yml b/Published/CORE-001045/rule.yml index 47aa49f2e..6b053e6fa 100644 --- a/Published/CORE-001045/rule.yml +++ b/Published/CORE-001045/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference study populations or cohorts - that are defined within the same study design as the study - arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00050' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference study populations or cohorts - that are defined within the same study design as the study - arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00050' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study arm must only reference study populations or cohorts that are defined + within the same study design as the study arm.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00050' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study arm must only reference study populations or cohorts that are defined + within the same study design as the study arm.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00050' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.**.studyDesigns)@$s. [ @@ -47,23 +45,22 @@ Core: Id: 'CORE-001045' Status: Published Version: '1' -Description: 'A study arm must only reference study populations or cohorts that - are defined within the same study design as the study arm.' +Description: 'A study arm must only reference study populations or cohorts that are defined within the + same study design as the study arm.' Executability: Fully Executable Outcome: - Message: 'The study arm references a populationId that does not match the id of - any study population or study cohort defined within the same study design as - the study arm.' + Message: 'The study arm references a populationId that does not match the id of any study population + or study cohort defined within the same study design as the study arm.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.population.id - - StudyDesign.population.cohorts.id - - name - - populationId + - StudyDesign.id + - StudyDesign.name + - StudyDesign.population.id + - StudyDesign.population.cohorts.id + - name + - populationId Rule Type: JSONata Scope: Entities: Include: - - StudyArm + - StudyArm Sensitivity: Record diff --git a/Published/CORE-001046/rule.yml b/Published/CORE-001046/rule.yml index eebfeca21..ee1f60610 100644 --- a/Published/CORE-001046/rule.yml +++ b/Published/CORE-001046/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the intervention model indicates a single group design then - only one intervention is expected. In all other cases more - interventions are expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00074' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If the intervention model indicates a single group design then only one intervention + is expected. In all other cases more interventions are expected.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00074' + Version: '1' + Version: '1.0' + Version: '3.0' Check: |- ($.study.versions.studyDesigns)@$sd. { @@ -33,25 +32,23 @@ Core: Id: 'CORE-001046' Status: Published Version: '1' -Description: 'If the intervention model indicates a single group design then - only one intervention is expected. In all other cases more interventions are - expected.' +Description: 'If the intervention model indicates a single group design then only one intervention is + expected. In all other cases more interventions are expected.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The number of study interventions defined for the study design is not - consistent with intervention model specified for the study design - either - the model indicates a single group and there is not only one study - intervention, or the model does not indicate a single group and there are - not multiple study interventions.' + Message: 'The number of study interventions defined for the study design is not consistent with intervention + model specified for the study design - either the model indicates a single group and there is not + only one study intervention, or the model does not indicate a single group and there are not multiple + study interventions.' Output Variables: - - id - - name - - interventionModel.code - - interventionModel.decode - - '# Study Interventions' + - id + - name + - interventionModel.code + - interventionModel.decode + - '# Study Interventions' Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' + - 'StudyDesign' Sensitivity: Record diff --git a/Published/CORE-001047/rule.yml b/Published/CORE-001047/rule.yml index 9f11a6f3f..d3728507f 100644 --- a/Published/CORE-001047/rule.yml +++ b/Published/CORE-001047/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept is referenced from an activity then it - is not expected to be referenced as well by a biomedical - concept category that is referenced from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00076' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept is referenced from an activity then it - is not expected to be referenced as well by a biomedical - concept category that is referenced from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00076' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a biomedical concept is referenced from an activity then it is not expected + to be referenced as well by a biomedical concept category that is referenced from the same activity.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00076' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If a biomedical concept is referenced from an activity then it is not expected + to be referenced as well by a biomedical concept category that is referenced from the same activity.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00076' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. [ @@ -77,23 +75,21 @@ Core: Id: 'CORE-001047' Status: Published Version: '1' -Description: 'If a biomedical concept is referenced from an activity then it is - not expected to be referenced as well by a biomedical concept category that is - referenced from the same activity.' +Description: 'If a biomedical concept is referenced from an activity then it is not expected to be referenced + as well by a biomedical concept category that is referenced from the same activity.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity references both a biomedical concept category and a - biomedical concept, but the biomedical concept is a member of the referenced - category or one of its subcategories.' + Message: 'The activity references both a biomedical concept category and a biomedical concept, but the + biomedical concept is a member of the referenced category or one of its subcategories.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - biomedicalConceptId - - bcCategoryId(s) containing BC + - StudyDesign.id + - StudyDesign.name + - name + - biomedicalConceptId + - bcCategoryId(s) containing BC Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-001048/rule.yml b/Published/CORE-001048/rule.yml index 4115456c1..25166dee7 100644 --- a/Published/CORE-001048/rule.yml +++ b/Published/CORE-001048/rule.yml @@ -1,34 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Epoch ordering using previous and next attributes is expected - to be consistent with the order of corresponding scheduled - activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00088' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Epoch ordering using previous and next attributes is expected - to be consistent with the order of corresponding scheduled - activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00088' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Epoch ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00088' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Epoch ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00088' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd. @@ -56,27 +54,25 @@ Core: Id: 'CORE-001048' Status: Published Version: '1' -Description: 'Epoch ordering using previous and next attributes is expected to - be consistent with the order of corresponding scheduled activity instances - according to their specified default conditions.' +Description: 'Epoch ordering using previous and next attributes is expected to be consistent with the + order of corresponding scheduled activity instances according to their specified default conditions.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The order of the epochs in the study design (as defined by the next - attribute) does not match the order of epochs as referenced from scheduled - activity instances in the main timeline that are ordered by default - condition.' + Message: 'The order of the epochs in the study design (as defined by the next attribute) does not match + the order of epochs as referenced from scheduled activity instances in the main timeline that are + ordered by default condition.' Output Variables: - - name - - ScheduleTimeline.id - - ScheduleTimeline.name - - ScheduleTimeline.mainTimeline - - Epoch order by previous/next - - Epoch order by timeline refs + - name + - ScheduleTimeline.id + - ScheduleTimeline.name + - ScheduleTimeline.mainTimeline + - Epoch order by previous/next + - Epoch order by timeline refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001049/rule.yml b/Published/CORE-001049/rule.yml index 4b2ca5a9e..cbf21dca8 100644 --- a/Published/CORE-001049/rule.yml +++ b/Published/CORE-001049/rule.yml @@ -1,30 +1,28 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere - in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00124' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere - in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00124' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere in the data model.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00124' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere in the data model.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00124' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -88,20 +86,18 @@ Core: Id: 'CORE-001049' Status: Published Version: '1' -Description: 'Referenced items in a parameter map must be available elsewhere in - the data model.' +Description: 'Referenced items in a parameter map must be available elsewhere in the data model.' Executability: Fully Executable Outcome: - Message: 'The item referenced in the parameter map is not available elsewhere in - the model.' + Message: 'The item referenced in the parameter map is not available elsewhere in the model.' Output Variables: - - SyntaxTemplateDictionary.id - - SyntaxTemplateDictionary.name - - tag - - reference + - SyntaxTemplateDictionary.id + - SyntaxTemplateDictionary.name + - tag + - reference Rule Type: JSONata Scope: Entities: Include: - - 'ParameterMap' + - 'ParameterMap' Sensitivity: Record diff --git a/Published/CORE-001050/rule.yml b/Published/CORE-001050/rule.yml index d3af883f5..a3a92cd1e 100644 --- a/Published/CORE-001050/rule.yml +++ b/Published/CORE-001050/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in the narrative content must be available - elsewhere in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00131' - Version: '1' - Version: '1.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Referenced items in the narrative content must be available elsewhere in the + data model.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00131' + Version: '1' + Version: '1.0' + Version: '3.0' Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -69,24 +69,22 @@ Core: Id: 'CORE-001050' Status: Published Version: '1' -Description: 'Referenced items in the narrative content must be available - elsewhere in the data model.' +Description: 'Referenced items in the narrative content must be available elsewhere in the data model.' Executability: Fully Executable Outcome: - Message: 'The item referenced in the narrative content text is not available - elsewhere in the model.' + Message: 'The item referenced in the narrative content text is not available elsewhere in the model.' Output Variables: - - StudyProtocolDocument.id - - StudyProtocolDocument.name - - StudyProtocolDocumentVersion.id - - StudyProtocolDocumentVersion.protocolVersion - - name - - sectionNumber - - sectionTitle - - 'Invalid Reference' + - StudyProtocolDocument.id + - StudyProtocolDocument.name + - StudyProtocolDocumentVersion.id + - StudyProtocolDocumentVersion.protocolVersion + - name + - sectionNumber + - sectionTitle + - 'Invalid Reference' Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-001051/rule.yml b/Published/CORE-001051/rule.yml index 5a1bdd131..6b86b54af 100644 --- a/Published/CORE-001051/rule.yml +++ b/Published/CORE-001051/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content is expected to point to a child and/or to a - content item text.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00163' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Narrative content is expected to point to a child and/or to a content item text.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00163' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -37,23 +36,21 @@ Core: Id: 'CORE-001051' Status: Published Version: '1' -Description: 'Narrative content is expected to point to a child and/or to a - content item text.' +Description: 'Narrative content is expected to point to a child and/or to a content item text.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: "The narrative content does not contain either a child or a narrative - content item." + Message: "The narrative content does not contain either a child or a narrative content item." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - sectionTitle + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-001052/rule.yml b/Published/CORE-001052/rule.yml index b4619f3db..ee92ef85f 100644 --- a/Published/CORE-001052/rule.yml +++ b/Published/CORE-001052/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version must not be referenced more - than once by the same study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00167' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study definition document version must not be referenced more than once by + the same study version.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00167' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions. { @@ -27,19 +27,18 @@ Core: Id: 'CORE-001052' Status: Published Version: '1' -Description: 'A study definition document version must not be referenced more - than once by the same study version.' +Description: 'A study definition document version must not be referenced more than once by the same study + version.' Executability: Fully Executable Outcome: - Message: "The study version references the same study definition document - version more than once (there are duplicate id values in - documentVersionIds)." + Message: "The study version references the same study definition document version more than once (there + are duplicate id values in documentVersionIds)." Output Variables: - - versionIdentifier - - "Duplicate documentVersionIds" + - versionIdentifier + - "Duplicate documentVersionIds" Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-001053/rule.yml b/Published/CORE-001053/rule.yml index c8d6e53c9..22a6d23ff 100644 --- a/Published/CORE-001053/rule.yml +++ b/Published/CORE-001053/rule.yml @@ -1,17 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All abbreviations defined for a study version must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00170' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'All abbreviations defined for a study version must be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00170' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ( @@ -38,13 +38,13 @@ Executability: Fully Executable Outcome: Message: "The abbreviation's abbreviated text is not unique within the study version." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - abbreviatedText - - expandedText + - StudyVersion.id + - StudyVersion.versionIdentifier + - abbreviatedText + - expandedText Rule Type: JSONata Scope: Entities: Include: - - 'Abbreviation' + - 'Abbreviation' Sensitivity: Record diff --git a/Published/CORE-001054/rule.yml b/Published/CORE-001054/rule.yml index cf8d5987c..920981b5c 100644 --- a/Published/CORE-001054/rule.yml +++ b/Published/CORE-001054/rule.yml @@ -1,19 +1,19 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be exactly one sponsor study identifier (i.e., a - study identifier whose scope is an organization that is - identified as the organization for the sponsor study role).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00172' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'There must be exactly one sponsor study identifier (i.e., a study identifier + whose scope is an organization that is identified as the organization for the sponsor study + role).' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00172' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- [$.study.versions@$sv. ( @@ -36,19 +36,18 @@ Core: Id: 'CORE-001054' Status: Published Version: '1' -Description: 'There must be exactly one sponsor study identifier (i.e., a study - identifier whose scope is an organization that is identified as the - organization for the sponsor study role).' +Description: 'There must be exactly one sponsor study identifier (i.e., a study identifier whose scope + is an organization that is identified as the organization for the sponsor study role).' Executability: Fully Executable Outcome: Message: 'The study version does not have exactly one sponsor study identifier.' Output Variables: - - versionIdentifier - - '# Sponsor Identifiers' - - 'Sponsor Identifiers' + - versionIdentifier + - '# Sponsor Identifiers' + - 'Sponsor Identifiers' Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - 'StudyVersion' Sensitivity: Record diff --git a/Published/CORE-001055/rule.yml b/Published/CORE-001055/rule.yml index 6f0678381..1c91f7cf3 100644 --- a/Published/CORE-001055/rule.yml +++ b/Published/CORE-001055/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content must only reference narrative content that is - specified within the same study definition document version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00204' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Narrative content must only reference narrative content that is specified within + the same study definition document version.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00204' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -55,26 +55,25 @@ Core: Id: 'CORE-001055' Status: Published Version: '1' -Description: 'Narrative content must only reference narrative content that is - specified within the same study definition document version.' +Description: 'Narrative content must only reference narrative content that is specified within the same + study definition document version.' Executability: Fully Executable Outcome: - Message: 'The narrative content references a previous, next or child id value - that does not match the id of any narrative content defined within the same - study definition document version.' + Message: 'The narrative content references a previous, next or child id value that does not match the + id of any narrative content defined within the same study definition document version.' Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - Invalid previousId - - Invalid nextId - - Invalid childIds + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - Invalid previousId + - Invalid nextId + - Invalid childIds Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - 'NarrativeContent' Sensitivity: Record diff --git a/Published/CORE-001056/rule.yml b/Published/CORE-001056/rule.yml index af2053d71..d7006b11d 100644 --- a/Published/CORE-001056/rule.yml +++ b/Published/CORE-001056/rule.yml @@ -1,154 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's sampling method must be - specified according to the extensible Observational Study - Sampling Method (C127260) SDTM codelist (e.g. an entry with a - code or decode used from the codelist should be consistent - with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00225' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An observational study design's sampling method must be specified according to + the extensible Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with + a code or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00225' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: samplingMethod - operator: exists - - name: samplingMethod - operator: equal_to - value: true - - not: - all: - - name: samplingMethod.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: samplingMethod.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: samplingMethod + operator: exists + - name: samplingMethod + operator: equal_to + value: true + - not: + all: + - name: samplingMethod.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: samplingMethod.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: samplingMethod.code - operator: equal_to - value: $code_for_decode_pref_term - - name: samplingMethod.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: samplingMethod.decode - operator: equal_to - value: $pref_term_for_code - - name: samplingMethod.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: samplingMethod.code + operator: equal_to + value: $code_for_decode_pref_term + - name: samplingMethod.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: samplingMethod.decode + operator: equal_to + value: $pref_term_for_code + - name: samplingMethod.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-001056' Status: Published Version: '1' -Description: "An observational study design's sampling method must be specified - according to the extensible Observational Study Sampling Method (C127260) SDTM - codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." +Description: "An observational study design's sampling method must be specified according to the extensible + Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C127260 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: samplingMethod.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: samplingMethod.code - version: samplingMethod.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: samplingMethod.code - version: samplingMethod.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: samplingMethod.decode - version: samplingMethod.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: samplingMethod.decode - version: samplingMethod.codeSystemVersion +- id: $codelist_code + map: + - output: C127260 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: samplingMethod.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: samplingMethod.code + version: samplingMethod.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: samplingMethod.code + version: samplingMethod.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: samplingMethod.decode + version: samplingMethod.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: samplingMethod.decode + version: samplingMethod.codeSystemVersion Outcome: - Message: 'The observational study design''s sampling method is not specified - according to the extensible Observational Study Sampling Method (C127260) - SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion - is not a valid terminology package date, and/or the code or decode (either - as preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The observational study design''s sampling method is not specified according to the extensible + Observational Study Sampling Method (C127260) SDTM codelist - codeSystem is not "http://www.cdisc.org", + codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred + term or as submission value) is found in the codelist (case insensitive) but the corresponding decode + or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - samplingMethod.code - - $code_for_decode_value - - $code_for_decode_pref_term - - samplingMethod.codeSystem - - samplingMethod.codeSystemVersion - - samplingMethod.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - samplingMethod.code + - $code_for_decode_value + - $code_for_decode_pref_term + - samplingMethod.codeSystem + - samplingMethod.codeSystemVersion + - samplingMethod.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001057/rule.yml b/Published/CORE-001057/rule.yml index 6e0e2f0b2..f77ed9069 100644 --- a/Published/CORE-001057/rule.yml +++ b/Published/CORE-001057/rule.yml @@ -1,167 +1,162 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's sub types must be specified - according to the extensible observational study design subtype - (C215486) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full - entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00226' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An observational study design's sub types must be specified according to the + extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code + or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00226' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: subTypes - operator: exists - - name: subTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'subTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: subTypes + operator: exists + - name: subTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: 'subTypes' + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-001057' Status: Published Version: '1' -Description: "An observational study design's sub types must be specified - according to the extensible observational study design subtype (C215486) DDF - codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." +Description: "An observational study design's sub types must be specified according to the extensible + observational study design subtype (C215486) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: - - Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code +- Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: - - id: $codelist_code - map: - - output: C215486 - parent_rel.Code: 'subTypes' - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion +- id: $codelist_code + map: + - output: C215486 + parent_rel.Code: 'subTypes' + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The observational study design''s sub type is not specified according - to the extensible observational study design subtype (C215486) DDF codelist - - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid - terminology package date, and/or the code or decode (either as preferred - term or as submission value) is found in the codelist (case insensitive) but - the corresponding decode or code does not match the codelist value (case - sensitive).' + Message: 'The observational study design''s sub type is not specified according to the extensible observational + study design subtype (C215486) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion + is not a valid terminology package date, and/or the code or decode (either as preferred term or as + submission value) is found in the codelist (case insensitive) but the corresponding decode or code + does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001058/rule.yml b/Published/CORE-001058/rule.yml index 16e8430f6..96f4d3474 100644 --- a/Published/CORE-001058/rule.yml +++ b/Published/CORE-001058/rule.yml @@ -1,153 +1,150 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's study phase must be specified according to the - extensible Trial Phase Response (C66737) SDTM codelist (e.g. - an entry with a code or decode used from the codelist should - be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00229' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study design's study phase must be specified according to the extensible Trial + Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00229' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyPhase.standardCode - operator: exists - - name: studyPhase.standardCode - operator: equal_to - value: true - - not: - all: - - name: studyPhase.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyPhase.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyPhase.standardCode + operator: exists + - name: studyPhase.standardCode + operator: equal_to + value: true + - not: + all: + - name: studyPhase.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: studyPhase.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyPhase.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: studyPhase.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyPhase.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: studyPhase.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-001058' Status: Published Version: '1' -Description: "A study design's study phase must be specified according to the - extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a - code or decode used from the codelist should be consistent with the full entry - in the codelist)." +Description: "A study design's study phase must be specified according to the extensible Trial Phase Response + (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C66737 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C66737 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion Outcome: - Message: 'The study design''s study phase is not specified according to the - extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not - "http://www.cdisc.org", codeSystemVersion is not a valid terminology package - date, and/or the code or decode (either as preferred term or as submission - value) is found in the codelist (case insensitive) but the corresponding - decode or code does not match the codelist value (case sensitive).' + Message: 'The study design''s study phase is not specified according to the extensible Trial Phase Response + (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid + terminology package date, and/or the code or decode (either as preferred term or as submission value) + is found in the codelist (case insensitive) but the corresponding decode or code does not match the + codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - studyPhase.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyPhase.standardCode.codeSystem - - studyPhase.standardCode.codeSystemVersion - - studyPhase.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - studyPhase.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyPhase.standardCode.codeSystem + - studyPhase.standardCode.codeSystemVersion + - studyPhase.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001059/rule.yml b/Published/CORE-001059/rule.yml index b72226938..764550b06 100644 --- a/Published/CORE-001059/rule.yml +++ b/Published/CORE-001059/rule.yml @@ -1,148 +1,146 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design''s study type must be specified using the Study - Type Response (C99077) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00230' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study design''s study type must be specified using the Study Type Response + (C99077) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00230' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyType - operator: equal_to - value: true - - not: - all: - - name: studyType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyType.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: studyType + operator: equal_to + value: true + - not: + all: + - name: studyType.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: studyType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyType.decode - operator: equal_to - value: $pref_term_for_code - - name: studyType.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: studyType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyType.decode + operator: equal_to + value: $pref_term_for_code + - name: studyType.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-001059' Status: Published Version: '1' -Description: 'A study design''s study type must be specified using the Study - Type Response (C99077) SDTM codelist.' +Description: 'A study design''s study type must be specified using the Study Type Response (C99077) SDTM + codelist.' Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C99077 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyType.code - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyType.code - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyType.decode - version: studyType.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyType.decode - version: studyType.codeSystemVersion +- id: $codelist_code + map: + - output: C99077 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyType.code + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyType.code + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyType.decode + version: studyType.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyType.decode + version: studyType.codeSystemVersion Outcome: - Message: 'The study design''s study type is not specified using the Study Type - Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The study design''s study type is not specified using the Study Type Response (C99077) SDTM + codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, the code or decode (either as preferred term or as submission value) is found in the + codelist (case insensitive) but the corresponding decode or code does not match the codelist value + (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - studyType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyType.codeSystem - - studyType.codeSystemVersion - - studyType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - studyType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyType.codeSystem + - studyType.codeSystemVersion + - studyType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - 'InterventionalStudyDesign' + - 'ObservationalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001060/rule.yml b/Published/CORE-001060/rule.yml index c3070d472..b9e71929a 100644 --- a/Published/CORE-001060/rule.yml +++ b/Published/CORE-001060/rule.yml @@ -1,151 +1,147 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A unit must be coded according to the extensible unit (C71620) - SDTM codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00233' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A unit must be coded according to the extensible unit (C71620) SDTM codelist + (e.g. an entry with a code or decode used from the codelist should be consistent with the full + entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00233' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: unit.standardCode - operator: exists - - name: unit.standardCode - operator: equal_to - value: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: unit.standardCode + operator: exists + - name: unit.standardCode + operator: equal_to + value: true + - not: + all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-001060' Status: Published Version: '1' -Description: "A unit must be coded according to the extensible unit (C71620) - SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." +Description: "A unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry + with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C71620 - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion +- id: $codelist_code + map: + - output: C71620 + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion Outcome: - Message: 'The unit is not coded according to the extensible unit (C71620) SDTM - codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is - not a valid terminology package date, and/or the code or decode (either as - preferred term or as submission value) is found in the codelist (case - insensitive) but the corresponding decode or code does not match the - codelist value (case sensitive).' + Message: 'The unit is not coded according to the extensible unit (C71620) SDTM codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the + code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - value + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Quantity' + - 'Quantity' Sensitivity: Record diff --git a/Published/CORE-001061/rule.yml b/Published/CORE-001061/rule.yml index c8de16a13..036e6289a 100644 --- a/Published/CORE-001061/rule.yml +++ b/Published/CORE-001061/rule.yml @@ -1,171 +1,169 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The unit of a planned age is expected to be specified using - terms from the Age Unit (C66781) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00237' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The unit of a planned age is expected to be specified using terms from the Age + Unit (C66781) SDTM codelist.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00237' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: plannedAge - operator: equal_to - value: true - - name: unit - operator: equal_to - value: true - value_is_literal: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions + - name: rel_type + operator: equal_to + value: 'definition' + - name: plannedAge + operator: equal_to + value: true + - name: unit + operator: equal_to + value: true + value_is_literal: true + - not: + all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: 'CORE-001061' Status: Published Version: '1' -Description: 'The unit of a planned age is expected to be specified using terms - from the Age Unit (C66781) SDTM codelist.' +Description: 'The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) + SDTM codelist.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: plannedAge.instanceType - Right: parent_entity - - Left: plannedAge.id - Right: parent_id - - rel_type - Name: Quantity +- Keys: + - Left: plannedAge.instanceType + Right: parent_entity + - Left: plannedAge.id + Right: parent_id + - rel_type + Name: Quantity Operations: - - id: $codelist_code - map: - - output: C66781 - parent_rel.Quantity: 'minValue' - - output: C66781 - parent_rel.Quantity: 'maxValue' - operator: map - - ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion - - id: $variable_with_issue - map: - - output: 'plannedAge.minValue' - parent_rel.Quantity: 'minValue' - - output: 'plannedAge.maxValue' - parent_rel.Quantity: 'maxValue' - operator: map +- id: $codelist_code + map: + - output: C66781 + parent_rel.Quantity: 'minValue' + - output: C66781 + parent_rel.Quantity: 'maxValue' + operator: map +- ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion +- id: $variable_with_issue + map: + - output: 'plannedAge.minValue' + parent_rel.Quantity: 'minValue' + - output: 'plannedAge.maxValue' + parent_rel.Quantity: 'maxValue' + operator: map Outcome: - Message: 'The unit of the planned age is not specified using the Age Unit - (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, the code or - decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive), and/or neither code nor decode is - found in the codelist.' + Message: 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem + is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code + or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) + but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither + code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $variable_with_issue - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $variable_with_issue + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' - - 'StudyCohort' + - 'StudyDesignPopulation' + - 'StudyCohort' Sensitivity: Record diff --git a/Published/CORE-001062/rule.yml b/Published/CORE-001062/rule.yml index 721da905b..bdd04f3fd 100644 --- a/Published/CORE-001062/rule.yml +++ b/Published/CORE-001062/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference child activities that are - specified within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00254' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity must only reference child activities that are specified within the + same study design.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00254' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.**.studyDesigns@$s. [ @@ -31,20 +31,20 @@ Core: Id: 'CORE-001062' Status: Published Version: '1' -Description: 'An activity must only reference child activities that are - specified within the same study design.' +Description: 'An activity must only reference child activities that are specified within the same study + design.' Executability: Fully Executable Outcome: - Message: 'The activity references a childId that does not match the id of any - activity defined within the same study design as the activity.' + Message: 'The activity references a childId that does not match the id of any activity defined within + the same study design as the activity.' Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - childId + - StudyDesign.id + - StudyDesign.name + - name + - childId Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-001063/rule.yml b/Published/CORE-001063/rule.yml index 9f180a2fc..8112a2f6f 100644 --- a/Published/CORE-001063/rule.yml +++ b/Published/CORE-001063/rule.yml @@ -1,152 +1,149 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study role code must be specified according to the extensible - study role code (C215480) DDF codelist (e.g. an entry with a - code or decode used from the codelist should be consistent - with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00259' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study role code must be specified according to the extensible study role code + (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00259' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - not: - all: - - name: code.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: code.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true + - name: rel_type + operator: equal_to + value: 'definition' + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - not: + all: + - name: code.codeSystem + operator: equal_to + value: 'http://www.cdisc.org' + - name: code.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true + - any: + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code.code - operator: equal_to - value: $code_for_decode_pref_term - - name: code.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: code.decode - operator: equal_to - value: $pref_term_for_code - - name: code.decode - operator: equal_to - value: $value_for_code + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code.code + operator: equal_to + value: $code_for_decode_pref_term + - name: code.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: code.decode + operator: equal_to + value: $pref_term_for_code + - name: code.decode + operator: equal_to + value: $value_for_code Core: Id: 'CORE-001063' Status: Published Version: '1' -Description: "A study role code must be specified according to the extensible - study role code (C215480) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the - codelist)." +Description: "A study role code must be specified according to the extensible study role code (C215480) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the + full entry in the codelist)." Executability: Fully Executable Operations: - - id: $codelist_code - map: - - output: C215480 - operator: map - - ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates - - codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code.code - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code.code - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: code.decode - version: code.codeSystemVersion - - codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: code.decode - version: code.codeSystemVersion +- id: $codelist_code + map: + - output: C215480 + operator: map +- ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates +- codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code.code + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code.code + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: code.decode + version: code.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: code.decode + version: code.codeSystemVersion Outcome: - Message: 'The study role code is not specified using to the extensible study - role code (C215480) DDF codelist - codeSystem is not "http://www.cdisc.org", - codeSystemVersion is not a valid terminology package date, and/or the code - or decode (either as preferred term or as submission value) is found in the - codelist (case insensitive) but the corresponding decode or code does not - match the codelist value (case sensitive).' + Message: 'The study role code is not specified using to the extensible study role code (C215480) DDF + codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology + package date, and/or the code or decode (either as preferred term or as submission value) is found + in the codelist (case insensitive) but the corresponding decode or code does not match the codelist + value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - code.code - - $code_for_decode_value - - $code_for_decode_pref_term - - code.codeSystem - - code.codeSystemVersion - - code.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - code.code + - $code_for_decode_value + - $code_for_decode_pref_term + - code.codeSystem + - code.codeSystemVersion + - code.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-001065/rule.yml b/Published/CORE-001065/rule.yml index 70582fb33..a87211e53 100644 --- a/Published/CORE-001065/rule.yml +++ b/Published/CORE-001065/rule.yml @@ -1,32 +1,30 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if study type is Interventional then at - least one intervention is expected to be referenced from a - procedure.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00101' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if study type is Interventional then at - least one intervention is expected to be referenced from a - procedure.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00101' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if study type is Interventional then at least one intervention + is expected to be referenced from a procedure.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00101' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Within a study design, if study type is Interventional then at least one intervention + is expected to be referenced from a procedure.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00101' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sv. ($sv.studyDesigns[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sd. @@ -49,21 +47,21 @@ Core: Id: 'CORE-001065' Status: Published Version: '1' -Description: 'Within a study design, if study type is Interventional then at - least one intervention is expected to be referenced from a procedure.' +Description: 'Within a study design, if study type is Interventional then at least one intervention is + expected to be referenced from a procedure.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study type is Interventional (code=C98388) but a study - intervention is not referenced from any procedure.' + Message: 'The study type is Interventional (code=C98388) but a study intervention is not referenced + from any procedure.' Output Variables: - - name - - studyType.code - - studyType.decode - - '# Referenced Study Interventions' + - name + - studyType.code + - studyType.decode + - '# Referenced Study Interventions' Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' + - 'StudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001066/rule.yml b/Published/CORE-001066/rule.yml index 5957cd81c..6b56838f5 100644 --- a/Published/CORE-001066/rule.yml +++ b/Published/CORE-001066/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The ordering of activities (using the previous and next - attributes) must include the parents (e.g. activities - referring to children) preceding their children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00161' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The ordering of activities (using the previous and next attributes) must include + the parents (e.g. activities referring to children) preceding their children.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00161' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions.studyDesigns@$sd. $sd.activities@$a. @@ -55,31 +54,28 @@ Core: Id: 'CORE-001066' Status: Published Version: '1' -Description: 'The ordering of activities (using the previous and next - attributes) must include the parents (e.g. activities referring to children) - preceding their children.' +Description: 'The ordering of activities (using the previous and next attributes) must include the parents + (e.g. activities referring to children) preceding their children.' Executability: Fully Executable Outcome: - Message: "The previous/next ordering of the activity with respect to child - activities is incorrect - the activity has children but its nextId is not - one if its childIds, the activity is a child but its previousId is not its - parent or another descendant of its parent, and/or the activity's previousId - refers to an activity with children but the activity is not one of those - children." + Message: "The previous/next ordering of the activity with respect to child activities is incorrect - + the activity has children but its nextId is not one if its childIds, the activity is a child but its + previousId is not its parent or another descendant of its parent, and/or the activity's previousId + refers to an activity with children but the activity is not one of those children." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - previousId - - "Previous Activity's childIds" - - nextId - - childIds - - "Parent Activity's id" - - "Parent Activity's other descendants' ids" - - "Issue(s)" + - StudyDesign.id + - StudyDesign.name + - name + - previousId + - "Previous Activity's childIds" + - nextId + - childIds + - "Parent Activity's id" + - "Parent Activity's other descendants' ids" + - "Issue(s)" Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-001067/rule.yml b/Published/CORE-001067/rule.yml index efd2b315e..74cc8e0e2 100644 --- a/Published/CORE-001067/rule.yml +++ b/Published/CORE-001067/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The expanded text for all abbreviations defined for a study - version are expected to be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00171' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'The expanded text for all abbreviations defined for a study version are expected + to be unique.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00171' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- study.versions@$sv. ( @@ -34,20 +34,18 @@ Core: Id: 'CORE-001067' Status: Published Version: '1' -Description: 'The expanded text for all abbreviations defined for a study - version are expected to be unique.' +Description: 'The expanded text for all abbreviations defined for a study version are expected to be unique.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: "The abbreviation's expanded text is not unique within the study - version (case insensitive)." + Message: "The abbreviation's expanded text is not unique within the study version (case insensitive)." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - abbreviatedText - - expandedText + - StudyVersion.id + - StudyVersion.versionIdentifier + - abbreviatedText + - expandedText Rule Type: JSONata Scope: Entities: Include: - - 'Abbreviation' + - 'Abbreviation' Sensitivity: Record diff --git a/Published/CORE-001068/rule.yml b/Published/CORE-001068/rule.yml index be0e5bd36..c85dbffa4 100644 --- a/Published/CORE-001068/rule.yml +++ b/Published/CORE-001068/rule.yml @@ -1,85 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study definition document version - must be unique regarding the combination of type and - geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00181' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Date values associated to a study definition document version must be unique + regarding the combination of type and geographic scopes of the date.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00181' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDefinitionDocumentVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: 'StudyDefinitionDocumentVersion' + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: Id: 'CORE-001068' Status: Published Version: '1' -Description: 'Date values associated to a study definition document version must - be unique regarding the combination of type and geographic scopes of the - date.' +Description: 'Date values associated to a study definition document version must be unique regarding the + combination of type and geographic scopes of the date.' Executability: Fully Executable Match Datasets: - - Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate - - Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope +- Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate +- Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study definition document version has more than one governance - date with the same type and geographic scope.' + Message: 'The study definition document version has more than one governance date with the same type + and geographic scope.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - version - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - version + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - 'StudyDefinitionDocumentVersion' Sensitivity: Record diff --git a/Published/CORE-001069/rule.yml b/Published/CORE-001069/rule.yml index 6121d4ee4..84eaedad9 100644 --- a/Published/CORE-001069/rule.yml +++ b/Published/CORE-001069/rule.yml @@ -1,24 +1,24 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content item text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00187' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Narrative content item text is expected to be HTML formatted.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00187' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: 'definition' + - name: $xhtml_errors + operator: non_empty Core: Id: 'CORE-001069' Status: Published @@ -26,21 +26,21 @@ Core: Description: 'Narrative content item text is expected to be HTML formatted.' Executability: Partially Executable - Possible Overreporting Operations: - - id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors +- id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: Message: 'The narrative content item text contains non-conformant XHTML.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContentItem' + - 'NarrativeContentItem' Sensitivity: Record diff --git a/Published/CORE-001070/rule.yml b/Published/CORE-001070/rule.yml index 6d7b11e2d..6506b690c 100644 --- a/Published/CORE-001070/rule.yml +++ b/Published/CORE-001070/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is not expected to be defined for any study role in a - study design with an open label blinding schema.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00191' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A masking is not expected to be defined for any study role in a study design + with an open label blinding schema.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00191' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- $.study.versions@$sv. [ @@ -42,23 +42,23 @@ Core: Id: 'CORE-001070' Status: Published Version: '1' -Description: 'A masking is not expected to be defined for any study role in a - study design with an open label blinding schema.' +Description: 'A masking is not expected to be defined for any study role in a study design with an open + label blinding schema.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A masking is defined for the study role, but the role applies to a - study design with an open label blinding schema.' + Message: 'A masking is defined for the study role, but the role applies to a study design with an open + label blinding schema.' Output Variables: - - name - - code - - masking.text - - masking.isMasked - - appliesToIds - - StudyDesign.id - - StudyDesign.blindingSchema + - name + - code + - masking.text + - masking.isMasked + - appliesToIds + - StudyDesign.id + - StudyDesign.blindingSchema Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - 'StudyRole' Sensitivity: Record diff --git a/Published/CORE-001071/rule.yml b/Published/CORE-001071/rule.yml index f7b61ffb6..4daabdb9e 100644 --- a/Published/CORE-001071/rule.yml +++ b/Published/CORE-001071/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is expected to be defined for at least two study - roles in a study design with a double blind blinding schema.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00192' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A masking is expected to be defined for at least two study roles in a study design + with a double blind blinding schema.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00192' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd @@ -50,21 +50,21 @@ Core: Id: 'CORE-001071' Status: Published Version: '1' -Description: 'A masking is expected to be defined for at least two study roles - in a study design with a double blind blinding schema.' +Description: 'A masking is expected to be defined for at least two study roles in a study design with + a double blind blinding schema.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has a double blind blinding schema (code=C15228) but - there are not at least two applicable study roles that are masked.' + Message: 'The study design has a double blind blinding schema (code=C15228) but there are not at least + two applicable study roles that are masked.' Output Variables: - - name - - blindingSchema.code - - blindingSchema.decode - - "# Masked Roles" - - "Applicable Roles" + - name + - blindingSchema.code + - blindingSchema.decode + - "# Masked Roles" + - "Applicable Roles" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001072/rule.yml b/Published/CORE-001072/rule.yml index 1e7d1e466..6903ba3fd 100644 --- a/Published/CORE-001072/rule.yml +++ b/Published/CORE-001072/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is expected to be defined for at least one study role - in a study design with a blinding schema that is not open - label or double blind.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00193' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A masking is expected to be defined for at least one study role in a study design + with a blinding schema that is not open label or double blind.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00193' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd @@ -52,22 +51,21 @@ Core: Id: 'CORE-001072' Status: Published Version: '1' -Description: 'A masking is expected to be defined for at least one study role in - a study design with a blinding schema that is not open label or double blind.' +Description: 'A masking is expected to be defined for at least one study role in a study design with a + blinding schema that is not open label or double blind.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has a blinding schema that is not open label or - double blind (code is not C49659 or C15228) but there is no applicable study - role that is masked.' + Message: 'The study design has a blinding schema that is not open label or double blind (code is not + C49659 or C15228) but there is no applicable study role that is masked.' Output Variables: - - name - - blindingSchema.code - - blindingSchema.decode - - "# Masked Roles" - - "Applicable Roles" + - name + - blindingSchema.code + - blindingSchema.decode + - "# Masked Roles" + - "Applicable Roles" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Published/CORE-001073/rule.yml b/Published/CORE-001073/rule.yml index 9a6bc9c79..fba0dec44 100644 --- a/Published/CORE-001073/rule.yml +++ b/Published/CORE-001073/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in the narrative content item texts must be - available elsewhere in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00244' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Referenced items in the narrative content item texts must be available elsewhere + in the data model.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00244' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -61,18 +61,17 @@ Core: Id: 'CORE-001073' Status: Published Version: '1' -Description: 'Referenced items in the narrative content item texts must be - available elsewhere in the data model.' +Description: 'Referenced items in the narrative content item texts must be available elsewhere in the + data model.' Executability: Fully Executable Outcome: - Message: 'The item referenced in the narrative content item text is not - available elsewhere in the model.' + Message: 'The item referenced in the narrative content item text is not available elsewhere in the model.' Output Variables: - - name - - 'Invalid Reference' + - name + - 'Invalid Reference' Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContentItem' + - 'NarrativeContentItem' Sensitivity: Record diff --git a/Published/CORE-001074/rule.yml b/Published/CORE-001074/rule.yml index cc4ebf105..098ef4696 100644 --- a/Published/CORE-001074/rule.yml +++ b/Published/CORE-001074/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Any parameter name referenced in a tag in the text should be - specified in the data dictionary parameter maps.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00246' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Any parameter name referenced in a tag in the text should be specified in the + data dictionary parameter maps.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00246' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- **.study.versions@$sv. ($sv.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st. @@ -48,29 +48,28 @@ Core: Id: 'CORE-001074' Status: Published Version: '1' -Description: 'Any parameter name referenced in a tag in the text should be - specified in the data dictionary parameter maps.' +Description: 'Any parameter name referenced in a tag in the text should be specified in the data dictionary + parameter maps.' Executability: Fully Executable Outcome: - Message: "The parameter name referenced in the text is not specified in the data - dictionary parameter map - the dictionaryId is missing or invalid, or the - parameter name does not match a tag in any of the dictionary's parameter - maps." + Message: "The parameter name referenced in the text is not specified in the data dictionary parameter + map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of + the dictionary's parameter maps." Output Variables: - - name - - Parameter reference - - Parameter name - - dictionaryId - - SyntaxTemplateDictionary.name - - Issue + - name + - Parameter reference + - Parameter name + - dictionaryId + - SyntaxTemplateDictionary.name + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterionItem' - - 'Characteristic' - - 'Condition' - - 'Objective' - - 'Endpoint' - - 'IntercurrentEvent' + - 'EligibilityCriterionItem' + - 'Characteristic' + - 'Condition' + - 'Objective' + - 'Endpoint' + - 'IntercurrentEvent' Sensitivity: Record diff --git a/Published/CORE-001075/rule.yml b/Published/CORE-001075/rule.yml index d60042e50..e19a44372 100644 --- a/Published/CORE-001075/rule.yml +++ b/Published/CORE-001075/rule.yml @@ -1,18 +1,17 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Id values are expected not to have spaces in their string - values.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00260' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Id values are expected not to have spaces in their string values.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00260' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- (**[$contains($string(id)," ")])@$i. { @@ -30,10 +29,10 @@ Executability: Partially Executable - Possible Overreporting Outcome: Message: 'The id value contains a space.' Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Published/CORE-001076/rule.yml b/Published/CORE-001076/rule.yml index 2980932d9..aead92921 100644 --- a/Published/CORE-001076/rule.yml +++ b/Published/CORE-001076/rule.yml @@ -1,96 +1,93 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity is expected to refer to at least one procedure, - biomedical concept, biomedical concept category, biomedical - concept surrogate, child activity, or timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00263' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'An activity is expected to refer to at least one procedure, biomedical concept, + biomedical concept category, biomedical concept surrogate, child activity, or timeline.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00263' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - name: rel_type + - name: rel_type + operator: equal_to + value: 'definition' + - any: + - name: definedProcedures + operator: not_exists + - name: definedProcedures + operator: empty + - name: definedProcedures operator: equal_to - value: 'definition' - - any: - - name: definedProcedures - operator: not_exists - - name: definedProcedures - operator: empty - - name: definedProcedures - operator: equal_to - value: false - - any: - - name: biomedicalConceptIds - operator: not_exists - - name: biomedicalConceptIds - operator: empty - - name: biomedicalConceptIds - operator: equal_to - value: false - - any: - - name: bcCategoryIds - operator: not_exists - - name: bcCategoryIds - operator: empty - - name: bcCategoryIds - operator: equal_to - value: false - - any: - - name: bcSurrogateIds - operator: not_exists - - name: bcSurrogateIds - operator: empty - - name: bcSurrogateIds - operator: equal_to - value: false - - any: - - name: childIds - operator: not_exists - - name: childIds - operator: empty - - name: childIds - operator: equal_to - value: false - - any: - - name: timelineId - operator: not_exists - - name: timelineId - operator: empty + value: false + - any: + - name: biomedicalConceptIds + operator: not_exists + - name: biomedicalConceptIds + operator: empty + - name: biomedicalConceptIds + operator: equal_to + value: false + - any: + - name: bcCategoryIds + operator: not_exists + - name: bcCategoryIds + operator: empty + - name: bcCategoryIds + operator: equal_to + value: false + - any: + - name: bcSurrogateIds + operator: not_exists + - name: bcSurrogateIds + operator: empty + - name: bcSurrogateIds + operator: equal_to + value: false + - any: + - name: childIds + operator: not_exists + - name: childIds + operator: empty + - name: childIds + operator: equal_to + value: false + - any: + - name: timelineId + operator: not_exists + - name: timelineId + operator: empty Core: Id: 'CORE-001076' Status: Published Version: '1' -Description: 'An activity is expected to refer to at least one procedure, - biomedical concept, biomedical concept category, biomedical concept surrogate, - child activity, or timeline.' +Description: 'An activity is expected to refer to at least one procedure, biomedical concept, biomedical + concept category, biomedical concept surrogate, child activity, or timeline.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity does not refer to any procedure, biomedical concept, - biomedical concept category, biomedical concept surrogate, child activity, - or timeline.' + Message: 'The activity does not refer to any procedure, biomedical concept, biomedical concept category, + biomedical concept surrogate, child activity, or timeline.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - definedProcedures - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds - - childIds - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - definedProcedures + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds + - childIds + - timelineId Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - 'Activity' Sensitivity: Record diff --git a/Published/CORE-001077/rule.yml b/Published/CORE-001077/rule.yml index c727db8df..115a0facb 100644 --- a/Published/CORE-001077/rule.yml +++ b/Published/CORE-001077/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If an interventional model indicates a cross-over, parallel or - factorial design then more than 1 intervention is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00213' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'If an interventional model indicates a cross-over, parallel or factorial design + then more than 1 intervention is expected.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00213' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ($.study.versions)@$sv. ($sv.studyDesigns[studyType.code = "C98388"])@$sd. @@ -34,25 +34,24 @@ Core: Id: 'CORE-001077' Status: Published Version: '1' -Description: 'If an interventional model indicates a cross-over, parallel or - factorial design then more than 1 intervention is expected.' +Description: 'If an interventional model indicates a cross-over, parallel or factorial design then more + than 1 intervention is expected.' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The number of study interventions referenced for the interventional - study design is not consistent with intervention model specified for the - study design - the model indicates a cross-over, parallel or factorial - design (model.code is C82637, C82639, or C82638) and there are not - references to multiple study interventions.' + Message: 'The number of study interventions referenced for the interventional study design is not consistent + with intervention model specified for the study design - the model indicates a cross-over, parallel + or factorial design (model.code is C82637, C82639, or C82638) and there are not references to multiple + study interventions.' Output Variables: - - name - - studyType.code - - studyType.decode - - model.code - - model.decode - - '# Referenced Study Interventions' + - name + - studyType.code + - studyType.decode + - model.code + - model.decode + - '# Referenced Study Interventions' Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - 'InterventionalStudyDesign' Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0005/rule.yml b/Unpublished/ADAMIG/AD0005/rule.yml index 106fd8f4b..7f10a19e8 100644 --- a/Unpublished/ADAMIG/AD0005/rule.yml +++ b/Unpublished/ADAMIG/AD0005/rule.yml @@ -1,135 +1,135 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.3 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.2 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.3 + Item: '4' + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.3 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '5' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.2 + Item: '4' + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.2 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '5' + Version: '5.0' + Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.1 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.1 + Item: '4' + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.1 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '5' + Version: '5.0' + Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.0 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: '4' + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.0 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '5' + Version: '5.0' + Version: '1.0' Check: all: #- name: variable_name # operator: ends_with # value: 'FL' # - name: #*FL like --FL - - operator: is_not_contained_by - value: - - Y - - N - - '' + - operator: is_not_contained_by + value: + - Y + - N + - '' #- name: CRIT1FL #*FL like --FL # operator: non_empty Core: @@ -148,16 +148,16 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - ADAM OTHER - - BASIC DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - BASIC DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0006/rule.yml b/Unpublished/ADAMIG/AD0006/rule.yml index b5b2a6eae..fa396af78 100644 --- a/Unpublished/ADAMIG/AD0006/rule.yml +++ b/Unpublished/ADAMIG/AD0006/rule.yml @@ -1,128 +1,128 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.3 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.3 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.3 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '6' + Version: '5.0' + Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.2 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.1 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables: 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.0 - Item: 5 (General Flag Variable Conventions) - Section: '3' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: 9 (General Flag Variable Conventions) - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.2 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.2 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '6' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.1 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.1 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '6' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables: 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.0 + Item: 5 (General Flag Variable Conventions) + Section: '3' + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: 9 (General Flag Variable Conventions) + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '6' + Version: '5.0' + Version: '1.0' Check: all: - - name: -- 'FN' - operator: exists - - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 - operator: exists - - name: --'FN' - operator: non_empty - - name: --'FN' - operator: does_not_contain - value: (0,1) + - name: -- 'FN' + operator: exists + - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 + operator: exists + - name: --'FN' + operator: non_empty + - name: --'FN' + operator: does_not_contain + value: (0,1) Core: Id: CDISC.ADaMIG.AD0006 Status: Draft @@ -133,16 +133,16 @@ Executability: Fully Executable Outcome: Message: Variable with a suffix of FN does must have the value Y, N or null Output Variables: - - --FL - - --FN + - --FL + - --FN Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0007/rule.yml b/Unpublished/ADAMIG/AD0007/rule.yml index 9a75d5c77..1f6bd016f 100644 --- a/Unpublished/ADAMIG/AD0007/rule.yml +++ b/Unpublished/ADAMIG/AD0007/rule.yml @@ -1,128 +1,128 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.3 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.3 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.3 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '7' + Version: '5.0' + Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.2 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.1 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables: 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.0 - Item: 5 (General Flag Variable Conventions) - Section: '3' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: 9 (General Flag Variable Conventions) - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.2 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.2 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '7' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.1 + Item: '5' + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.1 + Item: '9' + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '7' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables: 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.0 + Item: 5 (General Flag Variable Conventions) + Section: '3' + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: 9 (General Flag Variable Conventions) + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '7' + Version: '5.0' + Version: '1.0' Check: all: - - name: -- 'FN' - operator: exists - - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 - operator: exists - - name: --'FN' - operator: non_empty - - name: --'FN' - operator: does_not_contain - value: (0,1) + - name: -- 'FN' + operator: exists + - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 + operator: exists + - name: --'FN' + operator: non_empty + - name: --'FN' + operator: does_not_contain + value: (0,1) Core: Id: CDISC.ADaMIG.AD0007 Status: Draft @@ -133,16 +133,16 @@ Executability: Fully Executable Outcome: Message: Variable with a suffix of FN does must have the value Y, N or null Output Variables: - - --FL - - --FN + - --FL + - --FN Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0010/rule.yml b/Unpublished/ADAMIG/AD0010/rule.yml index 7cf104079..a6d9ca2f5 100644 --- a/Unpublished/ADAMIG/AD0010/rule.yml +++ b/Unpublished/ADAMIG/AD0010/rule.yml @@ -1,131 +1,131 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables:N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4 (General Flag Variable Conventions):' - Section: '3' - - Cited Guidance: >- - For subject-level character For character flags that are not - population flags, a scheme of Y/N/null, or Y/null may be - specified. As indicated in Table 3.2.6.1, some common - character flags use the scheme Y/null. Corresponding 1/0/null - and 1/null schemes apply to numeric flags that are not - population indicators. - Document: ADaM IG v1.0 - Item: '9 (General Flag Variable Conventions):' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: '4' + Section: '3.1.4' + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.0 + Item: '9' + Section: '3.1.4' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '10' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: '4' + Section: '3.1.4' + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.0 + Item: '9' + Section: '3.1.4' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '10' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: '4' + Section: '3.1.4' + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: '9' + Section: '3.1.4' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '10' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables:N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: '4 (General Flag Variable Conventions):' + Section: '3' + - Cited Guidance: >- + For subject-level character For character flags that are not + population flags, a scheme of Y/N/null, or Y/null may be + specified. As indicated in Table 3.2.6.1, some common + character flags use the scheme Y/null. Corresponding 1/0/null + and 1/null schemes apply to numeric flags that are not + population indicators. + Document: ADaM IG v1.0 + Item: '9 (General Flag Variable Conventions):' + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '10' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name - operator: ends_with - value: 'FL' - - name: vatiable_value - operator: equal_to - value: 'Y' - - any: - - all: - - name: Root(variable_name) - operator: ends_with - value: 'FN' - - name: root(variable_value) - operator: not_equal_to - value: '1' + - name: variable_name + operator: ends_with + value: 'FL' + - name: vatiable_value + operator: equal_to + value: 'Y' + - any: + - all: + - name: Root(variable_name) + operator: ends_with + value: 'FN' + - name: root(variable_value) + operator: not_equal_to + value: '1' # Core: Id: CDSIC.ADaMIG.AD0010 @@ -136,17 +136,17 @@ Description: >- root and a suffix of FN is not equal to 1' Executability: Fully Executable Outcome: - Message: A variable with a suffix of FL is equal to Y and a variable with the - same root and a suffix of FN is not equal to 1 + Message: A variable with a suffix of FL is equal to Y and a variable with the same root and a + suffix of FN is not equal to 1 Output Variables: - - variable_name + - variable_name Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0013/rule.yml b/Unpublished/ADAMIG/AD0013/rule.yml index 010449467..5c99dd6fa 100644 --- a/Unpublished/ADAMIG/AD0013/rule.yml +++ b/Unpublished/ADAMIG/AD0013/rule.yml @@ -1,173 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: '1' + Section: 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '13' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '13' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.2 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.2 + Item: '1' + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '13' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '13' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: '1' + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '13' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '13' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle - constraints, all ADaM variable names must be no more than 8 - characters in length, start with a letter (not underscore), - and be comprised only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than - 40 characters in length. All ADaM character variables must be - no more than 200 characters in length. - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions) - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length. + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions) + Section: '3' + Criteria: + Logical Expression: + Condition: '' + Rule: '13' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '13' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name - operator: longer_than - value: 8 + - name: variable_name + operator: longer_than + value: 8 Core: Id: CDISC.ADaMIG.AD0013 @@ -178,22 +162,22 @@ Executability: Fully Executable Outcome: Message: Variable name must be less than 8 charatcters Output Variables: - - variable_name #log a ticket to get schema updated - already logged for ID 16 - - variable_label + - variable_name #log a ticket to get schema updated - already logged for ID 16 + - variable_label Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0014/rule.yml b/Unpublished/ADAMIG/AD0014/rule.yml index 55a70875c..1eaa957b3 100644 --- a/Unpublished/ADAMIG/AD0014/rule.yml +++ b/Unpublished/ADAMIG/AD0014/rule.yml @@ -1,257 +1,242 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider - the requirements noted in the eCTD guidance document as well - as the need to conform to the SAS Transport format - requirements (e.g., the total length of the name cannot exceed - 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), - underscore (_), and numerals (0-9). All ADaM variable labels - must be no more than 40 characters in length. All ADaM - character variables must be no more than 200 characters in - length. - Document: ADaMIG v1.3 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'Model v2.1' + References: + - Citations: + - Cited Guidance: <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.3 + Item: '1' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' - - Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider - the requirements noted in the eCTD guidance document as well - as the need to conform to the SAS Transport format - requirements (e.g., the total length of the name cannot exceed - 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), - underscore (_), and numerals (0-9). All ADaM variable labels - must be no more than 40 characters in length. All ADaM - character variables must be no more than 200 characters in - length. - Document: ADaMIG v1.2 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: 'Model v2.1' + References: + - Citations: + - Cited Guidance: <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.2 + Item: '1' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' - - Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider - the requirements noted in the eCTD guidance document as well - as the need to conform to the SAS Transport format - requirements (e.g., the total length of the name cannot exceed - 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), - underscore (_), and numerals (0-9). All ADaM variable labels - must be no more than 40 characters in length. All ADaM - character variables must be no more than 200 characters in - length. - Document: ADaMIG v1.1 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: 'Model v2.1' + References: + - Citations: + - Cited Guidance: <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.1 + Item: '1' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' - - Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider - the requirements noted in the eCTD guidance document as well - as the need to conform to the SAS Transport format - requirements (e.g., the total length of the name cannot exceed - 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle - constraints, all ADaM variable names must be no more than 8 - characters in length, start with a letter (not underscore), - and be comprised only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than - 40 characters in length. All ADaM character variables must be - no more than 200 characters in length.8 characters). - Document: ADaMIG v1.0 - Item: '5 (General Variable Naming Conventions)' - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: 'Model v2.1' + References: + - Citations: + - Cited Guidance: <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length.8 characters). + Document: ADaMIG v1.0 + Item: '5 (General Variable Naming Conventions)' + Section: '3' + Criteria: + Logical Expression: + Condition: '' + Rule: '14' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '14' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name - operator: not_prefix_matches_regex - prefix: 0 - value: '[A-Z]' + - name: variable_name + operator: not_prefix_matches_regex + prefix: 0 + value: '[A-Z]' Core: Id: CDISC.ADaMIG.AD0014 @@ -262,22 +247,22 @@ Executability: Fully Executable Outcome: Message: A variable name does not start with a letter (A-Z) Output Variables: - - variable_name - - variable_label + - variable_name + - variable_label Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0016/rule.yml b/Unpublished/ADAMIG/AD0016/rule.yml index a8de4537a..fa4413f10 100644 --- a/Unpublished/ADAMIG/AD0016/rule.yml +++ b/Unpublished/ADAMIG/AD0016/rule.yml @@ -1,173 +1,157 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: '1' + Section: 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '16' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '16' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.2 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.2 + Item: '1' + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '16' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '16' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: '1' + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: '' + Rule: '16' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '16' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle - constraints, all ADaM variable names must be no more than 8 - characters in length, start with a letter (not underscore), - and be comprised only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than - 40 characters in length. All ADaM character variables must be - no more than 200 characters in length. - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions) - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length. + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions) + Section: '3' + Criteria: + Logical Expression: + Condition: '' + Rule: '16' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: '' + Relationship: Related + Release Notes: '' + Rule Identifier: + Id: '16' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_label - operator: longer_than - value: 40 + - name: variable_label + operator: longer_than + value: 40 Core: Id: CDISC.ADaMIG.AD0016 Status: Draft @@ -177,22 +161,22 @@ Executability: Fully Executable Outcome: Message: Label must be less than 40 charatcters Output Variables: - - variable_label #log a ticket to get schema updated - - variable_name + - variable_label #log a ticket to get schema updated + - variable_name Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0017/rule.yml b/Unpublished/ADAMIG/AD0017/rule.yml index ea0e5fe14..9059798b0 100644 --- a/Unpublished/ADAMIG/AD0017/rule.yml +++ b/Unpublished/ADAMIG/AD0017/rule.yml @@ -1,134 +1,116 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '1' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: '1' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '17' + Version: '1' + Version: '5.0' + Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length.'' - Document: ADaM IG v1.2 - Item: '1' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '1' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length.'' + Document: ADaM IG v1.2 + Item: '1' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '17' + Version: '1' + Version: '5.0' + Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format - and Oracle constraints, all ADaM variable names must be no - more than 8 characters in length, start with a letter (not - underscore), and be composed only of letters (A-Z), underscore - (_), and numerals (0-9). All ADaM variable labels must be no - more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: 3.1.1 - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '1' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: '1' + Section: 3.1.1 + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '1' + Section: 4.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '17' + Version: '1' + Version: '5.0' + Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as - the need to conform to the SAS Transport format requirements - (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle - constraints, all ADaM variable names must be no more than 8 - characters in length, start with a letter (not underscore), - and be comprised only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than - 40 characters in length. All ADaM character variables must be - no more than 200 characters in length - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions)':' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: '1' + Section: 4.1.2 + - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions)':' + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '17' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895 - operator: equal_to - value: char - - name: variable_value - operator: longer_than - value: 200 + - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895 + operator: equal_to + value: char + - name: variable_value + operator: longer_than + value: 200 Core: Id: CDISC.ADaMIG.AD0017 Status: Draft @@ -138,22 +120,22 @@ Executability: Fully Executable Outcome: Message: Variable value is greather than 200 characters long Output Variables: - - variable_name + - variable_name Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0019/rule.yml b/Unpublished/ADAMIG/AD0019/rule.yml index 7f391489e..9f7073823 100644 --- a/Unpublished/ADAMIG/AD0019/rule.yml +++ b/Unpublished/ADAMIG/AD0019/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '19' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '19' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '19' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '19' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: COMPLFL - operator: exists - - name: COMPLFL - operator: is_not_contained_by - value: - - Y - - N + - name: COMPLFL + operator: exists + - name: COMPLFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0019 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of COMPLFL are not following the "Y, N" codelist Output Variables: - - COMPLFL + - COMPLFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0020/rule.yml b/Unpublished/ADAMIG/AD0020/rule.yml index b55b41df5..886c36fe4 100644 --- a/Unpublished/ADAMIG/AD0020/rule.yml +++ b/Unpublished/ADAMIG/AD0020/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '20' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '20' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '20' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '20' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: FASFL - operator: exists - - name: FASFL - operator: is_not_contained_by - value: - - Y - - N + - name: FASFL + operator: exists + - name: FASFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0020 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of FASFL are not following the "Y, N" codelist Output Variables: - - FASFL + - FASFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0021/rule.yml b/Unpublished/ADAMIG/AD0021/rule.yml index 2a28ff35f..b584ffcbe 100644 --- a/Unpublished/ADAMIG/AD0021/rule.yml +++ b/Unpublished/ADAMIG/AD0021/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '21' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '21' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '21' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '21' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: ITTFL - operator: exists - - name: ITTFL - operator: is_not_contained_by - value: - - Y - - N + - name: ITTFL + operator: exists + - name: ITTFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0021 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of ITTFL are not following the "Y, N" codelist Output Variables: - - ITTFL + - ITTFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0022/rule.yml b/Unpublished/ADAMIG/AD0022/rule.yml index fa816dd42..7d4ac9fd1 100644 --- a/Unpublished/ADAMIG/AD0022/rule.yml +++ b/Unpublished/ADAMIG/AD0022/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '22' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '22' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '22' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '22' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: PPROTFL - operator: exists - - name: PPROTFL - operator: is_not_contained_by - value: - - Y - - N + - name: PPROTFL + operator: exists + - name: PPROTFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0022 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of PPROTFL are not following the "Y, N" codelist Output Variables: - - PPROTFL + - PPROTFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0023/rule.yml b/Unpublished/ADAMIG/AD0023/rule.yml index eb23ea21e..8cd9c7873 100644 --- a/Unpublished/ADAMIG/AD0023/rule.yml +++ b/Unpublished/ADAMIG/AD0023/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '23' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '23' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '23' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '23' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: SAFFL - operator: exists - - name: SAFFL - operator: is_not_contained_by - value: - - Y - - N + - name: SAFFL + operator: exists + - name: SAFFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0023 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of SAFFL are not following the "Y, N" codelist Output Variables: - - SAFFL + - SAFFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0024/rule.yml b/Unpublished/ADAMIG/AD0024/rule.yml index 1142a9405..731ba266b 100644 --- a/Unpublished/ADAMIG/AD0024/rule.yml +++ b/Unpublished/ADAMIG/AD0024/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '24' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '24' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '24' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '24' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: RANDFL - operator: exists - - name: RANDFL - operator: is_not_contained_by - value: - - Y - - N + - name: RANDFL + operator: exists + - name: RANDFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0024 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of RANDFL are not following the "Y, N" codelist Output Variables: - - RANDFL + - RANDFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0025/rule.yml b/Unpublished/ADAMIG/AD0025/rule.yml index 1fa687b7f..031a716d2 100644 --- a/Unpublished/ADAMIG/AD0025/rule.yml +++ b/Unpublished/ADAMIG/AD0025/rule.yml @@ -1,75 +1,75 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '25' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '25' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '25' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '25' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: ENRLFL - operator: exists - - name: ENRLFL - operator: is_not_contained_by - value: - - Y - - N + - name: ENRLFL + operator: exists + - name: ENRLFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0025 Status: Draft @@ -80,10 +80,10 @@ Executability: Fully Executable Outcome: Message: The values of ENRLFL are not following the "Y, N" codelist Output Variables: - - ENRLFL + - ENRLFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0026/rule.yml b/Unpublished/ADAMIG/AD0026/rule.yml index d36f1dd88..5e34dcf3d 100644 --- a/Unpublished/ADAMIG/AD0026/rule.yml +++ b/Unpublished/ADAMIG/AD0026/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '26' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '26' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '26' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '26' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: COMPLFN - operator: exists - - name: COMPLFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: COMPLFN + operator: exists + - name: COMPLFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0026 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of COMPLFN are not equal to 1 or 0 Output Variables: - - COMPLFN + - COMPLFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0027/rule.yml b/Unpublished/ADAMIG/AD0027/rule.yml index 526d7c286..ab3b7fe6e 100644 --- a/Unpublished/ADAMIG/AD0027/rule.yml +++ b/Unpublished/ADAMIG/AD0027/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '27' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '27' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '27' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '27' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: FASFN - operator: exists - - name: FASFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: FASFN + operator: exists + - name: FASFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0027 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of FASFN are not equal to 1 or 0 Output Variables: - - FASFN + - FASFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0028/rule.yml b/Unpublished/ADAMIG/AD0028/rule.yml index 12e00411a..adc9803b1 100644 --- a/Unpublished/ADAMIG/AD0028/rule.yml +++ b/Unpublished/ADAMIG/AD0028/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '28' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '28' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '28' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '28' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: ITTFN - operator: exists - - name: ITTFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: ITTFN + operator: exists + - name: ITTFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0028 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of ITTFN are not equal to 1 or 0 Output Variables: - - ITTFN + - ITTFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0029/rule.yml b/Unpublished/ADAMIG/AD0029/rule.yml index 488eee9ee..fa63986cb 100644 --- a/Unpublished/ADAMIG/AD0029/rule.yml +++ b/Unpublished/ADAMIG/AD0029/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '29' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '29' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '29' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '29' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: PPROTFN - operator: exists - - name: PPROTFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: PPROTFN + operator: exists + - name: PPROTFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0029 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of PPROTFN are not equal to 1 or 0 Output Variables: - - PPROTFN + - PPROTFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0030/rule.yml b/Unpublished/ADAMIG/AD0030/rule.yml index ca63695cb..fb46a4c73 100644 --- a/Unpublished/ADAMIG/AD0030/rule.yml +++ b/Unpublished/ADAMIG/AD0030/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '30' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '30' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '30' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '30' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: SAFFN - operator: exists - - name: SAFFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: SAFFN + operator: exists + - name: SAFFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0030 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of SAFFN are not equal to 1 or 0 Output Variables: - - SAFFN + - SAFFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0031/rule.yml b/Unpublished/ADAMIG/AD0031/rule.yml index e734df469..762e547d6 100644 --- a/Unpublished/ADAMIG/AD0031/rule.yml +++ b/Unpublished/ADAMIG/AD0031/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '31' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '31' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '31' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '31' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: RANDFN - operator: exists - - name: RANDFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: RANDFN + operator: exists + - name: RANDFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0031 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of RANDFN are not equal to 1 or 0 Output Variables: - - RANDFN + - RANDFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0032/rule.yml b/Unpublished/ADAMIG/AD0032/rule.yml index 9d4404dd8..919a3fc46 100644 --- a/Unpublished/ADAMIG/AD0032/rule.yml +++ b/Unpublished/ADAMIG/AD0032/rule.yml @@ -1,79 +1,79 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.3 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Citations: - - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '32' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '32' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '32' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '32' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: ENRLFN - operator: exists - - name: ENRLFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: ENRLFN + operator: exists + - name: ENRLFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0032 Status: Draft @@ -84,10 +84,10 @@ Executability: Fully Executable Outcome: Message: Some values of ENRLFN are not equal to 1 or 0 Output Variables: - - ENRLFN + - ENRLFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0039/rule.yml b/Unpublished/ADAMIG/AD0039/rule.yml index a06dbf705..b42dcf72e 100644 --- a/Unpublished/ADAMIG/AD0039/rule.yml +++ b/Unpublished/ADAMIG/AD0039/rule.yml @@ -1,33 +1,33 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADAMIG - Version: '1.3' - References: +- Organization: CDISC + Standards: + - Name: ADAMIG + References: # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Origin: ADaM and ADaMIG Conformance Rules - Rule Identifier: - Id: AD0039 - Version: '1' + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.1.3, Item 1: As described in Table 3.1.5.1, + variables whose names end in DTF are date imputation flags. *DTF + variables represent the + highest level of imputation of the *DT variable based on the source + SDTM dataset DTC variable. *DTF = Y if the year is + imputed. *DTF = M if year is present and month is imputed. *DTF + = D if only day is imputed. *DTF = null if *DT equals the + SDTM dataset DTC variable date part equivalent. If a date was imputed, + *DTF must be populated and is required. Both *DTF and + *TMF may be needed to describe the level of imputation in *DTM if + imputation was done. Note that the list of examples in + Table 3.1.3.1 is not exhaustive. + Document: IG v1.3 + Item: '1' + Section: 3.1.3 + Origin: ADaM and ADaMIG Conformance Rules + Rule Identifier: + Id: AD0039 + Version: '1' # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Citations: - - Document: IG v1.3 - Section: 3.1.3 - Item: '1' - Cited Guidance: >- - ADaM IG v1.3, Section 3.1.3, Item 1: As described in Table 3.1.5.1, - variables whose names end in DTF are date imputation flags. *DTF - variables represent the - highest level of imputation of the *DT variable based on the source - SDTM dataset DTC variable. *DTF = Y if the year is - imputed. *DTF = M if year is present and month is imputed. *DTF - = D if only day is imputed. *DTF = null if *DT equals the - SDTM dataset DTC variable date part equivalent. If a date was imputed, - *DTF must be populated and is required. Both *DTF and - *TMF may be needed to describe the level of imputation in *DTM if - imputation was done. Note that the list of examples in - Table 3.1.3.1 is not exhaustive. + Version: '4.0' + Version: '1.3' Check: all: # - name: "variable_name" @@ -35,9 +35,9 @@ Check: # value: ^[A-Z][A-Z0-9]{0,4}DTF$ # - name: "variable_name" # operator: non_empty - - name: ADTF - operator: does_not_use_valid_codelist_terms - value: DATEFL + - name: ADTF + operator: does_not_use_valid_codelist_terms + value: DATEFL Core: # Need to make yaml validation accept ADAMIG # Will we need to prepend ADaM rules with "AD0..."? @@ -45,19 +45,19 @@ Core: Id: CDISC.ADAMIG.AD0039 Status: Draft Version: '1' -Description: Raise an error when a variable ends with DTF and values are not according - to the DATEFL controlled terminology codelist +Description: Raise an error when a variable ends with DTF and values are not according to the DATEFL + controlled terminology codelist Outcome: Message: The values of ADTF are not following the DATEFL codelist Output Variables: - - ADTF + - ADTF Rule Type: Record Data Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ALL + - ALL Domains: Include: - - ADLB + - ADLB Sensitivity: Variable diff --git a/Unpublished/ADAMIG/AD0041/rule.yml b/Unpublished/ADAMIG/AD0041/rule.yml index 8422bd2e3..b2dc17743 100644 --- a/Unpublished/ADAMIG/AD0041/rule.yml +++ b/Unpublished/ADAMIG/AD0041/rule.yml @@ -1,36 +1,36 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Numeric date, time, and datetime variables should be - formatted, so as to be human-readable with no loss of - precision. - Document: IG v1.3 - Item: '1' - Section: 3.1.2 - - Cited Guidance: >- - Variables whose names end in DT are numeric dates. - Document: IG v1.3 - Item: '2' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '41' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Numeric date, time, and datetime variables should be + formatted, so as to be human-readable with no loss of + precision. + Document: IG v1.3 + Item: '1' + Section: 3.1.2 + - Cited Guidance: >- + Variables whose names end in DT are numeric dates. + Document: IG v1.3 + Item: '2' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '41' + Version: '5.0' + Version: '1.3' Check: #1. check variable type is numeric 2. has suffix DT 3. has date format (look up list?) all: - - name: variable_type #1 - operator: is_numeric #type should be avialble from metadata variable_type - - name: variable_name #2 - operator: ends_with - value: DT - - name: variable_name #3 - operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column + - name: variable_type #1 + operator: is_numeric #type should be avialble from metadata variable_type + - name: variable_name #2 + operator: ends_with + value: DT + - name: variable_name #3 + operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column Core: Id: CDISC.ADAMIG.AD0041 @@ -46,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ADLB + - ADLB Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0046/rule.yml b/Unpublished/ADAMIG/AD0046/rule.yml index b64337131..c40138ed2 100644 --- a/Unpublished/ADAMIG/AD0046/rule.yml +++ b/Unpublished/ADAMIG/AD0046/rule.yml @@ -1,81 +1,81 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. - Document: ADAM IG v1.3 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.3' - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Item 8: Variables whose names end in DY are relative day - variables. In ADaM as in the SDTM, there is no day 0. If there - is a need to create a relative day variable that includes day - 0, then its name must not end in DY. - Document: ADAM IG v1.2 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. + Document: ADAM IG v1.3 + Item: '8' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '46' + Version: '5.0' + Version: '1.3' + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Item 8: Variables whose names end in DY are relative day + variables. In ADaM as in the SDTM, there is no day 0. If there + is a need to create a relative day variable that includes day + 0, then its name must not end in DY. + Document: ADAM IG v1.2 + Item: '8' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '46' + Version: '5.0' + Version: '1.2' - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. - Document: ADAM IG v1.1 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.1' + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. + Document: ADAM IG v1.1 + Item: '8' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '46' + Version: '5.0' + Version: '1.1' - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. ADaM relative day variables need not - be anchored by SDTM RFSTDTC. When SDTM.RFSTDTC is not the - anchor date then the anchor date used must be stored in an - ADaM dataset. - Document: ADAM IG v1.0 - Item: '8 (General Timing Variable Conventions)' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.0' + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. ADaM relative day variables need not + be anchored by SDTM RFSTDTC. When SDTM.RFSTDTC is not the + anchor date then the anchor date used must be stored in an + ADaM dataset. + Document: ADAM IG v1.0 + Item: '8 (General Timing Variable Conventions)' + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '46' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name - operator: ends_with - value: 'DY' + - name: variable_name + operator: ends_with + value: 'DY' # - name: variable_name # operator: equal_to # value: 0 @@ -91,8 +91,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0047/rule.yml b/Unpublished/ADAMIG/AD0047/rule.yml index 285f3baab..059f8f5ec 100644 --- a/Unpublished/ADAMIG/AD0047/rule.yml +++ b/Unpublished/ADAMIG/AD0047/rule.yml @@ -1,62 +1,62 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: - - Origin: ADaM Conformance Rules - Version: '4.0' - Rule Identifier: - Id: '47' - Version: '1' - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.3 - Section: '3.2' - Item: Table 3.2.1 - - Name: ADaMIG - Version: '1.2' - References: - - Origin: ADaM Conformance Rules - Version: '4.0' - Rule Identifier: - Id: '47' - Version: '1' - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.2 - Section: '3.2' - Item: Table 3.2.1 - - Name: ADaMIG - Version: '1.1' - References: - - Origin: ADaM Conformance Rules - Version: '4.0' - Rule Identifier: - Id: '47' - Version: '1' - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.1 - Section: '3.2' - Item: Table 3.2.1 - - Name: ADaMIG - Version: '1.0' - References: - - Origin: ADaM Conformance Rules - Version: '4.0' - Rule Identifier: - Id: '47' - Version: '1' - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.0 - Section: '3.1' - Item: Table 3.1.1 +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.3 + Item: Table 3.2.1 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '47' + Version: '1' + Version: '4.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.2 + Item: Table 3.2.1 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '47' + Version: '1' + Version: '4.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.1 + Item: Table 3.2.1 + Section: '3.2' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '47' + Version: '1' + Version: '4.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '47' + Version: '1' + Version: '4.0' + Version: '1.0' Check: all: - - name: SITEID - operator: not_exists + - name: SITEID + operator: not_exists Core: Id: CDISC.ADAMIG.AD0047 Status: Draft @@ -69,8 +69,8 @@ Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Include: - - ADSL + - ADSL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0049/rule.yml b/Unpublished/ADAMIG/AD0049/rule.yml index 170b965eb..717a3c0ff 100644 --- a/Unpublished/ADAMIG/AD0049/rule.yml +++ b/Unpublished/ADAMIG/AD0049/rule.yml @@ -1,82 +1,82 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.1.1 - Section: '3.1' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.1.1 + Section: '3.1' + Criteria: + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '49' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: '3.2' + Criteria: + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '49' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: '3.2' + Criteria: + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '49' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: '3.2' + Criteria: + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '49' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: AGE - operator: not_exists + - name: AGE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0049 Status: Draft @@ -86,14 +86,14 @@ Executability: Fully Executable Outcome: Message: Variable AGE is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Include: - - ADSL + - ADSL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0050/rule.yml b/Unpublished/ADAMIG/AD0050/rule.yml index eb2772a6a..6ae22f60f 100644 --- a/Unpublished/ADAMIG/AD0050/rule.yml +++ b/Unpublished/ADAMIG/AD0050/rule.yml @@ -1,95 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: 'Table 3.1.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '50' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '50' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '50' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '50' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: AGEU - operator: not_exists + - name: AGEU + operator: not_exists Core: Id: CDISC.ADaMIG.AD050 Status: Draft @@ -99,11 +99,11 @@ Executability: Fully Executable Outcome: Message: AGEU is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0051/rule.yml b/Unpublished/ADAMIG/AD0051/rule.yml index e23da604d..948374eee 100644 --- a/Unpublished/ADAMIG/AD0051/rule.yml +++ b/Unpublished/ADAMIG/AD0051/rule.yml @@ -1,95 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: 'Table 3.1.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '51' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '51' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '51' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '51' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEX - operator: not_exists + - name: SEX + operator: not_exists Core: Id: CDISC.ADaMIG.AD051 Status: Draft @@ -99,11 +99,11 @@ Executability: Fully Executable Outcome: Message: SEX is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0052/rule.yml b/Unpublished/ADAMIG/AD0052/rule.yml index 466fbe8a8..4b1459660 100644 --- a/Unpublished/ADAMIG/AD0052/rule.yml +++ b/Unpublished/ADAMIG/AD0052/rule.yml @@ -1,95 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: 'Table 3.1.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '52' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '52' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '52' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: 'Table 3.2.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '52' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACE - operator: not_exists + - name: RACE + operator: not_exists Core: Id: CDISC.ADaMIG.AD052 Status: Draft @@ -99,12 +99,12 @@ Executability: Fully Executable Outcome: Message: RACE is not present in ADSL Output Variables: - - USUBJID - - AGE - - RACE + - USUBJID + - AGE + - RACE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0053/rule.yml b/Unpublished/ADAMIG/AD0053/rule.yml index 6837b74bf..2c51c4d71 100644 --- a/Unpublished/ADAMIG/AD0053/rule.yml +++ b/Unpublished/ADAMIG/AD0053/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - Version: '1.3' - References: +- Organization: CDISC + Standards: + - Name: ADaMIG + References: # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '53' - Version: '1' + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.1.1, Item 3: Any variable in an ADaM dataset + whose name is the same as an SDTM variable must be a copy of the + SDTM variable, + and its label, meaning, and values must not be modified. ADaM adheres + to a principle of harmonization known as "same name, same meaning, + same values." + Document: IG v1.3 + Item: '3' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '53' + Version: '1' # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Citations: - - Document: IG v1.3 - Section: 3.1.1 - Item: '3' - Cited Guidance: >- - ADaM IG v1.3, Section 3.1.1, Item 3: Any variable in an ADaM dataset - whose name is the same as an SDTM variable must be a copy of the - SDTM variable, - and its label, meaning, and values must not be modified. ADaM adheres - to a principle of harmonization known as "same name, same meaning, - same values." + Version: '4.0' + Version: '1.3' Check: all: - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid Core: # Need to make yaml validation accept ADAMIG # Will we need to prepend ADaM rules with "AD0..."? @@ -37,26 +37,26 @@ Core: Description: Raise an error when the values of USUBJID are not present in SDTM.DM Executability: Fully Executable Operations: - - operator: distinct - domain: DM - name: USUBJID - id: $dm_usubjid +- domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct Outcome: Message: The values of USUBJID are not present in SDTM.DM Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ALL + - ALL Data Structures: Include: - - ADAM OTHER - - ALL + - ADAM OTHER + - ALL Domains: Include: - - ADSL - - DM + - ADSL + - DM Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0070/rule.yml b/Unpublished/ADAMIG/AD0070/rule.yml index 86357b543..ef0009e31 100644 --- a/Unpublished/ADAMIG/AD0070/rule.yml +++ b/Unpublished/ADAMIG/AD0070/rule.yml @@ -1,72 +1,72 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - One-to-one map to TRxxAGy - Document: ADaM IG v1.0 - Item: '' - Section: 3.1, Table 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: '7' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '70' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: '7' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '70' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: '7' + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '70' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + One-to-one map to TRxxAGy + Document: ADaM IG v1.0 + Item: '' + Section: 3.1, Table 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '70' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name #in dataset - operator: starts_with - value: TR - - name: variable_name #in dataset - operator: contains - value: AG - - name: variable_name #in dataset - operator: ends_with - value: N + - name: variable_name #in dataset + operator: starts_with + value: TR + - name: variable_name #in dataset + operator: contains + value: AG + - name: variable_name #in dataset + operator: ends_with + value: N #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails # operator: not_exists @@ -79,17 +79,16 @@ Description: >- and a variable with the same root without a suffix of N is not present' Executability: Fully Executable Outcome: - Message: A variable with a prefix of TR, containing AG with a suffix of N is - present and a variable with the same root without a suffix of N is not - present + Message: A variable with a prefix of TR, containing AG with a suffix of N is present and a + variable with the same root without a suffix of N is not present Output Variables: - - variable_name - - TTR01AG1N - - TTR02AG1N - - SUBJID + - variable_name + - TTR01AG1N + - TTR02AG1N + - SUBJID Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0111/rule.yml b/Unpublished/ADAMIG/AD0111/rule.yml index 7c5802cc9..a0a9efc88 100644 --- a/Unpublished/ADAMIG/AD0111/rule.yml +++ b/Unpublished/ADAMIG/AD0111/rule.yml @@ -1,128 +1,123 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.2.3.1' - Section: '3.2.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'The MDBDS supports analysis needs by adding SPDEVID as a - required key variable and USUBJID as a conditionally required - variable. See the BDS class for further details.' - Document: 'ADaMIG-MD' - Item: 'Table 3.3.3.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: 'CDISC' + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' + Document: 'ADaMIG' + Item: 'Table 3.2.3.1' + Section: '3.2.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: 'Failure' + Origin: 'ADaM Conformance Rules' + Release Notes: '' + Rule Identifier: + Id: '111' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' + Document: 'ADaMIG' + Item: 'Table 3.3.3.1' + Section: '3.3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: 'Failure' + Origin: 'ADaM Conformance Rules' + Release Notes: '' + Rule Identifier: + Id: '111' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' + Document: 'ADaMIG' + Item: 'Table 3.3.3.1' + Section: '3.3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: 'Failure' + Origin: 'ADaM Conformance Rules' + Release Notes: '' + Rule Identifier: + Id: '111' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' + Document: 'ADaMIG' + Item: 'Table 3.3.3.1' + Section: '3.3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: 'Failure' + Origin: 'ADaM Conformance Rules' + Release Notes: '' + Rule Identifier: + Id: '111' + Version: '2' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: 'The MDBDS supports analysis needs by adding SPDEVID as a required key variable + and USUBJID as a conditionally required variable. See the BDS class for further details.' + Document: 'ADaMIG-MD' + Item: 'Table 3.3.3.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: 'Failure' + Origin: 'ADaM Conformance Rules' + Release Notes: '' + Rule Identifier: + Id: '111' + Version: '2' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ARELTM - operator: exists - - name: ARELTMU - operator: not_exists + - name: ARELTM + operator: exists + - name: ARELTMU + operator: not_exists Core: Id: CDISC.ADAMIG.111 Status: Draft @@ -132,17 +127,17 @@ Executability: Fully Executable Outcome: Message: 'When ARELTM is present, ARELTMU must also be present' Output Variables: - - USUBJID - - SUBJID - - ARELTM - - AVISIT + - USUBJID + - SUBJID + - ARELTM + - AVISIT Rule Type: Record Data #'more SDTM : Analysis DS variable Presence Check?' Scope: Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Datasets: Include: - - 'ALL' + - 'ALL' Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0112/rule.yml b/Unpublished/ADAMIG/AD0112/rule.yml index 4b429f4c8..ec6027895 100644 --- a/Unpublished/ADAMIG/AD0112/rule.yml +++ b/Unpublished/ADAMIG/AD0112/rule.yml @@ -1,88 +1,88 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.3 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present - References: - - Citations: - - Cited Guidance: >- - v1.0, Section 3.1: The MDBDS supports analysis needs by adding - SPDEVID as a required key variable and USUBJID as a - conditionally required variable. See the BDS class for further - details.. - Document: ADaM MD v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.0' #or '1.3' against rule set 1.3 in excel sheet? - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.2 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.1 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.0 - Item: '' - Section: '3.2.3, Table 3.2.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.3 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '112' + Version: '5.0' + - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present + References: + - Citations: + - Cited Guidance: >- + v1.0, Section 3.1: The MDBDS supports analysis needs by adding + SPDEVID as a required key variable and USUBJID as a + conditionally required variable. See the BDS class for further + details.. + Document: ADaM MD v1.0 + Item: '' + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '112' + Version: '5.0' + Version: '1.0' #or '1.3' against rule set 1.3 in excel sheet? + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.2 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '112' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.1 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '112' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.0 + Item: '' + Section: '3.2.3, Table 3.2.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '112' + Version: '5.0' + Version: '1.0' Check: all: - - name: ARELTM - operator: non_empty - value: '' - - name: ARELTMU - operator: empty + - name: ARELTM + operator: non_empty + value: '' + - name: ARELTMU + operator: empty Core: Id: CDSIC.ADaMIG.AD0112 Status: Draft @@ -93,18 +93,18 @@ Executability: Fully Executable Outcome: Message: ARELTM is populated and ARELTMU is not populated Output Variables: - - SUBJID - - USUBJID - - ARELTM - - ARELTMU + - SUBJID + - USUBJID + - ARELTM + - ARELTMU Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0113/rule.yml b/Unpublished/ADAMIG/AD0113/rule.yml index 5ff955004..cedcbd848 100644 --- a/Unpublished/ADAMIG/AD0113/rule.yml +++ b/Unpublished/ADAMIG/AD0113/rule.yml @@ -1,84 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.3 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present - References: - - Citations: - - Cited Guidance: >- - The MDBDS supports analysis needs by adding SPDEVID as a - required key variable and USUBJID as a conditionally required - variable. See the BDS class for further details. - Document: ADaM v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '2.0' #? where to set rule id version - Version: '5.0' - Version: '1.0' #or '1.3' against overall Conformance rule set 1.3 in excel sheet? - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.2 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.1 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.3 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '113' + Version: '5.0' + - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present + References: + - Citations: + - Cited Guidance: >- + The MDBDS supports analysis needs by adding SPDEVID as a + required key variable and USUBJID as a conditionally required + variable. See the BDS class for further details. + Document: ADaM v1.0 + Item: '' + Section: '3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '113' + Version: '2.0' #? where to set rule id version + Version: '5.0' + Version: '1.0' #or '1.3' against overall Conformance rule set 1.3 in excel sheet? + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.2 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '113' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.1 + Item: '' + Section: '3.3.3, Table 3.3.3.1' + Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.0 - Item: '' - Section: '3.2.3, Table 3.2.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.0' + Rule Identifier: + Id: '113' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.0 + Item: '' + Section: '3.2.3, Table 3.2.3.1' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '113' + Version: '5.0' + Version: '1.0' Check: all: - - name: ARELTMU - operator: exists - - name: ARELTM - operator: not_exists + - name: ARELTMU + operator: exists + - name: ARELTM + operator: not_exists Core: Id: CDSIC.ADaMIG.AD0113 Status: Draft @@ -89,18 +89,18 @@ Executability: Fully Executable Outcome: Message: ARELTMU is present and ARELTM is not present Output Variables: - - SUBJID - - USUBJID - - VISIT - - ARELTMU + - SUBJID + - USUBJID + - VISIT + - ARELTMU Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0252/rule.yml b/Unpublished/ADAMIG/AD0252/rule.yml index 4145100b0..a3698e8f8 100644 --- a/Unpublished/ADAMIG/AD0252/rule.yml +++ b/Unpublished/ADAMIG/AD0252/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: '' - Origin: '' - Release Notes: '' - Rule Identifier: - Id: '252' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: '' + Document: '' + Item: '' + Section: '' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: '' + Origin: '' + Release Notes: '' + Rule Identifier: + Id: '252' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: '' - operator: '' - value: '' + - name: '' + operator: '' + value: '' Core: Id: CDISC.ADAMIG.252 Status: Draft @@ -39,8 +39,8 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0869/rule.yml b/Unpublished/ADAMIG/AD0869/rule.yml index 11c10d8fa..f2f9f408f 100644 --- a/Unpublished/ADAMIG/AD0869/rule.yml +++ b/Unpublished/ADAMIG/AD0869/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '869' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '869' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACEN - operator: exists - - name: RACE - operator: not_exists + - name: RACEN + operator: exists + - name: RACE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0869 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: RACEN is present, but RACE is not present Output Variables: - - RACEN - - USUBJID - - SUBJID + - RACEN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0870/rule.yml b/Unpublished/ADAMIG/AD0870/rule.yml index ae85852c6..e92aec895 100644 --- a/Unpublished/ADAMIG/AD0870/rule.yml +++ b/Unpublished/ADAMIG/AD0870/rule.yml @@ -1,36 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values - beyond 1 and 2. Example values can be as follows ':' 1=Male, - 2=Male - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '870' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows ':' 1=Male, 2=Male + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '870' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEX - operator: non_empty - - name: SEXN - operator: empty + - name: SEX + operator: non_empty + - name: SEXN + operator: empty Core: Id: CDISC.ADaMIG.AD0870 Status: Draft @@ -40,16 +39,16 @@ Executability: Fully Executable Outcome: Message: 'SEX is populated, but SEXN is not populated' Output Variables: - - SEX - - SEXN - - USUBJID + - SEX + - SEXN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0871/rule.yml b/Unpublished/ADAMIG/AD0871/rule.yml index 29f595a0e..7147e2143 100644 --- a/Unpublished/ADAMIG/AD0871/rule.yml +++ b/Unpublished/ADAMIG/AD0871/rule.yml @@ -1,36 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values - beyond 1 and 2. Example values can be as follows':' 1=Male, - 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '871' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '871' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: empty + - name: SEXN + operator: non_empty + - name: SEX + operator: empty Core: Id: CDISC.ADaMIG.AD0871 Status: Draft @@ -40,16 +39,16 @@ Executability: Fully Executable Outcome: Message: 'SEXN is populated, but SEX is not populated' Output Variables: - - SEX - - SEXN - - USUBJID + - SEX + - SEXN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0878/rule.yml b/Unpublished/ADAMIG/AD0878/rule.yml index d6a8e4549..196c8f57e 100644 --- a/Unpublished/ADAMIG/AD0878/rule.yml +++ b/Unpublished/ADAMIG/AD0878/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '878' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '878' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRY - operator: is_inconsistent_across_dataset - value: COUNTRYN + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRY + operator: is_inconsistent_across_dataset + value: COUNTRYN Core: Id: CDISC.ADaMIG.AD0878 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: COUNTRY is not unique for a given value of COUNTRYN Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYN + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0879/rule.yml b/Unpublished/ADAMIG/AD0879/rule.yml index 2b4682b87..b6c21734e 100644 --- a/Unpublished/ADAMIG/AD0879/rule.yml +++ b/Unpublished/ADAMIG/AD0879/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '879' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '879' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYN - operator: exists - - name: COUNTRY - operator: not_exists + - name: COUNTRYN + operator: exists + - name: COUNTRY + operator: not_exists Core: Id: CDISC.ADaMIG.AD0879 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: COUNTRYN is present, but COUNTRY is not present Output Variables: - - COUNTRYN - - USUBJID - - SUBJID + - COUNTRYN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0880/rule.yml b/Unpublished/ADAMIG/AD0880/rule.yml index 76b71f429..f67498c67 100644 --- a/Unpublished/ADAMIG/AD0880/rule.yml +++ b/Unpublished/ADAMIG/AD0880/rule.yml @@ -1,34 +1,34 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '880' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '880' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRY - operator: non_empty - - name: COUNTRYL - operator: empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYL + operator: empty Core: Id: CDISC.ADaMIG.AD0880 Status: Draft @@ -38,16 +38,16 @@ Executability: Fully Executable Outcome: Message: 'COUNTRY is populated, but COUNTRYL is not populated' Output Variables: - - COUNTRY - - COUNTRYL - - USUBJID + - COUNTRY + - COUNTRYL + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0881/rule.yml b/Unpublished/ADAMIG/AD0881/rule.yml index 9799916f5..c88d5e228 100644 --- a/Unpublished/ADAMIG/AD0881/rule.yml +++ b/Unpublished/ADAMIG/AD0881/rule.yml @@ -1,34 +1,34 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '881' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '881' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: empty + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: empty Core: Id: CDISC.ADaMIG.AD0881 Status: Draft @@ -38,16 +38,16 @@ Executability: Fully Executable Outcome: Message: 'COUNTRYL is populated, but COUNTRY is not populated' Output Variables: - - COUNTRY - - COUNTRYL - - USUBJID + - COUNTRY + - COUNTRYL + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0882/rule.yml b/Unpublished/ADAMIG/AD0882/rule.yml index 414d661a8..b84838094 100644 --- a/Unpublished/ADAMIG/AD0882/rule.yml +++ b/Unpublished/ADAMIG/AD0882/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '882' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY. + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '882' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRYL - operator: is_inconsistent_across_dataset - value: COUNTRY + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYL + operator: is_inconsistent_across_dataset + value: COUNTRY Core: Id: CDISC.ADaMIG.AD0882 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: COUNTRYL is not unique for a given value of COUNTRY Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYL + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYL Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0883/rule.yml b/Unpublished/ADAMIG/AD0883/rule.yml index 8d8c0011c..24dee0827 100644 --- a/Unpublished/ADAMIG/AD0883/rule.yml +++ b/Unpublished/ADAMIG/AD0883/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '883' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '883' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRY - operator: is_inconsistent_across_dataset - value: COUNTRYL + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRY + operator: is_inconsistent_across_dataset + value: COUNTRYL Core: Id: CDISC.ADaMIG.AD0883 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: COUNTRY is not unique for a given value of COUNTRYL Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYL + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYL Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0884/rule.yml b/Unpublished/ADAMIG/AD0884/rule.yml index aee475f78..8c1ebe724 100644 --- a/Unpublished/ADAMIG/AD0884/rule.yml +++ b/Unpublished/ADAMIG/AD0884/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '884' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '884' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYL - operator: exists - - name: COUNTRY - operator: not_exists + - name: COUNTRYL + operator: exists + - name: COUNTRY + operator: not_exists Core: Id: CDISC.ADaMIG.AD0884 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: COUNTRYL is present, but COUNTRY is not present Output Variables: - - COUNTRYL - - USUBJID - - SUBJID + - COUNTRYL + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0885/rule.yml b/Unpublished/ADAMIG/AD0885/rule.yml index ab168a972..d10165272 100644 --- a/Unpublished/ADAMIG/AD0885/rule.yml +++ b/Unpublished/ADAMIG/AD0885/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '885' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '885' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: USUBJIDN - operator: not_exists + - name: USUBJIDN + operator: not_exists Core: Id: CDISC.ADaMIG.AD0885 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: USUBJIDN is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0886/rule.yml b/Unpublished/ADAMIG/AD0886/rule.yml index bf0785885..980daa4fa 100644 --- a/Unpublished/ADAMIG/AD0886/rule.yml +++ b/Unpublished/ADAMIG/AD0886/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '886' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '886' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: AFRLT - operator: not_exists + - name: AFRLT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0886 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: AFRLT is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0887/rule.yml b/Unpublished/ADAMIG/AD0887/rule.yml index a6b6da5b9..2b924724e 100644 --- a/Unpublished/ADAMIG/AD0887/rule.yml +++ b/Unpublished/ADAMIG/AD0887/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '887' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '887' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: EVID - operator: not_exists + - name: EVID + operator: not_exists Core: Id: CDISC.ADaMIG.AD0887 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: EVID is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0888/rule.yml b/Unpublished/ADAMIG/AD0888/rule.yml index e6e283231..de0810d77 100644 --- a/Unpublished/ADAMIG/AD0888/rule.yml +++ b/Unpublished/ADAMIG/AD0888/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '888' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '888' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: DV - operator: not_exists + - name: DV + operator: not_exists Core: Id: CDISC.ADaMIG.AD0888 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: DV is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0889/rule.yml b/Unpublished/ADAMIG/AD0889/rule.yml index 71a9a3e2c..868adaa88 100644 --- a/Unpublished/ADAMIG/AD0889/rule.yml +++ b/Unpublished/ADAMIG/AD0889/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '889' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '889' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: MDV - operator: not_exists + - name: MDV + operator: not_exists Core: Id: CDISC.ADaMIG.AD0889 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: MDV is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0890/rule.yml b/Unpublished/ADAMIG/AD0890/rule.yml index 21c0ea71d..dc6cbc642 100644 --- a/Unpublished/ADAMIG/AD0890/rule.yml +++ b/Unpublished/ADAMIG/AD0890/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '890' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: 'TABLE 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '890' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: AMT - operator: not_exists + - name: AMT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0890 Status: Draft @@ -36,15 +36,15 @@ Executability: Fully Executable Outcome: Message: AMT is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0891/rule.yml b/Unpublished/ADAMIG/AD0891/rule.yml index a8faac519..bb91f85e1 100644 --- a/Unpublished/ADAMIG/AD0891/rule.yml +++ b/Unpublished/ADAMIG/AD0891/rule.yml @@ -1,108 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '891' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '891' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '891' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '891' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: COHORTN - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORTN - operator: is_inconsistent_across_dataset - value: COHORT + - name: COHORTN + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORTN + operator: is_inconsistent_across_dataset + value: COHORT Core: Id: CDISC.ADaMIG.AD0891 Status: Draft @@ -112,15 +112,15 @@ Executability: Fully Executable Outcome: Message: COHORTN is not unique for a given value of COHORT Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTN + - USUBJID + - USUBJIDN + - COHORT + - COHORTN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE #Subclasses: #Include: # - NON-COMPARTMENTAL ANALYSIS diff --git a/Unpublished/ADAMIG/AD0892/rule.yml b/Unpublished/ADAMIG/AD0892/rule.yml index 47fdc01ab..5ffe9c416 100644 --- a/Unpublished/ADAMIG/AD0892/rule.yml +++ b/Unpublished/ADAMIG/AD0892/rule.yml @@ -1,108 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and - COHORTN. When COHORT and COHORTN are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '892' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '892' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '892' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '892' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: COHORTN - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORT - operator: is_inconsistent_across_dataset - value: COHORTN + - name: COHORTN + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORT + operator: is_inconsistent_across_dataset + value: COHORTN Core: Id: CDISC.ADaMIG.AD0892 Status: Draft @@ -112,16 +112,16 @@ Executability: Fully Executable Outcome: Message: COHORT is not unique for a given value of COHORTN Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTN + - USUBJID + - USUBJIDN + - COHORT + - COHORTN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0893/rule.yml b/Unpublished/ADAMIG/AD0893/rule.yml index 5ddbef93a..e54cb0e88 100644 --- a/Unpublished/ADAMIG/AD0893/rule.yml +++ b/Unpublished/ADAMIG/AD0893/rule.yml @@ -1,108 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '893' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '893' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '893' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '893' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: is_inconsistent_across_dataset - value: ACYCLE + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: is_inconsistent_across_dataset + value: ACYCLE Core: Id: CDISC.ADaMIG.AD0893 Status: Draft @@ -112,16 +112,16 @@ Executability: Fully Executable Outcome: Message: ACYCLEC is not unique for a given value of ACYCLE Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0894/rule.yml b/Unpublished/ADAMIG/AD0894/rule.yml index dc06a50d6..e07107ff7 100644 --- a/Unpublished/ADAMIG/AD0894/rule.yml +++ b/Unpublished/ADAMIG/AD0894/rule.yml @@ -1,108 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and - ACYCLEC. When ACYCLE and ACYCLEC are present, then on a given - record, either both must be populated or both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '894' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '894' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '894' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: 'Table 4.2.1' + Section: '4.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '894' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLE - operator: is_inconsistent_across_dataset - value: ACYCLEC + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLE + operator: is_inconsistent_across_dataset + value: ACYCLEC Core: Id: CDISC.ADaMIG.AD0894 Status: Draft @@ -112,16 +112,16 @@ Executability: Fully Executable Outcome: Message: ACYCLE is not unique for a given value of ACYCLEC Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0895/rule.yml b/Unpublished/ADAMIG/AD0895/rule.yml index c0f1af303..e444eca93 100644 --- a/Unpublished/ADAMIG/AD0895/rule.yml +++ b/Unpublished/ADAMIG/AD0895/rule.yml @@ -1,65 +1,65 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '895' + Version: '1' + Version: '5.0' + Version: '1.3' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '895' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '895' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '895' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: ANL02FL - operator: exists - - name: variable_label - operator: does_not_contain - value: '02' + - name: ANL02FL + operator: exists + - name: variable_label + operator: does_not_contain + value: '02' Core: Id: Status: Draft @@ -67,14 +67,13 @@ Core: Description: For analysis flag ANLzzFL, the label should contain the number zz. Executability: Fully Executable Outcome: - Message: trigger an error when zz in variable label is not equal to zz in - ANLzzFL variable name. + Message: trigger an error when zz in variable label is not equal to zz in ANLzzFL variable name. Rule Type: Variable Metadata Check Scope: Classes: Exclude: - - ADSL + - ADSL Domains: Exclude: - - ADSL + - ADSL Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml index f1d89b10d..d722b38af 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml @@ -1,32 +1,32 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADAMIG - Version: '1.3' - References: +- Organization: CDISC + Standards: + - Name: ADAMIG + References: # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Origin: ADaM Conformance Rules - Rule Identifier: - Id: AD0061 - Version: '1' + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.6: TRTSDT and/or TRTSDTM are + required if there is an investigational product. + Document: IG v1.3 + Section: 3.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: AD0061 + Version: '1' # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Citations: - - Document: IG v1.3 - Section: 3.2 - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.6: TRTSDT and/or TRTSDTM are - required if there is an investigational product. + Version: '4.0' + Version: '1.3' Check: all: - - name: $TRTSDT_EXISTS - operator: equal_to - value: false - - name: $TRTSDTM_EXISTS - operator: equal_to - value: false - - name: EX - operator: exists + - name: $TRTSDT_EXISTS + operator: equal_to + value: false + - name: $TRTSDTM_EXISTS + operator: equal_to + value: false + - name: EX + operator: exists Core: # Need to make yaml validation accept ADAMIG # Will we need to prepend ADaM rules with "AD0..."? @@ -34,17 +34,16 @@ Core: Id: CDISC.ADAMIG.AD0061 Status: Draft Version: '1' -Description: Raise an error when TRTSDT and/or TRTSDTM are not present, though data - exist in SDTM.EX +Description: Raise an error when TRTSDT and/or TRTSDTM are not present, though data exist in SDTM.EX Operations: - - id: $TRTSDT_EXISTS - domain: ADSL - name: TRTSDT - operator: variable_exists - - id: $TRTSDTM_EXISTS - domain: ADSL - name: TRTSDTM - operator: variable_exists +- domain: ADSL + id: $TRTSDT_EXISTS + name: TRTSDT + operator: variable_exists +- domain: ADSL + id: $TRTSDTM_EXISTS + name: TRTSDTM + operator: variable_exists Outcome: Message: SDTM.EX is present and neither TRTSDT or TRTSDTM are present @@ -54,9 +53,9 @@ Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ADSL + - ADSL Domains: Include: - - ADSL - - EX + - ADSL + - EX Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml index d91555033..4e650de43 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml @@ -1,116 +1,116 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.3 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of - clinical trial design.' - Document: ADaMIG v1.3 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of - the type of clinical trial design.' - Document: ADaM IG v1.3 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.3 + Item: '' + Section: '1.3' + - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial + design.' + Document: ADaMIG v1.3 + Item: '' + Section: '2.3.1' + - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical + trial design.' + Document: ADaM IG v1.3 + Item: '' + Section: '3.2' + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '54' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.2 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of - clinical trial design.' - Document: ADaM IG v1.2 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of - the type of clinical trial design.' - Document: ADaM IG v1.2 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.2 + Item: '' + Section: '1.3' + - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial + design.' + Document: ADaM IG v1.2 + Item: '' + Section: '2.3.1' + - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical + trial design.' + Document: ADaM IG v1.2 + Item: '' + Section: '3.2' + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '54' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.1 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of - clinical trial design.' - Document: ADaM IG v1.1 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of - the type of clinical trial design.' - Document: ADaM IG v1.1 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.1 + Item: '' + Section: '1.3' + - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial + design.' + Document: ADaM IG v1.1 + Item: '' + Section: '2.3.1' + - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical + trial design.' + Document: ADaM IG v1.1 + Item: '' + Section: '3.2' + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '54' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.0 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of - clinical trial design.' - Document: ADaM IG v1.0 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of - the type of clinical trial design.' - Document: ADaM IG v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.0 + Item: '' + Section: '1.3' + - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial + design.' + Document: ADaM IG v1.0 + Item: '' + Section: '2.3.1' + - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical + trial design.' + Document: ADaM IG v1.0 + Item: '' + Section: '3.1' + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '54' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' Check: all: - - name: USUBJID - operator: is_not_unique_set - value: - - STUDYID + - name: USUBJID + operator: is_not_unique_set + value: + - STUDYID Core: Id: CDISC.ADaMIG.AD0054 Status: Draft @@ -120,11 +120,11 @@ Executability: Fully Executable Outcome: Message: 'Duplicate USUBJIDs: Only one record permitted per USUBJID' Output Variables: - - USUBJID - - STUDYID + - USUBJID + - STUDYID Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml index 24681db27..fc9f25228 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml @@ -1,63 +1,63 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: '3' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '60' + Version: '5.0' + Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3 (General Timing Variable Conventions)' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: '3' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '60' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: '3' + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '60' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: '3 (General Timing Variable Conventions)' + Section: '3' + Origin: ADaM Conformance Rules + Rule Identifier: + Id: '60' + Version: '5.0' + Version: '1.0' Check: all: - - name: -- DTM - operator: is_not_numeric + - name: -- DTM + operator: is_not_numeric Core: Id: CDISC.ADaMIG.AD0060 @@ -69,16 +69,16 @@ Executability: Fully Executable Outcome: Message: Variable with a suffix of DTM must be numeric Output Variables: - - SUBJID - - --DTM + - SUBJID + - --DTM Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml index fcc34c085..5e21943a0 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml @@ -1,95 +1,95 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: 'Table 3.1.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '55' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: 'Table 3.2.1' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '55' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: 'Table 3.2.1' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '55' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: 'Table 3.2.1' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '55' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SUBJID - operator: not_exists + - name: SUBJID + operator: not_exists Core: Id: CDISC.ADaMIG.AD055 Status: Draft @@ -105,5 +105,5 @@ Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml index e489d25f6..1e749916f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: One-to-one map to TRTxxA - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: the secondary variable of the variable pair cannot be present in - the dataset unless the primary variable is also present - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: When a secondary variable is included in the dataset, then the - primary variable must also be included - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: When a secondary variable is included in the dataset, then the - primary variable must also be included - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: One-to-one map to TRTxxA + Document: ADaMIG + Item: 'Table 3.1.1' + Section: '3.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '64' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: the secondary variable of the variable pair cannot be present in the dataset + unless the primary variable is also present + Document: ADaMIG + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '64' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: When a secondary variable is included in the dataset, then the primary + variable must also be included + Document: ADaMIG + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '64' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: When a secondary variable is included in the dataset, then the primary + variable must also be included + Document: ADaMIG + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '64' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: variable_name # TRT11AN - operator: matches_regex # test 1 exist clause - value: ^TRT[0-9]{2}AN*$ - - name: $generated_variable_name # TRT11A - operator: is_not_contained_by - value: variable_name # [TRT11AN, ABCDE, FGHIJ] + - name: variable_name # TRT11AN + operator: matches_regex # test 1 exist clause + value: ^TRT[0-9]{2}AN*$ + - name: $generated_variable_name # TRT11A + operator: is_not_contained_by + value: variable_name # [TRT11AN, ABCDE, FGHIJ] Core: Id: CDISC.ADaMIG.AD064 Status: Draft @@ -104,22 +104,22 @@ Core: Description: '' Executability: Fully Executable Operations: - - find: ^TRT([0-9]{2})AN*$ - id: $generated_variable_name - name: variable_name - operator: regex_find_replace - replace: TRT\1A +- find: ^TRT([0-9]{2})AN*$ + id: $generated_variable_name + name: variable_name + operator: regex_find_replace + replace: TRT\1A # generates TRTxxA # TRT11AN -> TRT11A # ABCDE -> TRTA or null? Outcome: Message: TRTxxAN is present and TRTxxA is not present in ADSL Output Variables: - - USUBJID - - TRT01AN + - USUBJID + - TRT01AN Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml index 441b9d200..464324c25 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '844' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '844' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ALQFLN - operator: exists - - name: ALQFL - operator: not_exists + - name: ALQFLN + operator: exists + - name: ALQFL + operator: not_exists Core: Id: CDISC.ADaMIG.AD0844 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: ALQFLN is present, but ALQFL is not present Output Variables: - - ALQFLN - - USUBJID - - SUBJID + - ALQFLN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml index 1dc809fe7..264a929da 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is - normally 0=dose, 1=for the first observation of interest, etc. - The numeric versions of the primary/character variables can be - assigned from its corresponding character pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '845' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Unique numerical representation of DVID. Convention is normally 0=dose, + 1=for the first observation of interest, etc. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADaMPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '845' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: FORM - operator: non_empty - - name: FORMN - operator: empty + - name: FORM + operator: non_empty + - name: FORMN + operator: empty Core: Id: CDISC.ADaMIG.AD0845 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: 'FORM is populated, but FORMN is not populated' Output Variables: - - FORM - - FORMN - - USUBJID + - FORM + - FORMN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml index 80b3c816f..07e427aa3 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is - normally 0=dose, 1=for the first observation of interest, etc. - The numeric versions of the primary/character variables can be - assigned from its corresponding character pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '846' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Unique numerical representation of DVID. Convention is normally 0=dose, + 1=for the first observation of interest, etc. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADaMPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '846' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: empty + - name: FORMN + operator: non_empty + - name: FORM + operator: empty Core: Id: CDISC.ADaMIG.AD0846 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: 'FORMN is populated, but FORM is not populated' Output Variables: - - FORM - - FORMN - - USUBJID + - FORM + - FORMN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml index 3289111d4..80f5b078e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric - versions of the primary/character variables can be assigned - from its corresponding character pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '847' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Unique numerical representation of SITEID. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '847' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: non_empty - - name: FORMN - operator: is_inconsistent_across_dataset - value: FORM + - name: FORMN + operator: non_empty + - name: FORM + operator: non_empty + - name: FORMN + operator: is_inconsistent_across_dataset + value: FORM Core: Id: CDISC.ADaMIG.AD0847 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: FORMN is not unique for a given value of FORM Output Variables: - - USUBJID - - USUBJIDN - - FORM - - FORMN + - USUBJID + - USUBJIDN + - FORM + - FORMN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml index ab4e78749..26d0dc4a9 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric - versions of the primary/character variables can be assigned - from its corresponding character pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '848' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Unique numerical representation of SITEID. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '848' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: non_empty - - name: FORM - operator: is_inconsistent_across_dataset - value: FORMN + - name: FORMN + operator: non_empty + - name: FORM + operator: non_empty + - name: FORM + operator: is_inconsistent_across_dataset + value: FORMN Core: Id: CDISC.ADaMIG.AD0848 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: FORM is not unique for a given value of FORMN Output Variables: - - USUBJID - - USUBJIDN - - FORM - - FORMN + - USUBJID + - USUBJIDN + - FORM + - FORMN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml index 1e659c33c..324b77188 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '849' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '849' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: FORMN - operator: exists - - name: FORM - operator: not_exists + - name: FORMN + operator: exists + - name: FORM + operator: not_exists Core: Id: CDISC.ADaMIG.AD0849 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: FORMN is present, but FORM is not present Output Variables: - - FORMN - - USUBJID - - SUBJID + - FORMN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml index c6aad5850..ca6264a68 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml @@ -1,36 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character - versions of the primary/character variables can be assigned - from its corresponding numeric pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '850' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character versions of the + primary/character variables can be assigned from its corresponding numeric pair variable. + Document: ADaMPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '850' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ROUTE - operator: non_empty - - name: ROUTEN - operator: empty + - name: ROUTE + operator: non_empty + - name: ROUTEN + operator: empty Core: Id: CDISC.ADaMIG.AD0850 Status: Draft @@ -40,16 +39,16 @@ Executability: Fully Executable Outcome: Message: 'ROUTE is populated, but ROUTEN is not populated' Output Variables: - - ROUTE - - ROUTEN - - USUBJID + - ROUTE + - ROUTEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml index 75902a799..ac2b79123 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml @@ -1,36 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character - versions of the primary/character variables can be assigned - from its corresponding numeric pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '851' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character versions of the + primary/character variables can be assigned from its corresponding numeric pair variable. + Document: ADaMPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '851' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: empty + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: empty Core: Id: CDISC.ADaMIG.AD0851 Status: Draft @@ -40,16 +39,16 @@ Executability: Fully Executable Outcome: Message: 'ROUTEN is populated, but ROUTE is not populated' Output Variables: - - ROUTE - - ROUTEN - - USUBJID + - ROUTE + - ROUTEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml index 9044aa883..1a162bbf1 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric - versions of the primary/character variables can be assigned - from its corresponding character pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '852' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric versions of + the primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '852' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: non_empty - - name: ROUTEN - operator: is_inconsistent_across_dataset - value: ROUTE + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: non_empty + - name: ROUTEN + operator: is_inconsistent_across_dataset + value: ROUTE Core: Id: CDISC.ADaMIG.AD0852 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: ROUTEN is not unique for a given value of ROUTE Output Variables: - - USUBJID - - USUBJIDN - - ROUTE - - ROUTEN + - USUBJID + - USUBJIDN + - ROUTE + - ROUTEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml index 315c15314..012466e61 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric - versions of the primary/character variables can be assigned - from its corresponding character pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '853' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric versions of + the primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '853' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: non_empty - - name: ROUTE - operator: is_inconsistent_across_dataset - value: ROUTEN + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: non_empty + - name: ROUTE + operator: is_inconsistent_across_dataset + value: ROUTEN Core: Id: CDISC.ADaMIG.AD0853 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: ROUTE is not unique for a given value of ROUTEN Output Variables: - - USUBJID - - USUBJIDN - - ROUTE - - ROUTEN + - USUBJID + - USUBJIDN + - ROUTE + - ROUTEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml index 7b093c799..122fa0275 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '854' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '854' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ROUTEC - operator: exists - - name: ROUTE - operator: not_exists + - name: ROUTEC + operator: exists + - name: ROUTE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0854 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: ROUTEC is present, but ROUTE is not present Output Variables: - - ROUTEC - - USUBJID - - SUBJID + - ROUTEC + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml index 1eb4a62fa..e084a16bb 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml @@ -1,36 +1,36 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The - character versions of the primary/character variables can be - assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '855' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '855' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: empty Core: Id: CDISC.ADaMIG.AD0855 Status: Draft @@ -40,16 +40,16 @@ Executability: Fully Executable Outcome: Message: 'ACYCLE is populated, but ACYCLEC is not populated' Output Variables: - - ACYCLE - - ACYCLEC - - USUBJID + - ACYCLE + - ACYCLEC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml index 3cf07b4a8..1e5663474 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml @@ -1,36 +1,36 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The - character versions of the primary/character variables can be - assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '856' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '856' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: empty + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: empty Core: Id: CDISC.ADaMIG.AD0856 Status: Draft @@ -40,16 +40,16 @@ Executability: Fully Executable Outcome: Message: 'ACYCLEC is populated, but ACYCLE is not populated' Output Variables: - - ACYCLE - - ACYCLEC - - USUBJID + - ACYCLE + - ACYCLEC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml index 9d1d58429..5cc421fbe 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The - character versions of the primary/character variables can be - assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '857' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '857' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: is_inconsistent_across_dataset - value: ACYCLE + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: is_inconsistent_across_dataset + value: ACYCLE Core: Id: CDISC.ADaMIG.AD0857 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: ACYCLEC is not unique for a given value of ACYCLE Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml index 7690f0b98..7b04f0ffb 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml @@ -1,39 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The - character versions of the primary/character variables can be - assigned from its corresponding numeric pair variable.. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '858' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable.. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '858' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLE - operator: is_inconsistent_across_dataset - value: ACYCLEC + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLE + operator: is_inconsistent_across_dataset + value: ACYCLEC Core: Id: CDISC.ADaMIG.AD0858 Status: Draft @@ -43,16 +43,16 @@ Executability: Fully Executable Outcome: Message: ACYCLE is not unique for a given value of ACYCLEC Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml index 0df771b91..c326f77eb 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '859' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '859' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: ACYCLEC - operator: exists - - name: ACYCLE - operator: not_exists + - name: ACYCLEC + operator: exists + - name: ACYCLE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0859 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: ACYCLEC is present, but ACYCLE is not present Output Variables: - - ACYCLEC - - USUBJID - - SUBJID + - ACYCLEC + - USUBJID + - SUBJID Rule Type: Variable Metadata Check against Library Metadata Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml index d067dc165..37aea5790 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml @@ -1,37 +1,36 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must - be a one-to-one mapping to COHORT. The character versions of - the primary/character variables can be assigned from its - corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '860' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '860' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COHORT - operator: non_empty - - name: COHORTC - operator: empty + - name: COHORT + operator: non_empty + - name: COHORTC + operator: empty Core: Id: CDISC.ADaMIG.AD0860 Status: Draft @@ -41,16 +40,16 @@ Executability: Fully Executable Outcome: Message: 'COHORT is populated, but COHORTC is not populated' Output Variables: - - COHORT - - COHORTC - - USUBJID + - COHORT + - COHORTC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml index 065272ba6..a76b4d539 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml @@ -1,37 +1,36 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must - be a one-to-one mapping to COHORT. The character versions of - the primary/character variables can be assigned from its - corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '861' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '861' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: empty + - name: COHORTC + operator: non_empty + - name: COHORT + operator: empty Core: Id: CDISC.ADaMIG.AD0861 Status: Draft @@ -41,16 +40,16 @@ Executability: Fully Executable Outcome: Message: 'COHORTC is populated, but COHORT is not populated' Output Variables: - - COHORT - - COHORTC - - USUBJID + - COHORT + - COHORTC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml index 1e228c98a..f7dafd27e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml @@ -1,40 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must - be a one-to-one mapping to COHORT. The character versions of - the primary/character variables can be assigned from its - corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '862' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '862' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORTC - operator: is_inconsistent_across_dataset - value: COHORT + - name: COHORTC + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORTC + operator: is_inconsistent_across_dataset + value: COHORT Core: Id: CDISC.ADaMIG.AD0862 Status: Draft @@ -44,16 +43,16 @@ Executability: Fully Executable Outcome: Message: COHORTC is not unique for a given value of COHORT Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTC + - USUBJID + - USUBJIDN + - COHORT + - COHORTC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml index a78b06cbc..0df150914 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml @@ -1,40 +1,39 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must - be a one-to-one mapping to COHORT. The character versions of - the primary/character variables can be assigned from its - corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '863' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '863' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORT - operator: is_inconsistent_across_dataset - value: COHORTC + - name: COHORTC + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORT + operator: is_inconsistent_across_dataset + value: COHORTC Core: Id: CDISC.ADaMIG.AD0863 Status: Draft @@ -44,16 +43,16 @@ Executability: Fully Executable Outcome: Message: COHORT is not unique for a given value of COHORTC Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTC + - USUBJID + - USUBJIDN + - COHORT + - COHORTC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml index d619d7314..a4c90be06 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '864' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '864' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COHORTC - operator: exists - - name: COHORT - operator: not_exists + - name: COHORTC + operator: exists + - name: COHORT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0864 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: COHORTC is present, but COHORT is not present Output Variables: - - COHORTC - - USUBJID - - SUBJID + - COHORTC + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml index a75787302..b6fbc5d21 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml @@ -1,38 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the - specification. 1=American Indian OR Alaska Native, 2=Asian, - 3=Black/African American, 4=Native Hawaiian OR Other Pacific - Islander, 5=White. If races need to be categorized - differently, then use variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '865' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '865' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACE - operator: non_empty - - name: RACEN - operator: empty + - name: RACE + operator: non_empty + - name: RACEN + operator: empty Core: Id: CDISC.ADaMIG.AD0865 Status: Draft @@ -42,16 +41,16 @@ Executability: Fully Executable Outcome: Message: 'RACE is populated, but RACEN is not populated' Output Variables: - - RACE - - RACEN - - USUBJID + - RACE + - RACEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml index 455bfe573..fb533496a 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml @@ -1,38 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the - specification. 1=American Indian OR Alaska Native, 2=Asian, - 3=Black/African American, 4=Native Hawaiian OR Other Pacific - Islander, 5=White. If races need to be categorized - differently, then use variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '866' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '866' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: empty + - name: RACEN + operator: non_empty + - name: RACE + operator: empty Core: Id: CDISC.ADaMIG.AD0866 Status: Draft @@ -42,16 +41,16 @@ Executability: Fully Executable Outcome: Message: 'RACEN is populated, but RACE is not populated' Output Variables: - - RACE - - RACEN - - USUBJID + - RACE + - RACEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml index 2472acc8d..c4a3c8b37 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml @@ -1,41 +1,40 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the - specification. 1=American Indian OR Alaska Native, 2=Asian, - 3=Black/African American, 4=Native Hawaiian OR Other Pacific - Islander, 5=White. If RACEs need to be categorized - differently, then use variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '867' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '867' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: non_empty - - name: RACEN - operator: is_inconsistent_across_dataset - value: RACE + - name: RACEN + operator: non_empty + - name: RACE + operator: non_empty + - name: RACEN + operator: is_inconsistent_across_dataset + value: RACE Core: Id: CDISC.ADaMIG.AD0867 Status: Draft @@ -45,16 +44,16 @@ Executability: Fully Executable Outcome: Message: RACEN is not unique for a given value of RACE Output Variables: - - USUBJID - - USUBJIDN - - RACE - - RACEN + - USUBJID + - USUBJIDN + - RACE + - RACEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml index 03486b5ae..44ea01ef4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml @@ -1,41 +1,40 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the - specification. 1=American Indian OR Alaska Native, 2=Asian, - 3=Black/African American, 4=Native Hawaiian OR Other Pacific - Islander, 5=White. If RACEs need to be categorized - differently, then use variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '868' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: 'Table 3.2' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '868' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: non_empty - - name: RACE - operator: is_inconsistent_across_dataset - value: RACEN + - name: RACEN + operator: non_empty + - name: RACE + operator: non_empty + - name: RACE + operator: is_inconsistent_across_dataset + value: RACEN Core: Id: CDISC.ADaMIG.AD0868 Status: Draft @@ -45,16 +44,16 @@ Executability: Fully Executable Outcome: Message: RACE is not unique for a given value of RACEN Output Variables: - - USUBJID - - USUBJIDN - - RACE - - RACEN + - USUBJID + - USUBJIDN + - RACE + - RACEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml index f1bb29487..288e37771 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml @@ -1,39 +1,38 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values - beyond 1 and 2. Example values can be as follows':' 1=Male, - 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '872' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '872' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: non_empty - - name: SEXN - operator: is_inconsistent_across_dataset - value: SEX + - name: SEXN + operator: non_empty + - name: SEX + operator: non_empty + - name: SEXN + operator: is_inconsistent_across_dataset + value: SEX Core: Id: CDISC.ADaMIG.AD0872 Status: Draft @@ -43,16 +42,16 @@ Executability: Fully Executable Outcome: Message: SEXN is not unique for a given value of SEX Output Variables: - - USUBJID - - USUBJIDN - - SEX - - SEXN + - USUBJID + - USUBJIDN + - SEX + - SEXN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml index ea81235dd..40c92e6ae 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml @@ -1,39 +1,38 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values - beyond 1 and 2. Example values can be as follows':' 1=Male, - 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '873' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.3' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '873' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: non_empty - - name: SEX - operator: is_inconsistent_across_dataset - value: SEXN + - name: SEXN + operator: non_empty + - name: SEX + operator: non_empty + - name: SEX + operator: is_inconsistent_across_dataset + value: SEXN Core: Id: CDISC.ADaMIG.AD0873 Status: Draft @@ -43,16 +42,16 @@ Executability: Fully Executable Outcome: Message: SEX is not unique for a given value of SEXN Output Variables: - - USUBJID - - USUBJIDN - - SEX - - SEXN + - USUBJID + - USUBJIDN + - SEX + - SEXN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml index d38a64479..555e2a007 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the - primary variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '874' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: '6' + Section: '3.1.1' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '874' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: SEXN - operator: exists - - name: SEX - operator: not_exists + - name: SEXN + operator: exists + - name: SEX + operator: not_exists Core: Id: CDISC.ADaMIG.AD0874 Status: Draft @@ -39,16 +39,16 @@ Executability: Fully Executable Outcome: Message: SEXN is present, but SEX is not present Output Variables: - - SEXN - - USUBJID - - SUBJID + - SEXN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml index 2b510f23b..de51f1c17 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml @@ -1,34 +1,34 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '875' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '875' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRY - operator: non_empty - - name: COUNTRYN - operator: empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYN + operator: empty Core: Id: CDISC.ADaMIG.AD0875 Status: Draft @@ -38,16 +38,16 @@ Executability: Fully Executable Outcome: Message: 'COUNTRY is populated, but COUNTRYN is not populated' Output Variables: - - COUNTRY - - COUNTRYN - - USUBJID + - COUNTRY + - COUNTRYN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml index 52f020f0a..d3cf99aad 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml @@ -1,34 +1,34 @@ Authorities: - - Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '876' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: 'ADaMIG' + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '876' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: empty + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: empty Core: Id: CDISC.ADaMIG.AD0876 Status: Draft @@ -38,16 +38,16 @@ Executability: Fully Executable Outcome: Message: 'COUNTRYN is populated, but COUNTRY is not populated' Output Variables: - - COUNTRY - - COUNTRYN - - USUBJID + - COUNTRY + - COUNTRYN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml index 9b7999145..fece852a5 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml @@ -1,37 +1,37 @@ Authorities: - - Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '877' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' +- Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY. + Document: ADPPKIG v1.0 + Item: 'Table 3.3' + Section: '3.2' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: '' + Rule Identifier: + Id: '877' + Version: '1' + Validator Rule Message: '' + Version: '5.0' + Version: '1.3' Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRYN - operator: is_inconsistent_across_dataset - value: COUNTRY + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYN + operator: is_inconsistent_across_dataset + value: COUNTRY Core: Id: CDISC.ADaMIG.AD0877 Status: Draft @@ -41,16 +41,16 @@ Executability: Fully Executable Outcome: Message: COUNTRYN is not unique for a given value of COUNTRY Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYN + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000734/rule.yml b/Unpublished/FDA Business Rules/CORE-000734/rule.yml index b80a627be..e6b6b8098 100644 --- a/Unpublished/FDA Business Rules/CORE-000734/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000734/rule.yml @@ -1,87 +1,80 @@ # Variable: TSPARMCD, TSVAL # TSPARMCD = 'FDATCHSP' Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG). Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG). Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG). Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1104' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1104' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1104' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: TSPARMCD - operator: 'not_equal_to' - value: 'FDATCHSP' + - name: TSPARMCD + operator: 'not_equal_to' + value: 'FDATCHSP' Core: Id: CORE-000734 Status: Draft Version: '1' -Description: 'TSVAL (Standard Name) matches corresponding name as listed on the - study data standards resources website for technical specification documents.' +Description: 'TSVAL (Standard Name) matches corresponding name as listed on the study data standards resources + website for technical specification documents.' Executability: Fully Executable Outcome: - Message: 'TSVAL (Standard Name) does not match corresponding name as listed in - on the study data standards resources website for technical specification - documents.' + Message: 'TSVAL (Standard Name) does not match corresponding name as listed in on the study data standards + resources website for technical specification documents.' Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000737/rule.yml b/Unpublished/FDA Business Rules/CORE-000737/rule.yml index a4659e0d3..d1332ef2c 100644 --- a/Unpublished/FDA Business Rules/CORE-000737/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000737/rule.yml @@ -1,111 +1,111 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1102' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1102' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1102' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: TSPARMCD - operator: not_contains_all - value: - - 'ACTSUB' - - 'ADAPT' - - 'ADDON' - - 'AGEMAX' - - 'AGEMIN' - - 'COMPTRT' - - 'DCUTDESC' - - 'DCUTDTC' - - 'EXTTIND' - - 'FCNTRY' - - 'HLTSUBJI' - - 'LENGTH' - - 'NARMS' - - 'NCOHORT' - - 'OBJPRIM' - - 'OBJSEC' - - 'ONGOSIND' - - 'OUTMSPRI' - - 'PDPSTIND' - - 'PDSTIND' - - 'PIPIND' - - 'PLANSUB' - - 'RDIND' - - 'REGID' - - 'SENDTC' - - 'SEXPOP' - - 'SPONSOR' - - 'SDTMVER' - - 'SDTIGVER' - - 'STOPRULE' - - 'SSTDTC' - - 'STYPE' - - 'TBLIND' - - 'TCNTRL' - - 'THERAREA' - - 'TITLE' - - 'TPHASE' - - 'TTYPE' - - 'INDIC' - - 'RANDQT' - - name: 'TSVAL' - operator: non_empty + - name: TSPARMCD + operator: not_contains_all + value: + - 'ACTSUB' + - 'ADAPT' + - 'ADDON' + - 'AGEMAX' + - 'AGEMIN' + - 'COMPTRT' + - 'DCUTDESC' + - 'DCUTDTC' + - 'EXTTIND' + - 'FCNTRY' + - 'HLTSUBJI' + - 'LENGTH' + - 'NARMS' + - 'NCOHORT' + - 'OBJPRIM' + - 'OBJSEC' + - 'ONGOSIND' + - 'OUTMSPRI' + - 'PDPSTIND' + - 'PDSTIND' + - 'PIPIND' + - 'PLANSUB' + - 'RDIND' + - 'REGID' + - 'SENDTC' + - 'SEXPOP' + - 'SPONSOR' + - 'SDTMVER' + - 'SDTIGVER' + - 'STOPRULE' + - 'SSTDTC' + - 'STYPE' + - 'TBLIND' + - 'TCNTRL' + - 'THERAREA' + - 'TITLE' + - 'TPHASE' + - 'TTYPE' + - 'INDIC' + - 'RANDQT' + - name: 'TSVAL' + operator: non_empty Core: Id: CORE-000737 Status: Draft Version: '1' -Description: 'The set of parameters without conditions listed in the TCG, - Appendix B, is not included in the list of TSPARAMCD with TSVAL populated.' +Description: 'The set of parameters without conditions listed in the TCG, Appendix B, is not included + in the list of TSPARAMCD with TSVAL populated.' Executability: Fully Executable Outcome: - Message: 'The set of parameters without conditions listed in the TCG, Appendix - B, is not included in the list of TSPARAMCD with TSVAL populated.' + Message: 'The set of parameters without conditions listed in the TCG, Appendix B, is not included in + the list of TSPARAMCD with TSVAL populated.' Output Variables: - - TSVAL - - TSPARMCD + - TSVAL + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000738/rule.yml b/Unpublished/FDA Business Rules/CORE-000738/rule.yml index ea23ee53d..5c3b25c3d 100644 --- a/Unpublished/FDA Business Rules/CORE-000738/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000738/rule.yml @@ -1,56 +1,56 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1106' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1106' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1106' + Version: '1' + Version: '1.5' + Version: '3.4' Check: any: + - name: $crmdur_count + operator: less_than + value: 1 + - all: - name: $crmdur_count - operator: less_than + operator: 'greater_than_or_equal_to' value: 1 - - all: - - name: $crmdur_count - operator: 'greater_than_or_equal_to' - value: 1 - - name: TSPARMCD - operator: equal_to - value: 'CRMDUR' - - name: TSVAL - operator: empty + - name: TSPARMCD + operator: equal_to + value: 'CRMDUR' + - name: TSVAL + operator: empty Core: Id: CORE-000738 @@ -59,24 +59,24 @@ Core: Description: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.' Executability: Partially Executable Operations: - - domain: TS - filter: - TSPARMCD: CRMDUR - id: $crmdur_count - name: TSPARMCD - operator: record_count +- domain: TS + filter: + TSPARMCD: CRMDUR + id: $crmdur_count + name: TSPARMCD + operator: record_count Outcome: Message: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.' Output Variables: - - TSPARMCD - - TSVAL - - $crmdur_count + - TSPARMCD + - TSVAL + - $crmdur_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000748/rule.yml b/Unpublished/FDA Business Rules/CORE-000748/rule.yml index 26f9b04bf..3cfdb7eb9 100644 --- a/Unpublished/FDA Business Rules/CORE-000748/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000748/rule.yml @@ -2,66 +2,65 @@ # Condition: ARMNRS ^= ("SCREEN FAILURE", N"OT ASSIGNED", "ASSIGNED, NOT TREATED") # Rule: Value is present for subject in EX Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2504 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2504 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2504 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2504 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: ARMNRS - operator: is_not_contained_by_case_insensitive - value: - - "SCREEN FAILURE" - - "NOT ASSIGNED" - - "ASSIGNED, NOT TREATED" - - name: USUBJID - operator: is_not_contained_by - value: $usubjids_in_ex + - name: ARMNRS + operator: is_not_contained_by_case_insensitive + value: + - "SCREEN FAILURE" + - "NOT ASSIGNED" + - "ASSIGNED, NOT TREATED" + - name: USUBJID + operator: is_not_contained_by + value: $usubjids_in_ex Core: Id: CORE-000748 Status: Draft Version: '1' -Description: If a subject is assigned to an arm code, the subject should have a - record in EX. +Description: If a subject is assigned to an arm code, the subject should have a record in EX. Executability: Partially Executable Operations: - - domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct +- domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: Message: Subject is assigned to an arm (randomized) but has no record in EX. Output Variables: - - ARMNRS + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - INTERVENTIONS + - SPECIAL PURPOSE + - INTERVENTIONS Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB0804/rule.yml b/Unpublished/FDA Business Rules/FB0804/rule.yml index 5fe2815d3..a9f57af1d 100644 --- a/Unpublished/FDA Business Rules/FB0804/rule.yml +++ b/Unpublished/FDA Business Rules/FB0804/rule.yml @@ -1,97 +1,97 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and - last study treatment date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment + date/time.' + Document: 'FDA' + Section: 'FDAB008' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0804' + Version: '1' + Version: '1.5' + Version: '1.0' # rule failure criteria: TSPARMCD.EXPSTDTC => EXENDTC or EXENDTC => TSPARMCD.EXPENDTC Check: any: @@ -103,9 +103,9 @@ Check: # operator: date_greater_than_or_equal_to # value: EXENDTC # EXENDTC => TSPARMCD.EXPENDTC - - name: --ENDTC - operator: date_greater_than_or_equal_to - value: $ts_expendtc_value + - name: --ENDTC + operator: date_greater_than_or_equal_to + value: $ts_expendtc_value #value: '2001-01-01' Core: Status: Draft @@ -113,32 +113,32 @@ Core: Description: '' Executability: Fully Executable Operations: - - domain: TS - filter: - TSPARMCD: EXPENDTC - id: $ts_expendtc_value - name: TSVAL - operator: distinct - value_is_reference: false - - domain: TS - filter: - TSPARMCD: EXPSTDTC - id: $ts_expstdtc_value - name: TSVAL - operator: distinct +- domain: TS + filter: + TSPARMCD: EXPENDTC + id: $ts_expendtc_value + name: TSVAL + operator: distinct + value_is_reference: false +- domain: TS + filter: + TSPARMCD: EXPSTDTC + id: $ts_expstdtc_value + name: TSVAL + operator: distinct Outcome: - Message: 'Treatment exposure end date/time (EXENDTC) falls outside the date/time - experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset.' + Message: 'Treatment exposure end date/time (EXENDTC) falls outside the date/time experimental start + (EXPSTDTC) and end date (EXPENDTC) in the TS dataset.' Output Variables: - - EXENDTC - - $ts_expstdtc_value - - $ts_expendtc_value + - EXENDTC + - $ts_expstdtc_value + - $ts_expendtc_value Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB1113/rule.yml b/Unpublished/FDA Business Rules/FB1113/rule.yml index d657e7b24..04a75f5d6 100644 --- a/Unpublished/FDA Business Rules/FB1113/rule.yml +++ b/Unpublished/FDA Business Rules/FB1113/rule.yml @@ -2,104 +2,102 @@ # Condition: # Success Criteria: The count of occurrences of TSPARAMCD = not in the set (‘FCNTRY’, ‘OBJPRIM’, ‘OBJSEC’, ‘OUTMSPRI’, ‘OUTMSSEC’, 'RANDQT', ‘REGID’, ‘TITLE’, ‘TTYPE’) included in the list of TSPARAMCD with TSVAL populated is eq 1. Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1113' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1113' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1113' + Version: '1' + Version: '1.5' + Version: '3.4' Check: any: - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - name: $tsparmcd - operator: does_not_contain - value: 'CURTRT' - value_is_literal: true - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - name: TSPARMCD - operator: 'equal_to' - value: 'CURTRT' - value_is_literal: true - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: 'equal_to' + value: 'ADDON' + value_is_literal: true + - name: TSVAL + operator: 'equal_to' + value: 'Y' + value_is_literal: true + - name: $tsparmcd + operator: does_not_contain + value: 'CURTRT' + value_is_literal: true + - all: + - name: TSPARMCD + operator: 'equal_to' + value: 'ADDON' + value_is_literal: true + - name: TSVAL + operator: 'equal_to' + value: 'Y' + value_is_literal: true + - name: TSPARMCD + operator: 'equal_to' + value: 'CURTRT' + value_is_literal: true + - name: TSVAL + operator: empty Core: Id: Status: Draft Version: '1' -Description: The count of occurrences of TSPARAMCD = not in the set - ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', - 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is eq - 1. +Description: The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', + 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of + TSPARAMCD with TSVAL populated is eq 1. Executability: Fully Executable Operations: - - domain: TS - id: $tsparmcd - name: TSPARMCD - operator: distinct +- domain: TS + id: $tsparmcd + name: TSPARMCD + operator: distinct Outcome: - Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is - null.The count of occurrences of TSPARAMCD = not in the set - ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', - 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is - gt 1. + Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of + occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', + .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL + populated is gt 1. Output Variables: - - TSPARMCD - - TSVAL - - $tsparmcd + - TSPARMCD + - TSVAL + - $tsparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB1901/rule.yml b/Unpublished/FDA Business Rules/FB1901/rule.yml index fbcf2d665..fbdf0aa88 100644 --- a/Unpublished/FDA Business Rules/FB1901/rule.yml +++ b/Unpublished/FDA Business Rules/FB1901/rule.yml @@ -1,168 +1,167 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum - length of the actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: SUPPQUAL - operator: exists - - name: RELREC - operator: exists - - name: SUPPQUAL - operator: is_inconsistent_across_dataset - value: - - all_variables - - name: RELREC - operator: is_inconsistent_across_dataset - value: - - all_variables + - name: SUPPQUAL + operator: exists + - name: RELREC + operator: exists + - name: SUPPQUAL + operator: is_inconsistent_across_dataset + value: + - all_variables + - name: RELREC + operator: is_inconsistent_across_dataset + value: + - all_variables Core: Status: Draft Version: '1' -Description: All variables in each of the SUPPQUAL and RELREC datasets have a - length that is not longer than the length of the longest value for that - variable. +Description: All variables in each of the SUPPQUAL and RELREC datasets have a length that is not + longer than the length of the longest value for that variable. Executability: Partially Executable Outcome: Message: The length of the variable is longer than the data within the variable Output Variables: - - SUPPQUAL - - RELREC + - SUPPQUAL + - RELREC Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB6501/rule.yml b/Unpublished/FDA Business Rules/FB6501/rule.yml index ce2f6e917..6b52aeb1e 100644 --- a/Unpublished/FDA Business Rules/FB6501/rule.yml +++ b/Unpublished/FDA Business Rules/FB6501/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission # then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: DS - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: DS + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing DS dataset. Output Variables: - - DS - - define_dataset_has_no_data + - DS + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "DS" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6502/rule.yml b/Unpublished/FDA Business Rules/FB6502/rule.yml index 4a0d3b1dc..62a640ca2 100644 --- a/Unpublished/FDA Business Rules/FB6502/rule.yml +++ b/Unpublished/FDA Business Rules/FB6502/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission # then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: CL - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: CL + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing CL dataset. Output Variables: - - CL - - define_dataset_has_no_data + - CL + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "CL" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6503/rule.yml b/Unpublished/FDA Business Rules/FB6503/rule.yml index 024755f5c..b1cb18be2 100644 --- a/Unpublished/FDA Business Rules/FB6503/rule.yml +++ b/Unpublished/FDA Business Rules/FB6503/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission # then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: EG - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: EG + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing EG dataset. Output Variables: - - EG - - define_dataset_has_no_data + - EG + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "EG" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6504/rule.yml b/Unpublished/FDA Business Rules/FB6504/rule.yml index b788622fe..757a64ae2 100644 --- a/Unpublished/FDA Business Rules/FB6504/rule.yml +++ b/Unpublished/FDA Business Rules/FB6504/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission # then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: EX - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: EX + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing EX dataset. Output Variables: - - EX - - define_dataset_has_no_data + - EX + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "EX" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6505/rule.yml b/Unpublished/FDA Business Rules/FB6505/rule.yml index 39daca75a..c4454522a 100644 --- a/Unpublished/FDA Business Rules/FB6505/rule.yml +++ b/Unpublished/FDA Business Rules/FB6505/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission # then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: LB - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: LB + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing LB dataset. Output Variables: - - LB - - define_dataset_has_no_data + - LB + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "LB" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6506/rule.yml b/Unpublished/FDA Business Rules/FB6506/rule.yml index 23db7ad64..67c50c44c 100644 --- a/Unpublished/FDA Business Rules/FB6506/rule.yml +++ b/Unpublished/FDA Business Rules/FB6506/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission # then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: MA - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: MA + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing MA dataset. Output Variables: - - MA - - define_dataset_has_no_data + - MA + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "MA" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6507/rule.yml b/Unpublished/FDA Business Rules/FB6507/rule.yml index 9635c99aa..71cdb5490 100644 --- a/Unpublished/FDA Business Rules/FB6507/rule.yml +++ b/Unpublished/FDA Business Rules/FB6507/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission # then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: MI - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: MI + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing MI dataset. Output Variables: - - MI - - define_dataset_has_no_data + - MI + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "MI" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6508/rule.yml b/Unpublished/FDA Business Rules/FB6508/rule.yml index cc81827b3..2e53b0fe8 100644 --- a/Unpublished/FDA Business Rules/FB6508/rule.yml +++ b/Unpublished/FDA Business Rules/FB6508/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6507: When PC domain is present in the define.xml, but no PC dataset is present in the submission # then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: PC - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: PC + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing PC dataset. Output Variables: - - PC - - define_dataset_has_no_data + - PC + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "PC" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6509/rule.yml b/Unpublished/FDA Business Rules/FB6509/rule.yml index 2ed1de5c8..632af5a9a 100644 --- a/Unpublished/FDA Business Rules/FB6509/rule.yml +++ b/Unpublished/FDA Business Rules/FB6509/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6507: When PP domain is present in the define.xml, but no PP dataset is present in the submission # then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: PP - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: PP + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,15 +107,15 @@ Executability: Fully Executable Outcome: Message: Missing PP dataset. Output Variables: - - PP - - define_dataset_has_no_data + - PP + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "PP" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6510/rule.yml b/Unpublished/FDA Business Rules/FB6510/rule.yml index 243d65488..a80a1dd64 100644 --- a/Unpublished/FDA Business Rules/FB6510/rule.yml +++ b/Unpublished/FDA Business Rules/FB6510/rule.yml @@ -1,110 +1,103 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6510' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6510: When VS domain is present in the define.xml, but no VS dataset is present in the submission # then the define.xml must contain ItemGroupDef for VS with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: VS - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: VS + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -114,17 +107,17 @@ Executability: Fully Executable Outcome: Message: Missing VS dataset. Output Variables: - - VS - - define_dataset_has_no_data + - VS + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "VS" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6601/rule.yml b/Unpublished/FDA Business Rules/FB6601/rule.yml index e2b8cb9ff..ba6ee78a6 100644 --- a/Unpublished/FDA Business Rules/FB6601/rule.yml +++ b/Unpublished/FDA Business Rules/FB6601/rule.yml @@ -1,104 +1,98 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Not applicable to SEND 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV should be + submitted if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV should be + submitted if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6601: When CV domain is present in the define.xml, but no CV dataset is present in the submission # then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: CV - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: CV + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -108,17 +102,17 @@ Executability: Fully Executable Outcome: Message: Missing CV dataset. Output Variables: - - CV - - define_dataset_has_no_data + - CV + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "CV" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6602/rule.yml b/Unpublished/FDA Business Rules/FB6602/rule.yml index 1f76c25b2..51ca2b6c7 100644 --- a/Unpublished/FDA Business Rules/FB6602/rule.yml +++ b/Unpublished/FDA Business Rules/FB6602/rule.yml @@ -1,104 +1,98 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Not applicable to SEND 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report..' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report..' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6602: When RE domain is present in the define.xml, but no RE dataset is present in the submission # then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: RE - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: RE + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty # Core: Status: Draft @@ -108,17 +102,17 @@ Executability: Fully Executable Outcome: Message: Missing RE dataset. Output Variables: - - RE - - define_dataset_has_no_data + - RE + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "RE" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml index 379ce50ac..22ae3622d 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml @@ -1,47 +1,47 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - Version: '3.2 ' - References: - - Origin: FDA Business Rules - Rule Identifier: - Id: FDAB017 - Version: '1' - Version: '1.5' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Origin: FDA Business Rules + Rule Identifier: + Id: FDAB017 + Version: '1' + Version: '1.5' + Version: '3.2 ' Check: all: - - name: SSSTRESC - operator: does_not_use_valid_codelist_terms - value: DEAD - value_is_literal: true - - name: $ds_dsdecod - operator: does_not_contain - value: DEATH - value_is_literal: true + - name: SSSTRESC + operator: does_not_use_valid_codelist_terms + value: DEAD + value_is_literal: true + - name: $ds_dsdecod + operator: does_not_contain + value: DEATH + value_is_literal: true Core: Id: FDA.SDTMIG.CT2001 Status: Draft Version: '1' -Description: Variable must be populated with terms from its CDISC controlled terminology - codelist. New terms cannot be added into non-extensible codelists. +Description: Variable must be populated with terms from its CDISC controlled terminology codelist. + New terms cannot be added into non-extensible codelists. Operations: - - operator: distinct - domain: DS - name: DSDECOD - id: $ds_dsdecod - group: - - USUBJID +- domain: DS + group: + - USUBJID + id: $ds_dsdecod + name: DSDECOD + operator: distinct Outcome: Message: Variable value not found in non-extensible codelist. Output Variables: - - + - Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml index c6ed2d757..7bad09220 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml @@ -1,52 +1,52 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: # Because the data we're checking involves a pivoted join, there are multiple rows per # (USUBJID, AESEQ) combination: one per value of QNAM. We want to raise only one error per # (USUBJID, AESEQ) combination, so choose the row with the minimum value of QNAM. - - name: AETERM - operator: non_empty - - name: QNAM - operator: is_not_contained_by - value: AETRTEM + - name: AETERM + operator: non_empty + - name: QNAM + operator: is_not_contained_by + value: AETRTEM Core: Id: FDA.SDTMIG.FB0101 Status: Draft @@ -54,21 +54,21 @@ Core: Description: Treatment-emergent flag should be present in SUPPAE for each Adverse Event. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: SUPPAE +- Keys: + - USUBJID + Name: SUPPAE Outcome: Message: Missing treatment-emergent flag (AETRTEM) for Adverse Event. Output Variables: - - AETERM - - AESTDTC - - QNAM + - AETERM + - AESTDTC + - QNAM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml index bb9db48f6..48ffb2903 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml @@ -1,52 +1,52 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should - be submitted if collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should - be submitted if collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should - be submitted if collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected.' + Document: 'FDA' + Section: 'FDAB004' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0405' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected.' + Document: 'FDA' + Section: 'FDAB004' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0405' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected.' + Document: 'FDA' + Section: 'FDAB004' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB0405' + Version: '1.5' + Version: '3.4' Check: all: - - name: define_dataset_name - operator: equal_to - value: LB - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: LB + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty Core: Id: FDA.SDTMIG.FB0405 Status: Draft @@ -56,16 +56,16 @@ Executability: Fully Executable Outcome: Message: Missing LB dataset. Output Variables: - - define_dataset_name - - define_dataset_has_no_data - - filename - - domain + - define_dataset_name + - define_dataset_has_no_data + - filename + - domain Rule Type: Domain Presence Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml index 687540f9d..289cb15af 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml @@ -1,55 +1,55 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be - submitted if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be - submitted if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be - submitted if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: PC - operator: exists - - name: ItemGroupDef - operator: is_inconsistent_across_dataset - value: - - Domain: PC - - Attribute: def:HasNoData - - Value: 'Yes' + - name: PC + operator: exists + - name: ItemGroupDef + operator: is_inconsistent_across_dataset + value: + - Domain: PC + - Attribute: def:HasNoData + - Value: 'Yes' Core: Id: FDA.SDTMIG.FB0411 Status: Draft @@ -59,14 +59,14 @@ Executability: Fully Executable Outcome: Message: Dataset PC is missing Output Variables: - - PC - - ItemGroupDef.def:HasNoData + - PC + - ItemGroupDef.def:HasNoData Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml index 461f951e1..2096eb4bd 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml @@ -1,124 +1,124 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB080 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB080 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '3.4' # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: '1' + Version: '1.5' + Version: '1.0' Check: any: # This part of the rule is solely about --STDTC, NOT about --ENDTC @@ -127,37 +127,36 @@ Check: # the comparison done is between 2025-11-03 and 2025-11-02. # Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45 # then the comparison done is between 2025-11-03T07 and 2025-11-03T07 - - name: --STDTC - operator: date_less_than - value: RFXSTDTC - - name: --STDTC - operator: date_greater_than - value: RFXENDTC + - name: --STDTC + operator: date_less_than + value: RFXSTDTC + - name: --STDTC + operator: date_greater_than + value: RFXENDTC Core: Id: FDA.SDTMIG.FB0801 Status: Draft Version: '1' -Description: Treatment exposure start date/time (--STDTC) should fall on or - between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the - DM dataset. +Description: Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC) + and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: --STDTC does not fall on or between RFXSTDTC and RFENDTC. Output Variables: - - RFXSTDTC - - --STDTC - - RFXENDTC + - RFXSTDTC + - --STDTC + - RFXENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml index f2ae9cff9..40e3873fa 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml @@ -1,124 +1,124 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB080 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB080 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '3.4' # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: '1' + Version: '1.5' + Version: '1.0' Check: any: # This part of the rule is solely about --ENDTC, NOT about --STDTC @@ -127,38 +127,37 @@ Check: # the comparison done is between 2025-11-03 and 2025-11-02. # Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45 # then the comparison done is between 2025-11-03T07 and 2025-11-03T07 - - name: RFXSTDTC - operator: date_greater_than - value: --ENDTC - - name: --ENDTC - operator: date_greater_than - value: RFXENDTC + - name: RFXSTDTC + operator: date_greater_than + value: --ENDTC + - name: --ENDTC + operator: date_greater_than + value: RFXENDTC Core: Id: FDA.SDTMIG.FB0802 Status: Draft Version: '1' -Description: Treatment exposure end date/time (--ENDTC) should fall on or - between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the - DM dataset. +Description: Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC) + and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: --ENDTC does not fall on or between RFXSTDTC and RFENDTC. Output Variables: - - "USUBJID" - - "--ENDTC" - - "RFXSTDTC" - - "RFXENDTC" + - "USUBJID" + - "--ENDTC" + - "RFXSTDTC" + - "RFXENDTC" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml index d06a928c3..d1bbbaddb 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml @@ -1,131 +1,130 @@ Authorities: - - Organization: 'FDA' - Standards: +- Organization: 'FDA' + Standards: # Alsot applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and - last study treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: '1' + Version: '1.5' + Version: '1.0' # rule failure criteria: TSPARMCD.EXPSTDTC => EXSTDTC OR EXSTDTC => TSPARMCD.EXPENDTC Check: all: - - name: $ts_expstdtc_value - operator: date_greater_than_or_equal_to - value: --EXSTDTC + - name: $ts_expstdtc_value + operator: date_greater_than_or_equal_to + value: --EXSTDTC Core: Id: FDA.SDTMIG.FB0803 Status: Draft Version: '1' -Description: Treatment exposure start date/time (EXSTDTC) should fall on or - between the date/time experimental start (EXPSTDTC) and end date (EXPENDTC) in - the TS dataset. +Description: Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time + experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset. Executability: Fully Executable Operations: - - domain: TS - filter: - TSPARMCD: EXPSTDTC - id: $ts_expstdtc_value - name: TSVAL - operator: distinct +- domain: TS + filter: + TSPARMCD: EXPSTDTC + id: $ts_expstdtc_value + name: TSVAL + operator: distinct Outcome: Message: EXSTDTC does not fall on or between EXPENDTC and EXPENDTC in TS dataset. Output Variables: - - $ts_expstdtc_value - - --EXSTDTC + - $ts_expstdtc_value + - --EXSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX - - EC + - EX + - EC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml index 56146bc4b..c6417052c 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml @@ -1,71 +1,70 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1101' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1101' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1101' + Version: '1' + Version: '1.5' + Version: '3.4' Check: any: - - name: TA - operator: not_exists - - name: TE - operator: not_exists - - name: TS - operator: not_exists - - name: TV - operator: not_exists + - name: TA + operator: not_exists + - name: TE + operator: not_exists + - name: TS + operator: not_exists + - name: TV + operator: not_exists Core: Id: FDA.SDTMIG.FB1101 Status: Draft Version: '1' -Description: All trial design datasets as listed in the corresponding IG should - be present in the submission. +Description: All trial design datasets as listed in the corresponding IG should be present in the + submission. Executability: Fully Executable Outcome: - Message: Not all trial design datasets as listed in the corresponding IG have - been submitted. + Message: Not all trial design datasets as listed in the corresponding IG have been submitted. Rule Type: Domain Presence Check Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml index 7d830fc20..3ae7430d6 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml @@ -1,99 +1,92 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # ONLY applicable to SDTMIG, not to SEND - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG) Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG) Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG) Page 13: In - addition to the study parameters indicated in the appendix - section, if the study data submitted follows a Therapeutic - Area User Guide (TAUG) or an FDA Technical Specification,30 - use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: TSPARMCD - operator: equal_to - value: 'CTAUG' - - name: TSVAL - operator: is_not_contained_by - value: $terms + - name: TSPARMCD + operator: equal_to + value: 'CTAUG' + - name: TSVAL + operator: is_not_contained_by + value: $terms Core: Id: FDA.SDTMIG.FB1103 Status: Draft Version: '1' -Description: 'Raise an issue when TSVAL (Standard Name) does not match - corresponding name as listed in section 5.2 of the TCG for TAUGs and is in the - CTAUGRS codelist (C160925), as published in the CDISC Library.' +Description: 'Raise an issue when TSVAL (Standard Name) does not match corresponding name as listed in + section 5.2 of the TCG for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC + Library.' Executability: Fully Executable # 2025-09-29: still throws an error when tested on an Excel file # See Github ticket 1338: https://github.com/cdisc-org/cdisc-rules-engine/issues/1338 Operations: - - codelists: - - CTAUGRS - id: $terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - CTAUGRS + id: $terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: 'TSVAL (Standard Name) does not match corresponding name as listed in - section 5.2 of the TCG for TAUGs and is in the CTAUGRS codelist (C160925), - as published in the CDISC Library.' + Message: 'TSVAL (Standard Name) does not match corresponding name as listed in section 5.2 of the TCG + for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC Library.' Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml index e14039d4f..28cf040d5 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml @@ -2,90 +2,89 @@ # Condition: TSPARAMCD=’ADDON’ and TSVAL=’Y’ # Success Criteria: At least one occurrence of TSPARAMCD=’CURTRT’ is included in TS with TSVAL populated. Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1107' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1107' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1107' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - any: - - name: $tsparmcd - operator: does_not_contain - value: 'CURTRT' - value_is_literal: true - - name: TSPARMCD - operator: 'equal_to' - value: 'CURTRT' - value_is_literal: true - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: 'equal_to' + value: 'ADDON' + value_is_literal: true + - name: TSVAL + operator: 'equal_to' + value: 'Y' + value_is_literal: true + - any: + - name: $tsparmcd + operator: does_not_contain + value: 'CURTRT' + value_is_literal: true + - name: TSPARMCD + operator: 'equal_to' + value: 'CURTRT' + value_is_literal: true + - name: TSVAL + operator: empty Core: Id: FDA.SDTMIG.FB1107 Status: Draft Version: '1' -Description: At least one occurrence of TSPARAMCD='CURTRT' is included in TS - with TSVAL populated. +Description: At least one occurrence of TSPARAMCD='CURTRT' is included in TS with TSVAL populated. Executability: Fully Executable Operations: - - domain: TS - id: $tsparmcd - name: TSPARMCD - operator: distinct +- domain: TS + id: $tsparmcd + name: TSPARMCD + operator: distinct Outcome: Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null. Output Variables: - - TSPARMCD - - TSVAL - - $tsparmcd + - TSPARMCD + - TSVAL + - $tsparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml index c1266188a..241103572 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml @@ -1,67 +1,65 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1108' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1108' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1108' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: 'TSPARMCD' - operator: equal_to - value: DCUTDESC + - name: 'TSPARMCD' + operator: equal_to + value: DCUTDESC Core: Id: FDA.SDTMIG.FB1108 Status: Draft Version: '1' -Description: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same - TSGRPID and TSVAL values.' +Description: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values.' Executability: Fully Executable Outcome: - Message: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID - and TSVAL values.' + Message: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values.' Output Variables: - - TSPARMCD - - TSVAL - - TSGRPID + - TSPARMCD + - TSVAL + - TSGRPID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml index 59513fdf9..e48284d6e 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml @@ -1,171 +1,169 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1109' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1109' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1109' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: + - name: TSPARMCD + operator: equal_to + value: CTAUG + - name: TSVAL + operator: starts_with + value: QT + - any: - name: TSPARMCD + operator: not_contains_all + value: + - EGBLIND + - EGCTMON + - EGLEADPR + - EGLEADSM + - EGRDMETH + - EGREPLBL + - EGREPLTR + - EGTWVALG + - name: $blind_count operator: equal_to - value: CTAUG - - name: TSVAL - operator: starts_with - value: QT - - any: - - name: TSPARMCD - operator: not_contains_all - value: - - EGBLIND - - EGCTMON - - EGLEADPR - - EGLEADSM - - EGRDMETH - - EGREPLBL - - EGREPLTR - - EGTWVALG - - name: $blind_count - operator: equal_to - value: 1 - - name: $ctmon_count - operator: equal_to - value: 1 - - name: $leadpr_count - operator: equal_to - value: 1 - - name: $leadsm_count - operator: equal_to - value: 1 - - name: $rdmeth_count - operator: equal_to - value: 1 - - name: $replbl_count - operator: equal_to - value: 1 - - name: $repltr_count - operator: equal_to - value: 1 - - name: $twvalg_count - operator: equal_to - value: 1 + value: 1 + - name: $ctmon_count + operator: equal_to + value: 1 + - name: $leadpr_count + operator: equal_to + value: 1 + - name: $leadsm_count + operator: equal_to + value: 1 + - name: $rdmeth_count + operator: equal_to + value: 1 + - name: $replbl_count + operator: equal_to + value: 1 + - name: $repltr_count + operator: equal_to + value: 1 + - name: $twvalg_count + operator: equal_to + value: 1 Core: Id: FDA.SDTMIG.FB1109 Status: Draft Version: '1' -Description: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, - EGREPLTR, EGTWVALG) is included in the list of TSPARAMCD with TSVAL - populated.' +Description: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is + included in the list of TSPARAMCD with TSVAL populated.' Executability: Fully Executable Operations: - - domain: TS - filter: - TSPARMCD: EGBLIND - TSVAL: '' - id: $blind_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGCTMON - TSVAL: '' - id: $ctmon_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGLEADPR - TSVAL: '' - id: $leadpr_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGLEADSM - TSVAL: '' - id: $leadsm_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGRDMETH - TSVAL: '' - id: $rdmeth_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGREPLBL - TSVAL: '' - id: $replbl_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGREPLTR - TSVAL: '' - id: $repltr_count - name: TSPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: EGTWVALG - TSVAL: '' - id: $twvalg_count - name: TSPARMCD - operator: record_count +- domain: TS + filter: + TSPARMCD: EGBLIND + TSVAL: '' + id: $blind_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGCTMON + TSVAL: '' + id: $ctmon_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGLEADPR + TSVAL: '' + id: $leadpr_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGLEADSM + TSVAL: '' + id: $leadsm_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGRDMETH + TSVAL: '' + id: $rdmeth_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGREPLBL + TSVAL: '' + id: $replbl_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGREPLTR + TSVAL: '' + id: $repltr_count + name: TSPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: EGTWVALG + TSVAL: '' + id: $twvalg_count + name: TSPARMCD + operator: record_count Outcome: - Message: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, - EGREPLTR, EGTWVALG) is included in the list of TSPARAMCD with TSVAL - populated.' + Message: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is + included in the list of TSPARAMCD with TSVAL populated.' Output Variables: - - TSVAL - - $blind_count - - $ctmon_count - - $leadpr_count - - $leadsm_count - - $rdmeth_count - - $replbl_count - - $repltr_count - - $twvalg_count + - TSVAL + - $blind_count + - $ctmon_count + - $leadpr_count + - $leadsm_count + - $rdmeth_count + - $replbl_count + - $repltr_count + - $twvalg_count Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml index a0ed4fba8..4f90ea520 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml @@ -1,84 +1,84 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1112' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1112' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'TCG, Appendix B' + Document: 'FDA' + Section: 'FDAB011' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB1112' + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: $PCLASS_COUNT - operator: greater_than - value: 1 - - name: $INTTYPE_EXISTS + - name: $PCLASS_COUNT + operator: greater_than + value: 1 + - name: $INTTYPE_EXISTS + operator: equal_to + value: 1 + - all: + - name: TSPARMCD operator: equal_to - value: 1 - - all: - - name: TSPARMCD - operator: equal_to - value: PCLASS - - name: TSVAL - operator: non_empty + value: PCLASS + - name: TSVAL + operator: non_empty Core: Id: FDA.SDTMIG.FB1112 Status: Draft Version: '1' -Description: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of - TSPARAMCD with TSVAL populated is gt 1.' +Description: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated + is gt 1.' Executability: Partially Executable Operations: - - filter: - TSPARMCD: PCLASS - id: $PCLASS_COUNT - operator: record_count - - filter: - TSPARMCD: INTTYPE - id: $INTTYPE_EXISTS - operator: record_count +- filter: + TSPARMCD: PCLASS + id: $PCLASS_COUNT + operator: record_count +- filter: + TSPARMCD: INTTYPE + id: $INTTYPE_EXISTS + operator: record_count Outcome: - Message: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of - TSPARAMCD with TSVAL populated is gt 1.' + Message: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated + is gt 1.' Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml index 0b4ca2548..ad6281bb5 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml @@ -1,148 +1,147 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the - maximum length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: variable_size - operator: less_than_or_equal_to - value: 10 + - name: variable_size + operator: less_than_or_equal_to + value: 10 Core: Id: FDA.SDTMIG.FB1801 Status: Draft Version: '1' -Description: The length of each variable cannot be different between datasets - and should not be longer than the maximum length of the data contained by the - variable +Description: The length of each variable cannot be different between datasets and should not be + longer than the maximum length of the data contained by the variable Executability: Partially Executable # Operations: #- id: $size @@ -151,16 +150,16 @@ Executability: Partially Executable Outcome: Message: The length of the variable is longer than the data within the variable Output Variables: - - variable_size - - variable_value_length - - variable_name + - variable_size + - variable_value_length + - variable_name # - $size Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml index e23f08d5a..df186dec1 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml @@ -2,69 +2,68 @@ # Condition: DM.USUBJID in EX.USUBJID AND TSVAL = "INTERVENTIONAL" when TSPARMCD = "STYPE" # Rule: DM.ACTARMCD not in ("SCRNFAIL", "NOTASSGN", "NOTTRT") Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For interventional studies all treated subjects should have - exposure data. - Document: FDA - Section: FDAB023 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2303 - Version: '1' - Version: '1.5' - Version: '3.2' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For interventional studies all treated subjects should have exposure data. + Document: FDA + Section: FDAB023 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2303 + Version: '1' + Version: '1.5' + Version: '3.2' Check: all: - - name: ACTARMCD - operator: is_contained_by_case_insensitive - value: - - SCRNFAIL - - NOTASSGN - - NOTTRT - - name: TSPARMCD - operator: equal_to - value: "STYPE" - value_is_literal: true - - name: TSVAL - operator: equal_to - value: "INTERVENTIONAL" - value_is_literal: true - - name: USUBJID - operator: is_contained_by - value: $usubjids_in_ex + - name: ACTARMCD + operator: is_contained_by_case_insensitive + value: + - SCRNFAIL + - NOTASSGN + - NOTTRT + - name: TSPARMCD + operator: equal_to + value: "STYPE" + value_is_literal: true + - name: TSVAL + operator: equal_to + value: "INTERVENTIONAL" + value_is_literal: true + - name: USUBJID + operator: is_contained_by + value: $usubjids_in_ex Core: Id: FDA.SDTMIG.FB2303 Status: Draft Version: '1' -Description: All subjects in the Exposure domain who are participating in a - study that includes an interventional product must be assigned to a treatment. +Description: All subjects in the Exposure domain who are participating in a study that includes an + interventional product must be assigned to a treatment. Executability: Fully Executable Match Datasets: - - Keys: - - STUDYID - Name: TS +- Keys: + - STUDYID + Name: TS Operations: - - domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct +- domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: - Message: A subject has a record in EX but is not assigned to a treatment while - participating in an interventional study + Message: A subject has a record in EX but is not assigned to a treatment while participating in an + interventional study Output Variables: - - ACTARMCD - - TSPARMCD - - TSVAL + - ACTARMCD + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml index af2d97043..626374560 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml @@ -2,34 +2,34 @@ # Condition: ARMCD ^= (SCRNFAIL, NOTASSGN) DM.ARMCD ^= (SCRNFAIL, NOTASSGN) and DM.ACTARMCD ^= NOTTRT # Rule: DM.USUBJID in EX.USUBJID Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2503 - Version: '1' - Version: '1.5' - Version: '3.2' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2503 + Version: '1' + Version: '1.5' + Version: '3.2' Check: all: - - name: ARMCD - operator: is_not_contained_by_case_insensitive - value: - - SCRNFAIL - - NOTASSGN - - name: ACTARMCD - operator: is_not_contained_by_case_insensitive - value: - - NOTTRT - - name: USUBJID - operator: is_not_contained_by - value: $usubjids_in_ex + - name: ARMCD + operator: is_not_contained_by_case_insensitive + value: + - SCRNFAIL + - NOTASSGN + - name: ACTARMCD + operator: is_not_contained_by_case_insensitive + value: + - NOTTRT + - name: USUBJID + operator: is_not_contained_by + value: $usubjids_in_ex Core: Id: FDA.SDTMIG.FB2503 Status: Draft @@ -37,21 +37,21 @@ Core: Description: If a subject is assigned to an arm, the subject should have a record in EX. Executability: Partially Executable Operations: - - domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct +- domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: Message: Subject is assigned to an arm code (randomized) but has no record in EX. Output Variables: - - ARMCD - - ACTARMCD + - ARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml index 0c70770cc..67fe132c7 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml @@ -2,176 +2,166 @@ # Condition: --STDTC ^= Null and --DTC ^= Null # Rule: --STDTC <= --DTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if - collected, and study day of observation (--DY) should be - submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: --STDTC - operator: non_empty - - name: --DTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: --DTC + - name: --STDTC + operator: non_empty + - name: --DTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: --DTC Core: Id: FDA.SDTMIG.FB3211 Status: Draft Version: '1' -Description: Start Date/Time of Observation (--STDTC) is prior or equal to - Date/Time of Collection (--DTC) +Description: Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection + (--DTC) Executability: Fully Executable Outcome: Message: --STDTC falls after --DTC. Output Variables: - - --STDTC - - --DTC + - --STDTC + - --DTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - BE + - BE Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml index f277246db..60e9df886 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml @@ -1,167 +1,157 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3402' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # TODO: check/adapt for value with different granularity all: - - name: EXSTDTC - operator: date_greater_than - value: '$max_dsstdtc' + - name: EXSTDTC + operator: date_greater_than + value: '$max_dsstdtc' Core: Id: FDA.SDTMIG.FB3402 Status: Draft Version: '1' -Description: 'Start Date/Time of Treatment (EXSTDTC) should be prior or equal to - the Start Date/Time of the latest Disposition Event (DSSTDTC).' +Description: 'Start Date/Time of Treatment (EXSTDTC) should be prior or equal to the Start Date/Time of + the latest Disposition Event (DSSTDTC).' Executability: Fully Executable Operations: - - domain: DS - group: - - USUBJID - id: $max_dsstdtc - name: DSSTDTC - operator: max_date +- domain: DS + group: + - USUBJID + id: $max_dsstdtc + name: DSSTDTC + operator: max_date Outcome: Message: 'EXSTDTC falls after the last DSSTDTC.' Output Variables: - - EXSTDTC - - $max_dsstdtc + - EXSTDTC + - $max_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml index 5de444556..42f9c0d22 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml @@ -1,167 +1,157 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Study start and end date/time should include month, day, and year.' + Document: 'FDA' + Section: 'FDAB034' + Origin: FDA Business Rules + Rule Identifier: + Id: 'FB3403' + Version: '1' + Version: '1.5' + Version: '1.0' Check: # TODO: check/adapt for value with different granularity all: - - name: EXENDTC - operator: date_greater_than - value: '$max_dsstdtc' + - name: EXENDTC + operator: date_greater_than + value: '$max_dsstdtc' Core: Id: FDA.SDTMIG.FB3403 Status: Draft Version: '1' -Description: 'End Date/Time of Treatment (EXENDTC) should be prior or equal to - the Start Date/Time of the latest Disposition Event (DSSTDTC).' +Description: 'End Date/Time of Treatment (EXENDTC) should be prior or equal to the Start Date/Time of + the latest Disposition Event (DSSTDTC).' Executability: Fully Executable Operations: - - domain: DS - group: - - USUBJID - id: $max_dsstdtc - name: DSSTDTC - operator: max_date +- domain: DS + group: + - USUBJID + id: $max_dsstdtc + name: DSSTDTC + operator: max_date Outcome: Message: 'EXENDTC falls after the last DSSTDTC.' Output Variables: - - EXENDTC - - $max_dsstdtc + - EXENDTC + - $max_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml index c34f745fb..95ec236c3 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml @@ -2,80 +2,77 @@ # Condition: --STDTC ^= Null and DM.RFPENDTC ^= Null # Rule: --STDTC <= DM.RFPENDTC Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and - year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.4' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: '1' + Version: '1.5' + Version: '3.4' Check: all: - - name: --STDTC - operator: non_empty - - name: RFPENDTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: RFPENDTC + - name: --STDTC + operator: non_empty + - name: RFPENDTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: RFPENDTC Core: Id: FDA.SDTMIG.FB3405 Status: Draft Version: '1' -Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time - of End of Participation (RFPENDTC) +Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of + Participation (RFPENDTC) Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Outcome: Message: --STDTC falls after RFPENDTC. Output Variables: - - --STDTC - - RFPENDTC + - --STDTC + - RFPENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml index 0d35a3a34..839e2afb8 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml @@ -1,144 +1,144 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should - be submitted, if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, + if collected.' + Document: 'FDA' + Section: 'FDAB038' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB3801' + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: define_variable_is_collected - operator: equal_to - value: true - - name: $timing_variables - operator: shares_exactly_one_element_with - value: $dataset_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: $timing_variables + operator: shares_exactly_one_element_with + value: $dataset_variables Core: Id: FDA.SDTMIG.FB3801 Status: Draft @@ -146,25 +146,25 @@ Core: Description: 'Timing information should be submitted when collected.''' Executability: Partially Executable Operations: - - id: $dataset_variables - operator: get_column_order_from_dataset - - id: $timing_variables - key_name: role - key_value: Timing - operator: get_model_filtered_variables +- id: $dataset_variables + operator: get_column_order_from_dataset +- id: $timing_variables + key_name: role + key_value: Timing + operator: get_model_filtered_variables Outcome: Message: 'Timing information is collected but not submitted.' Output Variables: - - $dataset_variables - - $timing_variables + - $dataset_variables + - $timing_variables Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml index 71a350564..1aceb00df 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml @@ -1,173 +1,173 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across - pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: PPCAT - operator: non_empty - - name: PPSPEC - operator: not_equal_to - value: RELREC.PCSPEC - - name: PPCAT - operator: equal_to - value: RELREC.PCTEST + - name: PPCAT + operator: non_empty + - name: PPSPEC + operator: not_equal_to + value: RELREC.PCSPEC + - name: PPCAT + operator: equal_to + value: RELREC.PCTEST Core: Id: FDA.SDTMIG.FB7101 Status: Draft Version: '1' -Description: 'For the same drug or metabolite (PCTEST), specimen type (PCSPEC) - should be consistent across pharmacokinetic datasets within a submission.' +Description: 'For the same drug or metabolite (PCTEST), specimen type (PCSPEC) should be consistent across + pharmacokinetic datasets within a submission.' Executability: Partially Executable Match Datasets: - - Name: RELREC - Wildcard: PC +- Name: RELREC + Wildcard: PC Outcome: Message: PCSPEC is not equal to PPSPEC for the same drug or metabolite. Output Variables: - - PPCAT - - PPSPEC - - PPCAT - - RELREC.PCSPEC - - RELREC.PCTEST + - PPCAT + - PPSPEC + - PPCAT + - RELREC.PCSPEC + - RELREC.PCTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - RELATIONSHIP + - FINDINGS + - RELATIONSHIP Domains: Include: - - PP - - PC - - RELREC + - PP + - PC + - RELREC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml index 975e9e26a..c35e70851 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml @@ -1,58 +1,55 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, - Appendix C, is not included in the list of TSPARAMCD with - TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, - Appendix C, is not included in the list of TSPARAMCD with - TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, - Appendix C, is not included in the list of TSPARAMCD with - TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: '1' + Version: '1.5' + Version: '3.1.1' # List of parameters for which there must be a record, i.e. TSPARMCD: # 'AGEU','DOSDUR','DOSENDTC','DOSSTDTC','EXPENDTC','EXPSTDTC','GLPFL','GLPTYP','PCLASS','PPTCNAM','PPTEGID','PPTEGSYM','PPTMDA','ROUTE','SDESIGN','SEXPOP','SNDCTVER','SNDIGVER','SPECIES','SPLANSUB','SPLRNAM','SPREFID','SSPONSOR','SSTYP','STCAT','STDIR','STITLE','STRAIN','STRPSTAT','STSTDTC','TFCNTRY','TRMSAC','TRT','TRTCAS','TRTUNII','TRTV','TSTFLOC','TSTFNAM' # Starting from the code for FB1102 (which is for SDTM, but here the list is for SEND) Check: all: - - name: TSPARMCD - operator: not_contains_all - value: - - AGEU + - name: TSPARMCD + operator: not_contains_all + value: + - AGEU #- 'DOSDUR' #- 'DOSENDTC' #- 'DOSSTDTC' @@ -91,28 +88,27 @@ Check: #- 'TSTFLOC' #- 'TSTFNAM' - - name: 'TSVAL' - operator: non_empty + - name: 'TSVAL' + operator: non_empty Core: Id: FDA.SENDIG.FB1115 Status: Draft Version: '1' -Description: 'Check whether all values in the list are populated for TSPARMCD - and TSVAL is populated' +Description: 'Check whether all values in the list are populated for TSPARMCD and TSVAL is populated' Executability: Fully Executable Outcome: - Message: 'The set of parameters without conditions listed in the TCG, Appendix - C, is not included in the list of TSPARAMCD with TSVAL populated.' + Message: 'The set of parameters without conditions listed in the TCG, Appendix C, is not included in + the list of TSPARAMCD with TSVAL populated.' Output Variables: - - TSVAL - - TSPARMCD + - TSVAL + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml index 9f887b87d..4ea34a636 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml @@ -1,35 +1,33 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable to SENDIG version 3.1 and 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on - which group summaries (group means and incidences) are - calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4702 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on - which group summaries (group means and incidences) are - calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4702 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data.' + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4702 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data.' + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4702 + Version: '1' + Version: '1.5' + Version: '3.1.1' Check: all: # Rule = At least one of VISITDY or --NOMDY is populated as these are required timing variables @@ -42,31 +40,31 @@ Check: # 2025-09-30: also when --USCHFL and VISITDY columns (both permissible) are ABSENT # Then --NOMDY must be populated # PRECONDITIONS: Rule does not apply when --USCHFL is populated - - any: + - any: # --USCHFL column is absent or --USCHFL is empty - - name: --USCHFL - operator: not_exists - - name: --USCHFL - operator: empty - - any: + - name: --USCHFL + operator: not_exists + - name: --USCHFL + operator: empty + - any: # --VISITDY column is absent or --VISITDY is # P.S. VISITDY = PLANNED Study Day of Collection - - name: VISITDY - operator: not_exists - - name: VISITDY - operator: 'empty' - # TEST CONDITION. Remark that --MOMDY is "expected" - - name: --NOMDY + - name: VISITDY + operator: not_exists + - name: VISITDY operator: 'empty' + # TEST CONDITION. Remark that --MOMDY is "expected" + - name: --NOMDY + operator: 'empty' Core: Id: FDA.SENDIG.FB4702 Status: Draft Version: '1' # Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is # populated and --USCHFL is not populated' -Description: VISITDY or --NOMDY should be populated for scheduled records as - these are required timing variables for identification of the day on which - group summaries (Group Means and Incidences) are calculated. +Description: VISITDY or --NOMDY should be populated for scheduled records as these are required + timing variables for identification of the day on which group summaries (Group Means and + Incidences) are calculated. Executability: Fully Executable Outcome: #Message: 'Either VISITDY or --NOMDY must be populated when --ORRES is populated @@ -77,17 +75,17 @@ Scope: Classes: Include: # we can set to "FINDINGS", as --ORRES is only possible in FINDINGS - - FINDINGS + - FINDINGS Domains: Include: - - BW - - CL - - CV - - EG - - LB - - PC - - PM - - PP - - RE - - VS + - BW + - CL + - CV + - EG + - LB + - PC + - PM + - PP + - RE + - VS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml index 631b86388..28bed55aa 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml @@ -1,102 +1,102 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be - included in nonclinical data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical + data.' + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: 'TSVALCD' - operator: exists + - name: 'TSVALCD' + operator: exists Core: Id: FDA.SENDIG.FB5132 Status: Draft @@ -109,8 +109,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml index fefbb1ecc..7247554da 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml @@ -1,170 +1,163 @@ Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to - test compound rather than challenge agents or other - interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions.' + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - all: - - name: "RFSTDTC" - operator: "date_not_equal_to" - value: "$ex_exstdtc" - - any: - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$pr_prstdtc" - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$cm_cmstdtc" - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$ag_agstdtc" + - all: + - name: "RFSTDTC" + operator: "date_not_equal_to" + value: "$ex_exstdtc" + - any: + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$pr_prstdtc" + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$cm_cmstdtc" + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$ag_agstdtc" Core: Id: FDA.SENDIG.FB6403 Status: Draft Version: '1' -Description: 'RFSTDTC should be the first treatment exposure date/time from EX - and not equal to start dates from PR/CM/AG' +Description: 'RFSTDTC should be the first treatment exposure date/time from EX and not equal to start + dates from PR/CM/AG' Executability: Fully Executable Operations: - - domain: "EX" - group: - - USUBJID - id: "$ex_exstdtc" - name: "EXSTDTC" - operator: "min_date" - - domain: "PR" - group: - - USUBJID - id: "$pr_prstdtc" - name: "PRSTDTC" - operator: "min_date" - - domain: "CM" - group: - - USUBJID - id: "$cm_cmstdtc" - name: "CMSTDTC" - operator: "min_date" - - domain: "AG" - group: - - USUBJID - id: "$ag_agstdtc" - name: "AGSTDTC" - operator: "min_date" +- domain: "EX" + group: + - USUBJID + id: "$ex_exstdtc" + name: "EXSTDTC" + operator: "min_date" +- domain: "PR" + group: + - USUBJID + id: "$pr_prstdtc" + name: "PRSTDTC" + operator: "min_date" +- domain: "CM" + group: + - USUBJID + id: "$cm_cmstdtc" + name: "CMSTDTC" + operator: "min_date" +- domain: "AG" + group: + - USUBJID + id: "$ag_agstdtc" + name: "AGSTDTC" + operator: "min_date" Outcome: - Message: 'RFSTDTC is not the first treatment exposure date/time from EX and - equal to one of the start dates from PR/CM/AG' + Message: 'RFSTDTC is not the first treatment exposure date/time from EX and equal to one of the start + dates from PR/CM/AG' Output Variables: - - RFSTDTC - - $ex_exstdtc + - RFSTDTC + - $ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - SPECIAL PURPOSE + - INTERVENTIONS + - SPECIAL PURPOSE Domains: Include: - - DM - - EX - - PR - - CM - - AG + - DM + - EX + - PR + - CM + - AG Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml index a7171a48b..d2e221978 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6501' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission # then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes" Check: all: - - name: DS - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: DS + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6501 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml index 231f74321..980d01900 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml @@ -1,112 +1,104 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6502' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission # then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes" Check: all: - - name: CL - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: CL + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6502 Status: Draft Version: '1' -Description: 'CL dataset should be present in the submission when related data - is collected.' +Description: 'CL dataset should be present in the submission when related data is collected.' Executability: Fully Executable Outcome: Message: Missing CL dataset. @@ -114,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml index 8ba8435c3..18b56774a 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6503' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission # then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes" Check: all: - - name: EG - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: EG + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6503 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml index 256eebbc3..540283f27 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6504' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission # then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes" Check: all: - - name: EX - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: EX + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6504 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml index b86b30c13..8093835ee 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6505' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission # then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes" Check: all: - - name: LB - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: LB + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6505 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml index eeea6365c..581cc8ee0 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6506' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission # then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes" Check: all: - - name: MA - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: MA + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6506 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml index 36fb23cef..6d3303f8a 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6507' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission # then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes" Check: all: - - name: MI - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: MI + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6507 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml index 9af4acfea..1a090f2c8 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6508' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule 6508: When PC domain is present in the define.xml, but no PC dataset is present in the submission # then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes" Check: all: - - name: PC - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: PC + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6508 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml index 9d60efde9..b63e06498 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml @@ -1,106 +1,99 @@ Authorities: - - Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted - if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: 'FDA' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' + Document: 'FDA' + Section: 'FDAB056' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6509' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB6509: When PP domain is present in the define.xml, but no PP dataset is present in the submission # then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes" Check: all: - - name: PP - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: PP + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6509 Status: Draft @@ -113,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml index f0f017a0f..48ea71c22 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml @@ -1,100 +1,94 @@ Authorities: - - Organization: 'FDA' +- Organization: 'FDA' # FB6601 is not applicable to SENDIG-3.0 - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6601' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB5610: When CV domain is present in the define.xml, but no CV dataset is present in the submission # then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" Check: all: - - name: CV - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: CV + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6601 Status: Draft @@ -107,8 +101,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml index cd5a98304..0bdab39e0 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml @@ -1,101 +1,95 @@ Authorities: - - Organization: 'FDA' +- Organization: 'FDA' # FB6602 is not applicable to SENDIG-3.0 - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV - should be submitted if collected and included in the study - report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: 'SENDIG-AR' + References: + - Citations: + - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.' + Document: 'FDA' + Section: 'FDAB066' + Origin: 'FDA Business Rules' + Rule Identifier: + Id: 'FB6602' + Version: '1' + Version: '1.5' + Version: '1.0' # Rule FB5610: When RE domain is present in the define.xml, but no RE dataset is present in the submission # then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" Check: all: - - name: RE - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: RE + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6602 Status: Draft @@ -108,8 +102,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml index 79555c59e..b6771b1fc 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml @@ -1,34 +1,34 @@ Authorities: - - Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated - unless MISTRESC has a value of UNREMARKABLE (for SENDIGv3.1) - or NORMAL (for SENDIGv3.0) or MISTAT has a value of NOT DONE.' - Document: FDA - Section: FDAB082 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated - unless MISTRESC has a value of UNREMARKABLE (for SENDIGv3.1) - or NORMAL (for SENDIGv3.0) or MISTAT has a value of NOT DONE.' - Document: FDA - Section: FDAB082 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8202 - Version: '1' - Version: '1.5' - Version: '3.1.1' +- Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has + a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of + NOT DONE.' + Document: FDA + Section: FDAB082 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8202 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has + a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of + NOT DONE.' + Document: FDA + Section: FDAB082 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8202 + Version: '1' + Version: '1.5' + Version: '3.1.1' Check: all: # TODO: still causes an error as this is a check on the dataset level @@ -39,22 +39,21 @@ Check: # - name: TSVAL # operator: equal_to # value: CARCINOGENICITY - - all: - - name: MISTRESC - operator: not_equal_to - value: 'UNREMARKABLE' - - name: MISTAT - operator: not_equal_to - value: 'NOT DONE' - - name: MIRESCAT - operator: empty + - all: + - name: MISTRESC + operator: not_equal_to + value: 'UNREMARKABLE' + - name: MISTAT + operator: not_equal_to + value: 'NOT DONE' + - name: MIRESCAT + operator: empty Core: Id: FDA.SENDIG.FB8202 Status: Draft Version: '1' -Description: For carcinogenicity studies, MIRESCAT value should be populated - when MISTRESC does not have a value of UNREMARKABLE or MISTAT has a value of - NOT DONE. +Description: For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not + have a value of UNREMARKABLE or MISTAT has a value of NOT DONE. Executability: Fully Executable Outcome: Message: MIRESCAT value is missing. @@ -62,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml index de3527c1b..c6b87447b 100644 --- a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml @@ -1,160 +1,150 @@ Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TS - operator: not_exists + - name: TS + operator: not_exists Core: Id: FDA.TRC1734a Status: Draft @@ -167,8 +157,8 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml index 3c2051d6a..9c52fc649 100644 --- a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml @@ -2,188 +2,177 @@ # Condition: TS is present # Rule: TSPARMCD SSTDTC is present Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must - be present for each study in Module 4, sections 4.2.3.1, - 4.2.3.2, 4.2.3.4, and in Module 5, sections 5.3.1.1, 5.3.1.2, - 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.0' +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: '1' + Version: '1.5' + Version: '1.0' Check: all: - - name: TS - operator: exists - - name: $ts_tsparmcd - operator: does_not_contain - value: SSTDTC - value_is_literal: true + - name: TS + operator: exists + - name: $ts_tsparmcd + operator: does_not_contain + value: SSTDTC + value_is_literal: true Core: Id: FDA.TRC1734b Status: Draft Version: '1' -Description: FDA desired parameter Study Start Date (SSTDTC) should be present - in the TS domain. +Description: FDA desired parameter Study Start Date (SSTDTC) should be present in the TS domain. Executability: Fully Executable Operations: - - domain: TS - group: - - STUDYID - id: $ts_tsparmcd - name: TSPARMCD - operator: distinct +- domain: TS + group: + - STUDYID + id: $ts_tsparmcd + name: TSPARMCD + operator: distinct Outcome: Message: Missing TSPARMCD = SSTDTC record in TS dataset. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml index a43f9e4c1..faa6db47f 100644 --- a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml +++ b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml @@ -1,125 +1,124 @@ # FDAB1119 is just one of the many parts of FDAB011. This is currently just a temporary solution, Core: # as the better solution is to have all the SEND-required PARMCD-s in the CDISC Library and iterate over them Authorities: - - Organization: FDA - Standards: +- Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the - FDA Study Data Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'TSPARAMCD=RECSAC is included in TS with TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG).' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'TSPARAMCD=RECSAC is included in TS with TSVAL populated.' + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: '1' + Version: '1.5' + Version: '1.0' # FDAB1119 is just one of the many parts of FDAB011. This is currently just a temporary solution, Core: # as the better solution is to have all the SEND-required PARMCD-s in the CDISC Library and iterate over them Check: any: # No record with TSPARMCD=RECSAC # REMARK: test at the dataset level - - all: - - name: TSPARMCD - operator: does_not_contain - value: RECSAC + - all: + - name: TSPARMCD + operator: does_not_contain + value: RECSAC # TSVAL empty for TSPARMCD=RECSAC # REMARK: test at the record level # OR: should we use a "filter" here? - - all: - - name: TSPARMCD - operator: equal_to - value: RECSAC - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: equal_to + value: RECSAC + - name: TSVAL + operator: empty Core: Id: FFDA.SENDIG.FB1119 Status: Draft Version: '1' -Description: 'Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or - when its TSVAL is not populated' +Description: 'Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or when its TSVAL is not populated' Executability: Fully Executable Outcome: Message: TSPARMCD=RECSAC is missing or it's TSVAL value is empty @@ -127,8 +126,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml index 92009499d..e1f714b6b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml @@ -2,83 +2,81 @@ # Condition: --DUR ^= null # Rule: --DUR collected and not derived Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used only if collected on the CRF and not derived. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Collected duration of an event, intervention, or finding - represented in ISO 8601 character format. Used only if - collected on the CRF and not derived. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Collected duration of an event, intervention, or finding. Used - only if collected on the CRF and not derived. Format=ISO8601 - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used only if collected on the CRF and not derived. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Collected duration of an event, intervention, or finding represented in ISO + 8601 character format. Used only if collected on the CRF and not derived. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Collected duration of an event, intervention, or finding. Used only if + collected on the CRF and not derived. Format=ISO8601 + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_variable_is_collected - operator: equal_to - value: false - - name: variable_name - operator: matches_regex - value: ^..DUR$ - - name: $dur_is_null - operator: equal_to - value: false + - name: define_variable_is_collected + operator: equal_to + value: false + - name: variable_name + operator: matches_regex + value: ^..DUR$ + - name: $dur_is_null + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0002 Status: Draft Version: '1' -Description: Raise a message when --DUR exists in a dataset, confirm collected - and not derived. +Description: Raise a message when --DUR exists in a dataset, confirm collected and not derived. Executability: Fully Executable Operations: - - id: $dur_is_null - name: --DUR - operator: variable_is_null +- id: $dur_is_null + name: --DUR + operator: variable_is_null # Return true if at least one record is non null Outcome: Message: --DUR exists in a dataset, confirm collected and not derived. Output Variables: - - variable_name - - define_variable_is_collected - - row_number - - $dur_is_null + - variable_name + - define_variable_is_collected + - row_number + - $dur_is_null Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml index c2bc9a8a7..ed45f4dda 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml @@ -2,85 +2,84 @@ # Condition: Variable Core Status = Permissible and data is collected # Rule: Variable present in dataset and ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The sponsor does not have the discretion to exclude permissible - variables when they contain data. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The sponsor does not have the discretion to exclude permissible - variables when they contain data. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a - Permissible variable, then that variable must be included in - the SDTM dataset, even if null. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The sponsor does not have the discretion to exclude permissible variables + when they contain data. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The sponsor does not have the discretion to exclude permissible variables + when they contain data. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: define_variable_name - operator: non_empty - - name: library_variable_core + - name: define_variable_name + operator: non_empty + - name: library_variable_core + operator: equal_to + value: Perm + - name: define_variable_has_no_data + operator: empty + - any: + - name: variable_name + operator: not_exists + - name: variable_is_empty operator: equal_to - value: Perm - - name: define_variable_has_no_data - operator: empty - - any: - - name: variable_name - operator: not_exists - - name: variable_is_empty - operator: equal_to - value: 'Yes' + value: 'Yes' Core: Id: CDISC.SDTMIG.CG0015 Status: Draft Version: '1' -Description: Raise an error when a variable is permissible, data is collected - but variable has no data. +Description: Raise an error when a variable is permissible, data is collected but variable has no + data. Executability: Fully Executable Outcome: Message: 'Variable is permissible, data is collected but data is missing.' Output Variables: - - library_variable_name - - library_variable_core - - define_variable_name - - define_variable_has_no_data - - variable_name - - variable_is_empty + - library_variable_name + - library_variable_core + - define_variable_name + - define_variable_has_no_data + - variable_name + - variable_is_empty Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml index 574e2d1b0..992d7f32f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml @@ -2,98 +2,92 @@ # Condition: # Rule: Each record is unique per sponsor defined key variables as documented in the define.xml Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that the key variables shown in this table are examples - only. A sponsor's actual key structure may be different. - Document: IG v3.4 - Section: Table 3.2.1 - - Cited Guidance: Since the purpose of this column is to aid reviewers in - understanding the structure of a dataset, sponsors should list - all of the natural keys (see definition below) for the - dataset. These keys should define uniqueness for records - within a dataset, and may define a record sort order. The - identified keys for each dataset should be consistent with the - description of the dataset structure as described in the - Define-XML document. - Document: IG v3.4 - Section: 3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are - examples only. A sponsor's actual key structure may be - different.]|3.2.1.1[Since the purpose of this column is to aid - reviewers in understanding the structure of a dataset, - sponsors should list all of the natural keys (see definition - below) for the dataset. These keys should define uniqueness - for records within a dataset, and may define a record sort - order.] - Document: IG v3.2 - Section: Table 3.2.1|3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are - examples only. A sponsor's actual key structure may be - different.]||3.2.1.1[Since the purpose of this column is to - aid reviewers in understanding the structure of a dataset, - sponsors should list all of the natural keys (see definition - below) for the dataset. These keys should define uniqueness - for records within a dataset, and may define a record sort - order.] - Document: IG v3.3 - Section: Table 3.2.1|3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Note that the key variables shown in this table are examples only. A + sponsor's actual key structure may be different. + Document: IG v3.4 + Section: Table 3.2.1 + - Cited Guidance: Since the purpose of this column is to aid reviewers in understanding the + structure of a dataset, sponsors should list all of the natural keys (see definition + below) for the dataset. These keys should define uniqueness for records within a dataset, + and may define a record sort order. The identified keys for each dataset should be + consistent with the description of the dataset structure as described in the Define-XML + document. + Document: IG v3.4 + Section: 3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are examples + only. A sponsor's actual key structure may be different.]|3.2.1.1[Since the purpose of + this column is to aid reviewers in understanding the structure of a dataset, sponsors + should list all of the natural keys (see definition below) for the dataset. These keys + should define uniqueness for records within a dataset, and may define a record sort + order.] + Document: IG v3.2 + Section: Table 3.2.1|3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are examples + only. A sponsor's actual key structure may be different.]||3.2.1.1[Since the purpose of + this column is to aid reviewers in understanding the structure of a dataset, sponsors + should list all of the natural keys (see definition below) for the dataset. These keys + should define uniqueness for records within a dataset, and may define a record sort + order.] + Document: IG v3.3 + Section: Table 3.2.1|3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_dataset_key_sequence - operator: is_not_unique_set + - name: define_dataset_key_sequence + operator: is_not_unique_set # the operator can be changed to the opposite to make sure we get output #operator: is_unique_set Core: Id: CDISC.SDTMIG.CG0019 Status: Draft Version: '1' -Description: Trigger error if records are not unique as per sponsor defined key - variables as documented in the define.xml +Description: Trigger error if records are not unique as per sponsor defined key variables as + documented in the define.xml Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: SUPP-- +- Keys: + - USUBJID + Name: SUPP-- Outcome: - Message: Records are not unique as per sponsor defined key variables as - documented in the define.xml + Message: Records are not unique as per sponsor defined key variables as documented in the + define.xml Output Variables: - - define_dataset_key_sequence - - define_dataset_variable_order + - define_dataset_key_sequence + - define_dataset_variable_order Rule Type: Dataset Contents Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml index 36d5160ab..c23d1b255 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml @@ -2,88 +2,77 @@ # Condition: CMTRT has a decode value in the dictionary # Rule: CMDECOD ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by - the sponsor from the coding dictionary. It is expected that - the reported term (CMTRT) or the modified term (CMMODIFY) will - be coded using a standard dictionary - Document: IG v3.4 - Item: Assumption 2c - Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or - CMMODIFY. Equivalent to the generic medication name in WHO - Drug. The sponsor is expected to provide the dictionary name - and version used to map the terms utilizing the define.xml - external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be - left blank. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized - medication/therapy term derived by the sponsor from the coding - dictionary. It is expected that the reported term (CMTRT) or - the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.2[6.1][Specification][Standardized or - dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The - sponsor is expected to provide the dictionary name and version - used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a - decode value in the dictionary then CMDECOD will be left - blank.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized - medication/therapy term derived by the sponsor from the coding - dictionary. It is expected that the reported term (CMTRT) or - the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.3[6.1.2][Specification][Standardized or - dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The - sponsor is expected to provide the dictionary name and version - used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a - decode value in the dictionary then CMDECOD will be left - blank.] - Document: IG v3.3 - Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] - Section: IG v3.3[6.1.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by the sponsor + from the coding dictionary. It is expected that the reported term (CMTRT) or the modified + term (CMMODIFY) will be coded using a standard dictionary + Document: IG v3.4 + Item: Assumption 2c + Section: 6.1.2 + - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide + the dictionary name and version used to map the terms utilizing the define.xml external + codelist attributes. If an intervention term does not have a decode value in the + dictionary then CMDECOD will be left blank. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.3 + Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] + Section: IG v3.3[6.1.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: CMTRT - operator: non_empty - - name: CMDECOD - operator: empty + - name: CMTRT + operator: non_empty + - name: CMDECOD + operator: empty Core: Id: CDISC.SDTMIG.CG0096 Status: Draft @@ -93,17 +82,17 @@ Executability: Fully Executable Outcome: Message: CMDECOD must be populated when CMTRT is populated Output Variables: - - CMTRT - - CMDECOD + - CMTRT + - CMDECOD Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL #- INTERVENTIONS #- STUDY REFERENCE Domains: Include: - - CM - - WHODD + - CM + - WHODD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml index 71339e17d..76346de68 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml @@ -2,89 +2,78 @@ # Condition: CMTRT has a decode value in the dictionary # Rule: CMDECOD ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by - the sponsor from the coding dictionary. It is expected that - the reported term (CMTRT) or the modified term (CMMODIFY) will - be coded using a standard dictionary - Document: IG v3.4 - Item: Assumption 2c - Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or - CMMODIFY. Equivalent to the generic medication name in WHO - Drug. The sponsor is expected to provide the dictionary name - and version used to map the terms utilizing the define.xml - external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be - left blank. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized - medication/therapy term derived by the sponsor from the coding - dictionary. It is expected that the reported term (CMTRT) or - the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.2[6.1][Specification][Standardized or - dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The - sponsor is expected to provide the dictionary name and version - used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a - decode value in the dictionary then CMDECOD will be left - blank.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized - medication/therapy term derived by the sponsor from the coding - dictionary. It is expected that the reported term (CMTRT) or - the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.3[6.1.2][Specification][Standardized or - dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The - sponsor is expected to provide the dictionary name and version - used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a - decode value in the dictionary then CMDECOD will be left - blank.] - Document: IG v3.3 - Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] - Section: IG v3.3[6.1.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by the sponsor + from the coding dictionary. It is expected that the reported term (CMTRT) or the modified + term (CMMODIFY) will be coded using a standard dictionary + Document: IG v3.4 + Item: Assumption 2c + Section: 6.1.2 + - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide + the dictionary name and version used to map the terms utilizing the define.xml external + codelist attributes. If an intervention term does not have a decode value in the + dictionary then CMDECOD will be left blank. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.3 + Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] + Section: IG v3.3[6.1.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: CMTRT - operator: is_contained_by_case_insensitive - value: $DNames # $whodrug_refs_valid - - name: CMDECOD - operator: empty + - name: CMTRT + operator: is_contained_by_case_insensitive + value: $DNames # $whodrug_refs_valid + - name: CMDECOD + operator: empty Core: Id: CDISC.SDTMIG.CG0096b @@ -93,10 +82,10 @@ Core: Description: Raise an error when CMTRT is populated, CMDECOD is empty Executability: Fully Executable Operations: - - domain: WHODD #Custiom lookup - id: $DNames #$whodrug_refs_valid - name: DrugName - operator: distinct #valid_whodrug_references +- domain: WHODD #Custiom lookup + id: $DNames #$whodrug_refs_valid + name: DrugName + operator: distinct #valid_whodrug_references Outcome: Message: CMDECOD must be populated when CMTRT is populated @@ -107,12 +96,12 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL #- INTERVENTIONS #- STUDY REFERENCE Domains: Include: - - CM - - WHODD + - CM + - WHODD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml index b82083307..c548e14a7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml @@ -2,62 +2,59 @@ # Condition: # Rule: CMTRT = collected on CRF Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected - on a CRF. - Document: IG v3.4 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected - on a CRF. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected - on a CRF. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.4 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.2 + Item: Specification + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: variable_name - operator: equal_to - value: CMTRT + - name: variable_name + operator: equal_to + value: CMTRT # skipping cases when CMTRT is not provided (though this should never be the case) #- name: CMTRT # operator: non_empty # Generate an issue when CMTRT is not declared as "collected" in the define.xml - - name: define_variable_is_collected - operator: equal_to - value: false + - name: define_variable_is_collected + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0097 @@ -71,9 +68,9 @@ Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM + - CM # Sensitivity: Record # will generate an issue for each record. Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml index 38cd14f10..cf0bd2662 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml @@ -2,58 +2,58 @@ # Condition: # Rule: EXDOSU = protocol-specified unit Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing - protocol-specified values. - Document: IG v3.4 - Item: Specification - Section: 6.1.3.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing - protocol-specified values. - Document: IG v3.2 - Item: Specification - Section: '6.1' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing - protocol-specified values. - Document: IG v3.3 - Item: Specification - Section: 6.1.3.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.4 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.2 + Item: Specification + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.3 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: EXDOSU - operator: not_equal_to - value: TS.TSVAL - - name: TS.TSPARMCD - operator: starts_with - value: DOSU + - name: EXDOSU + operator: not_equal_to + value: TS.TSVAL + - name: TS.TSPARMCD + operator: starts_with + value: DOSU Core: Id: CDISC.SDTMIG.CG0103 Status: Draft @@ -66,8 +66,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Domain diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml index 7211cad60..0bc76f588 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml @@ -2,58 +2,58 @@ # Condition: # Rule: EXTRT = protocol-specified treatment Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given - during the dosing period for the observation. - Document: IG v3.4 - Item: Specification - Section: 6.1.3.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given - during the dosing period for the observation. - Document: IG v3.2 - Item: Specification - Section: '6.1' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given - during the dosing period for the observation. - Document: IG v3.3 - Item: Specification - Section: 6.1.3.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.4 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.2 + Item: Specification + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.3 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: EXTRT - operator: not_equal_to - value: TS.TSVAL - - name: TS.TSPARMCD - operator: starts_with - value: TRT + - name: EXTRT + operator: not_equal_to + value: TS.TSVAL + - name: TS.TSPARMCD + operator: starts_with + value: TRT Core: Id: CDISC.SDTMIG.CG0104 Status: Draft @@ -66,8 +66,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml index e9cd9c452..b436e85d9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml @@ -2,73 +2,69 @@ # Condition: AP Core Domain # Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to - identify the data as AP data to and distinguish them from - study subject data.][Associated Persons domain codes in the - DOMAIN column of every record are also given a prefix of AP-- - to identify the domains as AP domains and to distinguish them - from study subject domains. AP domain codes are therefore four - characters long.]' - Document: AP Guide v1.0 - Section: '2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0155 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to - identify the data as AP data to and distinguish them from - study subject data.][Associated Persons domain codes in the - DOMAIN column of every record are also given a prefix of AP-- - to identify the domains as AP domains and to distinguish them - from study subject domains. AP domain codes are therefore four - characters long.]' - Document: AP Guide v1.0 - Section: '2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0155 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data.][Associated Persons domain codes + in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains + as AP domains and to distinguish them from study subject domains. AP domain codes are therefore + four characters long.]' + Document: AP Guide v1.0 + Section: '2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0155 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data.][Associated Persons domain codes + in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains + as AP domains and to distinguish them from study subject domains. AP domain codes are therefore + four characters long.]' + Document: AP Guide v1.0 + Section: '2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0155 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: DOMAIN - operator: starts_with - value: AP - - name: DOMAIN - operator: not_matches_regex - value: "[A-Z]{4}$" + - name: DOMAIN + operator: starts_with + value: AP + - name: DOMAIN + operator: not_matches_regex + value: "[A-Z]{4}$" Core: Id: CDISC.SDTMIG.CG0155 Status: Draft Version: '1' -Description: Raise an error when DOMAIN value begins with AP and length of - domain variable is not 4 or DOMAIN value doesn't end with a valid SDTM domain. +Description: Raise an error when DOMAIN value begins with AP and length of domain variable is not 4 + or DOMAIN value doesn't end with a valid SDTM domain. Executability: Partially Executable - Possible Overreporting Outcome: Message: AP DOMAIN value should start with 'AP' and length should be equal to 4. Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - APRELSUB - - FA - - POOLDEF + - APRELSUB + - FA + - POOLDEF Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml index fb97ba216..63ea4376b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml @@ -2,56 +2,53 @@ # Condition: APID identifies group of associated persons defined in POOLDEF # Rule: APID in POOLDEF.POOLID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Identifier for a single associated person, a group - of associated persons, or a pool of associated persons. If APID - identifies a pool, POOLDEF records must exist for each associated - person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Identifier for a single associated person, a group - of associated persons, or a pool of associated persons. If APID - identifies a pool, POOLDEF records must exist for each associated - person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Identifier for a single associated person, a group - of associated persons, or a pool of associated persons. If APID - identifies a pool, POOLDEF records must exist for each associated - person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -66,8 +63,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - AP-- + - AP-- Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml index 41f5277b8..927edffb6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml @@ -2,55 +2,54 @@ # Condition: Relationship described is to a study subject # Rule: RSUBJID in DM.USUBJID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Relationship described is to a study subject.RSUBJID - is not in DM.USUBJID. - Document: APGuidev1.0 - Item: RSUBJID - Section: 2.1.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Relationship described is to a study subject.RSUBJID is not in DM.USUBJID. + Document: APGuidev1.0 + Item: RSUBJID + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: RSUBJID - operator: is_not_contained_by - value: $dm_rsubjid + - name: RSUBJID + operator: is_not_contained_by + value: $dm_rsubjid Core: Id: CDISC.SDTMIG.CG0157 Status: Draft @@ -58,22 +57,22 @@ Core: Description: Raise an error when RSUBJID in not in DM.USUBJID Executability: Fully Executable Operations: - - domain: DM - id: $dm_rsubjid - name: RSUBJID - operator: distinct +- domain: DM + id: $dm_rsubjid + name: RSUBJID + operator: distinct Outcome: Message: RSUBJID is not in DM.USUBJID. Output Variables: - - APDM.RSUBJID - - DM.USUBJID + - APDM.RSUBJID + - DM.USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - AP - - DM + - AP + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml index 5c133671c..d9e56d7f5 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml @@ -2,63 +2,63 @@ # Condition: Relationship described is to a pool # Rule: RSUBJID in POOLDEF.POOLID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RSUBJID - operator: is_not_contained_by - value: POOLDEF.POOLID + - name: + operator: + - name: RSUBJID + operator: is_not_contained_by + value: POOLDEF.POOLID Core: Id: CDISC.SDTMIG.CG0158 Status: Draft Version: '1' -Description: Trigger error if relationship described is to a pool and RSUBJID is not - in POOLDEF.POOLID +Description: Trigger error if relationship described is to a pool and RSUBJID is not in + POOLDEF.POOLID Executability: Fully Executable Outcome: Message: RSUBJID is not in POOLDEF.POOLID @@ -66,8 +66,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATE PERSONS + - ASSOCIATE PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml index 2f2a4493a..a12009b20 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml @@ -2,72 +2,72 @@ # Condition: Relationship described is to a study but not to individual study subjects # Rule: RSUBJID = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the - related subject or the POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RSUBJID - operator: non_empty + - name: + operator: + - name: RSUBJID + operator: non_empty Core: Id: CDISC.SDTMIG.CG0159 Status: Draft Version: '1' -Description: Trigger error if relationship described is to a study (but not to individual - study subject) and RSUBJID is not null +Description: Trigger error if relationship described is to a study (but not to individual study + subject) and RSUBJID is not null Executability: Fully Executable Outcome: - Message: Relationship described is to a study (but not to individua study subject) - and RSUBJID is not null + Message: Relationship described is to a study (but not to individua study subject) and RSUBJID is + not null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml index 3f2eda3b8..993699dca 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml @@ -2,87 +2,84 @@ # Condition: RSUBJID ^= null # Rule: Describes relationship of associated person to study subject or pool Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: RSUBJID - operator: non_empty - - name: SREL - operator: + - name: RSUBJID + operator: non_empty + - name: SREL + operator: Core: Id: CDISC.SDTMIG.CG0160 Status: Draft Version: '1' -Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship - of associated person to study subject or pool +Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship of + associated person to study subject or pool Executability: Fully Executable Outcome: - Message: SREL does not describe the relationship of associated person to study subject - or pool when RSUBJID is not null + Message: SREL does not describe the relationship of associated person to study subject or pool + when RSUBJID is not null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml index 7709aa969..3603abe80 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml @@ -2,87 +2,84 @@ # Condition: RDEVID ^= null # Rule: Describes relationship of associated person to device identified in RDEVID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship - of the associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to the - device identified in RDEVID. If RSUBJID and RDEVID are null, SREL - describes the relationship of the associated person(s) identified - in APID to the study identified in STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: RDEVID - operator: non_empty - - name: SREL - operator: + - name: RDEVID + operator: non_empty + - name: SREL + operator: Core: Id: CDISC.SDTMIG.CG0161 Status: Draft Version: '1' -Description: Trigger error when RDEVID ^= null and SREL does not describe relationship - of associated person to device identified in RDEVID +Description: Trigger error when RDEVID ^= null and SREL does not describe relationship of associated + person to device identified in RDEVID Executability: Fully Executable Outcome: - Message: SREL does not describe relationship of associated person to device identified - in RDEVID when RDEVID ^= null + Message: SREL does not describe relationship of associated person to device identified in RDEVID + when RDEVID ^= null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml index 9bdee06e6..1be0b4299 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml @@ -2,86 +2,79 @@ # Condition: RSUBJID = null and RDEVID = null # Rule: Describes relationship of associated person to study identified in STUDYID Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the - associated person(s) identified in APID to the subject or pool - identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are - null, SREL describes the relationship of the associated - person(s) identified in APID to the study identified in - STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the - associated person(s) identified in APID to the subject or - pool identified in RSUBJID. If RDEVID is populated, describes - the relationship of the associated person(s) identified in - APID to the device identified in RDEVID. If RSUBJID and - RDEVID are null, SREL describes the relationship of the - associated person(s) identified in APID to the study - identified in STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the - associated person(s) identified in APID to the subject or pool - identified in RSUBJID. If RDEVID is populated, describes the - relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are - null, SREL describes the relationship of the associated - person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: '1' + Version: '2.0' + Version: '3.3' Check: Core: Id: CDISC.SDTMIG.CG0162 Status: Draft Version: '1' -Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does - not describe the relationship of associated person to study identified in - STUDYID +Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the + relationship of associated person to study identified in STUDYID Executability: Not Executable Outcome: - Message: SREL does not describe the relationship of associated person to study - identified in STUDYID when RSUBJID = null and RDEVID = null + Message: SREL does not describe the relationship of associated person to study identified in + STUDYID when RSUBJID = null and RDEVID = null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml index 10f2e4f00..a4073e506 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml @@ -2,69 +2,63 @@ # Condition: # Rule: Comments are unsolicited, free-text and voluntary Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The Comments special-purpose domain provides a solution - for submitting free-text comments related to data in one or more - SDTM domains (as described in Section 8.5, Relating Comments to - a Parent Domain) or collected on a separate CRF page dedicated to - comments. Comments are generally not responses to specific questions; - instead, comments usually consist of voluntary, free-text or unsolicited - observations. - Document: IG v3.4 - Item: Assumption 1 - Section: '5.1' - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'The Comments special-purpose domain provides a solution - for submitting free-text comments related to data in one or more - SDTM domains (as described in Section 8: 8.5, Relating Comments - To A Parent Domain) or collected on a separate CRF page dedicated - to comments. Comments are generally not responses to specific questions; - instead, comments usually consist of voluntary, free-text or unsolicited - observations.' - Document: IG v3.2 - Item: Specification - Section: '5' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'The Comments special-purpose domain provides a solution - for submitting free-text comments related to data in one or more - SDTM domains (as described in Section 8: 8.5, Relating Comments - To A Parent Domain) or collected on a separate CRF page dedicated - to comments. Comments are generally not responses to specific questions; - instead, comments usually consist of voluntary, free-text or unsolicited - observations.' - Document: IG v3.3 - Item: Specification - Section: '5.1' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Comments special-purpose domain provides a solution for submitting + free-text comments related to data in one or more SDTM domains (as described in Section + 8.5, Relating Comments to a Parent Domain) or collected on a separate CRF page dedicated + to comments. Comments are generally not responses to specific questions; instead, comments + usually consist of voluntary, free-text or unsolicited observations. + Document: IG v3.4 + Item: Assumption 1 + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The Comments special-purpose domain provides a solution for submitting free-text + comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating + Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments + are generally not responses to specific questions; instead, comments usually consist of voluntary, + free-text or unsolicited observations.' + Document: IG v3.2 + Item: Specification + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The Comments special-purpose domain provides a solution for submitting free-text + comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating + Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments + are generally not responses to specific questions; instead, comments usually consist of voluntary, + free-text or unsolicited observations.' + Document: IG v3.3 + Item: Specification + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0167 Status: Draft @@ -77,8 +71,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml index 028b53e16..a63564e94 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml @@ -2,68 +2,65 @@ # Condition: No comment > 200 characters # Rule: COVALn not present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, - the first 200 characters of the comment will be in COVAL, the next - 200 in COVAL1, and additional text stored as needed to COVALn. See - example, Rows 3-4. ' - Document: IG v3.4 - Item: Assumption 3 - Section: '5.1' - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: When the comment text is longer than 200 characters, - the first 200 characters of the comment will be in COVAL, the next - 200 in COVAL1, and additional text stored as needed to COVALn. See - example, Rows 3-4. - Document: IG v3.2 - Item: Assumption 3 - Section: '5' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: When the comment text is longer than 200 characters, - the first 200 characters of the comment will be in COVAL, the next - 200 in COVAL1, and additional text stored as needed to COVALn. See - example, Rows 3-4. - Document: IG v3.3 - Item: Assumption 3 - Section: '5.1' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn. See example, Rows 3-4. ' + Document: IG v3.4 + Item: Assumption 3 + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the comment text is longer than 200 characters, the first 200 + characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text + stored as needed to COVALn. See example, Rows 3-4. + Document: IG v3.2 + Item: Assumption 3 + Section: '5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the comment text is longer than 200 characters, the first 200 + characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text + stored as needed to COVALn. See example, Rows 3-4. + Document: IG v3.3 + Item: Assumption 3 + Section: '5.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: COVAL1 - operator: exists - - name: COVAL1 - operator: empty + - name: COVAL1 + operator: exists + - name: COVAL1 + operator: empty Core: Id: CDISC.SDTMIG.CG0169 Status: Draft Version: '1' -Description: Trigger error when there are no comments greater than 200 characters - and COVALn is present +Description: Trigger error when there are no comments greater than 200 characters and COVALn is + present Executability: Fully Executable Outcome: Message: COVALn is present in dataset when no comments are greater than 200 characters @@ -71,8 +68,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml index c875ae76e..06804e91a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml @@ -2,85 +2,81 @@ # Condition: Collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the Findings About domain # Rule: The name of the variable is used as the value of FATESTCD. Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: - Sections 3.1.1, 3.1.2, or 3.1.3, and are represented in the - Findings About domain, then the name of the variable should be - used as the value of FATESTCD.' - Document: IG v3.4 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: - Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the - Findings About domain, then the name of the variable should be - used as the value of FATESTCD.' - Document: IG v3.2 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: - Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the - Findings About domain, then the name of the variable should be - used as the value of FATESTCD.' - Document: IG v3.3 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 3.1.1, + 3.1.2, or 3.1.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD.' + Document: IG v3.4 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, + 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD.' + Document: IG v3.2 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, + 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD.' + Document: IG v3.3 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: $label_referenced_variable_role - operator: is_contained_by - value: "Qualifier" - - name: FATESTCD - operator: is_contained_by - value: $label_referenced_variable_name + - name: $label_referenced_variable_role + operator: is_contained_by + value: "Qualifier" + - name: FATESTCD + operator: is_contained_by + value: $label_referenced_variable_name Core: Id: CDISC.SDTMIG.CG0173 Status: Draft Version: '1' -Description: Trigger error when collected data fits a Qualifier variable listed - in specified SDTM Sections and are represented in the Findings About domain, - and the name of the variable is used as FATESTCD +Description: Trigger error when collected data fits a Qualifier variable listed in specified SDTM + Sections and are represented in the Findings About domain, and the name of the variable is used as + FATESTCD Executability: Partially Executable - Possible Underreporting Operations: - - id: $label_referenced_variable_name - name: FATESTCD - operator: label_referenced_variable_metadata +- id: $label_referenced_variable_name + name: FATESTCD + operator: label_referenced_variable_metadata Outcome: - Message: Collected data fits a Qualifier variable listed in specified SDTM - Sections and are represented in the Findings About domain, and the name of - the variable is used as FATESTCD + Message: Collected data fits a Qualifier variable listed in specified SDTM Sections and are + represented in the Findings About domain, and the name of the variable is used as FATESTCD Output Variables: - - $label_referenced_variable_name + - $label_referenced_variable_name Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml index 4e5be2aa1..175be863b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml @@ -2,64 +2,62 @@ # Condition: LBORRES = continuous measurement # Rule: LBSTNRC = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - For normal range values that are character in ordinal scale or - if categorical ranges were supplied (e.g., "-1 to +1", - "NEGATIVE TO TRACE"). - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For normal range values that are character in ordinal scale or - if categorical ranges were supplied (e.g., "-1 to +1", - "NEGATIVE TO TRACE"). - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For normal range values that are character in ordinal scale or - if categorical ranges were supplied (e.g., "-1 to +1", - "NEGATIVE TO TRACE"). - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + For normal range values that are character in ordinal scale or + if categorical ranges were supplied (e.g., "-1 to +1", + "NEGATIVE TO TRACE"). + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For normal range values that are character in ordinal scale or if + categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For normal range values that are character in ordinal scale or if + categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: '1' + Version: '2.0' + Version: '3.3' Check: # Changed by Marcelina Hungria on 2025-07-22 # Fixed the regex per Description. # Changed to Fully Executable. See Jira ticket: CORERULES-160 (CG0184) all: - - name: LBORRES - operator: matches_regex - value: -?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRC - operator: non_empty + - name: LBORRES + operator: matches_regex + value: -?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRC + operator: non_empty Core: Id: CDISC.SDTMIG.CG0184 Status: Draft @@ -72,8 +70,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml index 9c8040033..d174409ae 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml @@ -2,54 +2,51 @@ # Condition: # Rule: LBORNRLO is expressed using the units in LBORRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Lower end of reference range for continuous measurement - in original units. - Document: SDTMIG v3.4 - Section: 6.3.5.6 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements - in original units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements - in original units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurement in original units. + Document: SDTMIG v3.4 + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: LBORNRLO - operator: equal_to - value: LBORRESU + - name: LBORNRLO + operator: equal_to + value: LBORRESU Core: Id: CDISC.SDTMIG.CG0186 Status: Draft @@ -62,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml index 2a411cb75..80395ba46 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml @@ -2,50 +2,47 @@ # Condition: # Rule: LBORNRHI is expressed using the units in LBORRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements - in original units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements - in original units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement - in original units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: '2' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurement in original units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: '2' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -60,8 +57,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml index 8b30c896f..899b8fcf6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml @@ -2,60 +2,60 @@ # Condition: # Rule: LBSTNRLO is expressed using the units in LBSTRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: LBSTRESU - operator: non_empty - - name: LBORRESU - operator: equal_to - value: LBSTRESU - - name: LBORNRLO - operator: not_equal_to - value: LBSTNRLO + - name: LBSTRESU + operator: non_empty + - name: LBORRESU + operator: equal_to + value: LBSTRESU + - name: LBORNRLO + operator: not_equal_to + value: LBSTNRLO Core: Id: CDISC.SDTMIG.CG0188 Status: Draft @@ -68,8 +68,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml index a9de80441..c0ea94066 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml @@ -2,60 +2,60 @@ # Condition: # Rule: LBSTNRHI is expressed using the units in LBSTRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements - in standardized units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements - in standardized units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements - in standardized units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: LBSTRESU - operator: non_empty - - name: LBORRESU - operator: equal_to - value: LBSTRESU - - name: LBORNRHI - operator: not_equal_to - value: LBSTNRHI + - name: LBSTRESU + operator: non_empty + - name: LBORRESU + operator: equal_to + value: LBSTRESU + - name: LBORNRHI + operator: not_equal_to + value: LBSTNRHI Core: Id: CDISC.SDTMIG.CG0189 Status: Draft @@ -68,8 +68,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml index 404a740cf..a7ee5542b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml @@ -2,60 +2,60 @@ # Condition: LBSTRESU ^= null # Rule: LBSTNRC is expressed using the units in LBSTRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.2 - Item: Specification - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.3 - Item: Specification - Section: 6.3.6 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.2 + Item: Specification + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: LBSTRESU - operator: non_empty - - name: - operator: - value: + - name: LBSTRESU + operator: non_empty + - name: + operator: + value: Core: Id: CDISC.SDTMIG.CG0190 Status: Draft Version: '1' -Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using - the units in LBSTRESU +Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in + LBSTRESU Executability: Fully Executable Outcome: Message: LBSTNRC is not expressed using the units in LBSTRESU when LBSTRESU is populated. @@ -63,8 +63,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml index 73bb6ee9d..e468fb27c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml @@ -2,22 +2,21 @@ # Condition: Organisms present in the specimen # Rule: MBTESTCD = 'ORGANISM' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0192 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen - is 'ORGANISM'. - Document: IG v3.2 - Item: Assumption 3 - Section: '6.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen is 'ORGANISM'. + Document: IG v3.2 + Item: Assumption 3 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0192 + Version: '1' + Version: '2.0' + Version: '3.2' Check: all: [] Core: @@ -32,8 +31,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml index 69415d911..d35283eb6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml @@ -2,50 +2,48 @@ # Condition: PEORRES ^= null and no abnormal findings # Rule: PEORRES = 'NORMAL' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Text description of any abnormal findings. If the - examination was completed and there were no abnormal findings, the - value should be NORMAL. - Document: IG v3.2 - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Text description of any abnormal findings. If the - examination was completed and there were no abnormal findings, the - value should be NORMAL. - Document: IG v3.3 - Section: 6.3.12 - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the examination was completed and there were no - abnormal findings, the value should be "NORMAL". - Document: IG v3.4 - Item: Specification - Section: 6.3.8 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text description of any abnormal findings. If the examination was completed + and there were no abnormal findings, the value should be NORMAL. + Document: IG v3.2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text description of any abnormal findings. If the examination was completed + and there were no abnormal findings, the value should be NORMAL. + Document: IG v3.3 + Section: 6.3.12 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the examination was completed and there were no abnormal findings, the + value should be "NORMAL". + Document: IG v3.4 + Item: Specification + Section: 6.3.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -60,8 +58,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PE + - PE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml index 590dd1781..1021ea678 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml @@ -2,79 +2,79 @@ # Condition: PESTRESC ^= null # Rule: PESTRESC = PEORRES OR a dictionary coded preferred term Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If there are findings for a body system, then either - the dictionary preferred term (if findings are coded using a dictionary) - or PEORRES (if findings are not encoded) should appear here. - Document: IG v3.4 - Item: Specification - Section: 6.3.8 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If there are findings for a body system, then either - the dictionary preferred term (if findings are coded using a dictionary) - or PEORRES (if findings are not coded) should appear here. - Document: IG v3.2 - Section: '6.3' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If there are findings for a body system, then either - the dictionary preferred term (if findings are coded using a dictionary) - or PEORRES (if findings are not coded) should appear here. - Document: IG v3.3 - Section: 6.3.12 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + encoded) should appear here. + Document: IG v3.4 + Item: Specification + Section: 6.3.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + coded) should appear here. + Document: IG v3.2 + Section: '6.3' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + coded) should appear here. + Document: IG v3.3 + Section: 6.3.12 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: + - name: PESTRESC + operator: non_empty + - any: - name: PESTRESC - operator: non_empty - - any: - - name: PESTRESC - operator: equal_to - value: PEORRES - - name: PESTRES - operator: is_contained_by - value: + operator: equal_to + value: PEORRES + - name: PESTRES + operator: is_contained_by + value: Core: Id: CDISC.SDTMIG.CG0197 Status: Draft Version: '1' -Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES - OR a dictionary coded preferred term +Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary + coded preferred term Executability: Fully Executable Outcome: Message: PESTRESC does not equal PEORRES OR a dictionary coded preferred term Output Variables: - - PESTRESC + - PESTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PE + - PE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml index 401d9df36..9a0c462cc 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml @@ -2,65 +2,61 @@ # Condition: # Rule: Relationships represented in RELREC are collected relationships Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Relationships represented in RELREC are collected - relationships, either by explicit references or check boxes on the - CRF, or by design of the CRF, such as vital signs captured during - an exercise stress test. - Document: IG v3.4 - Section: '8.2' - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Relationships represented in RELREC are collected - relationships, either by explicit references or check boxes on the - CRF, or by design of the CRF, such as vital signs captured during - an exercise stress test. - Document: IG v3.2 - Section: '8.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Relationships represented in RELREC are collected - relationships, either by explicit references or check boxes on the - CRF, or by design of the CRF, such as vital signs captured during - an exercise stress test. - Document: IG v3.3 - Section: '8.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.4 + Section: '8.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.2 + Section: '8.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.3 + Section: '8.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0198 Status: Draft Version: '1' -Description: Trigger error when relationship represented in RELREC is not a collected - relationship +Description: Trigger error when relationship represented in RELREC is not a collected relationship Executability: Fully Executable Outcome: Message: Relationship represented in RELREC is not a collected relationship @@ -68,8 +64,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - RELREC + - RELREC Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml index 510ed00fe..c4f4b404c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml @@ -2,82 +2,79 @@ # Condition: # Rule: --DTC is date/time of specimen collection or observation, not date/time of recording/acquisition Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data was recorded. - in order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.4 - Section: 4.4.8 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data was recorded. - in order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.2 - Section: 4.1.4.8 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data were recorded. - In order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.3 - Section: 4.4.8 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.2 + Section: 4.1.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data were + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.3 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0236 Status: Draft Version: '1' -Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time - of specimen collection or observation +Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time of + specimen collection or observation Executability: Fully Executable Outcome: - Message: --DTC is date/time of recording/acquisition, not date/time of specimen - collection or observation + Message: --DTC is date/time of recording/acquisition, not date/time of specimen collection or + observation Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml index 1343a4af2..be3c1cb11 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml @@ -2,85 +2,82 @@ # Condition: --DTC present in dataset # Rule: --DTC is date/time of recording/data acquisition Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data was recorded. - in order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.4 - Section: 4.4.8 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data was recorded. - in order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.2 - Section: 4.1.4.8 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For any domain based on the Findings general observation - class, such as lab tests which are based on a specimen, the collection - date is likely to be tied to when the specimen or source of the - finding was captured, not necessarily when the data were recorded. - In order to ensure that the critical timing information is always - represented in the same variable, the --DTC variable is used to - represent the time of specimen collection. - Document: IG v3.3 - Section: 4.4.8 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.2 + Section: 4.1.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data were + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.3 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --DTC - operator: exists - - name: - operator: + - name: --DTC + operator: exists + - name: + operator: Core: Id: CDISC.SDTMIG.CG0237 Status: Draft Version: '1' -Description: Trigger error when --DTC is present and not populated with the date/time - of recording/data acquisition +Description: Trigger error when --DTC is present and not populated with the date/time of + recording/data acquisition Executability: Fully Executable Outcome: - Message: --DTC is present in dataset and is not populated with the date/time of - recording/data acquisition + Message: --DTC is present in dataset and is not populated with the date/time of recording/data + acquisition Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml index c06ab2bca..d12d203ff 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml @@ -1,126 +1,89 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"Dates are generally used only as timing variables, ... but - there may be occasions when it may be preferable\ - - \ to model a date as a result (--ORRES) in a - Findings dataset. ... this situation may occasionally occur - when\ - - \ a) a group of questions (each of which has - a date response) is asked and analyzed together; or b) the - Event(s)\ - - \ and Intervention(s) in question are not - medically significant (often the case when included in - questionnaires).\ - - \ Consider the following cases - Calculated - due date, Date of last day on the job, Date of high school - graduation.\ - - \ One approach to modeling these data would - be to place the text of the question in --TEST and the - response to the\ - - \ question, a date represented in ISO 8601 - format, in --ORRES and --STRESC as long as these date results - do not\ - - \ contain the dates of medically significant - events or interventions. Again, use extreme caution when - storing dates\ - - \ as the results of Findings. Remember, in - most cases, these dates should be timing variables associated - with a\ - - \ record in an Intervention or Events - dataset.\"" - Document: IG v3.4 - Section: 4.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dates are generally used only as timing variables, ... but - there may be occasions when it may be preferable to model a - date as a result (--ORRES) in a Findings dataset. ... this - situation may occasionally occur when a) a group of questions - (each of which has a date response) is asked and analyzed - together; or b) the Event(s) and Intervention(s) in question - are not medically significant (often the case when included in - questionnaires). Consider the following cases: Calculated due - date; Date of last day on the job; Date of high school - graduation. One approach to modeling these data would be to - place the text of the question in --TEST and the response to - the question, a date represented in ISO 8601 format, in - --ORRES and --STRESC as long as these date results do not - contain the dates of medically significant events or - interventions. Again, use extreme caution when storing dates - as the results of Findings. Remember, in most cases, these - dates should be timing variables associated with a record in - an Intervention or Events dataset.' - Document: IG v3.2 - Section: 4.1.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dates are generally used only as timing variables, ... but - there may be occasions when it may be preferable to model a - date as a result (--ORRES) in a Findings dataset. ... this - situation may occasionally occur when a) a group of questions - (each of which has a date response) is asked and analyzed - together; or b) the Event(s) and Intervention(s) in question - are not medically significant (often the case when included in - questionnaires). Consider the following cases: Calculated due - date, Date of last day on the job, Date of high school - graduation. One approach to modeling these data would be to - place the text of the question in --TEST and the response to - the question, a date represented in ISO 8601 format, in - --ORRES and --STRESC as long as these date results do not - contain the dates of medically significant events or - interventions. Again, use extreme caution when storing dates - as the results of Findings. Remember, in most cases, these - dates should be timing variables associated with a record in - an Intervention or Events dataset.' - Document: IG v3.3 - Section: 4.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "\"Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable \n to model a date as a result (--ORRES) in a Findings dataset. ... + this situation may occasionally occur when \n a) a group of questions (each of which has a date + response) is asked and analyzed together; or b) the Event(s) \n and Intervention(s) in question + are not medically significant (often the case when included in questionnaires). \n Consider + the following cases - Calculated due date, Date of last day on the job, Date of high school + graduation. \n One approach to modeling these data would be to place the text of the question + in --TEST and the response to the \n question, a date represented in ISO 8601 format, in --ORRES + and --STRESC as long as these date results do not \n contain the dates of medically significant + events or interventions. Again, use extreme caution when storing dates \n as the results of + Findings. Remember, in most cases, these dates should be timing variables associated with a\ + \ \n record in an Intervention or Events dataset.\"" + Document: IG v3.4 + Section: 4.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this + situation may occasionally occur when a) a group of questions (each of which has a date response) + is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically + significant (often the case when included in questionnaires). Consider the following cases: + Calculated due date; Date of last day on the job; Date of high school graduation. One approach + to modeling these data would be to place the text of the question in --TEST and the response + to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these + date results do not contain the dates of medically significant events or interventions. Again, + use extreme caution when storing dates as the results of Findings. Remember, in most cases, + these dates should be timing variables associated with a record in an Intervention or Events + dataset.' + Document: IG v3.2 + Section: 4.1.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this + situation may occasionally occur when a) a group of questions (each of which has a date response) + is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically + significant (often the case when included in questionnaires). Consider the following cases: + Calculated due date, Date of last day on the job, Date of high school graduation. One approach + to modeling these data would be to place the text of the question in --TEST and the response + to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these + date results do not contain the dates of medically significant events or interventions. Again, + use extreme caution when storing dates as the results of Findings. Remember, in most cases, + these dates should be timing variables associated with a record in an Intervention or Events + dataset.' + Document: IG v3.3 + Section: 4.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: '1' + Version: '2.0' + Version: '3.3' # Variable: --ORRES # Condition: Date Value # Rule: --ORRES in ISO 8601 date format Check: all: - - any: - - name: --TEST - operator: contains_case_insensitive - value: date - - name: --TEST - operator: contains_case_insensitive - value: time - - name: --ORRES - operator: invalid_date + - any: + - name: --TEST + operator: contains_case_insensitive + value: date + - name: --TEST + operator: contains_case_insensitive + value: time + - name: --ORRES + operator: invalid_date Core: Id: CDISC.SDTMIG.CG0238 Status: Draft @@ -134,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml index f72d609c8..8cd031b19 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml @@ -2,72 +2,72 @@ # Condition: Element does not end with a decision that could lead to a shortened path within the Arm # Rule: TATRANS = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If an Element does not end with a decision that could - lead to a shortened path within the Arm, then TATRANS will be blank. - Document: IG v3.4 - Item: Assumption 7 - Section: 7.2.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If an Element does not end with a decision that could - lead to a shortened path within the Arm, then TATRANS will be blank. - Document: IG v3.2 - Item: Assumption 7 - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If an Element does not end with a decision that could - lead to a shortened path within the Arm, then TATRANS will be blank. - Document: IG v3.3 - Item: Assumption 7 - Section: 7.2.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.4 + Item: Assumption 7 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.2 + Item: Assumption 7 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.3 + Item: Assumption 7 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: TATRANS - operator: non_empty + - name: + operator: + - name: TATRANS + operator: non_empty Core: Id: CDISC.SDTMIG.CG0249 Status: Draft Version: '1' -Description: Trigger error when element does not end with a decision that could lead - to a shortened path within the Arm and TATRANS is not null +Description: Trigger error when element does not end with a decision that could lead to a shortened + path within the Arm and TATRANS is not null Executability: Fully Executable Outcome: - Message: TATRANS is populated when the element does not end with a decision that - could lead to a shortened path within the Arm + Message: TATRANS is populated when the element does not end with a decision that could lead to a + shortened path within the Arm Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml index bac069b87..37923e421 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml @@ -2,61 +2,58 @@ # Condition: # Rule: Each value of EPOCH is not associated with more than one conceptual trial period Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'EPOCH may be used as a timing variable in other datasets, - such as EX and DS, and values of EPOCH must be different for different - epochs. ' - Document: IG v3.4 - Item: Assumption 12 - Section: 7.2.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: '... values of EPOCH must be different for different - epochs.' - Document: IG v3.2 - Item: Assumption 11 - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: '... values of EPOCH must be different for different - epochs.' - Document: IG v3.3 - Item: Assumption 12 - Section: 7.2.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'EPOCH may be used as a timing variable in other datasets, such as EX and DS, + and values of EPOCH must be different for different epochs. ' + Document: IG v3.4 + Item: Assumption 12 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '... values of EPOCH must be different for different epochs.' + Document: IG v3.2 + Item: Assumption 11 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '... values of EPOCH must be different for different epochs.' + Document: IG v3.3 + Item: Assumption 12 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0250 Status: Draft Version: '1' -Description: Trigger error when at least one EPOCH is associated with more than one - conceptual trial period +Description: Trigger error when at least one EPOCH is associated with more than one conceptual trial + period Executability: Fully Executable Outcome: Message: At least one EPOCH is associated with more than one conceptual trial period @@ -64,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml index 84b8d30b7..0cdc28669 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml @@ -2,56 +2,56 @@ # Condition: Trial design branches # Rule: TABRANCH ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision - point in the trial design for subjects in the Arm. - Document: IG v3.4 - Item: Assumption 3 - Section: 7.2.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision - point in the trial design for subjects in the Arm - Document: IG v3.2 - Item: Assumption 3 - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision - point in the trial design for subjects in the Arm - Document: IG v3.3 - Item: Assumption 3 - Section: 7.2.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm. + Document: IG v3.4 + Item: Assumption 3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm + Document: IG v3.2 + Item: Assumption 3 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm + Document: IG v3.3 + Item: Assumption 3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: TABRANCH - operator: empty + - name: + operator: + - name: TABRANCH + operator: empty Core: Id: CDISC.SDTMIG.CG0251 Status: Draft @@ -64,8 +64,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml index c018b73c7..b8c7095bf 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml @@ -2,77 +2,74 @@ # Condition: Trial Design allows for a Subject to transition to an Element other than the next Element in sequence # Rule: TATRANS ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element - other than the next Element in sequence, then the conditions - for transitioning to those other Elements, and the alternative - Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element - other than the next Element in sequence, then the conditions - for transitioning to those other Elements, and the alternative - Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element - other than the next Element in sequence, then the conditions - for transitioning to those other Elements, and the alternative - Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.3 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.2 + Item: Specification + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.3 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: Core: Id: CDISC.SDTMIG.CG0252 Status: Draft Version: '1' -Description: Trigger error when trial Design allows for a Subject to transition - to an Element other than the next Element in sequence, and TATRANS is null +Description: Trigger error when trial Design allows for a Subject to transition to an Element other + than the next Element in sequence, and TATRANS is null Executability: Not Executable Outcome: - Message: TATRANS is null when trial Design allows for a Subject to transition to - an Element other than the next Element in sequence + Message: TATRANS is null when trial Design allows for a Subject to transition to an Element other + than the next Element in sequence Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml index c27662092..1a02113b0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml @@ -2,53 +2,53 @@ # Condition: Greater than one version of the IE criteria in study documentation # Rule: TIVERS ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, - then each complete set of criteria must be included in the TI - domain. TIVERS is used to distinguish between the versions. - Document: IG v3.4 - Item: Assumption 1 - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, - then each complete set of criteria must be included in the TI - domain. TIVERS is used to distinguish between the versions. - Document: IG v3.2 - Item: Assumption 1 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, - then each complete set of criteria must be included in the TI - domain. TIVERS is used to distinguish between the versions. - Document: IG v3.3 - Item: Assumption 1 - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.4 + Item: Assumption 1 + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.2 + Item: Assumption 1 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.3 + Item: Assumption 1 + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: @@ -57,18 +57,18 @@ Core: Id: CDISC.SDTMIG.CG0253 Status: Draft Version: '1' -Description: Trigger error when TIVERS is null and there is more than one - version of the IE criteria in study documentation +Description: Trigger error when TIVERS is null and there is more than one version of the IE criteria + in study documentation Executability: Not Executable Outcome: - Message: TIVERS is null when there is more than one version of the IE criteria - in study documentation + Message: TIVERS is null when there is more than one version of the IE criteria in study + documentation Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml index 945747b3b..bf0740435 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml @@ -2,72 +2,71 @@ # Condition: Greater than one version of the IE criteria # Rule: TIVERS present in dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion - criteria. May be omitted if there is only one version. - Document: IG v3.4 - Item: Specification - Section: 7.4.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion - criteria. May be omitted if there is only one version. - Document: IG v3.2 - Item: Specification - Section: '7.4' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion - criteria. May be omitted if there is only one version. - Document: IG v3.3 - Item: Specification - Section: 7.4.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.4 + Item: Specification + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.3 + Item: Specification + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: TIVERS - operator: exists + - name: + operator: + - name: TIVERS + operator: exists Core: Id: CDISC.SDTMIG.CG0254 Status: Draft Version: '1' -Description: Trigger error when TIVERS is not present in the data and there is more - than one version of the IE criteria +Description: Trigger error when TIVERS is not present in the data and there is more than one version + of the IE criteria Executability: Fully Executable Outcome: - Message: TIVERS is not present in the data when there is more than one version of - the IE criteria + Message: TIVERS is not present in the data when there is more than one version of the IE criteria Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml index ef442f0bb..1884859bb 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml @@ -2,47 +2,47 @@ # Condition: Reference Terminology is versioned. # Rule: TSVCDVER ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.2 + Item: Specification + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: Core: @@ -57,8 +57,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml index f05e9bbf5..ea77af0b3 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml @@ -2,72 +2,72 @@ # Condition: The timing and number of Visits for a trial does not depend on which ARM a subject is in # Rule: ARMCD = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which ARM a subject is in, then ARMCD should be null. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which ARM a subject is in, then ARMCD should be null. - Document: IG v3.2 - Item: Specification - Section: '7' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which ARM a subject is in, then ARMCD should be null. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: ARMCD - operator: non_empty + - name: + operator: + - name: ARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0295 Status: Draft Version: '1' -Description: Trigger error when ARMCD is populated and the timing and number of Visits - for a trial does not depend on which ARM a subject is in +Description: Trigger error when ARMCD is populated and the timing and number of Visits for a trial + does not depend on which ARM a subject is in Executability: Fully Executable Outcome: - Message: ARMCD is populated and the timing and number of Visits for a trial does - not depend on which ARM a subject is in + Message: ARMCD is populated and the timing and number of Visits for a trial does not depend on + which ARM a subject is in Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml index 3301657c2..c69501466 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml @@ -2,62 +2,62 @@ # Condition: The timing and number of Visits for a trial does not depend on which ARM a subject is in # Rule: ARM = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.2 - Item: Specification - Section: '7' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend - on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: ARM - operator: non_empty + - name: + operator: + - name: ARM + operator: non_empty Core: Id: CDISC.SDTMIG.CG0296 Status: Draft Version: '1' -Description: Trigger error when ARM is populated and the timing and number of Visits - for a trial does not depend on which ARM a subject is in +Description: Trigger error when ARM is populated and the timing and number of Visits for a trial + does not depend on which ARM a subject is in Executability: Fully Executable Outcome: Message: '' @@ -65,8 +65,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml index dddaef268..04c4db4b0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml @@ -2,51 +2,51 @@ # Condition: # Rule: VISIT is described in protocol Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.2 - Item: Specification - Section: '7' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.2 + Item: Specification + Section: '7' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0298 Status: Draft @@ -59,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml index cf1c6b202..f300b38aa 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml @@ -2,177 +2,176 @@ # Condition: Custom domain present in study # Rule: DOMAIN not in reserved or modeled standard Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "'A custom domain may only be created if the data are different - in nature and do not fit into an existing published domain.'" - Document: IG v3.4 - Item: NA - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following standard domains, listed in alphabetical order by - Domain Code, with their respective domain codes have been - defined or referenced by the CDISC SDS Team in this document. - Note that other domain models may be posted separately for - comment after this publication. See list in 2.5 - Document: IG v3.2 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A custom domain may only be created if the data are different in - nature and do not fit into an existing published domain. - Document: IG v3.3 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "'A custom domain may only be created if the data are different in nature and + do not fit into an existing published domain.'" + Document: IG v3.4 + Item: NA + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The following standard domains, listed in alphabetical order by Domain Code, + with their respective domain codes have been defined or referenced by the CDISC SDS Team + in this document. Note that other domain models may be posted separately for comment after + this publication. See list in 2.5 + Document: IG v3.2 + Section: '2.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A custom domain may only be created if the data are different in nature and + do not fit into an existing published domain. + Document: IG v3.3 + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: '1' + Version: '2.0' + Version: '3.3' Check: any: + - all: + - name: define_dataset_class + operator: equal_to + value: TRIAL DESIGN + - name: define_dataset_name + operator: is_contained_by + value: + - TA + - TD + - TE + - TI + - TM + - TS + - TV + - all: + - name: define_dataset_class + operator: equal_to + value: SPECIAL PURPOSE + - name: define_dataset_name + operator: is_contained_by + value: + - CO + - DM + - SE + - SM + - SV + - all: + - name: define_dataset_class + operator: equal_to + value: INTERVENTIONS + - name: define_dataset_name + operator: is_contained_by + value: + - AG + - CM + - EC + - EX + - ML + - PR + - SU + - all: + - name: define_dataset_class + operator: equal_to + value: EVENTS + - name: define_dataset_name + operator: is_contained_by + value: + - AE + - BE + - CE + - DS + - DV + - HO + - MH + - all: + - name: define_dataset_class + operator: equal_to + value: FINDINGS + - name: define_dataset_name + operator: is_contained_by + value: + - BS + - CP + - CV + - DA + - DD + - EG + - FT + - GF + - IE + - IS + - LB + - MB + - MI + - MK + - MS + - NV + - OE + - PC + - PE + - PP + - QS + - RE + - RP + - RS + - SC + - SS + - TR + - TU + - UR + - VS + - all: + - name: define_dataset_class + operator: equal_to + value: FINDINGS ABOUT + - name: define_dataset_name + operator: is_contained_by + value: + - FA + - SR + - all: - all: - - name: define_dataset_class - operator: equal_to - value: TRIAL DESIGN - - name: define_dataset_name - operator: is_contained_by - value: - - TA - - TD - - TE - - TI - - TM - - TS - - TV - - all: - - name: define_dataset_class - operator: equal_to - value: SPECIAL PURPOSE - - name: define_dataset_name - operator: is_contained_by - value: - - CO - - DM - - SE - - SM - - SV - - all: - - name: define_dataset_class - operator: equal_to - value: INTERVENTIONS - - name: define_dataset_name - operator: is_contained_by - value: - - AG - - CM - - EC - - EX - - ML - - PR - - SU - - all: - - name: define_dataset_class - operator: equal_to - value: EVENTS - - name: define_dataset_name - operator: is_contained_by - value: - - AE - - BE - - CE - - DS - - DV - - HO - - MH - - all: - - name: define_dataset_class - operator: equal_to - value: FINDINGS - - name: define_dataset_name - operator: is_contained_by - value: - - BS - - CP - - CV - - DA - - DD - - EG - - FT - - GF - - IE - - IS - - LB - - MB - - MI - - MK - - MS - - NV - - OE - - PC - - PE - - PP - - QS - - RE - - RP - - RS - - SC - - SS - - TR - - TU - - UR - - VS - - all: - - name: define_dataset_class - operator: equal_to - value: FINDINGS ABOUT - - name: define_dataset_name - operator: is_contained_by - value: - - FA - - SR - - all: - - all: - - name: define_dataset_class - operator: equal_to - value: RELATIONSHIP - - any: - - name: define_dataset_name - operator: is_not_contained_by - value: - - RELREC - - RELSPEC - - RELSUB - - SUPPQUAL - - name: define_dataset_name - operator: starts_with - value: SUPP - - all: - - name: define_dataset_class - operator: equal_to - value: STUDY REFERENCE - - name: define_dataset_name - operator: is_not_contained_by - value: - - OI + - name: define_dataset_class + operator: equal_to + value: RELATIONSHIP + - any: + - name: define_dataset_name + operator: is_not_contained_by + value: + - RELREC + - RELSPEC + - RELSUB + - SUPPQUAL + - name: define_dataset_name + operator: starts_with + value: SUPP + - all: + - name: define_dataset_class + operator: equal_to + value: STUDY REFERENCE + - name: define_dataset_name + operator: is_not_contained_by + value: + - OI Core: Id: CDISC.SDTMIG.CG0312 Status: Draft @@ -180,23 +179,23 @@ Core: Description: Raise an error when custom domains use the reserved or modelled standard names Executability: Fully Executable Operations: - - ct_attribute: Term CCODE - ct_packages: - - sdtmct-2020-03-27 - ct_version: TSVCDVER - id: $TERM_CCODES - name: DOMAIN - operator: get_codelist_attributes +- ct_attribute: Term CCODE + ct_packages: + - sdtmct-2020-03-27 + ct_version: TSVCDVER + id: $TERM_CCODES + name: DOMAIN + operator: get_codelist_attributes Outcome: Message: Custom domains use the reserved or modelled standard names. Output Variables: - - $TERM_CCODES + - $TERM_CCODES Rule Type: Define Item Group Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml index 6742cedb3..095d1c357 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml @@ -2,65 +2,64 @@ # Condition: Custom domain present in study # Rule: --TESTCD present in custom findings dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the topic variable from the identified general - observation class (e.g., --TESTCD for Findings) in the SDTM. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: For a Findings domain, the topic variable, --TESTCD, should use - Controlled Terminology (e.g., "SYSBP" for Systolic Blood - Pressure) - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) - Document: IG v3.2 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM. + Document: IG v3.4 + Item: Item 3.b. + Section: '2.6' + - Cited Guidance: For a Findings domain, the topic variable, --TESTCD, should use Controlled + Terminology (e.g., "SYSBP" for Systolic Blood Pressure) + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Item: 3.b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.3 + Item: 3.b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "FINDINGS" - - name: --TESTCD - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "FINDINGS" + - name: --TESTCD + operator: not_exists Core: Id: CDISC.SDTMIG.CG0320 @@ -69,26 +68,26 @@ Core: Description: Raise an error when variable --TESTCD is missing for custom Findings domains Executability: Fully Executable Operations: - - id: $dataset_variables - operator: get_column_order_from_dataset - - id: $custom_domain - operator: domain_is_custom +- id: $dataset_variables + operator: get_column_order_from_dataset +- id: $custom_domain + operator: domain_is_custom Outcome: Message: "--TESTCD does not exist in custom Findings domain." Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class - - define_dataset_key_sequence + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class + - define_dataset_key_sequence Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml index d8de0ffda..de1d1bbe8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml @@ -1,49 +1,46 @@ # Document Start Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom - domain, which must be based on one of the three SDTM general - observation classes. - Document: IG v3.4 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom - domain, which must be based on one of the three SDTM general - observation classes. - Document: IG v3.2 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom - domain, which must be based on one of the three SDTM general - observation classes. - Document: IG v3.3 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.4 + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.2 + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.3 + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: '1' + Version: '2.0' + Version: '3.3' # Variable: GEN # Condition: Custom domain present in study # Rule: Custom domain is based on one of the observation classes @@ -53,41 +50,41 @@ Authorities: # or to get the list of variables (or subsets, i.e, model_variables, model_identifiers, ...) from the IG underlying model - library metadata? Check: all: - - name: $custom_domain - operator: equal_to - value: true - - not: - any: - - name: --TESTCD - operator: exists - - name: --TRT - operator: exists - - name: --TERM - operator: exists - - not: - any: - - name: USUBJID - operator: exists - - name: POOLID - operator: exists - - name: SPDEVID - operator: exists - - name: SPTOBID - operator: exists + - name: $custom_domain + operator: equal_to + value: true + - not: + any: + - name: --TESTCD + operator: exists + - name: --TRT + operator: exists + - name: --TERM + operator: exists + - not: + any: + - name: USUBJID + operator: exists + - name: POOLID + operator: exists + - name: SPDEVID + operator: exists + - name: SPTOBID + operator: exists # pending to add the rest of check conditions Core: Id: CDISC.SDTMIG.CG0321 Status: Draft Version: '1' -Description: Trigger error when a custom domain is present and is not based on - one of the observation classes +Description: Trigger error when a custom domain is present and is not based on one of the + observation classes Executability: Fully Executable Operations: - - id: $custom_domain - operator: domain_is_custom - - id: $dataset_variables - operator: get_column_order_from_dataset +- id: $custom_domain + operator: domain_is_custom +- id: $dataset_variables + operator: get_column_order_from_dataset # - id: $model_filtered_variables` # key_name: "role" # key_value: "Identifier" @@ -95,9 +92,9 @@ Operations: Outcome: Message: Custom domain is not based on one of the observation classes Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain + - dataset_name + - $dataset_variables + - $custom_domain # - define_dataset_name # - define_dataset_is_non_standard # - define_dataset_class @@ -105,10 +102,10 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset # Document End diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml index f66b23de5..f4fb7d580 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml @@ -2,78 +2,77 @@ # Condition: ELEMENT is associated with > 1 ARM # Rule: ELEMENT value does not refer to any specific ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. - If the Element appears in more than one Arm in the Trial Arms dataset, - then the Element description (ELEMENT) must not refer to any Arms - Document: IG v3.4 - Item: Assumption 8 - Section: 7.2.2 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. - If the Element appears in more than one Arm in the Trial Arms dataset; - then the Element description (ELEMENT) must not refer to any Arms. - Document: IG v3.2 - Item: Assumption 8 for TE - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. - If the Element appears in more than one Arm in the Trial Arms dataset; - then the Element description (ELEMENT) must not refer to any Arms. - Document: IG v3.3 - Item: Assumption 8 - Section: 7.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset, then the Element description (ELEMENT) + must not refer to any Arms + Document: IG v3.4 + Item: Assumption 8 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) + must not refer to any Arms. + Document: IG v3.2 + Item: Assumption 8 for TE + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) + must not refer to any Arms. + Document: IG v3.3 + Item: Assumption 8 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: ELEMENT - operator: contains - value: ARM + - name: ELEMENT + operator: contains + value: ARM Core: Id: CDISC.SDTMIG.CG0322 Status: Draft Version: '1' -Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must - not refer to a specific ARM +Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a + specific ARM Executability: Fully Executable Match Datasets: - - Name: TA - Keys: - - ARM +- Keys: + - ARM + Name: TA Outcome: - Message: ELEMENT value refers to a specific ARM when ELEMENT is associated with - more than 1 arm + Message: ELEMENT value refers to a specific ARM when ELEMENT is associated with more than 1 arm Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml index c43660e64..9f08ec35a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml @@ -2,90 +2,86 @@ # Condition: ELEMENT is associated with > 1 EPOCH # Rule: ELEMENT value does not refer to any specific EPOCH Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. - If the Element appears in more than one Epoch in the Trial Arms - dataset, then the Element description (ELEMENT) must not refer to - any Epochs. - Document: IG v3.4 - Item: Assumption 9 - Section: 7.2.2 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. - If the Element appears in more than one Epoch in the Trial Arms - dataset; then the Element description (ELEMENT) must not refer to - any Epochs. - Document: IG v3.2 - Item: Assumption 9 for TE - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. - If the Element appears in more than one Epoch in the Trial Arms - dataset; then the Element description (ELEMENT) must not refer to - any Epochs. - Document: IG v3.3 - Item: Assumption 9 - Section: 7.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset, then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.4 + Item: Assumption 9 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset; then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.2 + Item: Assumption 9 for TE + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset; then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.3 + Item: Assumption 9 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: $ta_element - operator: is_not_unique_relationship - value: $ta_epoch - - name: ELEMENT - operator: contains - value: $ta_epoch + - name: $ta_element + operator: is_not_unique_relationship + value: $ta_epoch + - name: ELEMENT + operator: contains + value: $ta_epoch Core: Id: CDISC.SDTMIG.CG0323 Status: Draft Version: '1' -Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not - refer to a specific EPOCH. +Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a + specific EPOCH. Executability: Fully Executable Operations: - - domain: TA - id: $ta_element - name: ELEMENT - operator: distinct - - domain: TA - id: $ta_epoch - name: EPOCH - operator: distinct +- domain: TA + id: $ta_element + name: ELEMENT + operator: distinct +- domain: TA + id: $ta_epoch + name: EPOCH + operator: distinct Outcome: - Message: ELEMENT refers to a specific EPOCH when ELEMENT is associated with more - than 1 EPOCH + Message: ELEMENT refers to a specific EPOCH when ELEMENT is associated with more than 1 EPOCH Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA - - TE + - TA + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml index 1f1e2444d..0187b9af1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml @@ -2,78 +2,75 @@ # Condition: # Rule: TEENRL value does not refer to any specific ARM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The Trial Arms dataset, not the Trial Elements dataset, - describes where the subject moves next, so TEENRL must be expressed - without referring to Arm. - Document: IG v3.4 - Item: Assumption 13 - Section: 7.2.2 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; - describes where the subject moves next; so TEENRL must be expressed - without referring to Arm. - Document: IG v3.2 - Item: Assumption 13 for TE - Section: '7.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; - describes where the subject moves next; so TEENRL must be expressed - without referring to Arm. - Document: IG v3.3 - Item: Assumption 13 - Section: 7.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Trial Arms dataset, not the Trial Elements dataset, describes where the + subject moves next, so TEENRL must be expressed without referring to Arm. + Document: IG v3.4 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; describes where the + subject moves next; so TEENRL must be expressed without referring to Arm. + Document: IG v3.2 + Item: Assumption 13 for TE + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; describes where the + subject moves next; so TEENRL must be expressed without referring to Arm. + Document: IG v3.3 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: TEENRL - operator: contains - value: $ta_arm + - name: TEENRL + operator: contains + value: $ta_arm Core: Id: CDISC.SDTMIG.CG0324 Status: Draft Version: '1' -Description: TEENRL should not reference a specific ARM. This rule has only been - partially executed to identify explicit references to ARM. +Description: TEENRL should not reference a specific ARM. This rule has only been partially executed + to identify explicit references to ARM. Executability: Fully Executable Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: TEENRL refers to a specific ARM Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TE + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml index 6aba7c733..4896445be 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml @@ -2,84 +2,80 @@ # Condition: The use of 'MULTIPLE' reflects multiple values (as opposed to a valid response in the context of the finding (e.g., Questionnaire CT). # Rule: --ORRES ^ = 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a - Findings class dataset, multiple records should be submitted - for that --TESTCD. When a finding can have multiple results, - the key structure for the findings dataset must be adequate to - distinguish between the multiple results. See Section 4.1.9 - Assigning Natural Keys in the Metadata. - Document: IG v3.4 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Multiple Values for a Findings Result Variable. If multiple - result values (--ORRES) are reported for a test in a Findings - class dataset; multiple records should be submitted for that - --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; - EGORRES=ATRIAL FIBRILLATION. - EGTESTCD=RHYRATE; EGTEST=Rhythm - and Rate; EGORRES=ATRIAL FLUTTER' - Document: IG v3.2 - Section: 4.1.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a - Findings class dataset; multiple records should be submitted - for that --TESTCD. When a finding can have multiple results; - the key structure for the findings dataset must be adequate to - distinguish between the multiple results. See Section 4.1.9 - Assigning Natural Keys in the Metadata. - Document: IG v3.3 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings + class dataset, multiple records should be submitted for that --TESTCD. When a finding can + have multiple results, the key structure for the findings dataset must be adequate to + distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the + Metadata. + Document: IG v3.4 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Multiple Values for a Findings Result Variable. If multiple result values (--ORRES) + are reported for a test in a Findings class dataset; multiple records should be submitted for + that --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FIBRILLATION. + - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FLUTTER' + Document: IG v3.2 + Section: 4.1.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings + class dataset; multiple records should be submitted for that --TESTCD. When a finding can + have multiple results; the key structure for the findings dataset must be adequate to + distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the + Metadata. + Document: IG v3.3 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --ORRES - operator: does_not_contain - value: - - Questionnaire CT - - name: --ORRES - operator: equal_to - value: MULTIPLE + - name: --ORRES + operator: does_not_contain + value: + - Questionnaire CT + - name: --ORRES + operator: equal_to + value: MULTIPLE Core: Id: CDISC.SDTMIG.CG0347 Status: Draft Version: '1' -Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a - valid response in the context of the finding (e.g., Questionnaire CT) +Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the + context of the finding (e.g., Questionnaire CT) Executability: Fully Executable Outcome: - Message: --ORRES is equal to MULTIPLE when it is not a valid response in the - context of the finding (e.g., Questionnaire CT) + Message: --ORRES is equal to MULTIPLE when it is not a valid response in the context of the + finding (e.g., Questionnaire CT) Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml index 837780414..d731257c6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml @@ -2,70 +2,64 @@ # Condition: # Rule: TDANCVAR = date variable name in ADSL Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'A reference to the date variable name that provides - the start point from which the planned disease assessment schedule - is measured. This must be referenced from the ADaM ADSL dataset - e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference - date variable name.' - Document: IG v3.4 - Item: Specification - Section: 7.3.2 - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'IG v3.2[7.3][A reference to the date variable name - that provides the start point from which the planned disease assessment - schedule is measured. This must be referenced from the ADaM ADSL - dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a - reference date variable name.]|Model v1.4[3.5.1][A reference to - the date variable name that provides the start point from which - the planned disease assessment schedule is measured. This must be - referenced from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR - is to contain the name of a reference date variable name.]' - Document: IG v3.2|Model v1.4 - Section: IG v3.2[7.3]|Model v1.4[3.5.1] - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'IG v3.3[7.3.2][A reference to the date variable name - that provides the start point from which the planned disease assessment - schedule is measured. This must be referenced from the ADaM ADSL - dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of - a reference date variable name.]|Model v1.7[3.4.1][A reference to - the date variable name that provides the start point from which - the planned disease assessment schedule is measured. This must be - referenced from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR - is to contain the name of a reference date variable name.]' - Document: IG v3.3|Model v1.7 - Section: IG v3.3[7.3.2]|Model v1.7[3.4.1] +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'A reference to the date variable name that provides the start point from which + the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL + dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name.' + Document: IG v3.4 + Item: Specification + Section: 7.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'IG v3.2[7.3][A reference to the date variable name that provides the start point + from which the planned disease assessment schedule is measured. This must be referenced from + the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date + variable name.]|Model v1.4[3.5.1][A reference to the date variable name that provides the start + point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference + date variable name.]' + Document: IG v3.2|Model v1.4 + Section: IG v3.2[7.3]|Model v1.4[3.5.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'IG v3.3[7.3.2][A reference to the date variable name that provides the start + point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference + date variable name.]|Model v1.7[3.4.1][A reference to the date variable name that provides the + start point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference + date variable name.]' + Document: IG v3.3|Model v1.7 + Section: IG v3.3[7.3.2]|Model v1.7[3.4.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: TDANCVAR - operator: is_not_contained_by - value: '[date variable name in ADSL]' + - name: TDANCVAR + operator: is_not_contained_by + value: '[date variable name in ADSL]' Core: Id: CDISC.SDTMIG.CG0375 Status: Draft @@ -78,8 +72,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TD + - TD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml index 8af1bc7a3..abfbd0c83 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml @@ -2,50 +2,50 @@ # Condition: # Rule: --LLT = MedDRA lowest level TERM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The lowest-level term assigned to the event from MedDRA. - Document: Model v2.0 - Item: --LLT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Lowest Level Term. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Lowest Level Term. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The lowest-level term assigned to the event from MedDRA. + Document: Model v2.0 + Item: --LLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Lowest Level Term. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Lowest Level Term. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: '1' + Version: '2.0' + Version: '3.2' Check: all: - - name: $is_valid_llt_value - operator: equal_to - value: false + - name: $is_valid_llt_value + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0377 Status: Draft @@ -53,24 +53,24 @@ Core: Description: Raise an error when --LLT is not a valid MedDRA lowest level TERM. Executability: Fully Executable Operations: - - case_sensitive: true - dictionary_term_type: LLT - external_dictionary_type: meddra - id: $is_valid_llt_value - name: --LLT - operator: valid_external_dictionary_value +- case_sensitive: true + dictionary_term_type: LLT + external_dictionary_type: meddra + id: $is_valid_llt_value + name: --LLT + operator: valid_external_dictionary_value Outcome: Message: --LLT is not a valid MedDRA lowest level TERM. Output Variables: - - --LLT + - --LLT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml index f2d06a7fe..683d783c1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml @@ -2,82 +2,79 @@ # Condition: --DECOD ^= null # Rule: --DECOD = MedDRA preferred TERM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equivalent to the Preferred Term (PT in MedDRA). - Document: Model v2.0 - Item: --DECOD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the - topic variable; --TERM; or the modified topic variable - (--MODIFY); if applicable. Equivalent to the Preferred Term - (PT in MedDRA). - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the - topic variable; --TERM; or the modified topic variable - (--MODIFY); if applicable. Equivalent to the Preferred Term - (PT in MedDRA). - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Equivalent to the Preferred Term (PT in MedDRA). + Document: Model v2.0 + Item: --DECOD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic + variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic + variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: '1' + Version: '2.0' + Version: '3.2' Check: all: - - name: --DECOD - operator: non_empty - - name: $is_valid_pt_code - operator: equal_to - value: false + - name: --DECOD + operator: non_empty + - name: $is_valid_pt_code + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0378 Status: Draft Version: '1' -Description: Raise an error when --DECOD is completed but is not a valid MedDRA - preferred TERM. +Description: Raise an error when --DECOD is completed but is not a valid MedDRA preferred TERM. Executability: Fully Executable Operations: - - case_sensitive: true - dictionary_term_type: PT - external_dictionary_type: meddra - id: $is_valid_pt_code - name: --DECOD - operator: valid_external_dictionary_code +- case_sensitive: true + dictionary_term_type: PT + external_dictionary_type: meddra + id: $is_valid_pt_code + name: --DECOD + operator: valid_external_dictionary_code Outcome: Message: --DECOD is completed but value is not a valid MedDRA preferred TERM. Output Variables: - - --DECOD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml index 8667d4c30..97658b96b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml @@ -2,52 +2,51 @@ # Condition: # Rule: --PTCD = MedDRA preferred TERM code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The preferred term code assigned to the event from - MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --PTCD - operator: is_contained_by - value: - - MedDRA preferred term code + - name: --PTCD + operator: is_contained_by + value: + - MedDRA preferred term code Core: Id: CDISC.SDTMIG.CG0380 Status: Draft @@ -60,10 +59,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml index eb93d0709..a45296608 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml @@ -2,52 +2,52 @@ # Condition: # Rule: --HLT = MedDRA high level TERM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level term from the primary hierarchy assigned - to the event from MedDRA. - Document: Model v2.0 - Item: --HLT - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level term from the primary hierarchy assigned to the event from + MedDRA. + Document: Model v2.0 + Item: --HLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --HLT - operator: is_contained_by - value: - - MedDRA high level TERM + - name: --HLT + operator: is_contained_by + value: + - MedDRA high level TERM Core: Id: CDISC.SDTMIG.CG0381 Status: Draft @@ -60,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml index bbd1b414d..97c5caac9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml @@ -2,52 +2,52 @@ # Condition: # Rule: --HLTCD = MedDRA high level TERM code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level term code from the primary hierarchy - assigned to the event from MedDRA. - Document: Model v2.0 - Item: --HLTCD - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level term code from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --HLTCD - operator: is_contained_by - value: - - MedDRA high level TERM code + - name: --HLTCD + operator: is_contained_by + value: + - MedDRA high level TERM code Core: Id: CDISC.SDTMIG.CG0382 Status: Draft @@ -60,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml index 7b6148dcf..38a3839dd 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml @@ -2,52 +2,52 @@ # Condition: # Rule: --HLGT = MedDRA high level group TERM Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level group term from the primary hierarchy - assigned to the event from MedDRA. - Document: Model v2.0 - Item: --HLGT - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Group Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Group Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level group term from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLGT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --HLGT - operator: is_contained_by - value: - - MedDRA high level group TERM + - name: --HLGT + operator: is_contained_by + value: + - MedDRA high level group TERM Core: Id: CDISC.SDTMIG.CG0383 Status: Draft @@ -60,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml index a17f1c83e..6b5f47746 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml @@ -2,60 +2,57 @@ # Condition: # Rule: --HLGTCD = MedDRA high level group TERM code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level group term code from the primary hierarchy - assigned to the event from MedDRA. - Document: Model v2.0 - Item: --HLGTCD - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Group Term code from the primary - path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Group Term code from the primary - path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level group term code from the primary hierarchy assigned to the + event from MedDRA. + Document: Model v2.0 + Item: --HLGTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --HLGTCD - operator: is_contained_by - value: - - MedDRA high level group TERM code + - name: --HLGTCD + operator: is_contained_by + value: + - MedDRA high level group TERM code Core: Id: CDISC.SDTMIG.CG0384 Status: Draft Version: '1' -Description: Trigger error when --HLGTCD is not a valid MedDRA high level group TERM - code +Description: Trigger error when --HLGTCD is not a valid MedDRA high level group TERM code Executability: Fully Executable Outcome: Message: --HLGTCD is not a valid MedDRA high level group TERM code @@ -63,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml index 3504c6ead..af9181a81 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml @@ -2,58 +2,55 @@ # Condition: # Rule: --BODSYS = MedDRA system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: A standardized or dictionary derived name for the - body system or organ class. Body system or system organ class assigned - for analysis from a standard hierarchy (e.g., MedDRA) associated - with an event. - Document: Model v2.0 - Item: --BODSYS - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'Body system or system organ class assigned for analysis - from a standard hierarchy (e.g. MedDRA) associated with an event. - Example: GASTROINTESTINAL DISORDERS.' - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'Body system or system organ class assigned for analysis - from a standard hierarchy (e.g. MedDRA) associated with an event. - Example: GASTROINTESTINAL DISORDERS.' - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A standardized or dictionary derived name for the body system or organ + class. Body system or system organ class assigned for analysis from a standard hierarchy + (e.g., MedDRA) associated with an event. + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Body system or system organ class assigned for analysis from a standard hierarchy + (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.' + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Body system or system organ class assigned for analysis from a standard hierarchy + (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.' + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --BODSYS - operator: is_contained_by - value: - - MedDRA system organ class + - name: --BODSYS + operator: is_contained_by + value: + - MedDRA system organ class Core: Id: CDISC.SDTMIG.CG0385 Status: Draft @@ -66,10 +63,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml index 1e03135fe..eabb12458 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml @@ -2,55 +2,54 @@ # Condition: # Rule: --BDSYCD = MedDRA system organ class code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A standardized or dictionary derived short sequence of - characters used to represent the body system or organ class. - MedDRA System Organ Class code corresponding to --BODSYS - assigned for analysis. - Document: Model v2.0 - Item: --BDSYCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned - for analysis. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned - for analysis. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A standardized or dictionary derived short sequence of characters used to + represent the body system or organ class. MedDRA System Organ Class code corresponding to + --BODSYS assigned for analysis. + Document: Model v2.0 + Item: --BDSYCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for + analysis. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for + analysis. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - metadata: $valid_codes - operator: equal_to - value: true + - metadata: $valid_codes + operator: equal_to + value: true #- name: --BDSYCD # operator: is_contained_by # value: @@ -62,21 +61,21 @@ Core: Description: Trigger error when --BDSYCD is not a valid MedDRA system organ class code Executability: Fully Executable Operations: - - id: $valid_codes - name: --BDSYCD - operator: valid_meddra_code_references +- id: $valid_codes + name: --BDSYCD + operator: valid_meddra_code_references Outcome: Message: --BDSYCD is not a valid MedDRA system organ class code Output Variables: - - $valid_codes + - $valid_codes Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml index 9a0bec5bc..a78f975e1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml @@ -2,72 +2,70 @@ # Condition: # Rule: --LOINC = valid code in the version of the LOINC dictionary specified in define.xml Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: A short sequence of characters used to represent laboratory - and clinical tests within the Logical Observation Identifiers Names - and Codes (LOINC) database. - Document: Model v2.0 - Item: --LOINC - Section: Findings - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) - code for the topic variable such as a lab test. - Document: Model v1.4 - Section: 2.2.3 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) - code for the topic variable such as a lab test. - Document: Model v1.7 - Section: 2.2.3 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A short sequence of characters used to represent laboratory and clinical + tests within the Logical Observation Identifiers Names and Codes (LOINC) database. + Document: Model v2.0 + Item: --LOINC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) code for the topic + variable such as a lab test. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) code for the topic + variable such as a lab test. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --LOINC - operator: is_not_contained_by - value: - - LOINC codes contained in the version of the LOINC dictionary specified in - define.xml + - name: --LOINC + operator: is_not_contained_by + value: + - LOINC codes contained in the version of the LOINC dictionary specified in define.xml Core: Id: CDISC.SDTMIG.CG0400 Status: Draft Version: '1' -Description: Trigger error when --LOINC is not a valid code in the version of the - LOINC dictionary specified in define.xml +Description: Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary + specified in define.xml Executability: Fully Executable Outcome: - Message: --LOINC is not a valid code in the version of the LOINC dictionary specified - in define.xml + Message: --LOINC is not a valid code in the version of the LOINC dictionary specified in + define.xml Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml index bfffa97f9..a5321fed0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml @@ -2,63 +2,62 @@ # Condition: # Rule: TAETORD order of elements match order in TA within ARM of the Subject Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the planned order of the Element within the - Arm (see Trial Arms; Section 3.2.2 ). - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the planned order of the Element within the - Arm (see Section 3.1.2; Trial Arms). - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An assigned numeric identifier that gives the planned order of - the element within the trial arm of the study. - Document: Model v2.0 - Item: TAETORD - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the planned order of the Element within the Arm (see Trial + Arms; Section 3.2.2 ). + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the planned order of the Element within the Arm (see + Section 3.1.2; Trial Arms). + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An assigned numeric identifier that gives the planned order of the element + within the trial arm of the study. + Document: Model v2.0 + Item: TAETORD + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: TAETORD - operator: exists - - name: TAETORD - operator: is_not_ordered_set - value: - - ARM - - ARMCD + - name: TAETORD + operator: exists + - name: TAETORD + operator: is_not_ordered_set + value: + - ARM + - ARMCD Core: Id: CDISC.SDTMIG.CG0418 Status: Draft Version: '1' -Description: 'Trigger error when the order of TAETORD does not match the order - of Trial Arms' +Description: 'Trigger error when the order of TAETORD does not match the order of Trial Arms' Executability: Fully Executable Outcome: Message: 'TAETORD does not match the order of Trial Arms' @@ -66,8 +65,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml index b7f394c25..b7a5ee82e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml @@ -2,66 +2,64 @@ # Condition: --STRESC ^= null and units are applicable for the result # Rule: --STRESU ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The unit of measure for the standardized result of the - measurement, test, or examination. Variable(s) Qualified: - --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC - and --STREFN and --LLOQ and --ULOQ.' - Document: Model v2.0 - Item: --STRESU - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU:Standardized units used for --STRESC, --STRESN, - --STREFC, and --STREFN. Example: "mol/L".' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC + and --STREFN and --LLOQ and --ULOQ.' + Document: Model v2.0 + Item: --STRESU + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '--STRESU:Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. + Example: "mol/L".' + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: '1' + Version: '2.0' + Version: '3.3' Check: Core: Id: CDISC.SDTMIG.CG0425 Status: Draft Version: '1' -Description: Trigger error if --STRESU is null when --STRESC ^= null and units - are applicable for the result +Description: Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for + the result Executability: Not Executable Outcome: - Message: --STRESU is null when --STRESC ^= null and units are applicable for the - result + Message: --STRESU is null when --STRESC ^= null and units are applicable for the result Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml index 3ec81f330..beeabc02f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml @@ -2,88 +2,84 @@ # Condition: Variable Core Status = Expected and data collected # Rule: Variable value ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the study does not include the data item for an expected - variable, however, a null column must still be included in the - dataset, and a comment must be included in the Define-XML - document to state that the study does not include the data - item. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When no data has been collected for an expected variable; - however; a null column must still be included in the dataset; - and a comment must be included in the define.xml to state that - data was not collected. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the study does not include the data item for an expected - variable; however; a null column must still be included in the - dataset; and a comment must be included in the Define-XML - document to state that the study does not include the data - item. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the study does not include the data item for an expected variable, + however, a null column must still be included in the dataset, and a comment must be + included in the Define-XML document to state that the study does not include the data + item. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When no data has been collected for an expected variable; however; a null + column must still be included in the dataset; and a comment must be included in the + define.xml to state that data was not collected. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When the study does not include the data item for an expected variable; + however; a null column must still be included in the dataset; and a comment must be + included in the Define-XML document to state that the study does not include the data + item. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: variable_name - operator: is_contained_by - value: $expected_variables - - name: define_variable_is_collected - operator: equal_to - value: true - - name: variable_is_empty - operator: equal_to - value: true + - name: variable_name + operator: is_contained_by + value: $expected_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: variable_is_empty + operator: equal_to + value: true Core: Id: CDISC.SDTMIG.CG0431 Status: Draft Version: '1' -Description: Raise an error when the variable Core Status = Expected, data is - collected, but the variable has no data. +Description: Raise an error when the variable Core Status = Expected, data is collected, but the + variable has no data. Executability: Fully Executable Operations: - - id: $expected_variables - operator: expected_variables +- id: $expected_variables + operator: expected_variables Outcome: - Message: Variable is empty, where variable core status is expected and data is - collected. + Message: Variable is empty, where variable core status is expected and data is collected. Output Variables: - - variable_name - - variable_is_empty + - variable_name + - variable_is_empty Rule Type: Value Check with Dataset Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml index 415c19bd8..99c544d15 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml @@ -2,51 +2,51 @@ # Condition: # Rule: --SOC = MedDRA primary system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v2.0 - Item: --SOC - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v2.0 + Item: --SOC + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: --SOC - operator: is_contained_by - value: - - MedDRA primary system organ class + - name: --SOC + operator: is_contained_by + value: + - MedDRA primary system organ class Core: Id: CDISC.SDTMIG.CG0436 Status: Draft @@ -56,15 +56,15 @@ Executability: Fully Executable Outcome: Message: --SOC is not a valid MedDRA primary system organ class Output Variables: - - --SOC + - --SOC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml index af5c02228..ef0ecfbf8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml @@ -2,71 +2,70 @@ # Condition: # Rule: --SOCCD = MedDRA primary system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class code. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class code. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The system organ class code from the primary hierarchy assigned - in the MedDRA dictionary. - Document: Model v2.0 - Item: --SOCCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class code. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class code. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The system organ class code from the primary hierarchy assigned in the + MedDRA dictionary. + Document: Model v2.0 + Item: --SOCCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: --SOCCD - operator: is_contained_by - value: - - MedDRA primary system organ class code + - name: --SOCCD + operator: is_contained_by + value: + - MedDRA primary system organ class code Core: Id: CDISC.SDTMIG.CG0437 Status: Draft Version: '1' -Description: Trigger error when --SOCCD is not a valid MedDRA primary system - organ class code +Description: Trigger error when --SOCCD is not a valid MedDRA primary system organ class code Executability: Fully Executable Outcome: Message: --SOCCD is not a valid MedDRA primary system organ class code Output Variables: - - --SOCCD + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml index faa0c4eb1..0d12d3324 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml @@ -2,41 +2,39 @@ # Condition: # Rule: --SOCCD = MedDRA primary system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in - Table 1. TSVAL may have controlled terminology depending on - the value of TSPARMCD - Document: IG v3.2 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0442 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in - Table 1. TSVAL may have controlled terminology depending on - the value of TSPARMCD - Document: IG v3.3 - Section: 7.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0442 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0442 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Section: 7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0442 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - value: + - name: + operator: + value: Core: Id: CDISC.SDTMIG.CG0442 Status: Draft @@ -44,16 +42,15 @@ Core: Description: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Executability: Fully Executable Outcome: - Message: TSVAL is not a valid preferred term from FDA Substance Registration - System (SRS) + Message: TSVAL is not a valid preferred term from FDA Substance Registration System (SRS) Output Variables: - - --SOCCD + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml index e8ab396ec..3f96b003a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'CURTRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0443 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0443 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0443 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0443 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml index e33c45eef..9990daed5 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'COMPTRT' # Rule: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0445 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0445 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0445 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0445 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml index 535299ccd..6492d3078 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'COMPTRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0446 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0446 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0446 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0446 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml index cb28838a6..3cac1bfed 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD in ('INDIC', 'TDIGRP') # Rule: TSVAL is a valid term from SNOMED CT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0448 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0448 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0448 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0448 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml index 10e5a2e22..b97125a83 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD in ('INDIC', 'TDIGRP') # Rule: TSVALCD is a valid concept identifier from SNOMED CT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0449 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0449 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0449 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0449 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml index 48e9e2480..e986cf89e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'TRT' # Rule: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0450 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0450 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0450 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0450 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml index 1d7a09097..126f4e8c4 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'TRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0451 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0451 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0451 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0451 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml index e879411ba..8dc14ad58 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'PCLAS' # Rule: TSVAL is a valid term from NDF-RT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0453 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0453 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0453 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0453 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml index 6670a6b17..a557672f9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml @@ -2,38 +2,36 @@ # Condition: TSPARMCD = 'PCLAS' # Rule: TSVALCD is a valid code from NDF-RT Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0454 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0454 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Further information about the parameters is included - below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0454 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: '7.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0454 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: [] Core: @@ -48,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml index e7ab50f5f..4e192b4a0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml @@ -2,58 +2,57 @@ # Condition: # Rule: --HLT on path to MedDRA primary system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level term from the primary hierarchy assigned - to the event from MedDRA. - Document: Model v2.0 - Item: --HLT - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level term from the primary hierarchy assigned to the event from + MedDRA. + Document: Model v2.0 + Item: --HLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0460 Status: Draft Version: '1' -Description: Trigger error when --HLT is not on the path to MedDRA primary system - organ class +Description: Trigger error when --HLT is not on the path to MedDRA primary system organ class Executability: Fully Executable Outcome: Message: --HLT is not on the path to MedDRA primary system organ class @@ -61,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml index 0dfaf07bf..41617fb6d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml @@ -2,58 +2,57 @@ # Condition: # Rule: --HLGT on path to MedDRA primary system organ class Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The high-level term code from the primary hierarchy - assigned to the event from MedDRA. - Document: Model v2.0 - Item: --HLTCD - Section: Events - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.4 - Section: 2.2.2 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.7 - Section: 2.2.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The high-level term code from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0461 Status: Draft Version: '1' -Description: Trigger error when --HLGT is not on the path to MedDRA primary system - organ class +Description: Trigger error when --HLGT is not on the path to MedDRA primary system organ class Executability: Fully Executable Outcome: Message: --HLGT is not on the path to MedDRA primary system organ class @@ -61,10 +60,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - CE - - MH + - AE + - CE + - MH Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml index b9578d42a..c7821c66d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml @@ -2,59 +2,59 @@ # Condition: Custom domain present in study # Rule: --TRT present in custom interventions dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) in the SDTM - Document: IG v3.4 - Item: Assumption 3b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) - Document: IG v3.2 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM + Document: IG v3.4 + Item: Assumption 3b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.3 + Item: 3.b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "INTERVENTIONS" - - name: "--TRT" - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "INTERVENTIONS" + - name: "--TRT" + operator: not_exists Core: Id: CDISC.SDTMIG.CG0463 Status: Draft @@ -62,25 +62,25 @@ Core: Description: Trigger error when --TRT is not present in custom interventions dataset Executability: Fully Executable Operations: - - id: $dataset_variables - operator: get_column_order_from_dataset - - id: $custom_domain - operator: domain_is_custom +- id: $dataset_variables + operator: get_column_order_from_dataset +- id: $custom_domain + operator: domain_is_custom Outcome: Message: --TRT is not present in custom interventions dataset Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml index c73750630..6b954dcf8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml @@ -2,60 +2,60 @@ # Condition: Custom domain present in study # Rule: --TERM present in custom events dataset Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) in the SDTM - Document: IG v3.4 - Item: Assumption 3b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general - observation class (e.g., --TESTCD for Findings) - Document: IG v3.2 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the topic variable from the identified general - observation class (e.g., --TESTCD for Findings) in the SDTM. - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM + Document: IG v3.4 + Item: Assumption 3b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: '2' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Item: 3.b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: '2' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Include the topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM. + Document: IG v3.3 + Item: 3.b + Section: '2.6' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: '2' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "EVENTS" - - name: "--TERM" - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "EVENTS" + - name: "--TERM" + operator: not_exists Core: Id: CDISC.SDTMIG.CG0464 @@ -64,25 +64,25 @@ Core: Description: Trigger error when --TERM is not present in custom events dataset Executability: Fully Executable Operations: - - id: $dataset_variables - operator: get_column_order_from_dataset - - id: $custom_domain - operator: domain_is_custom +- id: $dataset_variables + operator: get_column_order_from_dataset +- id: $custom_domain + operator: domain_is_custom Outcome: Message: "--TERM is not present in custom events dataset" Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml index 553d3908b..f2f2fc0aa 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml @@ -2,53 +2,53 @@ # Condition: --LLOQ present in dataset # Rule: --LLOQ is expressed using the units in --STRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Units will be those used for --STRESU. - Document: Model v2.0 - Item: --LLOQ - Section: Findings - - Name: SDTMIG - Version: '3.2' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Indicates the lower limit of quantitation for an assay. - Units will be those used for --STRESU. - Document: Model v1.4 - Section: 2.2.3 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Indicates the lower limit of quantitation for an assay. - Units will be those used for --STRESU. - Document: Model v1.7 - Section: 2.2.3 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units will be those used for --STRESU. + Document: Model v2.0 + Item: --LLOQ + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the lower limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the lower limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --LLOQ - operator: exists - - name: - operator: + - name: --LLOQ + operator: exists + - name: + operator: Core: Id: CDISC.SDTMIG.CG0466 Status: Draft @@ -61,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml index 10d4424ae..e404c3f5d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml @@ -2,49 +2,47 @@ # Condition: Subject not assigned to treatment # Rule: ARMCD = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0523 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects - who were not assigned to treatment. The same reason will provide - the reason that both are null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0523 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects - who were not assigned to treatment - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment. The same reason will provide the reason that both are null. + Document: IG v3.4 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0523 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment + Document: IG v3.3 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0523 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: ARMCD - operator: non_empty + - name: + operator: + - name: ARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0523 Status: Draft Version: '1' -Description: Trigger error when ARMCD is populated for a subject who was not assigned - to treatment +Description: Trigger error when ARMCD is populated for a subject who was not assigned to treatment Executability: Fully Executable Outcome: Message: ARMCD is populated for a subject who was not assigned to treatment @@ -52,8 +50,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml index c5d9230b7..fe46bd52c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml @@ -2,49 +2,48 @@ # Condition: Subject not assigned to treatment # Rule: ACTARMCD = null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0524 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects - who were not assigned to treatment. The same reason will provide - the reason that both are null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0524 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects - who were not assigned to treatment - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment. The same reason will provide the reason that both are null. + Document: IG v3.4 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0524 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment + Document: IG v3.3 + Item: Assumption 4 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0524 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: ACTARMCD - operator: non_empty + - name: + operator: + - name: ACTARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0524 Status: Draft Version: '1' -Description: Trigger error when ACTARMCD is populated for a subject who was not assigned - to treatment +Description: Trigger error when ACTARMCD is populated for a subject who was not assigned to + treatment Executability: Fully Executable Outcome: Message: ACTARMCD is populated for a subject who was not assigned to treatment @@ -52,8 +51,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml index 1eef4e907..2c0e43fe2 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml @@ -2,53 +2,51 @@ # Condition: Sponsor collects Other, specify and chooses to map the value to SUPPDM # Rule: RACE = 'OTHER' or RACE = 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0525 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the race was collected via an "Other, Specify" - field and the sponsor chooses not to map the value as described - in the current FDA guidance (see CDISC Notes for RACE in the domain - specification), then the value of RACE should be “OTHER”. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0525 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If the race was collected via an "Other; Specify" - field and the sponsor chooses not to map the value as described - in the current FDA guidance (see CDISC Notes for RACE in the domain - specification) then the value of RACE should be 'OTHER'. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the race was collected via an "Other, Specify" field and the sponsor + chooses not to map the value as described in the current FDA guidance (see CDISC Notes for + RACE in the domain specification), then the value of RACE should be “OTHER”. + Document: IG v3.4 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0525 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the race was collected via an "Other; Specify" field and the sponsor + chooses not to map the value as described in the current FDA guidance (see CDISC Notes for + RACE in the domain specification) then the value of RACE should be 'OTHER'. + Document: IG v3.3 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0525 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: UNKNOWN + - name: + operator: + - name: RACE + operator: not_equal_to + value: UNKNOWN Core: Id: CDISC.SDTMIG.CG0525 Status: Draft Version: '1' -Description: Trigger error when Sponsor collects Other, specify and chooses to map - the value to SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE' +Description: Trigger error when Sponsor collects Other, specify and chooses to map the value to + SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE' Executability: Fully Executable Outcome: Message: ??? @@ -56,8 +54,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml index e983ce48b..95b731945 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml @@ -2,49 +2,48 @@ # Condition: Subject does not specify race # Rule: RACE = 'UNKNOWN' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0526 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: 'If a subject refuses to provide or does not know - their race information, the value of RACE could be “UNKNOWN”. ' - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0526 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If a subject refuses to provide race information; - the value of RACE could be 'UNKNOWN'. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'If a subject refuses to provide or does not know their race information, the + value of RACE could be “UNKNOWN”. ' + Document: IG v3.4 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0526 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If a subject refuses to provide race information; the value of RACE could be + 'UNKNOWN'. + Document: IG v3.3 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0526 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: UNKNOWN + - name: + operator: + - name: RACE + operator: not_equal_to + value: UNKNOWN Core: Id: CDISC.SDTMIG.CG0526 Status: Draft Version: '1' -Description: Trigger error when subject does not specify race and RACE is not equal - to "UNKNOWN" +Description: Trigger error when subject does not specify race and RACE is not equal to "UNKNOWN" Executability: Fully Executable Outcome: Message: RACE is not equal to "UNKNOWN" when subject did not specify race @@ -52,8 +51,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml index a8713984d..35b4b6923 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml @@ -2,61 +2,59 @@ # Condition: Mulitple races collected and primary race not specified # Rule: RACE = 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0527 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If multiple races are collected, then the value of - RACE should be “MULTIPLE” and the additional information will be - included in the Supplemental Qualifiers dataset. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0527 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: If multiple races were collected and one was designated - as primary; RACE in DM should be the primary race and additional - races should be reported in SUPPDM - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple races are collected, then the value of RACE should be “MULTIPLE” + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.4 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0527 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If multiple races were collected and one was designated as primary; RACE in + DM should be the primary race and additional races should be reported in SUPPDM + Document: IG v3.3 + Item: Assumption 6 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0527 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: MULTIPLE + - name: + operator: + - name: RACE + operator: not_equal_to + value: MULTIPLE Core: Id: CDISC.SDTMIG.CG0527 Status: Draft Version: '1' -Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races - collected and primary race not specified +Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and + primary race not specified Executability: Fully Executable Outcome: - Message: RACE does not equal "MULTIPLE" when multiple races collected and primary - race not specified + Message: RACE does not equal "MULTIPLE" when multiple races collected and primary race not + specified Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml index 3b39f665b..ea903fd3a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml @@ -2,73 +2,63 @@ # Condition: Milestone associated with RFSTDTC is start of treatment and ARMNRS =null # Rule: RFSTDTC ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0532 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Specification[Reference Start Date/time for the subject - in ISO 8601 character format. Usually equivalent to date/time when - subject was first exposed to study treatment. See Assumption 9 for - additional detail on when RFSTDTC may be null.]|Assumption 9[As - described in Section 4.1.4, Order of the Variables, RFSTDTC is used - to calculate study day variables. RFSTDTC is usually defined as - the date/time when a subject was first exposed to study drug. This - definition applies for most interventional studies, when the start - of treatment is the natural and preferred starting point for study - day variables and thus the logical value for RFSTDTC. In such studies, - when data are submitted for subjects who are ineligible for treatment - (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), subjects - who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT - ASSIGNED"), or subjects who were randomized but not treated (e.g., - ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with - designs that include a substantial portion of subjects who are not - expected to be treated, a different protocol milestone may be chosen - as the starting point for study day variables. Some examples include - non-interventional or observational studies, studies with a no-treatment - arm, or studies where there is a delay between randomization and - treatment.] - Document: IG v3.3 - Item: Specification|Assumption 9 - Section: '5.2' - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0532 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Specification[Reference Start Date/time for the subject - in ISO 8601 character format. Usually equivalent to date/time when - subject was first exposed to study treatment. See Assumption 9 for - additional detail on when RFSTDTC may be null.| Assumption 9 [RFSTDTC - is used to calculate study day variables. RFSTDTC is usually defined - as the date/time when a subject was first exposed to study drug. - This definition applies for most interventional studies, when the - start of treatment is the natural and preferred starting point for - study day variables and thus the logical value for RFSTDTC. In such - studies, when data are submitted for subjects who are ineligible - for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), - subjects who were enrolled but not assigned to an arm (e.g., ARMNRS - = "NOT ASSIGNED"), or subjects who were randomized but not treated - (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies - with designs that include a substantial portion of subjects who - are not expected to be treated, a different protocol milestone may - be chosen as the starting point for study day variables. Some examples - include non-interventional or observational studies, studies with - a no-treatment Arm, or studies where there is a delay between randomization - and treatment.] - Document: IG v3.4 - Item: Specification|Assumption 9 - Section: '5.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 + character format. Usually equivalent to date/time when subject was first exposed to study + treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.]|Assumption + 9[As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to calculate + study day variables. RFSTDTC is usually defined as the date/time when a subject was first + exposed to study drug. This definition applies for most interventional studies, when the + start of treatment is the natural and preferred starting point for study day variables and + thus the logical value for RFSTDTC. In such studies, when data are submitted for subjects + who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), + subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or + subjects who were randomized but not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will + be null. For studies with designs that include a substantial portion of subjects who are + not expected to be treated, a different protocol milestone may be chosen as the starting + point for study day variables. Some examples include non-interventional or observational + studies, studies with a no-treatment arm, or studies where there is a delay between + randomization and treatment.] + Document: IG v3.3 + Item: Specification|Assumption 9 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0532 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 + character format. Usually equivalent to date/time when subject was first exposed to study + treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.| Assumption + 9 [RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the + date/time when a subject was first exposed to study drug. This definition applies for most + interventional studies, when the start of treatment is the natural and preferred starting + point for study day variables and thus the logical value for RFSTDTC. In such studies, + when data are submitted for subjects who are ineligible for treatment (e.g., screen + failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not assigned to + an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but not treated + (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs that + include a substantial portion of subjects who are not expected to be treated, a different + protocol milestone may be chosen as the starting point for study day variables. Some + examples include non-interventional or observational studies, studies with a no-treatment + Arm, or studies where there is a delay between randomization and treatment.] + Document: IG v3.4 + Item: Specification|Assumption 9 + Section: '5.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0532 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -83,8 +73,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml index fa47e7b23..c73562759 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml @@ -5,92 +5,90 @@ # Author: Marcelina Hungria # Progress Date: 2025-10-23 Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For types of Disease Milestones that can occur multiple times, - MIDS will usually be an abbreviated version of MIDSTYPE and - will always end with a sequence number. Sequence numbers - should start with one and indicate the chronological order of - the instances of this type of Disease Milestone. - Document: IG v3.4 - Item: Assumption 2.b - Section: '5.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0546 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For types of Disease Milestones that can occur multiple times, - MIDS will usually be an abbreviated version of MIDSTYPE and - will always end with a sequence number. Sequence numbers - should start with one and indicate the chronological order of - the instances of this type of Disease Milestone. - Document: IG v3.3 - Item: Assumption 2.b - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0546 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For types of Disease Milestones that can occur multiple times, MIDS will + usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. + Sequence numbers should start with one and indicate the chronological order of the + instances of this type of Disease Milestone. + Document: IG v3.4 + Item: Assumption 2.b + Section: '5.4' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0546 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For types of Disease Milestones that can occur multiple times, MIDS will + usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. + Sequence numbers should start with one and indicate the chronological order of the + instances of this type of Disease Milestone. + Document: IG v3.3 + Item: Assumption 2.b + Section: '5.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0546 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: TMRPT - operator: equal_to - value: Y - - name: --STDTC - operator: not_equal_to - value: "" - - name: $records_per_usubjid_per_midstype - operator: greater_than - value: 1 - - name: MIDS - operator: target_is_sorted_by - value: - - name: SMSTDTC - null_position: first - sort_order: asc - within: - - USUBJID - - MIDSTYPE + - name: TMRPT + operator: equal_to + value: Y + - name: --STDTC + operator: not_equal_to + value: "" + - name: $records_per_usubjid_per_midstype + operator: greater_than + value: 1 + - name: MIDS + operator: target_is_sorted_by + value: + - name: SMSTDTC + null_position: first + sort_order: asc + within: + - USUBJID + - MIDSTYPE Core: Id: CDISC.SDTMIG.CG0546 Status: Draft Version: '1' -Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is - not suffixed with a sequence number in consistent chronological order +Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a + sequence number in consistent chronological order Executability: Fully Executable Match Datasets: - - Keys: - - MIDSTYPE - Name: TM +- Keys: + - MIDSTYPE + Name: TM Operations: - - group: - - USUBJID - - MIDSTYPE - id: $records_per_usubjid_per_midstype - operator: record_count +- group: + - USUBJID + - MIDSTYPE + id: $records_per_usubjid_per_midstype + operator: record_count Outcome: - Message: MIDS is not suffixed with a sequence number in consistent chronological - order with SMSTDTC. + Message: MIDS is not suffixed with a sequence number in consistent chronological order with + SMSTDTC. Output Variables: - - MIDSTYPE - - $records_per_usubjid_per_midstype + - MIDSTYPE + - $records_per_usubjid_per_midstype Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SM + - SM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml index 9a904660f..1e0eb9e88 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml @@ -2,38 +2,38 @@ # Condition: # Rule: --ORREF in same units as --ORRES Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0548 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. - Document: Model v2.0 - Item: --ORREF - Section: Findings - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0548 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. - Document: Model v1.7 - Item: --ORREF - Section: Table 2.2.3 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. + Document: Model v2.0 + Item: --ORREF + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0548 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. + Document: Model v1.7 + Item: --ORREF + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0548 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --ORREF - operator: + - name: --ORREF + operator: Core: Id: CDISC.SDTMIG.CG0548 Status: Draft @@ -46,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml index 28c972c8a..4f6d3f5ae 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml @@ -2,42 +2,40 @@ # Condition: # Rule: --STREFN in same units as --STRESN Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0551 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Reference value for continuous or numeric results - or findings in standard format or in standard units. --STREFN uses - the same units as --STRESN, if applicable. - Document: Model v2.0 - Item: --STREFN - Section: Findings - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0551 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Reference value for continuous or numeric results - or findings in standard format or in standard units. --STREFN uses - the same units as --STRESN, if applicable. - Document: Model v1.7 - Item: --STREFN - Section: Table 2.2.3 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: Model v2.0 + Item: --STREFN + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0551 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: Model v1.7 + Item: --STREFN + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0551 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: --STREFN - operator: + - name: --STREFN + operator: Core: Id: CDISC.SDTMIG.CG0551 Status: Draft @@ -50,8 +48,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml index e11a7f736..484b70daf 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml @@ -6,90 +6,83 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0555 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0555 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0555 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0555 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: does_not_contain_case_insensitive - value: "norm" - - name: PPORRESU - operator: is_not_contained_by - value: pkunit_terms + - name: PPTEST + operator: does_not_contain_case_insensitive + value: "norm" + - name: PPORRESU + operator: is_not_contained_by + value: pkunit_terms Core: Id: CDISC.SDTMIG.CG0555 Status: Draft Version: '1' -Description: Trigger error when parameter is non-normalized and value in - PPORRESU is not for a non-normalized parameter. +Description: Trigger error when parameter is non-normalized and value in PPORRESU is not for a + non-normalized parameter. Executability: Fully Executable Operations: - - codelists: - - PKUNIT - id: pkunit_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUNIT + id: pkunit_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is non-normalized, and the value in PPORRESU is not in - codelist PKUNIT. + Message: Parameter is non-normalized, and the value in PPORRESU is not in codelist PKUNIT. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml index b72beef95..0e90e1303 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml @@ -6,99 +6,93 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0556 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0556 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0556 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0556 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by dose" - - name: PPORRESU - operator: is_not_contained_by - value: pkudmg_terms - - name: PPORRESU - operator: is_not_contained_by - value: pkudug_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by dose" + - name: PPORRESU + operator: is_not_contained_by + value: pkudmg_terms + - name: PPORRESU + operator: is_not_contained_by + value: pkudug_terms Core: Id: CDISC.SDTMIG.CG0556 Status: Draft Version: '1' -Description: Trigger error when parameter is normalized by dose and value in - PPORRESU is not for a parameter normalized by dose. +Description: Trigger error when parameter is normalized by dose and value in PPORRESU is not for a + parameter normalized by dose. Executability: Fully Executable Operations: - - codelists: - - PKUDMG - id: pkudmg_terms - level: term - operator: codelist_terms - returntype: value - - codelists: - - PKUDUG - id: pkudug_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUDMG + id: pkudmg_terms + level: term + operator: codelist_terms + returntype: value +- codelists: + - PKUDUG + id: pkudug_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by dose, and the value in PPORRESU is not in - codelist PKUDMG nor in codelist PKUDUG. + Message: Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor + in codelist PKUDUG. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml index 67528e778..83a2ac023 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml @@ -6,99 +6,93 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0557 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0557 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0557 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0557 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by wt" - - name: PPORRESU - operator: is_not_contained_by - value: pkuwg_terms - - name: PPORRESU - operator: is_not_contained_by - value: pkuwkg_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by wt" + - name: PPORRESU + operator: is_not_contained_by + value: pkuwg_terms + - name: PPORRESU + operator: is_not_contained_by + value: pkuwkg_terms Core: Id: CDISC.SDTMIG.CG0557 Status: Draft Version: '1' -Description: Trigger error when parameter is normalized by weight and value in - PPORRESU is not for a parameter normalized by weight. +Description: Trigger error when parameter is normalized by weight and value in PPORRESU is not for a + parameter normalized by weight. Executability: Fully Executable Operations: - - codelists: - - PKUWG - id: pkuwg_terms - level: term - operator: codelist_terms - returntype: value - - codelists: - - PKUWKG - id: pkuwkg_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUWG + id: pkuwg_terms + level: term + operator: codelist_terms + returntype: value +- codelists: + - PKUWKG + id: pkuwkg_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by weight, and the value in PPORRESU is not in - codelist PKUWG nor in codelist PKUWKG. + Message: Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor + in codelist PKUWKG. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml index b2b0bd0a6..ec6724ba8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml @@ -6,90 +6,83 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0558 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0558 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0558 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0558 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: does_not_contain_case_insensitive - value: "norm" - - name: PPSTRESU - operator: is_not_contained_by - value: pkunit_terms + - name: PPTEST + operator: does_not_contain_case_insensitive + value: "norm" + - name: PPSTRESU + operator: is_not_contained_by + value: pkunit_terms Core: Id: CDISC.SDTMIG.CG0558 Status: Draft Version: '1' -Description: Trigger error when parameter is non-normalized and value in - PPSTRESU is not for a non-normalized parameter. +Description: Trigger error when parameter is non-normalized and value in PPSTRESU is not for a + non-normalized parameter. Executability: Fully Executable Operations: - - codelists: - - PKUNIT - id: pkunit_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUNIT + id: pkunit_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is non-normalized, and the value in PPSTRESU is not in - codelist PKUNIT. + Message: Parameter is non-normalized, and the value in PPSTRESU is not in codelist PKUNIT. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml index e1c21b585..b7f3bfab9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml @@ -6,99 +6,93 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0559 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0559 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0559 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0559 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by dose" - - name: PPSTRESU - operator: is_not_contained_by - value: pkudmg_terms - - name: PPSTRESU - operator: is_not_contained_by - value: pkudug_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by dose" + - name: PPSTRESU + operator: is_not_contained_by + value: pkudmg_terms + - name: PPSTRESU + operator: is_not_contained_by + value: pkudug_terms Core: Id: CDISC.SDTMIG.CG0559 Status: Draft Version: '1' -Description: Trigger error when parameter is normalized by dose and value in - PPSTRESU is not for a parameter normalized by dose. +Description: Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a + parameter normalized by dose. Executability: Fully Executable Operations: - - codelists: - - PKUDMG - id: pkudmg_terms - level: term - operator: codelist_terms - returntype: value - - codelists: - - PKUDUG - id: pkudug_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUDMG + id: pkudmg_terms + level: term + operator: codelist_terms + returntype: value +- codelists: + - PKUDUG + id: pkudug_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by dose, and the value in PPSTRESU is not in - codelist PKUDMG nor in codelist PKUDUG. + Message: Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor + in codelist PKUDUG. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml index 70395fa29..53b538272 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml @@ -6,99 +6,93 @@ # - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. # - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0560 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where - the choice depends on whether the value of the pharmacokinetic - parameter is normalized. Codelist PKUNIT is used for - non-normalized parameters. Codelists PKUDMG and PKUDUG are - used when parameters are normalized by dose amount in - milligrams or micrograms respectively. Codelists PKUWG and - PKUWKG are used when parameters are normalized by weight in - grams or kilograms respectively. Multiple subset codelists - were created for the unique unit expressions of the same - concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0560 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0560 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0560 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by wt" - - name: PPSTRESU - operator: is_not_contained_by - value: pkuwg_terms - - name: PPSTRESU - operator: is_not_contained_by - value: pkuwkg_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by wt" + - name: PPSTRESU + operator: is_not_contained_by + value: pkuwg_terms + - name: PPSTRESU + operator: is_not_contained_by + value: pkuwkg_terms Core: Id: CDISC.SDTMIG.CG0560 Status: Draft Version: '1' -Description: Trigger error when parameter is normalized by weight and value in - PPSTRESU is not for a parameter not normalized by weight. +Description: Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a + parameter not normalized by weight. Executability: Fully Executable Operations: - - codelists: - - PKUWG - id: pkuwg_terms - level: term - operator: codelist_terms - returntype: value - - codelists: - - PKUWKG - id: pkuwkg_terms - level: term - operator: codelist_terms - returntype: value +- codelists: + - PKUWG + id: pkuwg_terms + level: term + operator: codelist_terms + returntype: value +- codelists: + - PKUWKG + id: pkuwkg_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by weight, and the value in PPSTRESU is not in - codelist PKUWG nor in codelist PKUWKG. + Message: Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor + in codelist PKUWKG. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml index cadc9310f..c00f9b887 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml @@ -2,67 +2,63 @@ # Condition: Record is derived in a data collection tool. # Rule: RSDRVFL = 'Y' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0563 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Used to indicate a derived record (e.g., a record - that represents the average of other records such as a computed - baseline). Should be "Y" or null. - Document: SDTMIG v3.4 - Section: Section 6.3.9.3 - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0563 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: The RS domain is intended for collected data. This - includes records derived by the investigator or with a data collection - tool, but not sponsor-derived records. Sponsor-derived records and - results should be provided in an analysis dataset. For example, - BEST Response assessment records must be included in the RS domain - only when provided by an assessor, not the sponsor. a. Totals and - sub-totals in clinical classification measures are considered collected - data if recorded by an assessor. If these totals are operationally - derived through a data collection tool, such as an eCRF or ePRO - device, then RSDRVL should be "Y". - Document: IG v3.3 - Item: Assumption 4 - Section: 6.3.13.3 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record (e.g., a record that represents the + average of other records such as a computed baseline). Should be "Y" or null. + Document: SDTMIG v3.4 + Section: Section 6.3.9.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0563 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The RS domain is intended for collected data. This includes records derived + by the investigator or with a data collection tool, but not sponsor-derived records. + Sponsor-derived records and results should be provided in an analysis dataset. For + example, BEST Response assessment records must be included in the RS domain only when + provided by an assessor, not the sponsor. a. Totals and sub-totals in clinical + classification measures are considered collected data if recorded by an assessor. If these + totals are operationally derived through a data collection tool, such as an eCRF or ePRO + device, then RSDRVL should be "Y". + Document: IG v3.3 + Item: Assumption 4 + Section: 6.3.13.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0563 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: - operator: - - name: RSDRVFL - operator: not_equal_to - value: Y + - name: + operator: + - name: RSDRVFL + operator: not_equal_to + value: Y Core: Id: CDISC.SDTMIG.CG0563 Status: Draft Version: '1' -Description: Raise an error when record is derived in a data collection tool and RSDRVFL - is not equal to "Y" +Description: Raise an error when record is derived in a data collection tool and RSDRVFL is not + equal to "Y" Executability: Fully Executable Outcome: - Message: Record is derived in a data collection tool and RSDRVFL is not equal to - "Y" + Message: Record is derived in a data collection tool and RSDRVFL is not equal to "Y" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - RS + - RS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml index 6ba89bd19..4ff080e9e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml @@ -2,24 +2,23 @@ # Condition: Parent record does not exist, and NO name of event or intervention is coded # Rule: --OBJ = verbatim value Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0604 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: When findings are collected about an event or intervention, - and the name of the event or intervention is collected in an "Other, - specify" CRF field, the value in --OBJ variable depends on whether - the FA record has a parent record and whether the "Other, specify" - value was coded. - Document: IG v3.4 - Section: 4.2.7.4 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: 4.2.7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0604 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -34,9 +33,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - F - - A + - F + - A Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml index 440dc71dd..1ca86efc7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml @@ -2,24 +2,23 @@ # Condition: Parent record does not exist, and name of event or intervention is coded # Rule: --OBJ = coded value Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0605 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: When findings are collected about an event or intervention, - and the name of the event or intervention is collected in an "Other, - specify" CRF field, the value in --OBJ variable depends on whether - the FA record has a parent record and whether the "Other, specify" - value was coded. - Document: IG v3.4 - Section: 4.2.7.4 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: 4.2.7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0605 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -34,9 +33,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - F - - A + - F + - A Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml index 13d523ca2..89c5be804 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml @@ -2,44 +2,44 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTEST = name of the organism or antigen Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0607 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: In cases of tests that target an organism, group of - organisms, or antigen for identification, MBTEST equals the name - of the organism/antigen targeted by the identification assay. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0607 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: MBTEST - operator: not_equal_to - value: + - name: MBTEST + operator: not_equal_to + value: Core: Id: CDISC.SDTMIG.CG0607 Status: Draft Version: '1' -Description: Verify MBTEST equals the name of the organism/antigen targeted by the - identification assay. +Description: Verify MBTEST equals the name of the organism/antigen targeted by the identification + assay. Executability: Fully Executable Outcome: - Message: Test targets an organism, group of organisms, or antigen, but MBTEST is - not the name of the organism/antigen. + Message: Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of + the organism/antigen. Rule Type: Range and limit Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml index c321be4cb..a44161e6a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml @@ -2,45 +2,43 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTSTDTL='DETECTION' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0608 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: In cases of tests that target an organism, group of - organisms, or antigen for identification, MBTEST equals the name - of the organism/antigen targeted by the identification assay, and MBTSTDTL - should be “DETECTION”. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay, and MBTSTDTL should be “DETECTION”. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0608 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: MBTSTDTL - operator: not_equal_to - value: DETECTION + - name: MBTSTDTL + operator: not_equal_to + value: DETECTION Core: Id: CDISC.SDTMIG.CG0608 Status: Draft Version: '1' -Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group - of organisms, or antigen. +Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or + antigen. Executability: Fully Executable Outcome: - Message: Test targets an organism, group of organisms, or antigen, but MBTSTDTL - is not "DETECTION" + Message: Test targets an organism, group of organisms, or antigen, but MBTSTDTL is not "DETECTION" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml index e7e53b0cf..1c81f5c7b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml @@ -2,37 +2,35 @@ # Condition: Test for non-targeted identification of an organism # Rule: MBTESTCD='MCORGIDN' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0609 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For non-targeted identification of organisms (i.e., - tests that have the ability to identify a range of organisms without - specifically targeting any), the value for MBTESTCD/MBTEST should - be "MCORGIDN"/"Microbial Organism Identification", and the result - should be the name of the organism or group of organisms found - to be present. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For non-targeted identification of organisms (i.e., tests that have the + ability to identify a range of organisms without specifically targeting any), the value + for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the + result should be the name of the organism or group of organisms found to be present. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0609 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: MBTESTCD - operator: not_equal_to - value: MCORGIDN + - name: MBTESTCD + operator: not_equal_to + value: MCORGIDN Core: Id: CDISC.SDTMIG.CG0609 Status: Draft Version: '1' -Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification - of organisms. +Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of + organisms. Executability: Fully Executable Outcome: Message: Test targets an organism, group of organisms, or antigen, but @@ -40,8 +38,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml index 90671941a..63d338f22 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml @@ -2,45 +2,44 @@ # Condition: Test for culture characteristics # Rule: MBTEST = name of the organism or group of organisms Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0610 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Culture characteristics covers concepts such as growth/no - growth, colony quantification measures, colony color, colony morphology, - etc.... MBTESTCD/MBTEST should be the name of the organism or group - of organisms being characterized. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Culture characteristics covers concepts such as growth/no growth, colony + quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should + be the name of the organism or group of organisms being characterized. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0610 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: - - name: MBTEST - operator: not_equal_to - value: + - name: MBTEST + operator: not_equal_to + value: Core: Id: CDISC.SDTMIG.CG0610 Status: Draft Version: '1' -Description: If the test is for culture characteristics, verify that MBTEST equals - the name of the organism/antigen being characterized. +Description: If the test is for culture characteristics, verify that MBTEST equals the name of the + organism/antigen being characterized. Executability: Fully Executable Outcome: - Message: Test is for culture characteristics, but MBTEST is not the name of the organism - or group of organisms. + Message: Test is for culture characteristics, but MBTEST is not the name of the organism or group + of organisms. Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml index 8b8ea8a26..595a09e62 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml @@ -2,23 +2,23 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTEST = name of the organism or antigen Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0614 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: In cases of tests that target an organism, group of - organisms, or antigen for identification, MBTEST equals the name - of the organism/antigen targeted by the identification assay. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0614 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -33,8 +33,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml index 935acc3dc..c09ed2aba 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml @@ -2,24 +2,23 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTSTDTL = 'DETECTION' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0615 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: In cases of tests that target an organism, group of - organisms, or antigen for identification, MBTEST equals the name - of the organism/antigen targeted by the identification assay, and - MBTSTDTL should be “DETECTION”. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay, and MBTSTDTL should be “DETECTION”. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0615 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -34,8 +33,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml index 3612ebb92..354bef1d3 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml @@ -2,26 +2,24 @@ # Condition: Test for non-targeted identification of an organism # Rule: MBTESTCD = 'MCORGIDN' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0616 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: For non-targeted identification of organisms (i.e., - tests that have the ability to identify a range of organisms without - specifically targeting any), the value for MBTESTCD/MBTEST should - be "MCORGIDN"/"Microbial Organism Identification", and the result - should be the name of the organism or group of organisms found to - be present. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For non-targeted identification of organisms (i.e., tests that have the + ability to identify a range of organisms without specifically targeting any), the value + for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the + result should be the name of the organism or group of organisms found to be present. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0616 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -36,8 +34,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml index fbf778ff8..694978689 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml @@ -2,24 +2,23 @@ # Condition: Test for culture characteristics # Rule: MBTEST = name of the organism or group of organisms Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.4' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0617 - Version: '1' - Version: '2.0' - Citations: - - Cited Guidance: Culture characteristics covers concepts such as growth/no - growth, colony quantification measures, colony color, colony morphology, - etc.... MBTESTCD/MBTEST should be the name of the organism or group - of organisms being characterized. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Culture characteristics covers concepts such as growth/no growth, colony + quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should + be the name of the organism or group of organisms being characterized. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0617 + Version: '1' + Version: '2.0' + Version: '3.4' Check: all: [] Core: @@ -34,8 +33,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml index 91184c95b..ce776647c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml @@ -5,74 +5,72 @@ # if a library variable exists in the define, # it should exist in the datasets Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a - Permissible variable, then that variable must be included in - the SDTM dataset, even if null. Indicate no data were - available for that variable in the Define-XML document." - Document: IG v3.4 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0651 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a - Permissible variable, then that variable must be included in - the SDTM dataset, even if null. Indicate no data were - available for that variable in the Define-XML document. - Document: IG v3.3 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0651 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. Indicate + no data were available for that variable in the Define-XML document." + Document: IG v3.4 + Section: '2.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0651 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. Indicate + no data were available for that variable in the Define-XML document. + Document: IG v3.3 + Section: '2.5' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0651 + Version: '1' + Version: '2.0' + Version: '3.3' Check: all: - - name: define_variable_name - operator: is_contained_by - value: - - $permissible_variables - - name: define_variable_is_collected - operator: equal_to - value: true - - name: define_variable_name - operator: is_not_contained_by - value: $get_column_order_from_dataset + - name: define_variable_name + operator: is_contained_by + value: + - $permissible_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: define_variable_name + operator: is_not_contained_by + value: $get_column_order_from_dataset Core: Id: CDISC.SDTMIG.CG0651 Status: Draft Version: '1' -Description: Raise an error when variable Core Status = Permissible and data is - planned to be collected, but variable is not present +Description: Raise an error when variable Core Status = Permissible and data is planned to be + collected, but variable is not present Executability: Partially Executable - Possible Underreporting Operations: - - id: $permissible_variables - operator: permissible_variables - - id: $get_column_order_from_dataset - operator: get_column_order_from_dataset +- id: $permissible_variables + operator: permissible_variables +- id: $get_column_order_from_dataset + operator: get_column_order_from_dataset Outcome: - Message: Variable is missing, where variable core status is permissible and data - is planned to be collected. + Message: Variable is missing, where variable core status is permissible and data is planned to be + collected. Output Variables: - - define_variable_name - - $get_column_order_from_dataset + - define_variable_name + - $get_column_order_from_dataset Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml index 138171e56..0abc092b7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml @@ -2,76 +2,74 @@ # Condition: AP Core Domain # Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Associated Persons datasets are given a prefix of AP-- to - identify the data as AP data to and distinguish them from - study subject data. Associated Persons domain codes in the - DOMAIN column of every record are also given a prefix of AP-- - to identify the domains as AP domains and to distinguish them - from study subject domains. AP domain codes are therefore four - characters long. - Document: AP Guide v1.0 - Section: Section 2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0663 - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data. Associated Persons domain + codes in the DOMAIN column of every record are also given a prefix of AP-- to identify the + domains as AP domains and to distinguish them from study subject domains. AP domain codes + are therefore four characters long. + Document: AP Guide v1.0 + Section: Section 2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0663 + Version: '1' + Version: '2.0' + Version: '3.4' Check: any: # Fire query if domain name does not start with APFA and does not have the format "AP" followed by an alpha character, then an alphanum character - - all: - - name: DOMAIN - operator: not_prefix_matches_regex - prefix: 4 - value: ^APFA$ - - name: DOMAIN - operator: not_matches_regex - value: ^AP[A-Z][A-Z0-9]$ + - all: + - name: DOMAIN + operator: not_prefix_matches_regex + prefix: 4 + value: ^APFA$ + - name: DOMAIN + operator: not_matches_regex + value: ^AP[A-Z][A-Z0-9]$ # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character - - all: - - name: DOMAIN - operator: prefix_matches_regex - prefix: 4 - value: ^APFA$ - - name: DOMAIN - operator: not_suffix_matches_regex - suffix: 2 - value: '[A-Z0-9][A-Z0-9]$' + - all: + - name: DOMAIN + operator: prefix_matches_regex + prefix: 4 + value: ^APFA$ + - name: DOMAIN + operator: not_suffix_matches_regex + suffix: 2 + value: '[A-Z0-9][A-Z0-9]$' # Fire query if characters 3/4 refers to invalid SDTM domain - - name: DOMAIN - operator: suffix_is_not_contained_by - suffix: 2 - value: $valid_domain_name - # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) - name: DOMAIN - operator: matches_regex - value: ^APFA(AD|AX|AP|SQ|SA)$ + operator: suffix_is_not_contained_by + suffix: 2 + value: $valid_domain_name + # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) + - name: DOMAIN + operator: matches_regex + value: ^APFA(AD|AX|AP|SQ|SA)$ Core: Id: CDISC.SDTMIG.CG0663 Status: Draft Version: '1' -Description: Raise an error when an AP Core Domain does not have a value length - of 4 characters beginning with 'AP' and ending with 2 character SDTM domain +Description: Raise an error when an AP Core Domain does not have a value length of 4 characters + beginning with 'AP' and ending with 2 character SDTM domain Executability: Fully Executable Operations: - - id: $valid_domain_name - name: domain_suffix - operator: extract_metadata +- id: $valid_domain_name + name: domain_suffix + operator: extract_metadata Outcome: - Message: AP Core Domain does not have a value length of 4 characters beginning - with 'AP' and ending with 2 character SDTM domain + Message: AP Core Domain does not have a value length of 4 characters beginning with 'AP' and + ending with 2 character SDTM domain Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - AP-- + - AP-- Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml index f9330d567..bf18ad952 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml @@ -2,60 +2,59 @@ # Condition: # Rule: Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: xxx. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: yyyyyyy. - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0998 - Version: '2' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: xxx. + Document: IG v3.4 + Item: Item 3.b. + Section: '2.6' + - Cited Guidance: yyyyyyy. + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0998 + Version: '2' + Version: '2.0' + Version: '3.4' Check: any: - - name: TS - operator: not_exists - - name: TA - operator: not_exists - - name: TE - operator: not_exists + - name: TS + operator: not_exists + - name: TA + operator: not_exists + - name: TE + operator: not_exists Core: Id: CDISC.SDTMIG.CG0998 Status: Draft Version: '1' -Description: All TDM dataset(s) for the corresponding IG should be included in - every submission. +Description: All TDM dataset(s) for the corresponding IG should be included in every submission. Executability: Fully Executable Grouping_Variables: - - $study_domains +- $study_domains Operations: - - id: $study_domains - operator: study_domains - - id: $dataset_names - operator: dataset_names +- id: $study_domains + operator: study_domains +- id: $dataset_names + operator: dataset_names Outcome: Message: Missing one or more TDM dataset(s) Output Variables: - - $study_domains + - $study_domains # - dataset_name #Rule Type: Dataset Metadata Check Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml index 72df69234..40720ee52 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml @@ -2,62 +2,61 @@ # Condition: # Rule: Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: xxx. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: yyyyyyy. - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0999 - Version: '2' - Version: '2.0' - Version: '3.4' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: xxx. + Document: IG v3.4 + Item: Item 3.b. + Section: '2.6' + - Cited Guidance: yyyyyyy. + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0999 + Version: '2' + Version: '2.0' + Version: '3.4' Check: all: - - name: variable_name - operator: equal_to - value: library_variable_name - - name: variable_name - operator: equal_to - value: define_variable_name - - name: library_variable_ccode - operator: non_empty - - name: library_variable_ccode - operator: not_equal_to - value: define_variable_ccode + - name: variable_name + operator: equal_to + value: library_variable_name + - name: variable_name + operator: equal_to + value: define_variable_name + - name: library_variable_ccode + operator: non_empty + - name: library_variable_ccode + operator: not_equal_to + value: define_variable_ccode Core: Id: CDISC.SDTMIG.CG0999 Status: Draft Version: '1' -Description: Testing rule type Variables Metadata Check against Define XML and - Library Metadata +Description: Testing rule type Variables Metadata Check against Define XML and Library Metadata Executability: Fully Executable Outcome: Message: "Issue with codelist definition in the Define-XML document." Output Variables: - - variable_name - - library_variable_name - - library_variable_ccode - - library_variable_data_type - - define_variable_name - - define_variable_ccode + - variable_name + - library_variable_name + - library_variable_ccode + - library_variable_data_type + - define_variable_name + - define_variable_ccode Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011/rule.yml b/Unpublished/SDTMIG/CG0011/rule.yml index 51dea3977..13763c13a 100644 --- a/Unpublished/SDTMIG/CG0011/rule.yml +++ b/Unpublished/SDTMIG/CG0011/rule.yml @@ -1,57 +1,57 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: 'CDISC' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011' + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011' + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011' + Version: '1' + Version: '2.0' + Version: '3.4' Check: # REMARK: This rule is strongly related to rule SEND49 all: # variable has CT assigned - - name: define_variable_name - operator: is_not_contained_by - value: - - STUDYID - - DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN" + - name: define_variable_name + operator: is_not_contained_by + value: + - STUDYID + - DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN" # check whether variable has assigned CT in the CDISC Library - - name: library_variable_ccode - operator: non_empty + - name: library_variable_ccode + operator: non_empty # if yes, a "CodeListRef" must be available either on the "Variable-ItemDef" # or on each of the corresponding ValueList ItemDefs #- any: @@ -75,15 +75,15 @@ Executability: Fully Executable Outcome: Message: 'Test message' Output Variables: - - library_variable_ccode - - define_variable_ccode + - library_variable_ccode + - define_variable_ccode # Rule Type: Variable Metadata Check against Library Metadata Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - LB + - LB Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CG0011A1/rule.yml b/Unpublished/SDTMIG/CG0011A1/rule.yml index 2444277d6..e62aa9608 100644 --- a/Unpublished/SDTMIG/CG0011A1/rule.yml +++ b/Unpublished/SDTMIG/CG0011A1/rule.yml @@ -1,54 +1,54 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: 'CDISC' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A1' + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A1' + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A1' + Version: '1' + Version: '2.0' + Version: '3.4' Check: # PART A1: --DUR must be in ISO-8601 "duration" format all: - - name: --DUR - operator: non_empty - - name: --DUR + - name: --DUR + operator: non_empty + - name: --DUR # negative: true means: allow negative durations - negative: true - operator: invalid_duration + negative: true + operator: invalid_duration #- name: --DUR # operator: not_matches_regex # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ @@ -71,8 +71,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011A2/rule.yml b/Unpublished/SDTMIG/CG0011A2/rule.yml index a5488423e..9f0762753 100644 --- a/Unpublished/SDTMIG/CG0011A2/rule.yml +++ b/Unpublished/SDTMIG/CG0011A2/rule.yml @@ -1,52 +1,52 @@ # CG0011A = --DUR variables Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: 'CDISC' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A2' + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A2' + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011A2' + Version: '1' + Version: '2.0' + Version: '3.4' # Part A2: check whether --DUR is declared as "durationDatetime" Check: all: - - name: --DUR - negative: true - operator: invalid_duration + - name: --DUR + negative: true + operator: invalid_duration #operator: non_conformant_value_data_type #value: 'durationDatetime' Core: @@ -63,8 +63,8 @@ Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CG0011B1/rule.yml b/Unpublished/SDTMIG/CG0011B1/rule.yml index f15a84526..c4025f033 100644 --- a/Unpublished/SDTMIG/CG0011B1/rule.yml +++ b/Unpublished/SDTMIG/CG0011B1/rule.yml @@ -1,111 +1,111 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: 'CDISC' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011B1' + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011B1' + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011B1' + Version: '1' + Version: '2.0' + Version: '3.4' # TODO?: when 2 violations in same row, this is reported as 1 violation Check: any: - - all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: invalid_date - - all: - - name: --STDTC - operator: non_empty - - name: --STDTC - operator: invalid_date - - all: - - name: --ENDTC - operator: non_empty - - name: --ENDTC - operator: invalid_date + - all: + - name: --DTC + operator: non_empty + - name: --DTC + operator: invalid_date + - all: + - name: --STDTC + operator: non_empty + - name: --STDTC + operator: invalid_date + - all: + - name: --ENDTC + operator: non_empty + - name: --ENDTC + operator: invalid_date # DM-specific date/time variables - - all: - - name: RFSTDTC - operator: non_empty - - name: RFSTDTC - operator: invalid_date - - all: - - name: RFENDTC - operator: non_empty - - name: RFENDTC - operator: invalid_date - - all: - - name: RFXSTDTC - operator: non_empty - - name: RFXSTDTC - operator: invalid_date - - all: - - name: RFXENDTC - operator: non_empty - - name: RFXENDTC - operator: invalid_date - - all: - - name: RFCSTDTC - operator: non_empty - - name: RFCSTDTC - operator: invalid_date - - all: - - name: RFCENDTC - operator: non_empty - - name: RFCENDTC - operator: invalid_date - - all: - - name: RFICDTC - operator: non_empty - - name: RFICDTC - operator: invalid_date - - all: - - name: RFPENDTC - operator: non_empty - - name: RFPENDTC - operator: invalid_date - - all: - - name: DTHDTC - operator: non_empty - - name: DTHDTC - operator: invalid_date - - name: BRTHDTC + - all: + - name: RFSTDTC + operator: non_empty + - name: RFSTDTC + operator: invalid_date + - all: + - name: RFENDTC + operator: non_empty + - name: RFENDTC + operator: invalid_date + - all: + - name: RFXSTDTC + operator: non_empty + - name: RFXSTDTC + operator: invalid_date + - all: + - name: RFXENDTC + operator: non_empty + - name: RFXENDTC + operator: invalid_date + - all: + - name: RFCSTDTC + operator: non_empty + - name: RFCSTDTC + operator: invalid_date + - all: + - name: RFCENDTC + operator: non_empty + - name: RFCENDTC + operator: invalid_date + - all: + - name: RFICDTC + operator: non_empty + - name: RFICDTC + operator: invalid_date + - all: + - name: RFPENDTC + operator: non_empty + - name: RFPENDTC + operator: invalid_date + - all: + - name: DTHDTC + operator: non_empty + - name: DTHDTC operator: invalid_date + - name: BRTHDTC + operator: invalid_date Core: Status: Draft Version: '1' @@ -117,8 +117,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011C2/rule.yml b/Unpublished/SDTMIG/CG0011C2/rule.yml index 6a15bd167..8d6b27801 100644 --- a/Unpublished/SDTMIG/CG0011C2/rule.yml +++ b/Unpublished/SDTMIG/CG0011C2/rule.yml @@ -1,45 +1,45 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format - guidelines for variables, when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.4' +- Organization: 'CDISC' + Standards: + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011C2' + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011C2' + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: 'SDTMIG' + References: + - Citations: + - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided' + Document: 'SDTMIG' + Section: '3.2.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: 'CG0011C2' + Version: '1' + Version: '2.0' + Version: '3.4' # CG0011C2: if the variable is under controlled terminology (according CDISC-Library) # then a CodeList must be referenced in the define.xml Check: @@ -63,31 +63,30 @@ Check: #- name: library_variable_ccode # operator: equal_to # value: true - - name: library_variable_ccode - operator: non_empty - - name: define_variable_has_codelist - operator: equal_to - value: false + - name: library_variable_ccode + operator: non_empty + - name: define_variable_has_codelist + operator: equal_to + value: false Core: Status: Draft Version: '1' -Description: 'Variables that are under CT must have an associated codelist - defined in the define.xml' +Description: 'Variables that are under CT must have an associated codelist defined in the define.xml' Executability: Fully Executable Outcome: - Message: 'The variable is under controlled terminology, but no codelist has been - defined for it in the define.xml' + Message: 'The variable is under controlled terminology, but no codelist has been defined for it in the + define.xml' Output Variables: - - library_variable_ccode + - library_variable_ccode # Rule Type: Define Item Metadata Check against Library Metadata # Rule Type: Define Item Metadata Check against Library Metadata Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000205/rule.yml b/Unpublished/SDTMIG/CORE-000205/rule.yml index bcf2558c4..1e6ecbb01 100644 --- a/Unpublished/SDTMIG/CORE-000205/rule.yml +++ b/Unpublished/SDTMIG/CORE-000205/rule.yml @@ -2,47 +2,47 @@ # Condition: --ULOQ present in dataset # Rule: --ULOQ is expressed using the units in --STRESU Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units will be those used for --STRESU. - Document: Model v2.0 - Item: --ULOQ - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units - will be those used for --STRESU. - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units - will be those used for --STRESU. - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units will be those used for --STRESU. + Document: Model v2.0 + Item: --ULOQ + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000205 Status: Draft @@ -55,8 +55,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000343/rule.yml b/Unpublished/SDTMIG/CORE-000343/rule.yml index 6037e40b9..2735e39c7 100644 --- a/Unpublished/SDTMIG/CORE-000343/rule.yml +++ b/Unpublished/SDTMIG/CORE-000343/rule.yml @@ -2,63 +2,63 @@ # Condition: # Rule: Variable Format = SDTM-specified controlled terminology and format guidelines for variables, when provided Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format - guidelines for variables, when provided - Document: IG v3.4 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format - guidelines for variables, when provided - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format - guidelines for variables, when provided - Document: IG v3.3 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.4 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.3 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000343 Status: Draft Version: '1' -Description: Trigger error when variable format does not match SDTM-specified - controlled terminology or format guidelines for variables (when provided) +Description: Trigger error when variable format does not match SDTM-specified controlled terminology + or format guidelines for variables (when provided) Executability: Not Executable Outcome: - Message: Variable format does not match SDTM-specified controlled terminology or - format guidelines for variables (when provided) + Message: Variable format does not match SDTM-specified controlled terminology or format guidelines + for variables (when provided) Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CORE-000344/rule.yml b/Unpublished/SDTMIG/CORE-000344/rule.yml index 73311323c..57c4d606c 100644 --- a/Unpublished/SDTMIG/CORE-000344/rule.yml +++ b/Unpublished/SDTMIG/CORE-000344/rule.yml @@ -2,83 +2,77 @@ # Condition: Use of value 'MULTIPLE' is appropriate to the data being represented # Rule: Value in associated codelist or 'MULTIPLE' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated - by following SDTM-specified controlled terminology and format - guidelines for variables, when provided - Document: IG v3.4 - Section: 3.2.2 - - Cited Guidance: The SDTM permits one value for each Qualifier variable per - record. If multiple values exist (e.g., due to a "Check all - that apply" instruction on a CRF), then the value for the - Qualifier variable should be "MULTIPLE" and SUPP-- should be - used to store the individual responses. - Document: IG v3.4 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally - indicated by following SDTM-specified controlled terminology - and format guidelines for variables, when - provided]4.1.2.8.3[The SDTM permits one value for each - Qualifier variable per record. If multiple values exist (e.g., - due to a "Check all that apply" instruction on a CRF), then - the value for the Qualifier variable should be "MULTIPLE" and - SUPP-- should be used to store the individual responses.] - Document: IG v3.2 - Section: 3.2.2|4.1.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally - indicated by following SDTM-specified controlled terminology - and format guidelines for variables, when provided]4.2.8.3[The - SDTM permits one value for each Qualifier variable per record. - If multiple values exist (e.g., due to a "Check all that - apply" instruction on a CRF), then the value for the Qualifier - variable should be "MULTIPLE" and SUPP-- should be used to - store the individual responses.] - Document: IG v3.3 - Section: 3.2.2|4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided + Document: IG v3.4 + Section: 3.2.2 + - Cited Guidance: The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses. + Document: IG v3.4 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]4.1.2.8.3[The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses.] + Document: IG v3.2 + Section: 3.2.2|4.1.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]4.2.8.3[The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses.] + Document: IG v3.3 + Section: 3.2.2|4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000344 Status: Draft Version: '1' -Description: Trigger error if the value of a variable, which is associated with - an extensible codelist, is in the associated codelist or equal to 'MULTIPLE' +Description: Trigger error if the value of a variable, which is associated with an extensible + codelist, is in the associated codelist or equal to 'MULTIPLE' Executability: Not Executable Outcome: - Message: Variable is not equal to value within the extensible codelist, nor - equal to MULTIPLE + Message: Variable is not equal to value within the extensible codelist, nor equal to MULTIPLE Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000345/rule.yml b/Unpublished/SDTMIG/CORE-000345/rule.yml index fe62b7e49..e30c077e5 100644 --- a/Unpublished/SDTMIG/CORE-000345/rule.yml +++ b/Unpublished/SDTMIG/CORE-000345/rule.yml @@ -2,77 +2,71 @@ # Condition: Variable associated with extensible codelist and the use of value 'OTHER' is appropriate to the data being represented # Rule: Value in associated codelist or 'OTHER' Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated - by following SDTM-specified controlled terminology and format - guidelines for variables, when provided - Document: IG v3.4 - Section: 3.2.2 - - Cited Guidance: When the CRF includes a list of values for a qualifier field - that includes "Other" and the "Other" is supplemented with a - "Specify" free text field - Document: IG v3.4 - Section: 4.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally - indicated by following SDTM-specified controlled terminology - and format guidelines for variables, when - provided]|4.1.2.7.1[When the CRF includes a list of values for - a qualifier field that includes "Other" and the "Other" is - supplemented with a "Specify" free text field,] - Document: IG v3.2 - Section: 3.2.2|4.1.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally - indicated by following SDTM-specified controlled terminology - and format guidelines for variables, when - provided]|4.2.7.1[When the CRF includes a list of values for a - qualifier field that includes "Other" and the "Other" is - supplemented with a "Specify" free text field,] - Document: IG v3.3 - Section: 3.2.2|4.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided + Document: IG v3.4 + Section: 3.2.2 + - Cited Guidance: When the CRF includes a list of values for a qualifier field that includes + "Other" and the "Other" is supplemented with a "Specify" free text field + Document: IG v3.4 + Section: 4.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]|4.1.2.7.1[When the CRF includes a list of values for a qualifier field that + includes "Other" and the "Other" is supplemented with a "Specify" free text field,] + Document: IG v3.2 + Section: 3.2.2|4.1.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]|4.2.7.1[When the CRF includes a list of values for a qualifier field that + includes "Other" and the "Other" is supplemented with a "Specify" free text field,] + Document: IG v3.3 + Section: 3.2.2|4.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000345 Status: Draft Version: '1' -Description: Trigger error if the value of a variable, which is associated with - an extensible codelist, is in the associated codelist or equal to 'OTHER' +Description: Trigger error if the value of a variable, which is associated with an extensible + codelist, is in the associated codelist or equal to 'OTHER' Executability: Not Executable Outcome: - Message: Variable is not equal to value within the extensible codelist, nor - equal to OTHER + Message: Variable is not equal to value within the extensible codelist, nor equal to OTHER Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000346/rule.yml b/Unpublished/SDTMIG/CORE-000346/rule.yml index 11ffac590..9dda2b8e3 100644 --- a/Unpublished/SDTMIG/CORE-000346/rule.yml +++ b/Unpublished/SDTMIG/CORE-000346/rule.yml @@ -2,50 +2,50 @@ # Condition: --TERM modified for coding # Rule: --MODIFY ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value which represents an alteration to a collected value for - coding purposes. Synonym Qualifier of --TERM. - Document: Model v2.0 - Item: --MODIFY - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TERM is modified for coding purposes, then - the modified text is placed here. - Document: Model v1.4 - Item: Table 2.2.2 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TERM is modified for coding purposes, then - the modified text is placed here. - Document: Model v1.7 - Item: Table 2.2.2.1 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A value which represents an alteration to a collected value for coding + purposes. Synonym Qualifier of --TERM. + Document: Model v2.0 + Item: --MODIFY + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the value for --TERM is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.4 + Item: Table 2.2.2 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the value for --TERM is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.7 + Item: Table 2.2.2.1 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000346 Status: Draft @@ -58,8 +58,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000347/rule.yml b/Unpublished/SDTMIG/CORE-000347/rule.yml index 07583dd8d..22bca925a 100644 --- a/Unpublished/SDTMIG/CORE-000347/rule.yml +++ b/Unpublished/SDTMIG/CORE-000347/rule.yml @@ -2,87 +2,85 @@ # Condition: DSCAT = 'DISPOSITION EVENT' # Rule: DSTERM = 'COMPLETED' or the reason for discontinuation Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either - "COMPLETED" or, if the subject did not complete, specific - verbatim information about the reason for non-completion - Document: IG v3.4 - Item: Assumption 3b - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT='DISPOSITION EVENT", DSTERM contains either - "COMPLETED" or, if the subject did not complete, specific - verbatim information about the disposition event - Document: IG v3.2 - Item: Assumption 3a - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either - "COMPLETED" or, if the subject did not complete, specific - verbatim information about the reason for non-completion - Document: IG v3.3 - Item: Assumption 3b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains - either "COMPLETED" or, if the subject did not complete, - specific verbatim information about the reason for - non-completion - Document: TIG v1.0 - Item: Assumption 3b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0340 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: IG v3.4 + Item: Assumption 3b + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When DSCAT='DISPOSITION EVENT", DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the disposition event + Document: IG v3.2 + Item: Assumption 3a + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: IG v3.3 + Item: Assumption 3b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: TIG v1.0 + Item: Assumption 3b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0340 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Core: Id: CORE-000347 Status: Draft Version: '1' -Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not - equal 'COMPLETED' or the reason for discontinuation +Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or + the reason for discontinuation Executability: Not Executable Outcome: - Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation - when DSCAT = 'DISPOSITION EVENT' + Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT = + 'DISPOSITION EVENT' Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000348/rule.yml b/Unpublished/SDTMIG/CORE-000348/rule.yml index 9512156da..a6d2505b7 100644 --- a/Unpublished/SDTMIG/CORE-000348/rule.yml +++ b/Unpublished/SDTMIG/CORE-000348/rule.yml @@ -2,59 +2,56 @@ # Condition: # Rule: Event is not derived Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol - deviations and not for derived protocol deviations that are - more likely to be part of analysis. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol - deviations and not for derived protocol deviations that are - more likely to be part of analysis - Document: IG v3.2 - Item: Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol - deviations and not for derived protocol deviations that are - more likely to be part of analysis. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis + Document: IG v3.2 + Item: Assumption 1 + Section: '6.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000348 Status: Draft Version: '1' -Description: Trigger error if deviation record is a derived variable, not a - deviation that was collected +Description: Trigger error if deviation record is a derived variable, not a deviation that was + collected Executability: Not Executable Outcome: Message: Deviation event must not be derived deviation @@ -62,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DV + - DV Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000349/rule.yml b/Unpublished/SDTMIG/CORE-000349/rule.yml index 8b83f57c9..37a25028c 100644 --- a/Unpublished/SDTMIG/CORE-000349/rule.yml +++ b/Unpublished/SDTMIG/CORE-000349/rule.yml @@ -2,53 +2,50 @@ # Condition: # Rule: CMTRT = collected medication name only Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should - not include dosage, formulation, or other qualifying - information. - Document: IG v3.4 - Item: Assumption 2a - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should - not include dosage, formulation, or other qualifying - information. - Document: IG v3.2 - Item: Assumption 2a - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should - not include dosage, formulation, or other qualifying - information. - Document: IG v3.3 - Item: Assumption 2a - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.4 + Item: Assumption 2a + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.2 + Item: Assumption 2a + Section: '6.1' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.3 + Item: Assumption 2a + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000349 Status: Draft @@ -61,8 +58,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM + - CM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000350/rule.yml b/Unpublished/SDTMIG/CORE-000350/rule.yml index 6926731d4..2f6d8ab60 100644 --- a/Unpublished/SDTMIG/CORE-000350/rule.yml +++ b/Unpublished/SDTMIG/CORE-000350/rule.yml @@ -2,54 +2,54 @@ # Condition: --TRT modified # Rule: --MODIFY ^= null Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value which represents an alteration to a collected value for - coding purposes. Synonym Qualifier of --TRT. - Document: Model v2.0 - Item: --MODIFY - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TRT is modified for coding purposes, then the - modified text is placed here. - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TRT is modified for coding purposes, then the - modified text is placed here. - Document: Model v1.7 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.3' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A value which represents an alteration to a collected value for coding + purposes. Synonym Qualifier of --TRT. + Document: Model v2.0 + Item: --MODIFY + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the value for --TRT is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: If the value for --TRT is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.7 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: '1' + Version: '2.0' + Version: '3.3' Core: Id: CORE-000350 Status: Draft Version: '1' -Description: Trigger error if --TRT represents an alteration to the collected - value for coding purposes and --MODIFY is null +Description: Trigger error if --TRT represents an alteration to the collected value for coding + purposes and --MODIFY is null Executability: Not Executable Outcome: Message: --MODIFY is null when --TRT represents an alteration to the collected value. @@ -57,9 +57,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM - - SU + - CM + - SU Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000536/rule.yml b/Unpublished/SDTMIG/CORE-000536/rule.yml index 67dbc123e..cff437772 100644 --- a/Unpublished/SDTMIG/CORE-000536/rule.yml +++ b/Unpublished/SDTMIG/CORE-000536/rule.yml @@ -2,62 +2,59 @@ # Condition: # Rule: ARMCD is a valid planned arm code Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the - trial. - Document: IG 3.4 - Item: '' - Section: 7.2.1 TA - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The trial arms table describes each planned arm in the trial. - Document: IG v3.2 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the - trial. - Document: IG v3.3 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the - trial. - Document: TIG 1.0 - Item: '' - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0570 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: IG 3.4 + Item: '' + Section: 7.2.1 TA + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The trial arms table describes each planned arm in the trial. + Document: IG v3.2 + Section: '7.2' + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: '1' + Version: '2.0' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: IG v3.3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: TIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: TIG 1.0 + Item: '' + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0570 + Version: '1' + Version: '1.0' + Substandard: SDTM + Version: '1.0' Check: all: Core: @@ -72,9 +69,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH Sensitivity: Record diff --git a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml index d48ff4493..fbbb95503 100644 --- a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml +++ b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml @@ -1,56 +1,56 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: '1' + Version: '2.0' + Version: '3.2' Check: all: - - name: $valid_code_term_pairs - operator: not_equal_to - value: true + - name: $valid_code_term_pairs + operator: not_equal_to + value: true Core: Id: '' Status: Draft Version: '1' Description: MEDDRA CODE TERM PAIRS are wrong for SOCCD Operations: - - id: $valid_code_term_pairs - name: --SOCCD - operator: valid_meddra_code_term_pairs +- id: $valid_code_term_pairs + name: --SOCCD + operator: valid_meddra_code_term_pairs Outcome: Message: Invalid whodrug code hierarcy Output Variables: - - USUBJID - - --SOC - - --SOCCD + - USUBJID + - --SOC + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/NicTest/rule.yml b/Unpublished/SDTMIG/NicTest/rule.yml index 13c053fbf..5af88468a 100644 --- a/Unpublished/SDTMIG/NicTest/rule.yml +++ b/Unpublished/SDTMIG/NicTest/rule.yml @@ -1,29 +1,27 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - Version: '3.3' - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: Demo - Version: '1.0' - Version: '2.0' - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe - or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation - of the collected doses not taken, not given, or missed. Dose amount - variables (e.g., ECDOSE, ECDOSTXT) must not be set to zero (0) as - an alternative method for indicating doses not taken, not given, - or missed. - Document: SDTMIG v3.3 - Item: Assumption 4a - Section: 6.1.3.2 +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: SDTMIG v3.3 + Item: Assumption 4a + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: Demo + Version: '1.0' + Version: '2.0' + Version: '3.3' Check: all: - - name: EXOCCUR - operator: not_equal_to - value: N + - name: EXOCCUR + operator: not_equal_to + value: N Core: Id: NicTest Status: Draft @@ -35,8 +33,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Sensitivity: Record diff --git a/Unpublished/SDTMIG/WHODrug/rule.yml b/Unpublished/SDTMIG/WHODrug/rule.yml index 0aba16261..5eedcf743 100644 --- a/Unpublished/SDTMIG/WHODrug/rule.yml +++ b/Unpublished/SDTMIG/WHODrug/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.2' +- Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: '1' + Version: '2.0' + Version: '3.4' + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: '1' + Version: '2.0' + Version: '3.3' + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: '1' + Version: '2.0' + Version: '3.2' Check: all: - - name: $valid_whodrug_codes - operator: not_equal_to - value: true + - name: $valid_whodrug_codes + operator: not_equal_to + value: true Core: Id: WHODrug Status: Draft @@ -37,20 +37,20 @@ Core: Description: WHODRUG hierarchy is valid in provided whodrug dictionary version Executability: Fully Executable Operations: - - id: $valid_whodrug_codes - operator: whodrug_code_hierarchy +- id: $valid_whodrug_codes + operator: whodrug_code_hierarchy Outcome: Message: Invalid whodrug code hierarcy Output Variables: - - --DECOD - - --CLAS - - --CLASCD + - --DECOD + - --CLAS + - --CLASCD Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml index 7832893ee..fcc8fff54 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml @@ -1,94 +1,94 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.0 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFENDTC in the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.0 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: variable_name - operator: equal_to - value: RFENDTC - - any: + - name: variable_name + operator: equal_to + value: RFENDTC + - any: # TODO: change into define_variable_has_method (function requested https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) - - name: define_variable_has_comment - operator: equal_to - value: false + - name: define_variable_has_comment + operator: equal_to + value: false #- name: define_variable_origin_type # operator: equal_to # value: Derived @@ -96,20 +96,18 @@ Core: Id: CDISC.SENDIG.101 Status: Draft Version: '1' -Description: Raise a message when the define.xml does not explain how DM.RFENDTC - was populated, using either def:CommentOID (on ItemDef) or MethodOID (on - ItemRef) +Description: Raise a message when the define.xml does not explain how DM.RFENDTC was populated, + using either def:CommentOID (on ItemDef) or MethodOID (on ItemRef) Executability: Partially Executable - Possible Underreporting Outcome: - Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the - variable RFENDTC + Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the variable RFENDTC # Rule Type: Value Check against Define XML Variable Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml index d4de8277e..9f5177f35 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml @@ -1,89 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.2 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.2 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: '2' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.2 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.2 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: '2' + Version: '5.0' + Version: '1.0' Check: # Rule applies for the case that all of DM, TS, and TX are all present # which applies to >99% of the cases # When one of the above domains is not present, the rule may be skipped all: # DM: SPECIES variable does not exists - - name: SPECIES - operator: not_exists + - name: SPECIES + operator: not_exists # There is no TSPARMCD=SPECIES in TS #- name: $distinct_tsparmcd # operator: does_not_contain @@ -100,9 +95,8 @@ Core: Id: CDISC.SENDIG.105 Status: Draft Version: '1' -Description: Raise an error when the variable SPECIES is not present in DM, and - there is no record TSPARMCD=SPECIES in TS and there is no record - TXPARMCD=SPECIES in TX +Description: Raise an error when the variable SPECIES is not present in DM, and there is no record + TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX Executability: Fully Executable #Operations: # gets the distinct values of TSPARMCD @@ -120,8 +114,8 @@ Executability: Fully Executable # name: TXPARMCD # operator: distinct Outcome: - Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in - TS and there is no record TXPARMCD=SPECIES in TX + Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is + no record TXPARMCD=SPECIES in TX #Output Variables: # - $distinct_tsparmcd # - $distinct_txparmcd @@ -130,12 +124,12 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE # #- TRIAL DESIGN # - ALL Domains: Include: - - DM + - DM # - ALL # Sensitivity: Record Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml index e1d6543ae..cf4bbfe3b 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml @@ -1,20 +1,19 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the - TA domain. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND107 - Version: '1' - Version: '5.0' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the TA domain. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND107 + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: # TODO: operator "exists" must act on the set of datasets (i.e. the whole submission) @@ -32,41 +31,40 @@ Check: # operator: equal_to # value: true # Just trying an alternative 2024-06-04 - - name: ARMCD - operator: empty + - name: ARMCD + operator: empty #- name: $TA_exists # operator: equal_to # value: true - - name: $TA_present - operator: equal_to - value: true + - name: $TA_present + operator: equal_to + value: true Core: Id: CDISC.SENDIG.107 Status: Draft Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is - populated, ARMCD must be present in TA.ARMCD. This rule has been executed to - identify all cases when ARMCD is not present in TA.ARMCD and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + multi-stage arm assignments are in use. Executability: Fully Executable Operations: - - domain: DM # necessary? - id: $DM_ARMCD_null - name: ARMCD - operator: variable_is_null +- domain: DM # necessary? + id: $DM_ARMCD_null + name: ARMCD + operator: variable_is_null # Alternative approach 2024-06-04 # BUT this fails when there is no TA dataset at all - - domain: TA - id: $TA_exists - name: ARMCD - operator: variable_exists +- domain: TA + id: $TA_exists + name: ARMCD + operator: variable_exists # 2024-06-04: does this check whether TA is present in the study? # NO: it doesn't like that it works as I was thinking - - id: $TA_present - name: TA - operator: study_domains +- id: $TA_present + name: TA + operator: study_domains Outcome: Message: Arms are defined in TA.ARMCD, but DM.ARMCD is empty # Rule Type: Record Data @@ -74,10 +72,10 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE # - ALL Domains: Include: - - DM + - DM # - TA # ? Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml index 3fbc1c34e..b27c3f640 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml @@ -1,86 +1,86 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.0 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.0 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: variable_name - operator: equal_to - value: BRTHDTC - - name: define_variable_is_collected - operator: equal_to - value: false + - name: variable_name + operator: equal_to + value: BRTHDTC + - name: define_variable_is_collected + operator: equal_to + value: false Core: Id: CDISC.SENDIG.111 Status: Draft @@ -94,8 +94,8 @@ Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml index 65ca53656..f77eb70d1 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml @@ -1,103 +1,103 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.0 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm - involving BRTHDTC and RFSTDTC. Sponsors should indicate how - AGE was populated in the define file comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.0 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: variable_name - operator: equal_to - value: AGE + - name: variable_name + operator: equal_to + value: AGE # This may cause to be "overreporting", as there is no function define_variable_is_derived # but essentially, AGE should not be "assigned" - - name: define_variable_is_collected - operator: equal_to - value: false - - name: define_variable_has_comment - operator: equal_to - value: false + - name: define_variable_is_collected + operator: equal_to + value: false + - name: define_variable_has_comment + operator: equal_to + value: false # Commented out for the moment, as awaiting new function #- name: define_variable_has_method # operator: equal_to @@ -106,18 +106,18 @@ Core: Id: CDISC.SENDIG.112 Status: Draft Version: '1' -Description: When AGE is described as "derived" in the define.xml, check whether - either a Method or a Comment is assigned to the variable AGE in the define.xml +Description: When AGE is described as "derived" in the define.xml, check whether either a Method or + a Comment is assigned to the variable AGE in the define.xml Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'When AGE is described as "derived" in the define.xml, either a Comment - or a Method must be associated to the variable in the define.xml' + Message: 'When AGE is described as "derived" in the define.xml, either a Comment or a Method must be + associated to the variable in the define.xml' Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml index d4fb5b3da..3c625caad 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml @@ -1,44 +1,43 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because there are no time gaps between Elements, the - SEENDTC value for the last Element is the date of subject disposition. +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC value for the + last Element is the date of subject disposition. # ATTENTION: only applicable to SENDIG-3.0 # REPLACED by rule 284 as of SENDIG-3-1 - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND127 - Version: '1' - Version: '5.0' - Version: '3.1' + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND127 + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: # TODO: operator "exists" must act on the set of datasets (i.e. the whole submission) - - name: SEENDTC - operator: not_equal_to - value: '2006-06-10' + - name: SEENDTC + operator: not_equal_to + value: '2006-06-10' Core: Id: CDISC.SENDIG.127 Status: Draft Version: '1' -Description: Because there are no time gaps between Elements, the SEENDTC value for - the last Element is the date of subject disposition. +Description: Because there are no time gaps between Elements, the SEENDTC value for the last Element + is the date of subject disposition. Executability: Fully Executable Outcome: - Message: SEENDTC value of last element in SE is not equal to DSSTDTC in DS for the - subject + Message: SEENDTC value of last element in SE is not equal to DSSTDTC in DS for the subject Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml index 83ef5d2e6..e8b1aa14b 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml @@ -1,46 +1,45 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Define-XML document contains an explanation of - EXDOSE values with respect for intended or actual dose levels. - Document: IG v3.1 - Item: Assumption 4 - Section: 6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND137 - Version: '1' - Version: '5.0' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Define-XML document contains an explanation of EXDOSE values with + respect for intended or actual dose levels. + Document: IG v3.1 + Item: Assumption 4 + Section: 6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND137 + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: - - name: variable_name - operator: equal_to - value: EXDOSE - - name: define_variable_has_comment - operator: equal_to - value: false + - name: variable_name + operator: equal_to + value: EXDOSE + - name: define_variable_has_comment + operator: equal_to + value: false Core: Id: CDISC.SENDIG.137 Status: Draft Version: '1' -Description: Raise a message when the define.xml does not contain an explanation of - EXDOSE values with respect for intended or actual dose levels, using a reference - to a def:CommentDef +Description: Raise a message when the define.xml does not contain an explanation of EXDOSE values + with respect for intended or actual dose levels, using a reference to a def:CommentDef Executability: Partially Executable - Possible Underreporting Outcome: - Message: The define.xml does not contain an explanation of EXDOSE values with respect - for intended or actual dose levels + Message: The define.xml does not contain an explanation of EXDOSE values with respect for intended + or actual dose levels # Rule Type: Value Check against Define XML Variable Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml index f458f5ad9..8c6f7ccab 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml @@ -1,74 +1,70 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a - record of the final disposition of subjects as they reach - their final disposition, and this can be recorded at any stage - throughout the study. At study completion, one record must - exist for each subject used in the study. - Document: IG v3.0 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a - record of the final disposition of subjects as they reach - their final disposition, and this can be recorded at any stage - throughout the study. At study completion, one record must - exist for each subject used in the study. - Document: IG v3.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a - record of the final disposition of subjects as they reach - their final disposition, and this can be recorded at any stage - throughout the study. At study completion, one record must - exist for each subject used in the study. - Document: IG v3.1.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a - record of the final disposition of subjects as they reach - their final disposition, and this can be recorded at any stage - throughout the study. At study completion, one record must - exist for each subject used in the study. - Document: IG v3.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.0 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: '1' + Version: '5.0' + Version: '1.1' Check: # Rule: DS has one record per USUBJID in DM any: @@ -80,12 +76,12 @@ Check: # operator: is_not_contained_by # value: $dm_usubjid # DM.USUBJID must be in DS.USUBJID - - all: - - name: USUBJID - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $ds_usubjid + - all: + - name: USUBJID + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $ds_usubjid # TODO: how do we express that for each record in DM, there must exactly be one record in DS? Core: @@ -99,21 +95,20 @@ Operations: # id: $dm_usubjid # name: USUBJID # operator: distinct - - domain: DS - id: $ds_usubjid - name: USUBJID - operator: distinct +- domain: DS + id: $ds_usubjid + name: USUBJID + operator: distinct Outcome: - Message: There is no record in DS or there is more than 1 record in DS for a - record in DM + Message: There is no record in DS or there is more than 1 record in DS for a record in DM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - EVENTS + - SPECIAL PURPOSE + - EVENTS Domains: Include: # - DS - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml index 6d00ddf1f..b71ab189b 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml @@ -1,95 +1,90 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to - kg, but the BGSTRESU should remain consistent throughout the - course of the study. - Document: IG v3.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU for a subject may change over the course of the - study, for example, g to kg, but the BGSTRESU should remain - consistent throughout the course of the study. - Document: IG v3.0 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to - kg, but the BGSTRESU should remain consistent throughout the - course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to - kg, but the BGSTRESU should remain consistent throughout the - course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to - kg, but the BGSTRESU should remain consistent throughout the - course of the study. - Document: IG v3.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to - kg, but the BGSTRESU should remain consistent throughout the - course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The BGORRESU for a subject may change over the course of the study, for + example, g to kg, but the BGSTRESU should remain consistent throughout the course of the + study. + Document: IG v3.0 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: BGSTRESU - operator: is_inconsistent_across_dataset - value: BGTESTCD + - name: BGSTRESU + operator: is_inconsistent_across_dataset + value: BGTESTCD Core: Id: CDISC.SENDIG.153 Status: Draft @@ -99,14 +94,14 @@ Executability: Fully Executable Outcome: Message: BGSTRESU is not consistent within BGTESTCD Output Variables: - - BGSTRESU - - BGTESTCD + - BGSTRESU + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml index 76966aafb..f4e8c8edd 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml @@ -1,89 +1,88 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization - of results and should not be a duplication of CLTEST or CLSCAT which - are considered categories at the time of collection. - Document: IG v.3.0 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization - of results and should not be a duplication of CLTEST or CLSCAT which - are considered categories at the time of collection. - Document: IG v.3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization - of results and should not be a duplication of CLTEST or CLSCAT which - are considered categories at the time of collection. - Document: IG v.3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization - of results and should not be a duplication of CLTEST or CLSCAT which - are considered categories at the time of collection. - Document: IG v.3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.0 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: '1' + Version: '5.0' + Version: '1.1' Check: any: - - name: CLRESCAT - operator: equal_to - value: CLTEST - - name: CLRESCAT - operator: equal_to - value: CLSCAT + - name: CLRESCAT + operator: equal_to + value: CLTEST + - name: CLRESCAT + operator: equal_to + value: CLSCAT Core: Id: CDISC.SENDIG.161 Status: Draft Version: '1' -Description: Trigger error when CLRESCAT is equal to CLTEST or when CLRESCAT is equal - to CLSCAT +Description: Trigger error when CLRESCAT is equal to CLTEST or when CLRESCAT is equal to CLSCAT Executability: Fully Executable Outcome: Message: CLRESCAT may not be equal to CLTEST and CLRESCAT may not be equal to CLSCAT Output Variables: - - CLRESCAT - - CLTEST - - CLSCAT + - CLRESCAT + - CLTEST + - CLSCAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL + - CL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml index 7e8848899..a4e9045f8 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml @@ -1,88 +1,86 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: #- name: MIDTC # operator: non_empty #- name: MISPEC # operator: non_empty - - name: USUBJID - operator: is_not_unique_set - value: - - MISTESTCD - - MISPEC - - MISTRESC - - MILAT # Laterality: when present and populated - - MIDIR # Directionality: when present and populated - - MIANTREG # Anatomical region: when present and populated + - name: USUBJID + operator: is_not_unique_set + value: + - MISTESTCD + - MISPEC + - MISTRESC + - MILAT # Laterality: when present and populated + - MIDIR # Directionality: when present and populated + - MIANTREG # Anatomical region: when present and populated Core: Id: CDISC.SENDIG.180 Status: Draft Version: '1' -Description: Raise an error when there is more than one record present for any - particular Microscopic Finding in the MI Domain, for a specific subject, test - code, specimen, laterality, directionality, anatomical region and standardized - resulz +Description: Raise an error when there is more than one record present for any particular + Microscopic Finding in the MI Domain, for a specific subject, test code, specimen, laterality, + directionality, anatomical region and standardized resulz Executability: Fully Executable Outcome: - Message: The Microscopic Finding record is not unique for this subject, test - code, specimen, standardized result and laterality (when present and - populated), directionality (when present and populated) and anatomical - region (when present and populated) + Message: The Microscopic Finding record is not unique for this subject, test code, specimen, + standardized result and laterality (when present and populated), directionality (when present + and populated) and anatomical region (when present and populated) Output Variables: - - USUBJID - - MITESTCD - - MISTRESC - - MISPEC + - USUBJID + - MITESTCD + - MISTRESC + - MISPEC # The following variables and values should also appear in the output # when the column is present. # In case it is not, we get a "skip" @@ -93,8 +91,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml index cc9b8dbef..4e8d1273e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml @@ -1,125 +1,118 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # ATTENTION: NOT APPLICABLE to SENDIG v.3.0! For SENDIG 3.0, only "%" is allowed. # This is part 2 of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=RATIO may not be mixed - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure - ratios ('RATIO') or percentages (unit = %). Ratios and - percentages should not be mixed. - Document: IG v3.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure - ratios ('RATIO') or percentages (unit = %). Ratios and - percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure - ratios ('RATIO') or percentages (unit = %). Ratios and - percentages should not be mixed. - Document: IG v3.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure - ratios ('RATIO') or percentages (unit = %). Ratios and - percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure - ratios ('RATIO') or percentages (unit = %). Ratios and - percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # Precondition SEND190.1: # Rule is for OMTESTCD=OWBR,OWBW,OWHT - - any: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMTESTCD - operator: equal_to - value: OWHT + - any: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMTESTCD + operator: equal_to + value: OWHT # Part: Ratios and percentages should not be mixed. - - all: - - name: OMSTRESU - operator: is_inconsistent_across_dataset - value: - - OMTESTCD + - all: + - name: OMSTRESU + operator: is_inconsistent_across_dataset + value: + - OMTESTCD Core: Id: CDISC.SENDIG.190.1B Status: Draft Version: '1' -Description: "Second part of the rule: trigger error when, for the given test, - the value of OMSTRESU is inconsistent in the dataset when OMTESTCD is either - OWBR, OWBW or OWHT" +Description: "Second part of the rule: trigger error when, for the given test, the value of OMSTRESU is + inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT" Executability: Fully Executable Outcome: - Message: The organ weight standardized measurement unit must be consistent for - the given OMTESTCD. + Message: The organ weight standardized measurement unit must be consistent for the given OMTESTCD. Output Variables: - - OMTESTCD - - OMSTRESC - - OMSTRESN - - OMSTRESU + - OMTESTCD + - OMSTRESC + - OMSTRESN + - OMSTRESU Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml index 88999a117..3d2e9d32a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml @@ -1,163 +1,162 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # ATTENTION: ONLY APPLICABLE to SENDIG v.3.0! For SENDIG 3.1, only "%" and "RATIO" is allowed. # This is part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ measurement ratios within a single study should either be - pure ratios with no units specified or percentages with unit - shown as "%". It is strongly recommended that pure ratios and - percentages should not be mixed. - Document: IG v3.0 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190 - Version: '1' - Version: '5.0' - Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Organ measurement ratios within a single study should either be pure ratios + with no units specified or percentages with unit shown as "%". It is strongly recommended + that pure ratios and percentages should not be mixed. + Document: IG v3.0 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190 + Version: '1' + Version: '5.0' + Version: '3.0' Check: any: # Part A: of the rule: only "%" and null are allowed - - all: - - name: OMTESTCD - operator: equal_to - value: OWHT - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' + - all: + - name: OMTESTCD + operator: equal_to + value: OWHT + - name: OMSTRESU + operator: not_equal_to + value: '' + - name: OMSTRESU + operator: not_equal_to + value: '%' + - all: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMSTRESU + operator: not_equal_to + value: '' + - name: OMSTRESU + operator: not_equal_to + value: '%' + - all: + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMSTRESU + operator: not_equal_to + value: '' + - name: OMSTRESU + operator: not_equal_to + value: '%' # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed # 2026-03-03: we exclude OMSTAT='NOT DONE' # "RATIO" is not considered here # OMTESTCD=OWBR: Organ to Brain Weight Ratio # Raise a violation when the number of OMSTRESU='%'' rcords > 0 # AND the number of OMSTRESU=null rcords > 0 - - all: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owbr_percent - operator: greater_than - value: 0 - - name: $owbr_ratio_null_unit - operator: greater_than - value: 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: 'NOT DONE' + - name: $owbr_percent + operator: greater_than + value: 0 + - name: $owbr_ratio_null_unit + operator: greater_than + value: 0 # OMTESTCD=OWBW: Organ to BodyWeight Ratio # Raise a violation when the number of OMSTRESU='%'' rcords > 0 # AND the number of OMSTRESU=null rcords > 0 # 2026-03-03: we exclude OMSTAT='NOT DONE' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owbw_percent - operator: greater_than - value: 0 - - name: $owbw_ratio_null_unit - operator: greater_than - value: 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: 'NOT DONE' + - name: $owbw_percent + operator: greater_than + value: 0 + - name: $owbw_ratio_null_unit + operator: greater_than + value: 0 # OMTESTCD=OWHT: Organ to Heart Weight Ratio # Raise a violation when the number of OMSTRESU='%'' rcords > 0 # AND the number of OMSTRESU='RATIO'' rcords > 0 - - all: - - name: OMTESTCD - operator: equal_to - value: OWHT - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owht_percent - operator: greater_than - value: 0 - - name: $owht_ratio_null_unit - operator: greater_than - value: 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWHT + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: 'NOT DONE' + - name: $owht_percent + operator: greater_than + value: 0 + - name: $owht_ratio_null_unit + operator: greater_than + value: 0 Core: Id: CDISC.SENDIG.190B Status: Draft Version: '1' -Description: Trigger error when, for the given test, the value of OMSTRESU is - inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT +Description: Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the + dataset when OMTESTCD is either OWBR, OWBW or OWHT Executability: Fully Executable Operations: # OWBR: Organ to Brain Weight Ratio - - filter: - OMSTRESU: '%' - OMTESTCD: 'OWBR' - id: $owbr_percent - name: OMTESTCD # 2026-02-10 - operator: record_count - - filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWBR' +- filter: + OMSTRESU: '%' + OMTESTCD: 'OWBR' + id: $owbr_percent + name: OMTESTCD # 2026-02-10 + operator: record_count +- filter: + OMSTAT: '' # OMSTAT must be empty + OMSTRESU: '' + OMTESTCD: 'OWBR' # OMSTRESU: empty # 2026-02-10 - id: $owbr_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count + id: $owbr_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count # OWBW: Organ to BodyWeight Ratio - - filter: - OMSTRESU: '%' - OMTESTCD: 'OWBW' - id: $owbw_percent - name: OMTESTCD # 2026-02-10 - operator: record_count - - filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWBW' +- filter: + OMSTRESU: '%' + OMTESTCD: 'OWBW' + id: $owbw_percent + name: OMTESTCD # 2026-02-10 + operator: record_count +- filter: + OMSTAT: '' # OMSTAT must be empty + OMSTRESU: '' + OMTESTCD: 'OWBW' # OMSTRESU: empty # 2026-02-10 - id: $owbw_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count + id: $owbw_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count # OWHT: Organ to Heart Weight Ratio - - filter: - OMSTRESU: '%' - OMTESTCD: 'OWHT' - id: $owht_percent - name: OMTESTCD # 2026-02-10 - operator: record_count - - filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWHT' +- filter: + OMSTRESU: '%' + OMTESTCD: 'OWHT' + id: $owht_percent + name: OMTESTCD # 2026-02-10 + operator: record_count +- filter: + OMSTAT: '' # OMSTAT must be empty + OMSTRESU: '' + OMTESTCD: 'OWHT' # OMSTRESU: empty # 2026-02-10 - id: $owht_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count + id: $owht_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count # NOT USED FOR THE MOMENT # - domain: OM # id: $om_stresu_distinct @@ -165,25 +164,25 @@ Operations: # operator: distinct Outcome: - Message: The organ weight standardized measurement unit must be consistent for - the given OMTESTCD'. + Message: The organ weight standardized measurement unit must be consistent for the given + OMTESTCD'. Output Variables: - - OMTESTCD - - OMSTRESC - - OMSTRESN - - OMSTRESU - - $owbr_percent - - $owbr_ratio_null_unit - - $owbw_percent - - $owbw_ratio_null_unit - - $owht_percent - - $owht_ratio_null_unit + - OMTESTCD + - OMSTRESC + - OMSTRESN + - OMSTRESU + - $owbr_percent + - $owbr_ratio_null_unit + - $owbw_percent + - $owbw_ratio_null_unit + - $owht_percent + - $owht_ratio_null_unit Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml index 01a06e988..0fd22dd03 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml @@ -1,111 +1,105 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 3.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then - TFDETECT is based off the PM domain variable PMDTC (Start - Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 3.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '3.0' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 4.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 4.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '3.1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 4.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 4.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1.' + Document: 'SENDIG v3.0' + Item: 'Assumption 4.b' + Section: '6.3.14.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND203' + Version: '2' + Version: '5.0' + Version: '1.0' Check: all: - - name: PMDTC - operator: is_complete_date - - name: EXSTDTC - operator: is_complete_date - - name: TFDETECT # checking failure criteria - operator: not_equal_to - value: 2 #$val_dy # this is created in the operations statement that follows + - name: PMDTC + operator: is_complete_date + - name: EXSTDTC + operator: is_complete_date + - name: TFDETECT # checking failure criteria + operator: not_equal_to + value: 2 #$val_dy # this is created in the operations statement that follows # Questions Jozef (Discussion with Christy Kubin): # I presume we must add that PMSPID = TFSPID # Does this assume that all the records with a specific PMSPID all have the same @@ -115,33 +109,33 @@ Core: Id: CDISC.SENDIG.203 Status: Draft Version: '1' -Description: 'Raise an error when TFDETECT is not equal to the date portion of - PMDTC - date portion of EXSTDTC + 1.' +Description: 'Raise an error when TFDETECT is not equal to the date portion of PMDTC - date portion of + EXSTDTC + 1.' Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: PM - - Keys: - - USUBJID - Name: EX +- Keys: + - USUBJID + Name: PM +- Keys: + - USUBJID + Name: EX Operations: - - id: $val_dy - name: --DTC - operator: dy # does dy op take into acct +1? +- id: $val_dy + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: Message: 'TFDETECT is not equal to (PMDTC - EXSTDTC) + 1' Output Variables: #- $val_dy - - TFDETECT - - PMDTC - - EXSTDTC + - TFDETECT + - PMDTC + - EXSTDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml index 137dc7995..1eee935c5 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml @@ -1,180 +1,160 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.0 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different - Elements and must be represented as unique values in ELEMENT - and ETCD (i.e., Elements involving the same treatment but - different durations are different Elements). The same applies - to nontreatment Elements (e.g., a washout with a fixed - duration of 14 days is different from a washout that ends - after 7 days if drug cannot be detected in a blood sample or - after 14 days if drug can be detected in a blood sample). - Additional factors beyond treatment, start rule, and either - end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.0 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: '2' + Version: '5.0' + Version: '1.0' Check: any: - - all: - - name: ETCD - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEENRL - - name: TEDUR - operator: not_exists - - all: - - name: ETCD - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEDUR - - name: TEENRL - operator: not_exists + - all: - name: ETCD operator: is_not_unique_set value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ELEMENT + - TESTRL + - TEENRL + - name: TEDUR + operator: not_exists + - all: + - name: ETCD + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEDUR + - name: TEENRL + operator: not_exists + - name: ETCD + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Core: Id: CDISC.SENDIG.216 Status: Draft Version: '1' -Description: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR must be - unique for each ETCD. +Description: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR must be unique for each ETCD. Executability: Fully Executable Outcome: - Message: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is not unique for - each ETCD + Message: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is not unique for each ETCD Output Variables: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml index 2e9ef9d3e..7b3487dbc 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml @@ -2,127 +2,113 @@ # Condition: # Rule: No gaps between elements Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.0 - Item: Assumption 5 | Assumption 4 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element - ends, the next Element begins. A subject spends no time - "between" Elements; The Elements in each Arm must be - consecutive in time; it is not correct to leave any gaps in - time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.0 + Item: Assumption 5 | Assumption 4 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: @@ -139,9 +125,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA - - TE + - TA + - TE Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml index e92855e33..48bef19eb 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml @@ -1,123 +1,123 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.0 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '3.0' - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '3.1' - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.1' - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.2' - - Organization: CDISC - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match - values for the same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.0 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: 3.1.1 +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # TA.ETCD non-empty. Required as otherwise the "blank" value is checked against TE - - name: ETCD - operator: non_empty + - name: ETCD + operator: non_empty # TA.ETCD is not in the list of distinct values of ETCD in TE - - name: ETCD - operator: is_not_contained_by - value: $te_etcd + - name: ETCD + operator: is_not_contained_by + value: $te_etcd Core: Id: CDISC.SENDIG.222 Status: Draft Version: '1' -Description: The values of ETCD used in the Trial Arms dataset must match values - for the same Element in the Trial Elements dataset. +Description: The values of ETCD used in the Trial Arms dataset must match values for the same + Element in the Trial Elements dataset. Executability: Fully Executable Operations: - - domain: TE - id: $te_etcd - name: ETCD - operator: distinct +- domain: TE + id: $te_etcd + name: ETCD + operator: distinct Outcome: Message: TA.ETCD is not present in TE.ETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml index eef0d7bd3..40b9f727f 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml @@ -1,126 +1,119 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CDISC.SENDIG.223 Status: Draft Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is - populated, ARMCD must be present in TA.ARMCD. This rule has been executed to - identify all cases when ARMCD is not present in TA.ARMCD and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + multi-stage arm assignments are in use. Executability: Fully Executable Operations: - - domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct +- domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml index 3e137f9b4..102af0041 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml @@ -1,126 +1,119 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD - are defined as the planned Trial Arms in TA, and the planned - Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CDISC.SENDIG.225 Status: Draft Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is - populated, ARMCD must be present in TA.ARMCD. This rule has been executed to - identify all cases when ARMCD is not present in TA.ARMCD and therefore - acknowledges that false positives may be recorded when multi-stage arm - assignments are in use. +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + multi-stage arm assignments are in use. Executability: Fully Executable Operations: - - domain: TA - id: $ta_arm - name: ARM - operator: distinct +- domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARM is not present in TA.ARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml index 64f6e40d9..15b606716 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml @@ -1,120 +1,108 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.0 - Item: Specification - Section: 7.6.1 | 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column - should always be included in the Trial Summary dataset, in - order to provide proper study definition. (AGEU, SDESIGN, - DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, - SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, - STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, - TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.0 + Item: Specification + Section: 7.6.1 | 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: @@ -131,129 +119,128 @@ Check: # TODO: the following works, but it does not allow to show which one is missing # but I also do not think we should split this rule in 26 parts do we? - - name: $distinct_tsparmcd - operator: does_not_contain - value: AGEU - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SDESIGN - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: DOSDUR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: EXPENDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: EXPSTDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: GLPFL - value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: AGEU + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SDESIGN + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: DOSDUR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: EXPENDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: EXPSTDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: GLPFL + value_is_literal: true ## GLPTYP is only mandatory in SENDIG-3.0 ## SO TODO? split off SENDIG-3.0 in separate file/rule ##- name: $distinct_tsparmcd ## operator: does_not_contain ## value: GLPTYP ## value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: ROUTE - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDIGVER - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDCTVER - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPECIES - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPLRNAM - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPREFID - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SSPONSOR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STCAT - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STDIR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STSTDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STITLE - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SSTYP - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRT - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TFCNTRY - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TSTFLOC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TSTFNAM - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRMSAC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRTCAS - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRTV - value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: ROUTE + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SNDIGVER + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SNDCTVER + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPECIES + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPLRNAM + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPREFID + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SSPONSOR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STCAT + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STDIR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STSTDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STITLE + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SSTYP + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRT + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TFCNTRY + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TSTFLOC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TSTFNAM + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRMSAC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRTCAS + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRTV + value_is_literal: true Core: Id: CDISC.SENDIG.247 Status: Draft Version: '1' -Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, - GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, - STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC, - TRTCAS, TRTV, a record must be present in TS +Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, + SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, + TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV, a record must be present in TS Executability: Fully Executable Operations: - - id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct +- id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct Outcome: # TODO? Can we add soemthing here that shows which one is missing: # showing "A not in the list of B" @@ -262,8 +249,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml index e2e6126ac..505db7fc3 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml @@ -1,76 +1,73 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (from the SDTM model 1.5). - Document: IG v3.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (from the SDTM model 1.5). - Document: IG v3.1.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: '1' + Version: '5.0' + Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, - sponsors must not add any variables other than specified - Identifier variables (from the SDTM model 1.5). - Document: IG v3.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: '1' + Version: '5.0' + Version: '1.1' # REMARK: this will ONLY validate the define.xml dataset definitions # for which a dataset is actually being provided Check: all: - - name: define_variable_role - operator: equal_to - value: 'Identifier' + - name: define_variable_role + operator: equal_to + value: 'Identifier' #- name: define_variable_role # operator: equal_to # value: 'Identifier' - - name: define_variable_name - operator: is_not_contained_by - value: $model_variables + - name: define_variable_name + operator: is_not_contained_by + value: $model_variables Core: Id: CDISC.SENDIG.265.1 Status: Draft Version: '1' -Description: Raise an error when variable role is 'Identifier', but the variable - is not found in the SDTM model correspond to the role in the IG +Description: Raise an error when variable role is 'Identifier', but the variable is not found in the + SDTM model correspond to the role in the IG Executability: Fully Executable Operations: - - id: $model_variables - operator: get_column_order_from_library +- id: $model_variables + operator: get_column_order_from_library Outcome: Message: The Identfier variable in the define.xml is not found in the SDTM model #Output Variables: @@ -85,8 +82,8 @@ Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml index 109d0647b..0a268e954 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml @@ -1,83 +1,83 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.0 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.0 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: '2.1 | 2.3' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CDISC.SENDIG.266 Status: Draft @@ -85,17 +85,17 @@ Core: Description: Trigger when variable cannot be found in the SDTM model (v.1.7 for SENDIG-3.1) Executability: Fully Executable Operations: - - id: $allowed_variables +- id: $allowed_variables # This works on the IG level, not on the Model level - operator: get_column_order_from_library + operator: get_column_order_from_library Outcome: Message: Variable is not an allowed variable for an Observation Class Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml index 24d671146..5e8bd1cfd 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml @@ -1,59 +1,59 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.0 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: dataset_location - operator: not_matches_regex - value: '^[a-z0-9\-\.]+$' + - name: dataset_location + operator: not_matches_regex + value: '^[a-z0-9\-\.]+$' Core: Id: CDISC.SENDIG.277 Status: Draft @@ -63,15 +63,15 @@ Executability: Fully Executable Outcome: Message: File name must be all lowercase characters Output Variables: - - dataset_name - - dataset_label - - dataset_location + - dataset_name + - dataset_label + - dataset_location Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml index d8ef15a4e..7cdc80bbe 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml @@ -1,109 +1,107 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' + - name: 'variable_name' + operator: not_equal_to + value: 'STUDYID' + - name: 'variable_name' + operator: not_equal_to + value: 'USUBJID' + - name: 'variable_name' + operator: not_equal_to + value: 'POOLID' Core: Id: CDISC.SENDIG.299A Status: Draft Version: '1' -Description: 'No other variables than STUDYID, USUBJID and POOLID may be present - in the POOLDEF dataset' +Description: 'No other variables than STUDYID, USUBJID and POOLID may be present in the POOLDEF dataset' Executability: Fully Executable Outcome: - Message: 'No other variables than STUDYID, USUBJID and POOLID may be present in - POOLDEF' + Message: 'No other variables than STUDYID, USUBJID and POOLID may be present in POOLDEF' Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml index 693a3956a..ad2340603 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml @@ -1,134 +1,133 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'RDOMAIN' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVAR' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVARVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'QNAM' - - name: 'variable_name' - operator: not_equal_to - value: 'QLABEL' - - name: 'variable_name' - operator: not_equal_to - value: 'QVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'QORIG' - - name: 'variable_name' - operator: not_equal_to - value: 'QEVAL' + - name: 'variable_name' + operator: not_equal_to + value: 'STUDYID' + - name: 'variable_name' + operator: not_equal_to + value: 'RDOMAIN' + - name: 'variable_name' + operator: not_equal_to + value: 'USUBJID' + - name: 'variable_name' + operator: not_equal_to + value: 'POOLID' + - name: 'variable_name' + operator: not_equal_to + value: 'IDVAR' + - name: 'variable_name' + operator: not_equal_to + value: 'IDVARVAL' + - name: 'variable_name' + operator: not_equal_to + value: 'QNAM' + - name: 'variable_name' + operator: not_equal_to + value: 'QLABEL' + - name: 'variable_name' + operator: not_equal_to + value: 'QVAL' + - name: 'variable_name' + operator: not_equal_to + value: 'QORIG' + - name: 'variable_name' + operator: not_equal_to + value: 'QEVAL' Core: Id: CDISC.SENDIG.299B Status: Draft Version: '1' -Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, - POOLID, IDVAR, IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in - the SUPP-- dataset' +Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, + QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in the SUPP-- dataset' Executability: Fully Executable Outcome: - Message: 'SUPPxx may not contain any other variables than STUDYID, RDOMAIN, - USUBJID, POOLID, IDVAR, IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL' + Message: 'SUPPxx may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, + IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL' Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml index c56777c1d..cf260b85c 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml @@ -1,124 +1,124 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ...RELREC, SUPP--, and POOLDEF - are relationship datasets. These are described in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'RDOMAIN' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVAR' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVARVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'RELTYPE' - - name: 'variable_name' - operator: not_equal_to - value: 'RELID' + - name: 'variable_name' + operator: not_equal_to + value: 'STUDYID' + - name: 'variable_name' + operator: not_equal_to + value: 'RDOMAIN' + - name: 'variable_name' + operator: not_equal_to + value: 'USUBJID' + - name: 'variable_name' + operator: not_equal_to + value: 'POOLID' + - name: 'variable_name' + operator: not_equal_to + value: 'IDVAR' + - name: 'variable_name' + operator: not_equal_to + value: 'IDVARVAL' + - name: 'variable_name' + operator: not_equal_to + value: 'RELTYPE' + - name: 'variable_name' + operator: not_equal_to + value: 'RELID' Core: Id: CDISC.SENDIG.299C Status: Draft Version: '1' -Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, - POOLID, IDVAR, IDVARVAL, RELTYPE, RELID may be present in the RELREC dataset' +Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, + RELTYPE, RELID may be present in the RELREC dataset' Executability: Fully Executable Outcome: - Message: 'RELREC may not contain any other variables than STUDYID, RDOMAIN, - USUBJID, POOLID, IDVAR, IDVARVAL, RELTYPE, RELID' + Message: 'RELREC may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, + IDVARVAL, RELTYPE, RELID' Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml index 0509e8682..4d90ae6c7 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml @@ -1,72 +1,68 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty - dataset should not be submitted and should not be described in - the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.0 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: $record_count - operator: equal_to - value: 0 + - name: $record_count + operator: equal_to + value: 0 # check whether there is an entry for the dataset in the define.xml #- name: define_dataset_name # operator: exists - - name: define_dataset_name - operator: exists + - name: define_dataset_name + operator: exists #value: 'Not in dataset' #operator: not_equal_to #value: dataset_name @@ -77,21 +73,21 @@ Core: Description: Trigger error when a dataset has no records Executability: Fully Executable Operations: - - id: $record_count - operator: record_count +- id: $record_count + operator: record_count Outcome: Message: Dataset may not be empty, it must contain records Output Variables: - - dataset_name - - dataset_label - - $record_count - - define_dataset_name + - dataset_name + - dataset_label + - $record_count + - define_dataset_name Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml index 8ede25afc..21fffe236 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml @@ -1,29 +1,28 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When there are multiple terms that express the same base - concept, SEND CT provides the Preferred Term to include in a - submission, and thus the term to which the synonymous term(s) - should be mapped. - Document: IG v3.1 - Section: '4.3.7' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND304 - Version: '' - Version: '5.0' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When there are multiple terms that express the same base concept, SEND CT + provides the Preferred Term to include in a submission, and thus the term to which the + synonymous term(s) should be mapped. + Document: IG v3.1 + Section: '4.3.7' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND304 + Version: '' + Version: '5.0' + Version: '3.1' Check: all: - - name: LBTESTCD - operator: 'equal_to' - value: 'ALB' - - name: LBTEST - operator: not_equal_to - value: 'Albumin' + - name: LBTESTCD + operator: 'equal_to' + value: 'ALB' + - name: LBTEST + operator: not_equal_to + value: 'Albumin' Core: Id: CDISC.SENDIG.304 Status: Draft @@ -37,23 +36,23 @@ Operations: # level: term # operator: codelist_terms # returntype: value - - codelist: LBTEST - id: $extensible - operator: codelist_extensible +- codelist: LBTEST + id: $extensible + operator: codelist_extensible Outcome: Message: 'test message' Output Variables: - - LBTESTCD - - LBTEST + - LBTESTCD + - LBTEST # - $codelist_terms - - $extensible + - $extensible # - $synonyms Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml index 5736a7f26..97dd269b1 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml @@ -1,58 +1,58 @@ Authorities: - - Organization: CDISC +- Organization: CDISC # REMARK: not applicable to SENDIG-3.0 # 2023-10-22: CURRENT IMPLEMENTATION IS NOT CORRECT! - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they - are different by set. DM records with different values for - SPECIES cannot have the same SETCD value. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they - are different by set. DM records with different values for - SPECIES cannot have the same SETCD value. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they - are different by set. DM records with different values for - SPECIES cannot have the same SETCD value. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '1.1' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: #- name: SETCD # operator: is_not_unique_set # value: SPECIES - - name: SPECIES - operator: is_not_unique_set - value: SETCD + - name: SPECIES + operator: is_not_unique_set + value: SETCD Core: Id: CDISC.SENDIG.309 Status: Draft @@ -62,14 +62,14 @@ Executability: Fully Executable Outcome: Message: The same SETCD is assigned to different SPECIES Output Variables: - - SPECIES - - SETCD + - SPECIES + - SETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml index b9fa19fb0..de50403a3 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml @@ -1,53 +1,53 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: --NOMDY - operator: non_empty - - name: --NOMDY - operator: not_matches_regex + - name: --NOMDY + operator: non_empty + - name: --NOMDY + operator: not_matches_regex # value can be a negative or positive integer, but may not be 0. # This is more restrictive, but approved by the SEND team # than the original statement "--NOMDY must be an integer" - value: '^-?[1-9]{1}\d*$' + value: '^-?[1-9]{1}\d*$' Core: Id: CDISC.SENDIG.318 Status: Draft @@ -60,9 +60,9 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml index 452582388..eddb07aec 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml @@ -1,95 +1,90 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is - needed to identify the record. CLDTC is Expected, and the data - will, in most cases, contain CLDTC, CLDY, or both. However, - some studies (e.g., legacy studies) may not collect CLDTC or - CLDY; in those cases, CLNOMDY must be populated. - Document: IG v3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is - needed to identify the record. CLDTC is Expected, and the data - will, in most cases, contain CLDTC, CLDY, or both. However, - some studies (e.g., legacy studies) may not collect CLDTC or - CLDY; in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is - needed to identify the record. CLDTC is Expected, and the data - will, in most cases, contain CLDTC, CLDY, or both. However, - some studies (e.g., legacy studies) may not collect CLDTC or - CLDY; in those cases, CLNOMDY must be populated. - Document: IG v3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is - needed to identify the record. CLDTC is Expected, and the data - will, in most cases, contain CLDTC, CLDY, or both. However, - some studies (e.g., legacy studies) may not collect CLDTC or - CLDY; in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is - needed to identify the record. CLDTC is Expected, and the data - will, in most cases, contain CLDTC, CLDY, or both. However, - some studies (e.g., legacy studies) may not collect CLDTC or - CLDY; in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND319' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND319' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND319' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND319' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND319' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty - - name: --NOMDY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty + - name: --NOMDY + operator: empty Core: Id: CDISC.SENDIG.319 Status: Draft @@ -102,9 +97,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - CL + - LB + - CL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml index ef2c03349..20db6bbd6 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml @@ -1,72 +1,68 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location - specified in PMLOC. - Document: SENDIG v3.0 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location - specified in PMLOC. - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location - specified in PMLOC. - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per - subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.0 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: '1' + Version: '5.0' + Version: '1.1' Check: all: - - name: PMLOC - operator: non_empty - - name: PMSTRESC - operator: non_empty - - name: PMSTRESC + - name: PMLOC + operator: non_empty + - name: PMSTRESC + operator: non_empty + - name: PMSTRESC # operator: contains_case_insensitive # EXAMPLE: PSLOC = LEFT HIND LIMB # PSSTRESC = NON-ULCERATED LEFT HIND LIMB # operator: equals_string_part - BUT we do not know at what position to start ... - operator: equals_string_part - regex: ".{*}(..).*" - value: PMLOC + operator: equals_string_part + regex: ".{*}(..).*" + value: PMLOC #operator: matches_regex # regex: "[a-zA-Z](..)[a-zA-Z]" #regex: "*(..)*" @@ -82,17 +78,17 @@ Executability: Fully Executable Outcome: Message: PMSTRESC may not contain the finding with the location specified in PMLOC. Output Variables: - - USUBJID - - PMTESTCD - - PMORRES - - PMSTRESC - - PMLOC + - USUBJID + - PMTESTCD + - PMORRES + - PMSTRESC + - PMLOC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PM + - PM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml index 4632d41ad..a052fb110 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml @@ -1,43 +1,41 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 # FETUSID is "expected" in IC and FM, "required in FX" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for the fetus identifier is unique per subject within - a study. - Document: IG-DART v1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND356 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for the fetus identifier is unique per subject within - a study. - Document: IG-DART v1.2 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND356 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for the fetus identifier is unique per subject within a study. + Document: IG-DART v1.1 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND356 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for the fetus identifier is unique per subject within a study. + Document: IG-DART v1.2 + Section: '5.1.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND356 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: FETUSID - operator: non_empty - - name: FETUSID - operator: is_not_unique_set - value: - - USUBJID + - name: FETUSID + operator: non_empty + - name: FETUSID + operator: is_not_unique_set + value: + - USUBJID Core: Id: CDISC.SENDIG.356 Status: Draft @@ -50,10 +48,10 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - IC - - FM - - FX + - IC + - FM + - FX Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml index 9ed2a6b22..68554e29e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml @@ -1,46 +1,46 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND359 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND359 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND359 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND359 + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: # REMARK that the rule does not say anything about a value being 0 # nor about negative integers - - name: RPPLDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: RPPLSTDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: RPPLENDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: --RPDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ + - name: RPPLDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: RPPLSTDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: RPPLENDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: --RPDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ #- name: --RPSTDY # operator: not_matches_regex # value: ^[+-]?[0-9]+$ @@ -56,26 +56,26 @@ Executability: Fully Executable Outcome: Message: 'Repro Phase Day timing variable value must be an integer' Output Variables: - - RPPLDY - - RPPLSTDY - - RPPLENDY - - --RPDY - - --RPSTDY - - --RPENDY + - RPPLDY + - RPPLSTDY + - RPPLENDY + - --RPDY + - --RPSTDY + - --RPENDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - EX - - BW - - FW - - LB - - PC - - PP - - DS - - DD - - MA + - EX + - BW + - FW + - LB + - PC + - PP + - DS + - DD + - MA Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml index 3401aa0f5..57145d918 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml @@ -1,68 +1,67 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated - with a value in the PYFINDRS controlled terminology list. - Document: IG-DART v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated - with a value in the PYFINDRS controlled terminology list. - Document: IG-DART v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value + in the PYFINDRS controlled terminology list. + Document: IG-DART v1.1 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value + in the PYFINDRS controlled terminology list. + Document: IG-DART v1.2 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: PYTESTCD - operator: equal_to - value: PREGSTAT + - name: PYTESTCD + operator: equal_to + value: PREGSTAT # TODO: retrieve values from CDISC Library for codelist PYFINDRS - - name: PYSTRESC - operator: is_not_contained_by - value: - - ABORTED - - EARLY DELIVERY - - NOT PREGNANT - - PREGNANT - - RESORBED OR DEAD LITTER - - UNDETERMINED + - name: PYSTRESC + operator: is_not_contained_by + value: + - ABORTED + - EARLY DELIVERY + - NOT PREGNANT + - PREGNANT + - RESORBED OR DEAD LITTER + - UNDETERMINED Core: Id: CDISC.SENDIG.362 Status: Draft Version: '1' -Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value - of PYSTRESC is not one of the codelist PYFINDRS +Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not + one of the codelist PYFINDRS Executability: Fully Executable Outcome: - Message: The value of PYSTRESC is not one from the codelist PYFINDRS for - PYTESTCD 'PREGSTAT' + Message: The value of PYSTRESC is not one from the codelist PYFINDRS for PYTESTCD 'PREGSTAT' Output Variables: - - PYTESTCD - - PYSTRESC + - PYTESTCD + - PYSTRESC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - PY + - PY Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml index b2936bde5..bda3290c4 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml @@ -1,84 +1,84 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...' + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: #- name: variable_data_type @@ -95,31 +95,30 @@ Check: # It would then also allow whether a -DTC variable has been declared as one of "date", "datetime", "partialdate" ... # # First part: check whether variable name is defined in the define.xml - - name: variable_name - operator: equal_to - value: define_variable_name + - name: variable_name + operator: equal_to + value: define_variable_name # Second part: check whether the data types match - - name: variable_data_type - operator: not_equal_to - value: define_variable_data_type + - name: variable_data_type + operator: not_equal_to + value: define_variable_data_type Core: Id: CDISC.SENDIG.4 Status: Draft Version: '1' -Description: Raise an error when the data type in the define.xml does not - correspond to the data type in the dataset +Description: Raise an error when the data type in the define.xml does not correspond to the data + type in the dataset Executability: Fully Executable Outcome: - Message: Variable datatype in the define.xml does not correspond to the data - type in the dataset + Message: Variable datatype in the define.xml does not correspond to the data type in the dataset Output Variables: - - variable_name + - variable_name Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml index 3846c8f57..aa62ad983 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml @@ -1,45 +1,45 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variables with controlled terminology should follow the case - sensitivity of the Controlled Terminology List - Document: IG v3.0 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables with controlled terminology should follow the case - sensitivity of the Controlled Terminology List ' - Document: IG v3.1 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables with controlled terminology should follow the case - sensitivity of the Controlled Terminology List ' - Document: IG v3.1.1 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: 3.1.1 +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variables with controlled terminology should follow the case sensitivity of + the Controlled Terminology List + Document: IG v3.0 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables with controlled terminology should follow the case sensitivity of the + Controlled Terminology List ' + Document: IG v3.1 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Variables with controlled terminology should follow the case sensitivity of the + Controlled Terminology List ' + Document: IG v3.1.1 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: '1' + Version: '5.0' + Version: 3.1.1 Check: all: # TODO: replace "LBTESTCD" - by variable_name, variable_value ??? @@ -55,10 +55,10 @@ Check: #codelistcheck: value # can be "value" or "code" #codelistlevel: term # can be "term" or "codelist" - - name: LBTESTCD # name: variable_name - operator: does_not_use_valid_codelist_terms + - name: LBTESTCD # name: variable_name + operator: does_not_use_valid_codelist_terms # Next line must become a lookup in the IG - value: LBTESTCD # means terms of LBTESTCD codelist - TODO: replace by lookup for corresponding codelist + value: LBTESTCD # means terms of LBTESTCD codelist - TODO: replace by lookup for corresponding codelist Core: Id: CDISC.SENDIG.40 Status: Draft @@ -68,13 +68,13 @@ Executability: Fully Executable Outcome: Message: Variable does not use valid codelist terms Output Variables: - - LBTESTCD + - LBTESTCD Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml index 1974d4f9e..d4e481620 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml @@ -1,31 +1,31 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG-GENETOX - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND407 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG-GENETOX + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND407 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # TODO: also raise an error when GVSPEC/GVDTC (both "expected") absent - - name: GVSPEC - operator: non_empty - - name: GVDTC - operator: non_empty - - name: GVTESTCD - operator: is_not_unique_set - value: - - USUBJID - - GVSPEC - - GVDTC + - name: GVSPEC + operator: non_empty + - name: GVDTC + operator: non_empty + - name: GVTESTCD + operator: is_not_unique_set + value: + - USUBJID + - GVSPEC + - GVDTC Core: Id: CDISC.SENDIG.407 Status: Draft @@ -38,8 +38,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml index d93d0afe9..6e39d3c58 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml @@ -1,28 +1,28 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Comet is represented at the subject level, not the gel level. - Document: SENDIG-GENETOX - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND408 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Comet is represented at the subject level, not the gel level. + Document: SENDIG-GENETOX + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND408 + Version: '1' + Version: '5.0' + Version: '1.0' # Comet is represented at the subject level, not the gel level. # i.e. when GVCAT = 'IN VIVO COMET' then USUBJID must be populated, not POOLID # REMARK: but USUBJID = "required" anyway Check: all: - - name: 'GVCAT' - operator: equal_to - value: 'IN VIVO COMET' - - name: 'USUBJID' - operator: empty + - name: 'GVCAT' + operator: equal_to + value: 'IN VIVO COMET' + - name: 'USUBJID' + operator: empty Core: Id: CDISC.SENDIG.408 Status: Draft @@ -35,8 +35,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml index 69f22181d..c366a8907 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml @@ -1,121 +1,120 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: +- Organization: CDISC + Standards: + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG - label and the label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.0' + - Citations: + - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: # Precondition: define variable name = library variable name - - name: define_variable_name - operator: equal_to - value: library_variable_name - - name: define_variable_label - operator: not_equal_to + - name: define_variable_name + operator: equal_to + value: library_variable_name + - name: define_variable_label + operator: not_equal_to # Look up in the CDISC-Library API - see https://github.com/cdisc-org/cdisc-rules-engine/issues/243 - value: library_variable_label + value: library_variable_label Core: Id: CDISC.SENDIG.6A Status: Draft Version: '1' -Description: 'Raise an error when the variable label in the define.xml does not - correspond to the variable label in the Implementation Guide. NOTE: This rule - has been split in two parts: A. check define variable label against IG label - B. check define variable label against the label in the dataset ' +Description: 'Raise an error when the variable label in the define.xml does not correspond to the variable + label in the Implementation Guide. NOTE: This rule has been split in two parts: A. check define variable + label against IG label B. check define variable label against the label in the dataset ' Executability: Fully Executable Outcome: Message: The label of the variable is incorrect Output Variables: - - define_variable_name - - define_variable_label - - library_variable_label + - define_variable_name + - define_variable_label + - library_variable_label Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml index 5030c9cbb..76d1fe51e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml @@ -1,130 +1,123 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) - describe the relative day of the observation starting with the - reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY - operator: not_equal_to - value: $val_dy + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY + operator: not_equal_to + value: $val_dy Core: Id: CDISC.SENDIG.71 Status: Draft Version: "1" -Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if - --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion - of RFSTDTC) if --DTC precedes RFSTDTC +Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after + RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC Executability: Fully Executable Match Datasets: - - Keys: - - USUBJID - Name: DM +- Keys: + - USUBJID + Name: DM Operations: - - id: $val_dy - name: --DTC - operator: dy +- id: $val_dy + name: --DTC + operator: dy Outcome: Message: --DY was calculated incorrectly. Output Variables: - - $val_dy - - --DY - - --DTC - - RFSTDTC + - $val_dy + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml index c7c21d239..883a1a8e0 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml @@ -1,51 +1,50 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - Version: '3.0' - References: - - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND80 - Version: '1' - Version: '5.0' - Citations: - - Cited Guidance: When using time points, at least one corresponding - timing variable should be provided (e.g., VISITDY, --DTC, --DY). - Document: IG v3.0 - Item: Specification - Section: 4.2.1 +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When using time points, at least one corresponding timing variable should be + provided (e.g., VISITDY, --DTC, --DY). + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND80 + Version: '1' + Version: '5.0' + Version: '3.0' Check: all: - - name: --TPT - operator: non_empty - - name: VISITDY - operator: empty - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --TPT + operator: non_empty + - name: VISITDY + operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty # REMARK: ONLY applicable to SENDIG-3.0! # REMARK: rule says "e.g., VISITDY, --DTC, --DY": is this "e.g." sufficient! Core: Id: CDISC.SENDIG.80 Status: Draft Version: '1' -Description: When --TPT is populated, at least one of VISITDY, --DTC or --DY must - be populated +Description: When --TPT is populated, at least one of VISITDY, --DTC or --DY must be populated Executability: Fully Executable Outcome: Message: --TPT is populated, but none of of VISITDY, --DTC or --DY is populated Output Variables: - - --TPT + - --TPT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml index 94884f4ad..322c1ffcc 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml @@ -1,24 +1,23 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the - domain code. - Document: SENDIG v3.1 - Section: 4.1.4 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND1' - Version: '1' - Version: '5' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Section: 4.1.4 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND1' + Version: '1' + Version: '5' + Version: '3.1' Check: all: - - name: dataset_name - operator: equal_to_case_insensitive - value: DOMAIN + - name: dataset_name + operator: equal_to_case_insensitive + value: DOMAIN Core: Id: CDISC.SENDIG.SEND1 Status: Draft @@ -27,13 +26,13 @@ Description: Raise an error when the filename is not equal to the value of DOMAI Outcome: Message: The filename is not equal to the 2-character domain code. Output Variables: - - DOMAIN + - DOMAIN Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml index 8d55acc33..0306b325f 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml @@ -1,110 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - #need to determine what can be done with catalog version 5 if anything - Citations: - - Cited Guidance: One record per test per observation time per subject, - Tabulation. +- Organization: CDISC + Standards: + - Name: SENDIG + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: One record per test per observation time per subject, Tabulation. #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: '3.0' - - Name: SENDIG - References: - - #need to determine what can be done with catalog version 5 if anything - Citations: - - Cited Guidance: One record per test per observation time per subject, - Tabulation. + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND142' + Version: '1' + Version: '5' + Version: '3.0' + - Name: SENDIG + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: One record per test per observation time per subject, Tabulation. #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: '3.1' - - Name: SENDIG-DART - References: - - #need to determine what can be done with catalog version 5 if anything - Citations: - - Cited Guidance: One record per test per observation time per subject, - Tabulation. + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND142' + Version: '1' + Version: '5' + Version: '3.1' + - Name: SENDIG-DART + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: One record per test per observation time per subject, Tabulation. #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.1 - - Name: SENDIG-DART - References: - - #need to determine what can be done with catalog version 5 if anything - Citations: - - Cited Guidance: One record per test per observation time per subject, - Tabulation. + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND142' + Version: '1' + Version: '5' + Version: v1.1 + - Name: SENDIG-DART + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: One record per test per observation time per subject, Tabulation. #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.2 - - Name: SENDID-GENETOX - References: - - #need to determine what can be done with catalog version 5 if anything - Citations: - - Cited Guidance: One record per test per observation time per subject, - Tabulation. + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND142' + Version: '1' + Version: '5' + Version: v1.2 + - Name: SENDID-GENETOX + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: One record per test per observation time per subject, Tabulation. #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.0 #double check the last few + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND142' + Version: '1' + Version: '5' + Version: v1.0 #double check the last few Check: all: - - name: BWDTC - operator: non_empty - - name: BWTESTCD - operator: is_not_unique_set - value: - - USUBJID - - BWDTC + - name: BWDTC + operator: non_empty + - name: BWTESTCD + operator: is_not_unique_set + value: + - USUBJID + - BWDTC Core: Id: CDISC.SENDIG.SEND142 Status: Draft Version: '1' -Description: Raise an error when there is more than one record present for any - particular Body Weight test, in the BW Domain, for a subject on a particular - date. +Description: Raise an error when there is more than one record present for any particular Body + Weight test, in the BW Domain, for a subject on a particular date. #The check for this rule was revised to NOT check the records where BWDTC is null Outcome: Message: The Body Weight test is not unique for this subject and date/time. Output Variables: - - USUBJID - - BWTESTCD - - BWDTC + - USUBJID + - BWTESTCD + - BWDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW + - BW Sensitivity: Domain diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml index 71d83e4a9..f0812c6cb 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml @@ -1,138 +1,137 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.2 - - Name: SENDID-GENETOX - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, - regardless of mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.0 +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND157' + Version: '1' + Version: '5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND157' + Version: '1' + Version: '5' + Version: '3.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND157' + Version: '1' + Version: '5' + Version: v1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND157' + Version: '1' + Version: '5' + Version: v1.2 + - Name: SENDID-GENETOX + References: + - Citations: + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: 'SEND157' + Version: '1' + Version: '5' + Version: v1.0 Check: any: - - name: --SPID - operator: is_not_unique_set - value: -"USUBJID" + - name: --SPID + operator: is_not_unique_set + value: -"USUBJID" Core: Id: CDISC.SENDIG.SEND157 Status: Draft Version: '1' -Description: Raise an error when the mass identification is not unique within - the subject, regardless of the mass location. +Description: Raise an error when the mass identification is not unique within the subject, + regardless of the mass location. Outcome: - Message: The mass identification is not unique within the subject regardless of - the mass location. + Message: The mass identification is not unique within the subject regardless of the mass location. Output Variables: - - --SPID - - USUBJID + - --SPID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL - - PM - - MA - - MI - - TF + - CL + - PM + - MA + - MI + - TF Sensitivity: Variable diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml index e94c5f2a2..9d333fed3 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml @@ -1,113 +1,98 @@ # REMARK: Not applicable to SENDIG-3.0 Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a - one-to-one relationship between the values of --TPT and - --TPTNUM. Uniqueness for these time points is determined by a - combination of the domain, study day, and, if present, - category and/or subcategory (--CAT/--SCAT). Other variables, - such as --TESTCD and --METHOD, may also be needed in some - cases to define uniqueness. When this occurs, clarification - should be provided as a comment to --TPTNUM in the define - file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND293' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND293' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND293' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND293' + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND293' + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: empty Core: Id: CDISC.SENDIG.SEND293 Status: Draft @@ -120,8 +105,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml index 58c83eb03..20008335a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml @@ -1,23 +1,23 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: GVSCAT is always populated with the analysis intention. - Document: SENDIG-DART - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND411 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: GVSCAT is always populated with the analysis intention. + Document: SENDIG-DART + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND411 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # GVSCAT must be populated with the analysis intention all: - - name: 'GVSCAT' - operator: empty + - name: 'GVSCAT' + operator: empty Core: Id: CDISC.SENDIG.SEND411 Status: Draft @@ -30,8 +30,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml index 51f520eb6..6db5fa579 100644 --- a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml +++ b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml @@ -2,201 +2,188 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: - - Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and - punctuation) used by the terminology maintenance organizations - (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.0' - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is - extensible or not. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is - extensible or not. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is - extensible or not. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: 3.1.1 +- Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.2' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.3' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.4' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '1.2' + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: '1' + Version: '1.5' + Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: '1' + Version: '5.0' + Version: 3.1.1 # Comment/Answer Christy Kubin: # The intent of this rule is to check the values in the dataset against the CT in the CDISC library. # The define file should not be checked in this case. Check: all: - - name: LBTESTCD ## only for exploring - operator: not_equal_to - value: 'test variable' + - name: LBTESTCD ## only for exploring + operator: not_equal_to + value: 'test variable' # See DDF00110 (Richard Marshall) - - name: $codelist_extensible - operator: equal_to - value: false + - name: $codelist_extensible + operator: equal_to + value: false #- codelistcheck: value # codelistlevel: term # name: --STAT @@ -219,16 +206,16 @@ Core: Id: FDA.SDTMIG.FB1901 Status: Draft Version: '1' -Description: When CDISC published Controlled Terminology indicates that a - codelist is non-extensible then only terms from the codelist should be used. +Description: When CDISC published Controlled Terminology indicates that a codelist is non-extensible + then only terms from the codelist should be used. Executability: Fully Executable Operations: # See DDF00110 (Richard Marshall) - - codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: category.codeSystemVersion +- codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: category.codeSystemVersion #- id: $column_order_from_library # operator: get_column_order_from_library # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist @@ -262,8 +249,8 @@ Outcome: Message: A new term has been added to a non-extensible code list. Output Variables: # - $column_order_from_library - - $codelist_extensible - - $codelist_code + - $codelist_extensible + - $codelist_code # - variable_name # - $var_codelist # - $CODELISTEXTENSIBLE @@ -272,8 +259,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND100/rule.yml b/Unpublished/SENDIG/SEND100/rule.yml index e131dc7c4..3d92a7d17 100644 --- a/Unpublished/SENDIG/SEND100/rule.yml +++ b/Unpublished/SENDIG/SEND100/rule.yml @@ -1,111 +1,110 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.0 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate - RFSTDTC in the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.0 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: RFSTDTC - operator: non_empty + - name: RFSTDTC + operator: non_empty # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) - - name: define_variable_has_comment - operator: equal_to - value: false + - name: define_variable_has_comment + operator: equal_to + value: false Core: Id: SEND100 Status: Draft Version: '1' -Description: Check in the define.xml whether there is a "Method" - (@MethodOID/MethodDef) attached to the DM variable DM +Description: Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to + the DM variable DM Executability: Fully Executable Outcome: - Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the - variable RFSTDTC + Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the variable RFSTDTC Output Variables: - - RFSTDTC - - RFENDTC + - RFSTDTC + - RFENDTC Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND106.1/rule.yml b/Unpublished/SENDIG/SEND106.1/rule.yml index ff062852f..9cc09144b 100644 --- a/Unpublished/SENDIG/SEND106.1/rule.yml +++ b/Unpublished/SENDIG/SEND106.1/rule.yml @@ -1,148 +1,142 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Implementation of SEND106.1 like for SEND106, but for 3.1, 3.1.1, DART and Genetox - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: '1' + Version: '5.0' + Version: '1.0' Check: # 2025-02-25: NOT TESTED AT ALL YET - first need to resolve issues for SEND106 all: # STRAIN is missing from DM or from a DM record - - any: - - name: STRAIN - operator: not_exists - - name: STRAIN - operator: empty + - any: + - name: STRAIN + operator: not_exists + - name: STRAIN + operator: empty # Either TSPARMCD=STRAIN is missing from TS # or TSVAL is null when TSPARMCD=STRAIN # or TXVAL is null when TXPARMCD=STRAIN - - all: - - any: - - name: $distinct_tsparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - all: - - name: TSPARMCD - operator: equal_to - value: STRAIN - value_is_literal: true - - name: TSVAL - operator: empty - - any: - - name: $distinct_txparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - all: - - name: TXPARMCD - operator: equal_to - value: STRAIN - value_is_literal: true - - name: TXVAL - operator: empty + - all: + - any: + - name: $distinct_tsparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - all: + - name: TSPARMCD + operator: equal_to + value: STRAIN + value_is_literal: true + - name: TSVAL + operator: empty + - any: + - name: $distinct_txparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - all: + - name: TXPARMCD + operator: equal_to + value: STRAIN + value_is_literal: true + - name: TXVAL + operator: empty Core: Id: SEND106.1 Status: Draft Version: '1' -Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS - and TX, report an error +Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an + error Executability: Fully Executable # 2025-02-25: Jozef: what is this doing? Match Datasets: - - Keys: - - STUDYID - Name: TS +- Keys: + - STUDYID + Name: TS Operations: # gets the distinct values of TSPARMCD - - domain: TS - id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct +- domain: TS + id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct # gets the distinct values of TXPARMCD Outcome: - Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is - not present in DM + Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is not present in DM Output Variables: - - TSPARMCD - - TSVAL - - TXPARMCD - - TXVAL - - STRAIN + - TSPARMCD + - TSVAL + - TXPARMCD + - TXVAL + - STRAIN Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND238/rule.yml b/Unpublished/SENDIG/SEND238/rule.yml index 06d45d04c..8f31eb37d 100644 --- a/Unpublished/SENDIG/SEND238/rule.yml +++ b/Unpublished/SENDIG/SEND238/rule.yml @@ -1,144 +1,132 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of - TXPARMCD, TXPARM, and TXVAL whenever possible. If two Trial - Sets (identified by distinct SETCD values) have the same set - of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must - contain nformation that distinguishes the two Trial Sets from - each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # We only report a violation when the texts in SET are identical. # This is very probably underreporting - - name: 'SET' - operator: 'is_not_unique_set' - value: - - TXPARMCD - - TXPARM - - TXVAL + - name: 'SET' + operator: 'is_not_unique_set' + value: + - TXPARMCD + - TXPARM + - TXVAL Core: Status: Draft Version: '1' -Description: 'Report a violation when the texts in SET are identical for the - combination of SET, TXPARMCD, TXPARM' +Description: 'Report a violation when the texts in SET are identical for the combination of SET, TXPARMCD, + TXPARM' Executability: Fully Executable Outcome: Message: 'The combination of SET, TXPARMCD, TXPARM and TXVAL must be unique' Output Variables: - - SETCD - - SET - - TXPARMCD - - TXPARM - - TXVAL + - SETCD + - SET + - TXPARMCD + - TXPARM + - TXVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND239/rule.yml b/Unpublished/SENDIG/SEND239/rule.yml index 360531760..e67cf9920 100644 --- a/Unpublished/SENDIG/SEND239/rule.yml +++ b/Unpublished/SENDIG/SEND239/rule.yml @@ -1,108 +1,102 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" - column in Section 7.4.2 should be included in a well-formed TX - domain submission. These TXPARMCD values are expected to occur - in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: '1' + Version: '5.0' + Version: '1.2' Check: # all: # count the number of TRTDOC records within each group @@ -110,21 +104,21 @@ Check: # if there are issues with other sets, these are not reported # When Sensitivity=Record, a violation is reported for EACH row within the set that violates the rule any: - - name: $num_trtdos - operator: equal_to - value: 0 - - name: $num_trtdosu - operator: equal_to - value: 0 - - name: $num_armcd - operator: equal_to - value: 0 - - name: $num_spgrpcd - operator: equal_to - value: 0 - - name: $num_grplbl - operator: equal_to - value: 0 + - name: $num_trtdos + operator: equal_to + value: 0 + - name: $num_trtdosu + operator: equal_to + value: 0 + - name: $num_armcd + operator: equal_to + value: 0 + - name: $num_spgrpcd + operator: equal_to + value: 0 + - name: $num_grplbl + operator: equal_to + value: 0 Core: Status: Draft Version: '1' @@ -134,58 +128,58 @@ Executability: Fully Executable # with TXPARMCD = TRTDOS, TRTDOSU, ARMCD, SPGRPCD, and GRPLBL Operations: # count the number of records for TXPARMCD=TRTDOS within each SETCD group - - filter: - TXPARMCD: TRTDOS - group: - - SETCD - id: $num_trtdos - operator: record_count +- filter: + TXPARMCD: TRTDOS + group: + - SETCD + id: $num_trtdos + operator: record_count # count the number of records for TXOARMCD=TRTDOSU within each SETCD group - - filter: - TXPARMCD: TRTDOSU - group: - - SETCD - id: $num_trtdosu - operator: record_count +- filter: + TXPARMCD: TRTDOSU + group: + - SETCD + id: $num_trtdosu + operator: record_count # count the number of records for TXPARMCD=ARMCD within each SETCD group - - filter: - TXPARMCD: ARMCD - group: - - SETCD - id: $num_armcd - operator: record_count +- filter: + TXPARMCD: ARMCD + group: + - SETCD + id: $num_armcd + operator: record_count # count the number of records for TXPARMCD=SPGRPCD within each SETCD group - - filter: - TXPARMCD: SPGRPCD - group: - - SETCD - id: $num_spgrpcd - operator: record_count +- filter: + TXPARMCD: SPGRPCD + group: + - SETCD + id: $num_spgrpcd + operator: record_count # count the number of records for TXPARMCD=GRPLBL within each SETCD group - - filter: - TXPARMCD: GRPLBL - group: - - SETCD - id: $num_grplbl - operator: record_count +- filter: + TXPARMCD: GRPLBL + group: + - SETCD + id: $num_grplbl + operator: record_count Outcome: - Message: 'For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD, - TXPARMCD=GRPLBL, TXPARMCD=TRTDOC and TXPARMCD=TRTDOSU must be provided' + Message: 'For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD, TXPARMCD=GRPLBL, TXPARMCD=TRTDOC + and TXPARMCD=TRTDOSU must be provided' Output Variables: - - SETCD - - $num_trtdos - - $num_trtdosu - - $num_armcd - - $num_spgrpcd - - $num_grplbl + - SETCD + - $num_trtdos + - $num_trtdosu + - $num_armcd + - $num_spgrpcd + - $num_grplbl Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When set to "Dataset" only the first violation is # When set to "Record", EVERY row within the set that violates the rule is reported Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND261/rule.yml b/Unpublished/SENDIG/SEND261/rule.yml index 8385a9194..d9673a9b1 100644 --- a/Unpublished/SENDIG/SEND261/rule.yml +++ b/Unpublished/SENDIG/SEND261/rule.yml @@ -1,104 +1,98 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.0 - Section: '8.7' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a - given set of subjects. While the same value of POOLID may not - be re-used to refer to different sets of subjects, different - POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.0 + Section: '8.7' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: '8.5' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: '1' + Version: '5.0' + Version: '1.0' # IMPORTANT REMARK 2025-09-10: The code of this rule is identical to that of SEND262.1 # as we believe that both rules have essentially the same meaning. # TODO: discuss with the team whether 261 and 262.1 must be merged (216 is published ...) Check: all: - - name: POOLID - operator: is_not_unique_set - value: USUBJID + - name: POOLID + operator: is_not_unique_set + value: USUBJID Core: Status: Draft Version: '1' @@ -110,8 +104,8 @@ Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND283/rule.yml b/Unpublished/SENDIG/SEND283/rule.yml index 697521f57..54d476140 100644 --- a/Unpublished/SENDIG/SEND283/rule.yml +++ b/Unpublished/SENDIG/SEND283/rule.yml @@ -1,132 +1,121 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # NOT applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; - therefore, the value of SEENDTC for one Element will always be - immediately before or the same as the value of SESTDTC for the - next Element. Each Element continues until the time at which - the next Element begins, and a subject must be in only one - element at a time. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; - therefore, the value of SEENDTC for one Element will always be - immediately before or the same as the value of SESTDTC for the - next Element. Each Element continues until the time at which - the next Element begins, and a subject must be in only one - element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; - therefore, the value of SEENDTC for one Element will always be - immediately before or the same as the value of SESTDTC for the - next Element. Each Element continues until the time at which - the next Element begins, and a subject must be in only one - element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; - therefore, the value of SEENDTC for one Element will always be - immediately before or the same as the value of SESTDTC for the - next Element. Each Element continues until the time at which - the next Element begins, and a subject must be in only one - element at a time. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; - therefore, the value of SEENDTC for one Element will always be - immediately before or the same as the value of SESTDTC for the - next Element. Each Element continues until the time at which - the next Element begins, and a subject must be in only one - element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # 2025-05-06: IMPORTANT: The implementation CURRENTLY ONLY checks that DSSTDTC is LATER # than the highest date value of SEENDTC for the subject. # As such, the rule is currently "partially executable". - - name: 'DSSTDTC' - operator: 'date_less_than' - value: '$max_seendtc' + - name: 'DSSTDTC' + operator: 'date_less_than' + value: '$max_seendtc' # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction Core: Status: Draft Version: '1' -Description: 'The value of SEENDTC for the last Element must immediately precede - or be the same as the date/time of disposition (DSSTDTC) for the subject.' +Description: 'The value of SEENDTC for the last Element must immediately precede or be the same as the + date/time of disposition (DSSTDTC) for the subject.' Executability: Partially Executable - Possible Underreporting Operations: - - domain: SE - group: - - USUBJID - id: $max_seendtc - name: SEENDTC - operator: max_date +- domain: SE + group: + - USUBJID + id: $max_seendtc + name: SEENDTC + operator: max_date Outcome: # TODO? Should we reverse this? - Message: 'Date/time of disposition event DSSTDTC is not equal to or immediately - after last element date/time' + Message: 'Date/time of disposition event DSSTDTC is not equal to or immediately after last element date/time' Output Variables: - - DSSTDTC - - $max_seendtc + - DSSTDTC + - $max_seendtc Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND298/rule.yml b/Unpublished/SENDIG/SEND298/rule.yml index 02c04ab32..78675339f 100644 --- a/Unpublished/SENDIG/SEND298/rule.yml +++ b/Unpublished/SENDIG/SEND298/rule.yml @@ -1,112 +1,101 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Remark: does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ... Trial Design Model - datasets, consisting of Trial Elements (TE), Trial Arms (TA), - Trial Sets (TX), and Trial Summary (TS), contain information - about the study design but do not contain subject data. These - are described in Section 7 ...' - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: rial Design Model datasets, - consisting of Trial Elements (TE), Trial Arms (TA), Trial Sets - (TX), and Trial Summary (TS), contain information about the - study design but do not contain subject data. These are - described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ... Trial Design Model - datasets, consisting of Trial Elements (TE), Trial Arms (TA), - Trial Sets (TX), and Trial Summary (TS), contain information - about the study design but do not contain subject data. These - are described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ... Trial Design Model - datasets, consisting of Trial Elements (TE), Trial Arms (TA), - Trial Sets (TX), and Trial Summary (TS), contain information - about the study design but do not contain subject data. These - are described in Section 7 ...' - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each - of which has a fixed structure: ... Trial Design Model - datasets, consisting of Trial Elements (TE), Trial Arms (TA), - Trial Sets (TX), and Trial Summary (TS), contain information - about the study design but do not contain subject data. These - are described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ...' + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: rial Design Model datasets, consisting of Trial Elements (TE), Trial Arms + (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design but + do not contain subject data. These are described in Section 7 ...' + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ...' + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ...' + Document: IG v3.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ...' + Document: IG v3.1.1 + Item: Specification + Section: '2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Status: Draft Version: '1' -Description: 'Trigger error when variable is not an allowed variable for the TE, - TA, TX, or TS domain' +Description: 'Trigger error when variable is not an allowed variable for the TE, TA, TX, or TS domain' Executability: Fully Executable Operations: - - id: $allowed_variables +- id: $allowed_variables # operator: get_model_column_order - NO !!! - operator: get_column_order_from_library + operator: get_column_order_from_library Outcome: Message: 'The variable is not an allowed variable for the domain' Rule Type: Variable Metadata Check @@ -114,12 +103,12 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE - - TA - - TX - - TS + - TE + - TA + - TX + - TS # We use "Record" as when using "Dataset", only the first violation is reported Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND300/rule.yml b/Unpublished/SENDIG/SEND300/rule.yml index d8dc51026..1cab00849 100644 --- a/Unpublished/SENDIG/SEND300/rule.yml +++ b/Unpublished/SENDIG/SEND300/rule.yml @@ -1,51 +1,50 @@ Authorities: - - Organization: CDISC - Standards: +- Organization: CDISC + Standards: # Remark: does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'In the event that no records are present in a dataset, the - empty dataset should not be submitted and should not be - described in the data definition file.' - Document: IG v3.1 - Item: Specification - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'In the event that no records are present in a dataset, the empty dataset should + not be submitted and should not be described in the data definition file.' + Document: IG v3.1 + Item: Specification + Section: '3.2.1' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: - - name: $records_in_dataset - operator: equal_to - value: 0 + - name: $records_in_dataset + operator: equal_to + value: 0 # check whether the dataset is described in the define.xml - - name: define_dataset_name - operator: not_equal_to - value: 'test' + - name: define_dataset_name + operator: not_equal_to + value: 'test' Core: Status: Draft Version: '1' Description: 'Empty datasets may not be described in the define.xml' Executability: Fully Executable Operations: - - id: $records_in_dataset - operator: record_count +- id: $records_in_dataset + operator: record_count Outcome: Message: 'Empty dataset may not be described in the define.xml' Output Variables: - - dataset_name - - define_dataset_name + - dataset_name + - define_dataset_name Rule Type: Dataset Contents Check against Define XML # Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND310/rule.yml b/Unpublished/SENDIG/SEND310/rule.yml index c718e6322..a4081c930 100644 --- a/Unpublished/SENDIG/SEND310/rule.yml +++ b/Unpublished/SENDIG/SEND310/rule.yml @@ -1,96 +1,95 @@ Authorities: - - Organization: 'CDISC' - Standards: +- Organization: 'CDISC' + Standards: # Not applicable to SENDIG 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if - they are different by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND310' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND310' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND310' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND310' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different + by set.' + Document: 'IG v3.1.1' + Section: '5.1.1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND310' + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: # First case: STRAIN - - all: + - all: # Only apply when STRAIN is present, as it is "permissible" - - name: 'STRAIN' - operator: exists - - name: STRAIN - operator: is_inconsistent_across_dataset - value: SETCD + - name: 'STRAIN' + operator: exists + - name: STRAIN + operator: is_inconsistent_across_dataset + value: SETCD # Second case: SPECIES - - all: + - all: # only apply when SPECIES is present, as it is "permissible" - - name: SPECIES - operator: exists - - name: SPECIES - operator: is_inconsistent_across_dataset - value: SETCD + - name: SPECIES + operator: exists + - name: SPECIES + operator: is_inconsistent_across_dataset + value: SETCD Core: Status: Draft Version: '1' -Description: 'DM records with different values for DM.STRAIN must have different - values for DM.SETCD.' +Description: 'DM records with different values for DM.STRAIN must have different values for DM.SETCD.' Executability: Fully Executable # Operations: # The following operations, only used for reporting purposes, @@ -110,19 +109,18 @@ Executability: Fully Executable # name: SPECIES # operator: distinct Outcome: - Message: 'Within each SETCD, only a single STRAIN and only a single SPECIES is - allowed' + Message: 'Within each SETCD, only a single STRAIN and only a single SPECIES is allowed' Output Variables: - - STRAIN - - SPECIES + - STRAIN + - SPECIES #- $distinct_strain #- $distinct_species Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND313/rule.yml b/Unpublished/SENDIG/SEND313/rule.yml index 46fbf5073..113d4b8ec 100644 --- a/Unpublished/SENDIG/SEND313/rule.yml +++ b/Unpublished/SENDIG/SEND313/rule.yml @@ -1,42 +1,42 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When using COVAL1-COVALn, the variable label should match the - corresponding variable name (e.g., Comment1, Comment2).' - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND313' - Version: '1' - Version: '5.0' - Version: '3.1' +- Organization: 'CDISC' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When using COVAL1-COVALn, the variable label should match the corresponding variable + name (e.g., Comment1, Comment2).' + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND313' + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: # The first two checks select COVALn variables, excluding "COVAL" itself - - name: variable_name - operator: starts_with - value: COVAL - - name: variable_name - operator: longer_than - value: 5 + - name: variable_name + operator: starts_with + value: COVAL + - name: variable_name + operator: longer_than + value: 5 # check whether 6th and 7th character represent a digit - - any: + - any: # 6th character - - name: variable_name - operator: matches_regex - value: ^.{5}\d{1} + - name: variable_name + operator: matches_regex + value: ^.{5}\d{1} # 6th and 7th character - - name: variable_name - operator: matches_regex - value: ^.{5}\d{2} - name: variable_name - operator: suffix_not_equal_to - suffix: 1 - value: '1' # this need to be replaced by the last 1 or 2 charaters of the label + operator: matches_regex + value: ^.{5}\d{2} + - name: variable_name + operator: suffix_not_equal_to + suffix: 1 + value: '1' # this need to be replaced by the last 1 or 2 charaters of the label # Proposal Els #- name: variable_label # operator: does_not_equal_string_part @@ -51,10 +51,10 @@ Executability: Fully Executable Operations: # we need something here to retrieve the last character of the label # but it looks as we cannot use "operator" in the same way as in "Check" - - id: $last_character - name: variable_label - operator: matches_regex - value: ".$" +- id: $last_character + name: variable_label + operator: matches_regex + value: ".$" Outcome: Message: 'Variable Label must end with the number n in the variable name' @@ -62,8 +62,8 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND321/rule.yml b/Unpublished/SENDIG/SEND321/rule.yml index 01c9ab16c..97bf6e581 100644 --- a/Unpublished/SENDIG/SEND321/rule.yml +++ b/Unpublished/SENDIG/SEND321/rule.yml @@ -1,32 +1,31 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM - controlled list. - Document: IG v3.1 - Section: 6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND321' - Version: '1' - Version: '5.0' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM controlled list. + Document: IG v3.1 + Section: 6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND321' + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: - - any: - - name: MIRESCAT - operator: equal_to - value: 'MALIGNANT' - - name: MIRESCAT - operator: equal_to - value: 'BENIGN' - - name: MISTRESC - operator: is_not_contained_by + - any: + - name: MIRESCAT + operator: equal_to + value: 'MALIGNANT' + - name: MIRESCAT + operator: equal_to + value: 'BENIGN' + - name: MISTRESC + operator: is_not_contained_by # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!! - value: $NEOPASM_CODELIST + value: $NEOPASM_CODELIST # The following does not seem to work => "invalid operator" #- name: MISTRESC # operator: does_not_use_valid_codelist_terms @@ -34,34 +33,34 @@ Check: Core: Status: Draft Version: '1' -Description: 'Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and - the value in MISTRESC is not from the NEOPLASM codelist (NCI C88025)' +Description: 'Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and the value in MISTRESC is + not from the NEOPLASM codelist (NCI C88025)' Executability: Fully Executable Operations: # 2025-09-11: This still returns an EMPTY list! # or just - codelist: NEOPLASM - - codelists: - - NEOPLASM - ct_package_type: SEND - id: $NEOPASM_CODELIST - level: term +- codelists: + - NEOPLASM + ct_package_type: SEND + id: $NEOPASM_CODELIST + level: term # level: codelist - operator: codelist_terms - returntype: value + operator: codelist_terms + returntype: value # version: '2024-03-29' #version: codeSystemVersion Outcome: - Message: 'The term for the record is not present in the NEOPLASM codelist and - may be a term added to the extensible list' + Message: 'The term for the record is not present in the NEOPLASM codelist and may be a term added to + the extensible list' Output Variables: - - MISTRESC - - $NEOPASM_CODELIST + - MISTRESC + - $NEOPASM_CODELIST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND327/rule.yml b/Unpublished/SENDIG/SEND327/rule.yml index da95cd00f..b399ebb5b 100644 --- a/Unpublished/SENDIG/SEND327/rule.yml +++ b/Unpublished/SENDIG/SEND327/rule.yml @@ -1,63 +1,60 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 - - Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile - analysis, then PCELTM must be populated as "PT0H" because - negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile - analysis, then PCELTM must be populated as "PT0H" because - negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile - analysis, then PCELTM must be populated as "PT0H" because - negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND327' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND327' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND327' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat - - name: PCELTM - operator: non_empty + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat + - name: PCELTM + operator: non_empty # value of PCELTM may not start with a dash (minus-character) - - name: PCELTM - operator: starts_with - value: '-' + - name: PCELTM + operator: starts_with + value: '-' # Alternative test for first character being "-" # - name: PCELTM # operator: prefix_equal_to @@ -66,26 +63,25 @@ Check: Core: Status: Draft Version: '1' -Description: 'Duration in PCELTM may not be negative when record used in - concentration profile in PP' +Description: 'Duration in PCELTM may not be negative when record used in concentration profile in PP' Executability: Fully Executable Operations: - - domain: PP +- domain: PP # TODO: ensure that we do NEED OR NOT NEED to use "group", as "distinct" is already on the subject level? - group: - - USUBJID - id: $pp_ppcat - name: PPCAT - operator: distinct + group: + - USUBJID + id: $pp_ppcat + name: PPCAT + operator: distinct Outcome: - Message: 'A negative value for PCELTM is not allowed as the record is used in a - concentration profile in PP' + Message: 'A negative value for PCELTM is not allowed as the record is used in a concentration profile + in PP' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND328-1/rule.yml b/Unpublished/SENDIG/SEND328-1/rule.yml index c85986e53..10bc6bede 100644 --- a/Unpublished/SENDIG/SEND328-1/rule.yml +++ b/Unpublished/SENDIG/SEND328-1/rule.yml @@ -1,68 +1,62 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-1' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-1' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-1' + Version: '1' + Version: '5.0' + Version: '1.2' Check: # Part 1, USUBJID is present and populated, and PCSCAT is present all: - - name: USUBJID - operator: exists - - name: USUBJID - operator: non_empty + - name: USUBJID + operator: exists + - name: USUBJID + operator: non_empty # case that PCSCAT is present - - name: PCSCAT - operator: exists + - name: PCSCAT + operator: exists # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - - name: PCELTM - operator: equal_to - value: 'PT0H' + - name: PCELTM + operator: equal_to + value: 'PT0H' # 2025-07-09: PPCAT must correspond to PCTESTCD # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' @@ -71,17 +65,17 @@ Check: # value: $pp_cat # reference of measurement in PC must be equal to reference of profile in PP # TODO: This must be for the GIVEN SUBJECT! - - name: PCTPTREF - operator: is_contained_by - value: $pp_tptref + - name: PCTPTREF + operator: is_contained_by + value: $pp_tptref # reference time (time point) must be equal to reference time of profile in PP - - name: PCRFTDTC - operator: is_contained_by - value: $pp_rftdtc + - name: PCRFTDTC + operator: is_contained_by + value: $pp_rftdtc # Report a violation when the number of records for PCELTM=PT0H is not 1 - - name: $pc_group - operator: not_equal_to - value: 1 + - name: $pc_group + operator: not_equal_to + value: 1 Core: Id: SEND328-1 Status: Draft @@ -89,64 +83,64 @@ Core: Description: '' Executability: Fully Executable Operations: - - domain: PC +- domain: PC # we will count the number of records for which PCELTM = PT0H within each group - filter: - PCELTM: PT0H + filter: + PCELTM: PT0H # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF - group: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC # added 2025-07-09 - - PCTPTREF - id: $pc_group - operator: record_count + group: + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC # added 2025-07-09 + - PCTPTREF + id: $pc_group + operator: record_count # 2025-07-09: PPCAT and PCTESTCD must correspond - - domain: PP +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_cat - name: PPCAT - operator: distinct + group: + - USUBJID + id: $pp_cat + name: PPCAT + operator: distinct # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") - - domain: PP +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_tptref - name: PPTPTREF - operator: distinct - - domain: PP + group: + - USUBJID + id: $pp_tptref + name: PPTPTREF + operator: distinct +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_rftdtc - name: PPRFTDTC - operator: distinct + group: + - USUBJID + id: $pp_rftdtc + name: PPRFTDTC + operator: distinct Outcome: - Message: 'specimen concentrations to calculate a time concentration profile may - only have one record with PCELTM=PT0H' + Message: 'specimen concentrations to calculate a time concentration profile may only have one record + with PCELTM=PT0H' Output Variables: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC - - PCTPTREF - - $pc_group - - $pp_cat - - $pp_tptref - - $pp_rftdtc + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC + - PCTPTREF + - $pc_group + - $pp_cat + - $pp_tptref + - $pp_rftdtc Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND328-2/rule.yml b/Unpublished/SENDIG/SEND328-2/rule.yml index 8284fb897..dc733ab26 100644 --- a/Unpublished/SENDIG/SEND328-2/rule.yml +++ b/Unpublished/SENDIG/SEND328-2/rule.yml @@ -1,67 +1,61 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 - PT0H records for the same profile; instead, the immediate - postdose sample should be separated from predose samples with - a different PCELTM value so that each is uniquely - identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-2' + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: 'SENDIG-GENETOX' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-2' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable.' + Document: 'IG v3.1.1' + Section: '6.3.11.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND328-2' + Version: '1' + Version: '5.0' + Version: '1.2' Check: # Part 2, USUBJID is present and populated, and PCSCAT is absent all: - - name: USUBJID - operator: exists - - name: USUBJID - operator: non_empty - - name: PCSCAT - operator: not_exists + - name: USUBJID + operator: exists + - name: USUBJID + operator: non_empty + - name: PCSCAT + operator: not_exists # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - - name: PCELTM - operator: equal_to - value: 'PT0H' + - name: PCELTM + operator: equal_to + value: 'PT0H' # 2025-07-09: PPCAT must correspond to PCTESTCD # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' @@ -70,17 +64,17 @@ Check: # value: $pp_cat # reference of measurement in PC must be equal to reference of profile in PP # P.S. This must be for the GIVEN SUBJECT! - - name: PCTPTREF - operator: is_contained_by - value: $pp_tptref + - name: PCTPTREF + operator: is_contained_by + value: $pp_tptref # reference time (time point) must be equal to reference time of profile in PP - - name: PCRFTDTC - operator: is_contained_by - value: $pp_rftdtc + - name: PCRFTDTC + operator: is_contained_by + value: $pp_rftdtc # Report a violation when the number of records for PCELTM=PT0H is not 1 - - name: $pc_group_no_pcscat - operator: not_equal_to - value: 1 + - name: $pc_group_no_pcscat + operator: not_equal_to + value: 1 Core: Id: SEND328-2 Status: Draft @@ -88,62 +82,62 @@ Core: Description: '' Executability: Fully Executable Operations: - - domain: PC +- domain: PC # we will count the number of records for which PCELTM = PT0H within each group - filter: - PCELTM: PT0H + filter: + PCELTM: PT0H # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent - group: - - USUBJID - - PCTESTCD - - PCCAT - - PCSPEC # added 2025-07-09 - - PCTPTREF - id: $pc_group_no_pcscat - operator: record_count + group: + - USUBJID + - PCTESTCD + - PCCAT + - PCSPEC # added 2025-07-09 + - PCTPTREF + id: $pc_group_no_pcscat + operator: record_count # 2025-07-09: PPCAT and PCTESTCD must correspond - - domain: PP +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_cat - name: PPCAT - operator: distinct + group: + - USUBJID + id: $pp_cat + name: PPCAT + operator: distinct # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") - - domain: PP +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_tptref - name: PPTPTREF - operator: distinct - - domain: PP + group: + - USUBJID + id: $pp_tptref + name: PPTPTREF + operator: distinct +- domain: PP # we only want it for the current subject - group: - - USUBJID - id: $pp_rftdtc - name: PPRFTDTC - operator: distinct + group: + - USUBJID + id: $pp_rftdtc + name: PPRFTDTC + operator: distinct Outcome: - Message: 'specimen concentrations to calculate a time concentration profile may - only have one record with PCELTM=PT0H' + Message: 'specimen concentrations to calculate a time concentration profile may only have one record + with PCELTM=PT0H' Output Variables: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC - - PCTPTREF - - $pp_cat - - $pp_tptref - - $pp_rftdtc - - $pc_group_no_pcscat + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC + - PCTPTREF + - $pp_cat + - $pp_tptref + - $pp_rftdtc + - $pc_group_no_pcscat Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND333/rule.yml b/Unpublished/SENDIG/SEND333/rule.yml index 56d7abc18..afceb559c 100644 --- a/Unpublished/SENDIG/SEND333/rule.yml +++ b/Unpublished/SENDIG/SEND333/rule.yml @@ -1,81 +1,78 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 - - Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration - profile, the PCNOMDY and PCTPTREF pair must be the same as the - PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration - profile, the PCNOMDY and PCTPTREF pair must be the same as the - PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration - profile, the PCNOMDY and PCTPTREF pair must be the same as the - PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND333' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND333' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND333' + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat # TODO: count number of distinct values of PPCAT for this subject #- name: $pp_cat # operator: equal_to # value: 'blabla' # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF - - any: - - name: PCNOMDY # old - operator: empty - - name: PCTPTREF # old - operator: empty - - name: PCELTM # old - operator: empty + - any: + - name: PCNOMDY # old + operator: empty + - name: PCTPTREF # old + operator: empty + - name: PCELTM # old + operator: empty Core: Status: Draft Version: '1' -Description: 'When PC record is used in only 1 concentration profile, ensure - that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF' +Description: 'When PC record is used in only 1 concentration profile, ensure that PCNOMDY=PPNOMDY and + PPCTPTREF=PPTPTREF' Executability: Fully Executable Operations: # get the distinct values of PPCAT per subject in domain PP - - domain: PP +- domain: PP # We need to group per subject - group: - - USUBJID - id: $pp_ppcat - name: PPCAT - operator: distinct + group: + - USUBJID + id: $pp_ppcat + name: PPCAT + operator: distinct #- id: $countppcat # name: $pp_ppcat # operator: record_count @@ -83,30 +80,30 @@ Operations: # just trying something else #- group: # - PCTESTCD - - domain: PP - filter: - PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD - group: - - USUBJID - id: $profile_count - operator: record_count +- domain: PP + filter: + PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD + group: + - USUBJID + id: $profile_count + operator: record_count Outcome: - Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record - contributes to a concentration profile in PP' + Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration + profile in PP' Output Variables: - - USUBJID - - PCNOMDY - - PCTPTREF - - PCELTM - - $pp_ppcat - - $profile_count + - USUBJID + - PCNOMDY + - PCTPTREF + - PCELTM + - $pp_ppcat + - $profile_count #- $countppcat Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND340/rule.yml b/Unpublished/SENDIG/SEND340/rule.yml index ab0de48c3..5b5f134cf 100644 --- a/Unpublished/SENDIG/SEND340/rule.yml +++ b/Unpublished/SENDIG/SEND340/rule.yml @@ -1,19 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If expected variables in a domain are all null, a comment should - be included in the Define-XML document to explain why all - records are null. - Document: SENDIG - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND340 - Version: '1' - Version: '5.0' - Version: '3.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If expected variables in a domain are all null, a comment should be included + in the Define-XML document to explain why all records are null. + Document: SENDIG + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND340 + Version: '1' + Version: '5.0' + Version: '3.1' Check: all: #- name: variable_name @@ -22,11 +21,11 @@ Check: # value: # - $expected_variables # Get any "expected" columns that are empty - - all: + - all: # This checks on the individual record, not for an empty column - - metadata: $var_perm - operator: variable_metadata_not_equal_to - value: 'Exp' + - metadata: $var_perm + operator: variable_metadata_not_equal_to + value: 'Exp' #- operator: non_empty #- name: USUBJID # operator: not_equal_to @@ -41,13 +40,13 @@ Core: Id: SEND340 Status: Draft Version: '1' -Description: If expected variables in a domain are all null, a comment should be - included in the Define-XML document to explain why all records are null. +Description: If expected variables in a domain are all null, a comment should be included in the + Define-XML document to explain why all records are null. Executability: Fully Executable Operations: - - id: $var_perm - name: core - operator: variable_library_metadata +- id: $var_perm + name: core + operator: variable_library_metadata #- id: $expected_variables # operator: expected_variables #- id: $VARIABLE_NULL @@ -56,17 +55,17 @@ Operations: Outcome: Message: Expected variable with missing value for all records Output Variables: - - $var_perm + - $var_perm # - $expected_variables # Rule Type: 'Variable Metadata Check against Library Metadata' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record #Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND348/rule.yml b/Unpublished/SENDIG/SEND348/rule.yml index df3663830..9588d627e 100644 --- a/Unpublished/SENDIG/SEND348/rule.yml +++ b/Unpublished/SENDIG/SEND348/rule.yml @@ -1,120 +1,117 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 - - Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, - the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be - populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, - the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be - populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, - the timing variables PCNOMDY, PCTPTREF, and PCELTM must all be - populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND348' + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND348' + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND348' + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: # Case that USUBJID is populated - - all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat_usubjid + - all: + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat_usubjid - - any: - - name: PCNOMDY - operator: empty - - name: PCTPTREF - operator: empty - - name: PCELTM - operator: empty + - any: + - name: PCNOMDY + operator: empty + - name: PCTPTREF + operator: empty + - name: PCELTM + operator: empty # case that POOLID is populated. ATTENTION: POOLID is permissible! - - all: + - all: # PC-POOLID column is present - - name: POOLID - operator: exists + - name: POOLID + operator: exists # PC-POOLID is populated - - name: POOLID - operator: non_empty - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat_poolid - - any: - - name: PCNOMDY - operator: empty - - name: PCTPTREF - operator: empty - - name: PCELTM - operator: empty + - name: POOLID + operator: non_empty + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat_poolid + - any: + - name: PCNOMDY + operator: empty + - name: PCTPTREF + operator: empty + - name: PCELTM + operator: empty Core: Status: Draft Version: '1' Description: 'When PCTESTCD = PPCAT, then PCNOMDY, PCTPTREF and PCELTM must be populated' Executability: Fully Executable Operations: - - domain: PP +- domain: PP # group by USUBJID - group: - - USUBJID - id: $pp_ppcat_usubjid - name: PPCAT - operator: distinct - - domain: PP + group: + - USUBJID + id: $pp_ppcat_usubjid + name: PPCAT + operator: distinct +- domain: PP # group by POOLID - group: - - POOLID - id: $pp_ppcat_poolid - name: PPCAT - operator: distinct + group: + - POOLID + id: $pp_ppcat_poolid + name: PPCAT + operator: distinct Outcome: - Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record - contributes to a concentration profile in PP' + Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration + profile in PP' Output Variables: - - USUBJID - - POOLID # can this lead to a "skip" when POOLID column absent? - - PCNOMDY - - PCTPTREF - - PCELTM - - $pp_ppcat_usubjid - - $pp_ppcat_poolid + - USUBJID + - POOLID # can this lead to a "skip" when POOLID column absent? + - PCNOMDY + - PCTPTREF + - PCELTM + - $pp_ppcat_usubjid + - $pp_ppcat_poolid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND362/rule.yml b/Unpublished/SENDIG/SEND362/rule.yml index e6f7740a3..755e6b02f 100644 --- a/Unpublished/SENDIG/SEND362/rule.yml +++ b/Unpublished/SENDIG/SEND362/rule.yml @@ -1,59 +1,57 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: FETUSID should be populated for implantations that have - individual fetal examinations or measurements that will be - captured in other domains. The USUBJID / FETUSID combination - must be consistent across domains within a study. - Document: DART-IG v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: FETUSID should be populated for implantations that have - individual fetal examinations or measurements that will be - captured in other domains. The USUBJID / FETUSID combination - must be consistent across domains within a study. - Document: DART-IG v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: FETUSID should be populated for implantations that have individual fetal + examinations or measurements that will be captured in other domains. The USUBJID / FETUSID + combination must be consistent across domains within a study. + Document: DART-IG v1.1 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: FETUSID should be populated for implantations that have individual fetal + examinations or measurements that will be captured in other domains. The USUBJID / FETUSID + combination must be consistent across domains within a study. + Document: DART-IG v1.2 + Section: '5.1.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: - - any: - - name: USUBJID - operator: non_empty + - any: + - name: USUBJID + operator: non_empty #- name: FETUSID # operator: empty Core: Status: Draft Version: '1' -Description: 'Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements) - is not found in IC (Implantation Classification)' +Description: 'Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements) is not found in IC (Implantation + Classification)' # Also see Christy's mail 2025-10-13 - issues the question of the difference between SEND262 and SEND263 Executability: Fully Executable Outcome: - Message: 'The combination of USUBJID and FETUSID in FM (Fetus Measurements) was - not found in IC (Implantation Classification)' + Message: 'The combination of USUBJID and FETUSID in FM (Fetus Measurements) was not found in IC (Implantation + Classification)' Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - FM + - FM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND399/rule.yml b/Unpublished/SENDIG/SEND399/rule.yml index c506fa835..c799c3c52 100644 --- a/Unpublished/SENDIG/SEND399/rule.yml +++ b/Unpublished/SENDIG/SEND399/rule.yml @@ -1,83 +1,74 @@ Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards - for the submission of data from nonclinical Developmental and - Reproductive Toxicology (DART) studies, and is referred to as - the SENDIG-DART. This IG is based on and should be used in - close concert with Version 3.1 of the Standard for Exchange of - Nonclinical Data Implementation Guide (SENDIG) and Version 1.6 - of the CDISC Study Data Tabulation Model (SDTM), available at - https://www.cdisc.org/standards/.' - Document: 'SENDIG DART' - Section: '1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND399' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards - for the submission of data from nonclinical Developmental and - Reproductive Toxicology (DART) studies, and is referred to as - the SENDIG-DART. This IG is based on and should be used in - close concert with Version 3.1 of the Standard for Exchange of - Nonclinical Data Implementation Guide (SENDIG) and Version 1.6 - of the CDISC Study Data Tabulation Model (SDTM), available at - https://www.cdisc.org/standards/.' - Document: 'SENDIG DART' - Section: '1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND399' - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: 'CDISC' + Standards: + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards for the submission + of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred + to as the SENDIG-DART. This IG is based on and should be used in close concert with Version + 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version + 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/.' + Document: 'SENDIG DART' + Section: '1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND399' + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: 'SENDIG-DART' + References: + - Citations: + - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards for the submission + of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred + to as the SENDIG-DART. This IG is based on and should be used in close concert with Version + 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version + 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/.' + Document: 'SENDIG DART' + Section: '1.1' + Origin: 'SEND Conformance Rules' + Rule Identifier: + Id: 'SEND399' + Version: '1' + Version: '5.0' + Version: '1.2' Check: any: # check on whether there is a record with TSPARMCD=SNDIGVER - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDIGVER + - name: $distinct_tsparmcd + operator: does_not_contain + value: SNDIGVER # when there is a record with TSPARMCD=SNDIGVER, # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2 - - all: - - name: TSPARMCD - operator: equal_to - value: SNDIGVER - - name: TSVAL - operator: is_not_contained_by - value: - - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION - GUIDE VERSION 1.1 - - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION - GUIDE VERSION 1.2 + - all: + - name: TSPARMCD + operator: equal_to + value: SNDIGVER + - name: TSVAL + operator: is_not_contained_by + value: + - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.1 + - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.2 Core: Status: Draft Version: '1' -Description: 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL = - Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist' +Description: 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL = Controlled Terminology term + for SENDIG-DART from the SNDIGVER codelist' Executability: Fully Executable Operations: - - id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct +- id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct Outcome: - Message: 'A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL - for SNDIGVER must be the Controlled Terminology term for SENDIG-DART from - the SNDIGVER codelist.' + Message: 'A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL for SNDIGVER must be the + Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist.' Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND4/rule.yml b/Unpublished/SENDIG/SEND4/rule.yml index a207dc7a1..f0a04462d 100644 --- a/Unpublished/SENDIG/SEND4/rule.yml +++ b/Unpublished/SENDIG/SEND4/rule.yml @@ -1,99 +1,99 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ...The data Type.' - Document: SENDIG v3.0 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ... The data Type.' - Document: SENDIG v3.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ...The data Type.' - Document: SENDIG v3.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes - to describe variable-level metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type.' + Document: SENDIG v3.0 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ... The data Type.' + Document: SENDIG v3.1 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type.' + Document: SENDIG v3.1.1 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type.' + Document: SENDIG v3.1.1 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type.' + Document: SENDIG v3.1 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type.' + Document: SENDIG v3.1.1 + Section: '3.2.2' + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: #- name: variable_data_type # operator: not_equal_to # # value: 'Char' # temporary (uppercase) # value: define_variable_data_type - - name: variable_name # JUST TRYING ... - operator: equal_to - value: define_variable_name - - name: variable_data_type + - name: variable_name # JUST TRYING ... + operator: equal_to + value: define_variable_name + - name: variable_data_type # ALTHOUGH equivalent: variable_data_type equal_to "Char" DOES NOT WORK !!! #operator: equal_to #value: "Char" - operator: not_equal_to # Character - value: "Num" + operator: not_equal_to # Character + value: "Num" #- all: # # ALTHOUGH mostly equivalent, define_variable_data_type equal_to "text" DOES NOT WORK !!! # - name: define_variable_data_type @@ -114,17 +114,17 @@ Executability: Fully Executable Outcome: Message: 'variable data type mismatch' Output Variables: - - variable_name - - define_variable_name - - variable_data_type - - define_variable_data_type + - variable_name + - define_variable_name + - variable_data_type + - define_variable_data_type # Rule Type: Record Data Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND41/rule.yml b/Unpublished/SENDIG/SEND41/rule.yml index e3638fb48..13d17f10d 100644 --- a/Unpublished/SENDIG/SEND41/rule.yml +++ b/Unpublished/SENDIG/SEND41/rule.yml @@ -1,25 +1,25 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When extending a controlled terminology list, the - case-sensitivity convention of that list should be followed. - Document: IG v3.0 - Item: Specification - Section: 4.2.4 | 4.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND41' - Version: '1' - Version: '5.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: When extending a controlled terminology list, the case-sensitivity + convention of that list should be followed. + Document: IG v3.0 + Item: Specification + Section: 4.2.4 | 4.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: 'SEND41' + Version: '1' + Version: '5.0' + Version: '3.0' Check: all: - - name: SITEID - operator: 'equal_to' - value: '701' + - name: SITEID + operator: 'equal_to' + value: '701' Core: Status: Draft Version: '1' @@ -31,8 +31,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND49/rule.yml b/Unpublished/SENDIG/SEND49/rule.yml index 216127f60..598f0cdf9 100644 --- a/Unpublished/SENDIG/SEND49/rule.yml +++ b/Unpublished/SENDIG/SEND49/rule.yml @@ -1,149 +1,142 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.0 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.1.0 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a - SEND domain, the name of the codelist will be populated in the - Controlled Terms, Codelist, or Format column of the domain - model to indicate that a distinct set of controlled values - exist and is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.2' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.0 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '1.0' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.0 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: '1' + Version: '5.0' + Version: '1.2' Check: all: # This first condition (define_variable_name != 'STUDYID') seems to be necessary to select the variables - - name: define_variable_name - operator: not_equal_to - value: 'STUDYID' + - name: define_variable_name + operator: not_equal_to + value: 'STUDYID' # 2025-08-16: library_variable_code looks to work well - - name: 'library_variable_ccode' - operator: non_empty - - any: + - name: 'library_variable_ccode' + operator: non_empty + - any: # - name: define_vlm_ccode # operator: not_equal_to # value: 'test' - - name: define_variable_ccode - operator: empty - - name: define_variable_ccode - operator: not_equal_to - value: library_variable_ccode + - name: define_variable_ccode + operator: empty + - name: define_variable_ccode + operator: not_equal_to + value: library_variable_ccode Core: Status: Draft Version: '1' -Description: 'For a variable identified in the SENDIG as being subject to CDISC - published Controlled Terminology, the Codelist listed in the Define-XML - document must properly reference the Controlled Terminology Codelist used.' +Description: 'For a variable identified in the SENDIG as being subject to CDISC published Controlled Terminology, + the Codelist listed in the Define-XML document must properly reference the Controlled Terminology Codelist + used.' Executability: Fully Executable Outcome: - Message: 'As a controlled terminology codelist exists for the variable in the - SEND domain, the codelist must be referenced for the variable in the - define.xml' + Message: 'As a controlled terminology codelist exists for the variable in the SEND domain, the codelist + must be referenced for the variable in the define.xml' Output Variables: - - define_variable_name - - define_variable_ccode - - library_variable_ccode - - define_vlm_ccode + - define_variable_name + - define_variable_ccode + - library_variable_ccode + - define_vlm_ccode Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND5/rule.yml b/Unpublished/SENDIG/SEND5/rule.yml index 296fb6778..97bfd9ab6 100644 --- a/Unpublished/SENDIG/SEND5/rule.yml +++ b/Unpublished/SENDIG/SEND5/rule.yml @@ -1,113 +1,107 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.0 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The Variable Name - (limited to 8 characters for compatibility with the SAS v5 - Transport format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.0 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: define_variable_name - operator: not_equal_to + - name: define_variable_name + operator: not_equal_to # P.S.: library_variable_name points to the IG plus to the model. - value: library_variable_name + value: library_variable_name Core: Status: Draft Version: '1' -Description: 'Checks the variable name in the define.xml for its existence in - the CDISC Library for the provided SENDIG version' +Description: 'Checks the variable name in the define.xml for its existence in the CDISC Library for the + provided SENDIG version' Executability: Fully Executable Outcome: Message: 'The variable in the define.xml is not from the SENDIG' @@ -115,9 +109,9 @@ Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Record Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND50.99/rule.yml b/Unpublished/SENDIG/SEND50.99/rule.yml index 3de4bc11a..5073747c1 100644 --- a/Unpublished/SENDIG/SEND50.99/rule.yml +++ b/Unpublished/SENDIG/SEND50.99/rule.yml @@ -1,31 +1,29 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. Transport format)" - Document: IG v3.0 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50.99 - Version: "1" - Version: "5.0" - Version: "3.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.0 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50.99 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: define_variable_name - operator: not_equal_to - value: STUDYID - - name: define_vlm_ccode - operator: 'not_equal_to' - value: '99999' + - name: define_variable_name + operator: not_equal_to + value: STUDYID + - name: define_vlm_ccode + operator: 'not_equal_to' + value: '99999' Core: Status: Draft Version: '1' @@ -37,8 +35,8 @@ Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND50/rule.yml b/Unpublished/SENDIG/SEND50/rule.yml index fb26183ee..56057aa4a 100644 --- a/Unpublished/SENDIG/SEND50/rule.yml +++ b/Unpublished/SENDIG/SEND50/rule.yml @@ -1,116 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. Transport format)" - Document: IG v3.0 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. Transport format)" - Document: IG v3.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. - Document: IG v3.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled - terminology should be included in the data definition file - wherever applicable. See the define.xml specification for - details on including or referencing controlled terminology - lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.0" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.0 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # The rule fails (false positive) when the codelist reference in the define.xml # is on the ValueList level, and NOT on the Variable level. # ALSO: the current implementation only reports the FIRST violation per dataset - - name: library_variable_ccode - operator: not_equal_to - value: '' + - name: library_variable_ccode + operator: not_equal_to + value: '' # 2025-11-08: TEMPORARY solution: #- name: define_variable_has_codelist # operator: equal_to @@ -120,29 +108,29 @@ Check: # "do not check when there is no codelist referenced on the Variable level, # but there is a ValueList referenced". # Remark however this may lead to false negatives - - name: library_variable_ccode - operator: not_equal_to - value: define_variable_ccode + - name: library_variable_ccode + operator: not_equal_to + value: define_variable_ccode Core: Status: Draft Version: '1' Description: '' Executability: Fully Executable Outcome: - Message: 'The associated codelist for this variable does not match the codelist - provided in the define.xml through the CDISC-NCI Code' + Message: 'The associated codelist for this variable does not match the codelist provided in the define.xml + through the CDISC-NCI Code' Output Variables: - - define_variable_name - - library_variable_ccode - - define_variable_ccode - - define_vlm_ccode + - define_variable_name + - library_variable_ccode + - define_variable_ccode + - define_vlm_ccode # Rule Type: Define Item Metadata Check against Library Metadata Rule Type: Value Level Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND57.1/rule.yml b/Unpublished/SENDIG/SEND57.1/rule.yml index 62daa8916..153f8951c 100644 --- a/Unpublished/SENDIG/SEND57.1/rule.yml +++ b/Unpublished/SENDIG/SEND57.1/rule.yml @@ -1,125 +1,113 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple - individual values. In these cases, each contributing value is - a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding - variable, each contributing value must be included as its - controlled terminology submission value, and delimited from - other terms by a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.2" +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # selector to select all variables, except for STUDY #- name: variable_name # operator: not_equal_to # value: 'STUDYID' - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: non_empty + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: non_empty ## The following works for FB1502 test data #- name: variable_value # operator: equal_to @@ -131,25 +119,24 @@ Check: # value: ';' # value_is_literal: true # Trying with a regex: does not return anything even when value has a semicolon - - name: variable_value - operator: matches_regex - value: ';' + - name: variable_value + operator: matches_regex + value: ';' Core: Status: Draft Version: '1' Description: '' Executability: Fully Executable Outcome: - Message: "The variable value is a list of values separated by a semicolon, and - the variable is under controlled terminology, but not all values after - splitting are in the controlled terminology list" + Message: "The variable value is a list of values separated by a semicolon, and the variable is under + controlled terminology, but not all values after splitting are in the controlled terminology list" # Rule Type: Record Data Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND7/rule.yml b/Unpublished/SENDIG/SEND7/rule.yml index 22ac5d78e..0bf9c91ce 100644 --- a/Unpublished/SENDIG/SEND7/rule.yml +++ b/Unpublished/SENDIG/SEND7/rule.yml @@ -1,110 +1,104 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes - to describe variable-level metadata: ...The set of controlled - terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to - Section 4.3 for more information on Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '3.1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '1.2' + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: '1' + Version: '5.0' + Version: '1.0' Check: all: #- name: library_variable_has_codelist # operator: equal_to # value: true - - name: define_variable_ccode - operator: not_equal_to - value: library_variable_ccode + - name: define_variable_ccode + operator: not_equal_to + value: library_variable_ccode Core: Status: Draft Version: '1' @@ -113,16 +107,16 @@ Executability: Fully Executable Outcome: Message: Variable Codelist does not match with the one provided by the CDISC Library Output Variables: - - define_variable_name - - define_variable_ccode + - define_variable_name + - define_variable_ccode # THE FOLLOWING causes "not in dataset" # - library_variable_ccode Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND98/rule.yml b/Unpublished/SENDIG/SEND98/rule.yml index 562b0cdd6..d5f19a0ed 100644 --- a/Unpublished/SENDIG/SEND98/rule.yml +++ b/Unpublished/SENDIG/SEND98/rule.yml @@ -1,47 +1,47 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique identifier for a study site within a submission. Use only - if subjects are housed at different sites. - Document: IG v3.0 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND98 - Version: '1' - Version: '5.0' - Version: '3.0' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Unique identifier for a study site within a submission. Use only if subjects + are housed at different sites. + Document: IG v3.0 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND98 + Version: '1' + Version: '5.0' + Version: '3.0' # SITEID should only be used if the in-life portion of the study is conducted at different sites # When in-life portion is conducted at a single site, SITEID must me null Check: all: # With thanks to Richard Marshall for the suggestion in cdisccore.slack - - name: SITEID - operator: non_empty - - name: SITEID - operator: has_same_values + - name: SITEID + operator: non_empty + - name: SITEID + operator: has_same_values Core: Status: Draft Version: '1' Description: '' Executability: Fully Executable Operations: - - domain: DM - id: $distinct_siteid - name: SITEID - operator: distinct +- domain: DM + id: $distinct_siteid + name: SITEID + operator: distinct Outcome: - Message: 'SITEID may only be populated when there is more than one site where - the in-life portion of the study was conducted' + Message: 'SITEID may only be populated when there is more than one site where the in-life portion of + the study was conducted' Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml index 057bb4f4e..6141cbaa4 100644 --- a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml +++ b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml @@ -1,63 +1,63 @@ Authorities: - - Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: This is where you describe the rule in human - readable sentence(s). - Type: Success - Origin: SEND Conformance Rules - Related Rules: - - Id: '' - Relationship: Predecessor | Related | Successor - Release Notes: '' - Rule Identifier: - Id: SEND_AUTHORING_TEMPLATE - Version: '0.1' - Validator Rule Message: This is where you enter the message that will - be output when this rule is triggered. - Version: '5.0' - Version: 3.0 | 3.1 | 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Success - Origin: SEND Conformance Rules - Related Rules: - - Id: '' - Relationship: Predecessor | Related | Successor - Release Notes: '' - Rule Identifier: - Id: '' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' +- Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: '' + Document: '' + Item: '' + Section: '' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: This is where you describe the rule in human readable + sentence(s). + Type: Success + Origin: SEND Conformance Rules + Related Rules: + - Id: '' + Relationship: Predecessor | Related | Successor + Release Notes: '' + Rule Identifier: + Id: SEND_AUTHORING_TEMPLATE + Version: '0.1' + Validator Rule Message: This is where you enter the message that will be output when this rule + is triggered. + Version: '5.0' + Version: 3.0 | 3.1 | 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: '' + Document: '' + Item: '' + Section: '' + Criteria: + Logical Expression: + Condition: '' + Rule: '' + Plain Language Expression: '' + Type: Success + Origin: SEND Conformance Rules + Related Rules: + - Id: '' + Relationship: Predecessor | Related | Successor + Release Notes: '' + Rule Identifier: + Id: '' + Version: '' + Validator Rule Message: '' + Version: '5.0' + Version: '1.1' Check: all: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - '...': '' any: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - '...': '' not: operator: variable_metadata_not_equal_to Core: @@ -68,721 +68,721 @@ Executability: >- Fully Executable | Partially Executable | Partially Executable - Possible Overreporting | Partially Executable - Possible Underreporting Match Datasets: - - Is Relationship: true - Keys: - - '' - Name: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... +- Is Relationship: true + Keys: + - '' + Name: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... Operations: - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: define_variable_metadata - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: distinct - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: domain_is_custom - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: domain_label - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: dy - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: extract_metadata - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: expected_variables - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_codelist_attributes - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_column_order_from_dataset - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_column_order_from_library - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_model_column_order - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_model_filtered_variables - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_parent_model_column_order - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: label_referenced_variable_metadata - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: max - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: max_date - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: mean - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: min - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: min_date - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: name_referenced_variable_metadata - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: permissible_variables - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: record_count - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: required_variables - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: study_domains - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_codelist_dates - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_code_references - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_code_term_pairs - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_term_references - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_whodrug_references - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_count - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_exists - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_is_null - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_library_metadata - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_names - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_value_count - - attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: whodrug_code_hierarchy +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: define_variable_metadata +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: distinct +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: domain_is_custom +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: domain_label +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: dy +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: extract_metadata +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: expected_variables +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_codelist_attributes +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_column_order_from_dataset +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_column_order_from_library +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_model_column_order +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_model_filtered_variables +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: get_parent_model_column_order +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: label_referenced_variable_metadata +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: max +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: max_date +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: mean +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: min +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: min_date +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: name_referenced_variable_metadata +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: permissible_variables +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: record_count +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: required_variables +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: study_domains +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: valid_codelist_dates +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: valid_meddra_code_references +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: valid_meddra_code_term_pairs +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: valid_meddra_term_references +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: valid_whodrug_references +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_count +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_exists +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_is_null +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_library_metadata +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_names +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: variable_value_count +- attribute_name: variable_value_length + ct_attribute: '' + ct_packages: + - '' + ct_version: '' + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - '' + id: '' + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: '' + name: '' + operator: whodrug_code_hierarchy Outcome: Message: '' Output Variables: - - variable_value_length + - variable_value_length Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Exclude: - - ALL - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - INTERVENTIONS - - RELATIONSHIP - - SPECIAL PURPOSE - - STUDY REFERENCE - - TRIAL DESIGN + - ALL + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - INTERVENTIONS + - RELATIONSHIP + - SPECIAL PURPOSE + - STUDY REFERENCE + - TRIAL DESIGN Include: - - ALL - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - INTERVENTIONS - - RELATIONSHIP - - SPECIAL PURPOSE - - STUDY REFERENCE - - TRIAL DESIGN + - ALL + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - INTERVENTIONS + - RELATIONSHIP + - SPECIAL PURPOSE + - STUDY REFERENCE + - TRIAL DESIGN Data Structures: Exclude: - - ADAM OTHER - - ALL - - BASIC DATA STRUCTURE - - DEVICE LEVEL ANALYSIS DATASET - - MEDICAL DEVICE BASIC DATA STRUCTURE - - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - ALL + - BASIC DATA STRUCTURE + - DEVICE LEVEL ANALYSIS DATASET + - MEDICAL DEVICE BASIC DATA STRUCTURE + - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Include: - - ADAM OTHER - - ALL - - BASIC DATA STRUCTURE - - DEVICE LEVEL ANALYSIS DATASET - - MEDICAL DEVICE BASIC DATA STRUCTURE - - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - ALL + - BASIC DATA STRUCTURE + - DEVICE LEVEL ANALYSIS DATASET + - MEDICAL DEVICE BASIC DATA STRUCTURE + - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Exclude: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Include: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Domains: Exclude: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Include: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- include_split_datasets: true | false Subclasses: Exclude: - - ADVERSE EVENT - - ALL - - MEDICAL DEVICE TIME-TO-EVENT - - NON-COMPARTMENTAL ANALYSIS - - TIME-TO-EVENT + - ADVERSE EVENT + - ALL + - MEDICAL DEVICE TIME-TO-EVENT + - NON-COMPARTMENTAL ANALYSIS + - TIME-TO-EVENT Include: - - ADVERSE EVENT - - ALL - - MEDICAL DEVICE TIME-TO-EVENT - - NON-COMPARTMENTAL ANALYSIS - - TIME-TO-EVENT + - ADVERSE EVENT + - ALL + - MEDICAL DEVICE TIME-TO-EVENT + - NON-COMPARTMENTAL ANALYSIS + - TIME-TO-EVENT Sensitivity: Record diff --git a/Unpublished/TIG/TIG0031/rule.yml b/Unpublished/TIG/TIG0031/rule.yml index b86893fc4..1a06c5b84 100644 --- a/Unpublished/TIG/TIG0031/rule.yml +++ b/Unpublished/TIG/TIG0031/rule.yml @@ -2,56 +2,56 @@ # Condition: Record has an associated PARENT record # Rule: Value for LEVEL = value for PARENT LEVEL + 1 Authorities: - - Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: If a record has a PARENT, LEVEL must be populated with a LEVEL - that is sequentially one greater than the PARENT record (e.g., - value for LEVEL = value for PARENT LEVEL + 1). - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0031' - Version: '1' - Version: '1.0' - Version: '1.0' +- Organization: 'CDISC' + Standards: + - Name: 'TIG' + References: + - Citations: + - Cited Guidance: If a record has a PARENT, LEVEL must be populated with a LEVEL that is + sequentially one greater than the PARENT record (e.g., value for LEVEL = value for PARENT + LEVEL + 1). + Document: 'TIG 1.0' + Item: 'assumption 6' + Section: '2.8.9.23' + Origin: TIG Conformance Rules + Rule Identifier: + Id: 'TIG0031' + Version: '1' + Version: '1.0' + Version: '1.0' Check: all: - - name: PARENT - operator: non_empty - - name: LEVEL - operator: equal_to - value: $LEVEL_join + 1 + - name: PARENT + operator: non_empty + - name: LEVEL + operator: equal_to + value: $LEVEL_join + 1 Core: Status: Draft Version: '1' -Description: Raise an error when a record has a PARENT record but the value for - LEVEL does not equal the level of the PARENT LEVEL + 1. +Description: Raise an error when a record has a PARENT record but the value for LEVEL does not equal + the level of the PARENT LEVEL + 1. Executability: Fully Executable Match Datasets: - - Keys: - - SETCD - - Left: PARENT - Right: REFID - Name: RELREF +- Keys: + - SETCD + - Left: PARENT + Right: REFID + Name: RELREF Outcome: - Message: Record has a PARENT record but the value for LEVEL does not equal the - level of the PARENT LEVEL + 1. + Message: Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT + LEVEL + 1. Output Variables: - - LEVEL - - PARENT - - SETCD + - LEVEL + - PARENT + - SETCD Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Unpublished/TIG/TIG0044/rule.yml b/Unpublished/TIG/TIG0044/rule.yml index a31db5a16..78a6537a4 100644 --- a/Unpublished/TIG/TIG0044/rule.yml +++ b/Unpublished/TIG/TIG0044/rule.yml @@ -1,68 +1,67 @@ # Variable: STRAIN # Rule: Record with TSPARMCD = "STRAIN" is present in TS and TSVAL ^= null for that record OR Record with TXPARMCD = "STRAIN" is present in TX and TXVAL ^= null for that record Authorities: - - Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information - must be present at a higher level (either Trial Sets or Trial - Summary). - Document: TIG 1.0 - Item: STRAIN CDISC Notes - Section: 2.8.9.6 SEND Demographics (DM) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0044 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' +- Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: TIG 1.0 + Item: STRAIN CDISC Notes + Section: 2.8.9.6 SEND Demographics (DM) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0044 + Version: '1' + Version: '1.0' + Substandard: SEND + Version: '1.0' Check: all: - - name: $tsparmcdstrain_count - operator: equal_to - value: 0 - - name: $txparmcdstrain_count - operator: equal_to - value: 0 + - name: $tsparmcdstrain_count + operator: equal_to + value: 0 + - name: $txparmcdstrain_count + operator: equal_to + value: 0 Core: Id: Status: Draft Version: '1' -Description: Part A - Raise an error when there is no record with TSPARMCD = - "STRAIN" present in TS or TSVAL is not completed and no record with TXPARMCD = - "STRAIN" present in TX or TXVAL is not completed. +Description: Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS + or TSVAL is not completed and no record with TXPARMCD = "STRAIN" present in TX or TXVAL is not + completed. Executability: Fully Executable Operations: - - domain: TX - filter: - TXPARMCD: STRAIN - group: - - SETCD - id: $txparmcdstrain_count - name: TXPARMCD - operator: record_count - - domain: TS - filter: - TSPARMCD: STRAIN - id: $tsparmcdstrain_count - name: TSPARMCD - operator: record_count +- domain: TX + filter: + TXPARMCD: STRAIN + group: + - SETCD + id: $txparmcdstrain_count + name: TXPARMCD + operator: record_count +- domain: TS + filter: + TSPARMCD: STRAIN + id: $tsparmcdstrain_count + name: TSPARMCD + operator: record_count Outcome: - Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed - TSVAL or a record in TX with TXPARMCD = "STRAIN" and completed TXVAL. + Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record + in TX with TXPARMCD = "STRAIN" and completed TXVAL. Output Variables: - - $txparmcdstrain_count - - $tsparmcdstrain_count + - $txparmcdstrain_count + - $tsparmcdstrain_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Unpublished/USDM/DDF00262/rule.yml b/Unpublished/USDM/DDF00262/rule.yml index df86fd990..5b35967f6 100644 --- a/Unpublished/USDM/DDF00262/rule.yml +++ b/Unpublished/USDM/DDF00262/rule.yml @@ -1,18 +1,18 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced id values must be valid according to the USDM schema - based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00262' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Referenced id values must be valid according to the USDM schema based on the + API specification.' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'DDF00262' + Version: '1' + Version: '1.0' + Version: '4.0' Check: |- ( $idl := **[id and instanceType]{id:$distinct(instanceType)}; @@ -328,19 +328,18 @@ Core: Id: '' Status: Draft Version: '1' -Description: 'Referenced id values must be valid according to the USDM schema - based on the API specification.' +Description: 'Referenced id values must be valid according to the USDM schema based on the API specification.' Executability: Fully Executable Outcome: - Message: 'The referenced id value is not valid - the id value doesn''t match any - object or the id value refers to an instance of an incorrect entity.' + Message: 'The referenced id value is not valid - the id value doesn''t match any object or the id value + refers to an instance of an incorrect entity.' Output Variables: - - 'Id Attribute' - - 'Id Value' - - Issue + - 'Id Attribute' + - 'Id Value' + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'ALL' + - 'ALL' Sensitivity: Record diff --git a/Unpublished/USDM/USDM_TEMPLATE/rule.yml b/Unpublished/USDM/USDM_TEMPLATE/rule.yml index b428d021c..29763705f 100644 --- a/Unpublished/USDM/USDM_TEMPLATE/rule.yml +++ b/Unpublished/USDM/USDM_TEMPLATE/rule.yml @@ -1,35 +1,35 @@ Authorities: - - Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: '' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'USDM_TEMPLATE' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: '' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'USDM_TEMPLATE' - Version: '1' - Version: '1.0' - Version: '4.0' +- Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: '' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'USDM_TEMPLATE' + Version: '1' + Version: '1.0' + Version: '3.0' + - Name: USDM + References: + - Citations: + - Cited Guidance: '' + Document: 'USDM_CORE_Rules.xlsx' + Origin: 'USDM Conformance Rules' + Rule Identifier: + Id: 'USDM_TEMPLATE' + Version: '1' + Version: '1.0' + Version: '4.0' Check: all: - - operator: variable_metadata_not_equal_to - - ...: '' + - operator: variable_metadata_not_equal_to + - '...': '' any: - - operator: variable_metadata_not_equal_to - - ...: '' + - operator: variable_metadata_not_equal_to + - '...': '' not: operator: variable_metadata_not_equal_to Core: @@ -45,30 +45,30 @@ Executability: >- # - if needed, remove this comment # - if not needed, remove the Match Datasets section Match Datasets: - - Keys: - - '' - - Left: '' - Right: '' - Name: >- - ... +- Keys: + - '' + - Left: '' + Right: '' + Name: >- + ... # Operations is optional # - if needed, remove this comment # - if not needed, remove the Operations section Operations: - - ...: '' +- '...': '' Outcome: Message: '' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Exclude: - - '' + - '' Include: - - '' + - '' Sensitivity: Record From 019a0c10c5e66a3c75f3ca11de79310e3ac4c2b7 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Thu, 16 Jul 2026 10:27:46 -0400 Subject: [PATCH 06/18] sort rules --- Published/CORE-000097/rule.yml | 30 ------------------- Published/CORE-000118/rule.yml | 26 ---------------- Published/CORE-000167/rule.yml | 4 +-- Published/CORE-000173/rule.yml | 2 +- Published/CORE-000262/rule.yml | 2 +- Published/CORE-000269/rule.yml | 2 +- Published/CORE-000432/rule.yml | 6 ++-- Published/CORE-000457/rule.yml | 8 ++--- .../SDTMIG/CDISC.SDTMIG.CG0096/rule.yml | 2 +- .../SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml | 2 +- .../SDTMIG/CDISC.SDTMIG.CG0162/rule.yml | 2 +- .../SDTMIG/CDISC.SDTMIG.CG0610/rule.yml | 2 +- 12 files changed, 16 insertions(+), 72 deletions(-) diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 1af285d9d..1a5f4c417 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -31,15 +31,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0218 -<<<<<<< HEAD Version: '1' Version: '2.0' Version: '3.2' -======= - Version: "1" - Version: "2.0" - Version: "3.2" ->>>>>>> main - Name: SDTMIG References: - Citations: @@ -49,7 +43,6 @@ Authorities: visits. Document: IG v3.3 Item: Assumption 11 -<<<<<<< HEAD Section: '5.5' Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: @@ -57,15 +50,6 @@ Authorities: Version: '1' Version: '2.0' Version: '3.3' -======= - Section: "5.5" - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: "1" - Version: "2.0" - Version: "3.3" ->>>>>>> main - Name: TIG References: - Citations: @@ -77,17 +61,10 @@ Authorities: Origin: TIG Conformance Rules Rule Identifier: Id: TIG0432 -<<<<<<< HEAD Version: '1' Version: '1.0' Substandard: SDTM Version: '1.0' -======= - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" ->>>>>>> main Check: all: - name: EPOCH @@ -104,11 +81,7 @@ Check: Core: Id: CORE-000097 Status: Published -<<<<<<< HEAD Version: '1' -======= - Version: "1" ->>>>>>> main Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting @@ -118,15 +91,12 @@ Match Datasets: Name: SE Outcome: Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. -<<<<<<< HEAD -======= Output Variables: - SESTDTC - SVSTDTC - SEENDTC - EPOCH - SE.EPOCH ->>>>>>> main Rule Type: Record Data Scope: Classes: diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index d9fe2c24b..1fa4b99b7 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -58,15 +58,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0404 -<<<<<<< HEAD Version: '2' Version: '2.0' Version: '3.2' -======= - Version: "2" - Version: "2.0" - Version: "3.2" ->>>>>>> main - Name: SDTMIG References: - Citations: @@ -85,15 +79,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0404 -<<<<<<< HEAD Version: '2' Version: '2.0' Version: '3.3' -======= - Version: "2" - Version: "2.0" - Version: "3.3" ->>>>>>> main - Name: TIG References: - Citations: @@ -120,17 +108,10 @@ Authorities: Origin: TIG Conformance Rules Rule Identifier: Id: TIG0562 -<<<<<<< HEAD Version: '1' Version: '1.0' Substandard: SDTM Version: '1.0' -======= - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" ->>>>>>> main Check: all: @@ -144,22 +125,15 @@ Check: Core: Id: CORE-000118 Status: Published -<<<<<<< HEAD Version: '1' -======= - Version: "1" ->>>>>>> main Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not present in dataset. Executability: Fully Executable Outcome: Message: --STAT is not present in dataset when --PRESP is equal to "Y" and --OCCUR is blank -<<<<<<< HEAD Output Variables: - --PRESP - --OCCUR -======= ->>>>>>> main Rule Type: Record Data Scope: Classes: diff --git a/Published/CORE-000167/rule.yml b/Published/CORE-000167/rule.yml index c1bd1a5a9..584a0bce9 100644 --- a/Published/CORE-000167/rule.yml +++ b/Published/CORE-000167/rule.yml @@ -8,8 +8,8 @@ Authorities: References: - Citations: - Cited Guidance: The description of a time point that acts as a fixed reference for a series - of planned time points, used for study data tabulation. Description of the fixed - reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. Document: Model v2.0 Section: Timing Origin: SDTM and SDTMIG Conformance Rules diff --git a/Published/CORE-000173/rule.yml b/Published/CORE-000173/rule.yml index 2ffaa6204..9dd9085c3 100644 --- a/Published/CORE-000173/rule.yml +++ b/Published/CORE-000173/rule.yml @@ -61,7 +61,7 @@ Authorities: References: - Citations: - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of - the trial Elements a subject actually passed through in their participation in the trial. + the trial Elements a subject actually passed through in their participation in the trial. Section 10.8.30 Trial Elements and Section 10.8.29 Trial Arms, as these datasets define a trial's planned Elements and describe the planned sequences of Elements for the Arms of the trial. diff --git a/Published/CORE-000262/rule.yml b/Published/CORE-000262/rule.yml index 7e83872a3..744db62fe 100644 --- a/Published/CORE-000262/rule.yml +++ b/Published/CORE-000262/rule.yml @@ -23,7 +23,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifies the start of the observation as being before, during, or after + - Cited Guidance: Identifies the start of the observation as being before, during, or after the sponsor-defined reference period.The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point represented by RFSTDTC and RFENDTC in Demographics. diff --git a/Published/CORE-000269/rule.yml b/Published/CORE-000269/rule.yml index 053f09738..55380c4ad 100644 --- a/Published/CORE-000269/rule.yml +++ b/Published/CORE-000269/rule.yml @@ -7,7 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). Document: IG v3.4 Item: '' diff --git a/Published/CORE-000432/rule.yml b/Published/CORE-000432/rule.yml index 0850bda32..e84d7395e 100644 --- a/Published/CORE-000432/rule.yml +++ b/Published/CORE-000432/rule.yml @@ -88,7 +88,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: Short character value for the Trial Set parameter described in TXPARM. + - Cited Guidance: Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. Document: TIG v1.0 Item: TXPARMCD CDISC Notes @@ -109,8 +109,8 @@ Core: Id: CORE-000432 Status: Published Version: "1" -Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. - Maximum 8 characters. +Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum + 8 characters. Executability: Fully Executable Outcome: Message: TXPARMCD value has more than 8 characters diff --git a/Published/CORE-000457/rule.yml b/Published/CORE-000457/rule.yml index 64c06b3b9..83baea898 100644 --- a/Published/CORE-000457/rule.yml +++ b/Published/CORE-000457/rule.yml @@ -9,10 +9,10 @@ Authorities: - Citations: - Cited Guidance: There is a one-to-one correspondence between a domain dataset and it's Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The - single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. - The set of Supplemental Qualifiers for each domain is included in a separate dataset with - the name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers - relate back to. + single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The + set of Supplemental Qualifiers for each domain is included in a separate dataset with the + name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers relate + back to. Document: IG v3.2 Section: 8.4.2 Origin: SDTM and SDTMIG Conformance Rules diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml index c23d1b255..bd7172df7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml @@ -13,7 +13,7 @@ Authorities: Document: IG v3.4 Item: Assumption 2c Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes. If an intervention term does not have a decode value in the diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml index 76346de68..25fc09d4c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml @@ -13,7 +13,7 @@ Authorities: Document: IG v3.4 Item: Assumption 2c Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes. If an intervention term does not have a decode value in the diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml index 1be0b4299..1e982051a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml @@ -25,7 +25,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated + - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml index 63d338f22..36623f2bd 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml @@ -28,7 +28,7 @@ Core: Id: CDISC.SDTMIG.CG0610 Status: Draft Version: '1' -Description: If the test is for culture characteristics, verify that MBTEST equals the name of the +Description: If the test is for culture characteristics, verify that MBTEST equals the name of the organism/antigen being characterized. Executability: Fully Executable Outcome: From 332a2e77c4f06b98e56ef7356812e02f1d8a6d24 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Fri, 17 Jul 2026 15:57:05 -0400 Subject: [PATCH 07/18] prettier format --- .github/ISSUE_TEMPLATE/1-rule-issue.yml | 2 +- .github/ISSUE_TEMPLATE/config.yml | 2 +- .github/workflows/publish.yml | 2 +- .github/workflows/submodule_update.yml | 2 +- .../workflows/validate-rule-contributions.yml | 4 +- .github/workflows/validate-yaml-format.yml | 89 +- .github/workflows/validate-yaml-schema.yml | 10 +- .pre-commit-config.yaml | 4 +- .vscode/extensions.json | 3 +- .vscode/settings.json | 11 +- Deprecated/CORE-000002/rule.yml | 35 +- Deprecated/CORE-000003/rule.yml | 33 +- Deprecated/CORE-000005/rule.yml | 31 +- Deprecated/CORE-000008/rule.yml | 58 +- Deprecated/CORE-000031/rule.yml | 20 +- Deprecated/CORE-000032/rule.yml | 20 +- Deprecated/CORE-000072/rule.yml | 19 +- Deprecated/CORE-000073/rule.yml | 16 +- Deprecated/CORE-000076/rule.yml | 33 +- Deprecated/CORE-000077/rule.yml | 33 +- Deprecated/CORE-000078/rule.yml | 33 +- Deprecated/CORE-000079/rule.yml | 31 +- Deprecated/CORE-000082/rule.yml | 14 +- Deprecated/CORE-000089/rule.yml | 33 +- Deprecated/CORE-000091/rule.yml | 30 +- Deprecated/CORE-000109/rule.yml | 26 +- Deprecated/CORE-000115/rule.yml | 38 +- Deprecated/CORE-000145/rule.yml | 34 +- Deprecated/CORE-000146/rule.yml | 42 +- Deprecated/CORE-000149/rule.yml | 22 +- Deprecated/CORE-000150/rule.yml | 31 +- Deprecated/CORE-000153/rule.yml | 31 +- Deprecated/CORE-000174/rule.yml | 39 +- Deprecated/CORE-000175/rule.yml | 39 +- Deprecated/CORE-000176/rule.yml | 39 +- Deprecated/CORE-000178/rule.yml | 29 +- Deprecated/CORE-000181/rule.yml | 37 +- Deprecated/CORE-000188/rule.yml | 36 +- Deprecated/CORE-000193/rule.yml | 23 +- Deprecated/CORE-000211/rule.yml | 26 +- Deprecated/CORE-000215/rule.yml | 23 +- Deprecated/CORE-000216/rule.yml | 24 +- Deprecated/CORE-000226/rule.yml | 45 +- Deprecated/CORE-000229/rule.yml | 20 +- Deprecated/CORE-000230/rule.yml | 22 +- Deprecated/CORE-000231/rule.yml | 29 +- Deprecated/CORE-000232/rule.yml | 29 +- Deprecated/CORE-000233/rule.yml | 39 +- Deprecated/CORE-000234/rule.yml | 33 +- Deprecated/CORE-000235/rule.yml | 29 +- Deprecated/CORE-000251/rule.yml | 61 +- Deprecated/CORE-000259/rule.yml | 59 +- Deprecated/CORE-000264/rule.yml | 41 +- Deprecated/CORE-000292/rule.yml | 31 +- Deprecated/CORE-000297/rule.yml | 23 +- Deprecated/CORE-000322/rule.yml | 16 +- Deprecated/CORE-000326/rule.yml | 13 +- Deprecated/CORE-000329/rule.yml | 17 +- Deprecated/CORE-000330/rule.yml | 13 +- Deprecated/CORE-000331/rule.yml | 26 +- Deprecated/CORE-000332/rule.yml | 19 +- Deprecated/CORE-000333/rule.yml | 18 +- Deprecated/CORE-000335/rule.yml | 20 +- Deprecated/CORE-000338/rule.yml | 22 +- Deprecated/CORE-000339/rule.yml | 22 +- Deprecated/CORE-000340/rule.yml | 22 +- Deprecated/CORE-000362/rule.yml | 38 +- Deprecated/CORE-000364/rule.yml | 13 +- Deprecated/CORE-000365/rule.yml | 31 +- 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+- Published/CORE-000116/rule.yml | 84 +- Published/CORE-000117/rule.yml | 254 +-- Published/CORE-000118/rule.yml | 264 +-- Published/CORE-000119/rule.yml | 111 +- Published/CORE-000120/rule.yml | 115 +- Published/CORE-000121/rule.yml | 123 +- Published/CORE-000122/rule.yml | 146 +- Published/CORE-000123/rule.yml | 135 +- Published/CORE-000124/rule.yml | 135 +- Published/CORE-000125/rule.yml | 135 +- Published/CORE-000126/rule.yml | 132 +- Published/CORE-000127/rule.yml | 135 +- Published/CORE-000128/rule.yml | 135 +- Published/CORE-000129/rule.yml | 132 +- Published/CORE-000130/rule.yml | 135 +- Published/CORE-000131/rule.yml | 138 +- Published/CORE-000132/rule.yml | 591 +++---- Published/CORE-000133/rule.yml | 134 +- Published/CORE-000134/rule.yml | 164 +- Published/CORE-000135/rule.yml | 158 +- Published/CORE-000136/rule.yml | 160 +- Published/CORE-000137/rule.yml | 312 ++-- Published/CORE-000138/rule.yml | 212 +-- Published/CORE-000139/rule.yml | 208 +-- 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| 368 ++-- Published/CORE-000202/rule.yml | 177 +- Published/CORE-000203/rule.yml | 180 +- Published/CORE-000204/rule.yml | 174 +- Published/CORE-000206/rule.yml | 463 ++--- Published/CORE-000207/rule.yml | 442 ++--- Published/CORE-000208/rule.yml | 134 +- Published/CORE-000209/rule.yml | 141 +- Published/CORE-000210/rule.yml | 132 +- Published/CORE-000212/rule.yml | 155 +- Published/CORE-000213/rule.yml | 154 +- Published/CORE-000214/rule.yml | 155 +- Published/CORE-000217/rule.yml | 270 +-- Published/CORE-000218/rule.yml | 360 ++-- Published/CORE-000219/rule.yml | 298 ++-- Published/CORE-000220/rule.yml | 162 +- Published/CORE-000221/rule.yml | 185 +- Published/CORE-000222/rule.yml | 146 +- Published/CORE-000223/rule.yml | 123 +- Published/CORE-000224/rule.yml | 123 +- Published/CORE-000225/rule.yml | 169 +- Published/CORE-000227/rule.yml | 150 +- Published/CORE-000228/rule.yml | 152 +- Published/CORE-000236/rule.yml | 209 +-- Published/CORE-000237/rule.yml | 298 ++-- 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| 194 ++- Published/CORE-000456/rule.yml | 206 +-- Published/CORE-000457/rule.yml | 158 +- Published/CORE-000458/rule.yml | 249 +-- Published/CORE-000459/rule.yml | 212 +-- Published/CORE-000460/rule.yml | 205 +-- Published/CORE-000461/rule.yml | 52 +- Published/CORE-000462/rule.yml | 161 +- Published/CORE-000463/rule.yml | 192 +-- Published/CORE-000465/rule.yml | 117 +- Published/CORE-000466/rule.yml | 150 +- Published/CORE-000471/rule.yml | 184 +- Published/CORE-000472/rule.yml | 177 +- Published/CORE-000474/rule.yml | 173 +- Published/CORE-000475/rule.yml | 214 +-- Published/CORE-000476/rule.yml | 102 +- Published/CORE-000477/rule.yml | 129 +- Published/CORE-000478/rule.yml | 167 +- Published/CORE-000479/rule.yml | 182 +- Published/CORE-000480/rule.yml | 173 +- Published/CORE-000481/rule.yml | 182 +- Published/CORE-000482/rule.yml | 204 +-- Published/CORE-000484/rule.yml | 138 +- Published/CORE-000485/rule.yml | 227 +-- Published/CORE-000486/rule.yml | 169 +- 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Published/CORE-000640/rule.yml | 207 +-- Published/CORE-000641/rule.yml | 207 +-- Published/CORE-000642/rule.yml | 254 +-- Published/CORE-000643/rule.yml | 297 ++-- Published/CORE-000645/rule.yml | 186 +- Published/CORE-000648/rule.yml | 188 +- Published/CORE-000649/rule.yml | 207 +-- Published/CORE-000650/rule.yml | 186 +- Published/CORE-000651/rule.yml | 417 ++--- Published/CORE-000652/rule.yml | 85 +- Published/CORE-000653/rule.yml | 223 +-- Published/CORE-000654/rule.yml | 207 +-- Published/CORE-000660/rule.yml | 68 +- Published/CORE-000661/rule.yml | 207 +-- Published/CORE-000662/rule.yml | 207 +-- Published/CORE-000663/rule.yml | 207 +-- Published/CORE-000664/rule.yml | 207 +-- Published/CORE-000665/rule.yml | 207 +-- Published/CORE-000667/rule.yml | 207 +-- Published/CORE-000668/rule.yml | 207 +-- Published/CORE-000669/rule.yml | 207 +-- Published/CORE-000670/rule.yml | 100 +- Published/CORE-000671/rule.yml | 160 +- Published/CORE-000672/rule.yml | 303 ++-- 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+- Published/CORE-000956/rule.yml | 45 +- Published/CORE-000957/rule.yml | 259 +-- Published/CORE-000958/rule.yml | 259 +-- Published/CORE-000959/rule.yml | 259 +-- Published/CORE-000960/rule.yml | 64 +- Published/CORE-000961/rule.yml | 90 +- Published/CORE-000962/rule.yml | 86 +- Published/CORE-000963/rule.yml | 86 +- Published/CORE-000964/rule.yml | 50 +- Published/CORE-000965/rule.yml | 50 +- Published/CORE-000966/rule.yml | 56 +- Published/CORE-000967/rule.yml | 52 +- Published/CORE-000968/rule.yml | 57 +- Published/CORE-000969/rule.yml | 65 +- Published/CORE-000970/rule.yml | 55 +- Published/CORE-000971/rule.yml | 54 +- Published/CORE-000972/rule.yml | 305 ++-- Published/CORE-000973/rule.yml | 42 +- Published/CORE-000974/rule.yml | 47 +- Published/CORE-000975/rule.yml | 259 +-- Published/CORE-000976/rule.yml | 259 +-- Published/CORE-000977/rule.yml | 259 +-- Published/CORE-000978/rule.yml | 255 +-- Published/CORE-000979/rule.yml | 283 +-- Published/CORE-000980/rule.yml | 44 +- 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.../CDISC.ADaMIG.AD0268.yml | 221 +-- .../CDISC.ADaMIG.AD0269.yml | 201 +-- .../CDISC.ADaMIG.AD0270.yml | 201 +-- .../CDISC.ADaMIG.AD0271.yml | 201 +-- .../CDISC.ADaMIG.AD0279.yml | 316 ++-- .../CDISC.ADaMIG.AD0363.yml | 34 +- .../CDISC.ADaMIG.AD0364.yml | 171 +- .../CDISC.ADaMIG.AD0373.yml | 80 +- .../CDISC.ADaMIG.AD0522b.yml | 102 +- .../CDISC.ADaMIG.AD0523b.yml | 102 +- .../CDISC.ADaMIG.AD0524.yml | 102 +- .../CDISC.ADaMIG.AD0525.yml | 102 +- .../CDISC.ADaMIG.AD0529.yml | 102 +- .../CDISC.ADaMIG.AD0530.yml | 102 +- .../ADAMIG/CDISC.ADaMIG.AD055/rule.yml | 182 +- .../CDISC.ADaMIG.AD0619.yml | 34 +- .../ADAMIG/CDISC.ADaMIG.AD064/rule.yml | 220 +-- .../CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml | 94 +- .../CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml | 101 +- .../CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml | 92 +- .../CDISC.ADaMIG.AD0800.yml | 31 +- .../CDISC.ADaMIG.AD0802.yml | 29 +- .../CDISC.ADaMIG.AD0804.yml | 29 +- .../CDISC.ADaMIG.AD0805.yml | 31 +- .../CDISC.ADaMIG.AD0806.yml | 31 +- 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Rules/FB0804/rule.yml | 247 +-- .../FDA Business Rules/FB1113/rule.yml | 166 +- .../FDA Business Rules/FB1901/rule.yml | 311 ++-- .../FDA Business Rules/FB6501/rule.yml | 202 +-- .../FDA Business Rules/FB6502/rule.yml | 202 +-- .../FDA Business Rules/FB6503/rule.yml | 202 +-- .../FDA Business Rules/FB6504/rule.yml | 202 +-- .../FDA Business Rules/FB6505/rule.yml | 202 +-- .../FDA Business Rules/FB6506/rule.yml | 202 +-- .../FDA Business Rules/FB6507/rule.yml | 202 +-- .../FDA Business Rules/FB6508/rule.yml | 202 +-- .../FDA Business Rules/FB6509/rule.yml | 202 +-- .../FDA Business Rules/FB6510/rule.yml | 204 +-- .../FDA Business Rules/FB6601/rule.yml | 198 +-- .../FDA Business Rules/FB6602/rule.yml | 198 +-- .../FDA.SDTMIG.CT2001/rule.yml | 59 +- .../FDA.SDTMIG.FB0101/rule.yml | 104 +- .../FDA.SDTMIG.FB0405/rule.yml | 109 +- .../FDA.SDTMIG.FB0411/rule.yml | 111 +- .../FDA.SDTMIG.FB0801/rule.yml | 287 ++-- .../FDA.SDTMIG.FB0802/rule.yml | 289 ++-- .../FDA.SDTMIG.FB0803/rule.yml | 226 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.../FDA.SENDIG.FB6506/rule.yml | 192 +-- .../FDA.SENDIG.FB6507/rule.yml | 192 +-- .../FDA.SENDIG.FB6508/rule.yml | 192 +-- .../FDA.SENDIG.FB6509/rule.yml | 192 +-- .../FDA.SENDIG.FB6601/rule.yml | 189 ++- .../FDA.SENDIG.FB6602/rule.yml | 190 ++- .../FDA.SENDIG.FB8202/rule.yml | 89 +- .../FDA Business Rules/FDA.TRC1734a/rule.yml | 304 ++-- .../FDA Business Rules/FDA.TRC1734b/rule.yml | 324 ++-- .../FFDA.SENDIG.FB1119/rule.yml | 224 +-- .../SDTMIG/CDISC.SDTMIG.CG0002/rule.yml | 123 +- .../SDTMIG/CDISC.SDTMIG.CG0015/rule.yml | 132 +- .../SDTMIG/CDISC.SDTMIG.CG0019/rule.yml | 151 +- .../SDTMIG/CDISC.SDTMIG.CG0096/rule.yml | 158 +- .../SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml | 164 +- .../SDTMIG/CDISC.SDTMIG.CG0097/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0103/rule.yml | 111 +- .../SDTMIG/CDISC.SDTMIG.CG0104/rule.yml | 111 +- .../SDTMIG/CDISC.SDTMIG.CG0155/rule.yml | 99 +- .../SDTMIG/CDISC.SDTMIG.CG0156/rule.yml | 107 +- .../SDTMIG/CDISC.SDTMIG.CG0157/rule.yml | 114 +- .../SDTMIG/CDISC.SDTMIG.CG0158/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0159/rule.yml | 111 +- .../SDTMIG/CDISC.SDTMIG.CG0160/rule.yml | 135 +- .../SDTMIG/CDISC.SDTMIG.CG0161/rule.yml | 135 +- .../SDTMIG/CDISC.SDTMIG.CG0162/rule.yml | 127 +- .../SDTMIG/CDISC.SDTMIG.CG0167/rule.yml | 121 +- .../SDTMIG/CDISC.SDTMIG.CG0169/rule.yml | 114 +- .../SDTMIG/CDISC.SDTMIG.CG0173/rule.yml | 123 +- .../SDTMIG/CDISC.SDTMIG.CG0184/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0186/rule.yml | 94 +- .../SDTMIG/CDISC.SDTMIG.CG0187/rule.yml | 94 +- .../SDTMIG/CDISC.SDTMIG.CG0188/rule.yml | 115 +- .../SDTMIG/CDISC.SDTMIG.CG0189/rule.yml | 115 +- .../SDTMIG/CDISC.SDTMIG.CG0190/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0192/rule.yml | 40 +- .../SDTMIG/CDISC.SDTMIG.CG0196/rule.yml | 97 +- .../SDTMIG/CDISC.SDTMIG.CG0197/rule.yml | 120 +- .../SDTMIG/CDISC.SDTMIG.CG0198/rule.yml | 107 +- .../SDTMIG/CDISC.SDTMIG.CG0236/rule.yml | 127 +- .../SDTMIG/CDISC.SDTMIG.CG0237/rule.yml | 131 +- .../SDTMIG/CDISC.SDTMIG.CG0238/rule.yml | 169 +- .../SDTMIG/CDISC.SDTMIG.CG0249/rule.yml | 111 +- .../SDTMIG/CDISC.SDTMIG.CG0250/rule.yml | 100 +- .../SDTMIG/CDISC.SDTMIG.CG0251/rule.yml | 105 +- .../SDTMIG/CDISC.SDTMIG.CG0252/rule.yml | 115 +- .../SDTMIG/CDISC.SDTMIG.CG0253/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0254/rule.yml | 108 +- .../SDTMIG/CDISC.SDTMIG.CG0267/rule.yml | 88 +- .../SDTMIG/CDISC.SDTMIG.CG0295/rule.yml | 111 +- .../SDTMIG/CDISC.SDTMIG.CG0296/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0298/rule.yml | 94 +- .../SDTMIG/CDISC.SDTMIG.CG0312/rule.yml | 359 ++-- .../SDTMIG/CDISC.SDTMIG.CG0320/rule.yml | 144 +- .../SDTMIG/CDISC.SDTMIG.CG0321/rule.yml | 164 +- .../SDTMIG/CDISC.SDTMIG.CG0322/rule.yml | 118 +- .../SDTMIG/CDISC.SDTMIG.CG0323/rule.yml | 136 +- .../SDTMIG/CDISC.SDTMIG.CG0324/rule.yml | 116 +- .../SDTMIG/CDISC.SDTMIG.CG0347/rule.yml | 127 +- .../SDTMIG/CDISC.SDTMIG.CG0375/rule.yml | 123 +- .../SDTMIG/CDISC.SDTMIG.CG0377/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0378/rule.yml | 118 +- .../SDTMIG/CDISC.SDTMIG.CG0380/rule.yml | 98 +- .../SDTMIG/CDISC.SDTMIG.CG0381/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0382/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0383/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0384/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0385/rule.yml | 109 +- .../SDTMIG/CDISC.SDTMIG.CG0386/rule.yml | 123 +- .../SDTMIG/CDISC.SDTMIG.CG0400/rule.yml | 109 +- .../SDTMIG/CDISC.SDTMIG.CG0418/rule.yml | 113 +- .../SDTMIG/CDISC.SDTMIG.CG0425/rule.yml | 95 +- .../SDTMIG/CDISC.SDTMIG.CG0431/rule.yml | 130 +- .../SDTMIG/CDISC.SDTMIG.CG0436/rule.yml | 100 +- .../SDTMIG/CDISC.SDTMIG.CG0437/rule.yml | 103 +- .../SDTMIG/CDISC.SDTMIG.CG0442/rule.yml | 74 +- .../SDTMIG/CDISC.SDTMIG.CG0443/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0445/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0446/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0448/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0449/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0450/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0451/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0453/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0454/rule.yml | 72 +- .../SDTMIG/CDISC.SDTMIG.CG0460/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0461/rule.yml | 101 +- .../SDTMIG/CDISC.SDTMIG.CG0463/rule.yml | 131 +- .../SDTMIG/CDISC.SDTMIG.CG0464/rule.yml | 133 +- .../SDTMIG/CDISC.SDTMIG.CG0466/rule.yml | 98 +- .../SDTMIG/CDISC.SDTMIG.CG0523/rule.yml | 76 +- .../SDTMIG/CDISC.SDTMIG.CG0524/rule.yml | 79 +- .../SDTMIG/CDISC.SDTMIG.CG0525/rule.yml | 85 +- .../SDTMIG/CDISC.SDTMIG.CG0526/rule.yml | 78 +- .../SDTMIG/CDISC.SDTMIG.CG0527/rule.yml | 84 +- .../SDTMIG/CDISC.SDTMIG.CG0532/rule.yml | 126 +- .../SDTMIG/CDISC.SDTMIG.CG0546/rule.yml | 138 +- .../SDTMIG/CDISC.SDTMIG.CG0548/rule.yml | 68 +- .../SDTMIG/CDISC.SDTMIG.CG0551/rule.yml | 74 +- .../SDTMIG/CDISC.SDTMIG.CG0555/rule.yml | 131 +- .../SDTMIG/CDISC.SDTMIG.CG0556/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0557/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0558/rule.yml | 131 +- .../SDTMIG/CDISC.SDTMIG.CG0559/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0560/rule.yml | 152 +- .../SDTMIG/CDISC.SDTMIG.CG0563/rule.yml | 91 +- .../SDTMIG/CDISC.SDTMIG.CG0604/rule.yml | 47 +- .../SDTMIG/CDISC.SDTMIG.CG0605/rule.yml | 47 +- .../SDTMIG/CDISC.SDTMIG.CG0607/rule.yml | 53 +- .../SDTMIG/CDISC.SDTMIG.CG0608/rule.yml | 50 +- .../SDTMIG/CDISC.SDTMIG.CG0609/rule.yml | 52 +- .../SDTMIG/CDISC.SDTMIG.CG0610/rule.yml | 53 +- .../SDTMIG/CDISC.SDTMIG.CG0614/rule.yml | 45 +- .../SDTMIG/CDISC.SDTMIG.CG0615/rule.yml | 45 +- .../SDTMIG/CDISC.SDTMIG.CG0616/rule.yml | 47 +- .../SDTMIG/CDISC.SDTMIG.CG0617/rule.yml | 45 +- .../SDTMIG/CDISC.SDTMIG.CG0651/rule.yml | 108 +- .../SDTMIG/CDISC.SDTMIG.CG0663/rule.yml | 110 +- .../SDTMIG/CDISC.SDTMIG.CG0998/rule.yml | 70 +- .../SDTMIG/CDISC.SDTMIG.CG0999/rule.yml | 80 +- Unpublished/SDTMIG/CG0011/rule.yml | 146 +- Unpublished/SDTMIG/CG0011A1/rule.yml | 120 +- Unpublished/SDTMIG/CG0011A2/rule.yml | 108 +- Unpublished/SDTMIG/CG0011B1/rule.yml | 221 +-- Unpublished/SDTMIG/CG0011C2/rule.yml | 112 +- Unpublished/SDTMIG/CORE-000205/rule.yml | 90 +- Unpublished/SDTMIG/CORE-000343/rule.yml | 99 +- Unpublished/SDTMIG/CORE-000344/rule.yml | 125 +- Unpublished/SDTMIG/CORE-000345/rule.yml | 113 +- Unpublished/SDTMIG/CORE-000346/rule.yml | 97 +- Unpublished/SDTMIG/CORE-000347/rule.yml | 140 +- Unpublished/SDTMIG/CORE-000348/rule.yml | 102 +- Unpublished/SDTMIG/CORE-000349/rule.yml | 99 +- Unpublished/SDTMIG/CORE-000350/rule.yml | 98 +- Unpublished/SDTMIG/CORE-000536/rule.yml | 114 +- Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml | 78 +- Unpublished/SDTMIG/NicTest/rule.yml | 49 +- Unpublished/SDTMIG/WHODrug/rule.yml | 74 +- Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml | 196 ++- Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml | 193 ++- Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml | 95 +- Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml | 166 +- Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml | 220 +-- Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml | 52 +- Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml | 57 +- Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml | 166 +- Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml | 184 +- Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml | 144 +- Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml | 154 +- .../SENDIG/CDISC.SENDIG.190.1B/rule.yml | 198 +-- Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml | 332 ++-- Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml | 243 +-- Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml | 284 ++-- Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml | 232 +-- Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml | 215 +-- Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml | 209 +-- Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml | 209 +-- Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml | 451 ++--- .../SENDIG/CDISC.SENDIG.265.1/rule.yml | 122 +- Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml | 167 +- Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml | 118 +- Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml | 187 +- Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml | 241 +-- Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml | 223 +-- Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml | 153 +- Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml | 71 +- Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml | 112 +- Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml | 105 +- Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml | 179 +- Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml | 150 +- Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml | 74 +- Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml | 126 +- Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml | 97 +- Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml | 193 ++- Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml | 104 +- Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml | 56 +- Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml | 44 +- Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml | 198 +-- Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml | 211 +-- Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml | 59 +- .../SENDIG/CDISC.SENDIG.SEND1/rule.yml | 42 +- .../SENDIG/CDISC.SENDIG.SEND142/rule.yml | 178 +- .../SENDIG/CDISC.SENDIG.SEND157/rule.yml | 256 +-- .../SENDIG/CDISC.SENDIG.SEND293/rule.yml | 193 ++- .../SENDIG/CDISC.SENDIG.SEND411/rule.yml | 42 +- Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml | 486 +++--- Unpublished/SENDIG/SEND100/rule.yml | 191 ++- Unpublished/SENDIG/SEND106.1/rule.yml | 236 +-- Unpublished/SENDIG/SEND238/rule.yml | 237 +-- Unpublished/SENDIG/SEND239/rule.yml | 329 ++-- Unpublished/SENDIG/SEND261/rule.yml | 194 ++- Unpublished/SENDIG/SEND283/rule.yml | 208 +-- Unpublished/SENDIG/SEND298/rule.yml | 198 +-- Unpublished/SENDIG/SEND300/rule.yml | 65 +- Unpublished/SENDIG/SEND310/rule.yml | 183 +- Unpublished/SENDIG/SEND313/rule.yml | 96 +- Unpublished/SENDIG/SEND321/rule.yml | 101 +- Unpublished/SENDIG/SEND327/rule.yml | 147 +- Unpublished/SENDIG/SEND328-1/rule.yml | 262 +-- Unpublished/SENDIG/SEND328-2/rule.yml | 258 +-- Unpublished/SENDIG/SEND333/rule.yml | 183 +- Unpublished/SENDIG/SEND340/rule.yml | 86 +- Unpublished/SENDIG/SEND348/rule.yml | 199 +-- Unpublished/SENDIG/SEND362/rule.yml | 89 +- Unpublished/SENDIG/SEND399/rule.yml | 116 +- Unpublished/SENDIG/SEND4/rule.yml | 228 +-- Unpublished/SENDIG/SEND41/rule.yml | 49 +- Unpublished/SENDIG/SEND49/rule.yml | 251 +-- Unpublished/SENDIG/SEND5/rule.yml | 212 +-- Unpublished/SENDIG/SEND50.99/rule.yml | 57 +- Unpublished/SENDIG/SEND50/rule.yml | 242 +-- Unpublished/SENDIG/SEND57.1/rule.yml | 251 +-- Unpublished/SENDIG/SEND7/rule.yml | 212 +-- Unpublished/SENDIG/SEND98/rule.yml | 60 +- .../SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml | 1510 +++++++++-------- Unpublished/TIG/TIG0031/rule.yml | 75 +- Unpublished/TIG/TIG0044/rule.yml | 93 +- Unpublished/USDM/DDF00262/rule.yml | 48 +- Unpublished/USDM/USDM_TEMPLATE/rule.yml | 92 +- scripts/sort_yaml.py | 44 +- template/template-rule.yml | 58 +- 1458 files changed, 105791 insertions(+), 100606 deletions(-) diff --git a/.github/ISSUE_TEMPLATE/1-rule-issue.yml b/.github/ISSUE_TEMPLATE/1-rule-issue.yml index a5307fc8f..4e6f6b704 100644 --- a/.github/ISSUE_TEMPLATE/1-rule-issue.yml +++ b/.github/ISSUE_TEMPLATE/1-rule-issue.yml @@ -45,4 +45,4 @@ body: attributes: label: Test Data description: "If reporting a bug, attach your test data files here (CSV, Excel, etc.). You can drag and drop multiple files directly into this field." - placeholder: Drag and drop files here, or describe the test data inline. \ No newline at end of file + placeholder: Drag and drop files here, or describe the test data inline. diff --git a/.github/ISSUE_TEMPLATE/config.yml b/.github/ISSUE_TEMPLATE/config.yml index ec4bb386b..3ba13e0ce 100644 --- a/.github/ISSUE_TEMPLATE/config.yml +++ b/.github/ISSUE_TEMPLATE/config.yml @@ -1 +1 @@ -blank_issues_enabled: false \ No newline at end of file +blank_issues_enabled: false diff --git a/.github/workflows/publish.yml b/.github/workflows/publish.yml index 7cd64b078..4edb33086 100644 --- a/.github/workflows/publish.yml +++ b/.github/workflows/publish.yml @@ -97,4 +97,4 @@ jobs: - name: Push if: steps.newdirs.outputs.HAS_NEW_DIRS == 'true' run: | - git push \ No newline at end of file + git push diff --git a/.github/workflows/submodule_update.yml b/.github/workflows/submodule_update.yml index f551a59c2..f07d3ee06 100644 --- a/.github/workflows/submodule_update.yml +++ b/.github/workflows/submodule_update.yml @@ -33,4 +33,4 @@ jobs: body: | Automated update of the `engine` submodule to the latest commit on `cdisc-rules-engine/main`. branch: auto/update-engine-submodule - base: main \ No newline at end of file + base: main diff --git a/.github/workflows/validate-rule-contributions.yml b/.github/workflows/validate-rule-contributions.yml index a9cd1fc22..1316aef8e 100644 --- a/.github/workflows/validate-rule-contributions.yml +++ b/.github/workflows/validate-rule-contributions.yml @@ -3,7 +3,7 @@ name: Validate Rule Contributions on: pull_request: paths: - - 'Unpublished/**' + - "Unpublished/**" types: [opened, synchronize, reopened] workflow_dispatch: {} @@ -27,7 +27,7 @@ jobs: - name: Set up Python 3.12 uses: actions/setup-python@v5 with: - python-version: '3.12' + python-version: "3.12" - name: Install engine dependencies run: | diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml index 8afa3825b..705ddb333 100644 --- a/.github/workflows/validate-yaml-format.yml +++ b/.github/workflows/validate-yaml-format.yml @@ -1,4 +1,4 @@ -name: Validate YAML Formatting +name: Sort and Format Rule YAML on: pull_request: paths: @@ -7,21 +7,50 @@ on: types: [opened, synchronize, reopened] workflow_dispatch: {} jobs: - check-yaml-format: + format-yaml: runs-on: ubuntu-latest permissions: - contents: read + contents: write pull-requests: write steps: - - name: Checkout + - name: Determine PR origin + id: origin + run: | + if [ "${{ github.event_name }}" = "workflow_dispatch" ] || [ "${{ github.event.pull_request.head.repo.full_name }}" = "${{ github.repository }}" ]; then + echo "is_internal=true" >> $GITHUB_OUTPUT + else + echo "is_internal=false" >> $GITHUB_OUTPUT + fi + + # Same-repo branches: check out the actual head branch so we can push fixes to it. + - name: Checkout (same-repo branch) + if: steps.origin.outputs.is_internal == 'true' uses: actions/checkout@v4 with: + ref: ${{ github.head_ref || github.ref_name }} fetch-depth: 0 + + # Fork PRs: check out the default merge ref. Read-only, never pushed to. + - name: Checkout (fork PR) + if: steps.origin.outputs.is_internal == 'false' + uses: actions/checkout@v4 + with: + fetch-depth: 0 + - name: Set up Python 3.12 uses: actions/setup-python@v5 with: python-version: "3.12" - run: pip install ruamel.yaml + # Both paths check formatting (sort + Prettier), so both need Node. + # Only the internal path actually writes/pushes fixes. + - name: Set up Node.js + uses: actions/setup-node@v4 + with: + node-version: "20" + - name: Install Prettier + run: npm ci + - name: Detect changed rule.yml files id: changed-files run: | @@ -39,28 +68,51 @@ jobs: echo "has_files=true" >> $GITHUB_OUTPUT echo "$FILES" > /tmp/changed_rule_files.txt fi - - name: Check YAML sorting and formatting - id: format-check - if: steps.changed-files.outputs.has_files == 'true' + + # Same-repo: sort + format in place, then commit and push the fix. + - name: Sort and format (same-repo) + if: steps.origin.outputs.is_internal == 'true' && steps.changed-files.outputs.has_files == 'true' + run: | + FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ') + python scripts/sort_yaml.py $FILES + + - name: Commit and push formatting fixes + id: commit + if: steps.origin.outputs.is_internal == 'true' && steps.changed-files.outputs.has_files == 'true' + run: | + if [ -n "$(git status --porcelain)" ]; then + git config user.name "github-actions[bot]" + git config user.email "github-actions[bot]@users.noreply.github.com" + git add -A + git commit -m "chore: auto-sort and format rule.yml files" + git push origin HEAD:${{ github.head_ref || github.ref_name }} + echo "pushed=true" >> $GITHUB_OUTPUT + else + echo "pushed=false" >> $GITHUB_OUTPUT + fi + + # Fork PRs: full sort + format check (read-only, never writes or pushes). + # A failure here shows as a red X on the PR's checks list; the job log + # lists exactly which files and prints the fix command to run locally. + - name: Check sorting and formatting (fork PR) + if: steps.origin.outputs.is_internal == 'false' && steps.changed-files.outputs.has_files == 'true' run: | FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ') python scripts/sort_yaml.py --check $FILES - continue-on-error: true - - name: Post format check result to PR - if: always() && github.event_name == 'pull_request' && steps.changed-files.outputs.has_files == 'true' + + - name: Post result to PR + if: always() && steps.origin.outputs.is_internal == 'true' && github.event_name == 'pull_request' && steps.changed-files.outputs.has_files == 'true' uses: actions/github-script@v7 with: github-token: ${{ secrets.GITHUB_TOKEN }} script: | - const outcome = '${{ steps.format-check.outcome }}'; + const pushed = '${{ steps.commit.outputs.pushed }}'; const marker = ''; let body = marker + '\n'; - if (outcome === 'success') { - body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files are correctly sorted and formatted.'; + if (pushed === 'true') { + body += '## \u270f\ufe0f YAML Auto-Formatted\n\nOne or more `rule.yml` files were not sorted/formatted correctly, so this workflow sorted and formatted them automatically and pushed a commit to this branch. Pull the latest changes before continuing.'; } else { - body += '## \u274c YAML Format Check Failed\n\n'; - body += 'One or more `rule.yml` files are not correctly sorted/formatted alphabetically by key.\n\n'; - body += 'Run the following command locally to fix them:\n\n```bash\npython scripts/sort_yaml.py\n```\n\nThen commit and push.'; + body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files were already correctly sorted and formatted.'; } const { data: comments } = await github.rest.issues.listComments({ owner: context.repo.owner, repo: context.repo.repo, @@ -78,8 +130,3 @@ jobs: issue_number: context.issue.number, body, }); } - - name: Fail if format check failed - if: steps.format-check.outcome == 'failure' - run: | - echo "YAML format check failed. Run 'python scripts/sort_yaml.py' to fix." - exit 1 diff --git a/.github/workflows/validate-yaml-schema.yml b/.github/workflows/validate-yaml-schema.yml index 253766b26..56c92be4b 100644 --- a/.github/workflows/validate-yaml-schema.yml +++ b/.github/workflows/validate-yaml-schema.yml @@ -3,8 +3,8 @@ name: Validate YAML against Schema on: pull_request: paths: - - 'Published/**/rule.yml' - - 'Unpublished/**/rule.yml' + - "Published/**/rule.yml" + - "Unpublished/**/rule.yml" types: [opened, synchronize, reopened] workflow_dispatch: inputs: @@ -14,7 +14,7 @@ on: (e.g. "Published/CORE-000001/rule.yml"). Leave blank to validate all changed rule files detected from the last commit. required: false - default: '' + default: "" # Only one run per PR branch at a time; cancel superseded runs. concurrency: @@ -32,7 +32,7 @@ jobs: env: # draft/2020-12 schema — switch to rule-merged if you need $defs inlined SCHEMA_URL: >- - https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json + https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json steps: # ----------------------------------------------------------------------- @@ -49,7 +49,7 @@ jobs: - name: Set up Python 3.12 uses: actions/setup-python@v6 with: - python-version: '3.12' + python-version: "3.12" # ----------------------------------------------------------------------- # 3. Install validation dependencies diff --git a/.pre-commit-config.yaml b/.pre-commit-config.yaml index 070e5ec2e..b4379bdfa 100644 --- a/.pre-commit-config.yaml +++ b/.pre-commit-config.yaml @@ -2,9 +2,9 @@ repos: - repo: local hooks: - id: sort-yaml-rules - name: Sort and format rule YAML files + name: Sort rule YAML files language: python - entry: python scripts/sort_yaml.py --check + entry: python scripts/sort_yaml.py --no-format types: [yaml] files: ".*/rule\\.yml$" additional_dependencies: [ruamel.yaml] diff --git a/.vscode/extensions.json b/.vscode/extensions.json index fe086e4f5..ac8464a43 100644 --- a/.vscode/extensions.json +++ b/.vscode/extensions.json @@ -1,8 +1,9 @@ { "recommendations": [ "redhat.vscode-yaml", + "esbenp.prettier-vscode", "GrapeCity.gc-excelviewer", "mechatroner.rainbow-csv", "emeraldwalk.runonsave" ] -} \ No newline at end of file +} diff --git a/.vscode/settings.json b/.vscode/settings.json index cc469d2b4..b8e8225a6 100644 --- a/.vscode/settings.json +++ b/.vscode/settings.json @@ -7,8 +7,13 @@ { "match": "rule\\.yml$", "isAsync": false, - "cmd": "${workspaceFolder}/venv/bin/python ${workspaceFolder}/scripts/sort_yaml.py ${file}" + "cmd": "${workspaceFolder}/venv/bin/python ${workspaceFolder}/scripts/sort_yaml.py --no-format ${file}" } ] - } -} \ No newline at end of file + }, + "[yaml]": { + "editor.defaultFormatter": "esbenp.prettier-vscode", + "editor.formatOnSave": true + }, + "yaml.format.enable": false +} diff --git a/Deprecated/CORE-000002/rule.yml b/Deprecated/CORE-000002/rule.yml index 230f54c43..595d575c2 100644 --- a/Deprecated/CORE-000002/rule.yml +++ b/Deprecated/CORE-000002/rule.yml @@ -1,19 +1,20 @@ # Variable: SESTDTC -# Condition: +# Condition: # Rule: SESTDTC ^= null Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0208 - Version: '3' - Version: '2.0' + Version: "3" + Version: "2.0" Citations: - - Cited Guidance: Note that SESTDTC is required, although --STDTC is + - Cited Guidance: + Note that SESTDTC is required, although --STDTC is not required in any other subject-level dataset. The purpose of the dataset is to record the Elements a subject actually passed through. We assume that if it is known that a subject passed through @@ -22,17 +23,18 @@ Authorities: may not be null, although some records may not have all the components (e.g., year, month, day, hour, minute) of the date/time value collected. Document: SDTM v1.4 - Section: '5.3' + Section: "5.3" - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0208 - Version: '3' - Version: '2.0' + Version: "3" + Version: "2.0" Citations: - - Cited Guidance: Note that SESTDTC is required, although --STDTC is + - Cited Guidance: + Note that SESTDTC is required, although --STDTC is not required in any other subject-level dataset. The purpose of the dataset is to record the Elements a subject actually passed through. We assume that if it is known that a subject passed through @@ -44,15 +46,16 @@ Authorities: Item: Assumption 11 Section: 5 SE - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0208 - Version: '3' - Version: '2.0' + Version: "3" + Version: "2.0" Citations: - - Cited Guidance: Note that SESTDTC is required, although --STDTC is + - Cited Guidance: + Note that SESTDTC is required, although --STDTC is not required in any other subject-level dataset. The purpose of the dataset is to record the Elements a subject actually passed through. We assume that if it is known that a subject passed through @@ -62,7 +65,7 @@ Authorities: (e.g., year, month, day, hour, minute) of the date/time value collected. Document: IG v3.3 Item: Assumption 9 - Section: '5.3' + Section: "5.3" Check: all: - name: SESTDTC @@ -70,7 +73,7 @@ Check: Core: Id: CORE-000002 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SESTDTC is null. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000003/rule.yml b/Deprecated/CORE-000003/rule.yml index 12edd7a47..6ec06ed75 100644 --- a/Deprecated/CORE-000003/rule.yml +++ b/Deprecated/CORE-000003/rule.yml @@ -1,19 +1,20 @@ # Variable: TRLOC -# Condition: +# Condition: # Rule: TRLOC not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0299 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement/assessment record, because this would be a duplication of information already represented in TU. The multi-domain approach to representing oncology assessment data @@ -21,32 +22,34 @@ Authorities: Document: SDTM v3.4 Section: 6.3.12.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0299 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this data. Document: IG v3.2 Item: Specification - Section: '6.3' + Section: "6.3" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0299 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000003 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TRLOC is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000005/rule.yml b/Deprecated/CORE-000005/rule.yml index 09d6090f6..76b693a20 100644 --- a/Deprecated/CORE-000005/rule.yml +++ b/Deprecated/CORE-000005/rule.yml @@ -5,45 +5,48 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0102 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Doses of placebo should be represented by EXTRT = + - Cited Guidance: + Doses of placebo should be represented by EXTRT = "PLACEBO" and EXDOSE = "0" (indicating 0 mg of active ingredient was taken or administered). Document: SDTMIG v3.4 Item: Assumption 2b Section: 6.1.3.1 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0102 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Doses of placebo should be represented by EXTRT = + - Cited Guidance: + Doses of placebo should be represented by EXTRT = 'PLACEBO' and EXDOSE = 0 (indicating 0 mg of active ingredient was taken or administered). Document: IG v3.2 Item: Assumption 2b - Section: '6.1' + Section: "6.1" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0102 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Doses of placebo should be represented by EXTRT = + - Cited Guidance: + Doses of placebo should be represented by EXTRT = 'PLACEBO' and EXDOSE = 0 (indicating 0 mg of active ingredient was taken or administered). Document: IG v3.3 @@ -60,7 +63,7 @@ Check: Core: Id: CORE-000005 Status: Published - Version: '1' + Version: "1" Description: When EXTRT is PLACEBO, EXDOSE must equal 0 Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000008/rule.yml b/Deprecated/CORE-000008/rule.yml index 9799cfdf1..f2c16e27b 100644 --- a/Deprecated/CORE-000008/rule.yml +++ b/Deprecated/CORE-000008/rule.yml @@ -7,22 +7,24 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date + - Cited Guidance: + For example, if a subject's Survival Status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS. Document: IG v3.2 Item: Assumption 2 - Section: '6.3' + Section: "6.3" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0132 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date + - Cited Guidance: + For example, if a subject's Survival Status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS. Document: IG v3.3 @@ -31,13 +33,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0132 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: 4.5.8[4. If the subject's survival status is "dead", the + - Cited Guidance: + 4.5.8[4. If the subject's survival status is "dead", the Demographics (DM) variables DTHDTC and DTHFL must be appropriately populated.]|6.3.11[For example, if a subject's survival status is "DEAD", the date of death must be stored in @@ -48,51 +51,54 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0132 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" #CG0132 is identical to rule FB0601. Added metadata for FB0601. - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0601 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0601 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0601 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: SSSTRESC @@ -106,7 +112,7 @@ Check: Core: Id: CORE-000008 Status: Published - Version: '1' + Version: "1" Description: When survival status is completed as 'DEAD' in the SS dataset then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. diff --git a/Deprecated/CORE-000031/rule.yml b/Deprecated/CORE-000031/rule.yml index 4d2004e9e..4adcb6745 100644 --- a/Deprecated/CORE-000031/rule.yml +++ b/Deprecated/CORE-000031/rule.yml @@ -5,25 +5,28 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0659 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 Section: 6.3.9.1 - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 Section: 6.3.9.2 - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 @@ -43,8 +46,9 @@ Check: Core: Id: CORE-000031 Status: Published - Version: '1' -Description: --EVAL must not be used to model QRS data. This includes the 'QS' and + Version: "1" +Description: + --EVAL must not be used to model QRS data. This includes the 'QS' and 'FT' domains as well as the 'RS' domain when the record pertains to a Clinical Classification Use Case). This rule has been fully executed for the QS and FT domains only. Executability: Fully Executable diff --git a/Deprecated/CORE-000032/rule.yml b/Deprecated/CORE-000032/rule.yml index 55bc68922..4fd81e67c 100644 --- a/Deprecated/CORE-000032/rule.yml +++ b/Deprecated/CORE-000032/rule.yml @@ -5,25 +5,28 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0660 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 Section: 6.3.9.1 - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 Section: 6.3.9.2 - - Cited Guidance: --EVAL and --EVALID must not be used to model QRS + - Cited Guidance: + --EVAL and --EVALID must not be used to model QRS data in SDTM. Document: SDTMIG v3.4 Item: Assumption 8 @@ -43,8 +46,9 @@ Check: Core: Id: CORE-000032 Status: Published - Version: '1' -Description: --EVALID must not be used to model QRS data. This includes the 'QS' + Version: "1" +Description: + --EVALID must not be used to model QRS data. This includes the 'QS' and 'FT' domains as well as the 'RS' domain when the record pertains to a Clinical Classification Use Case). This rule has been fully executed for the QS and FT domains only. diff --git a/Deprecated/CORE-000072/rule.yml b/Deprecated/CORE-000072/rule.yml index c8a027b31..b75d9a413 100644 --- a/Deprecated/CORE-000072/rule.yml +++ b/Deprecated/CORE-000072/rule.yml @@ -1,31 +1,32 @@ # Variable: --BEATNO -# Condition: +# Condition: # Rule: --BEATNO not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0542 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: --BEATNO is to be used in the EG domain only. Document: SDTM v2.0 Section: Findings - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0542 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The concept of domain-specific variables was first + - Cited Guidance: + The concept of domain-specific variables was first introduced in SDTM v1.5. These variables are for use only in a specific domain and will be identified in the appropriate implementation guide. @@ -39,7 +40,7 @@ Check: Core: Id: CORE-000072 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --BEATNO is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000073/rule.yml b/Deprecated/CORE-000073/rule.yml index e6d017683..6d7987c11 100644 --- a/Deprecated/CORE-000073/rule.yml +++ b/Deprecated/CORE-000073/rule.yml @@ -1,29 +1,29 @@ # Variable: RPATHCD -# Condition: +# Condition: # Rule: RPATHCD not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0533 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: Not in clinical trials. Document: Model v2.0 Section: Demographics - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0533 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: Not to be used with human clinical trials. Document: Model v1.7 @@ -35,7 +35,7 @@ Check: Core: Id: CORE-000073 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RPATHCD is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000076/rule.yml b/Deprecated/CORE-000076/rule.yml index fab261634..6d08783b6 100644 --- a/Deprecated/CORE-000076/rule.yml +++ b/Deprecated/CORE-000076/rule.yml @@ -1,19 +1,20 @@ # Variable: TRPORTOT -# Condition: +# Condition: # Rule: TRPORTOT not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0302 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement/assessment record, because this would be a duplication of information already represented in TU. The multi-domain approach to representing oncology assessment data @@ -22,32 +23,34 @@ Authorities: Section: 6.3.12.2 Item: TR Description/Overview - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0302 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this data. Document: IG v3.2 Item: Specification - Section: '6.3' + Section: "6.3" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0302 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this @@ -62,7 +65,7 @@ Check: Core: Id: CORE-000076 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TRPORTOT is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000077/rule.yml b/Deprecated/CORE-000077/rule.yml index 2a92c29d6..426f4f80a 100644 --- a/Deprecated/CORE-000077/rule.yml +++ b/Deprecated/CORE-000077/rule.yml @@ -1,19 +1,20 @@ # Variable: TRDIR -# Condition: +# Condition: # Rule: TRDIR not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0301 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement/assessment record, because this would be a duplication of information already represented in TU. The multi-domain approach to representing oncology assessment data @@ -21,32 +22,34 @@ Authorities: Document: SDTMIG v3.4 Section: 6.3.12.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0301 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this data. Document: IG v3.2 Item: Specification - Section: '6.3' + Section: "6.3" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0301 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000077 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TRDIR is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000078/rule.yml b/Deprecated/CORE-000078/rule.yml index bb9bbf1f1..ff1882646 100644 --- a/Deprecated/CORE-000078/rule.yml +++ b/Deprecated/CORE-000078/rule.yml @@ -1,19 +1,20 @@ # Variable: TRLAT -# Condition: +# Condition: # Rule: TRLAT not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0300 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement/assessment record, because this would be a duplication of information already represented in TU. The multi-domain approach to representing oncology assessment data @@ -22,32 +23,34 @@ Authorities: Section: 6.3.12.2 Item: TR Description/Overview - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0300 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this data. Document: IG v3.2 Item: Specification - Section: '6.3' + Section: "6.3" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0300 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The TR domain does not include anatomical location + - Cited Guidance: + The TR domain does not include anatomical location information on each measurement record because this would be a duplication of information already represented in TU. This duplication of data was a deciding factor in multi-domain approach to representing this @@ -62,7 +65,7 @@ Check: Core: Id: CORE-000078 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TRLAT is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000079/rule.yml b/Deprecated/CORE-000079/rule.yml index ab59c8b81..5d88ae02d 100644 --- a/Deprecated/CORE-000079/rule.yml +++ b/Deprecated/CORE-000079/rule.yml @@ -5,45 +5,48 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0095 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Events[Variable Qualifier of --LOC]|Interventions[Variable + - Cited Guidance: + Events[Variable Qualifier of --LOC]|Interventions[Variable Qualifier of --LOC]|Findings[Variable Qualifier of --LOC] Document: Model v2.0 Section: Events|Interventions|Findings Item: --LAT - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0095 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Qualifier for anatomical location further detailing + - Cited Guidance: + Qualifier for anatomical location further detailing laterality. Document: Model v1.4 Section: 2.2.2 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0095 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Qualifier for anatomical location further detailing + - Cited Guidance: + Qualifier for anatomical location further detailing laterality. Document: Model v1.7 - Item: 'Table 3.2.2: --LAT' + Item: "Table 3.2.2: --LAT" Section: 2.2.2 Check: all: @@ -54,7 +57,7 @@ Check: Core: Id: CORE-000079 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --LOC is not present and --LAT is present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000082/rule.yml b/Deprecated/CORE-000082/rule.yml index 51bcdc6b5..c4b8d98f3 100644 --- a/Deprecated/CORE-000082/rule.yml +++ b/Deprecated/CORE-000082/rule.yml @@ -5,26 +5,26 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0561 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: If PEORRES is null, PESTRESC must be null. Document: IG v3.4 Item: Specification Section: 6.3.8 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0561 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: If PEORRES is null, PESTRESC must be null. Document: IG v3.3 @@ -39,7 +39,7 @@ Check: Core: Id: CORE-000082 Status: Published - Version: '1' + Version: "1" Description: Verify that PESTRESC is null when PEORRES is null Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000089/rule.yml b/Deprecated/CORE-000089/rule.yml index 85371e6da..c55bc2f32 100644 --- a/Deprecated/CORE-000089/rule.yml +++ b/Deprecated/CORE-000089/rule.yml @@ -5,52 +5,55 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0106 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: '"--TRTV[A carrier or inert medium in which a medicinally + - Cited Guidance: + '"--TRTV[A carrier or inert medium in which a medicinally active agent is administered.]| --VAMT[Amount of the prepared product (treatment plus vehicle) administered.]"' Document: Model v2.0 Item: --TRTV|--VAMT Section: Interventions - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0106 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: '[--TRTV:Vehicle for administration of treatment, + - Cited Guidance: + "[--TRTV:Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.][--VAMT: Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.][--VAMTU: Units for the prepared product (treatment + vehicle). Examples: - mL, mg.]' + mL, mg.]" Document: Model v1.4 Section: 2.2.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0106 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: '[--TRTV:Vehicle for administration of treatment, + - Cited Guidance: + "[--TRTV:Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE.][--VAMT: Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone.][--VAMTU: Units for the prepared product (treatment + vehicle). Examples: - mL, mg.]' + mL, mg.]" Document: Model v1.7 Section: 2.2.1 Check: @@ -62,7 +65,7 @@ Check: Core: Id: CORE-000089 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TRTV is empty, --VAMT is not empty Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000091/rule.yml b/Deprecated/CORE-000091/rule.yml index ab8b1b073..580c2ca40 100644 --- a/Deprecated/CORE-000091/rule.yml +++ b/Deprecated/CORE-000091/rule.yml @@ -5,48 +5,50 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0108 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - Cited Guidance: Variable Qualifier of --VAMT. Document: Model v2.0 Item: --VAMTU Section: Interventions - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0108 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment, such + - Cited Guidance: + "--TRTV:Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units - for the prepared product (treatment + vehicle). Examples: mL, mg.' + for the prepared product (treatment + vehicle). Examples: mL, mg." Document: Model v1.4 Section: 2.2.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0108 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment, such + - Cited Guidance: + "--TRTV:Vehicle for administration of treatment, such as a liquid in which the treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units - for the prepared product (treatment + vehicle). Examples: mL, mg.' + for the prepared product (treatment + vehicle). Examples: mL, mg." Document: Model v1.7 Section: 2.2.1 Check: @@ -58,7 +60,7 @@ Check: Core: Id: CORE-000091 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TRTV is null, --VAMTU is not null Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000109/rule.yml b/Deprecated/CORE-000109/rule.yml index 428bf9683..485375586 100644 --- a/Deprecated/CORE-000109/rule.yml +++ b/Deprecated/CORE-000109/rule.yml @@ -1,40 +1,42 @@ # Variable: SMSTDTC -# Condition: +# Condition: # Rule: SMSTDTC ^= null Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0547 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The start date/time of the Disease Milestone is the + - Cited Guidance: + The start date/time of the Disease Milestone is the critical date/time, and must be populated. If the Disease Milestone is an event, then the meaning of “start date” for the event may need to be defined. Document: SDTMIG v3.4 - Section: '5.4' + Section: "5.4" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0547 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The start date/time of the Disease Milestone is the + - Cited Guidance: + The start date/time of the Disease Milestone is the critical date/time, and must be populated. If the Disease Milestone is an event, then the meaning of 'start date' for the event may need to be defined Document: IG v3.3 Item: Assumption 3.a - Section: '5.5' + Section: "5.5" Check: all: - name: SMSTDTC @@ -42,7 +44,7 @@ Check: Core: Id: CORE-000109 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SMSTDTC is null. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000115/rule.yml b/Deprecated/CORE-000115/rule.yml index 3b128fc58..942023723 100644 --- a/Deprecated/CORE-000115/rule.yml +++ b/Deprecated/CORE-000115/rule.yml @@ -1,40 +1,44 @@ # Variable: ARM -# Condition: +# Condition: # Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated') Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0570 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The trial arms table describes each planned arm in + - Cited Guidance: + The trial arms table describes each planned arm in the trial. Document: SDTMIG v3.4 - Section: '7.2' - - Cited Guidance: The trial arms table describes each planned arm in + Section: "7.2" + - Cited Guidance: + The trial arms table describes each planned arm in the trial. Document: SDTMIG v3.4 Section: 7.3.1 - - Cited Guidance: The trial arms table describes each planned arm in + - Cited Guidance: + The trial arms table describes each planned arm in the trial. Document: SDTMIG v3.4 - Section: '5.2' + Section: "5.2" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0570 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The trial arms table describes each planned arm in + - Cited Guidance: + The trial arms table describes each planned arm in the trial. Document: IG v3.3 Item: Specification @@ -51,12 +55,14 @@ Check: Core: Id: CORE-000115 Status: Published - Version: '1' -Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned + Version: "1" +Description: + Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated' Executability: Fully Executable Outcome: - Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Treatment' + Message: + ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Treatment' or 'Not Treated'. Rule Type: Record Data Scope: diff --git a/Deprecated/CORE-000145/rule.yml b/Deprecated/CORE-000145/rule.yml index f1ac80482..1d436b6d5 100644 --- a/Deprecated/CORE-000145/rule.yml +++ b/Deprecated/CORE-000145/rule.yml @@ -5,50 +5,53 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0255 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each complete set of criteria must be included in the TI domain. TIVERS is used to distinguish between the versions. Document: IG v3.4 Item: Assumption 1 Section: 7.4.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0255 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each complete set of criteria must be included in the TI domain. TIVERS is used to distinguish between the versions. Document: IG v3.3 Item: Assumption 1 Section: 7.4.1 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0255 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each complete set of criteria must be included in the TI domain. TIVERS is used to distinguish between the versions. Document: IG v3.2 Item: Assumption 1 - Section: '7.4' + Section: "7.4" Check: all: - name: TIVERS @@ -59,8 +62,9 @@ Check: Core: Id: CORE-000145 Status: Published - Version: '1' -Description: Trigger error when TIVERS is present and IETESTCD is not unique within + Version: "1" +Description: + Trigger error when TIVERS is present and IETESTCD is not unique within TIVERS Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000146/rule.yml b/Deprecated/CORE-000146/rule.yml index 0651b70f9..b2a26b834 100644 --- a/Deprecated/CORE-000146/rule.yml +++ b/Deprecated/CORE-000146/rule.yml @@ -5,65 +5,71 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0256 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version. Document: IG v3.4 Item: Specification Section: 7.4.1 - - Cited Guidance: Individual criteria do not have versions. If a criterion + - Cited Guidance: + Individual criteria do not have versions. If a criterion changes, it should be treated as a new criterion, with a new value for IETESTCD. Document: IG v3.4 Item: Assumption 3 Section: 7.4.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0256 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version. Document: IG v3.3 Item: Specification Section: 7.4.1 - - Cited Guidance: Individual criteria do not have versions. If a criterion + - Cited Guidance: + Individual criteria do not have versions. If a criterion changes, it should be treated as a new criterion, with a new value for IETESTCD. Document: IG v3.3 Item: Assumption 3 Section: 7.4.1 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0256 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be omitted if there is only one version. Document: IG v3.2 Item: Specification - Section: '7.4' - - Cited Guidance: Individual criteria do not have versions. If a criterion + Section: "7.4" + - Cited Guidance: + Individual criteria do not have versions. If a criterion changes, it should be treated as a new criterion, with a new value for IETESTCD. Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Check: all: - name: TIVERS @@ -74,7 +80,7 @@ Check: Core: Id: CORE-000146 Status: Published - Version: '1' + Version: "1" Description: Trigger error when IETESTCD is not unique within dataset Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000149/rule.yml b/Deprecated/CORE-000149/rule.yml index 69ad5931c..24d55e75b 100644 --- a/Deprecated/CORE-000149/rule.yml +++ b/Deprecated/CORE-000149/rule.yml @@ -5,39 +5,39 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0259 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: TSVAL can only be null when TSVALNF is populated. Document: IG v3.4 Item: Specification Section: 7.4.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0259 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: TSVAL can only be null when TSVALNF is populated. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0259 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - Cited Guidance: TSVAL can only be null when TSVALNF is populated. Document: IG v3.3 @@ -52,7 +52,7 @@ Check: Core: Id: CORE-000149 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TSVAL is null and TSVALNF is null Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000150/rule.yml b/Deprecated/CORE-000150/rule.yml index afcce4410..53e246fd2 100644 --- a/Deprecated/CORE-000150/rule.yml +++ b/Deprecated/CORE-000150/rule.yml @@ -5,43 +5,46 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0260 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Null flavor for the value of TSPARM, to be populated + - Cited Guidance: + Null flavor for the value of TSPARM, to be populated if and only if TSVAL is null. Document: IG v3.4 Item: Specification Section: 7.4.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0260 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Null flavor for the value of TSPARM, to be populated + - Cited Guidance: + Null flavor for the value of TSPARM, to be populated if and only if TSVAL = null. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0260 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Null flavor for the value of TSPARM, to be populated + - Cited Guidance: + Null flavor for the value of TSPARM, to be populated if and only if TSVAL = null. Document: IG v3.3 Item: Specification @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000150 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TSVAL is populated and TSVALNF is also populated. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000153/rule.yml b/Deprecated/CORE-000153/rule.yml index 5fbc223dc..7ab61ab77 100644 --- a/Deprecated/CORE-000153/rule.yml +++ b/Deprecated/CORE-000153/rule.yml @@ -5,43 +5,46 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0266 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The version number of the Reference Terminology, if + - Cited Guidance: + The version number of the Reference Terminology, if applicable. Document: IG v3.4 Item: Specification Section: 7.4.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0266 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The version number of the Reference Terminology, if + - Cited Guidance: + The version number of the Reference Terminology, if applicable. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0266 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The version number of the Reference Terminology, if + - Cited Guidance: + The version number of the Reference Terminology, if applicable. Document: IG v3.3 Item: Specification @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000153 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TSVCDVER is populated and TSVCDREF is null Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000174/rule.yml b/Deprecated/CORE-000174/rule.yml index 14510d205..93f2b79b0 100644 --- a/Deprecated/CORE-000174/rule.yml +++ b/Deprecated/CORE-000174/rule.yml @@ -1,19 +1,20 @@ # Variable: SPECIES -# Condition: +# Condition: # Rule: SPECIES not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0356 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: "The following variables can be used for non-clinical\ + - Cited Guidance: + "The following variables can be used for non-clinical\ \ studies (SEND) but must NEVER be used in the Demographics domain\ \ for human clinical trials. However, the use of these variables\ \ is currently being evaluated in Findings general observation\ @@ -21,41 +22,43 @@ Authorities: \ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\ \ (Demographics)" Document: IG 3.4 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0356 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: 'The following variables can be used for non-clinical + - Cited Guidance: + "The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials. However; the use of these variables is currently being evaluated in Findings general observation class domains being developed for use in the tabulations of virology data: - SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)' + SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)" Document: IG v3.2 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0356 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The following variables can be used for non-clinical + - Cited Guidance: + The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials; where all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI); for information about representing taxonomic information for non-host organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics) Document: IG v3.3 - Section: '2.7' + Section: "2.7" Check: all: - name: SPECIES @@ -63,7 +66,7 @@ Check: Core: Id: CORE-000174 Status: Published - Version: '1' + Version: "1" Description: Verify variable SPECIES does not exist in DM dataset Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000175/rule.yml b/Deprecated/CORE-000175/rule.yml index 4f8ef8e80..fbe6c3379 100644 --- a/Deprecated/CORE-000175/rule.yml +++ b/Deprecated/CORE-000175/rule.yml @@ -1,19 +1,20 @@ # Variable: STRAIN -# Condition: +# Condition: # Rule: STRAIN not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0357 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: "The following variables can be used for non-clinical\ + - Cited Guidance: + "The following variables can be used for non-clinical\ \ studies (SEND) but must NEVER be used in the Demographics domain\ \ for human clinical trials. However, the use of these variables\ \ is currently being evaluated in Findings general observation\ @@ -21,41 +22,43 @@ Authorities: \ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\ \ (Demographics)" Document: IG 3.4 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0357 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: 'The following variables can be used for non-clinical + - Cited Guidance: + "The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials. However; the use of these variables is currently being evaluated in Findings general observation class domains being developed for use in the tabulations of virology data: - - SPECIES (Demographics) - STRAIN (Demographics) - SBSTRAIN (Demographics)' + - SPECIES (Demographics) - STRAIN (Demographics) - SBSTRAIN (Demographics)" Document: IG v3.2 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0357 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The following variables can be used for non-clinical + - Cited Guidance: + The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials; where all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI); for information about representing taxonomic information for non-host organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics) Document: IG v3.3 - Section: '2.7' + Section: "2.7" Check: all: - name: STRAIN @@ -63,7 +66,7 @@ Check: Core: Id: CORE-000175 Status: Published - Version: '1' + Version: "1" Description: Verify variable STRAIN does not exist in DM dataset Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000176/rule.yml b/Deprecated/CORE-000176/rule.yml index 60c2de6a5..c6b0fe31e 100644 --- a/Deprecated/CORE-000176/rule.yml +++ b/Deprecated/CORE-000176/rule.yml @@ -1,19 +1,20 @@ # Variable: SBSTRAIN -# Condition: +# Condition: # Rule: SBSTRAIN not present in dataset Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0358 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: "The following variables can be used for non-clinical\ + - Cited Guidance: + "The following variables can be used for non-clinical\ \ studies (SEND) but must NEVER be used in the Demographics domain\ \ for human clinical trials. However, the use of these variables\ \ is currently being evaluated in Findings general observation\ @@ -21,41 +22,43 @@ Authorities: \ data:\n SPECIES (Demographics)\n STRAIN (Demographics)\n SBSTRAIN\ \ (Demographics)" Document: IG 3.4 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0358 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: 'The following variables can be used for non-clinical + - Cited Guidance: + "The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials. However; the use of these variables is currently being evaluated in Findings general observation class domains being developed for use in the tabulations of virology data: - SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)' + SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics)" Document: IG v3.2 - Section: '2.7' + Section: "2.7" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0358 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The following variables can be used for non-clinical + - Cited Guidance: + The following variables can be used for non-clinical studies (SEND) but must NEVER be used in the Demographics domain for human clinical trials; where all subjects are human. See Section 9.2; Non-host Organism Identifiers (OI); for information about representing taxonomic information for non-host organisms such as bacteria and viruses. SPECIES (Demographics) STRAIN (Demographics) SBSTRAIN (Demographics) Document: IG v3.3 - Section: '2.7' + Section: "2.7" Check: all: - name: SBSTRAIN @@ -63,7 +66,7 @@ Check: Core: Id: CORE-000176 Status: Published - Version: '1' + Version: "1" Description: Verify variable SBSTRAIN does not exist in DM dataset Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000178/rule.yml b/Deprecated/CORE-000178/rule.yml index 942cdb176..62b694505 100644 --- a/Deprecated/CORE-000178/rule.yml +++ b/Deprecated/CORE-000178/rule.yml @@ -5,15 +5,16 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0172 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details, but those details are to be stored in appropriate separate domains. For @@ -25,15 +26,16 @@ Authorities: Item: Assumption 1 Section: 6.3.11 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0172 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, @@ -45,15 +47,16 @@ Authorities: Item: Assumption 1 Section: 6.3.15 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0172 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, @@ -76,7 +79,7 @@ Check: Core: Id: CORE-000178 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SSSTRESC = 'DEAD' and SSDTC < max DS.DSSTDTC. Executability: Fully Executable Operations: diff --git a/Deprecated/CORE-000181/rule.yml b/Deprecated/CORE-000181/rule.yml index 1ea68f131..b7d0e7508 100644 --- a/Deprecated/CORE-000181/rule.yml +++ b/Deprecated/CORE-000181/rule.yml @@ -1,5 +1,5 @@ # Variable: DOMAIN -# Condition: +# Condition: # Rule: DOMAIN value length = 4 Authorities: - Organization: CDISC @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character + - Cited Guidance: + Each domain dataset is distinguished by a unique, two-character code Document: IG v3.4 - Section: '2.2' + Section: "2.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0309 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character + - Cited Guidance: + Each domain dataset is distinguished by a unique, two-character code Document: IG v3.2 - Section: '2.2' + Section: "2.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0309 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character + - Cited Guidance: + Each domain dataset is distinguished by a unique, two-character code Document: IG v3.3 - Section: '2.2' + Section: "2.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0309 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: DOMAIN @@ -51,7 +54,7 @@ Check: Core: Id: CORE-000181 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AP-- domain value length is not equal to 4. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000188/rule.yml b/Deprecated/CORE-000188/rule.yml index 0935a689e..f91351d4a 100644 --- a/Deprecated/CORE-000188/rule.yml +++ b/Deprecated/CORE-000188/rule.yml @@ -5,52 +5,56 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0191 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The domain pair uses DOMAIN as an Identifier to group + - Cited Guidance: + The domain pair uses DOMAIN as an Identifier to group parent records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship to be described in RELREC. Document: IG v3.4 Item: Item 1, bullet 5 - Section: '2.6' - - Cited Guidance: MS is used for representing data from drug susceptibility + Section: "2.6" + - Cited Guidance: + MS is used for representing data from drug susceptibility testing on the organisms identified in MB. Document: IG v3.4 Section: 6.3.5.4 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0191 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: '2.6[Item 1, Bullet 5][The domain pair uses DOMAIN + - Cited Guidance: + "2.6[Item 1, Bullet 5][The domain pair uses DOMAIN as an Identifier to group parent records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship to be described in RELREC.]|6.3[MS Assumption 1][Definition: The MS domain is designed to store any findings related to the organisms found and submitted - in MB.]' + in MB.]" Document: IG v3.2 Item: 2.6[Item 1, Bullet 5]|6.3[MS Assumption 1] Section: 2.6|6.3 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0191 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: 2.6[Item 1][The domain pair uses DOMAIN as an Identifier + - Cited Guidance: + 2.6[Item 1][The domain pair uses DOMAIN as an Identifier to group parent records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship to be described in RELREC.]|6.3.7[MS is used for representing data from drug susceptibility testing on @@ -67,7 +71,7 @@ Check: Core: Id: CORE-000188 Status: Published - Version: '1' + Version: "1" Description: Trigger error if MS dataset is present and MB dataset is not present. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000193/rule.yml b/Deprecated/CORE-000193/rule.yml index f442688e0..f58f9ea3d 100644 --- a/Deprecated/CORE-000193/rule.yml +++ b/Deprecated/CORE-000193/rule.yml @@ -5,29 +5,31 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0503 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The start date/time of the Disease Milestone Instance + - Cited Guidance: + The start date/time of the Disease Milestone Instance Name in MIDS. Document: Model v2.0 Item: MIDSDTC Section: Timing - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0503 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: The start date/time of the Disease Milestone Instance + - Cited Guidance: + The start date/time of the Disease Milestone Instance Name in MIDS. Document: Model v1.7 Item: MIDSDTC @@ -41,8 +43,9 @@ Check: Core: Id: CORE-000193 Status: Published - Version: '1' -Description: Raise an error when variable MIDSDTC is present and MIDS variable is + Version: "1" +Description: + Raise an error when variable MIDSDTC is present and MIDS variable is missing. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000211/rule.yml b/Deprecated/CORE-000211/rule.yml index c9d5bd064..ec677c744 100644 --- a/Deprecated/CORE-000211/rule.yml +++ b/Deprecated/CORE-000211/rule.yml @@ -1,5 +1,5 @@ # Variable: QNAM -# Condition: +# Condition: # Rule: ADSL Population flags not in SUPPDM Authorities: - Organization: CDISC @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: The standard Supplemental Qualifiers included in previous + - Cited Guidance: + The standard Supplemental Qualifiers included in previous versions of the SDTMIG (COMPLT, FULLSET, ITT, PPROT, and SAFETY) should not be used. Note that the ADaM subject-level analysis dataset (ADSL) specifies standard variable names for @@ -17,17 +18,18 @@ Authorities: variables. Document: IG v3.4 Item: Assumption 5 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0528 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: The standard Supplemental Qualifiers included in previous + - Cited Guidance: + The standard Supplemental Qualifiers included in previous versions of the SDTMIG (COMPLT; FULLSET; ITT; PPROT; and SAFETY) should not be used. Note that the ADaM subject-level analysis dataset (ADSL) specifies standard variable names for @@ -37,13 +39,13 @@ Authorities: variables. Document: IG v3.3 Item: Assumption 5 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0528 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: RDOMAIN @@ -55,7 +57,7 @@ Check: Core: Id: CORE-000211 Status: Published - Version: '1' + Version: "1" Description: SUPPDM must not include population flags. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000215/rule.yml b/Deprecated/CORE-000215/rule.yml index ef860be06..d448fdd04 100644 --- a/Deprecated/CORE-000215/rule.yml +++ b/Deprecated/CORE-000215/rule.yml @@ -7,12 +7,14 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: DSSCAT = 'STUDY TREATMENT' can be used as a generic identifier + - Cited Guidance: + DSSCAT = 'STUDY TREATMENT' can be used as a generic identifier when a study has only a single treatment. Document: IG v3.4 Item: Assumption 2.b.2 Section: 6.2.3 - - Cited Guidance: If a study has multiple treatments, then DSSCAT should name the + - Cited Guidance: + If a study has multiple treatments, then DSSCAT should name the individual treatment. Document: IG v3.4 Item: Assumption 2.b.3 @@ -20,13 +22,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0539 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Assumption 2.b.2[DSSCAT = 'STUDY TREATMENT' can be used as a + - Cited Guidance: + Assumption 2.b.2[DSSCAT = 'STUDY TREATMENT' can be used as a generic identifier when a study has only a single treatment.]|Assumption 2.b.3[If a study has multiple treatments, then DSSCAT should name the individual treatment.] @@ -36,9 +39,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0539 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: $disposition_event_count @@ -56,7 +59,7 @@ Check: Core: Id: CORE-000215 Status: Published - Version: '1' + Version: "1" Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY TREATMENT' diff --git a/Deprecated/CORE-000216/rule.yml b/Deprecated/CORE-000216/rule.yml index 57947caa0..862cf7dc7 100644 --- a/Deprecated/CORE-000216/rule.yml +++ b/Deprecated/CORE-000216/rule.yml @@ -5,35 +5,37 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0545 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: For Disease Milestones that can occur only once (TMRPT = "N") + - Cited Guidance: + For Disease Milestones that can occur only once (TMRPT = "N") the value of MIDS may be the value in MIDSTYPE or may an abbreviated version. Document: IG v3.4 Item: Assumption 2.a - Section: '5.4' + Section: "5.4" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0545 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: For Disease Milestones that can occur only once (TMRPT = "N") + - Cited Guidance: + For Disease Milestones that can occur only once (TMRPT = "N") the value of MIDS may be the value in MIDSTYPE or may an abbreviated version. Document: IG v3.4 Item: Assumption 2.a - Section: '5.5' + Section: "5.5" Check: all: - name: MIDSTYPE @@ -48,7 +50,7 @@ Check: Core: Id: CORE-000216 Status: Published - Version: '1' + Version: "1" Description: MIDSTYPE must be unique within subject when MIDSTYPE = TM.MIDSTYPE and TM.TMRPT = 'N' Executability: Fully Executable diff --git a/Deprecated/CORE-000226/rule.yml b/Deprecated/CORE-000226/rule.yml index f7349d2ba..25fb2ba9f 100644 --- a/Deprecated/CORE-000226/rule.yml +++ b/Deprecated/CORE-000226/rule.yml @@ -1,5 +1,5 @@ # Variable: --DTHREL -# Condition: +# Condition: # Rule: --DTHREL not present in dataset Authorities: - Organization: CDISC @@ -7,52 +7,55 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical + - Cited Guidance: + "The following SDTM variables, defined for use in non-clinical studies (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" Document: Model v1.4 - Item: ' ' - Section: '2.7' + Item: " " + Section: "2.7" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0352 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL (Findings) - --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' + --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" Document: IG v3.2 - Section: '2.7' + Section: "2.7" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0352 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing - Variables) --NOMLBL (Timing Variables)' + Variables) --NOMLBL (Timing Variables)" Document: IG v3.3 - Section: '2.7' + Section: "2.7" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0352 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: --DTHREL @@ -60,7 +63,7 @@ Check: Core: Id: CORE-000226 Status: Published - Version: '1' + Version: "1" Description: Verifying presence of SEND variable --DTHREL Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000229/rule.yml b/Deprecated/CORE-000229/rule.yml index a67292bab..ea9c6f5be 100644 --- a/Deprecated/CORE-000229/rule.yml +++ b/Deprecated/CORE-000229/rule.yml @@ -15,9 +15,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0361 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: @@ -27,9 +27,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0361 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -39,9 +39,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0361 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: USUBJID @@ -51,7 +51,7 @@ Check: Core: Id: CORE-000229 Status: Published - Version: '1' + Version: "1" Description: Verify that When USUBJID is populated, POOLID is not populated Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000230/rule.yml b/Deprecated/CORE-000230/rule.yml index d4dce7312..a5bb11866 100644 --- a/Deprecated/CORE-000230/rule.yml +++ b/Deprecated/CORE-000230/rule.yml @@ -18,21 +18,21 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0362 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - Cited Guidance: Either USUBJID or POOLID must be populated. Document: Model v1.4 - Section: '' + Section: "" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0362 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -42,9 +42,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0362 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: POOLID @@ -54,7 +54,7 @@ Check: Core: Id: CORE-000230 Status: Published - Version: '1' + Version: "1" Description: Verify that when POOLID is populated, USUBJID is not populated Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000231/rule.yml b/Deprecated/CORE-000231/rule.yml index 3485c4c32..379a2e42d 100644 --- a/Deprecated/CORE-000231/rule.yml +++ b/Deprecated/CORE-000231/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier used to identify a related subject or pool of + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v2.0 @@ -16,13 +17,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0363 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier used to identify a related subject or pool of + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v1.4 @@ -30,13 +32,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0363 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier used to identify a related subject or pool of + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v1.7 @@ -44,9 +47,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0363 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: RSUBJID @@ -57,7 +60,7 @@ Check: Core: Id: CORE-000231 Status: Published - Version: '1' + Version: "1" Description: Verify that when RSUBJID populated, RSUBJID does not equal USUBJID Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000232/rule.yml b/Deprecated/CORE-000232/rule.yml index 398c668db..249dbeb82 100644 --- a/Deprecated/CORE-000232/rule.yml +++ b/Deprecated/CORE-000232/rule.yml @@ -5,44 +5,47 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0364 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Identifier used to identify a related subject or pool + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v2.0 Item: RSUBJID Section: RELSUB - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0364 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Identifier used to identify a related subject or pool + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v1.4 Section: 4.1.4 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0364 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Identifier used to identify a related subject or pool + - Cited Guidance: + Identifier used to identify a related subject or pool of subjects. RSUBJID will be populated with either the USUBJID of the related subject or the POOLID of the related pool. Document: Model v1.7 @@ -57,7 +60,7 @@ Check: Core: Id: CORE-000232 Status: Published - Version: '1' + Version: "1" Description: Verify when RSUBJID is populated it does not equal POOLID Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000233/rule.yml b/Deprecated/CORE-000233/rule.yml index 7adc43728..89731148d 100644 --- a/Deprecated/CORE-000233/rule.yml +++ b/Deprecated/CORE-000233/rule.yml @@ -5,48 +5,51 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0365 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons other than study + - Cited Guidance: + Associated Persons (AP) are persons other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. Document: Model v2.0 - Item: ' ' + Item: " " Section: Associated Persons - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0365 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons who can be associated + - Cited Guidance: + Associated Persons (AP) are persons who can be associated with a study; a particular study subject or a device used in the study. Document: Model v1.4 Section: 5.1.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0365 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons who can be associated + - Cited Guidance: + Associated Persons (AP) are persons who can be associated with a study; a particular study subject or a device used in the study. Document: Model v1.7 - Section: '6.1' + Section: "6.1" Check: all: - name: RSUBJID @@ -56,12 +59,14 @@ Check: Core: Id: CORE-000233 Status: Published - Version: '1' -Description: Related Device Identifier (RDEVID) and Related Subject or Pool Identifier + Version: "1" +Description: + Related Device Identifier (RDEVID) and Related Subject or Pool Identifier (RSUBJID) should not both be populated for the same record. Executability: Fully Executable Outcome: - Message: RDEVID must be empty when RSUBJID is populated and RSUBJID must be empty + Message: + RDEVID must be empty when RSUBJID is populated and RSUBJID must be empty when RDEVID is populated Output Variables: - RSUBJID diff --git a/Deprecated/CORE-000234/rule.yml b/Deprecated/CORE-000234/rule.yml index a66f247c6..1d6675467 100644 --- a/Deprecated/CORE-000234/rule.yml +++ b/Deprecated/CORE-000234/rule.yml @@ -5,48 +5,51 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0366 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons other than study + - Cited Guidance: + Associated Persons (AP) are persons other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. Document: Model v2.0 - Item: ' ' + Item: " " Section: Associated Persons - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0366 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons who can be associated + - Cited Guidance: + Associated Persons (AP) are persons who can be associated with a study; a particular study subject or a device used in the study. Document: Model v1.4 Section: 5.1.1 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0366 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Associated Persons (AP) are persons who can be associated + - Cited Guidance: + Associated Persons (AP) are persons who can be associated with a study; a particular study subject or a device used in the study. Document: Model v1.7 - Section: '6.1' + Section: "6.1" Check: all: - name: RDEVID @@ -56,7 +59,7 @@ Check: Core: Id: CORE-000234 Status: Published - Version: '1' + Version: "1" Description: Verify that RSUBJID is empty when RDEVID is populated Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000235/rule.yml b/Deprecated/CORE-000235/rule.yml index 5eaaa0a15..2ae07b9e8 100644 --- a/Deprecated/CORE-000235/rule.yml +++ b/Deprecated/CORE-000235/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier for a related study subject or pool of study + - Cited Guidance: + Identifier for a related study subject or pool of study subjects. The subject(s) may be human or animal. RSUBJID will be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data @@ -19,13 +20,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0367 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier for a related study subject or pool of study + - Cited Guidance: + Identifier for a related study subject or pool of study subjects. The subject(s) may be human or animal. RSUBJID will be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data @@ -36,13 +38,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0367 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Identifier for a related subject or pool of subjects. RSUBJID + - Cited Guidance: + Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data about associated persons who are related to the study but not @@ -52,9 +55,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0367 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: RSUBJID @@ -68,7 +71,7 @@ Check: Core: Id: CORE-000235 Status: Published - Version: '1' + Version: "1" Description: Verify that RSUBJID=DM.USUBJID when RSUBJID is populated and RSUBJID is not equal to POOLID Executability: Fully Executable diff --git a/Deprecated/CORE-000251/rule.yml b/Deprecated/CORE-000251/rule.yml index 97ffb764b..a6f9cfbf0 100644 --- a/Deprecated/CORE-000251/rule.yml +++ b/Deprecated/CORE-000251/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For example, if a subject's survival status is "DEAD", the date + - Cited Guidance: + For example, if a subject's survival status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS. Document: SDTMIG v3.4 @@ -16,13 +17,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0067 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date + - Cited Guidance: + For example, if a subject's Survival Status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS. Document: SDTMIG v3.3 @@ -31,66 +33,70 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0067 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date + - Cited Guidance: + For example, if a subject's Survival Status is "DEAD", the date of death must be stored in DM and within a final disposition record in DS. Document: SDTMIG v3.2 Item: Assumption 2 - Section: '6.3' + Section: "6.3" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0067 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" #CG0067 is identical to rule FB0614. Added metadata for FB0614 by Malini Narreddy on 2025-03-07 - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0614 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0614 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0614 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: SSSTRESC @@ -104,7 +110,7 @@ Check: Core: Id: CORE-000251 Status: Published - Version: '1' + Version: "1" Description: When survival status is completed as 'DEAD' in the SS dataset then a record should be present in the DS dataset where DSDECOD = 'DEATH' for the corresponding subject. @@ -117,7 +123,8 @@ Operations: name: DSDECOD operator: distinct Outcome: - Message: SSTRESC in SS dataset is "DEAD", but a record is missing in DS dataset + Message: + SSTRESC in SS dataset is "DEAD", but a record is missing in DS dataset where DSDECOD = "DEATH". Output Variables: - SSSTRESC diff --git a/Deprecated/CORE-000259/rule.yml b/Deprecated/CORE-000259/rule.yml index e56701308..e8b05074f 100644 --- a/Deprecated/CORE-000259/rule.yml +++ b/Deprecated/CORE-000259/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details, but those details are to be stored in appropriate separate domains. For @@ -21,13 +22,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0171 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, @@ -41,13 +43,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0171 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Subject Status does not contain details about the circumstances + - Cited Guidance: + Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, @@ -61,51 +64,54 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0171 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" #CG0171 is identical to rule FB0613. Added metadata for FB0613 on 2025-01-20 - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0613 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0613 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0613 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: SSSTRESC @@ -118,7 +124,7 @@ Check: Core: Id: CORE-000259 Status: Published - Version: '1' + Version: "1" Description: Date/time of collection of subject status in SS dataset where survival status (SSSTRESC) = 'DEAD' should be equal to or after the Date/Time of Death (DTHDTC) in the DM dataset for the corresponding subject. #Message has been updated as per the FDA Business Rules Spreadsheet. @@ -128,7 +134,8 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: SSDTC in SS dataset where SSTRESC = 'DEAD' is not equal to or after the + Message: + SSDTC in SS dataset where SSTRESC = 'DEAD' is not equal to or after the DTHDTC in the DM dataset. #Error message has been updated as per the FDA Business Rules Spreadsheet. Output Variables: - SSSTRESC diff --git a/Deprecated/CORE-000264/rule.yml b/Deprecated/CORE-000264/rule.yml index efd52702f..42434c7da 100644 --- a/Deprecated/CORE-000264/rule.yml +++ b/Deprecated/CORE-000264/rule.yml @@ -5,15 +5,16 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0039 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Body system or organ class used + - Cited Guidance: + Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may @@ -21,21 +22,23 @@ Authorities: Document: SDTMIG v3.4 Item: Specification Section: 6.2.1 - - Cited Guidance: Body system or system organ class assigned for analysis + - Cited Guidance: + Body system or system organ class assigned for analysis from a standard hierarchy (e.g. MedDRA) associated with an event. Document: Model v2.0 Item: --BODSYS Section: Events - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0039 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Body system or organ class used + - Cited Guidance: + Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may @@ -43,21 +46,23 @@ Authorities: Document: SDTMIG v3.3 Item: Specification Section: 6.2.1 - - Cited Guidance: Body system or system organ class assigned for analysis + - Cited Guidance: + Body system or system organ class assigned for analysis from a standard hierarchy (e.g. MedDRA) associated with an event. Document: Model v1.7 Item: Table 2.2.2.1 --BODSYS Section: 2.2.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0039 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Body system or organ class used + - Cited Guidance: + Dictionary derived. Body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may @@ -65,7 +70,8 @@ Authorities: Document: SDTMIG v3.3 Item: Specification Section: 6.2 AE - - Cited Guidance: Body system or system organ class assigned for analysis + - Cited Guidance: + Body system or system organ class assigned for analysis from a standard hierarchy (e. g. MedDRA) associated with an event. Document: Model v1.4 Item: Table 2.2.2.1 --BODSYS @@ -78,8 +84,9 @@ Check: Core: Id: CORE-000264 Status: Published - Version: '1' -Description: Raise an error if primary SOC is used for analysis and -BODSYS is not + Version: "1" +Description: + Raise an error if primary SOC is used for analysis and -BODSYS is not equal to -SOC Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000292/rule.yml b/Deprecated/CORE-000292/rule.yml index 346ef0ed3..2d99a2e1e 100644 --- a/Deprecated/CORE-000292/rule.yml +++ b/Deprecated/CORE-000292/rule.yml @@ -5,46 +5,49 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0107 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: "\"When the EC domain is implemented in conjunction\ + - Cited Guidance: + "\"When the EC domain is implemented in conjunction\ \ with the EX domain, EXVAMT and EXVAMTU should not be used in EX;\n\ \ collected values instead would be represented in ECDOSE and ECDOSU.\"" Document: IG v3.4 Item: Assumption 6c Section: 6.1.3.1 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0107 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented + - Cited Guidance: + When the EC domain (See Section 6.1.2.3) is implemented in conjunction with the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE and ECDOSU Document: IG v3.2 Item: Assumption 6c - Section: '6.1' + Section: "6.1" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0107 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented + - Cited Guidance: + When the EC domain (See Section 6.1.2.3) is implemented in conjunction with the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE and ECDOSU @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000292 Status: Published - Version: '1' + Version: "1" Description: When EC exists, EXVAMTU should not be used. Executability: Fully Executable Operations: diff --git a/Deprecated/CORE-000297/rule.yml b/Deprecated/CORE-000297/rule.yml index cb5406cb2..6a2d9a22e 100644 --- a/Deprecated/CORE-000297/rule.yml +++ b/Deprecated/CORE-000297/rule.yml @@ -5,15 +5,16 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0501 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: The name of a specific instance of a Disease Milestone + - Cited Guidance: + The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 5.1.4.3, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and @@ -22,15 +23,16 @@ Authorities: Item: MIDS Section: Timing - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0501 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: The name of a specific instance of a Disease Milestone + - Cited Guidance: + The name of a specific instance of a Disease Milestone Type (MIDSTYPE) described in the Trial Disease Milestones dataset (see Section 3.5, Trial Disease Milestones). This should be unique within a subject. Used only in conjunction with RELMIDS and MIDSDTC. @@ -47,8 +49,9 @@ Check: Core: Id: CORE-000297 Status: Published - Version: '1' -Description: Raise an error when variable MIDS is present in any of the dataset and + Version: "1" +Description: + Raise an error when variable MIDS is present in any of the dataset and TM dataset is missing. Executability: Fully Executable Operations: diff --git a/Deprecated/CORE-000322/rule.yml b/Deprecated/CORE-000322/rule.yml index 43621b190..3985cea7d 100644 --- a/Deprecated/CORE-000322/rule.yml +++ b/Deprecated/CORE-000322/rule.yml @@ -5,20 +5,21 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0066 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: d. When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD + - Cited Guidance: + d. When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will contain the same value drawn from the sponsor's controlled terminology. Document: IG v3.2 Item: Assumption 3d - Section: '6.2' + Section: "6.2" Check: all: - name: DSCAT @@ -31,8 +32,9 @@ Check: Core: Id: CORE-000322 Status: Published - Version: '1' -Description: When DSCAT equals PROTOCOL MILESTONE, then DSTERM should be equal to + Version: "1" +Description: + When DSCAT equals PROTOCOL MILESTONE, then DSTERM should be equal to DSDECOD Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000326/rule.yml b/Deprecated/CORE-000326/rule.yml index 41c7cb2bb..5b01f4d2f 100644 --- a/Deprecated/CORE-000326/rule.yml +++ b/Deprecated/CORE-000326/rule.yml @@ -1,5 +1,5 @@ # Variable: EXMETHOD -# Condition: +# Condition: # Rule: EXMETHOD not present in dataset Authorities: - Organization: CDISC @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Method of administration of the treatment. Not to be used with + - Cited Guidance: + Method of administration of the treatment. Not to be used with human clinical trials. Document: Model v1.7 Item: EXMETHOD @@ -15,9 +16,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0568 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: EXMETHOD @@ -25,7 +26,7 @@ Check: Core: Id: CORE-000326 Status: Published - Version: '1' + Version: "1" Description: Trigger error when EXMETHOD exists in the EX dataset for human clinical trials Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000329/rule.yml b/Deprecated/CORE-000329/rule.yml index b1d9ebe3f..90894ec81 100644 --- a/Deprecated/CORE-000329/rule.yml +++ b/Deprecated/CORE-000329/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'A sponsor may collect one disposition event for the trial as a + - Cited Guidance: + "A sponsor may collect one disposition event for the trial as a whole, or they may collect disposition for each Epoch of the trial. When disposition is collected for each Epoch, the variable EPOCH should be included in the DS dataset. When @@ -18,16 +19,16 @@ Authorities: general-observation-class domains, where EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC or --DTC falls. The values of EPOCH are drawn from the Trial Arms - domain, Section 7.2 - Experimental Design: Trial Arms (TA)' + domain, Section 7.2 - Experimental Design: Trial Arms (TA)" Document: IG v3.2 - Item: 'DS Assumption 3.C:' - Section: '6.2' + Item: "DS Assumption 3.C:" + Section: "6.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0063 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: DSCAT @@ -42,7 +43,7 @@ Check: Core: Id: CORE-000329 Status: Published - Version: '1' + Version: "1" Description: Raise an error when multiple records within same USUBJID exist with DSCAT = DISPOSITION EVENT but EPOCH is empty Executability: Fully Executable diff --git a/Deprecated/CORE-000330/rule.yml b/Deprecated/CORE-000330/rule.yml index 26aa4c971..fffd0939d 100644 --- a/Deprecated/CORE-000330/rule.yml +++ b/Deprecated/CORE-000330/rule.yml @@ -7,20 +7,21 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Data for screen failure subjects, if submitted, should be + - Cited Guidance: + Data for screen failure subjects, if submitted, should be included in the Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen Failure". Subjects withdrawn from a trial before assignment to an Arm, if they are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'. Document: IG v3.2 Item: Assumption 4 - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0122 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ARM @@ -36,7 +37,7 @@ Check: Core: Id: CORE-000330 Status: Published - Version: '1' + Version: "1" Description: 'ACTARM value must match ARM value in Demographics when ARM equals "Screen Failure" or "Not Assigned"' Executability: Fully Executable diff --git a/Deprecated/CORE-000331/rule.yml b/Deprecated/CORE-000331/rule.yml index 1d1f3bf9d..4c2c9fd20 100644 --- a/Deprecated/CORE-000331/rule.yml +++ b/Deprecated/CORE-000331/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Code of actual Arm. When an Arm is not planned (not in Trial + - Cited Guidance: + Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not @@ -15,14 +16,15 @@ Authorities: all other cases Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0124 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" - Citations: - - Cited Guidance: Code of actual Arm. When an Arm is not planned (not in Trial + - Cited Guidance: + Code of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARMCD will be UNPLAN. Randomized subjects who were not treated will be given a value of NOTTRT. Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not @@ -30,13 +32,13 @@ Authorities: all other cases Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0125 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARMCD @@ -52,7 +54,7 @@ Check: Core: Id: CORE-000331 Status: Published - Version: '1' + Version: "1" Description: 'ACTARMCD values in Demographics are restricted to ARMCD values in Trial Arms when ACTARMCD is not equal to "SCRNFAIL", "NOTASSGN", "NOTTRT", or "UNPLAN"' @@ -63,8 +65,8 @@ Operations: name: ARMCD operator: distinct Outcome: - Message: 'DM.ACTARMCD must equal SCRNFAIL, NOTASSGN, NOTTRT, or UNPLAN if the - value is not present in TA.ARMCD' + Message: "DM.ACTARMCD must equal SCRNFAIL, NOTASSGN, NOTTRT, or UNPLAN if the + value is not present in TA.ARMCD" Output Variables: - ACTARMCD #- $armcd_list diff --git a/Deprecated/CORE-000332/rule.yml b/Deprecated/CORE-000332/rule.yml index b40fa93e3..53c88f351 100644 --- a/Deprecated/CORE-000332/rule.yml +++ b/Deprecated/CORE-000332/rule.yml @@ -8,40 +8,41 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: MBRESCAT is expected in all records where a microorganism has + - Cited Guidance: + MBRESCAT is expected in all records where a microorganism has been identified to differentiate between colonizing organisms and the one(s) that are causing the infection. It is not expected when there is 'No growth' or when the results are from a gram stain Document: IG v3.2 Item: Assumption 6 - Section: '6.3' + Section: "6.3" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0193 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" # IMPLEMENTATION: WHEN: MBTESTCD = 'ORGANISM' and MBSTRESC != 'NO GROWTH' and MBMETHOD != 'GRAM STAIN' # THEN: Check: all: - name: MBTESTCD operator: equal_to - value: 'ORGANISM' + value: "ORGANISM" - name: MBSTRESC operator: not_equal_to_case_insensitive - value: 'NO GROWTH' + value: "NO GROWTH" - name: MBMETHOD operator: not_equal_to_case_insensitive - value: 'GRAM STAIN' + value: "GRAM STAIN" - name: MBRESCAT operator: empty Core: Id: CORE-000332 Status: Published - Version: '1' + Version: "1" Description: Raise an error when MBTESTCD=ORGANISM, MSSTRESC!='NO GROWTH', MBMETHOD!='GRAM STAIN' and MBRESCAT is empty Executability: Fully Executable diff --git a/Deprecated/CORE-000333/rule.yml b/Deprecated/CORE-000333/rule.yml index 497981058..ec8efb95c 100644 --- a/Deprecated/CORE-000333/rule.yml +++ b/Deprecated/CORE-000333/rule.yml @@ -14,22 +14,22 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0215 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - Cited Guidance: Protocol-defined description of clinical encounter. Document: IG v3.3 Item: Specification - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0215 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: @@ -44,8 +44,8 @@ Check: Core: Id: CORE-000333 Status: Published - Version: '1' -Description: 'Raise an error when SVUPDES is null and SV.VISIT is not in TV.VISIT' + Version: "1" +Description: "Raise an error when SVUPDES is null and SV.VISIT is not in TV.VISIT" Executability: Partially Executable - Possible Overreporting Operations: - domain: TV diff --git a/Deprecated/CORE-000335/rule.yml b/Deprecated/CORE-000335/rule.yml index e56b38bff..e7f167089 100644 --- a/Deprecated/CORE-000335/rule.yml +++ b/Deprecated/CORE-000335/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the + - Cited Guidance: + IG v3.2[7.4][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.2[Appendix C1][Required only when there is only one @@ -21,13 +22,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0280 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -43,9 +45,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0280 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -62,7 +64,7 @@ Check: Core: Id: CORE-000335 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = "RANDQT" and the value provided in TSVAL is not a number between 0 and 1. Executability: Fully Executable diff --git a/Deprecated/CORE-000338/rule.yml b/Deprecated/CORE-000338/rule.yml index 7cb178b39..6571aa323 100644 --- a/Deprecated/CORE-000338/rule.yml +++ b/Deprecated/CORE-000338/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0457 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0457 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,7 +47,7 @@ Check: Core: Id: CORE-000338 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = "ACTSUB" and the value provided in TSVAL is not an integer greater than 0. Executability: Fully Executable diff --git a/Deprecated/CORE-000339/rule.yml b/Deprecated/CORE-000339/rule.yml index fc1c5766a..925f4a92e 100644 --- a/Deprecated/CORE-000339/rule.yml +++ b/Deprecated/CORE-000339/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0456 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0456 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,7 +47,7 @@ Check: Core: Id: CORE-000339 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = FCNTRY and TSVCDREF is not equal to 'ISO 3166-1 alpha-3' Executability: Fully Executable diff --git a/Deprecated/CORE-000340/rule.yml b/Deprecated/CORE-000340/rule.yml index 068ae44cb..269fbf347 100644 --- a/Deprecated/CORE-000340/rule.yml +++ b/Deprecated/CORE-000340/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0440 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0440 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,7 +47,7 @@ Check: Core: Id: CORE-000340 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = "PLANSUB" and the value provided in TSVAL is not an integer greater than 0. Executability: Fully Executable diff --git a/Deprecated/CORE-000362/rule.yml b/Deprecated/CORE-000362/rule.yml index fdd15cbf8..fdf754a85 100644 --- a/Deprecated/CORE-000362/rule.yml +++ b/Deprecated/CORE-000362/rule.yml @@ -5,15 +5,16 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0037 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Code for the body system or organ class used + - Cited Guidance: + Dictionary derived. Code for the body system or organ class used by the sponsor. When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables, which may not necessarily be the @@ -21,21 +22,23 @@ Authorities: Document: SDTMIG v3.4 Item: Specification Section: Events - - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS + - Cited Guidance: + MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis. Document: Model v2.0 Item: --BDSYCD Section: Events - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0037 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Code for body system or organ class used by + - Cited Guidance: + Dictionary derived. Code for body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary @@ -43,21 +46,23 @@ Authorities: Document: SDTMIG v3.3 Item: Specification Section: 6.2.1 - - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS + - Cited Guidance: + MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis Document: Model v1.7 Item: Table 2.2.2.1 -BDSYCD Section: 2.2.2 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0037 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Dictionary derived. Code for body system or organ class used by + - Cited Guidance: + Dictionary derived. Code for body system or organ class used by the sponsor from the coding dictionary (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary @@ -65,7 +70,8 @@ Authorities: Document: SDTMIG v3.3 Item: Specification Section: 6.2. AE - - Cited Guidance: MedDRA System Organ Class code corresponding to --BODSYS + - Cited Guidance: + MedDRA System Organ Class code corresponding to --BODSYS assigned for analysis Document: Model v1.4 Item: Table 2.2.2.1 -BDSYCD @@ -78,7 +84,7 @@ Check: Core: Id: CORE-000362 Status: Published - Version: '1' + Version: "1" Description: Raise an error when primary SOC is used for analysis and SOC Code is not equal to Body System Code Executability: Fully Executable diff --git a/Deprecated/CORE-000364/rule.yml b/Deprecated/CORE-000364/rule.yml index ae762fac9..b45577059 100644 --- a/Deprecated/CORE-000364/rule.yml +++ b/Deprecated/CORE-000364/rule.yml @@ -7,20 +7,21 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will contain + - Cited Guidance: + When DSCAT='PROTOCOL MILESTONE', DSTERM and DSDECOD will contain the same value drawn from the sponsor's controlled terminology. Examples of controlled terms include 'INFORMED CONSENT OBTAINED' and 'RANDOMIZED.' EPOCH should not be populated when DSCAT = "PROTOCOL MILESTONE". Document: IG v3.2 Item: Assumption 3d - Section: '6.2' + Section: "6.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0073 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" Check: all: - name: DSCAT @@ -31,7 +32,7 @@ Check: Core: Id: CORE-000364 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DSCAT = "PROTOCOL MILESTONE" but EPOCH is not equal to null. Executability: Fully Executable diff --git a/Deprecated/CORE-000365/rule.yml b/Deprecated/CORE-000365/rule.yml index 6b8482d3a..a1eeb3028 100644 --- a/Deprecated/CORE-000365/rule.yml +++ b/Deprecated/CORE-000365/rule.yml @@ -5,15 +5,16 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0077 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: This categorization should not group all records (within the MH + - Cited Guidance: + This categorization should not group all records (within the MH Domain) into one generic group such as "Medical History" or "General Medical History" because this is redundant information with the domain code. If no smaller categorization @@ -23,15 +24,16 @@ Authorities: Item: Assumptions 3.a.1 Section: 6.2.6 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0077 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: This categorization should not group all records (within the MH + - Cited Guidance: + This categorization should not group all records (within the MH Domain) into one generic group such as "Medical History" or "General Medical History" because this is redundant information with the domain code. If no smaller categorization @@ -39,17 +41,18 @@ Authorities: this variable. Document: IG v3.2 Item: Assumptions 3.a.i - Section: '6.2' + Section: "6.2" - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0077 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: This categorization should not group all records (within the MH + - Cited Guidance: + This categorization should not group all records (within the MH Domain) into one generic group such as "Medical History" or "General Medical History" because this is redundant information with the domain code. If no smaller categorization @@ -67,7 +70,7 @@ Check: Core: Id: CORE-000365 Status: Published - Version: '1' + Version: "1" Description: MHCAT should not group all records. If no smaller categorization can be applied, then it is not necessary to include or populate this variable. Executability: Fully Executable diff --git a/Deprecated/CORE-000366/rule.yml b/Deprecated/CORE-000366/rule.yml index b53e0221d..a2e6cd3f4 100644 --- a/Deprecated/CORE-000366/rule.yml +++ b/Deprecated/CORE-000366/rule.yml @@ -7,26 +7,27 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: "Specification[ACTARMCD: Randomized subjects who were not + - Cited Guidance: + 'Specification[ACTARMCD: Randomized subjects who were not treated will be given a value of NOTTRT. Values should be - \"SCRNFAIL\" for screen failures and \"NOTASSGN\" for subjects + "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not assigned to treatment]|Assumption 4[Subjects withdrawn from a trial before assignment to an Arm, if they are not - screen failures, should have ARMCD = 'NOTASSGN' and ARM = 'Not - Assigned'.]|Assumption 10[subjects who are ineligible for + screen failures, should have ARMCD = ''NOTASSGN'' and ARM = ''Not + Assigned''.]|Assumption 10[subjects who are ineligible for treatment (e.g., screen failures with ARMCD=SCRNFAIL), subjects who were enrolled but not assigned to an arm (ARMCD=NOTASSGN), or subjects who were randomized but not - treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]" + treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]' Document: IG v3.2 Item: Specification|Assumption 4|Assumption 10 - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0109 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARMCD @@ -41,7 +42,7 @@ Check: Core: Id: CORE-000366 Status: Published - Version: '1' + Version: "1" Description: Raise an error when subject has no records in EX but ACTARMCD is not equal to SCRNFAIL, NOTASSGN or NOTTRT. Executability: Fully Executable diff --git a/Deprecated/CORE-000367/rule.yml b/Deprecated/CORE-000367/rule.yml index 0f3959763..be2ebf908 100644 --- a/Deprecated/CORE-000367/rule.yml +++ b/Deprecated/CORE-000367/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Description of actual Arm. When an Arm is not planned (not in + - Cited Guidance: + Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized subjects who were not treated will be given a value of “Not Treated”. Values should be “Screen Failure” for screen @@ -16,17 +17,18 @@ Authorities: cases. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0117 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Description of actual Arm. When an Arm is not planned (not in + - Cited Guidance: + Description of actual Arm. When an Arm is not planned (not in Trial Arms), ACTARM will be “Unplanned Treatment”. Randomized subjects who were not treated will be given a value of “Not Treated”. Values should be “Screen Failure” for screen @@ -35,13 +37,13 @@ Authorities: cases. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0118 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -61,7 +63,7 @@ Check: Core: Id: CORE-000367 Status: Published - Version: '1' + Version: "1" Description: Raise an error when no TA.ARM exists for ACTARM in DM and ACTARM does not equal Screen Failure, Not Assigned, Not Treated, or Unplanned Treatment in DM diff --git a/Deprecated/CORE-000368/rule.yml b/Deprecated/CORE-000368/rule.yml index 9b168f70e..950421e10 100644 --- a/Deprecated/CORE-000368/rule.yml +++ b/Deprecated/CORE-000368/rule.yml @@ -10,23 +10,23 @@ Authorities: - Cited Guidance: Name of the Arm to which the subject was assigned. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0120 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" - Citations: - Cited Guidance: Name of the Arm to which the subject was assigned. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0121 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ARM @@ -42,7 +42,7 @@ Check: Core: Id: CORE-000368 Status: Published - Version: '1' + Version: "1" Description: 'ARM values in Demographics are restricted to ARM values in Trial Arms when not equal to "Screen Failure" or "Not Assigned"' Executability: Fully Executable diff --git a/Deprecated/CORE-000369/rule.yml b/Deprecated/CORE-000369/rule.yml index 0a06e5c15..12ed9537d 100644 --- a/Deprecated/CORE-000369/rule.yml +++ b/Deprecated/CORE-000369/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'IG v3.2[5][Specification: RFENDTC][Required for all randomized + - Cited Guidance: + "IG v3.2[5][Specification: RFENDTC][Required for all randomized subjects; null for screen failures or unassigned subjects.]|IG v3.2[5][Specification: ACTARM][Randomized subjects who were not treated will be given a value of “Not Treated”. Values @@ -21,17 +22,18 @@ Authorities: treatment (e.g., screen failures with ARMCD=SCRNFAIL), subjects who were enrolled but not assigned to an arm (ARMCD=NOTASSGN), or subjects who were randomized but not - treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]' + treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]" Document: IG v3.2 - Item: 'IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG - v3.2[5][Assumption 10]' + Item: + "IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG + v3.2[5][Assumption 10]" Section: IG v3.2[5] Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0141 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -48,12 +50,13 @@ Check: Core: Id: CORE-000369 Status: Published - Version: '1' -Description: 'Raise an error when RFENDTC is not null, but ACTARM is Screen - Failure, Not Assigned, or Not Treated' + Version: "1" +Description: "Raise an error when RFENDTC is not null, but ACTARM is Screen + Failure, Not Assigned, or Not Treated" Executability: Fully Executable Outcome: - Message: RFENDTC must be null when ACTARM in (Screen Failure, Not Assigned, Not + Message: + RFENDTC must be null when ACTARM in (Screen Failure, Not Assigned, Not Treated). Rule Type: Record Data Scope: diff --git a/Deprecated/CORE-000371/rule.yml b/Deprecated/CORE-000371/rule.yml index bbe72148c..85b2d0d7a 100644 --- a/Deprecated/CORE-000371/rule.yml +++ b/Deprecated/CORE-000371/rule.yml @@ -1,5 +1,5 @@ # Variable: ARM -# Condition: +# Condition: # Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Treatment', 'Not Treated') Authorities: - Organization: CDISC @@ -14,9 +14,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0244 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" Check: all: - name: ARM @@ -29,12 +29,13 @@ Check: Core: Id: CORE-000371 Status: Published - Version: '1' + Version: "1" Description: 'Raise an error when ARM is "Screen Failure", "Not Assigned", "Unplanned Treatment" or "Not Treated"' Executability: Fully Executable Outcome: - Message: 'ARM is "Screen Failure", "Not Assigned", "Unplanned Treatment" or "Not + Message: + 'ARM is "Screen Failure", "Not Assigned", "Unplanned Treatment" or "Not Treated"' Rule Type: Record Data Scope: diff --git a/Deprecated/CORE-000372/rule.yml b/Deprecated/CORE-000372/rule.yml index ce437f269..161e1fc17 100644 --- a/Deprecated/CORE-000372/rule.yml +++ b/Deprecated/CORE-000372/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,25 +17,26 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0269 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0269 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -51,7 +53,7 @@ Check: Core: Id: CORE-000372 Status: Published - Version: '1' + Version: "1" Description: 'For TS.TSPARMCD = "ADDON" records, TS.TSVAL value must equal "N" or "Y" when not missing' Executability: Fully Executable diff --git a/Deprecated/CORE-000373/rule.yml b/Deprecated/CORE-000373/rule.yml index b6471352c..349c183c3 100644 --- a/Deprecated/CORE-000373/rule.yml +++ b/Deprecated/CORE-000373/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,25 +17,26 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0271 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0271 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -51,7 +53,7 @@ Check: Core: Id: CORE-000373 Status: Published - Version: '1' + Version: "1" Description: 'For TS.TSPARMCD = "RANDOM" records, TS.TSVAL value must equal "N" or "Y" when not missing' Executability: Fully Executable diff --git a/Deprecated/CORE-000375/rule.yml b/Deprecated/CORE-000375/rule.yml index 426ee07a4..674f770f8 100644 --- a/Deprecated/CORE-000375/rule.yml +++ b/Deprecated/CORE-000375/rule.yml @@ -7,33 +7,35 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For objective data, the value in QEVAL will be null. For + - Cited Guidance: + For objective data, the value in QEVAL will be null. For subjective data (when QORIG=”ASSIGNED”), the value in QEVAL should reflect the role of the person or institution assigning the value (e.g., SPONSOR or ADJUDICATION COMMITTEE). Document: IG v3.2 - Section: '8.4' + Section: "8.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0202 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: For objective data, the value in QEVAL will be null. For + - Cited Guidance: + For objective data, the value in QEVAL will be null. For subjective data (when QORIG=”ASSIGNED”), the value in QEVAL should reflect the role of the person or institution assigning the value (e.g., SPONSOR or ADJUDICATION COMMITTEE). Document: IG v3.3 - Section: '8.4' + Section: "8.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0202 - Version: '2' - Version: '2.0' - Version: '3.3' + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - name: QORIG @@ -45,11 +47,11 @@ Check: Core: Id: CORE-000375 Status: Published - Version: '1' -Description: 'Raise an error when QORIG = ASSIGNED and QEVAL is not populated.' + Version: "1" +Description: "Raise an error when QORIG = ASSIGNED and QEVAL is not populated." Executability: Fully Executable Outcome: - Message: 'QORIG = ASSIGNED but QEVAL is not populated' + Message: "QORIG = ASSIGNED but QEVAL is not populated" Output Variables: - QORIG - QEVAL diff --git a/Deprecated/CORE-000377/rule.yml b/Deprecated/CORE-000377/rule.yml index 132e34dee..10383ad85 100644 --- a/Deprecated/CORE-000377/rule.yml +++ b/Deprecated/CORE-000377/rule.yml @@ -7,17 +7,18 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Values should be "SCRNFAIL" for screen failures and "NOTASSGN" + - Cited Guidance: + Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not assigned to treatment. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0129 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ARMCD @@ -31,13 +32,13 @@ Check: Core: Id: CORE-000377 Status: Published - Version: '1' + Version: "1" Description: 'ARMCD value must match ACTARMCD value in Demographics when ARMCD equals "SCRFNFAIL" or "NOTASSGN"' Executability: Fully Executable Outcome: - Message: 'DM.ARMCD must equal DM.ACTARMCD when subject is either a screen - failure or not assigned to treatment' + Message: "DM.ARMCD must equal DM.ACTARMCD when subject is either a screen + failure or not assigned to treatment" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000378/rule.yml b/Deprecated/CORE-000378/rule.yml index fa788ece3..62f460077 100644 --- a/Deprecated/CORE-000378/rule.yml +++ b/Deprecated/CORE-000378/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'IG v3.2[5][Specification: RFENDTC][Required for all randomized + - Cited Guidance: + "IG v3.2[5][Specification: RFENDTC][Required for all randomized subjects; null for screen failures or unassigned subjects.]|IG v3.2[5][Specification: ACTARM][Randomized subjects who were not treated will be given a value of “Not Treated”. Values @@ -21,17 +22,18 @@ Authorities: treatment (e.g., screen failures with ARMCD=SCRNFAIL), subjects who were enrolled but not assigned to an arm (ARMCD=NOTASSGN), or subjects who were randomized but not - treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]' + treated (ACTARMCD=NOTTRT), RFSTDTC will be null.]" Document: IG v3.2 - Item: 'IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG - v3.2[5][Assumption 10]' + Item: + "IG v3.2[5][Specification: RFENDTC]|IG v3.2[5][Specification: ACTARM]|IG + v3.2[5][Assumption 10]" Section: IG v3.2[5] Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0142 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -48,9 +50,9 @@ Check: Core: Id: CORE-000378 Status: Published - Version: '1' -Description: 'Raise an error when RFENDTC is null, but ACTARM is not Screen - Failure, Not Assigned, or Not Treated' + Version: "1" +Description: "Raise an error when RFENDTC is null, but ACTARM is not Screen + Failure, Not Assigned, or Not Treated" Executability: Fully Executable Outcome: Message: RFENDTC must not be null when ACTARM is a value other than Screen diff --git a/Deprecated/CORE-000379/rule.yml b/Deprecated/CORE-000379/rule.yml index 13f5cfa94..916459fc7 100644 --- a/Deprecated/CORE-000379/rule.yml +++ b/Deprecated/CORE-000379/rule.yml @@ -10,13 +10,13 @@ Authorities: - Cited Guidance: Null for screen failures or unassigned subjects. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0145 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -33,12 +33,13 @@ Check: Core: Id: CORE-000379 Status: Published - Version: '1' -Description: 'Raise an error when RFSTDTC is not null, but ACTARM is either - Screen Failure, Not Assigned, or Not Treated' + Version: "1" +Description: "Raise an error when RFSTDTC is not null, but ACTARM is either + Screen Failure, Not Assigned, or Not Treated" Executability: Partially Executable Outcome: - Message: RFSTDTC must be null when ACTARM in (Screen failure, Not Assigned, Not + Message: + RFSTDTC must be null when ACTARM in (Screen failure, Not Assigned, Not Treated). Rule Type: Record Data Scope: diff --git a/Deprecated/CORE-000380/rule.yml b/Deprecated/CORE-000380/rule.yml index 024e50a27..32af0154e 100644 --- a/Deprecated/CORE-000380/rule.yml +++ b/Deprecated/CORE-000380/rule.yml @@ -10,13 +10,13 @@ Authorities: - Cited Guidance: Required for all randomized subjects. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0146 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -33,9 +33,9 @@ Check: Core: Id: CORE-000380 Status: Published - Version: '1' -Description: 'Raise an error when RFSTDTC is null, but ACTARM is neither Screen - Failure, Not Assigned, nor Not Treated' + Version: "1" +Description: "Raise an error when RFSTDTC is null, but ACTARM is neither Screen + Failure, Not Assigned, nor Not Treated" Executability: Fully Executable Outcome: Message: RFSTDTC must not be null when ACTARM is not in (Screen Failure, Not diff --git a/Deprecated/CORE-000452/rule.yml b/Deprecated/CORE-000452/rule.yml index 5bdc87541..a55c2e378 100644 --- a/Deprecated/CORE-000452/rule.yml +++ b/Deprecated/CORE-000452/rule.yml @@ -13,9 +13,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0432 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -25,9 +25,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0432 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - any: @@ -43,7 +43,7 @@ Check: Core: Id: CORE-000452 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGEU is empty, but AGE or AGETXT is not empty. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000453/rule.yml b/Deprecated/CORE-000453/rule.yml index 1ddb46ca6..91a2d1844 100644 --- a/Deprecated/CORE-000453/rule.yml +++ b/Deprecated/CORE-000453/rule.yml @@ -13,9 +13,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0433 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -25,9 +25,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0433 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: AGEU @@ -45,7 +45,7 @@ Check: Core: Id: CORE-000453 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGE is empty, but AGEU is not empty. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000467/rule.yml b/Deprecated/CORE-000467/rule.yml index f59a10ef9..36f6f9a10 100644 --- a/Deprecated/CORE-000467/rule.yml +++ b/Deprecated/CORE-000467/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0441 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0441 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -44,7 +46,7 @@ Check: Core: Id: CORE-000467 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = STOPRULE and TSVAL is not completed. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000468/rule.yml b/Deprecated/CORE-000468/rule.yml index 88337a749..5a8eb23c7 100644 --- a/Deprecated/CORE-000468/rule.yml +++ b/Deprecated/CORE-000468/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is INTERVENTIONAL" this @@ -18,13 +19,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0276 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -36,9 +38,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0276 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -52,9 +54,9 @@ Check: Core: Id: CORE-000468 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE - and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty.' + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE + and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty." Executability: Fully Executable Operations: - filter: @@ -65,8 +67,8 @@ Operations: id: $STYPE_INTERVENTIONAL operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL = - INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty.' + Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL = + INTERVENTIONAL but TSVAL for TSPARMCD = TRT is empty." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000469/rule.yml b/Deprecated/CORE-000469/rule.yml index 761b599e2..3587b540a 100644 --- a/Deprecated/CORE-000469/rule.yml +++ b/Deprecated/CORE-000469/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is INTERVENTIONAL" this @@ -18,13 +19,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0277 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -36,9 +38,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0277 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -52,9 +54,9 @@ Check: Core: Id: CORE-000469 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE - and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty.' + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE + and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty." Executability: Fully Executable Operations: - filter: @@ -65,8 +67,8 @@ Operations: id: $STYPE_INTERVENTIONAL operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL = - INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty.' + Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL = + INTERVENTIONAL but TSVAL for TSPARMCD = INTMODEL is empty." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000470/rule.yml b/Deprecated/CORE-000470/rule.yml index 6b5130fd8..ccd9d1d62 100644 --- a/Deprecated/CORE-000470/rule.yml +++ b/Deprecated/CORE-000470/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is "INTERVENTIONAL" this @@ -18,13 +19,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0278 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -36,9 +38,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0278 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -52,9 +54,9 @@ Check: Core: Id: CORE-000470 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE - and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty.' + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE + and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty." Executability: Fully Executable Operations: - filter: @@ -65,8 +67,8 @@ Operations: id: $STYPE_INTERVENTIONAL operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL = - INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty.' + Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL = + INTERVENTIONAL but TSVAL for TSPARMCD = INTTYPE is empty." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000473/rule.yml b/Deprecated/CORE-000473/rule.yml index d945393d3..75bd5698c 100644 --- a/Deprecated/CORE-000473/rule.yml +++ b/Deprecated/CORE-000473/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the + - Cited Guidance: + IG v3.2[7.4][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.2[Appendix C1][If the study population is healthy subjects @@ -22,13 +23,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0272 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -45,9 +47,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0272 - Version: '2' - Version: '2.0' - Version: '3.3' + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -59,17 +61,17 @@ Check: - all: - name: TSVAL operator: not_equal_to - value: 'HEALTHY SUBJECTS' + value: "HEALTHY SUBJECTS" value_is_literal: true - name: TSVAL operator: non_empty Core: Id: CORE-000473 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = Y but TSVAL for TSPARMCD = TDIGRP is not empty or does - not equal HEALTHY SUBJECTS.' + not equal HEALTHY SUBJECTS." Executability: Fully Executable Operations: - filter: @@ -80,9 +82,9 @@ Operations: id: $HLTSUBJI_Y operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = Y but + Message: "A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = Y but TSVAL for TSPARMCD = TDIGRP is not empty or does not equal HEALTHY - SUBJECTS.' + SUBJECTS." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000483/rule.yml b/Deprecated/CORE-000483/rule.yml index 5b8645b19..f96b7359b 100644 --- a/Deprecated/CORE-000483/rule.yml +++ b/Deprecated/CORE-000483/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0455 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0455 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,7 +47,7 @@ Check: Core: Id: CORE-000483 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = PCLAS but TSVCDREF is not equal to 'MED-RT'. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000497/rule.yml b/Deprecated/CORE-000497/rule.yml index 956d62bcc..3ba5fe26b 100644 --- a/Deprecated/CORE-000497/rule.yml +++ b/Deprecated/CORE-000497/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.3[Appendix C1][If study type is "INTERVENTIONAL" and if @@ -19,13 +20,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0279 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -39,9 +41,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0279 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -55,10 +57,10 @@ Check: Core: Id: CORE-000497 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = STYPE + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = STYPE and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = TPCLAS is empty but - applicable.' + applicable." Executability: Partially Executable - Possible Overreporting Operations: - filter: @@ -69,9 +71,9 @@ Operations: id: $STYPE_INTERVENTIONAL operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = STYPE and TSVAL = + Message: "A record exists in TS where TSPARMCD = STYPE and TSVAL = INTERVENTIONAL but TSVAL for TSPARMCD = PCLAS is empty when PCLAS is - applicable.' + applicable." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000501/rule.yml b/Deprecated/CORE-000501/rule.yml index 5c62fbe7e..4010b8fe5 100644 --- a/Deprecated/CORE-000501/rule.yml +++ b/Deprecated/CORE-000501/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Planned study day of the start of the visit based upon RFSTDTC + - Cited Guidance: + Planned study day of the start of the visit based upon RFSTDTC in Demographics. Should not be populated for Unplanned Visits Document: IG v3.2 Item: Specification @@ -15,23 +16,24 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0216 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be + - Cited Guidance: + VISITDY is the Planned Study Day of a visit. It should not be populated for unplanned visits. Document: IG v3.3 Item: Assumption 4 - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0216 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: @@ -42,11 +44,11 @@ Check: Core: Id: CORE-000501 Status: Published - Version: '1' -Description: 'Raise an error if SVUPDES is not null when VISITDY is populated.' + Version: "1" +Description: "Raise an error if SVUPDES is not null when VISITDY is populated." Executability: Fully Executable Outcome: - Message: 'VISITDY is populated when SVUPDES is also populated.' + Message: "VISITDY is populated when SVUPDES is also populated." Output Variables: - USUBJID - SVUPDES diff --git a/Deprecated/CORE-000504/rule.yml b/Deprecated/CORE-000504/rule.yml index 458f81ada..12957f56c 100644 --- a/Deprecated/CORE-000504/rule.yml +++ b/Deprecated/CORE-000504/rule.yml @@ -7,34 +7,36 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0283 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0283 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,11 +47,11 @@ Check: Core: Id: CORE-000504 Status: Published - Version: '1' -Description: 'Raise an error when TSVAL for TSPARMCD=DCUTDTC is not a valid date/time' + Version: "1" +Description: "Raise an error when TSVAL for TSPARMCD=DCUTDTC is not a valid date/time" Executability: Fully Executable Outcome: - Message: 'Invalid date for TSVAL for TSPARMCD = DCUTDTC (Data Cutoff Date)' + Message: "Invalid date for TSVAL for TSPARMCD = DCUTDTC (Data Cutoff Date)" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000506/rule.yml b/Deprecated/CORE-000506/rule.yml index c45beea4e..dce620d1d 100644 --- a/Deprecated/CORE-000506/rule.yml +++ b/Deprecated/CORE-000506/rule.yml @@ -7,34 +7,36 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0286 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0286 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -45,11 +47,11 @@ Check: Core: Id: CORE-000506 Status: Published - Version: '1' -Description: 'Raise an error when TSVAL for TSPARMCD=SENDTC is not a valid date/time' + Version: "1" +Description: "Raise an error when TSVAL for TSPARMCD=SENDTC is not a valid date/time" Executability: Fully Executable Outcome: - Message: 'Invalid date for TSVAL for TSPARMCD = SENDTC (Study End Date)' + Message: "Invalid date for TSVAL for TSPARMCD = SENDTC (Study End Date)" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000510/rule.yml b/Deprecated/CORE-000510/rule.yml index 5a688429b..70d4b45d5 100644 --- a/Deprecated/CORE-000510/rule.yml +++ b/Deprecated/CORE-000510/rule.yml @@ -7,27 +7,29 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For domains with two-letter domain codes (i.e., other than + - Cited Guidance: + For domains with two-letter domain codes (i.e., other than SUPPxx and RELREC), split dataset names can be up to four characters in length... The four-character dataset-name limitation allows the use of a Supplemental Qualifier dataset associated with the split dataset Document: IG v3.4 - Item: '6' + Item: "6" Section: 4.1.7 - Cited Guidance: AP domain codes are therefore four characters long. Document: AP Guide v1.0 - Section: '2' + Section: "2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0017 - Version: '2' - Version: '2.0' - Version: '3.4' + Version: "2" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: 4.1.1.7[Split dataset names can be up to four characters in + - Cited Guidance: + 4.1.1.7[Split dataset names can be up to four characters in length. For example, if splitting by --CAT, then dataset names would be the domain name plus up to two additional characters (e.g., QS36 for SF-36). If splitting Findings About by parent @@ -41,13 +43,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0017 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: 4.1.7[Split dataset names can be up to four characters in + - Cited Guidance: + 4.1.7[Split dataset names can be up to four characters in length. For example, if splitting by --CAT, then dataset names would be the domain name plus up to two additional characters (e.g., QS36 for SF-36). If splitting Findings About by parent @@ -61,9 +64,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0017 - Version: '2' - Version: '2.0' - Version: '3.3' + Version: "2" + Version: "2.0" + Version: "3.3" Check: any: - name: dataset_name @@ -75,7 +78,7 @@ Check: Core: Id: CORE-000510 Status: Published - Version: '1' + Version: "1" Description: Split datasets (excluding supplemental qualifiers) is expected to have a have a length of 3 or 4 characters Executability: Fully Executable diff --git a/Deprecated/CORE-000515/rule.yml b/Deprecated/CORE-000515/rule.yml index 68748c8e8..6d72d6cc2 100644 --- a/Deprecated/CORE-000515/rule.yml +++ b/Deprecated/CORE-000515/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: The Disposition dataset provides an accounting for all subjects + - Cited Guidance: + The Disposition dataset provides an accounting for all subjects who entered the study and may include protocol milestones; such as randomization; as well as the subject's completion status or reason for discontinuation for the entire study or @@ -19,9 +20,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0412 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARMCD @@ -36,7 +37,7 @@ Check: Core: Id: CORE-000515 Status: Published - Version: '1' + Version: "1" Description: 'Raise an error when DM.ACTARMCD does not equal "SCRNFAIL", "NOTASSGN" or "NOTTRT", and there are no DS records for the same subject' Executability: Fully Executable diff --git a/Deprecated/CORE-000522/rule.yml b/Deprecated/CORE-000522/rule.yml index 5b5501348..44f934a9b 100644 --- a/Deprecated/CORE-000522/rule.yml +++ b/Deprecated/CORE-000522/rule.yml @@ -10,9 +10,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB1401 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -22,9 +22,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB1401 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: @@ -34,9 +34,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB1401 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: DSCAT @@ -44,7 +44,7 @@ Check: Core: Id: CORE-000522 Status: Published - Version: '1' + Version: "1" Description: Category for Disposition Event (DSCAT) should be populated. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000530/rule.yml b/Deprecated/CORE-000530/rule.yml index 7bea945fa..7a78739ff 100644 --- a/Deprecated/CORE-000530/rule.yml +++ b/Deprecated/CORE-000530/rule.yml @@ -7,17 +7,18 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Values should be "Screen Failure" for screen failures and "Not + - Cited Guidance: + Values should be "Screen Failure" for screen failures and "Not Assigned" for subjects not assigned to treatment. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0119 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARM @@ -33,9 +34,9 @@ Check: Core: Id: CORE-000530 Status: Published - Version: '1' -Description: 'Raise an error when ACTARM is Screen Failure or Not Assigned, and - ACTARM does not equal ARM' + Version: "1" +Description: "Raise an error when ACTARM is Screen Failure or Not Assigned, and + ACTARM does not equal ARM" Executability: Fully Executable Outcome: Message: ACTARM should be equal to ARM when ACTARM is Screen Failure or Not Assigned. diff --git a/Deprecated/CORE-000531/rule.yml b/Deprecated/CORE-000531/rule.yml index 8899eb85b..4770659bc 100644 --- a/Deprecated/CORE-000531/rule.yml +++ b/Deprecated/CORE-000531/rule.yml @@ -7,34 +7,36 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Data for screen failure subjects, if submitted, should be + - Cited Guidance: + Data for screen failure subjects, if submitted, should be included in the Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen Failure". Subjects withdrawn from a trial before assignment to an Arm, if they are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'. Document: IG v3.2 Item: Assumption 4 - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0126 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" - Citations: - - Cited Guidance: Data for screen failure subjects, if submitted, should be + - Cited Guidance: + Data for screen failure subjects, if submitted, should be included in the Demographics dataset, with ARMCD = "SCRNFAIL' and ARM = "Screen Failure". Subjects withdrawn from a trial before assignment to an Arm, if they are not screen failures, should have ARMCD ='NOTASSGN' and ARM = 'Not Assigned'. Document: IG v3.2 Item: Assumption 4 - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0128 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ARMCD @@ -48,7 +50,7 @@ Check: Core: Id: CORE-000531 Status: Published - Version: '1' + Version: "1" Description: 'ARMCD values in Demographics are restricted to ARMCD values in Trial Arms when DM.ARMCD is not equal to "SCRNFAIL" or "NOTASSGN"' Executability: Fully Executable @@ -58,8 +60,8 @@ Operations: name: ARMCD operator: distinct Outcome: - Message: 'DM.ARMCD must equal SCRNFAIL or NOTASSGN if the value is not present - in TA.ARMCD' + Message: "DM.ARMCD must equal SCRNFAIL or NOTASSGN if the value is not present + in TA.ARMCD" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000532/rule.yml b/Deprecated/CORE-000532/rule.yml index 934ce24e4..f9d2adb2d 100644 --- a/Deprecated/CORE-000532/rule.yml +++ b/Deprecated/CORE-000532/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the + - Cited Guidance: + IG v3.2[7.4][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD.]|IG v3.2[Appendix C1][Required when ADDON equals "Y"] @@ -17,13 +18,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0275 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -35,9 +37,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0275 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -51,9 +53,9 @@ Check: Core: Id: CORE-000532 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = ADDON - and TSVAL = Y but TSVAL for TSPARMCD = CURTRT is empty.' + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = ADDON + and TSVAL = Y but TSVAL for TSPARMCD = CURTRT is empty." Executability: Fully Executable Operations: - filter: @@ -64,8 +66,8 @@ Operations: id: $ADDON_Y operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = ADDON and TSVAL = Y but TSVAL - for TSPARMCD = CURTRT is empty.' + Message: "A record exists in TS where TSPARMCD = ADDON and TSVAL = Y but TSVAL + for TSPARMCD = CURTRT is empty." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000533/rule.yml b/Deprecated/CORE-000533/rule.yml index c133f526f..995c191f3 100644 --- a/Deprecated/CORE-000533/rule.yml +++ b/Deprecated/CORE-000533/rule.yml @@ -7,22 +7,23 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'When study population flags are included in SDTM, they are + - Cited Guidance: + "When study population flags are included in SDTM, they are treated as Supplemental Qualifiers (see Section 8: 8.4, Relating Non-Standard Variables Values To A Parent Domain) to DM and placed in the SUPPDM dataset. Controlled terms for these subject-level population flags, (e.g., COMPLT, SAFETY, ITT and PPROT) are listed in Appendix C2 - Supplemental - Qualifier Name Codes.' + Qualifier Name Codes." Document: IG v3.2 Item: Assumption 5 Section: 5|Appendix C2 Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0138 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: QNAM @@ -36,12 +37,12 @@ Check: Core: Id: CORE-000533 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'A SUPP domain other than SUPPDM contains population flags (name - fragments reserved)' + Message: "A SUPP domain other than SUPPDM contains population flags (name + fragments reserved)" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000543/rule.yml b/Deprecated/CORE-000543/rule.yml index 8504ef994..35c4355a4 100644 --- a/Deprecated/CORE-000543/rule.yml +++ b/Deprecated/CORE-000543/rule.yml @@ -7,17 +7,18 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Values should be "SCRNFAIL" for screen failures and "NOTASSGN" + - Cited Guidance: + Values should be "SCRNFAIL" for screen failures and "NOTASSGN" for subjects not assigned to treatment. Document: IG v3.2 Item: Specification - Section: '5' + Section: "5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0127 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: ACTARMCD @@ -31,7 +32,7 @@ Check: Core: Id: CORE-000543 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ACTARMCD equals "SCRFNFAIL" or "NOTASSGN" but ARMCD doesn't equal ACTARMCD. Executability: Fully Executable diff --git a/Deprecated/CORE-000544/rule.yml b/Deprecated/CORE-000544/rule.yml index d30d064da..312cff569 100644 --- a/Deprecated/CORE-000544/rule.yml +++ b/Deprecated/CORE-000544/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to ensure uniqueness within the dataset. @@ -17,29 +18,31 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0028 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Sequence number to ensure uniqueness of records within a dataset + - Cited Guidance: + Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1. Document: Model v1.4 - Item: 'Table 2.2.4: --SEQ' + Item: "Table 2.2.4: --SEQ" Section: 2.2.4 Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0028 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Sequence number to ensure uniqueness of records within a dataset + - Cited Guidance: + Sequence number to ensure uniqueness of records within a dataset for a subject (or within a parameter, in the case of the Trial Summary domain). May be any valid number (including decimals) and does not have to start at 1. @@ -49,9 +52,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0028 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: any: - all: @@ -77,7 +80,7 @@ Check: Core: Id: CORE-000544 Status: Published - Version: '1' + Version: "1" Description: Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is split into multiple files. diff --git a/Deprecated/CORE-000562/rule.yml b/Deprecated/CORE-000562/rule.yml index d76939ddb..35702c7c1 100644 --- a/Deprecated/CORE-000562/rule.yml +++ b/Deprecated/CORE-000562/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[7.4][Assumption 3][Further information about the + - Cited Guidance: + IG v3.2[7.4][Assumption 3][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.2[Appendix C1][If the study population is healthy subjects @@ -22,13 +23,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0273 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -45,9 +47,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0273 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -61,9 +63,9 @@ Check: Core: Id: CORE-000562 Status: Published - Version: '1' -Description: 'Raise an error when a record exists in TS where TSPARMCD = - HLTSUBJI and TSVAL = N but TSVAL for TSPARMCD = TDIGRP is empty.' + Version: "1" +Description: "Raise an error when a record exists in TS where TSPARMCD = + HLTSUBJI and TSVAL = N but TSVAL for TSPARMCD = TDIGRP is empty." Executability: Fully Executable Operations: - filter: @@ -74,8 +76,8 @@ Operations: id: $HLTSUBJI_N operator: record_count Outcome: - Message: 'A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = N but - TSVAL for TSPARMCD = TDIGRP is empty.' + Message: "A record exists in TS where TSPARMCD = HLTSUBJI and TSVAL = N but + TSVAL for TSPARMCD = TDIGRP is empty." Output Variables: - TSGRPID - TSPARMCD diff --git a/Deprecated/CORE-000563/rule.yml b/Deprecated/CORE-000563/rule.yml index cf36de2a0..4409da59b 100644 --- a/Deprecated/CORE-000563/rule.yml +++ b/Deprecated/CORE-000563/rule.yml @@ -7,34 +7,36 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0282 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0282 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -49,11 +51,11 @@ Check: Core: Id: CORE-000563 Status: Published - Version: '1' -Description: 'TSVAL must be either Y or N when TSPARMCD is ADAPT' + Version: "1" +Description: "TSVAL must be either Y or N when TSPARMCD is ADAPT" Executability: Fully Executable Outcome: - Message: 'TSVAL must be either Y or N when TSPARMCD is ADAPT' + Message: "TSVAL must be either Y or N when TSPARMCD is ADAPT" Rule Type: Record Data Scope: Classes: diff --git a/Deprecated/CORE-000564/rule.yml b/Deprecated/CORE-000564/rule.yml index 8ced75488..3efec797d 100644 --- a/Deprecated/CORE-000564/rule.yml +++ b/Deprecated/CORE-000564/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0458 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0458 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -47,7 +49,7 @@ Check: Core: Id: CORE-000564 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSPARMCD = INDIC or TSPARMCD = TDIGRP but TSVCDREF is not equal to 'SNOMED'. Executability: Fully Executable diff --git a/Deprecated/CORE-000579/rule.yml b/Deprecated/CORE-000579/rule.yml index 1f5596636..7e1c35c63 100644 --- a/Deprecated/CORE-000579/rule.yml +++ b/Deprecated/CORE-000579/rule.yml @@ -7,48 +7,51 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: In the event that no records are present in a dataset (e.g., a + - Cited Guidance: + In the event that no records are present in a dataset (e.g., a small PK study where no subjects took concomitant medications), the empty dataset should not be submitted and should not be described in the Define-XML document. Document: IG v3.4 - Section: '3.2' + Section: "3.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0408 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: In the event that no records are present in a dataset (e.g., a + - Cited Guidance: + In the event that no records are present in a dataset (e.g., a small PK study where no subjects took concomitant medications); the empty dataset should not be submitted and should not be described in the define.xml document. Document: IG v3.2 - Section: '3.2' + Section: "3.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0408 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: In the event that no records are present in a dataset (e.g., a + - Cited Guidance: + In the event that no records are present in a dataset (e.g., a small PK study where no subjects took concomitant medications); the empty dataset should not be submitted and should not be described in the Define-XML document. Document: IG v3.3 - Section: '3.2' + Section: "3.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0408 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: $records_in_dataset @@ -57,7 +60,7 @@ Check: Core: Id: CORE-000579 Status: Published - Version: '1' + Version: "1" Description: Raise an error when a dataset has no records. Executability: Fully Executable Operations: diff --git a/Deprecated/CORE-000582/rule.yml b/Deprecated/CORE-000582/rule.yml index fb2baca86..50c8b57db 100644 --- a/Deprecated/CORE-000582/rule.yml +++ b/Deprecated/CORE-000582/rule.yml @@ -4,7 +4,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns + - Cited Guidance: + Text over 200 characters can be added to additional columns TSVAL1-TSVALn. Document: IG v3.4 Item: Specification @@ -12,27 +13,29 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0262 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns + - Cited Guidance: + Text over 200 characters can be added to additional columns TSVAL1-TSVALn. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0262 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns + - Cited Guidance: + Text over 200 characters can be added to additional columns TSVAL1-TSVALn. Document: IG v3.3 Item: Specification @@ -40,9 +43,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0262 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" # Variable: TSVALn # Condition: TSVAL(n+1) ^= null # Rule: TSVALn ^= null @@ -53,7 +56,7 @@ Check: Core: Id: CORE-000582 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSVAL(n+1) ^= null and TSVALn = null Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000585/rule.yml b/Deprecated/CORE-000585/rule.yml index 400466733..e782cb96b 100644 --- a/Deprecated/CORE-000585/rule.yml +++ b/Deprecated/CORE-000585/rule.yml @@ -1,5 +1,5 @@ # Variable: GEN -# Condition: +# Condition: # Rule: STUDYID, USUBJID or POOLID, DOMAIN, and --SEQ exist Authorities: - Organization: CDISC @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: STUDYID, DOMAIN, USUBJID (or POOLID), and --SEQ are required in + - Cited Guidance: + STUDYID, DOMAIN, USUBJID (or POOLID), and --SEQ are required in all domains based on one of the three general observation classes. Document: Model v1.4 @@ -15,9 +16,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0313 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: any: - any: @@ -35,7 +36,7 @@ Check: Core: Id: CORE-000585 Status: Published - Version: '1' + Version: "1" Description: Raise an error when one of the following variables; STUDYID, DOMAIN, USUBJID (or POOLID) or --SEQ is not present in the dataset. Executability: Fully Executable @@ -52,7 +53,7 @@ Rule Type: Record Data Scope: Classes: Include: - # Correction 2025-04-15: limit to 3 observational classes + # Correction 2025-04-15: limit to 3 observational classes # This prevents requiring e.g. DMSEQ, RELREC and SUPPxx datasets - INTERVENTIONS - EVENTS diff --git a/Deprecated/CORE-000586/rule.yml b/Deprecated/CORE-000586/rule.yml index aa5064912..6adba0ad0 100644 --- a/Deprecated/CORE-000586/rule.yml +++ b/Deprecated/CORE-000586/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for + - Cited Guidance: + "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' should be presented; and that summaries should be 'grouped by treatment and by major reason.' The CDISC SDS Team interprets this guidance as requiring one @@ -21,9 +22,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0398 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" Check: all: - name: DSCAT @@ -38,13 +39,14 @@ Check: Core: Id: CORE-000586 Status: Published - Version: '1' -Description: 'Raise an error when DSCAT = DISPOSITION EVENT and there is more - than one record per subject for an EPOCH' + Version: "1" +Description: "Raise an error when DSCAT = DISPOSITION EVENT and there is more + than one record per subject for an EPOCH" Executability: Fully Executable Outcome: - Message: 'Multiple records exist within the same EPOCH for a subject when DSCAT - = DISPOSITION EVENT' + Message: + "Multiple records exist within the same EPOCH for a subject when DSCAT + = DISPOSITION EVENT" Output Variables: - DSCAT - EPOCH diff --git a/Deprecated/CORE-000587/rule.yml b/Deprecated/CORE-000587/rule.yml index fcd484e8f..1b6e2ceed 100644 --- a/Deprecated/CORE-000587/rule.yml +++ b/Deprecated/CORE-000587/rule.yml @@ -7,34 +7,36 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0284 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0284 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -50,11 +52,11 @@ Check: Core: Id: CORE-000587 Status: Published - Version: '1' -Description: 'Check that TVAL is an integer > 0 when TSPARMCD is NARMS' + Version: "1" +Description: "Check that TVAL is an integer > 0 when TSPARMCD is NARMS" Executability: Fully Executable Outcome: - Message: 'TSVAL must be an integer greater than zero when TSPARMCD is NARMS' + Message: "TSVAL must be an integer greater than zero when TSPARMCD is NARMS" Output Variables: - TSPARMCD - TSVAL diff --git a/Deprecated/CORE-000655/rule.yml b/Deprecated/CORE-000655/rule.yml index c54b628c8..4b4f6dc45 100644 --- a/Deprecated/CORE-000655/rule.yml +++ b/Deprecated/CORE-000655/rule.yml @@ -10,9 +10,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2501 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -22,9 +22,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2501 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: @@ -34,9 +34,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2501 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: ARMCD @@ -49,7 +49,7 @@ Check: Core: Id: CORE-000655 Status: Published - Version: '1' + Version: "1" Description: Values in ARMCD and ACTARMCD should match Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000656/rule.yml b/Deprecated/CORE-000656/rule.yml index 3ebc21106..f35473d02 100644 --- a/Deprecated/CORE-000656/rule.yml +++ b/Deprecated/CORE-000656/rule.yml @@ -10,9 +10,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2502 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -22,9 +22,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2502 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: @@ -34,9 +34,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2502 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - all: @@ -50,7 +50,7 @@ Check: Core: Id: CORE-000656 Status: Published - Version: '1' + Version: "1" Description: Values in ARM and ACTARM should match Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000657/rule.yml b/Deprecated/CORE-000657/rule.yml index 6c9bbface..bd3d3790f 100644 --- a/Deprecated/CORE-000657/rule.yml +++ b/Deprecated/CORE-000657/rule.yml @@ -2,58 +2,61 @@ # Condition: AEOUT = "NOT RECOVERED/NOT RESOLVED" # Rule: AEENDTC = Null Authorities: - - Organization: 'FDA' + - Organization: "FDA" Standards: - - Name: 'SDTMIG' + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3409' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' + Id: "FB3409" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3409' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' + Id: "FB3409" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3409' - Version: '1' - Version: '1.5' - Version: '3.4' + Id: "FB3409" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: AEOUT operator: equal_to - value: 'NOT RECOVERED/NOT RESOLVED' + value: "NOT RECOVERED/NOT RESOLVED" - name: AEENDTC operator: non_empty Core: Id: CORE-000657 Status: Published - Version: '1' + Version: "1" Description: When Adverse Event Outcome (AEOUT) is populated with 'NOT RECOVERED/NOT RESOLVED', then the End Date/Time of Adverse Event (AEENDTC) should not be populated diff --git a/Deprecated/CORE-000658/rule.yml b/Deprecated/CORE-000658/rule.yml index d490b1aa8..72a10cc9c 100644 --- a/Deprecated/CORE-000658/rule.yml +++ b/Deprecated/CORE-000658/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3412 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3412 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3412 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: RFICDTC @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000658 Status: Published - Version: '1' + Version: "1" Description: Date/Time of Informed Consent (RFICDTC) should be prior or equal to the Date/Time of First Study Treatment (RFXSTDTC). Executability: Fully Executable diff --git a/Deprecated/CORE-000659/rule.yml b/Deprecated/CORE-000659/rule.yml index c15f46318..5a596a5bd 100644 --- a/Deprecated/CORE-000659/rule.yml +++ b/Deprecated/CORE-000659/rule.yml @@ -2,58 +2,61 @@ # Condition: AEOUT = "RECOVERED/RESOLVED" # Rule: AEENDTC <> Null Authorities: - - Organization: 'FDA' + - Organization: "FDA" Standards: - - Name: 'SDTMIG' + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3410' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' + Id: "FB3410" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3410' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' + Id: "FB3410" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and - year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: 'FDA Business Rules' + - Cited Guidance: + "Study start and end date/time should include month, day, and + year." + Document: "FDA" + Section: "FDAB034" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB3410' - Version: '1' - Version: '1.5' - Version: '3.4' + Id: "FB3410" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: AEOUT - operator: 'equal_to' - value: 'RECOVERED/RESOLVED' + operator: "equal_to" + value: "RECOVERED/RESOLVED" - name: AEENDTC operator: empty Core: Id: CORE-000659 Status: Published - Version: '1' + Version: "1" Description: When Adverse Event Outcome (AEOUT) is populated with RECOVERED/RESOLVED, then the End Date/Time of Adverse Event (AEENDTC) should be populated. diff --git a/Deprecated/CORE-000679/rule.yml b/Deprecated/CORE-000679/rule.yml index aa5c5c67a..cb4aeaedf 100644 --- a/Deprecated/CORE-000679/rule.yml +++ b/Deprecated/CORE-000679/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0608 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0608 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0608 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: DTHFL @@ -56,7 +59,7 @@ Check: Core: Id: CORE-000679 Status: Published - Version: '1' + Version: "1" Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then a record should be present in the DS dataset where DSDECOD = 'DEATH' for the corresponding subject. @@ -73,7 +76,8 @@ Operations: name: DSDECOD operator: distinct Outcome: - Message: DTHFL in DM dataset is "Y" but a record is missing in DS dataset where + Message: + DTHFL in DM dataset is "Y" but a record is missing in DS dataset where DSDECOD = "DEATH". Output Variables: - USUBJID diff --git a/Deprecated/CORE-000685/rule.yml b/Deprecated/CORE-000685/rule.yml index 0790b8813..e98541be6 100644 --- a/Deprecated/CORE-000685/rule.yml +++ b/Deprecated/CORE-000685/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -20,13 +21,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0571 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -39,15 +41,16 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0571 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -56,13 +59,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0923 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -71,13 +75,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0923 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -86,9 +91,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0923 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: VISITNUM @@ -109,7 +114,7 @@ Check: Core: Id: CORE-000685 Status: Published - Version: '1' + Version: "1" Description: VISITNUM is present in the dataset and --TPTREF is not present in the dataset then --TPT and --TPTNUM should have a one-to-one relationship per unique value of VISITNUM. diff --git a/Deprecated/CORE-000686/rule.yml b/Deprecated/CORE-000686/rule.yml index 49061e9c8..2cc4ad70a 100644 --- a/Deprecated/CORE-000686/rule.yml +++ b/Deprecated/CORE-000686/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -20,13 +21,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0572 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -39,15 +41,16 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0572 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -56,13 +59,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0924 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -71,13 +75,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0924 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -86,9 +91,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0924 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: VISITNUM @@ -109,7 +114,7 @@ Check: Core: Id: CORE-000686 Status: Published - Version: '1' + Version: "1" Description: VISITNUM not present in dataset and --TPTREF present in dataset then --TPT and --TPTNUM should have a one-to-one relationship per unique values of --TPTREF. diff --git a/Deprecated/CORE-000689/rule.yml b/Deprecated/CORE-000689/rule.yml index 02751e873..277416fa8 100644 --- a/Deprecated/CORE-000689/rule.yml +++ b/Deprecated/CORE-000689/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -20,13 +21,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0573 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may include domain, visit, and reference time point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference @@ -39,15 +41,16 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0573 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -56,13 +59,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0925 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -71,13 +75,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0925 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -86,9 +91,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0925 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: VISITNUM @@ -111,7 +116,7 @@ Check: Core: Id: CORE-000689 Status: Published - Version: '1' + Version: "1" Description: VISITNUM and --TPTREF are present then --TPT and --TPTNUM should have a one-to-one relationship per unique combination of VISITNUM and --TPTREF values. diff --git a/Deprecated/CORE-000701/rule.yml b/Deprecated/CORE-000701/rule.yml index e01bec5f3..5b1000734 100644 --- a/Deprecated/CORE-000701/rule.yml +++ b/Deprecated/CORE-000701/rule.yml @@ -8,7 +8,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: EPOCH should be included for clinical subject-level observations + - Cited Guidance: + EPOCH should be included for clinical subject-level observations (e.g., adverse events, laboratory, concomitant medications, exposure, and vital signs). Document: FDA @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2201 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: EPOCH should be included for clinical subject-level observations + - Cited Guidance: + EPOCH should be included for clinical subject-level observations (e.g., adverse events, laboratory, concomitant medications, exposure, and vital signs). Document: FDA @@ -30,13 +32,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2201 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: EPOCH should be included for clinical subject-level observations + - Cited Guidance: + EPOCH should be included for clinical subject-level observations (e.g., adverse events, laboratory, concomitant medications, exposure, and vital signs). Document: FDA @@ -44,9 +47,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2201 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - name: EPOCH @@ -56,7 +59,7 @@ Check: Core: Id: CORE-000701 Status: Published - Version: '1' + Version: "1" Description: EPOCH should be populated for clinical subject-level observations. Executability: Partially Executable - Possible Overreporting Outcome: diff --git a/Deprecated/CORE-000705/rule.yml b/Deprecated/CORE-000705/rule.yml index 83724a6e0..9ad43b62f 100644 --- a/Deprecated/CORE-000705/rule.yml +++ b/Deprecated/CORE-000705/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0610 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0610 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0610 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: DTHFL @@ -53,7 +56,7 @@ Check: Core: Id: CORE-000705 Status: Published - Version: '1' + Version: "1" Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then Date/Time of Death (DTHDTC)should be populated in the DM dataset for the corresponding subject. diff --git a/Deprecated/CORE-000706/rule.yml b/Deprecated/CORE-000706/rule.yml index 9d12daa75..adfd8e95f 100644 --- a/Deprecated/CORE-000706/rule.yml +++ b/Deprecated/CORE-000706/rule.yml @@ -1,13 +1,14 @@ # Variable: --LLT, --LLTCD # Condition: -# Rule: --LLTCD and --LLT have a one-to-one relationship +# Rule: --LLTCD and --LLT have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0906 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0906 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0906 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --LLT @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000706 Status: Published - Version: '1' + Version: "1" Description: --LLTCD and --LLT should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000709/rule.yml b/Deprecated/CORE-000709/rule.yml index 6a3cd17bc..d45883896 100644 --- a/Deprecated/CORE-000709/rule.yml +++ b/Deprecated/CORE-000709/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0607 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0607 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0607 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - any: @@ -62,7 +65,7 @@ Check: Core: Id: CORE-000709 Status: Published - Version: '1' + Version: "1" Description: When a record is present in the CE dataset where CETERM or CEDECOD = 'DEATH' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. @@ -72,7 +75,8 @@ Match Datasets: - USUBJID Name: CE Outcome: - Message: CETERM or CEDECOD is 'DEATH' in CE dataset, but DTHFL in DM dataset is + Message: + CETERM or CEDECOD is 'DEATH' in CE dataset, but DTHFL in DM dataset is not "Y". Output Variables: - CETERM diff --git a/Deprecated/CORE-000713/rule.yml b/Deprecated/CORE-000713/rule.yml index 119ed7db3..5183af6ae 100644 --- a/Deprecated/CORE-000713/rule.yml +++ b/Deprecated/CORE-000713/rule.yml @@ -7,29 +7,31 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3411 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3411 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: RFICDTC @@ -42,7 +44,7 @@ Check: Core: Id: CORE-000713 Status: Published - Version: '1' + Version: "1" Description: Date/Time of Informed Consent (RFICDTC) should be prior or equal to the Subject Reference Start Date/Time (RFSTDTC). Executability: Fully Executable diff --git a/Deprecated/CORE-000716/rule.yml b/Deprecated/CORE-000716/rule.yml index 154e2fb8d..f1c3e030f 100644 --- a/Deprecated/CORE-000716/rule.yml +++ b/Deprecated/CORE-000716/rule.yml @@ -1,13 +1,14 @@ # Variable: --SOC, -SOCCD # Condition: -# Rule: --SOCCD and --SOC have a one-to-one relationship +# Rule: --SOCCD and --SOC have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0911 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0911 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0911 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --SOC @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000716 Status: Published - Version: '1' + Version: "1" Description: --SOCCD and --SOC should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000717/rule.yml b/Deprecated/CORE-000717/rule.yml index b9cbbf334..a6e769f28 100644 --- a/Deprecated/CORE-000717/rule.yml +++ b/Deprecated/CORE-000717/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3401 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3401 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3401 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: AESTDTC @@ -53,7 +56,7 @@ Check: Core: Id: CORE-000717 Status: Published - Version: '1' + Version: "1" Description: Start Date/Time of Adverse Event (AESTDTC) should be prior or equal to the Start Date/Time of the latest Disposition Event (DSSTDTC). Executability: Fully Executable diff --git a/Deprecated/CORE-000719/rule.yml b/Deprecated/CORE-000719/rule.yml index c6899a713..bd3a549f4 100644 --- a/Deprecated/CORE-000719/rule.yml +++ b/Deprecated/CORE-000719/rule.yml @@ -1,13 +1,14 @@ # Variable: --HLGT, --HLGTCD # Condition: -# Rule: --HLGTCD and --HLGT have a one-to-one relationship +# Rule: --HLGTCD and --HLGT have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0908 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0908 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0908 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --HLGT @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000719 Status: Published - Version: '1' + Version: "1" Description: --HLGTCD and --HLGT should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000720/rule.yml b/Deprecated/CORE-000720/rule.yml index 9d36a6b67..abe258a57 100644 --- a/Deprecated/CORE-000720/rule.yml +++ b/Deprecated/CORE-000720/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3406 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3406 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3406 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --DTC @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000720 Status: Published - Version: '1' + Version: "1" Description: Date/Time of Collection (--DTC) variable value should be prior or equal to Date/Time of End of Participation (RFPENDTC). Executability: Fully Executable diff --git a/Deprecated/CORE-000723/rule.yml b/Deprecated/CORE-000723/rule.yml index 66fba2547..8f5567f00 100644 --- a/Deprecated/CORE-000723/rule.yml +++ b/Deprecated/CORE-000723/rule.yml @@ -1,13 +1,14 @@ # Variable: --HLT, --HLTCD # Condition: -# Rule: --HLTCD and --HLT have a one-to-one relationship +# Rule: --HLTCD and --HLT have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0907 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0907 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0907 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --HLT @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000723 Status: Published - Version: '1' + Version: "1" Description: --HLTCD and --HLT should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000726/rule.yml b/Deprecated/CORE-000726/rule.yml index 8b07cde86..ae5a8fd0f 100644 --- a/Deprecated/CORE-000726/rule.yml +++ b/Deprecated/CORE-000726/rule.yml @@ -8,7 +8,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial + - Cited Guidance: + 'When collecting ethnicity demographic data from clinical trial participants, the following two minimum choices should be offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"' Document: FDA @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5701 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial + - Cited Guidance: + 'When collecting ethnicity demographic data from clinical trial participants, the following two minimum choices should be offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"' Document: FDA @@ -30,13 +32,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5701 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: 'When collecting ethnicity demographic data from clinical trial + - Cited Guidance: + 'When collecting ethnicity demographic data from clinical trial participants, the following two minimum choices should be offered: "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO"' Document: FDA @@ -44,9 +47,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5701 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - all: @@ -74,7 +77,7 @@ Check: Core: Id: CORE-000726 Status: Published - Version: '1' + Version: "1" Description: When Ethnicity was collected and it was not mapped as "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO". Executability: Partially Executable @@ -83,7 +86,8 @@ Match Datasets: - USUBJID Name: SUPPDM Outcome: - Message: Ethnicity has been collected but the values is not mapped to "HISPANIC + Message: + Ethnicity has been collected but the values is not mapped to "HISPANIC OR LATINO" or "NOT HISPANIC OR LATINO" Output Variables: - ETHNIC diff --git a/Deprecated/CORE-000728/rule.yml b/Deprecated/CORE-000728/rule.yml index f00157656..aba989ab8 100644 --- a/Deprecated/CORE-000728/rule.yml +++ b/Deprecated/CORE-000728/rule.yml @@ -1,13 +1,14 @@ # Variable: TSVAL, TSVALCD # Condition: TSVCDREF ^= null -# Rule: TSVALCD and TSVAL have a one-to-one relationship +# Rule: TSVALCD and TSVAL have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0904 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0904 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0904 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: TSVCDREF @@ -65,7 +68,7 @@ Check: Core: Id: CORE-000728 Status: Published - Version: '1' + Version: "1" Description: TSVALCD and TSVAL should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000729/rule.yml b/Deprecated/CORE-000729/rule.yml index 9390ac87b..7bed00037 100644 --- a/Deprecated/CORE-000729/rule.yml +++ b/Deprecated/CORE-000729/rule.yml @@ -1,13 +1,14 @@ # Variable: INVID, INVNAM # Condition: -# Rule: INVNAM and INVID have a one-to-one relationship +# Rule: INVNAM and INVID have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0912 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0912 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0912 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: INVID @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000729 Status: Published - Version: '1' + Version: "1" Description: INVID and INVNAM shoumd have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000730/rule.yml b/Deprecated/CORE-000730/rule.yml index 29663eb2d..bc92122af 100644 --- a/Deprecated/CORE-000730/rule.yml +++ b/Deprecated/CORE-000730/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0438 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0438 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -47,12 +49,12 @@ Check: Core: Id: CORE-000730 Status: Published - Version: '1' -Description: 'When TSPARMCD is equal to AGEMIN and TSVAL is not null, TSVAL - should conform to ISO 8601' + Version: "1" +Description: "When TSPARMCD is equal to AGEMIN and TSVAL is not null, TSVAL + should conform to ISO 8601" Executability: Fully Executable Outcome: - Message: 'TSVAL does not conform to ISO 8601' + Message: "TSVAL does not conform to ISO 8601" Output Variables: - TSVAL - TSPARMCD diff --git a/Deprecated/CORE-000731/rule.yml b/Deprecated/CORE-000731/rule.yml index 17540f7c3..8c116f164 100644 --- a/Deprecated/CORE-000731/rule.yml +++ b/Deprecated/CORE-000731/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0439 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0439 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD @@ -47,12 +49,12 @@ Check: Core: Id: CORE-000731 Status: Published - Version: '1' -Description: 'When TSPARMCD = LENGTH and TSVAL ^= NULL, TSVAL needs to conform - to ISO 8601 time period' + Version: "1" +Description: "When TSPARMCD = LENGTH and TSVAL ^= NULL, TSVAL needs to conform + to ISO 8601 time period" Executability: Fully Executable Outcome: - Message: 'TSVAL is not NULL and does not conform to ISO 8601 time period' + Message: "TSVAL is not NULL and does not conform to ISO 8601 time period" Output Variables: - TSVAL - TSPARMCD diff --git a/Deprecated/CORE-000733/rule.yml b/Deprecated/CORE-000733/rule.yml index b019dc3d5..851a7dc63 100644 --- a/Deprecated/CORE-000733/rule.yml +++ b/Deprecated/CORE-000733/rule.yml @@ -7,27 +7,29 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: '|IG v3.2[Appendix C1][Further information about the parameters + - Cited Guidance: + "|IG v3.2[Appendix C1][Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD]|IG v3.2[Appendix C1][Required only when there is only one investigational treatment. The value is always a number between 0 and 1. There are cases where the ratio is 1 (e.g., crossover study or open label study where all subjects are - exposed to investigational therapy).]' + exposed to investigational therapy).]" Document: IG v3.2 Item: IG v3.2[7.4][Assumption 3]|IG v3.2[Appendix C1] Section: IG v3.2[7.4]|IG v3.2[Appendix C1] Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0281 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.4.2][Assumption 3][Further information about the + - Cited Guidance: + IG v3.3[7.4.2][Assumption 3][Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in @@ -43,9 +45,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0281 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: any: - name: $trt_count @@ -61,9 +63,9 @@ Check: Core: Id: CORE-000733 Status: Published - Version: '1' -Description: 'At least one observation where TSPARMCD = TRT is present and there - is only one investigational treatment' + Version: "1" +Description: "At least one observation where TSPARMCD = TRT is present and there + is only one investigational treatment" Executability: Fully Executable Operations: - domain: TS @@ -79,7 +81,7 @@ Operations: name: TSPARMCD operator: record_count Outcome: - Message: 'TSPARMCD = RANDQT record is not present' + Message: "TSPARMCD = RANDQT record is not present" Output Variables: - TSPARMCD - $trt_count diff --git a/Deprecated/CORE-000735/rule.yml b/Deprecated/CORE-000735/rule.yml index 92dd35963..2886f11d6 100644 --- a/Deprecated/CORE-000735/rule.yml +++ b/Deprecated/CORE-000735/rule.yml @@ -7,33 +7,35 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'Further information about the parameters is included below in + - Cited Guidance: + "Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD' + on the value of TSPARMCD" Document: SDTM and SDTMIG Conformance Rules v2.0 Item: Assumption 3 - Section: '7.4' - Origin: 'SDTM and SDTMIG Conformance Rules' + Section: "7.4" + Origin: "SDTM and SDTMIG Conformance Rules" Rule Identifier: - Id: 'CG0444' - Version: '1' - Version: '2.0' - Version: '3.2' + Id: "CG0444" + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: 'Further information about the parameters is included below in + - Cited Guidance: + "Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending - on the value of TSPARMCD' + on the value of TSPARMCD" Document: SDTM and SDTMIG Conformance Rules v2.0 Item: Assumption 3 - Section: '7.4' - Origin: 'SDTM and SDTMIG Conformance Rules' + Section: "7.4" + Origin: "SDTM and SDTMIG Conformance Rules" Rule Identifier: - Id: 'CG0444' - Version: '1' - Version: '2.0' - Version: '3.3' + Id: "CG0444" + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - any: @@ -48,17 +50,17 @@ Check: value: TRT - name: TSVCDREF operator: not_equal_to - value: 'UNII' + value: "UNII" Core: Id: CORE-000735 Status: Published - Version: '1' -Description: 'When TSPARMCD is equal to COMPTRT, CURTRT or TRT, TSVCDREF should equal UNII' + Version: "1" +Description: "When TSPARMCD is equal to COMPTRT, CURTRT or TRT, TSVCDREF should equal UNII" Executability: Fully Executable Outcome: - Message: 'Throw error when TSPARMCD is equal to COMPTRT, CURTRT, or TRT and - TSVCDREF ^= UNII' + Message: "Throw error when TSPARMCD is equal to COMPTRT, CURTRT, or TRT and + TSVCDREF ^= UNII" Output Variables: - TSPARMCD - TSVCDREF diff --git a/Deprecated/CORE-000739/rule.yml b/Deprecated/CORE-000739/rule.yml index bb5730bb6..0fcc670aa 100644 --- a/Deprecated/CORE-000739/rule.yml +++ b/Deprecated/CORE-000739/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: The EX domain is required for all studies that include + - Cited Guidance: + The EX domain is required for all studies that include protocol-specified study treatment. Document: IG v3.4 Item: Assumption 1c @@ -15,26 +16,28 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0407 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: The EX domain is required for all studies that include + - Cited Guidance: + The EX domain is required for all studies that include protocol-specified study treatment. Document: IG v3.2 - Section: '6.1' + Section: "6.1" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0407 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: The EX domain is required for all studies that include + - Cited Guidance: + The EX domain is required for all studies that include protocol-specified study treatment. Document: IG v3.3 Item: Assumption 1.c @@ -42,9 +45,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0407 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: EX @@ -52,12 +55,13 @@ Check: Core: Id: CORE-000739 Status: Published - Version: '1' + Version: "1" Description: Trigger error when study includes protocol-specified study treatment and EX is not present Executability: Fully Executable Outcome: - Message: EX is not present in study when study includes protocol-specified study + Message: + EX is not present in study when study includes protocol-specified study treatment Rule Type: Domain Presence Check Scope: diff --git a/Deprecated/CORE-000740/rule.yml b/Deprecated/CORE-000740/rule.yml index 59a895f24..b6ad6c15f 100644 --- a/Deprecated/CORE-000740/rule.yml +++ b/Deprecated/CORE-000740/rule.yml @@ -1,5 +1,5 @@ # Variable: GEN -# Condition: +# Condition: # Rule: A set of records exist with at least one record with TSPARMCD equal to each of the required values in the list of Trial Summary Codes in Appendix C1 Authorities: - Organization: CDISC @@ -7,74 +7,76 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included below in + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL may have controlled terminology depending on the value of TSPARMCD Document: IG v3.2 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0287 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Further information about the parameters is included Appendix + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. Conditions for including parameters are included in Appendix C1, Trial Summary Codes. Document: IG v3.3 Item: Assumption 3 - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0287 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSPARMCD operator: not_contains_all value: - - 'ADDON' - - 'AGEMAX' - - 'AGEMIN' - - 'LENGTH' - - 'PLANSUB' - - 'RANDOM' - - 'SEXPOP' - - 'STOPRULE' - - 'TBLIND' - - 'TCNTRL' - - 'TITLE' - - 'TPHASE' - - 'TTYPE' - - 'OBJPRIM' - - 'SPONSOR' - - 'REGID' - - 'OUTMSPRI' - - 'FCNTRY' - - 'ADAPT' - - 'DCUTDTC' - - 'DCUTDESC' - - 'NARMS' - - 'STYPE' - - 'SSTDTC' - - 'SENDTC' - - 'ACTSUB' - - 'HLTSUBJI' + - "ADDON" + - "AGEMAX" + - "AGEMIN" + - "LENGTH" + - "PLANSUB" + - "RANDOM" + - "SEXPOP" + - "STOPRULE" + - "TBLIND" + - "TCNTRL" + - "TITLE" + - "TPHASE" + - "TTYPE" + - "OBJPRIM" + - "SPONSOR" + - "REGID" + - "OUTMSPRI" + - "FCNTRY" + - "ADAPT" + - "DCUTDTC" + - "DCUTDESC" + - "NARMS" + - "STYPE" + - "SSTDTC" + - "SENDTC" + - "ACTSUB" + - "HLTSUBJI" Core: Id: CORE-000740 Status: Published - Version: '1' -Description: 'A required value of TSPARMCD is not found' + Version: "1" +Description: "A required value of TSPARMCD is not found" Executability: Fully Executable Outcome: - Message: 'A required value of TSPARMCD is not found' + Message: "A required value of TSPARMCD is not found" Output Variables: - TSPARMCD Rule Type: Record Data diff --git a/Deprecated/CORE-000741/rule.yml b/Deprecated/CORE-000741/rule.yml index 2b20601a1..99fc5fbec 100644 --- a/Deprecated/CORE-000741/rule.yml +++ b/Deprecated/CORE-000741/rule.yml @@ -1,42 +1,42 @@ Authorities: - - Organization: 'FDA' + - Organization: "FDA" Standards: - - Name: 'SDTMIG' + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1111' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' + Id: "FB1111" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1111' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' + Id: "FB1111" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1111' - Version: '1' - Version: '1.5' - Version: '3.4' + Id: "FB1111" + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - name: TSPARMCD @@ -69,7 +69,7 @@ Check: value: 1 Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000741 Description: The set ('INTMODEL’, 'INTTYPE','PCLASS') is not in the list of TSPARAMCD with TSVAL populated. diff --git a/Deprecated/CORE-000742/rule.yml b/Deprecated/CORE-000742/rule.yml index 9d87adc75..824719393 100644 --- a/Deprecated/CORE-000742/rule.yml +++ b/Deprecated/CORE-000742/rule.yml @@ -1,45 +1,45 @@ Authorities: - - Organization: 'FDA' + - Organization: "FDA" Standards: - - Name: 'SDTMIG' + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1110' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' + Id: "FB1110" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1110' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' + Id: "FB1110" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB1110' - Version: '1' - Version: '1.5' - Version: '3.4' + Id: "FB1110" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: '$HLTSUBJI' + - name: "$HLTSUBJI" operator: equal_to value: 1 - name: $INDIC @@ -47,9 +47,9 @@ Check: value: 1 Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000742 -Description: 'TSVALNF is not equal to NA when TSPARAMCD=INDIC' +Description: "TSVALNF is not equal to NA when TSPARAMCD=INDIC" Executability: Fully Executable Operations: - filter: @@ -63,7 +63,7 @@ Operations: id: $HLTSUBJI operator: record_count Outcome: - Message: 'TSVALNF is not equal to NA when TSPARAMCD=INDIC' + Message: "TSVALNF is not equal to NA when TSPARAMCD=INDIC" Output Variables: - TSPARMCD - TSVAL diff --git a/Deprecated/CORE-000743/rule.yml b/Deprecated/CORE-000743/rule.yml index af0594e24..f1cbbf19b 100644 --- a/Deprecated/CORE-000743/rule.yml +++ b/Deprecated/CORE-000743/rule.yml @@ -1,13 +1,14 @@ # Variable: IETEST, IETESTCD # Condition: -# Rule: IETESTCD and IETEST have a one-to-one relationship +# Rule: IETESTCD and IETEST have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0918 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0918 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0918 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: IETEST @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000743 Status: Published - Version: '1' + Version: "1" Description: IETESTCD and IETEST should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000745/rule.yml b/Deprecated/CORE-000745/rule.yml index f60bb2b28..0026cc3f4 100644 --- a/Deprecated/CORE-000745/rule.yml +++ b/Deprecated/CORE-000745/rule.yml @@ -1,13 +1,14 @@ # Variable: OIPARM, OIPARMCD # Condition: -# Rule: OIPARMCD and OIPARM have a one-to-one relationship +# Rule: OIPARMCD and OIPARM have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0915 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0915 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0915 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: OIPARM @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000745 Status: Published - Version: '1' + Version: "1" Description: OIPARMCD and OIPARM should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000746/rule.yml b/Deprecated/CORE-000746/rule.yml index 3025da563..c2715afc3 100644 --- a/Deprecated/CORE-000746/rule.yml +++ b/Deprecated/CORE-000746/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data. + - Cited Guidance: + The term "Spanish origin" can be used to collect ethnicity data. If the term "Spanish origin" is collected, it should be mapped to the controlled terminology "HISPANIC OR LATINO" for submission. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5801 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data. + - Cited Guidance: + The term "Spanish origin" can be used to collect ethnicity data. If the term "Spanish origin" is collected, it should be mapped to the controlled terminology "HISPANIC OR LATINO" for submission. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5801 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Spanish origin" can be used to collect ethnicity data. + - Cited Guidance: + The term "Spanish origin" can be used to collect ethnicity data. If the term "Spanish origin" is collected, it should be mapped to the controlled terminology "HISPANIC OR LATINO" for submission. @@ -46,26 +49,26 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB5801 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: ETHNIC operator: non_empty - name: ETHNIC operator: not_equal_to - value: 'HISPANIC OR LATINO' + value: "HISPANIC OR LATINO" - name: QNAM operator: equal_to value: CETHNIC - name: QVAL operator: equal_to - value: 'SPANISH ORIGIN' + value: "SPANISH ORIGIN" Core: Id: CORE-000746 Status: Published - Version: '1' + Version: "1" Description: When ethnicity term 'Spanish origin' is collected (SUPPDM.CETHNIC), it should be mapped to Ethnicity (ETHNIC) 'HISPANIC OR LATINO' in the DM dataset diff --git a/Deprecated/CORE-000747/rule.yml b/Deprecated/CORE-000747/rule.yml index fb3775697..0a647242e 100644 --- a/Deprecated/CORE-000747/rule.yml +++ b/Deprecated/CORE-000747/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the + - Cited Guidance: + The term "Hatian or Negro" can be used collect race data. If the term "Hatian or Negro" is collected, it should be mapped to the controlled terminology "BLACK OR AFRICAN AMERICAN" for submission. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB6001 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the + - Cited Guidance: + The term "Hatian or Negro" can be used collect race data. If the term "Hatian or Negro" is collected, it should be mapped to the controlled terminology "BLACK OR AFRICAN AMERICAN" for submission. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB6001 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: The term "Hatian or Negro" can be used collect race data. If the + - Cited Guidance: + The term "Hatian or Negro" can be used collect race data. If the term "Hatian or Negro" is collected, it should be mapped to the controlled terminology "BLACK OR AFRICAN AMERICAN" for submission. @@ -46,26 +49,26 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB6001 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: RACE operator: non_empty - name: RACE operator: not_equal_to - value: 'BLACK OR AFRICAN AMERICAN' + value: "BLACK OR AFRICAN AMERICAN" - name: QNAM operator: equal_to value: CRACE - name: QVAL operator: equal_to - value: 'HATIAN or NEGRO' + value: "HATIAN or NEGRO" Core: Id: CORE-000747 Status: Published - Version: '1' + Version: "1" Description: When Race Term 'Haitian' or 'Negro' (SUPPDM.CRACE) is collected, it should be mapped to Race (RACE) 'BLACK OR AFRICAN AMERICAN' in the DM dataset. Executability: Fully Executable diff --git a/Deprecated/CORE-000761/rule.yml b/Deprecated/CORE-000761/rule.yml index 96a011745..7b4172bb1 100644 --- a/Deprecated/CORE-000761/rule.yml +++ b/Deprecated/CORE-000761/rule.yml @@ -13,22 +13,22 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0289 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - Cited Guidance: The version number of the Reference Terminology, if applicable. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0289 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: @@ -39,9 +39,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0289 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TSVCDREF @@ -53,7 +53,7 @@ Check: Core: Id: CORE-000761 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TSVCDREF = 'CDISC' and TSVCDVER is not a valid published version (date) Executability: Fully Executable diff --git a/Deprecated/CORE-000766/rule.yml b/Deprecated/CORE-000766/rule.yml index 1278d67f8..45a5c63c1 100644 --- a/Deprecated/CORE-000766/rule.yml +++ b/Deprecated/CORE-000766/rule.yml @@ -7,19 +7,20 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and + - Cited Guidance: + When findings are collected about an event or intervention, and the name of the event or intervention is collected in an "Other, specify" CRF field, the value in --OBJ variable depends on whether the FA record has a parent record and whether the "Other, specify" value was coded. Document: IG v3.4 - Section: '4.2.7.4' + Section: "4.2.7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0601 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - name: --DECOD @@ -30,9 +31,9 @@ Check: Core: Id: CORE-000766 Status: Published - Version: '1' -Description: 'When findings are collected, and the Events parent record exists - and --DECOD is null, FAOBJ should not be equal to --TERM' + Version: "1" +Description: "When findings are collected, and the Events parent record exists + and --DECOD is null, FAOBJ should not be equal to --TERM" Executability: Fully Executable Match Datasets: - Name: RELREC diff --git a/Deprecated/CORE-000767/rule.yml b/Deprecated/CORE-000767/rule.yml index 26b1535be..c9b5ed488 100644 --- a/Deprecated/CORE-000767/rule.yml +++ b/Deprecated/CORE-000767/rule.yml @@ -7,19 +7,20 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and + - Cited Guidance: + When findings are collected about an event or intervention, and the name of the event or intervention is collected in an "Other, specify" CRF field, the value in --OBJ variable depends on whether the FA record has a parent record and whether the "Other, specify" value was coded. Document: IG v3.4 - Section: '4.2.7.4' + Section: "4.2.7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0603 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - name: --DECOD @@ -30,15 +31,16 @@ Check: Core: Id: CORE-000767 Status: Published - Version: '1' -Description: 'When findings are collected, and the parent record exists and - --DECOD is not null, FAOBJ should not be equal to --DECOD' + Version: "1" +Description: "When findings are collected, and the parent record exists and + --DECOD is not null, FAOBJ should not be equal to --DECOD" Executability: Fully Executable Match Datasets: - Name: RELREC Wildcard: FA Outcome: - Message: Parent record exists and --DECOD is not null, but FAOBJ is not equal to + Message: + Parent record exists and --DECOD is not null, but FAOBJ is not equal to --DECOD. Output Variables: - RELREC.FAOBJ diff --git a/Deprecated/CORE-000777/rule.yml b/Deprecated/CORE-000777/rule.yml index 128c5afe1..bc8d5ba27 100644 --- a/Deprecated/CORE-000777/rule.yml +++ b/Deprecated/CORE-000777/rule.yml @@ -5,29 +5,31 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0502 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: The temporal relationship of the observation to the Disease + - Cited Guidance: + The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Document: Model v2.0 Item: RELMIDS Section: Timing - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0502 - Version: '2' - Version: '2.0' + Version: "2" + Version: "2.0" Citations: - - Cited Guidance: 'The temporal relationship of the observation to the Disease + - Cited Guidance: + 'The temporal relationship of the observation to the Disease Milestone Instance Name in MIDS. Examples: "IMMEDIATELY BEFORE", "AT TIME OF", "AFTER".' Document: Model v1.7 @@ -43,7 +45,7 @@ Check: Core: Id: CORE-000777 Status: Published - Version: '1' + Version: "1" Description: Raise an error when variable RELMIDS is present in any of the dataset and TM dataset is missing in a study. Executability: Fully Executable diff --git a/Deprecated/CORE-000778/rule.yml b/Deprecated/CORE-000778/rule.yml index d116715d0..f7e4f88eb 100644 --- a/Deprecated/CORE-000778/rule.yml +++ b/Deprecated/CORE-000778/rule.yml @@ -5,30 +5,32 @@ Authorities: - Organization: CDISC Standards: - Name: SDTMIG - Version: '3.4' + Version: "3.4" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0650 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The nomenclature would include the additional one-to-two characters used to identify the split dataset. Document: IG v3.4 - Item: '7' + Item: "7" Section: 4.1.7 - Name: SDTMIG - Version: '3.2' + Version: "3.2" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0650 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: AP Guide v1.0[2][Associated Persons datasets are given a prefix + - Cited Guidance: + AP Guide v1.0[2][Associated Persons datasets are given a prefix of AP-- to identify the data as AP data to and distinguish them from study subject data.]|IG v3.2[4.1.1.7][Item 6][For example, if splitting by --CAT, then dataset names would be @@ -38,15 +40,16 @@ Authorities: Item: AP Guide v1.0[Section 2][Bullet 1]|IG v3.2[4.1.1.7][Item 6] Section: 2|4.1.1.7 - Name: SDTMIG - Version: '3.3' + Version: "3.3" References: - Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0650 - Version: '1' - Version: '2.0' + Version: "1" + Version: "2.0" Citations: - - Cited Guidance: AP Guide v1.0[2][Associated Persons datasets are given a prefix + - Cited Guidance: + AP Guide v1.0[2][Associated Persons datasets are given a prefix of AP-- to identify the data as AP data to and distinguish them from study subject data.]|IG v3.3[4.1.7][Item 6][For example, if splitting by --CAT, then dataset names would be @@ -66,13 +69,14 @@ Check: Core: Id: CORE-000778 Status: Published - Version: '1' + Version: "1" Description: When an Associated Persons non-supplemental qualifier dataset is associated with a split dataset, the dataset name length must be greater than 4 and less than, or equal to, 6. Executability: Fully Executable Outcome: - Message: Associated Persons non-supplemental qualifier dataset associated with a + Message: + Associated Persons non-supplemental qualifier dataset associated with a split dataset does not have a dataset name with a length greater than 4 and less than, or equal to, 6. Rule Type: Dataset Metadata Check diff --git a/Deprecated/CORE-000779/rule.yml b/Deprecated/CORE-000779/rule.yml index 277e8c58f..47e7d2a17 100644 --- a/Deprecated/CORE-000779/rule.yml +++ b/Deprecated/CORE-000779/rule.yml @@ -1,5 +1,5 @@ # Variable: TDSTOFF -# Condition: +# Condition: # Rule: TDSTOFF = 0 or positive value in ISO 8601 Duration format Authorities: - Organization: CDISC @@ -7,25 +7,27 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: 'A fixed offset from the date provided by the variable + - Cited Guidance: + "A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this variable will be either zero or a positive value and will be - represented in ISO 8601 character format. ' + represented in ISO 8601 character format. " Document: IG v3.4 Item: Specification Section: 7.3.2 Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0376 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[7.3][A fixed offset from the date provided by the + - Cited Guidance: + IG v3.2[7.3][A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this @@ -42,13 +44,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0376 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[7.3][A fixed offset from the date provided by the + - Cited Guidance: + IG v3.3[7.3][A fixed offset from the date provided by the variable referenced in TDANCVAR. This is used when the timing of planned cycles does not start on the exact day referenced in the variable indicated in TDANCVAR. The value of this @@ -65,9 +68,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0376 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: TDSTOFF @@ -79,7 +82,7 @@ Check: Core: Id: CORE-000779 Status: Published - Version: '1' + Version: "1" Description: TDSTOFF must be equal to 0 or a positive value in ISO 8601 Duration format Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000787/rule.yml b/Deprecated/CORE-000787/rule.yml index 56102f013..e3bb2601e 100644 --- a/Deprecated/CORE-000787/rule.yml +++ b/Deprecated/CORE-000787/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: While it would be possible to allow a value such as NONE or + - Cited Guidance: + While it would be possible to allow a value such as NONE or UNBOUNDED to be entered in TSVAL, validation programs would then have to recognize this special term as an exception to the expected data format. Therefore, it was decided that a @@ -18,13 +19,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0291 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: While it would be possible to allow a value such as NONE or + - Cited Guidance: + While it would be possible to allow a value such as NONE or UNBOUNDED to be entered in TSVAL, validation programs would then have to recognize this special term as an exception to the expected data format. Therefore, it was decided that a @@ -35,13 +37,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0291 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: While it would be possible to allow a value such as NONE or + - Cited Guidance: + While it would be possible to allow a value such as NONE or UNBOUNDED to be entered in TSVAL, validation programs would then have to recognize this special term as an exception to the expected data format. Therefore, it was decided that a @@ -52,9 +55,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0291 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: TSVALNF @@ -69,7 +72,7 @@ Check: Core: Id: CORE-000787 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSVALNF is empty and TSVAL is populated with values or synonyms of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null flavors) diff --git a/Deprecated/CORE-000790/rule.yml b/Deprecated/CORE-000790/rule.yml index 76c470612..e83d7daec 100644 --- a/Deprecated/CORE-000790/rule.yml +++ b/Deprecated/CORE-000790/rule.yml @@ -13,9 +13,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB2505 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" Check: all: - name: ARM @@ -33,7 +33,7 @@ Check: Core: Id: "CORE-000790" Status: Published - Version: '1' + Version: "1" Description: If a subject is assigned to an arm, the subject should have a record in EX. Executability: Partially Executable Operations: diff --git a/Deprecated/CORE-000792/rule.yml b/Deprecated/CORE-000792/rule.yml index 0bb3f3766..7b8199ca8 100644 --- a/Deprecated/CORE-000792/rule.yml +++ b/Deprecated/CORE-000792/rule.yml @@ -1,13 +1,14 @@ # Variable: --CLAS, --CLASCD # Condition: -# Rule: --CLASCD and --CLAS have a one-to-one relationship +# Rule: --CLASCD and --CLAS have a one-to-one relationship Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -16,13 +17,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0905 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -31,13 +33,14 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0905 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include short name and name of test; parameter name and parameter code or number; variable name and variable label, etc. @@ -46,9 +49,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB0905 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --CLAS @@ -61,7 +64,7 @@ Check: Core: Id: CORE-000792 Status: Published - Version: '1' + Version: "1" Description: --CLASCD and --CLAS should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000841/rule.yml b/Deprecated/CORE-000841/rule.yml index d9a32350c..02f5757c0 100644 --- a/Deprecated/CORE-000841/rule.yml +++ b/Deprecated/CORE-000841/rule.yml @@ -7,54 +7,57 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0612 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0612 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0612 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: AEOUT operator: equal_to - value: 'FATAL' + value: "FATAL" - name: AEENDTC operator: not_equal_to value: DTHDTC Core: Id: CORE-000841 Status: Published - Version: '1' + Version: "1" Description: End Date/Time of Adverse Event (AEENDTC) in AE dataset of Adverse Event where AEOUT = 'FATAL' should be equal to the Date/Time of Death (DTHDTC) in the DM dataset for the corresponding subject. diff --git a/Deprecated/CORE-000842/rule.yml b/Deprecated/CORE-000842/rule.yml index a38fad3ca..e90e8888e 100644 --- a/Deprecated/CORE-000842/rule.yml +++ b/Deprecated/CORE-000842/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: "The method for deriving these values should be consistent with + - Cited Guidance: + "The method for deriving these values should be consistent with the visit definitions in the Trial Visits dataset [see Section '7.3 - Schedule for Assessments: Trial Visits (TV)']." Document: IG v3.2 @@ -16,24 +17,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0213 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: The method for deriving these values should be consistent with + - Cited Guidance: + The method for deriving these values should be consistent with the visit definitions in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). Document: IG v3.3 Item: Description - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0213 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - any: @@ -47,7 +49,7 @@ Check: Core: Id: CORE-000842 Status: Published - Version: '1' + Version: "1" Description: When SVUPDES is not populated, then the VISITNUM should be equal to a VISITNUM in TV Executability: Partially Executable - Possible Overreporting diff --git a/Deprecated/CORE-000843/rule.yml b/Deprecated/CORE-000843/rule.yml index dc78b64d9..844396712 100644 --- a/Deprecated/CORE-000843/rule.yml +++ b/Deprecated/CORE-000843/rule.yml @@ -7,7 +7,8 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: "Records for unplanned visits should be included in the SV + - Cited Guidance: + "Records for unplanned visits should be included in the SV dataset. For unplanned visits, SVUPDES should be populated with a description of the reason for the unplanned visit. Some judgment may be required to determine what constitutes an @@ -28,13 +29,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0214 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Records for unplanned visits should be included in the SV + - Cited Guidance: + Records for unplanned visits should be included in the SV dataset. For unplanned visits, SVUPDES should be populated with a description of the reason for the unplanned visit. Some judgment may be required to determine what constitutes an @@ -51,13 +53,13 @@ Authorities: visit variables for unplanned visits. Document: IG v3.3 Item: Assumption 3 - Section: '5.5' + Section: "5.5" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0214 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: SVUPDES @@ -68,7 +70,7 @@ Check: Core: Id: CORE-000843 Status: Published - Version: '1' + Version: "1" Description: When SVUPDES is populated, then the VISITNUM should not be equal to a VISITNUM in TV Executability: Fully Executable diff --git a/Deprecated/CORE-000844/rule.yml b/Deprecated/CORE-000844/rule.yml index da5a7b446..045611a82 100644 --- a/Deprecated/CORE-000844/rule.yml +++ b/Deprecated/CORE-000844/rule.yml @@ -1,4 +1,4 @@ -# Variable: +# Variable: # Condition: RACE = MULTIPLE # Rule: Multiple SUPPDM.QNAM records exist for the subject Authorities: @@ -7,33 +7,35 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' and the additional information will be included in the Supplemental Qualifiers dataset. Document: IG v3.3 Item: Assumption 6 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0531 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: If multiple races are collected, then the value of RACE should + - Cited Guidance: + If multiple races are collected, then the value of RACE should be “MULTIPLE” and the additional information will be included in the Supplemental Qualifiers dataset. Document: IG v3.4 Item: Assumption 6 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0531 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - name: $multiple_race @@ -44,7 +46,7 @@ Check: Core: Id: CORE-000844 Status: Published - Version: '1' + Version: "1" Description: Part A - Raise an error when RACE in DM equals 'MULTIPLE' and SUPPDM dataset is not present. Executability: Fully Executable diff --git a/Deprecated/CORE-000846/rule.yml b/Deprecated/CORE-000846/rule.yml index 078397da1..7b5fdc81c 100644 --- a/Deprecated/CORE-000846/rule.yml +++ b/Deprecated/CORE-000846/rule.yml @@ -1,4 +1,4 @@ -# Variable: +# Variable: # Condition: RACE = MULTIPLE # Rule: Multiple SUPPDM.QNAM records exist for the subject Authorities: @@ -7,33 +7,35 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' and the additional information will be included in the Supplemental Qualifiers dataset. Document: IG v3.3 Item: Assumption 6 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0531 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: If multiple races are collected, then the value of RACE should + - Cited Guidance: + If multiple races are collected, then the value of RACE should be “MULTIPLE” and the additional information will be included in the Supplemental Qualifiers dataset. Document: IG v3.4 Item: Assumption 6 - Section: '5.2' + Section: "5.2" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0531 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - name: RACE @@ -46,7 +48,7 @@ Check: Core: Id: CORE-000846 Status: Published - Version: '1' + Version: "1" Description: Part C - Raise an error when RACE in DM equals 'MULTIPLE' but no multiple RACE records are present in SUPPDM. Executability: Fully Executable diff --git a/Deprecated/CORE-000880/rule.yml b/Deprecated/CORE-000880/rule.yml index c7ffceb35..06c91167b 100644 --- a/Deprecated/CORE-000880/rule.yml +++ b/Deprecated/CORE-000880/rule.yml @@ -1,5 +1,5 @@ -#Rule: --PDUR is greater than or equal to zero -#Logic: --PDUR >= 0 +#Rule: --PDUR is greater than or equal to zero +#Logic: --PDUR >= 0 #Condition: --PDUR ^= null Authorities: - Organization: FDA @@ -15,9 +15,9 @@ Authorities: Origin: FDA Business Rules Rule Identifier: Id: FB4006 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --PDUR @@ -28,7 +28,7 @@ Check: Core: Id: CORE-000880 Status: Published - Version: '1' + Version: "1" Description: Planned Duration (--PDUR) value should not be negative. Executability: Fully Executable Outcome: diff --git a/Deprecated/CORE-000885/rule.yml b/Deprecated/CORE-000885/rule.yml index 74b604eda..79bf2dbe0 100644 --- a/Deprecated/CORE-000885/rule.yml +++ b/Deprecated/CORE-000885/rule.yml @@ -7,29 +7,31 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2302 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2302 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - all: @@ -65,7 +67,7 @@ Check: Core: Id: CORE-000885 Status: Published - Version: '1' + Version: "1" Description: All subjects in the Demographics domain who are participating in a study that includes an interventional product must have at least one corresponding record in the Exposure domain, except for subjects who failed diff --git a/Deprecated/CORE-000886/rule.yml b/Deprecated/CORE-000886/rule.yml index 7d8b9c007..b1bece09c 100644 --- a/Deprecated/CORE-000886/rule.yml +++ b/Deprecated/CORE-000886/rule.yml @@ -1,35 +1,37 @@ # Variable: ARMNRS # Condition: DM.USUBJID not in EX.USUBJID AND TSVAL = "INTERVENTIONAL" when TSPARMCD = "STYPE" -# Rule: ARMNRS^=null +# Rule: ARMNRS^=null Authorities: - Organization: FDA Standards: - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2306 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2306 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: ARMNRS @@ -47,7 +49,7 @@ Check: value: $usubjids_in_ex Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000886 Description: All subjects that have no record in the Exposure domain who are participating in a study that includes an interventional product should have diff --git a/Deprecated/CORE-000887/rule.yml b/Deprecated/CORE-000887/rule.yml index ae035c47e..efbb36110 100644 --- a/Deprecated/CORE-000887/rule.yml +++ b/Deprecated/CORE-000887/rule.yml @@ -7,16 +7,17 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2301 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" Check: all: - name: TSPARMCD @@ -38,7 +39,7 @@ Check: value: $usubjiids_in_ex Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000887 Description: All subjects in the Demographics domain who are participating in a study that includes an interventional product must have at least one diff --git a/Deprecated/CORE-000913/rule.yml b/Deprecated/CORE-000913/rule.yml index 5348ce826..06db200d2 100644 --- a/Deprecated/CORE-000913/rule.yml +++ b/Deprecated/CORE-000913/rule.yml @@ -7,47 +7,50 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0611 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0611 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0611 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: DSDECOD operator: equal_to - value: 'DEATH' + value: "DEATH" value_is_literal: true - name: DSSTDTC operator: not_equal_to @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000913 Status: Published - Version: '1' + Version: "1" Description: Disposition date time (DSSTDTC) for DEATH record in the DS dataset should be equal to the Date of Death (DTHDTC) in the DM dataset for the corresponding subject. @@ -65,7 +68,8 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: DSSTDTC for DEATH record in DS dataset is not equal to DTHDTC in the DM + Message: + DSSTDTC for DEATH record in DS dataset is not equal to DTHDTC in the DM dataset. Output Variables: - DSDECOD diff --git a/Deprecated/CORE-000915/rule.yml b/Deprecated/CORE-000915/rule.yml index 457118c13..0667cacfd 100644 --- a/Deprecated/CORE-000915/rule.yml +++ b/Deprecated/CORE-000915/rule.yml @@ -2,41 +2,43 @@ # Condition: --LOBXFL="Y" and --STRESC ^= Null # Rule: Only one --LOBXFL per record having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values Authorities: - - Organization: 'FDA' + - Organization: "FDA" Standards: - - Name: 'SDTMIG' + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB2604' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' + Id: "FB2604" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" References: - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" Rule Identifier: - Id: 'FB2604' - Version: '1' - Version: '1.5' - Version: '3.4' + Id: "FB2604" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --STRESC operator: non_empty - name: --LOBXFL operator: equal_to - value: 'Y' + value: "Y" value_is_literal: true - name: --LOBXFL operator: is_not_unique_set @@ -49,7 +51,7 @@ Check: - USUBJID Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000915 Description: There should be only one record with a last observation before exposure flag and non missing character standard result value having the same diff --git a/Deprecated/CORE-000927/rule.yml b/Deprecated/CORE-000927/rule.yml index fbec22b97..f2086df1a 100644 --- a/Deprecated/CORE-000927/rule.yml +++ b/Deprecated/CORE-000927/rule.yml @@ -7,29 +7,31 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2304 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2304 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: ARMNRS @@ -51,7 +53,7 @@ Check: value: $usubjids_in_ex Core: Status: Published - Version: '1' + Version: "1" Id: CORE-000927 Description: All subjects in the Exposure domain who are participating in a study that includes an interventional product must be assigned to an ARM. diff --git a/Deprecated/CORE-000952/rule.yml b/Deprecated/CORE-000952/rule.yml index 98e2a41d7..c24ffd54a 100644 --- a/Deprecated/CORE-000952/rule.yml +++ b/Deprecated/CORE-000952/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3407 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3407 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and + - Cited Guidance: + Study start and end date/time should include month, day, and year. Document: FDA Section: FDAB034 Origin: FDA Business Rules Rule Identifier: Id: FB3407 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: --ENDTC @@ -55,7 +58,7 @@ Check: Core: Id: CORE-000952 Status: Published - Version: '1' + Version: "1" Description: End Date/Time (--ENDTC) variable value should be prior or equal to the Date/Time of End of Participation (RFPENDTC). Executability: Fully Executable diff --git a/Deprecated/CORE-001043/rule.yml b/Deprecated/CORE-001043/rule.yml index bdf0cce12..1f29d77b0 100644 --- a/Deprecated/CORE-001043/rule.yml +++ b/Deprecated/CORE-001043/rule.yml @@ -7,42 +7,45 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Age should be provided for all subjects, except where not + - Cited Guidance: + Age should be provided for all subjects, except where not collected for screen failures. Document: FDA Section: FDAB005 Origin: FDA Business Rules Rule Identifier: Id: FB0501 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Age should be provided for all subjects, except where not + - Cited Guidance: + Age should be provided for all subjects, except where not collected for screen failures. Document: FDA Section: FDAB005 Origin: FDA Business Rules Rule Identifier: Id: FB0501 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: Age should be provided for all subjects, except where not + - Cited Guidance: + Age should be provided for all subjects, except where not collected for screen failures. Document: FDA Section: FDAB005 Origin: FDA Business Rules Rule Identifier: Id: FB0501 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: AGE @@ -66,7 +69,7 @@ Check: Core: Id: CORE-001043 Status: Published - Version: '1' + Version: "1" Description: Age should be provided for all subjects, except where not collected for screen failures. Executability: Fully Executable diff --git a/Deprecated/CORE-001064/rule.yml b/Deprecated/CORE-001064/rule.yml index e2122258e..f47752833 100644 --- a/Deprecated/CORE-001064/rule.yml +++ b/Deprecated/CORE-001064/rule.yml @@ -7,16 +7,17 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: For interventional studies all treated subjects should have + - Cited Guidance: + For interventional studies all treated subjects should have exposure data. Document: FDA Section: FDAB023 Origin: FDA Business Rules Rule Identifier: Id: FB2305 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" Check: all: - name: ACTARMCD @@ -39,7 +40,7 @@ Check: Core: Id: CORE-001064 Status: Published - Version: '1' + Version: "1" Description: All subjects that have no record in the Exposure domain who are participating in a study that includes an interventional product should not be assigned to a treatment. #needs an update based on update in FDA business rules spreadsheet# diff --git a/Deprecated/CORE-001078/rule.yml b/Deprecated/CORE-001078/rule.yml index aa179d5d8..6a3629d8b 100644 --- a/Deprecated/CORE-001078/rule.yml +++ b/Deprecated/CORE-001078/rule.yml @@ -7,59 +7,62 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0609 - Version: '1' - Version: '1.5' - Version: '3.2' + Version: "1" + Version: "1.5" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0609 - Version: '1' - Version: '1.5' - Version: '3.3' + Version: "1" + Version: "1.5" + Version: "3.3" - Name: SDTMIG References: - Citations: - - Cited Guidance: All death information should be populated for subjects that died + - Cited Guidance: + All death information should be populated for subjects that died during the study including any post treatment follow-up. Document: FDA Section: FDAB006 Origin: FDA Business Rules Rule Identifier: Id: FB0609 - Version: '1' - Version: '1.5' - Version: '3.4' + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - name: DTHFL operator: equal_to - value: 'Y' + value: "Y" value_is_literal: true - name: $ae_aeout operator: does_not_contain - value: 'FATAL' + value: "FATAL" value_is_literal: true - name: $ae_aesdth operator: does_not_contain - value: 'Y' + value: "Y" value_is_literal: true Core: Status: Published - Version: '1' + Version: "1" Id: CORE-001078 Description: When Death flag (DTHFL) in the DM dataset is populated as 'Y' then a record should be present in the AE dataset where AEOUT = 'FATAL' and AESDTH @@ -89,7 +92,8 @@ Operations: name: AESDTH operator: distinct Outcome: - Message: DTHFL in DM dataset is "Y" but a record is missing in AE dataset where + Message: + DTHFL in DM dataset is "Y" but a record is missing in AE dataset where AESDTH = "Y" and AEOUT = "FATAL". Output Variables: - $ae_aeout diff --git a/Deprecated/CORE-001079/rule.yml b/Deprecated/CORE-001079/rule.yml index e5147426d..fffa2512d 100644 --- a/Deprecated/CORE-001079/rule.yml +++ b/Deprecated/CORE-001079/rule.yml @@ -1,19 +1,19 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable = Model List of Allowed Variables for Observation Class Authorities: - Organization: CDISC Standards: - # 2025-11-18: SDTMIG-3-3 is implemented as a separate rule - # as SDTMIG has "domain-specific" variables: + # as SDTMIG has "domain-specific" variables: # which are NOT in the "SDTM Model" # For SDTMIG-3-2 there are none such "domain-specific" variables # and for SDTMIG-3-4 they are also present in the "SDTM Model". - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . . + - Cited Guidance: + IG v3.3[2.5][Sponsors may not add any other variables. . . . Standard variables must not be renamed or modified for novel usage]|IG v3.3[2.5][[Using SDTM-specified standard variable names]|Model v1.7[3.2.2 2.1][Each observation can be described @@ -26,9 +26,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0013 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" #- Name: SDTMIG # References: # - Citations: @@ -52,9 +52,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0351 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: # 2025-11-17: exclude EXMETHOD, EGBEATNO, ICIMPLBL, MSAGENT, MSCONC, MSCONCU @@ -82,7 +82,7 @@ Check: Core: Id: CORE-001079 Status: Published - Version: '1' + Version: "1" Description: Raise an error when a variable is not an allowed variable for an Observation Class Executability: Partially Executable - Possible Underreporting diff --git a/Deprecated/CORE-001080/rule.yml b/Deprecated/CORE-001080/rule.yml index 21e61869e..c7d57a313 100644 --- a/Deprecated/CORE-001080/rule.yml +++ b/Deprecated/CORE-001080/rule.yml @@ -14,9 +14,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0288 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: @@ -27,22 +27,22 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0288 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" - Name: SDTMIG References: - Citations: - Cited Guidance: The version number of the Reference Terminology, if applicable. Document: IG v3.2 Item: Specification - Section: '7.4' + Section: "7.4" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0288 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - name: TSVCDREF @@ -57,7 +57,7 @@ Check: Core: Id: CORE-001080 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TSVCDREF ='CDISC' and TSVALCD is not a valid code in the version identified in TSVCDVER. Executability: Fully Executable diff --git a/Deprecated/CORE-001081/rule.yml b/Deprecated/CORE-001081/rule.yml index 74e9eb4bf..7922e95f5 100644 --- a/Deprecated/CORE-001081/rule.yml +++ b/Deprecated/CORE-001081/rule.yml @@ -1,5 +1,5 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Metadata attribute of Variable Role = IG Role for domains in IG, Metadata attribute of Variable Role = Model Role for custom domains Authorities: @@ -8,22 +8,24 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: Each variable can be classified according to its Role. A Role + - Cited Guidance: + Each variable can be classified according to its Role. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into five major roles. Document: IG v3.4 - Section: '2.1' + Section: "2.1" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0010 - Version: '2' - Version: '2.0' - Version: '3.4' + Version: "2" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[3.1][Since these roles are predefined for all standard + - Cited Guidance: + IG v3.2[3.1][Since these roles are predefined for all standard domains that follow the general observation classes]|Model v1.4[2][Each variable . . . can be classified according to its Role] @@ -32,24 +34,25 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0010 - Version: '2' - Version: '2.0' - Version: '3.2' + Version: "2" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: Each variable can be classified according to its Role. A Role + - Cited Guidance: + Each variable can be classified according to its Role. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. Variables can be classified into five major roles. Document: IG v3.3 - Section: '2.1' + Section: "2.1" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0010 - Version: '2' - Version: '2.0' - Version: '3.3' + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - name: define_variable_role @@ -58,7 +61,7 @@ Check: Core: Id: CORE-001081 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the metadata attribute of variable role does not match the IG role for domain in IG, or model role (for custom domains) Executability: Fully Executable diff --git a/Deprecated/CORE-001082/rule.yml b/Deprecated/CORE-001082/rule.yml index aefa3e9d2..ebd3bd0af 100644 --- a/Deprecated/CORE-001082/rule.yml +++ b/Deprecated/CORE-001082/rule.yml @@ -1,5 +1,5 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable Type = IG Type for domains in IG, Type = Model Type for custom domains Authorities: - Organization: CDISC @@ -10,21 +10,23 @@ Authorities: - Cited Guidance: Using SDTM-specified data types for all variables Document: IG v3.4 Section: 3.2.2 - - Cited Guidance: Note that the SDTM type specified in this document is either + - Cited Guidance: + Note that the SDTM type specified in this document is either character or numeric, as these are the only types supported by SAS v.5 transport files.] Document: Model v2.0 - Section: '2.1' + Section: "2.1" Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0012 - Version: '1' - Version: '2.0' - Version: '3.4' + Version: "1" + Version: "2.0" + Version: "3.4" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.2[3.2.2][Using SDTM-specified data types for all + - Cited Guidance: + IG v3.2[3.2.2][Using SDTM-specified data types for all variables]|Model v1.4[2][The data Type (e.g., whether the variable value is a character or numeric)] Document: IG v3.2|Model v1.4 @@ -32,13 +34,14 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0012 - Version: '1' - Version: '2.0' - Version: '3.2' + Version: "1" + Version: "2.0" + Version: "3.2" - Name: SDTMIG References: - Citations: - - Cited Guidance: IG v3.3[3.2.2][Using SDTM-specified data types for all + - Cited Guidance: + IG v3.3[3.2.2][Using SDTM-specified data types for all variables]|Model v1.7[2.1][The SDTM describes the name, label, role, and type for the standard variables. Note that the SDTM type specified in this document is either character or @@ -49,9 +52,9 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0012 - Version: '1' - Version: '2.0' - Version: '3.3' + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - name: variable_data_type @@ -60,12 +63,13 @@ Check: Core: Id: CORE-001082 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the variable type does not match IG Type (for domains in IG) or Model Type (custom domains) Executability: Fully Executable Outcome: - Message: Variable data type specified in the dataset does not match the variable + Message: + Variable data type specified in the dataset does not match the variable data type in the IG or the Model. Output Variables: - variable_name diff --git a/Published/CORE-000001/rule.yml b/Published/CORE-000001/rule.yml index 5fa8ef6bb..a536e43ed 100644 --- a/Published/CORE-000001/rule.yml +++ b/Published/CORE-000001/rule.yml @@ -2,78 +2,82 @@ # Condition: IECAT = 'INCLUSION' # Rule: IEORRES = 'N' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only those - criteria that the subject did not meet, and not the responses to all criteria. - Document: SDTM v3.4 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only those criteria - that the subject did not meet, and not the responses to all criteria. - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only those criteria - that the subject did not meet, and not the responses to all criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0176 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only those - criteria that the subject did not meet, and not the responses to all criteria. - Document: TIG 1.0 - Item: Assumption 1 - Section: '2.8.10.13' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0405 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: SDTM v3.4 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.2 + Item: Assumption 2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0176 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: TIG 1.0 + Item: Assumption 1 + Section: "2.8.10.13" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0405 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IECAT - operator: equal_to - value: INCLUSION - value_is_literal: true - - name: IEORRES - operator: not_equal_to - value: N - value_is_literal: true + - name: IECAT + operator: equal_to + value: INCLUSION + value_is_literal: true + - name: IEORRES + operator: not_equal_to + value: N + value_is_literal: true Core: Id: CORE-000001 Status: Published - Version: '1' + Version: "1" Description: Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is not equal to 'N'. Executability: Fully Executable Outcome: @@ -82,9 +86,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000004/rule.yml b/Published/CORE-000004/rule.yml index 7923d0aa2..c7ae33e98 100644 --- a/Published/CORE-000004/rule.yml +++ b/Published/CORE-000004/rule.yml @@ -2,125 +2,134 @@ # Condition: ECOCCUR = 'N' # Rule: ECDOSE = null or > 0 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL is infused at - a visit, then ECOCCUR = 'N' is the standard representation of the collected doses not - taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be - set to zero (0) as an alternative method for indicating doses not taken, not given, or - missed. - Document: IG v3.4 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be - populated with positive (non-zero) values in cases where the sponsor feels it is necessary - and/or appropriate to represent specific dose amounts not taken, not given, or missed. - Document: IG v3.4 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of - the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not - taken, not given, or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that indicate dose - amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases - where the sponsor feels it is necessary and/or appropriate to represent specific dose - amounts not taken, not given, or missed.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 4a]|IG v3.2[6.1][Assumption 4b] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are taken within a - timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of - the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, - ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not - taken, not given, or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that indicate - dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in - cases where the sponsor feels it is necessary and/or appropriate to represent specific - dose amounts not taken, not given, or missed.] - Document: IG v3.3 - Item: IG v3.3[6.1.3.2][Assumption 4a]|IG v3.3[6.1.3.2][Assumption 4b] - Section: IG v3.3[6.1.3.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0101 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: '[Assumption 4a][For example, if 0 tablets are taken within a timeframe or 0 mL - is infused at a visit, then ECOCCUR = ''N'' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not - be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed.' - Document: TIG 1.0 - Item: Assumption 4a - Section: 2.8.10.11 - - Cited Guidance: '[Assumption 4b][Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary - and/or appropriate to represent specific dose amounts not taken, not given, or missed.]' - Document: TIG 1.0 - Item: Assumption 4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0366 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For example, if 0 tablets are taken within a timeframe or 0 mL is infused at + a visit, then ECOCCUR = 'N' is the standard representation of the collected doses not + taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be + set to zero (0) as an alternative method for indicating doses not taken, not given, or + missed. + Document: IG v3.4 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: + Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[6.1][Assumption 4a][For example, if 0 tablets are taken within a + timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of + the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, + ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not + taken, not given, or missed.]|IG v3.2[6.1][Assumption 4b][Qualifiers that indicate dose + amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases + where the sponsor feels it is necessary and/or appropriate to represent specific dose + amounts not taken, not given, or missed.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 4a]|IG v3.2[6.1][Assumption 4b] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[6.1.3.2][Assumption 4a][For example, if 0 tablets are taken within a + timeframe or 0 mL infused at a visit, then ECOCCUR = 'N' is the standard representation of + the collected doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, + ECDOSTXT) must not be set to zero (0) as an alternative method for indicating doses not + taken, not given, or missed.]|IIG v3.3[6.1.3.2][Assumption 4b][Qualifiers that indicate + dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in + cases where the sponsor feels it is necessary and/or appropriate to represent specific + dose amounts not taken, not given, or missed.] + Document: IG v3.3 + Item: IG v3.3[6.1.3.2][Assumption 4a]|IG v3.3[6.1.3.2][Assumption 4b] + Section: IG v3.3[6.1.3.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0101 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "[Assumption 4a][For example, if 0 tablets are taken within a timeframe or 0 mL + is infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not + be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed." + Document: TIG 1.0 + Item: Assumption 4a + Section: 2.8.10.11 + - Cited Guidance: + "[Assumption 4b][Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed.]" + Document: TIG 1.0 + Item: Assumption 4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0366 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ECOCCUR # The condition is ECOCCUR = "N" - operator: equal_to - value: N - - name: ECDOSE + - name: ECOCCUR # The condition is ECOCCUR = "N" + operator: equal_to + value: N + - name: + ECDOSE # The rule is ECDOSE is null or > 0 # so the failure criteria is not empty and LE 0 # which is the same as just LE 0 - operator: less_than_or_equal_to - value: 0 + operator: less_than_or_equal_to + value: 0 Core: Id: CORE-000004 Status: Published - Version: '1' -Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used + Version: "1" +Description: + When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used to indicate a dose wasn't taken. Executability: Fully Executable Outcome: - Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or + Message: + ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or equal to 0 Output Variables: - - ECDOSE - - ECOCCUR + - ECDOSE + - ECOCCUR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000006/rule.yml b/Published/CORE-000006/rule.yml index 4b5f21ac4..42b9240a3 100644 --- a/Published/CORE-000006/rule.yml +++ b/Published/CORE-000006/rule.yml @@ -1,85 +1,85 @@ # Variable: DTHFL -# Condition: +# Condition: # Rule: DTHFL in ('Y',null) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Should be "Y" or null - Document: Model v2.0 - Item: DTHFL - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Should be Y or null. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ' Should be "Y" or null.' - Document: Model v1.7 - Item: DTHFL Description - Section: Table 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0131 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ' Should be "Y" or null.' - Document: SDTM v2.1 - Item: DTHFL - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0381 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Should be "Y" or null + Document: Model v2.0 + Item: DTHFL + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Should be Y or null. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ' Should be "Y" or null.' + Document: Model v1.7 + Item: DTHFL Description + Section: Table 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0131 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: ' Should be "Y" or null.' + Document: SDTM v2.1 + Item: DTHFL + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0381 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DTHFL - operator: not_equal_to - value: Y - - name: DTHFL - operator: non_empty + - name: DTHFL + operator: not_equal_to + value: Y + - name: DTHFL + operator: non_empty Core: Id: CORE-000006 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DTHFL ^= "Y" and not null Executability: Fully Executable Outcome: Message: DTHFL is not "Y" or null Output Variables: - - DTHFL + - DTHFL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000007/rule.yml b/Published/CORE-000007/rule.yml index e2618565f..42dce3221 100644 --- a/Published/CORE-000007/rule.yml +++ b/Published/CORE-000007/rule.yml @@ -2,131 +2,139 @@ # Condition: DTHDTC ^= null # Rule: DTHFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DTHDTC[The date or date and time of death, represented in a standardized - character format.] DTHFL[An indication that the subject died.] - Document: Model v2.0 - Item: DTHDTC|DTHFL - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value of 'Y' indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value of "Y" indicates the subject died. Should be "Y" or null. Should be - populated even when the death date is unknown. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0435 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: DTHDTC[The date or date and time of death, represented in a standardized - character format.]|DTHFL[An indication that the subject died.] - Document: SDTM v2.1 - Item: DTHDTC|DTHFL - Section: 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0587 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - #CG0435 is identical to rule FB0606. Added metadata for FB0606. -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0606 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + DTHDTC[The date or date and time of death, represented in a standardized + character format.] DTHFL[An indication that the subject died.] + Document: Model v2.0 + Item: DTHDTC|DTHFL + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A value of 'Y' indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A value of "Y" indicates the subject died. Should be "Y" or null. Should be + populated even when the death date is unknown. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0435 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + DTHDTC[The date or date and time of death, represented in a standardized + character format.]|DTHFL[An indication that the subject died.] + Document: SDTM v2.1 + Item: DTHDTC|DTHFL + Section: 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0587 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + #CG0435 is identical to rule FB0606. Added metadata for FB0606. + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0606 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: DTHDTC - operator: non_empty - - name: DTHFL - operator: not_equal_to - value: Y + - name: DTHDTC + operator: non_empty + - name: DTHFL + operator: not_equal_to + value: Y Core: Id: CORE-000007 Status: Published - Version: '1' -Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL) + Version: "1" +Description: + When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Outcome: Message: DTHDTC is populated but DTHFL in DM dataset is not "Y". Output Variables: - - DTHDTC - - DTHFL + - DTHDTC + - DTHFL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000009/rule.yml b/Published/CORE-000009/rule.yml index be626e322..0c7ba1855 100644 --- a/Published/CORE-000009/rule.yml +++ b/Published/CORE-000009/rule.yml @@ -2,203 +2,212 @@ # Condition: ETCD = 'UNPLAN' # Rule: ELEMENT = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of 'UNPLAN' then ELEMENT should - be null. - Document: SDTMIG v3.4 - Item: Specification - Section: 5.3 Specification - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should - be null. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should - be null. - Document: IG v3.3 - Item: Specification - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0152 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If ETCD has a value of UNPLAN, then Element should be blank. - Document: SENDIG v3.0 - Item: Specification - Section: 5.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element.For unplanned Elements, ETCD should be - populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element.For unplanned Elements, ETCD should be - populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element.For unplanned Elements, ETCD should be - populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element.For unplanned Elements, ETCD should be - populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element.For unplanned Elements, ETCD should be - populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated - with a description of the unplanned Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND124.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ETCD has a value of "UNPLAN", then ELEMENT should be null. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0393 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: TIG v1.0 - Item: Assumption 5 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0061 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The name of the Element. If ETCD has a value of 'UNPLAN' then ELEMENT should + be null. + Document: SDTMIG v3.4 + Item: Specification + Section: 5.3 Specification + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should + be null. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The name of the Element. If ETCD has a value of "UNPLAN" then ELEMENT should + be null. + Document: IG v3.3 + Item: Specification + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0152 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If ETCD has a value of UNPLAN, then Element should be blank. + Document: SENDIG v3.0 + Item: Specification + Section: 5.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element.For unplanned Elements, ETCD should be + populated with 'UNPLAN', ELEMENT should be left blank, and SEUPDES should be populated + with a description of the unplanned Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND124.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: If ETCD has a value of "UNPLAN", then ELEMENT should be null. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0393 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: TIG v1.0 + Item: Assumption 5 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0061 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: ETCD - operator: equal_to - value: UNPLAN - - name: ELEMENT - operator: non_empty + - name: ETCD + operator: equal_to + value: UNPLAN + - name: ELEMENT + operator: non_empty Core: Id: CORE-000009 Status: Published - Version: '1' + Version: "1" Description: Verify that ELEMENT value is blank when ETCD is equal to UNPLAN Executability: Fully Executable Outcome: Message: ELEMENT variable has a non-null value when ETCD has a value of 'UNPLAN' Output Variables: - - ETCD - - ELEMENT + - ETCD + - ELEMENT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000010/rule.yml b/Published/CORE-000010/rule.yml index 95676aa3b..0f1d60a45 100644 --- a/Published/CORE-000010/rule.yml +++ b/Published/CORE-000010/rule.yml @@ -1,88 +1,92 @@ # Variable: ARMCD -# Condition: +# Condition: # Rule: ARMCD value length <= 20 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have the character - restrictions that apply to --TESTCD - Document: SDTMIG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.2 - Section: 4.1.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.3 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0153 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. The maximum length of ARMCD is longer than that for other short variables to - accommodate the kind of values that are likely to be needed for crossover trials. - Document: TIG 1.0 - Item: Specification ARMCD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0394 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have the character + restrictions that apply to --TESTCD + Document: SDTMIG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Section: 4.1.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.3 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0153 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. The maximum length of ARMCD is longer than that for other short variables to + accommodate the kind of values that are likely to be needed for crossover trials. + Document: TIG 1.0 + Item: Specification ARMCD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0394 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: matches_regex - value: ^(.){21,}$ + - name: ARMCD + operator: matches_regex + value: ^(.){21,}$ Core: Id: CORE-000010 Status: Published - Version: '1' + Version: "1" Description: Verify ARMCD value length is <= 20 Executability: Fully Executable Outcome: Message: ARMCD value length is greater than 20 Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TA + - DM + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000011/rule.yml b/Published/CORE-000011/rule.yml index cd5ab9fc3..4404808c5 100644 --- a/Published/CORE-000011/rule.yml +++ b/Published/CORE-000011/rule.yml @@ -2,93 +2,97 @@ # Condition: IECAT = 'EXCLUSION' # Rule: IEORRES = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only those - criteria that the subject did not meet, and not the responses to all criteria.  - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only those criteria - that the subject did not meet, and not the responses to all criteria. - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect response to only those criteria - that the subject did not meet, and not the responses to all criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0175 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to collect responses to only those - criteria that the subject did not meet, and not the responses to all criteria. - Document: TIG 1.0 - Item: Assumption 1 - Section: '2.8.10.13' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0404 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria.  + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.2 + Item: Assumption 2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect response to only those criteria + that the subject did not meet, and not the responses to all criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0175 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to collect responses to only those + criteria that the subject did not meet, and not the responses to all criteria. + Document: TIG 1.0 + Item: Assumption 1 + Section: "2.8.10.13" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0404 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IECAT - operator: equal_to - value: EXCLUSION - value_is_literal: true - - name: IEORRES - operator: not_equal_to - value: Y - value_is_literal: true + - name: IECAT + operator: equal_to + value: EXCLUSION + value_is_literal: true + - name: IEORRES + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000011 Status: Published - Version: '1' + Version: "1" Description: Raise an error when IECAT is equal to 'EXCLUSION' and IEORRES is not equal to 'Y'. Executability: Fully Executable Outcome: Message: IEORRES is not equal to 'Y' when IECAT equals 'EXCLUSION'. Output Variables: - - IECAT - - IEORRES + - IECAT + - IEORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000012/rule.yml b/Published/CORE-000012/rule.yml index 44e8f70de..3ec5a84a4 100644 --- a/Published/CORE-000012/rule.yml +++ b/Published/CORE-000012/rule.yml @@ -1,94 +1,98 @@ # Variable: AEOCCUR -# Condition: +# Condition: # Rule: AEOCCUR not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, and - --REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. - They are not permitted because the AE domain contains only records for adverse events that - actually occurred. - Document: SDTMIG v3.4 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, - and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. - They are not permitted because the AE domain contains only records for adverse events that - actually occurred. - Document: SDTMIG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, - and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. - They are not permitted because the AE domain contains only records for adverse events that - actually occurred. - Document: SDTMIG v3.2 - Item: Assumption 8 - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0040 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. - They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events that actually occurred.''' - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0319 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following Qualifiers would not be used in AE; --OCCUR, --STAT, and + --REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.4 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following Qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following Qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: SDTMIG v3.2 + Item: Assumption 8 + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0040 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred.'" + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0319 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AEOCCUR - operator: exists + - name: AEOCCUR + operator: exists Core: Id: CORE-000012 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AEOCCUR exists in AE dataset. Executability: Fully Executable Outcome: Message: AEOCCUR is present in AE dataset. Output Variables: - - AEOCCUR + - AEOCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000013/rule.yml b/Published/CORE-000013/rule.yml index a5c4a8486..a9fa6b143 100644 --- a/Published/CORE-000013/rule.yml +++ b/Published/CORE-000013/rule.yml @@ -1,96 +1,100 @@ # Variable: AESTAT -# Condition: +# Condition: # Rule: AESTAT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", - and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE - domain. They are not permitted because the AE domain contains only records for adverse - events that actually occurred. - Document: SDTMIG v3.4 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", - and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE - domain. They are not permitted because the AE domain contains only records for adverse - events that actually occurred. - Document: SDTMIG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", - and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE - domain. They are not permitted because the AE domain contains only records for adverse - events that actually occurred. - Document: SDTMIG v3.2 - Item: Assumption 8 - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0044 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. - They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events that actually occurred. See Assumption - 4b for information on how to deal with negative responses or missing responses to probing questions - for prespecified adverse events.' - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0323 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.4 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --> The following Qualifiers would not be used in AE; "--OCCUR", "--STAT", + and "--REASND". They are the only Qualifiers from the SDTM Events Class not in the AE + domain. They are not permitted because the AE domain contains only records for adverse + events that actually occurred. + Document: SDTMIG v3.2 + Item: Assumption 8 + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0044 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The following qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred. See Assumption + 4b for information on how to deal with negative responses or missing responses to probing questions + for prespecified adverse events." + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0323 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESTAT - operator: exists + - name: AESTAT + operator: exists Core: Id: CORE-000013 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESTAT is present in AE dataset. Executability: Fully Executable Outcome: Message: AESTAT variable is present in AE dataset. Output Variables: - - AESTAT + - AESTAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000014/rule.yml b/Published/CORE-000014/rule.yml index 473b6515e..c43d3e068 100644 --- a/Published/CORE-000014/rule.yml +++ b/Published/CORE-000014/rule.yml @@ -2,142 +2,148 @@ # Condition: (--PRESP ^= 'Y' and --OCCUR is present in dataset) or (--STAT=NOT DONE) # Rule: --OCCUR = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Item: --PRESP|--OCCUR|--STAT - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered - . Should be null or have a value of NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered - . Should be null or have a value of NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0087 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0352 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Item: --PRESP|--OCCUR|--STAT + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0087 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: + Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0352 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - any: + - any: + - all: + - any: + - name: --PRESP + operator: not_exists + - name: --PRESP + operator: not_equal_to + value: Y + - name: --OCCUR + operator: exists + - name: --OCCUR + operator: non_empty + - all: + - name: --STAT + operator: equal_to + value: NOT DONE - all: - - any: - - name: --PRESP - operator: not_exists - - name: --PRESP - operator: not_equal_to - value: Y - - name: --OCCUR - operator: exists - - name: --OCCUR - operator: non_empty - - all: - - name: --STAT - operator: equal_to - value: NOT DONE - - all: - - name: --OCCUR - operator: non_empty + - name: --OCCUR + operator: non_empty Core: Id: CORE-000014 Status: Published - Version: '1' -Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or + Version: "1" +Description: + Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or --STAT is equal to "NOT DONE" and --OCCUR is not blank Executability: Fully Executable Outcome: Message: --OCCUR should only be provided when --PRESP is equal to "Y". Output Variables: - - --PRESP - - --OCCUR - - --STAT + - --PRESP + - --OCCUR + - --STAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000015/rule.yml b/Published/CORE-000015/rule.yml index aec1ea367..95daa9711 100644 --- a/Published/CORE-000015/rule.yml +++ b/Published/CORE-000015/rule.yml @@ -2,117 +2,122 @@ # Condition: --PRESP not present in dataset # Rule: --OCCUR not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model - v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified - on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: - Used to record whether a pre-specified event occurred when information about the occurrence - of a specific event is solicited.]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model - v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified - on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: - Used to record whether a pre-specified event occurred when information about the occurrence - of a specific event is solicited.]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0088 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0353 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0088 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: + Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0353 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: not_exists - - name: --OCCUR - operator: exists + - name: --PRESP + operator: not_exists + - name: --OCCUR + operator: exists Core: Id: CORE-000015 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --PRESP does not exists in a dataset and --OCCUR exist. Executability: Fully Executable Outcome: Message: --PRESP is missing in dataset when --OCCUR is present. Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000016/rule.yml b/Published/CORE-000016/rule.yml index b7cbb4a56..100d78b3b 100644 --- a/Published/CORE-000016/rule.yml +++ b/Published/CORE-000016/rule.yml @@ -2,118 +2,124 @@ # Condition: --OCCUR ^= null # Rule: --PRESP = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.] - Document: Model v2.0 - Section: Events - - Cited Guidance: Interventions[--PRESP][An indication that the intervention was prospectively - stated or detailed on the CRF. Values should be "Y" or null.]|Interventions[--OCCUR][An - indication as to whether a prespecified intervention has occurred.] - Document: Model v2.0 - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model - v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified - on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: - Used to record whether a pre-specified event occurred when information about the occurrence - of a specific event is solicited.]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model - v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified - on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: - Used to record whether a pre-specified event occurred when information about the occurrence - of a specific event is solicited.]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0089 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: (--PRESP) An indication that the event was prospectively stated or detailed - on the CRF. Values should be "Y" or null. (--OCCUR) An indication as to whether a - prespecified event has occurred. - Document: SDTM v2.1 - Item: --PRESP|--OCCUR - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: (--PRESP) An indication that the intervention was prospectively stated or - detailed on the CRF. Values should be "Y" or null.(--OCCUR) An indication as to whether a - prespecified intervention has occurred. - Document: SDTM v2.1 - Item: --PRESP|--OCCUR - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0354 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.] + Document: Model v2.0 + Section: Events + - Cited Guidance: + Interventions[--PRESP][An indication that the intervention was prospectively + stated or detailed on the CRF. Values should be "Y" or null.]|Interventions[--OCCUR][An + indication as to whether a prespecified intervention has occurred.] + Document: Model v2.0 + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.]|Model + v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe by --TERM was pre-specified + on a CRF. Value is Y for pre-specified events, null for spontaneously reported events.][--OCCUR: + Used to record whether a pre-specified event occurred when information about the occurrence + of a specific event is solicited.]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0089 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + (--PRESP) An indication that the event was prospectively stated or detailed + on the CRF. Values should be "Y" or null. (--OCCUR) An indication as to whether a + prespecified event has occurred. + Document: SDTM v2.1 + Item: --PRESP|--OCCUR + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: + (--PRESP) An indication that the intervention was prospectively stated or + detailed on the CRF. Values should be "Y" or null.(--OCCUR) An indication as to whether a + prespecified intervention has occurred. + Document: SDTM v2.1 + Item: --PRESP|--OCCUR + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0354 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --OCCUR - operator: non_empty - - any: - - name: --PRESP - operator: not_exists - - name: --PRESP - operator: not_equal_to - value: Y - value_is_literal: true + - name: --OCCUR + operator: non_empty + - any: + - name: --PRESP + operator: not_exists + - name: --PRESP + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000016 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --OCCUR is not empty and --PRESP is not equal to "Y". Executability: Fully Executable Outcome: Message: --PRESP should be populated as "Y" when --OCCUR is provided. Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000017/rule.yml b/Published/CORE-000017/rule.yml index 2f7eacbbf..f42eed095 100644 --- a/Published/CORE-000017/rule.yml +++ b/Published/CORE-000017/rule.yml @@ -2,96 +2,100 @@ # Condition: IDVARVAL ^= null # Rule: RDOMAIN ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). Null for - comments collected on a general comments or additional information CRF page. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). Used only when - individual comments are related to domain records. null for comments collected on separate - CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). Used only when - individual comments are related to domain records. null for comments collected on separate - CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0166 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). Null for - comments collected on a general comments or additional information CRF page. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0398 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Two-character abbreviation for the domain of the parent record(s). Null for + comments collected on a general comments or additional information CRF page. + Document: SDTMIG v3.4 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Value of identifying variable of the parent record(s). Used only when + individual comments are related to domain records. null for comments collected on separate + CRFs. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Value of identifying variable of the parent record(s). Used only when + individual comments are related to domain records. null for comments collected on separate + CRFs. + Document: IG v3.3 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0166 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Two-character abbreviation for the domain of the parent record(s). Null for + comments collected on a general comments or additional information CRF page. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0398 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVARVAL - operator: non_empty - - any: - - name: RDOMAIN - operator: empty - - name: RDOMAIN - operator: not_exists + - name: IDVARVAL + operator: non_empty + - any: + - name: RDOMAIN + operator: empty + - name: RDOMAIN + operator: not_exists Core: Id: CORE-000017 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RDOMAIN is null when IDVARVAL is not null. Executability: Fully Executable Outcome: Message: RDOMAIN has a missing value when IDVARVAL has a non-missing value. Output Variables: - - RDOMAIN - - IDVARVAL - - IDVAR + - RDOMAIN + - IDVARVAL + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000018/rule.yml b/Published/CORE-000018/rule.yml index 279f64db5..041af2252 100644 --- a/Published/CORE-000018/rule.yml +++ b/Published/CORE-000018/rule.yml @@ -2,131 +2,137 @@ # Condition: --PRESP = 'Y' and --STAT = null and --OCCUR is present in dataset # Rule: --OCCUR ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: Model v2.0 - Item: --PRESP|--OCCUR|--STAT - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered - . Should be null or have a value of NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered - . Should be null or have a value of NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0086 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to - whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a - question about the occurrence of a prespecified event was not answered. Should be null or - have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention - was prospectively stated or detailed on the CRF. Values should be "Y" or - null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|--STAT - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0351 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: Model v2.0 + Item: --PRESP|--OCCUR|--STAT + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events, null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered + . Should be null or have a value of NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0086 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF. Values should be "Y" or null.]|Events|[--OCCUR][An indication as to + whether a prespecified event has occurred.]|Events[--STAT][Used to indicate when a + question about the occurrence of a prespecified event was not answered. Should be null or + have a value of "NOT DONE".]|Interventions[--PRESP][An indication that the intervention + was prospectively stated or detailed on the CRF. Values should be "Y" or + null.]|Interventions[--OCCUR][An indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|--STAT + Section: + Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0351 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --STAT - operator: empty - - name: --OCCUR - operator: exists - - name: --OCCUR - operator: empty + - name: --PRESP + operator: equal_to + value: Y + - name: --STAT + operator: empty + - name: --OCCUR + operator: exists + - name: --OCCUR + operator: empty Core: Id: CORE-000018 Status: Published - Version: '1' -Description: Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in + Version: "1" +Description: + Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in dataset and --OCCUR is blank Executability: Fully Executable Outcome: Message: --OCCUR is blank when --PRESP is equal to "Y" and --STAT is not provided. Output Variables: - - --PRESP - - --OCCUR - - --STAT + - --PRESP + - --OCCUR + - --STAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - AE - - DS - - DV - - EX + - AE + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000019/rule.yml b/Published/CORE-000019/rule.yml index b038bbe0c..ad141ed60 100644 --- a/Published/CORE-000019/rule.yml +++ b/Published/CORE-000019/rule.yml @@ -1,165 +1,176 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable label length <= 40 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should be provided - as data variable labels for all variables, including Supplemental Qualifier variables. - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters, should be provided - as data variable labels for all variables, including Supplemental Qualifier variables. - Document: IG v3.3 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0311 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND3 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as - data variable labels for all variables, including Supplemental Qualifier variables. - Document: TIG 1.0 - Item: 'Num 5' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0486 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as - data variable labels for all variables, including Supplemental Qualifier variables. - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 5 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0211 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters, should be provided + as data variable labels for all variables, including Supplemental Qualifier variables. + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset + Document: IG v3.2 + Section: "2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters, should be provided + as data variable labels for all variables, including Supplemental Qualifier variables. + Document: IG v3.3 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0311 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND3 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG 1.0 + Item: "Num 5" + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0486 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 5 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0211 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_label - operator: longer_than - value: 40 + - name: variable_label + operator: longer_than + value: 40 Core: Id: CORE-000019 Status: Published - Version: '1' + Version: "1" Description: Raise and error if Variable label length > 40 characters Executability: Fully Executable Outcome: @@ -168,9 +179,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000020/rule.yml b/Published/CORE-000020/rule.yml index e1fa1d5e7..270151f91 100644 --- a/Published/CORE-000020/rule.yml +++ b/Published/CORE-000020/rule.yml @@ -2,110 +2,114 @@ # Condition: ETCD = 'UNPLAN' # Rule: TAETORD = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for - the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any - Element with an ETCD value of UNPLAN. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for - the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any - Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject - passed through an Element that, although defined in the TE dataset, was out of place for - the Arm to which the subject was assigned. For example, if a subject in a parallel study - of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then - TAETORD would be left blank for the SE record for their Drug B Element. If a subject was - assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, - then the sponsor would have to decide for which of these subject Element records TAETORD - should be populated. The rationale for this decision should be documented in the Comments - column of the define.xml. - Document: IG v3.2 - Item: Assumption 8 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for - the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any - Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject - passed through an Element that, although defined in the TE dataset, was out of place for - the Arm to which the subject was assigned. For example, if a subject in a parallel study - of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then - TAETORD would be left blank for the SE record for their Drug B Element. If a subject was - assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, - then the sponsor would have to decide for which of these subject Element records TAETORD - should be populated. The rationale for this decision should be documented in the Comments - column of the define.xml. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0206 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: TAETORD will not be populated for subject Elements that are not planned for - the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any - Element with an ETCD value of “UNPLAN”. - Document: TIG 1.0 - Item: Assumption 5 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0426 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of UNPLAN. + Document: IG v3.4 + Item: Assumption 6 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject + passed through an Element that, although defined in the TE dataset, was out of place for + the Arm to which the subject was assigned. For example, if a subject in a parallel study + of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then + TAETORD would be left blank for the SE record for their Drug B Element. If a subject was + assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, + then the sponsor would have to decide for which of these subject Element records TAETORD + should be populated. The rationale for this decision should be documented in the Comments + column of the define.xml. + Document: IG v3.2 + Item: Assumption 8 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of "UNPLAN". TAETORD will also not be populated if a subject + passed through an Element that, although defined in the TE dataset, was out of place for + the Arm to which the subject was assigned. For example, if a subject in a parallel study + of Drug A vs. Drug B was assigned to receive Drug A, but received Drug B instead, then + TAETORD would be left blank for the SE record for their Drug B Element. If a subject was + assigned to receive the sequence of Elements A, B, C, D, and instead received A, D, B, C, + then the sponsor would have to decide for which of these subject Element records TAETORD + should be populated. The rationale for this decision should be documented in the Comments + column of the define.xml. + Document: IG v3.3 + Item: Assumption 6 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0206 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + TAETORD will not be populated for subject Elements that are not planned for + the Arm to which the subject was assigned. Thus, TAETORD will not be populated for any + Element with an ETCD value of “UNPLAN”. + Document: TIG 1.0 + Item: Assumption 5 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0426 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ETCD - operator: equal_to - value: UNPLAN - - name: TAETORD - operator: non_empty + - name: ETCD + operator: equal_to + value: UNPLAN + - name: TAETORD + operator: non_empty Core: Id: CORE-000020 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ETCD="UNPLAN" and TAETORD is not null. Executability: Fully Executable Outcome: Message: TAETORD should be null when ETCD = 'UNPLAN'. Output Variables: - - ETCD - - TAETORD + - ETCD + - TAETORD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000021/rule.yml b/Published/CORE-000021/rule.yml index 39bdca0d5..3682a2ba5 100644 --- a/Published/CORE-000021/rule.yml +++ b/Published/CORE-000021/rule.yml @@ -2,118 +2,123 @@ # Condition: --ORRES ^= null or --DRVFL = 'Y' # Rule: --STRESC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v2.0[Findings][The standardized result of the measurement, test, or - examination in character format. --STRESC should store all results or findings in - character format; if results are numeric, they should also be stored in numeric format in - --STRESN. If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these - results effectively have the same meaning, they could be represented in standard format in - --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result value for all findings, - copied or derived from LBORRES in a standard format or standard units.] - Document: Model v2.0|IG v3.4 - Item: Specification - Section: Findings|6.3.5.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.3 LB][Contains the result value for all findings; copied or - derived from LBORRES in a standard format or standard units. LBSTRESC should store all - results or findings in character format; if results are numeric; they should also be - stored in numeric format in LBSTRESN. For example; if a test has results 'NONE'; 'NEG'; - and 'NEGATIVE' in LBORRES and these results effectively have the same meaning; they could - be represented in standard format in LBSTRESC as 'NEGATIVE'. For other examples; see - general assumptions.]|Model v1.4[2.2.3][Contains the result value for all findings; copied - or derived from --ORRES in a standard format or in standard units.] - Document: IG v3.2|Model v1.4 - Section: IG v3.2[6.3 LB]|Model v1.4[2.2.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.3.6][Contains the result value for all findings; copied or derived - from --ORRES in a standard format or in standard units.]|Model v1.7[2.2.3] Contains the - result value for all findings; copied or derived from LBORRES in a standard format or - standard units. LBSTRESC should store all results or findings in character format; if - results are numeric; they should also be stored in numeric format in LBSTRESN. For - example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and these results - effectively have the same meaning; they could be represented in standard format in - LBSTRESC as 'NEGATIVE'. For other examples; see general assumptions.] - Document: IG v3.3|Model v1.7 - Section: IG v3.3[6.3.6]|Model v1.7[2.2.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0397 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The standardized result of the measurement, test, or examination in - character format. --STRESC should store all results or findings in character format; if - results are numeric, they should also be stored in numeric format in --STRESN. If various - tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively - have the same meaning, they could be represented in standard format in --STRESC as - "NEGATIVE" - Document: SDTM v2.1 - Section: 3.3.3 The Findings Observation Class - - Cited Guidance: Values will be populated in --STRESC when --ORRES is populated. Numeric - values represented in --STRESC will be assigned to --STRESN. - Document: TIG v1.0 - Item: Table 3 Num 3 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0559 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Model v2.0[Findings][The standardized result of the measurement, test, or + examination in character format. --STRESC should store all results or findings in + character format; if results are numeric, they should also be stored in numeric format in + --STRESN. If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these + results effectively have the same meaning, they could be represented in standard format in + --STRESC as "NEGATIVE".]|IG v3.4[6.3.5.3][Contains the result value for all findings, + copied or derived from LBORRES in a standard format or standard units.] + Document: Model v2.0|IG v3.4 + Item: Specification + Section: Findings|6.3.5.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[6.3 LB][Contains the result value for all findings; copied or + derived from LBORRES in a standard format or standard units. LBSTRESC should store all + results or findings in character format; if results are numeric; they should also be + stored in numeric format in LBSTRESN. For example; if a test has results 'NONE'; 'NEG'; + and 'NEGATIVE' in LBORRES and these results effectively have the same meaning; they could + be represented in standard format in LBSTRESC as 'NEGATIVE'. For other examples; see + general assumptions.]|Model v1.4[2.2.3][Contains the result value for all findings; copied + or derived from --ORRES in a standard format or in standard units.] + Document: IG v3.2|Model v1.4 + Section: IG v3.2[6.3 LB]|Model v1.4[2.2.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[6.3.6][Contains the result value for all findings; copied or derived + from --ORRES in a standard format or in standard units.]|Model v1.7[2.2.3] Contains the + result value for all findings; copied or derived from LBORRES in a standard format or + standard units. LBSTRESC should store all results or findings in character format; if + results are numeric; they should also be stored in numeric format in LBSTRESN. For + example; if a test has results 'NONE'; 'NEG'; and 'NEGATIVE' in LBORRES and these results + effectively have the same meaning; they could be represented in standard format in + LBSTRESC as 'NEGATIVE'. For other examples; see general assumptions.] + Document: IG v3.3|Model v1.7 + Section: IG v3.3[6.3.6]|Model v1.7[2.2.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0397 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The standardized result of the measurement, test, or examination in + character format. --STRESC should store all results or findings in character format; if + results are numeric, they should also be stored in numeric format in --STRESN. If various + tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively + have the same meaning, they could be represented in standard format in --STRESC as + "NEGATIVE" + Document: SDTM v2.1 + Section: 3.3.3 The Findings Observation Class + - Cited Guidance: + Values will be populated in --STRESC when --ORRES is populated. Numeric + values represented in --STRESC will be assigned to --STRESN. + Document: TIG v1.0 + Item: Table 3 Num 3 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0559 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - any: - - name: --ORRES - operator: non_empty - - name: --DRVFL - operator: equal_to - value: Y - - all: - - name: --STRESC - operator: empty + - any: + - name: --ORRES + operator: non_empty + - name: --DRVFL + operator: equal_to + value: Y + - all: + - name: --STRESC + operator: empty Core: Id: CORE-000021 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the value for --STRESC is null. Executability: Fully Executable Outcome: Message: --STRESC should not be blank when either --ORRES is provided or --DRVFL = 'Y' . Output Variables: - - --ORRES - - --DRVFL - - --STRESC + - --ORRES + - --DRVFL + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000022/rule.yml b/Published/CORE-000022/rule.yml index bfa9fe72c..3b2af74d2 100644 --- a/Published/CORE-000022/rule.yml +++ b/Published/CORE-000022/rule.yml @@ -2,145 +2,151 @@ # Condition: AESCAN = 'Y' or AESCONG = 'Y' or AESDISAB = 'Y' or AESDTH = 'Y' or AESHOSP = 'Y' or AESLIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' # Rule: AESER = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question, as in the example below, the values of the variables that capture reasons an - event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables maybe null. However, if Serious - is answered "Yes", at least one of them will have a "Y" response. - Document: SDTMIG v3.4 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question, as in the example below, the values of the variables that capture reasons an - event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables maybe null. However, if Serious - is answered "Yes", at least one of them will have a "Y" response. - Document: SDTMIG v3.3 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question, as in the example below, the values of the variables that capture reasons an - event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No", the values for these variables may be null. However, if Serious - is answered "Yes", at least one of them will have a "Y" response. - Document: SDTMIG v3.2 - Item: Assumption 6a - Section: 6.2. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0041 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question the values of the variables that capture reasons an event is considered serious - (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a - response is collected for each seriousness category, all category variables (e.g., AESDTH, - AESHOSP) would be populated and AESER would be derived. - Document: TIG 1.0 - Item: Assumption 7a - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0320 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables maybe null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.4 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables maybe null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.3 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No", the values for these variables may be null. However, if Serious + is answered "Yes", at least one of them will have a "Y" response. + Document: SDTMIG v3.2 + Item: Assumption 6a + Section: 6.2. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0041 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question the values of the variables that capture reasons an event is considered serious + (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a + response is collected for each seriousness category, all category variables (e.g., AESDTH, + AESHOSP) would be populated and AESER would be derived. + Document: TIG 1.0 + Item: Assumption 7a + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0320 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - any: - - name: AESCAN - operator: equal_to + - any: + - name: AESCAN + operator: equal_to + value: Y + value_is_literal: true + - name: AESCONG + operator: equal_to + value: Y + value_is_literal: true + - name: AESDISAB + operator: equal_to + value: Y + value_is_literal: true + - name: AESDTH + operator: equal_to + value: Y + value_is_literal: true + - name: AESHOSP + operator: equal_to + value: Y + value_is_literal: true + - name: AESLIFE + operator: equal_to + value: Y + value_is_literal: true + - name: AESOD + operator: equal_to + value: Y + value_is_literal: true + - name: AESMIE + operator: equal_to + value: Y + value_is_literal: true + - name: AESER + operator: not_equal_to value: Y value_is_literal: true - - name: AESCONG - operator: equal_to - value: Y - value_is_literal: true - - name: AESDISAB - operator: equal_to - value: Y - value_is_literal: true - - name: AESDTH - operator: equal_to - value: Y - value_is_literal: true - - name: AESHOSP - operator: equal_to - value: Y - value_is_literal: true - - name: AESLIFE - operator: equal_to - value: Y - value_is_literal: true - - name: AESOD - operator: equal_to - value: Y - value_is_literal: true - - name: AESMIE - operator: equal_to - value: Y - value_is_literal: true - - name: AESER - operator: not_equal_to - value: Y - value_is_literal: true Core: Id: CORE-000022 Status: Published - Version: '1' -Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or + Version: "1" +Description: + Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE = 'Y' and AESER = 'N' or is empty. Executability: Fully Executable Outcome: - Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, + Message: + At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty. Output Variables: - - AETERM - - AESTDTC - - AESER - - AESCAN - - AESCONG - - AESDISAB - - AESDTH - - AESHOSP - - AESLIFE - - AESOD - - AESMIE + - AETERM + - AESTDTC + - AESER + - AESCAN + - AESCONG + - AESDISAB + - AESDTH + - AESHOSP + - AESLIFE + - AESOD + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000023/rule.yml b/Published/CORE-000023/rule.yml index ca9cc19a9..7b8d4ae0f 100644 --- a/Published/CORE-000023/rule.yml +++ b/Published/CORE-000023/rule.yml @@ -2,103 +2,105 @@ # Condition: --TOXGR not present in dataset # Rule: --TOX not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Findings - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.7 - Section: 2.2.2 - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0084 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--TOX][Variable Qualifier of --TOXGR]|Findings[--TOX][Variable - Qualifier of --TOXGR] - Document: SDTM v2.1 - Item: --TOX - Section: Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings Observation - Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0349 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Findings + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.7 + Section: 2.2.2 + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0084 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--TOX][Variable Qualifier of --TOXGR]|Findings[--TOX][Variable + Qualifier of --TOXGR] + Document: SDTM v2.1 + Item: --TOX + Section: + Section 3.1.2 The Events Observation Class|Section 3.1.3 The Findings Observation + Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0349 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TOXGR - operator: not_exists - - name: --TOX # checking failure criteria; when --TOXGR is not present, but --TOX is, there's a problem because --TOX is only supposed to be there to qualify --TOXGR - operator: exists + - name: --TOXGR + operator: not_exists + - name: --TOX # checking failure criteria; when --TOXGR is not present, but --TOX is, there's a problem because --TOX is only supposed to be there to qualify --TOXGR + operator: exists Core: Id: CORE-000023 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TOXGR is not present in dataset, but --TOX is present Executability: Fully Executable Outcome: @@ -107,10 +109,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000024/rule.yml b/Published/CORE-000024/rule.yml index 55c50b53e..2c68c4972 100644 --- a/Published/CORE-000024/rule.yml +++ b/Published/CORE-000024/rule.yml @@ -2,69 +2,69 @@ # Condition: --BODSYS ^= null # Rule: --BDSYCD ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: Model v2.0 - Item: --BODSYS - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.4 - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0082 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: SDTM v2.1 - Item: --BODSYS - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0347 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.4 + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0082 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: SDTM v2.1 + Item: --BODSYS + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0347 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --BODSYS - operator: non_empty - - name: --BDSYCD - operator: empty + - name: --BODSYS + operator: non_empty + - name: --BDSYCD + operator: empty Core: Id: CORE-000024 Status: Published - Version: '1' + Version: "1" Description: Raise an error if --BODSYS is not empty, --BDSYCD is empty Executability: Fully Executable Outcome: @@ -73,9 +73,9 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000025/rule.yml b/Published/CORE-000025/rule.yml index 536087a2c..519df490b 100644 --- a/Published/CORE-000025/rule.yml +++ b/Published/CORE-000025/rule.yml @@ -1,85 +1,85 @@ # Variable: IESTRESC -# Condition: +# Condition: # Rule: IESTRESC = IEORRES Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format - Document: SDTMIG v3.4 - Item: '' - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. - Document: IG v3.3 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0177 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. - Document: TIG 1.0 - Item: Specification-IESTRESC - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0406 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format + Document: SDTMIG v3.4 + Item: "" + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: IG v3.3 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0177 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Response to Inclusion/Exclusion criterion result in standard format. + Document: TIG 1.0 + Item: Specification-IESTRESC + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0406 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IESTRESC - operator: not_equal_to - value: IEORRES + - name: IESTRESC + operator: not_equal_to + value: IEORRES Core: Id: CORE-000025 Status: Published - Version: '1' + Version: "1" Description: IESTRESC is not equal to IEORRES Executability: Fully Executable Outcome: Message: IESTRESC is not equal to IEORRES Output Variables: - - IEORRES - - IESTRESC + - IEORRES + - IESTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000026/rule.yml b/Published/CORE-000026/rule.yml index 455ab694b..40f47e4b7 100644 --- a/Published/CORE-000026/rule.yml +++ b/Published/CORE-000026/rule.yml @@ -2,80 +2,84 @@ # Condition: --TPT present in dataset # Rule: --TPTNUM present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT and --TPTNUM - must be used. - Document: IG v3.3 - Section: 4.4.10 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are used, --TPTNUM is expected. Within the context that - defines uniqueness for a time point, which may include domain, visit, and reference time - point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other - words, if domain, visit, and reference time point uniquely identify subject data, then if - two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and - --TPTNUM, then these records may not have different time point descriptions in --TPT. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are used, --TPTNUM is expected. Within the context that - defines uniqueness for a time point, which may include domain, visit, and reference time - point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other - words, if domain, visit, and reference time point uniquely identify subject data, then if - two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and - --TPTNUM, then these records may not have different time point descriptions in --TPT. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0468 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Time points will be represented using both --TPT and --TPTNUM. There will be - a one-to-one relationship between values of --TPT and --TPTNUM. - Document: TIG 1.0 - Item: Num 5 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0598 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When time points are represented in SDTMIG domains, both --TPT and --TPTNUM + must be used. + Document: IG v3.3 + Section: 4.4.10 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When time points are used, --TPTNUM is expected. Within the context that + defines uniqueness for a time point, which may include domain, visit, and reference time + point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other + words, if domain, visit, and reference time point uniquely identify subject data, then if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different time point descriptions in --TPT. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When time points are used, --TPTNUM is expected. Within the context that + defines uniqueness for a time point, which may include domain, visit, and reference time + point, there must be a one-to-relationship between values of --TPT and --TPTNUM. in other + words, if domain, visit, and reference time point uniquely identify subject data, then if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different time point descriptions in --TPT. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0468 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Time points will be represented using both --TPT and --TPTNUM. There will be + a one-to-one relationship between values of --TPT and --TPTNUM. + Document: TIG 1.0 + Item: Num 5 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0598 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TPT - operator: exists - - name: --TPTNUM - operator: not_exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: not_exists Core: Id: CORE-000026 Status: Published - Version: '1' + Version: "1" Description: When --TPT is present in a dataset, --TPTNUM must also be present. Executability: Fully Executable Outcome: @@ -84,9 +88,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000027/rule.yml b/Published/CORE-000027/rule.yml index 1d4a39b61..49c854fca 100644 --- a/Published/CORE-000027/rule.yml +++ b/Published/CORE-000027/rule.yml @@ -2,270 +2,283 @@ # Condition: TEDUR = null # Rule: TEENRL ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. - Document: SDTMIG v3.4 - Item: Specification - Section: 7.2.2 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. - Document: SDTMIG v3.4 - Item: Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be - populated.] - Document: IG v3.2 - Item: Specification|Assumption 12 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be - populated.] - Document: IG v3.3 - Item: Specification|Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0328 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. - Document: TIG 1.0 - Item: Specification TEENRL - Section: 2.8.10.28 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. - Document: TIG 1.0 - Item: Assumption 12 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0496 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be populated for each Element. - Document: IG v3.4 - Item: Specification - Section: 7.2.2 - - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. - Document: IG v3.4 - Item: Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be - populated.] - Document: IG v3.2 - Item: Specification|Assumption 12 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each - Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be - populated.] - Document: IG v3.3 - Item: Specification|Assumption 12 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0329 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification TEENRL [Either TEENRL or TEDUR must be present for each - Element. - Document: TIG 1.0 - Item: Specification TEENRL - Section: 2.8.10.28 - - Cited Guidance: Assumption 12[At least one of TEENRL and TEDUR must be populated. Both may - be populated.] - Document: TIG 1.0 - Item: Assumption 12 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0497 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.0 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND214 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be - present. - Document: TIG v1.0 - Item: TEENRL CDISC Notes - Section: 2.8.9.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0141 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. + Document: SDTMIG v3.4 + Item: Specification + Section: 7.2.2 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: SDTMIG v3.4 + Item: Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.2 + Item: Specification|Assumption 12 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.3 + Item: Specification|Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0328 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element. + Document: TIG 1.0 + Item: Specification TEENRL + Section: 2.8.10.28 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: TIG 1.0 + Item: Assumption 12 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0496 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Either TEENRL or TEDUR must be populated for each Element. + Document: IG v3.4 + Item: Specification + Section: 7.2.2 + - Cited Guidance: At least one of TEENRL and TEDUR must be populated. Both may be populated. + Document: IG v3.4 + Item: Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.2 + Item: Specification|Assumption 12 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Either TEENRL or TEDUR must be present for each + Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be + populated.] + Document: IG v3.3 + Item: Specification|Assumption 12 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0329 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Specification TEENRL [Either TEENRL or TEDUR must be present for each + Element. + Document: TIG 1.0 + Item: Specification TEENRL + Section: 2.8.10.28 + - Cited Guidance: + Assumption 12[At least one of TEENRL and TEDUR must be populated. Both may + be populated.] + Document: TIG 1.0 + Item: Assumption 12 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0497 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.0 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND214 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Either TEENRL or TEDUR must be present for each Element; both may be + present. + Document: TIG v1.0 + Item: TEENRL CDISC Notes + Section: 2.8.9.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0141 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - any: - - name: TEDUR - operator: empty - - name: TEDUR - operator: not_exists - - any: - - name: TEENRL - operator: empty - - name: TEENRL - operator: not_exists + - any: + - name: TEDUR + operator: empty + - name: TEDUR + operator: not_exists + - any: + - name: TEENRL + operator: empty + - name: TEENRL + operator: not_exists Core: Id: CORE-000027 Status: Published - Version: '1' + Version: "1" Description: Either TEENRL or TEDUR must be present for each Element. Executability: Fully Executable Outcome: Message: At least one of TEENRL and TEDUR must be populated. Output Variables: - - ETCD - - TEDUR - - TEENRL + - ETCD + - TEDUR + - TEENRL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000028/rule.yml b/Published/CORE-000028/rule.yml index 010878334..d04a33512 100644 --- a/Published/CORE-000028/rule.yml +++ b/Published/CORE-000028/rule.yml @@ -2,94 +2,98 @@ # Condition: --TPTREF = null # Rule: --ELTM = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The interval of time between a planned time point and a fixed reference - point, represented in a standardized character format. The fixed reference point is in - --TPTREF. - Document: SDTM Model v2.0 - Item: --ELTM - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Planned Elapsed time relative to a planned fixed reference (--TPTREF) such - as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive - measures. Not a clock time or a date/time variable, but an interval. Format=ISO8601 - Document: SDTM Model v1.7 - Item: Table 2.2.5, --ELTM - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Planned Elapsed time in ISO 8601 character format relative to a planned - fixed reference (--TPTREF) such as "Previous Dose" or "Previous Meal". - Document: SDTM Model v1.4 - Item: Table 2.2.5, --ELTM - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0008 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: "When instances of an activity are scheduled at planned time intervals relative - to a fixed reference point (e.g., an exposure), the following timing variables will be used: - --TPTREF- Represents a description of the fixed reference point from which the planned observation - will be made.-ELTM represents the planned elapsed time from the fixed timepoint reference to - the planned observation." - Document: TIG 1.0 - Item: Table 2 Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0293 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The interval of time between a planned time point and a fixed reference + point, represented in a standardized character format. The fixed reference point is in + --TPTREF. + Document: SDTM Model v2.0 + Item: --ELTM + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Planned Elapsed time relative to a planned fixed reference (--TPTREF) such + as "Previous Dose" or "Previous Meal". This variable is useful where there are repetitive + measures. Not a clock time or a date/time variable, but an interval. Format=ISO8601 + Document: SDTM Model v1.7 + Item: Table 2.2.5, --ELTM + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Planned Elapsed time in ISO 8601 character format relative to a planned + fixed reference (--TPTREF) such as "Previous Dose" or "Previous Meal". + Document: SDTM Model v1.4 + Item: Table 2.2.5, --ELTM + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0008 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "When instances of an activity are scheduled at planned time intervals relative + to a fixed reference point (e.g., an exposure), the following timing variables will be used: + --TPTREF- Represents a description of the fixed reference point from which the planned observation + will be made.-ELTM represents the planned elapsed time from the fixed timepoint reference to + the planned observation." + Document: TIG 1.0 + Item: Table 2 Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0293 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TPTREF - operator: empty - - name: --ELTM - operator: non_empty + - name: --TPTREF + operator: empty + - name: --ELTM + operator: non_empty Core: Id: CORE-000028 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TPTREF is empty, but --ELTM is not empty Executability: Fully Executable Outcome: Message: --TPTREF is empty and --ELTM is not empty Output Variables: - - --TPTREF - - --ELTM + - --TPTREF + - --ELTM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000029/rule.yml b/Published/CORE-000029/rule.yml index 8886532ea..4078b9178 100644 --- a/Published/CORE-000029/rule.yml +++ b/Published/CORE-000029/rule.yml @@ -2,58 +2,61 @@ # Condition: --TPTNUM present in dataset # Rule: --TPT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When time points are represented in SDTMIG domains, both --TPT and --TPTNUM - must be used. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0661 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: TIG 1.0 - Document: Time points will be represented using both --TPT and --TPTNUM. There will be a - one-to-one relationship between values of --TPT and --TPTNUM. - Item: Planned Timing table NUM 5 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0697 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When time points are represented in SDTMIG domains, both --TPT and --TPTNUM + must be used. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0661 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: TIG 1.0 + Document: + Time points will be represented using both --TPT and --TPTNUM. There will be a + one-to-one relationship between values of --TPT and --TPTNUM. + Item: Planned Timing table NUM 5 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0697 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: not_exists + - name: --TPTNUM + operator: exists + - name: --TPT + operator: not_exists Core: Id: CORE-000029 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TPTNUM exists in a dataset and --TPT does not exist. Executability: Fully Executable Outcome: - Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented + Message: + --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented in SDTMIG domains, both --TPT and --TPTNUM must be used. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000030/rule.yml b/Published/CORE-000030/rule.yml index 60432e289..859dae8c0 100644 --- a/Published/CORE-000030/rule.yml +++ b/Published/CORE-000030/rule.yml @@ -2,81 +2,86 @@ # Condition: --PRESP not present in dataset # Rule: --REASND not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP[An indication that the event or intervention was prospectively - stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event - or intervention has occurred.] - Document: SDTM v2.0 - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously - reported events. (--PRESP/Interventions) Used when a specific intervention is - pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with - --STAT when value is NOT DONE - Document: SDTM v1.7 - Section: 2.2.1 (Interventions )|2.2.2 (Events) - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--PRESP/Events) Used to indicate whether the event describe by --TERM was - pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously - reported events. (--PRESP/Interventions) Used when a specific intervention is - pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with - --STAT when value is NOT DONE - Document: SDTM v1.4 - Section: 2.2.1 (Interventions )|2.2.2 (Events) - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0053 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --PRESP[An indication that the event or intervention was prospectively - stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event - or intervention has occurred.] - Document: SDTM v2.1 - Item: '--PRESP|--STAT' - Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0329 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --PRESP[An indication that the event or intervention was prospectively + stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event + or intervention has occurred.] + Document: SDTM v2.0 + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--PRESP/Events) Used to indicate whether the event describe by --TERM was + pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events. (--PRESP/Interventions) Used when a specific intervention is + pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with + --STAT when value is NOT DONE + Document: SDTM v1.7 + Section: 2.2.1 (Interventions )|2.2.2 (Events) + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--PRESP/Events) Used to indicate whether the event describe by --TERM was + pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events. (--PRESP/Interventions) Used when a specific intervention is + pre-specified on a CRF. Values should be "Y" or null. (--REASND) Used in conjunction with + --STAT when value is NOT DONE + Document: SDTM v1.4 + Section: 2.2.1 (Interventions )|2.2.2 (Events) + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0053 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + --PRESP[An indication that the event or intervention was prospectively + stated or detailed on the CRF.]|--OCCUR[An indication as to whether a prespecified event + or intervention has occurred.] + Document: SDTM v2.1 + Item: "--PRESP|--STAT" + Section: 3.1.2 The Events Observation Class|3.1.2 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0329 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: not_exists - - name: --REASND - operator: exists + - name: --PRESP + operator: not_exists + - name: --REASND + operator: exists Core: Id: CORE-000030 Status: Published - Version: '1' -Description: Raise and error when --REASND is present in dataset and --PRESP is not present in + Version: "1" +Description: + Raise and error when --REASND is present in dataset and --PRESP is not present in dataset Executability: Fully Executable Outcome: @@ -85,12 +90,12 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000033/rule.yml b/Published/CORE-000033/rule.yml index a47a1b0f5..55d8b2f5c 100644 --- a/Published/CORE-000033/rule.yml +++ b/Published/CORE-000033/rule.yml @@ -2,89 +2,91 @@ # Condition: DSTERM = 'COMPLETED' # Rule: DSDECOD = 'COMPLETED' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the - controlled terminology codelist NCOMPLT. - Document: SDTMIG v3.4 - Item: Assumption 3.b.i. - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. - Document: SDTMIG v3.3 - Item: Assumption 3b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. - Document: SDTMIG v3.2 - Item: Assumption 3b - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0065 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the - Controlled Terminology codelist NCOMPLT. - Document: TIG 1.0 - Item: Assumption 3.b.i. - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0337 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + controlled terminology codelist NCOMPLT. + Document: SDTMIG v3.4 + Item: Assumption 3.b.i. + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. + Document: SDTMIG v3.3 + Item: Assumption 3b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: b. When DSTERM = 'COMPLETED', DSDECOD = 'COMPLETED'. + Document: SDTMIG v3.2 + Item: Assumption 3b + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0065 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + Controlled Terminology codelist NCOMPLT. + Document: TIG 1.0 + Item: Assumption 3.b.i. + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0337 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSTERM - operator: equal_to - value: COMPLETED - - name: DSDECOD - operator: not_equal_to - value: COMPLETED + - name: DSTERM + operator: equal_to + value: COMPLETED + - name: DSDECOD + operator: not_equal_to + value: COMPLETED Core: Id: CORE-000033 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DSTERM = "COMPLETED" and DSDECOD not equal to "COMPLETED". Executability: Fully Executable Outcome: Message: DSDECOD is not equal to "COMPLETED" when DSTERM equals "COMPLETED". Output Variables: - - DSTERM - - DSDECOD + - DSTERM + - DSDECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000034/rule.yml b/Published/CORE-000034/rule.yml index caf89127b..efe69c20a 100644 --- a/Published/CORE-000034/rule.yml +++ b/Published/CORE-000034/rule.yml @@ -2,96 +2,100 @@ # Condition: DSDECOD = 'DEATH' # Rule: DSSTDTC = DM.DTHDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should - represent the date/time that is captured in the clinical-trial database. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should - represent the date/time that is captured in the clinical-trial database. - Document: SDTMIG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should - represent the date/time that is captured in the clinical-trial database. - Document: SDTMIG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0069 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Date/time of death for any subject who died, in ISO 8601 format. Should - represent the date/time that is captured in the clinical-trial database. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0339 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: SDTMIG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0069 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Date/time of death for any subject who died, in ISO 8601 format. Should + represent the date/time that is captured in the clinical-trial database. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0339 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSDECOD - operator: equal_to - value: DEATH - - name: DSSTDTC - operator: not_equal_to - value: DTHDTC + - name: DSDECOD + operator: equal_to + value: DEATH + - name: DSSTDTC + operator: not_equal_to + value: DTHDTC Core: Id: CORE-000034 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DSSTDTC is not equal to DM.DTHDTC and DSDECOD is equal to "DEATH" Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: DSSTDTC does not equal DM.DTHDTC, when DSDECOD equals "DEATH". Output Variables: - - DSDECOD - - DSSTDTC - - DTHDTC + - DSDECOD + - DSSTDTC + - DTHDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000035/rule.yml b/Published/CORE-000035/rule.yml index 993112798..48301120a 100644 --- a/Published/CORE-000035/rule.yml +++ b/Published/CORE-000035/rule.yml @@ -2,58 +2,61 @@ # Condition: SVPRESP = null # Rule: VISITDY = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY is the Planned Study Day of a visit. It should not be populated for - unplanned visits. - Document: SDTMIG v3.4 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0658 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The planned study day of visit variable (VISITDY) should not be populated - for unplanned visits. - Document: TIG 1.0 - Item: Assumption 8 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0696 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + VISITDY is the Planned Study Day of a visit. It should not be populated for + unplanned visits. + Document: SDTMIG v3.4 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0658 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The planned study day of visit variable (VISITDY) should not be populated + for unplanned visits. + Document: TIG 1.0 + Item: Assumption 8 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0696 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: empty - - name: VISITDY - operator: non_empty + - name: SVPRESP + operator: empty + - name: VISITDY + operator: non_empty Core: Id: CORE-000035 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVPRESP is null and VISITDY is not null. Executability: Fully Executable Outcome: - Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit. + Message: + VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit. It should not be populated for unplanned visits. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000036/rule.yml b/Published/CORE-000036/rule.yml index 61e69e6ee..80a4efac3 100644 --- a/Published/CORE-000036/rule.yml +++ b/Published/CORE-000036/rule.yml @@ -2,78 +2,80 @@ # Condition: SVPRESP = 'Y' # Rule: VISIT in TV.VISIT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned Visits.... If a - subject-level dataset includes both VISITNUM and VISIT, then records that include values - of VISITNUM that appear in the TV dataset should also include the corresponding values of - VISIT from the TV dataset. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0657 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned visits, null - for unplanned visits.]|Section 10.8.33[Assumption 6] [The values of VISITNUM in the TV - dataset are the valid values of VISITNUM for planned Visits. Any values of VISITNUM that - appear in subject-level datasets that are not in the TV dataset are assumed to correspond - to unplanned Visits. If a subject-level dataset includes both VISITNUM and VISIT, then - records that include values of VISITNUM that appear in the TV dataset should also include - the corresponding values of VISIT from the TV dataset.] - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.25|2.8.10.33 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0695 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: "5.5" + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits.... If a + subject-level dataset includes both VISITNUM and VISIT, then records that include values + of VISITNUM that appear in the TV dataset should also include the corresponding values of + VISIT from the TV dataset. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0657 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + 2.8.10.25 [Specification][SVPRESP] [Value is "Y" for planned visits, null + for unplanned visits.]|Section 10.8.33[Assumption 6] [The values of VISITNUM in the TV + dataset are the valid values of VISITNUM for planned Visits. Any values of VISITNUM that + appear in subject-level datasets that are not in the TV dataset are assumed to correspond + to unplanned Visits. If a subject-level dataset includes both VISITNUM and VISIT, then + records that include values of VISITNUM that appear in the TV dataset should also include + the corresponding values of VISIT from the TV dataset.] + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.25|2.8.10.33 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0695 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISIT - operator: is_not_contained_by - value: $tv_visit + - name: SVPRESP + operator: equal_to + value: Y + - name: VISIT + operator: is_not_contained_by + value: $tv_visit Core: Id: CORE-000036 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVPRESP is "Y" and VISIT is not present in TV.VISIT. Executability: Fully Executable Operations: -- domain: TV - id: $tv_visit - name: VISIT - operator: distinct + - domain: TV + id: $tv_visit + name: VISIT + operator: distinct Outcome: Message: Planned visit is not found in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000037/rule.yml b/Published/CORE-000037/rule.yml index b6e889530..e6d4ca40d 100644 --- a/Published/CORE-000037/rule.yml +++ b/Published/CORE-000037/rule.yml @@ -1,46 +1,46 @@ # Variable: SVPRESP -# Condition: +# Condition: # Rule: SVPRESP in ("Y", null) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values should be "Y" or null. - Document: SDTM v2.0 - Section: Subject Visits - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0653 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject Visits[SVPRESP][Values should be "Y" or null.] - Document: SDTM v2.1 - Item: SVPRESP - Section: 3.2.3.3 Subject Visits - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0691 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Values should be "Y" or null. + Document: SDTM v2.0 + Section: Subject Visits + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0653 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Subject Visits[SVPRESP][Values should be "Y" or null.] + Document: SDTM v2.1 + Item: SVPRESP + Section: 3.2.3.3 Subject Visits + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0691 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: not_equal_to - value: Y - - name: SVPRESP - operator: non_empty + - name: SVPRESP + operator: not_equal_to + value: Y + - name: SVPRESP + operator: non_empty Core: Id: CORE-000037 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVPRESP not "Y" or null. Executability: Fully Executable Outcome: @@ -49,9 +49,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000038/rule.yml b/Published/CORE-000038/rule.yml index bf6a245c7..7eac71920 100644 --- a/Published/CORE-000038/rule.yml +++ b/Published/CORE-000038/rule.yml @@ -2,56 +2,58 @@ # Condition: SVOCCUR ^= null # Rule: SVPRESP = "Y" Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the visit is planned. Values should be "Y" or null. - Document: SDTM v2.0 - Item: SVPRESP - Section: Subject Visits - - Cited Guidance: An indication as to whether a prespecified (planned) visit has occurred. - Document: SDTM v2.0 - Item: SVOCCUR - Section: Subject Visits - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0654 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject Visits[SVPRESP][An indication that the visit is planned. Values - should be "Y" or null.] - Document: SDTM v1.0 - Item: SVPRESP - Section: 3.2.3.3 Subject Visits - - Cited Guidance: Subject Visits[SVOCCUR][An indication as to whether a prespecified (planned) - visit has occurred.] - Document: SDTM v1.0 - Item: SVOCCUR - Section: 3.2.3.3 Subject Visits - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0692 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the visit is planned. Values should be "Y" or null. + Document: SDTM v2.0 + Item: SVPRESP + Section: Subject Visits + - Cited Guidance: An indication as to whether a prespecified (planned) visit has occurred. + Document: SDTM v2.0 + Item: SVOCCUR + Section: Subject Visits + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0654 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Subject Visits[SVPRESP][An indication that the visit is planned. Values + should be "Y" or null.] + Document: SDTM v1.0 + Item: SVPRESP + Section: 3.2.3.3 Subject Visits + - Cited Guidance: + Subject Visits[SVOCCUR][An indication as to whether a prespecified (planned) + visit has occurred.] + Document: SDTM v1.0 + Item: SVOCCUR + Section: 3.2.3.3 Subject Visits + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0692 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVOCCUR - operator: non_empty - - name: SVPRESP - operator: not_equal_to - value: Y + - name: SVOCCUR + operator: non_empty + - name: SVPRESP + operator: not_equal_to + value: Y Core: Id: CORE-000038 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVOCCUR is not null and SVPRESP is not "Y". Executability: Fully Executable Outcome: @@ -60,9 +62,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000039/rule.yml b/Published/CORE-000039/rule.yml index 63270a86e..e0e632906 100644 --- a/Published/CORE-000039/rule.yml +++ b/Published/CORE-000039/rule.yml @@ -2,75 +2,77 @@ # Condition: SVPRESP = 'Y' # Rule: VISITNUM in TV.VISITNUM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in - particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, - Models for Special-Purpose Domains, for additional information about handling unplanned - Visits. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0655 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was planned (i.e., - visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned - visits. Planned and unplanned visits with a subject, whether or not they are physical - visits to the site, are represented in this domain. - Document: TIG 1.0 - Item: Specifications - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0693 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: "5.5" + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in + particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, + Models for Special-Purpose Domains, for additional information about handling unplanned + Visits. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0655 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Specification-SVPRESP Used to indicate whether the visit was planned (i.e., + visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned + visits. Planned and unplanned visits with a subject, whether or not they are physical + visits to the site, are represented in this domain. + Document: TIG 1.0 + Item: Specifications + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0693 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISITNUM - operator: is_not_contained_by - value: $tv_visitnum + - name: SVPRESP + operator: equal_to + value: Y + - name: VISITNUM + operator: is_not_contained_by + value: $tv_visitnum Core: Id: CORE-000039 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVPRESP="Y" and VISITNUM is not in TV.VISITNUM Executability: Fully Executable Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM for planned visit is not in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000040/rule.yml b/Published/CORE-000040/rule.yml index 3c23c0373..428367c29 100644 --- a/Published/CORE-000040/rule.yml +++ b/Published/CORE-000040/rule.yml @@ -2,74 +2,76 @@ # Condition: SVPRESP = null # Rule: VISITNUM not in TV.VISITNUM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. - Document: SDTMIG v3.4 - Item: SVPRESP - Section: '5.5' - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in - particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, - Models for Special-Purpose Domains, for additional information about handling unplanned - Visits. - Document: SDTMIG v3.4 - Item: Assumption 6 - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0656 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification-SVPRESP Used to indicate whether the visit was planned (i.e., - visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned - visits. Planned and unplanned visits with a subject, whether or not they are physical - visits to the site, are represented in this domain. - Document: TIG 1.0 - Item: Specifications - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0694 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value is "Y" for planned visits, null for unplanned visits. + Document: SDTMIG v3.4 + Item: SVPRESP + Section: "5.5" + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned Visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned Visits. This applies, in + particular, to the subject-level Subject Visits (SV) dataset; see SV under Section 5, + Models for Special-Purpose Domains, for additional information about handling unplanned + Visits. + Document: SDTMIG v3.4 + Item: Assumption 6 + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0656 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Specification-SVPRESP Used to indicate whether the visit was planned (i.e., + visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned + visits. Planned and unplanned visits with a subject, whether or not they are physical + visits to the site, are represented in this domain. + Document: TIG 1.0 + Item: Specifications + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0694 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: empty - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum + - name: SVPRESP + operator: empty + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum Core: Id: CORE-000040 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SVPRESP is null and VISITNUM is present in TV.VISITNUM Executability: Fully Executable Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM for unplanned visit is present in TV. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000041/rule.yml b/Published/CORE-000041/rule.yml index e9fa4326d..7e3431d2a 100644 --- a/Published/CORE-000041/rule.yml +++ b/Published/CORE-000041/rule.yml @@ -2,110 +2,118 @@ # Condition: TSVAL not populated with values or synonyms of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null flavors), unless the term is included in published terminology. # Rule: TSVALNF = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Some codelists used for TSVAL include terms which are also null flavors. For - example, the Pharmaceutical Dosage Form codelist includes the values 'UNKNOWN' and 'NOT - APPLICABLE. In such cases, TSVAL should have the term from the codelist and TSVALNF should - be null. - Document: SDTMIG v3.4 - Item: Assumption 11 - Section: 7.4.2 - - Cited Guidance: While it would be possible to allow a value such as NONE or UNBOUNDED to be - entered in TSVAL, validation programs would then have to recognize this special term as - an exception to the expected data format. Therefore, it was decided that a separate null - flavor variable that uses the ISO 21090 null flavor terminology would be a better - solution. - Document: SDTMIG v3.4 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0649 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Some codelists used for TSVAL include terms which are also null flavors. For - example, the Pharmaceutical Dosage Form codelist includes the values "UNKNOWN" and "NOT - APPLICABLE". In such cases, TSVAL should have the term from the codelist and TSVALNF - should be null. - Document: TIG v1.0 - Item: Assumption 11 - Section: 2.8.10.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0689 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: While it would be possible to allow a value such as NONE or UNBOUNDED to be - entered in TSVAL, validation programs would then have to recognize this special term as an - exception to the expected data format. Therefore, it was decided that a separate null - flavor variable that uses the ISO 21090 null flavor terminology would be a better - solution. - Document: IG v3.2 - Section: 'Section 7.4-TS: Use of Null Flavor Enumeration' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0459 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The variable TSVALNF is based on the idea of a "null flavor" as embodied in - the ISO 21090 standard; "Health Informatics' Harmonized data types for information - exchange." A null flavor is an ancillary piece of data that provides additional - information when its primary piece of data is null (has a missing value). There is - controlled terminology for the null flavor data item which includes such familiar values - as Unknown; Other; and Not Applicable among its fourteen terms - Document: IG v3.3 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0459 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Some codelists used for TSVAL include terms which are also null flavors. For + example, the Pharmaceutical Dosage Form codelist includes the values 'UNKNOWN' and 'NOT + APPLICABLE. In such cases, TSVAL should have the term from the codelist and TSVALNF should + be null. + Document: SDTMIG v3.4 + Item: Assumption 11 + Section: 7.4.2 + - Cited Guidance: + While it would be possible to allow a value such as NONE or UNBOUNDED to be + entered in TSVAL, validation programs would then have to recognize this special term as + an exception to the expected data format. Therefore, it was decided that a separate null + flavor variable that uses the ISO 21090 null flavor terminology would be a better + solution. + Document: SDTMIG v3.4 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0649 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Some codelists used for TSVAL include terms which are also null flavors. For + example, the Pharmaceutical Dosage Form codelist includes the values "UNKNOWN" and "NOT + APPLICABLE". In such cases, TSVAL should have the term from the codelist and TSVALNF + should be null. + Document: TIG v1.0 + Item: Assumption 11 + Section: 2.8.10.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0689 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + While it would be possible to allow a value such as NONE or UNBOUNDED to be + entered in TSVAL, validation programs would then have to recognize this special term as an + exception to the expected data format. Therefore, it was decided that a separate null + flavor variable that uses the ISO 21090 null flavor terminology would be a better + solution. + Document: IG v3.2 + Section: "Section 7.4-TS: Use of Null Flavor Enumeration" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0459 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The variable TSVALNF is based on the idea of a "null flavor" as embodied in + the ISO 21090 standard; "Health Informatics' Harmonized data types for information + exchange." A null flavor is an ancillary piece of data that provides additional + information when its primary piece of data is null (has a missing value). There is + controlled terminology for the null flavor data item which includes such familiar values + as Unknown; Other; and Not Applicable among its fourteen terms + Document: IG v3.3 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0459 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: TSVAL - operator: non_empty - - name: TSVAL - operator: not_matches_regex - value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative - infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but unknown|NAV|Temporarily - unavailable|NASK|Not asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$) - - name: TSVALNF - operator: non_empty + - name: TSVAL + operator: non_empty + - name: TSVAL + operator: not_matches_regex + value: + (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative + infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but unknown|NAV|Temporarily + unavailable|NASK|Not asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$) + - name: TSVALNF + operator: non_empty Core: Id: CORE-000041 Status: Published - Version: '1' -Description: Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms - of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null + Version: "1" +Description: + Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms + of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null flavors) but TSVALNF is completed. Executability: Fully Executable Outcome: - Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor description but + Message: + TSVAL is not populated with an ISO 21090 null flavor or null flavor description but TSVALNF is populated. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000042/rule.yml b/Published/CORE-000042/rule.yml index 3e7f9244a..3c19cc7d2 100644 --- a/Published/CORE-000042/rule.yml +++ b/Published/CORE-000042/rule.yml @@ -1,42 +1,42 @@ -# Variable: -# Condition: +# Variable: +# Condition: # Rule: TJ dataset not present Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The TT dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Trial Repro Stages - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0647 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 5.1.3.1 Trial Repro Stages - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0687 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The TT dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Trial Repro Stages + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0647 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 5.1.3.1 Trial Repro Stages + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0687 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - name: TT - operator: exists + - name: TT + operator: exists Core: Id: CORE-000042 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TT dataset is present. Executability: Fully Executable Outcome: @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - TT + - TT Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000043/rule.yml b/Published/CORE-000043/rule.yml index 7fc307256..482efd4b6 100644 --- a/Published/CORE-000043/rule.yml +++ b/Published/CORE-000043/rule.yml @@ -1,42 +1,42 @@ -# Variable: -# Condition: +# Variable: +# Condition: # Rule: TP dataset not present Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The TP dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Trial Repro Paths - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0648 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 5.1.3.2 Trial Repro Paths - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0688 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The TP dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Trial Repro Paths + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0648 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 5.1.3.2 Trial Repro Paths + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0688 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TP - operator: exists + - name: TP + operator: exists Core: Id: CORE-000043 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TP dataset is present. Executability: Fully Executable Outcome: @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - TP + - TP Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000044/rule.yml b/Published/CORE-000044/rule.yml index fd7f1d04e..5f500408e 100644 --- a/Published/CORE-000044/rule.yml +++ b/Published/CORE-000044/rule.yml @@ -1,42 +1,42 @@ -# Variable: -# Condition: +# Variable: +# Condition: # Rule: SJ dataset not present Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SJ dataset must not be used in human clinical trials. - Document: SDTM v2.0 - Section: Subject Repro Stages - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0646 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Section: Section 3.2.3.2 Subject Repro Stages - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0686 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The SJ dataset must not be used in human clinical trials. + Document: SDTM v2.0 + Section: Subject Repro Stages + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0646 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Section: Section 3.2.3.2 Subject Repro Stages + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0686 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - name: SJ - operator: exists + - name: SJ + operator: exists Core: Id: CORE-000044 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SJ dataset is present. Executability: Fully Executable Outcome: @@ -45,9 +45,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SJ + - SJ Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000045/rule.yml b/Published/CORE-000045/rule.yml index 17b8c1826..3cb012780 100644 --- a/Published/CORE-000045/rule.yml +++ b/Published/CORE-000045/rule.yml @@ -2,79 +2,82 @@ # Condition: ARMCD = null # Rule: ARMNRS^=null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, - ARMCD is null and ARMNRS is populated - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0517 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0517 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, - ARMCD is null and ARMNRS is populated - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0612 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0517 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0517 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0612 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: empty - - name: ARMNRS - operator: empty + - name: ARMCD + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000045 Status: Published - Version: '1' + Version: "1" Description: Verify ARMNRS is not null when ARMCD is null Executability: Fully Executable Outcome: Message: ARMNRS value is missing when ARMCD value is missing Output Variables: - - ARMCD - - ARMNRS + - ARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000046/rule.yml b/Published/CORE-000046/rule.yml index 35390cde0..380a3ccc1 100644 --- a/Published/CORE-000046/rule.yml +++ b/Published/CORE-000046/rule.yml @@ -2,79 +2,82 @@ # Condition: ARM = null # Rule: ARMNRS^=null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm, ARM - is null and ARMNRS is populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0519 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0519 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned arm, ARM is null and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0614 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm, ARM + is null and ARMNRS is populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0519 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0519 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0614 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARM - operator: empty - - name: ARMNRS - operator: empty + - name: ARM + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000046 Status: Published - Version: '1' + Version: "1" Description: Verify ARMNRS is not null when ARM is null Executability: Fully Executable Outcome: Message: ARMNRS is missing when ARM value is missing Output Variables: - - ARM - - ARMNRS + - ARM + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index 91e911edb..a4808977d 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -2,89 +2,94 @@ # Condition: Study does not use multi-stage arm assignments and ACTARM ^= null # Rule: ARM in TA.ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned arm, ARM is null and ARMNRS is populated." - Document: SDTMIG v3.4 - Item: Specification and ACTARM CDISC Notes - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0518 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multistage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned arm, ARM is null and ARMNRS is populated. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0613 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated." + Document: SDTMIG v3.4 + Item: Specification and ACTARM CDISC Notes + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0518 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multistage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned arm, ARM is null and ARMNRS is populated. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0613 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARM - operator: non_empty - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ACTARM + operator: non_empty + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000047 Status: Published - Version: '1' -Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be - present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in - TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARM is populated, ARM must be + present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in + TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: - Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is - allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study + Message: + ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is + allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage assignment study Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000048/rule.yml b/Published/CORE-000048/rule.yml index bdadf8ebe..284078c98 100644 --- a/Published/CORE-000048/rule.yml +++ b/Published/CORE-000048/rule.yml @@ -1,44 +1,44 @@ # Variable: --METHOD -# Condition: +# Condition: # Rule: --METHOD not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not be used in human clinical trials. - Document: SDTM v2.0 - Item: --METHOD - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0621 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --METHOD - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0662 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not be used in human clinical trials. + Document: SDTM v2.0 + Item: --METHOD + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0621 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --METHOD + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0662 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --METHOD - operator: exists + - name: --METHOD + operator: exists Core: Id: CORE-000048 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --METHOD is present in an Interventions dataset. Executability: Fully Executable Outcome: @@ -47,9 +47,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000049/rule.yml b/Published/CORE-000049/rule.yml index 5e0a42009..587792c0b 100644 --- a/Published/CORE-000049/rule.yml +++ b/Published/CORE-000049/rule.yml @@ -1,94 +1,98 @@ # Variable: --USCHFL -# Condition: +# Condition: # Rule: --USCHFL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies - (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, - --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), - --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing - Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0507 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --USCHFL - Section: Interventions|Events|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0622 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), - --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0507 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--USCHFL - Section: Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 - The Events - Observations Class | Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend - Domains | 2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0602 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --USCHFL - Section: Interventions|Events|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0663 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, + --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), + --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing + Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0507 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --USCHFL + Section: Interventions|Events|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0622 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0507 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--USCHFL + Section: + Section 3.1.1 - The Interventions Observations Class | Section 3.1.2 - The Events + Observations Class | Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend + Domains | 2.8.3 How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0602 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --USCHFL + Section: Interventions|Events|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0663 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --USCHFL - operator: exists + - name: --USCHFL + operator: exists Core: Id: CORE-000049 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --USCHFL is present. Executability: Fully Executable Outcome: @@ -97,9 +101,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000050/rule.yml b/Published/CORE-000050/rule.yml index b104b28f8..addc5f422 100644 --- a/Published/CORE-000050/rule.yml +++ b/Published/CORE-000050/rule.yml @@ -1,44 +1,44 @@ # Variable: --RSTIND -# Condition: +# Condition: # Rule: --RSTIND not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RSTIND - Section: Interventions|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0623 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RSTIND - Section: Interventions|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0664 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RSTIND + Section: Interventions|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0623 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RSTIND + Section: Interventions|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0664 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RSTIND - operator: exists + - name: --RSTIND + operator: exists Core: Id: CORE-000050 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RSTIND is present. Executability: Fully Executable Outcome: @@ -47,10 +47,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000051/rule.yml b/Published/CORE-000051/rule.yml index 3cc331b90..8b7bd1030 100644 --- a/Published/CORE-000051/rule.yml +++ b/Published/CORE-000051/rule.yml @@ -1,44 +1,44 @@ # Variable: --RSTMOD -# Condition: +# Condition: # Rule: --RSTMOD not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RSTMOD - Section: Interventions|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0624 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RSTMOD - Section: Interventions|Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0665 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RSTMOD + Section: Interventions|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0624 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RSTMOD + Section: Interventions|Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0665 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RSTMOD - operator: exists + - name: --RSTMOD + operator: exists Core: Id: CORE-000051 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RSTMOD is present. Executability: Fully Executable Outcome: @@ -47,10 +47,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000052/rule.yml b/Published/CORE-000052/rule.yml index 248d1a981..53f98b0b2 100644 --- a/Published/CORE-000052/rule.yml +++ b/Published/CORE-000052/rule.yml @@ -1,43 +1,43 @@ # Variable: --IMPBL -# Condition: +# Condition: # Rule: --IMPBL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --IMPLBL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0625 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --IMPLBL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0666 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --IMPLBL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0625 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --IMPLBL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0666 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --IMPLBL - operator: exists + - name: --IMPLBL + operator: exists Core: Id: CORE-000052 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --IMPLBL is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000054/rule.yml b/Published/CORE-000054/rule.yml index cc7da647f..7cc5a5dd7 100644 --- a/Published/CORE-000054/rule.yml +++ b/Published/CORE-000054/rule.yml @@ -1,43 +1,43 @@ # Variable: --DTHREL -# Condition: +# Condition: # Rule: --DTHREL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --DTHREL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0627 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --DTHREL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0668 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --DTHREL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0627 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --DTHREL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0668 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DTHREL - operator: exists + - name: --DTHREL + operator: exists Core: Id: CORE-000054 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DTHREL is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000055/rule.yml b/Published/CORE-000055/rule.yml index 0e5dd8d09..00a77384d 100644 --- a/Published/CORE-000055/rule.yml +++ b/Published/CORE-000055/rule.yml @@ -1,43 +1,43 @@ # Variable: --EXCLFL -# Condition: +# Condition: # Rule: --EXCLFL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --EXCLFL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0628 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --EXCLFL - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0669 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --EXCLFL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0628 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --EXCLFL + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0669 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --EXCLFL - operator: exists + - name: --EXCLFL + operator: exists Core: Id: CORE-000055 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --EXCLFL is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000056/rule.yml b/Published/CORE-000056/rule.yml index 45fe7e6d4..9494c0a70 100644 --- a/Published/CORE-000056/rule.yml +++ b/Published/CORE-000056/rule.yml @@ -1,43 +1,43 @@ # Variable: --REASEX -# Condition: +# Condition: # Rule: --REASEX not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --REASEX is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0629 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --REASEX - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0670 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --REASEX is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0629 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --REASEX + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0670 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --REASEX - operator: exists + - name: --REASEX + operator: exists Core: Id: CORE-000056 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --REASEX is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000057/rule.yml b/Published/CORE-000057/rule.yml index d4adc8d9f..c9e73e13d 100644 --- a/Published/CORE-000057/rule.yml +++ b/Published/CORE-000057/rule.yml @@ -1,92 +1,96 @@ # Variable: FETUSID -# Condition: +# Condition: # Rule: FETUSID not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: FETUSID is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Identifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0509 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies - (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials - --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) - --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) - --NOMDY (Timing Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0630 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), - --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0509 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--FETUSID - Section: Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains |2.8.3 How - to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0604 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: FETUSID - Section: Identifiers - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0671 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: FETUSID is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Identifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0509 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0630 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0509 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--FETUSID + Section: + Section 3.1.4 - Identifiers for All Classes | 2.8.2 How Extend Domains |2.8.3 How + to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0604 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: FETUSID + Section: Identifiers + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0671 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: FETUSID - operator: exists + - name: FETUSID + operator: exists Core: Id: CORE-000057 Status: Published - Version: '1' + Version: "1" Description: FETUSID must not be present in SDTM domains. Executability: Fully Executable Outcome: @@ -95,9 +99,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000058/rule.yml b/Published/CORE-000058/rule.yml index cb33cc49d..cac905751 100644 --- a/Published/CORE-000058/rule.yml +++ b/Published/CORE-000058/rule.yml @@ -1,43 +1,43 @@ # Variable: RPHASE -# Condition: +# Condition: # Rule: RPHASE not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPHASE is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0631 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPHASE - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0672 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPHASE is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0631 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPHASE + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0672 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RPHASE - operator: exists + - name: RPHASE + operator: exists Core: Id: CORE-000058 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RPHASE is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000059/rule.yml b/Published/CORE-000059/rule.yml index eb7326d94..1e8b5f8a5 100644 --- a/Published/CORE-000059/rule.yml +++ b/Published/CORE-000059/rule.yml @@ -1,43 +1,43 @@ # Variable: RPPLDY -# Condition: +# Condition: # Rule: RPPLDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0632 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPPLDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0673 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0632 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPPLDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0673 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RPPLDY - operator: exists + - name: RPPLDY + operator: exists Core: Id: CORE-000059 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RPPLDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000060/rule.yml b/Published/CORE-000060/rule.yml index 7f48b5073..2c0a461c1 100644 --- a/Published/CORE-000060/rule.yml +++ b/Published/CORE-000060/rule.yml @@ -1,43 +1,43 @@ # Variable: RPPLSTDY -# Condition: +# Condition: # Rule: RPPLSTDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLSTDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0633 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPPLSTDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0674 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLSTDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0633 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPPLSTDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0674 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RPPLSTDY - operator: exists + - name: RPPLSTDY + operator: exists Core: Id: CORE-000060 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RPPLSTDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000061/rule.yml b/Published/CORE-000061/rule.yml index 33f9c595e..b2a822d69 100644 --- a/Published/CORE-000061/rule.yml +++ b/Published/CORE-000061/rule.yml @@ -1,43 +1,43 @@ # Variable: RPLENDY -# Condition: +# Condition: # Rule: RPLENDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RPPLENDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0634 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: RPLENDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0675 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: RPPLENDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0634 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: RPLENDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0675 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RPPLENDY - operator: exists + - name: RPPLENDY + operator: exists Core: Id: CORE-000061 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RPPLENDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000064/rule.yml b/Published/CORE-000064/rule.yml index e44549d85..c09e5fb55 100644 --- a/Published/CORE-000064/rule.yml +++ b/Published/CORE-000064/rule.yml @@ -1,43 +1,43 @@ # Variable: --RPDY -# Condition: +# Condition: # Rule: --NOMLBL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0637 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0678 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0637 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0678 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RPDY - operator: exists + - name: --RPDY + operator: exists Core: Id: CORE-000064 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RPDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000065/rule.yml b/Published/CORE-000065/rule.yml index f6a58c03f..fa7975cd5 100644 --- a/Published/CORE-000065/rule.yml +++ b/Published/CORE-000065/rule.yml @@ -1,43 +1,43 @@ # Variable: --RPSTDY -# Condition: +# Condition: # Rule: --RPSTDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPSTDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0638 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPSTDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0679 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPSTDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0638 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPSTDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0679 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RPSTDY - operator: exists + - name: --RPSTDY + operator: exists Core: Id: CORE-000065 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RPSTDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000066/rule.yml b/Published/CORE-000066/rule.yml index 049dad592..80023fddc 100644 --- a/Published/CORE-000066/rule.yml +++ b/Published/CORE-000066/rule.yml @@ -1,43 +1,43 @@ # Variable: --RPENDY -# Condition: +# Condition: # Rule: --RPENDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --RPENDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0639 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RPENDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0680 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --RPENDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0639 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RPENDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0680 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RPENDY - operator: exists + - name: --RPENDY + operator: exists Core: Id: CORE-000066 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RPENDY is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000067/rule.yml b/Published/CORE-000067/rule.yml index a385bf775..c99dd83f7 100644 --- a/Published/CORE-000067/rule.yml +++ b/Published/CORE-000067/rule.yml @@ -1,43 +1,43 @@ # Variable: --DETECT -# Condition: +# Condition: # Rule: --DETECT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --DETECT is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0640 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --DETECT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0681 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --DETECT is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0640 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --DETECT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0681 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DETECT - operator: exists + - name: --DETECT + operator: exists Core: Id: CORE-000067 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DETECT is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000068/rule.yml b/Published/CORE-000068/rule.yml index d7f06d869..0273ee1a7 100644 --- a/Published/CORE-000068/rule.yml +++ b/Published/CORE-000068/rule.yml @@ -1,43 +1,43 @@ # Variable: AGETXT -# Condition: +# Condition: # Rule: AGETXT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AGETXT is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0641 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0682 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: AGETXT is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0641 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0682 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AGETXT - operator: exists + - name: AGETXT + operator: exists Core: Id: CORE-000068 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGETXT is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000069/rule.yml b/Published/CORE-000069/rule.yml index e28128ae0..ce9176462 100644 --- a/Published/CORE-000069/rule.yml +++ b/Published/CORE-000069/rule.yml @@ -1,43 +1,43 @@ # Variable: SPECIES -# Condition: +# Condition: # Rule: SPECIES not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SPECIES is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0642 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: SPECIES - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0683 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SPECIES is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0642 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: SPECIES + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0683 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SPECIES - operator: exists + - name: SPECIES + operator: exists Core: Id: CORE-000069 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SPECIES is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000070/rule.yml b/Published/CORE-000070/rule.yml index c6981caee..785f53b69 100644 --- a/Published/CORE-000070/rule.yml +++ b/Published/CORE-000070/rule.yml @@ -1,43 +1,43 @@ # Variable: STRAIN -# Condition: +# Condition: # Rule: STRAIN not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: STRAIN is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0643 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: STRAIN - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0684 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: STRAIN is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0643 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: STRAIN + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0684 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: STRAIN - operator: exists + - name: STRAIN + operator: exists Core: Id: CORE-000070 Status: Published - Version: '1' + Version: "1" Description: Raise an error when STRAIN is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000071/rule.yml b/Published/CORE-000071/rule.yml index 3f955909b..dae7c62be 100644 --- a/Published/CORE-000071/rule.yml +++ b/Published/CORE-000071/rule.yml @@ -1,43 +1,43 @@ # Variable: SBSTRAIN -# Condition: +# Condition: # Rule: SBSTRAIN not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SBSTRAIN is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0644 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: SBSTRAIN - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0685 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: SBSTRAIN is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0644 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: SBSTRAIN + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0685 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SBSTRAIN - operator: exists + - name: SBSTRAIN + operator: exists Core: Id: CORE-000071 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SBSTRAIN is present. Executability: Fully Executable Outcome: @@ -46,9 +46,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000074/rule.yml b/Published/CORE-000074/rule.yml index 7d565ddb2..87c5dc167 100644 --- a/Published/CORE-000074/rule.yml +++ b/Published/CORE-000074/rule.yml @@ -1,79 +1,83 @@ # Variable: --IMPLBL -# Condition: +# Condition: # Rule: --IMPLBL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies - (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, - --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), - --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing - Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0508 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), - --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0508 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--IMPLBL - Section: Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend Domains |2.8.3 - How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0603 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials, + --USCHFL (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), + --REASEX (Findings), --IMPLBL (Findings), FETUSID (Identifiers), --DETECT (Timing + Variables), --NOMDY (Timing Variables), --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0508 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0508 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--IMPLBL + Section: + Section 3.1.1 - The Findings Observations Class | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0603 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --IMPLBL - operator: exists + - name: --IMPLBL + operator: exists Core: Id: CORE-000074 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --IMPLBL is present. Executability: Fully Executable Outcome: Message: --IMPLBL is present. Output Variables: - - --IMPLBL + - --IMPLBL Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000075/rule.yml b/Published/CORE-000075/rule.yml index ac66408eb..f70e59918 100644 --- a/Published/CORE-000075/rule.yml +++ b/Published/CORE-000075/rule.yml @@ -1,92 +1,96 @@ # Variable: AEREASND -# Condition: +# Condition: # Rule: AEREASND not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR, --STAT, - and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. - They are not permitted because the AE domain contains only records for adverse events that - actually occurred. - Document: IG v3.4 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. - They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events that actually occurred.' - Document: IG v3.2 - Item: Assumption 8 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. - They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted - because the AE domain contains only records for adverse events that actually occurred.' - Document: IG v3.3 - Item: Assumption 9 - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0304 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR, --STAT, - and--REASND. They are the only qualifiers from the SDTM Events class not in the AE domain. - They are not permitted because the AE domain contains only records for adverse events that - actually occurred - Document: TIG 1.0 - Item: Assumption 10 - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0481 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following Qualifiers would not be used in AE, --OCCUR, --STAT, + and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred. + Document: IG v3.4 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred." + Document: IG v3.2 + Item: Assumption 8 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following Qualifiers would not be used in AE: --OCCUR, --STAT, and--REASND. + They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted + because the AE domain contains only records for adverse events that actually occurred." + Document: IG v3.3 + Item: Assumption 9 + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0304 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The following qualifiers would not be used in AE; --OCCUR, --STAT, + and--REASND. They are the only qualifiers from the SDTM Events class not in the AE domain. + They are not permitted because the AE domain contains only records for adverse events that + actually occurred + Document: TIG 1.0 + Item: Assumption 10 + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0481 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AEREASND - operator: exists + - name: AEREASND + operator: exists Core: Id: CORE-000075 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AEREASND is present. Executability: Fully Executable Outcome: Message: AEREASND is present. Output Variables: - - AEREASND + - AEREASND Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000080/rule.yml b/Published/CORE-000080/rule.yml index bb559c8bc..b82af1f5d 100644 --- a/Published/CORE-000080/rule.yml +++ b/Published/CORE-000080/rule.yml @@ -2,98 +2,103 @@ # Condition: --ELTM, --TPTNUM, and --TPT not present in dataset # Rule: --TPTREF not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference for a series - of planned time points, used for study data tabulation. Description of the fixed reference - point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: Model v2.0 - Item: --TPTREF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '(--TPTREF) Description of the fixed reference point referred to by --ELTM, --TPTNUM, - and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.' - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, - --STINT, and --ENINT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".' - Document: Model v1.7 - Item: 'Table 2.2.5.1: --TPTREF' - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0093 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference for a series - of planned time points, used for study data tabulation. Description of the fixed reference - point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: SDTM v2.1 - Item: --TPTREF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0358 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: Model v2.0 + Item: --TPTREF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "(--TPTREF) Description of the fixed reference point referred to by --ELTM, --TPTNUM, + and --TPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL." + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Description of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, + --STINT, and --ENINT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".' + Document: Model v1.7 + Item: "Table 2.2.5.1: --TPTREF" + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0093 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: SDTM v2.1 + Item: --TPTREF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0358 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ELTM - operator: not_exists - - name: --TPTNUM - operator: not_exists - - name: --TPT - operator: not_exists - - name: --TPTREF - operator: exists + - name: --ELTM + operator: not_exists + - name: --TPTNUM + operator: not_exists + - name: --TPT + operator: not_exists + - name: --TPTREF + operator: exists Core: Id: CORE-000080 Status: Published - Version: '1' -Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but + Version: "1" +Description: + Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but --TPTREF is present. Executability: Fully Executable Outcome: Message: --TPTREF is present when --ELTM, --TPTNUM, and --TPT are not present. Output Variables: - - --TPTREF - - --ELTM - - --TPTNUM - - --TPT + - --TPTREF + - --ELTM + - --TPTNUM + - --TPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000081/rule.yml b/Published/CORE-000081/rule.yml index c9565484c..9ffa87db0 100644 --- a/Published/CORE-000081/rule.yml +++ b/Published/CORE-000081/rule.yml @@ -2,159 +2,178 @@ # Condition: --PRESP not present in dataset # Rule: --STAT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed - on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified event was not answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or - detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified intervention was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed - on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified event was not answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or - detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified intervention was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --PRESP, an indication that the event was prospectively stated or detailed - on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified event was not answered. - Document: SDTM v2.0 - Section: Events - - Cited Guidance: --PRESP, an indication that the intervention was prospectively stated or - detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a - prespecified intervention was not answered. - Document: SDTM v2.0 - Section: Interventions - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.]| - Document: SDTM v1.7 - Section: Model v1.7[2.2.1 (Interventions )] - - Cited Guidance: Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.7 - Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific - intervention is pre-specified on a CRF. Values should be "Y" or null.] - Document: SDTM v1.4 - Section: Model v1.4[2.2.1 (Interventions) - - Cited Guidance: Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event - describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null - for spontaneously reported events. --STAT Used to indicate when a question about the - occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT - DONE] - Document: SDTM v1.4 - Section: Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0056 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'Events[--PRESP][An indication that the event was prospectively stated or detailed - on the CRF.]|Events[--STAT][Used to indicate when a question about the occurrence of a prespecified - event was not answered.]|Interventions[--PRESP][An indication that the intervention was prospectively - stated or detailed on the CRF.]|Interventions[--STAT][Used to indicate when a question about - the occurrence of a prespecified intervention was not answered.]' - Document: SDTM v2.1 - Item: --PRESP|--STAT - Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0330 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: + --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: + Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: + Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: + Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: + Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: + --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: + Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: + Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: + Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: + Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --PRESP, an indication that the event was prospectively stated or detailed + on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified event was not answered. + Document: SDTM v2.0 + Section: Events + - Cited Guidance: + --PRESP, an indication that the intervention was prospectively stated or + detailed on the CRF. --STAT, used to indicate when a question about the occurrence of a + prespecified intervention was not answered. + Document: SDTM v2.0 + Section: Interventions + - Cited Guidance: + Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.]| + Document: SDTM v1.7 + Section: Model v1.7[2.2.1 (Interventions )] + - Cited Guidance: + Model v1.7[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.7 + Section: Model v1.7[2.2.2 (Events)] + - Cited Guidance: + Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + intervention is pre-specified on a CRF. Values should be "Y" or null.] + Document: SDTM v1.4 + Section: Model v1.4[2.2.1 (Interventions) + - Cited Guidance: + Model v1.4[2.2.2 (Events)][--PRESP Used to indicate whether the event + describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null + for spontaneously reported events. --STAT Used to indicate when a question about the + occurrence of a pre-specified event was not answered. Should be null or hav a value of NOT + DONE] + Document: SDTM v1.4 + Section: Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0056 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "Events[--PRESP][An indication that the event was prospectively stated or detailed + on the CRF.]|Events[--STAT][Used to indicate when a question about the occurrence of a prespecified + event was not answered.]|Interventions[--PRESP][An indication that the intervention was prospectively + stated or detailed on the CRF.]|Interventions[--STAT][Used to indicate when a question about + the occurrence of a prespecified intervention was not answered.]" + Document: SDTM v2.1 + Item: --PRESP|--STAT + Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0330 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: not_exists - - name: --STAT - operator: exists + - name: --PRESP + operator: not_exists + - name: --STAT + operator: exists Core: Id: CORE-000081 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --PRESP is not present but --STAT is present. Executability: Fully Executable Outcome: @@ -163,12 +182,12 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000083/rule.yml b/Published/CORE-000083/rule.yml index fe79ab590..b72f3a030 100644 --- a/Published/CORE-000083/rule.yml +++ b/Published/CORE-000083/rule.yml @@ -2,85 +2,90 @@ # Condition: --LOBXFL = 'Y' and --DRVFL = null # Rule: --ORRES ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. - Document: Model v2.0 - Item: --LOBXFL - Section: The Findings Observation Class - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0553 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Should be "Y" or null. - Document: Model v1.7 - Item: --LOBXFL - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0553 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Operationally derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. - Document: SDTM v2.1 - Item: --LOBXFL - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0641 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Operationally derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. + Document: Model v2.0 + Item: --LOBXFL + Section: The Findings Observation Class + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0553 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Should be "Y" or null. + Document: Model v1.7 + Item: --LOBXFL + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0553 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Operationally derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. Should be "Y" or null. + Document: SDTM v2.1 + Item: --LOBXFL + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0641 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ORRES - operator: empty - - name: --LOBXFL - operator: equal_to - value: Y - - any: - - name: --DRVFL - operator: not_exists - - name: --DRVFL - operator: not_equal_to + - name: --ORRES + operator: empty + - name: --LOBXFL + operator: equal_to value: Y + - any: + - name: --DRVFL + operator: not_exists + - name: --DRVFL + operator: not_equal_to + value: Y Core: Id: CORE-000083 Status: Published - Version: '1' -Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not + Version: "1" +Description: + Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not present in the dataset Executability: Fully Executable Outcome: - Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset + Message: + --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset or is not equal to "Y" Output Variables: - - --ORRES - - --LOBXFL - - --DRVFL + - --ORRES + - --LOBXFL + - --DRVFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000084/rule.yml b/Published/CORE-000084/rule.yml index b8074e722..e9e31b654 100644 --- a/Published/CORE-000084/rule.yml +++ b/Published/CORE-000084/rule.yml @@ -2,88 +2,92 @@ # Condition: --ENTPT present in dataset # Rule: --ENRTPT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a reference - time point. The sponsor-defined reference time point is in --ENTPT. - Document: Model v2.0 - Item: --ENRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after the - sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENRTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0057 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a reference - time point. The sponsor-defined reference time point is in --ENTPT. - Document: SDTM v2.1 - Item: --ENRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0331 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: Model v2.0 + Item: --ENRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENRTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0057 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: SDTM v2.1 + Item: --ENRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0331 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ENTPT - operator: exists - - name: --ENRTPT - operator: not_exists + - name: --ENTPT + operator: exists + - name: --ENRTPT + operator: not_exists Core: Id: CORE-000084 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --ENTPT exists in a dataset and --ENRTPT does not exist. Executability: Fully Executable Outcome: Message: --ENTPT exists in a dataset, but --ENRTPT does not exist. Output Variables: - - --ENTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000085/rule.yml b/Published/CORE-000085/rule.yml index a5dbb4c0c..b73db6a30 100644 --- a/Published/CORE-000085/rule.yml +++ b/Published/CORE-000085/rule.yml @@ -2,89 +2,93 @@ # Condition: --STTPT ^= null # Rule: --STRTPT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to a reference - time point. The sponsor-defined reference time point is in --STTPT. - Document: Model v2.0 - Item: --STRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before or after the - sponsor-defined reference time point defined by variable --STTPT. - Document: Model v1.7 - Item: Table 2.2.5.1, --STRTPT - Section: 2.2.5. Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STRTPT) Identifies the start of the observation as being before or after - the sponsor-defined reference time point defined by variable --STTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0059 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to a reference - time point. The sponsor-defined reference time point is in --STTPT. - Document: SDTM v2.1 - Item: --STRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0333 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: Model v2.0 + Item: --STRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before or after the + sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.7 + Item: Table 2.2.5.1, --STRTPT + Section: 2.2.5. Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--STRTPT) Identifies the start of the observation as being before or after + the sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0059 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: SDTM v2.1 + Item: --STRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0333 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --STTPT - operator: non_empty - - name: --STRTPT - operator: empty + - name: --STTPT + operator: non_empty + - name: --STRTPT + operator: empty Core: Id: CORE-000085 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --STTPT is completed and --STRTPT is empty Executability: Fully Executable Outcome: Message: --STTPT is completed and --STRTPT is empty Output Variables: - - --STTPT - - --STRTPT + - --STTPT + - --STRTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000086/rule.yml b/Published/CORE-000086/rule.yml index 47204e931..ee7a6d900 100644 --- a/Published/CORE-000086/rule.yml +++ b/Published/CORE-000086/rule.yml @@ -1,104 +1,108 @@ # Variable: DVSTDTC -# Condition: +# Condition: # Rule: DVSTDTC >= DM.RFICDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to capture protocol deviations that - occurred during the course of the study (see ICH E3 Section 10.2 at - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). - Usually these are deviations that occur after the subject has been randomized or received - the first treatment. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain model is to capture protocol deviations that - occurred during the course of the study (see ICH E3 Section 10.2 at - http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). - Usually these are deviations that occur after the subject has been randomized or received - the first treatment. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The intent of the domain is to capture protocol violations and deviations - during the course of the study and will store only those criteria violation by or deviated - from by the subject and not a response to each violation or deviation. - Document: IG v3.2 - Item: '' - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0075 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 1. The DV domain is an Events model for collected protocol deviations and - not for derived protocol deviations that are more likely to be part of analysis. Events - typically include what the event was, captured in --TERM (the topic variable), and when it - happened (captured in its start and/or end dates). The intent of the domain model is to - capture protocol deviations that occurred during the course of the study (see ICH E3, - Section 10.2[1]). - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.19 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0341 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to capture protocol deviations that + occurred during the course of the study (see ICH E3 Section 10.2 at + http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). + Usually these are deviations that occur after the subject has been randomized or received + the first treatment. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain model is to capture protocol deviations that + occurred during the course of the study (see ICH E3 Section 10.2 at + http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf). + Usually these are deviations that occur after the subject has been randomized or received + the first treatment. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The intent of the domain is to capture protocol violations and deviations + during the course of the study and will store only those criteria violation by or deviated + from by the subject and not a response to each violation or deviation. + Document: IG v3.2 + Item: "" + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0075 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + 1. The DV domain is an Events model for collected protocol deviations and + not for derived protocol deviations that are more likely to be part of analysis. Events + typically include what the event was, captured in --TERM (the topic variable), and when it + happened (captured in its start and/or end dates). The intent of the domain model is to + capture protocol deviations that occurred during the course of the study (see ICH E3, + Section 10.2[1]). + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.19 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0341 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DVSTDTC - operator: date_less_than - value: RFICDTC + - name: DVSTDTC + operator: date_less_than + value: RFICDTC Core: Id: CORE-000086 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DVSTDTC is earlier than RFICDTC in DM. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: DVSTDTC is earlier than RFICDTC in DM. Output Variables: - - DVSTDTC - - RFICDTC + - DVSTDTC + - RFICDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DV + - DV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000087/rule.yml b/Published/CORE-000087/rule.yml index 997fc80fa..67934bddc 100644 --- a/Published/CORE-000087/rule.yml +++ b/Published/CORE-000087/rule.yml @@ -2,87 +2,87 @@ # Condition: --SER ^= null # Rule: --SER in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: Model v2.0 - Item: --SER - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. - Document: Model v1.7 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0387 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: SDTM v2.1 - Item: --SER - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0549 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: Model v2.0 + Item: --SER + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. + Document: Model v1.7 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Is this is a serious event? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0387 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: SDTM v2.1 + Item: --SER + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0549 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESER - operator: non_empty - - name: AESER - operator: is_not_contained_by - value: - - Y - - N + - name: AESER + operator: non_empty + - name: AESER + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000087 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESER is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESER is completed, but not equal to "N" or "Y" Output Variables: - - AESER + - AESER Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000088/rule.yml b/Published/CORE-000088/rule.yml index 5c72ba2b0..408188add 100644 --- a/Published/CORE-000088/rule.yml +++ b/Published/CORE-000088/rule.yml @@ -1,189 +1,196 @@ # Variable: SETCD -# Condition: +# Condition: # Rule: SETCD value length <= 8 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v2.0 - Item: SETCD - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0149 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND25 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Short name of the Trial Set. The same element may occur more than once - within an Arm. Maximum 8 characters. - Document: TIG v1.0 - Item: SETCD CDISC Notes - Section: 2.8.9.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0169 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Maximum of 8 characters. - Document: SDTM v2.1 - Item: SETCD - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0390 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v2.0 + Item: SETCD + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0149 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND25 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Short name of the Trial Set. The same element may occur more than once + within an Arm. Maximum 8 characters. + Document: TIG v1.0 + Item: SETCD CDISC Notes + Section: 2.8.9.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0169 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Maximum of 8 characters. + Document: SDTM v2.1 + Item: SETCD + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0390 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SETCD - operator: matches_regex - value: ^(.){9,}$ + - name: SETCD + operator: matches_regex + value: ^(.){9,}$ Core: Id: CORE-000088 Status: Published - Version: '1' + Version: "1" Description: Verify that the length of value in SETCD variable is <= 8 Executability: Fully Executable Outcome: Message: SETCD value length is greater than 8 Output Variables: - - SETCD + - SETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TX + - DM + - TX Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000090/rule.yml b/Published/CORE-000090/rule.yml index 03781f133..aa1cc8c60 100644 --- a/Published/CORE-000090/rule.yml +++ b/Published/CORE-000090/rule.yml @@ -2,94 +2,98 @@ # Condition: RDOMAIN = null # Rule: IDVAR = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual - comments are related to domain records.Null for comments collected on separate CRFs. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. null for comments collected on separate CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. null for comments collected on separate CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0164 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. Null for comments collected on separate CRFs. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0397 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual + comments are related to domain records.Null for comments collected on separate CRFs. + Document: SDTMIG v3.4 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.3 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0164 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0397 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVAR - operator: non_empty - - name: RDOMAIN - operator: empty + - name: IDVAR + operator: non_empty + - name: RDOMAIN + operator: empty Core: Id: CORE-000090 Status: Published - Version: '1' + Version: "1" Description: Verify IDVAR is null when RDOMAIN is null Executability: Fully Executable Outcome: Message: RDOMAIN has a missing value but IDVAR has a non-missing value Output Variables: - - RDOMAIN - - IDVAR + - RDOMAIN + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000092/rule.yml b/Published/CORE-000092/rule.yml index 0fe853965..0d6133209 100644 --- a/Published/CORE-000092/rule.yml +++ b/Published/CORE-000092/rule.yml @@ -2,138 +2,138 @@ # Condition: --DOSTXT ^= null # Rule: --DOSE = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSTXT is populated. - Document: Model v2.0 - Item: --DOSE - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: Model v2.0 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. - Document: Model v1.4 - Item: --DOSE Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated - Document: Model v1.4 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. - Document: Model v1.7 - Item: --DOSE Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0110 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: Model v1.7 - Item: --DOSTXT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0111 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSTXT is populated. - Document: SDTM v2.1 - Item: --DOSE - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0374 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not populated when --DOSE is populated. - Document: SDTM v2.1 - Item: --DOSTXT - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0375 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSTXT is populated. + Document: Model v2.0 + Item: --DOSE + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: Model v2.0 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. + Document: Model v1.4 + Item: --DOSE Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated + Document: Model v1.4 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Amount of --TRT when numeric. Not populated when --DOSTXT is populated. + Document: Model v1.7 + Item: --DOSE Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0110 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: Model v1.7 + Item: --DOSTXT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0111 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSTXT is populated. + Document: SDTM v2.1 + Item: --DOSE + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0374 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not populated when --DOSE is populated. + Document: SDTM v2.1 + Item: --DOSTXT + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0375 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DOSTXT - operator: non_empty - - name: --DOSE - operator: non_empty + - name: --DOSTXT + operator: non_empty + - name: --DOSE + operator: non_empty Core: Id: CORE-000092 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DOSE ^= null and --DOSTXT ^= null. Executability: Fully Executable Outcome: Message: Both --DOSE and --DOSTXT values are populated Output Variables: - - --DOSE - - --DOSTXT + - --DOSE + - --DOSTXT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000093/rule.yml b/Published/CORE-000093/rule.yml index aa29644eb..16997dd89 100644 --- a/Published/CORE-000093/rule.yml +++ b/Published/CORE-000093/rule.yml @@ -2,93 +2,94 @@ # Condition: --DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null # Rule: --DOSU ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT - Document: Model v2.0 - Item: --DOSU - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg).' - Document: Model v1.4 - Item: --DOSU Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", "mg/kg".' - Document: Model v1.7 - Item: Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0114 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT - Document: SDTM v2.1 - Item: --DOSU - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0377 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT + Document: Model v2.0 + Item: --DOSU + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Units for --DOSE, --DOSTOT, or --DOSTXT (Examples: ng, mg, mg/kg)." + Document: Model v1.4 + Item: --DOSU Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 'Units for --DOSE, --DOSTOT, or --DOSTXT. Examples: "ng", "mg", "mg/kg".' + Document: Model v1.7 + Item: Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0114 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Units for --DOSE, --DOSTOT, or --DOSTXT + Document: SDTM v2.1 + Item: --DOSU + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0377 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DOSU - operator: empty - - any: - - name: --DOSE - operator: non_empty - - name: --DOSTXT - operator: non_empty - - name: --DOSTOT - operator: non_empty + - name: --DOSU + operator: empty + - any: + - name: --DOSE + operator: non_empty + - name: --DOSTXT + operator: non_empty + - name: --DOSTOT + operator: non_empty Core: Id: CORE-000093 Status: Published - Version: '1' -Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT + Version: "1" +Description: + Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null) Executability: Fully Executable Outcome: Message: Missing value for --DOSU, when --DOSE, --DOSTXT or --DOSTOT is provided Output Variables: - - --DOSE - - --DOSTXT - - --DOSTOT - - --DOSU + - --DOSE + - --DOSTXT + - --DOSTOT + - --DOSU Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000094/rule.yml b/Published/CORE-000094/rule.yml index 6fec9fe17..3a988a39d 100644 --- a/Published/CORE-000094/rule.yml +++ b/Published/CORE-000094/rule.yml @@ -1,76 +1,80 @@ # Variable: --DOSTXT -# Condition: +# Condition: # Rule: --DOSTXT value is non-numeric Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, substance, - radiation) taken or absorbed at a single administration. - Document: Model v2.0 - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per day, 200-400. Not - populated when --DOSE is populated.' - Document: Model v1.4 - Item: 'Specification: --DOSTXT' - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dosing information collected in text form. Examples: <1 per day, 200-400. Not - populated when --DOSE is populated.' - Document: Model v1.7 - Item: Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0112 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A textual description of the quantity of an agent (e.g., drug, substance, - radiation) taken or absorbed at a single administration. - Document: SDTM v2.1 - Item: --DOSTXT - Section: 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0376 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A textual description of the quantity of an agent (e.g., drug, substance, + radiation) taken or absorbed at a single administration. + Document: Model v2.0 + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Dosing information collected in text form. Examples: <1 per day, 200-400. Not + populated when --DOSE is populated." + Document: Model v1.4 + Item: "Specification: --DOSTXT" + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Dosing information collected in text form. Examples: <1 per day, 200-400. Not + populated when --DOSE is populated." + Document: Model v1.7 + Item: Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0112 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A textual description of the quantity of an agent (e.g., drug, substance, + radiation) taken or absorbed at a single administration. + Document: SDTM v2.1 + Item: --DOSTXT + Section: 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0376 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DOSTXT - operator: matches_regex - value: ^\d*\.?\d*$ - - name: --DOSTXT - operator: non_empty + - name: --DOSTXT + operator: matches_regex + value: ^\d*\.?\d*$ + - name: --DOSTXT + operator: non_empty Core: Id: CORE-000094 Status: Published - Version: '1' + Version: "1" Description: Raise an error if --DOSTXT value is numeric. Executability: Fully Executable Outcome: @@ -79,9 +83,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000095/rule.yml b/Published/CORE-000095/rule.yml index c54843546..1cbad677e 100644 --- a/Published/CORE-000095/rule.yml +++ b/Published/CORE-000095/rule.yml @@ -2,87 +2,91 @@ # Condition: SEUPDES ^= null # Rule: ETCD = 'UNPLAN' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element. The value of ETCD for an unplanned Element - is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element. The value of ETCD for an unplanned Element - is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element - only if ETCD has the value of "UNPLAN". - Document: IG v3.2 - Item: Assumption 6 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element. The value of ETCD for an unplanned Element - is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element - only if ETCD has the value of "UNPLAN". - Document: IG v3.3 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0211 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the applicant decides that the subject's experience for a particular - period of time cannot be represented with one of the planned elements, then that period of - time should be represented as an unplanned element. The value of ETCD for an unplanned - element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned - element. - Document: TIG 1.0 - Item: Assumption 3 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0430 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element. + Document: IG v3.4 + Item: Assumption 4 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.2 + Item: Assumption 6 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.3 + Item: Assumption 4 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0211 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If the applicant decides that the subject's experience for a particular + period of time cannot be represented with one of the planned elements, then that period of + time should be represented as an unplanned element. The value of ETCD for an unplanned + element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned + element. + Document: TIG 1.0 + Item: Assumption 3 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0430 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SEUPDES - operator: non_empty - - name: ETCD - operator: not_equal_to - value: UNPLAN + - name: SEUPDES + operator: non_empty + - name: ETCD + operator: not_equal_to + value: UNPLAN Core: Id: CORE-000095 Status: Published - Version: '1' + Version: "1" Description: Raise an error when SEUPDES ^= null, ETCD ^= 'UNPLAN' Executability: Fully Executable Outcome: @@ -91,9 +95,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000096/rule.yml b/Published/CORE-000096/rule.yml index 3f95f561d..46a012b63 100644 --- a/Published/CORE-000096/rule.yml +++ b/Published/CORE-000096/rule.yml @@ -2,98 +2,101 @@ # Condition: --LOC not present in dataset # Rule: --PORTOT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifer of --LOC.] Interventions[Variable Qualifer of - --LOC.] Findings[Variable Qualifer of --LOC.] - Document: Model v2.0 - Item: --PORTOT - Section: Events Interventions Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing the distribution, which - means arrangement of, apportioning of the intervention administration. - Document: Model v1.4 - Item: --PORTOT Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing the distribution, which - means arrangement of, apportioning of the intervention administration. - Document: Model v1.7 - Item: --PORTOT Specification - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0115 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: Findings[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --PORTOT - Section: Section 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0378 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[Variable Qualifer of --LOC.] Interventions[Variable Qualifer of + --LOC.] Findings[Variable Qualifer of --LOC.] + Document: Model v2.0 + Item: --PORTOT + Section: Events Interventions Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Qualifier for anatomical location further detailing the distribution, which + means arrangement of, apportioning of the intervention administration. + Document: Model v1.4 + Item: --PORTOT Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Qualifier for anatomical location further detailing the distribution, which + means arrangement of, apportioning of the intervention administration. + Document: Model v1.7 + Item: --PORTOT Specification + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0115 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: Findings[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --PORTOT + Section: Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0378 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --LOC - operator: not_exists - - name: --PORTOT - operator: exists + - name: --LOC + operator: not_exists + - name: --PORTOT + operator: exists Core: Id: CORE-000096 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --LOC does not exists in a dataset, --PORTOT exists. Executability: Fully Executable Outcome: Message: --PORTOT variable is present, when --LOC variable does not exist in a dataset. Output Variables: - - --LOC - - --PORTOT + - --LOC + - --PORTOT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 1a5f4c417..7ad197c4c 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -2,108 +2,113 @@ # Condition: EPOCH present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC # Rule: EPOCH = SE.EPOCH Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit. - Document: IG v3.4 - Item: Assumption 11 - Section: "5.5" - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: "1" - Version: "2.0" - Version: "3.4" - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit.It would be inappropriate to add the variables that support time points - (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.2 - Item: Assumption 11 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit.It would be inappropriate to add the variables that support time points - (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.3 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0218 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit. - Document: TIG 1.0 - Item: Assumption 11 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0432 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: IG v3.4 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.2 + Item: Assumption 11 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.3 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0218 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: TIG 1.0 + Item: Assumption 11 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0432 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: EPOCH - operator: exists - - name: SESTDTC - operator: date_less_than_or_equal_to - value: SVSTDTC - - name: SVSTDTC - operator: date_less_than_or_equal_to - value: SEENDTC - - name: EPOCH - operator: not_equal_to - value: SE.EPOCH + - name: EPOCH + operator: exists + - name: SESTDTC + operator: date_less_than_or_equal_to + value: SVSTDTC + - name: SVSTDTC + operator: date_less_than_or_equal_to + value: SEENDTC + - name: EPOCH + operator: not_equal_to + value: SE.EPOCH Core: Id: CORE-000097 Status: Published - Version: '1' -Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and + Version: "1" +Description: + Raise an error when variable EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - USUBJID - Name: SE + - Keys: + - USUBJID + Name: SE Outcome: Message: EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Output Variables: - - SESTDTC - - SVSTDTC - - SEENDTC - - EPOCH - - SE.EPOCH + - SESTDTC + - SVSTDTC + - SEENDTC + - EPOCH + - SE.EPOCH Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000098/rule.yml b/Published/CORE-000098/rule.yml index b40f32c6e..9d1292f76 100644 --- a/Published/CORE-000098/rule.yml +++ b/Published/CORE-000098/rule.yml @@ -2,103 +2,103 @@ # Condition: --LOC not present in dataset # Rule: --DIR not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Events - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Interventions - - Cited Guidance: Variable Qualifer of --LOC. - Document: Model v2.0 - Item: --DIR - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing directionality ... - Document: Model v1.4 - Item: --DIR Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Qualifier for anatomical location further detailing directionality ... - Document: Model v1.7 - Item: --DIR Specification - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0116 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: Findings[Variable Qualifier of --LOC.] - Document: SDTM v2.1 - Item: --DIR - Section: Section 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0379 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Events + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Interventions + - Cited Guidance: Variable Qualifer of --LOC. + Document: Model v2.0 + Item: --DIR + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing directionality ... + Document: Model v1.4 + Item: --DIR Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Qualifier for anatomical location further detailing directionality ... + Document: Model v1.7 + Item: --DIR Specification + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0116 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: Findings[Variable Qualifier of --LOC.] + Document: SDTM v2.1 + Item: --DIR + Section: Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0379 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --LOC - operator: not_exists - - name: --DIR - operator: exists + - name: --LOC + operator: not_exists + - name: --DIR + operator: exists Core: Id: CORE-000098 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --LOC does not exists in a dataset, --DIR exists. Executability: Fully Executable Outcome: Message: --DIR variable is present, when --LOC variable does not exist in a dataset. Output Variables: - - --LOC - - --DIR + - --LOC + - --DIR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000099/rule.yml b/Published/CORE-000099/rule.yml index 71ae9323b..17882a27a 100644 --- a/Published/CORE-000099/rule.yml +++ b/Published/CORE-000099/rule.yml @@ -2,95 +2,99 @@ # Condition: --ORRES ^= null # Rule: --STAT = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The --ORRES variable contains the result of the measurement or finding as - originally received or collected. --ORRES is an expected variable and should always be - populated, except (1) when --STAT = "NOT DONE" (because there is no result for such a - record) or (2) for derived records. - Document: IG v3.4 - Item: --STAT - Section: 4.5.1.1 - - Cited Guidance: Should be null or have a value of "NOT DONE". - Document: Model v2.0 - Item: --STAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in - LBORRES. - Document: IG v3.2 - Section: 6.3 LB - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in - LBORRES. - Document: IG v3.3 - Section: 6.3.6 LB - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0422 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2.8.7.3 This section describes how to populate --ORRES. Tests Not Done have - --ORRES null and --STAT "NOT DONE". {All Findings Domain Specifications- --STAT} Used - to indicate that a test was not done or a measurement was not taken. Should be null if a - result exists in REORRES. - Document: TIG 1.0 - Item: Findings Class Domains- Num 3 and Num 5 - Section: 2.8.7.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0577 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The --ORRES variable contains the result of the measurement or finding as + originally received or collected. --ORRES is an expected variable and should always be + populated, except (1) when --STAT = "NOT DONE" (because there is no result for such a + record) or (2) for derived records. + Document: IG v3.4 + Item: --STAT + Section: 4.5.1.1 + - Cited Guidance: Should be null or have a value of "NOT DONE". + Document: Model v2.0 + Item: --STAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Used to indicate exam not done. Should be null if a result exists in + LBORRES. + Document: IG v3.2 + Section: 6.3 LB + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Used to indicate exam not done. Should be null if a result exists in + LBORRES. + Document: IG v3.3 + Section: 6.3.6 LB + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0422 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + 2.8.7.3 This section describes how to populate --ORRES. Tests Not Done have + --ORRES null and --STAT "NOT DONE". {All Findings Domain Specifications- --STAT} Used + to indicate that a test was not done or a measurement was not taken. Should be null if a + result exists in REORRES. + Document: TIG 1.0 + Item: Findings Class Domains- Num 3 and Num 5 + Section: 2.8.7.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0577 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ORRES - operator: non_empty - - name: --STAT - operator: non_empty + - name: --ORRES + operator: non_empty + - name: --STAT + operator: non_empty Core: Id: CORE-000099 Status: Published - Version: '1' + Version: "1" Description: Raise an error when both --ORRES and --STAT values are populated Executability: Fully Executable Outcome: Message: Value for --STAT is populated, when --ORRES is populated Output Variables: - - --ORRES - - --STAT + - --ORRES + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000100/rule.yml b/Published/CORE-000100/rule.yml index 29d521835..e83959c98 100644 --- a/Published/CORE-000100/rule.yml +++ b/Published/CORE-000100/rule.yml @@ -2,96 +2,100 @@ # Condition: --VAMT ^= null # Rule: --TRTV ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A carrier or inert medium in which a medicinally active agent is - administered. - Document: Model v2.0 - Item: --TRTV - Section: Interventions - - Cited Guidance: Amount of the prepared product (treatment plus vehicle) administered. - Document: Model v2.0 - Item: --VAMT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a liquid in which the - treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment - + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for - the prepared product (treatment + vehicle). Examples: mL; mg.' - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--TRTV:Vehicle for administration of treatment; such as a liquid in which the - treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment - + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for - the prepared product (treatment + vehicle). Examples: mL; mg.' - Document: Model v1.7 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0423 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: --TRTV[A carrier or inert medium in which a medicinally active agent is - administered.]|--VAMT[Amount of the prepared product (treatment plus vehicle) - administered.] - Document: SDTM v2.1 - Item: Specifications '--TRTV|'--VAMT - Section: Section 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0578 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A carrier or inert medium in which a medicinally active agent is + administered. + Document: Model v2.0 + Item: --TRTV + Section: Interventions + - Cited Guidance: Amount of the prepared product (treatment plus vehicle) administered. + Document: Model v2.0 + Item: --VAMT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "--TRTV:Vehicle for administration of treatment; such as a liquid in which the + treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for + the prepared product (treatment + vehicle). Examples: mL; mg." + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "--TRTV:Vehicle for administration of treatment; such as a liquid in which the + treatment drug is dissolved. Example: SALINE. --VAMT: Amount of the prepared product (treatment + + vehicle) administered or given. Note: should not be diluent amount alone. --VAMTU: Units for + the prepared product (treatment + vehicle). Examples: mL; mg." + Document: Model v1.7 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0423 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + --TRTV[A carrier or inert medium in which a medicinally active agent is + administered.]|--VAMT[Amount of the prepared product (treatment plus vehicle) + administered.] + Document: SDTM v2.1 + Item: Specifications '--TRTV|'--VAMT + Section: Section 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0578 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --VAMT - operator: non_empty - - name: --TRTV - operator: empty + - name: --VAMT + operator: non_empty + - name: --TRTV + operator: empty Core: Id: CORE-000100 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --VAMT is not empty, but --TRTV is empty. Executability: Fully Executable Outcome: Message: Missing --TRTV value, when --VAMT value is populated. Output Variables: - - --TRTV - - --VAMT + - --TRTV + - --VAMT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000101/rule.yml b/Published/CORE-000101/rule.yml index 880a2d6c0..754c53f29 100644 --- a/Published/CORE-000101/rule.yml +++ b/Published/CORE-000101/rule.yml @@ -2,89 +2,93 @@ # Condition: --RESCAT ^= null # Rule: --STRESC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A grouping or classification of the results of an assessment. The result is - in --STRESC. - Document: Model v2.0 - Item: --RESCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or derived from - --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of - a finding.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESC: Contains the result value for all findings, copied or derived from - --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of - a finding.' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0427 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: --RESCAT A grouping or classification of the results of an assessment. The - result is in --STRESC. - Document: SDTM v2.1 - Item: Specification --RESCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0581 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A grouping or classification of the results of an assessment. The result is + in --STRESC. + Document: Model v2.0 + Item: --RESCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "--STRESC: Contains the result value for all findings, copied or derived from + --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of + a finding." + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "--STRESC: Contains the result value for all findings, copied or derived from + --ORRES in a standard format or in standard units. --RESCAT: used to categorize the result of + a finding." + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0427 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + --RESCAT A grouping or classification of the results of an assessment. The + result is in --STRESC. + Document: SDTM v2.1 + Item: Specification --RESCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0581 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RESCAT - operator: non_empty - - name: --STRESC - operator: empty + - name: --RESCAT + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000101 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RESCAT is not empty, but --STRESC is empty Executability: Fully Executable Outcome: Message: Missing --STRESC value, when --RESCAT value is populated. Output Variables: - - --RESCAT - - --STRESC + - --RESCAT + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000102/rule.yml b/Published/CORE-000102/rule.yml index d78bb6b10..a465dbe8d 100644 --- a/Published/CORE-000102/rule.yml +++ b/Published/CORE-000102/rule.yml @@ -2,98 +2,101 @@ # Condition: --TOX ^= null # Rule: --TOXGR ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: Model v2.0 - Item: --TOX - Section: Events|Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: - HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor - Comments column of the Define-XML document.' - Document: Model v1.4 - Item: --TOX - Section: 2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: - HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor - Comments column of the Define-XML document.' - Document: Model v1.7 - Item: --TOX - Section: 2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0428 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --TOXGR - Document: SDTM v2.1 - Item: --TOX - Section: Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation - Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0582 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: Model v2.0 + Item: --TOX + Section: Events|Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: + HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor + Comments column of the Define-XML document." + Document: Model v1.4 + Item: --TOX + Section: 2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Description of toxicity quantified by --TOXGR such as NCI CTCAE Short Name. Examples: + HYPERCALCEMIA; HYPOCALCEMIA. Sponsor should specify which scale and version is used in the Sponsor + Comments column of the Define-XML document." + Document: Model v1.7 + Item: --TOX + Section: 2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0428 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --TOXGR + Document: SDTM v2.1 + Item: --TOX + Section: + Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation + Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0582 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TOX - operator: non_empty - - name: --TOXGR - operator: empty + - name: --TOX + operator: non_empty + - name: --TOXGR + operator: empty Core: Id: CORE-000102 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TOX is not empty, but --TOXGR is empty. Executability: Fully Executable Outcome: Message: --TOXGR should not be null when --TOX is populated. Output Variables: - - --TOX - - --TOXGR + - --TOX + - --TOXGR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - AE - - MH - - CE - - EG - - LB - - PC - - PP + - AE + - MH + - CE + - EG + - LB + - PC + - PP Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000103/rule.yml b/Published/CORE-000103/rule.yml index 1f1cd6d2b..341f19145 100644 --- a/Published/CORE-000103/rule.yml +++ b/Published/CORE-000103/rule.yml @@ -2,103 +2,109 @@ # Condition: --SCAT ^= null # Rule: --CAT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table - 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used - to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Interventions[A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further - grouping or classification of the category for the topic of the finding, event, or - intervention. The category is in --CAT.]|Findings[A further grouping or classification of - the category for the topic of the finding, event, or intervention. The category is in - --CAT.] - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events - Observation Class Section|3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0583 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table + 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used + to define a further categorization of --CAT values.]" + Document: Model v1.7 + Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]" + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Interventions[A further grouping or classification of the category for the + topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further + grouping or classification of the category for the topic of the finding, event, or + intervention. The category is in --CAT.]|Findings[A further grouping or classification of + the category for the topic of the finding, event, or intervention. The category is in + --CAT.] + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: + Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Observation Class Section|3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0583 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: non_empty - - name: --CAT - operator: empty + - name: --SCAT + operator: non_empty + - name: --CAT + operator: empty Core: Id: CORE-000103 Status: Published - Version: '1' + Version: "1" Description: Part A - Raise an error when --SCAT is not empty, but --CAT is empty. Executability: Fully Executable Outcome: Message: --CAT should not be null when --SCAT is populated Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000104/rule.yml b/Published/CORE-000104/rule.yml index 104f70d03..c7fb51083 100644 --- a/Published/CORE-000104/rule.yml +++ b/Published/CORE-000104/rule.yml @@ -2,106 +2,112 @@ # Condition: --SCAT present in dataset # Rule: --CAT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.2 The Events Observation Class Section - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0584 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]" + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.2 The Events Observation Class Section + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0584 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: exists - - name: --CAT - operator: not_exists + - name: --SCAT + operator: exists + - name: --CAT + operator: not_exists Core: Id: CORE-000104 Status: Published - Version: '1' + Version: "1" Description: Part A - Raise an error when --SCAT exists in a dataset, but --CAT does not exist. Executability: Fully Executable Outcome: Message: --SCAT exists in a dataset, but --CAT does not exist. Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000105/rule.yml b/Published/CORE-000105/rule.yml index a70b22783..35e6d4535 100644 --- a/Published/CORE-000105/rule.yml +++ b/Published/CORE-000105/rule.yml @@ -2,106 +2,111 @@ # Condition: --LOBXFL = 'Y' # Rule: --STRESC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Result value is in --STRESC. - Document: Model v2.0 - Item: --STRESC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0569 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Should be "Y" or null. - Document: Model v1.7 - Item: --LOXBFL - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0569 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Operationally-derived indicator used to identify the last non-missing value - prior to RFXSTDTC. Result value is in --STRESC. - Document: SDTM v2.1 - Item: --STRESC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0653 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2602 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. + Document: Model v2.0 + Item: --STRESC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0569 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Should be "Y" or null. + Document: Model v1.7 + Item: --LOXBFL + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0569 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Operationally-derived indicator used to identify the last non-missing value + prior to RFXSTDTC. Result value is in --STRESC. + Document: SDTM v2.1 + Item: --STRESC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0653 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2602 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2602 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: --LOBXFL - operator: equal_to - value: Y - value_is_literal: true - - name: --STRESC - operator: empty + - name: --LOBXFL + operator: equal_to + value: Y + value_is_literal: true + - name: --STRESC + operator: empty Core: Id: CORE-000105 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --LOBXFL = 'Y' and --STRESC is empty. Executability: Fully Executable Outcome: Message: --LOBXFL = 'Y', but --STRESC is empty. Output Variables: - - --LOBXFL - - --TESTCD - - --STRESC + - --LOBXFL + - --TESTCD + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000106/rule.yml b/Published/CORE-000106/rule.yml index dd210a660..9b7cd2067 100644 --- a/Published/CORE-000106/rule.yml +++ b/Published/CORE-000106/rule.yml @@ -2,91 +2,95 @@ # Condition: --ENTPT ^= null # Rule: --ENRTPT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the end of an observation. This is the sponsor-defined - reference point referred to by --ENRTPT. - Document: Model v2.0 - Item: --ENTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after the - sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0045 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the end of an observation. This is the sponsor-defined - reference point referred to by --ENRTPT - Document: SDTM v2.1 - Item: --ENTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0324 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: Model v2.0 + Item: --ENTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0045 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT + Document: SDTM v2.1 + Item: --ENTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0324 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENRTPT - operator: empty + - name: --ENTPT + operator: non_empty + - name: --ENRTPT + operator: empty Core: Id: CORE-000106 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --ENTPT is completed and --ENRTPT is not completed. Executability: Fully Executable Outcome: Message: --ENTPT is completed, but --ENRTPT is not completed. Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000107/rule.yml b/Published/CORE-000107/rule.yml index 4a430b627..0173e6d72 100644 --- a/Published/CORE-000107/rule.yml +++ b/Published/CORE-000107/rule.yml @@ -1,110 +1,118 @@ # Variable: GEN -# Condition: +# Condition: # Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 - general observation classes. Each general class domain must also include at least one of - the following subject identifiers USUBJID, SPDEVID, or POOLID. - Document: Model v2.0 - Section: Identifiers - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP - datasets, and will identify records as AP data.' - Document: Model v2.0 - Section: Associated Persons Data - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0554 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 - general observation classes. Each general class domain must also include at least one of the - following subject identifiers: USUBJID, APID, SPDEVID, or POOLID.' - Document: Model v1.7 - Section: 2.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0554 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 - general observation classes. Each general class domain must also include at least one of - the following subject identifiers - SUBJID, SPDEVID, or POOLID. - Document: SDTM v2.1 - Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP - datasets, and will identify records as AP data. - Document: SDTM v2.1 - Section: Section 4.0 Associated Persons Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0642 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers USUBJID, SPDEVID, or POOLID. + Document: Model v2.0 + Section: Identifiers + - Cited Guidance: + The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data.' + Document: Model v2.0 + Section: Associated Persons Data + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0554 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of the + following subject identifiers: USUBJID, APID, SPDEVID, or POOLID." + Document: Model v1.7 + Section: 2.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0554 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers - SUBJID, SPDEVID, or POOLID. + Document: SDTM v2.1 + Section: Section 3.1.4 Identifiers For All Classes + - Cited Guidance: + The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data. + Document: SDTM v2.1 + Section: Section 4.0 Associated Persons Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0642 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: DOMAIN - operator: prefix_matches_regex - prefix: 2 - value: (AP|ap) - - name: APID - operator: not_exists - - all: - - name: DOMAIN - operator: not_prefix_matches_regex - prefix: 2 - value: (AP|ap) - - name: STUDYID - operator: exists - - name: --SEQ - operator: exists - - name: USUBJID - operator: not_exists - - name: SPDEVID - operator: not_exists - - name: POOLID - operator: not_exists - #added for TIG - - name: SPTOBID - operator: not_exists - - name: STOCONID - operator: not_exists + - all: + - name: DOMAIN + operator: prefix_matches_regex + prefix: 2 + value: (AP|ap) + - name: APID + operator: not_exists + - all: + - name: DOMAIN + operator: not_prefix_matches_regex + prefix: 2 + value: (AP|ap) + - name: STUDYID + operator: exists + - name: --SEQ + operator: exists + - name: USUBJID + operator: not_exists + - name: SPDEVID + operator: not_exists + - name: POOLID + operator: + not_exists + #added for TIG + - name: SPTOBID + operator: not_exists + - name: STOCONID + operator: not_exists Core: Id: CORE-000107 Status: Published - Version: '1' -Description: APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and - --SEQ being required for all domains based on one of the 3 general observation classes, one of + Version: "1" +Description: + APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and + --SEQ being required for all domains based on one of the 3 general observation classes, one of USUBJID, APID, SPDEVID, or POOLID must also be present. Executability: Fully Executable Outcome: - Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID, + Message: + An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID, SPTOBID, STOCONID should be present. Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS - - FINDINGS ABOUT - - FINDINGS + - EVENTS + - INTERVENTIONS + - FINDINGS ABOUT + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000108/rule.yml b/Published/CORE-000108/rule.yml index d8d23a089..12ecbc188 100644 --- a/Published/CORE-000108/rule.yml +++ b/Published/CORE-000108/rule.yml @@ -2,149 +2,158 @@ # Condition: DD record present for subject # Rule: DTHFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even - when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: A findings domain that contains the diagnosis of the cause of death for a - subject. - Document: IG v3.4 - Item: DD Description - Section: 6.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown.]|DD Assumption 1[This domain captures - information pertaining to the death of a subject, including the causes of death.] - Document: IG v3.2 - Item: Specification|DD Assumption 1 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[5.2][Indicates the subject died. Should be Y or null. Should be - populated even when the death date is unknown.]||IG v3.3[6.3.2][A findings domain that - contains the diagnosis of the cause of death for a subject] - Document: IG v3.3 - Section: IG v3.3[5.2]|IG v3.3[6.3.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0133 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even - when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0382 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - #CG0133 is identical to rule FB0602. Added metadata for FB0602. -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0602 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: "5.2" + - Cited Guidance: + A findings domain that contains the diagnosis of the cause of death for a + subject. + Document: IG v3.4 + Item: DD Description + Section: 6.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown.]|DD Assumption 1[This domain captures + information pertaining to the death of a subject, including the causes of death.] + Document: IG v3.2 + Item: Specification|DD Assumption 1 + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[5.2][Indicates the subject died. Should be Y or null. Should be + populated even when the death date is unknown.]||IG v3.3[6.3.2][A findings domain that + contains the diagnosis of the cause of death for a subject] + Document: IG v3.3 + Section: IG v3.3[5.2]|IG v3.3[6.3.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0133 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0382 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + #CG0133 is identical to rule FB0602. Added metadata for FB0602. + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0602 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: DTHFL - operator: not_equal_to - value: 'Y' - - name: USUBJID - operator: is_contained_by - value: $usubjids_in_dd + - name: DTHFL + operator: not_equal_to + value: "Y" + - name: USUBJID + operator: is_contained_by + value: $usubjids_in_dd Core: Id: CORE-000108 Status: Published - Version: '1' -Description: When a record is present in the DD dataset then death flag (DTHFL) should be populated + Version: "1" +Description: + When a record is present in the DD dataset then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DD + - Keys: + - USUBJID + Name: DD Operations: -- domain: DD - id: $usubjids_in_dd - name: USUBJID - operator: distinct + - domain: DD + id: $usubjids_in_dd + name: USUBJID + operator: distinct Outcome: Message: DD record is present, but DTHFL in DM dataset is not "Y". Output Variables: - - DTHFL - - USUBJID + - DTHFL + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000110/rule.yml b/Published/CORE-000110/rule.yml index 2d9ca9a2b..5b0d67ad4 100644 --- a/Published/CORE-000110/rule.yml +++ b/Published/CORE-000110/rule.yml @@ -2,80 +2,83 @@ # Condition: --ORREF ^= null or --DRVFL='Y' # Rule: --STREFC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in - a standard format. - Document: SDTM v2.0 - Item: --STREFC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0549 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in - a standard format. - Document: Model v1.7 - Item: --STREFC - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0549 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Reference value for the result or finding copied or derived from --ORREF in - a standard format. - Document: SDTM v2.1 - Item: --STREFC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0637 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: SDTM v2.0 + Item: --STREFC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0549 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: Model v1.7 + Item: --STREFC + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0549 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Reference value for the result or finding copied or derived from --ORREF in + a standard format. + Document: SDTM v2.1 + Item: --STREFC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0637 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - any: - - name: --ORREF - operator: non_empty - - name: --DRVFL - operator: equal_to - value: Y - - name: --STREFC - operator: empty + - any: + - name: --ORREF + operator: non_empty + - name: --DRVFL + operator: equal_to + value: Y + - name: --STREFC + operator: empty Core: Id: CORE-000110 Status: Published - Version: '1' + Version: "1" Description: Raise an error when (--ORREF ^= null or --DRVFL='Y') and --STREFC is null. Executability: Fully Executable Outcome: Message: --STREFC is null when --ORREF is non-empty or --DRVFL is equal to 'Y' Output Variables: - - --ORREF - - --DRVFL - - --STREFC + - --ORREF + - --DRVFL + - --STREFC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000111/rule.yml b/Published/CORE-000111/rule.yml index 1b5b0919c..ce6bef3b3 100644 --- a/Published/CORE-000111/rule.yml +++ b/Published/CORE-000111/rule.yml @@ -1,72 +1,73 @@ # Variable: --AGENT -# Condition: +# Condition: # Rule: --AGENT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --AGENT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0564 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. - These variables are for use only in a specific domain and will be identified in the - appropriate implementation guide. - Document: Model v1.7 - Item: MSAGENT - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0564 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --AGENT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0649 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --AGENT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0564 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSAGENT + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0564 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --AGENT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0649 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --AGENT - operator: exists + - name: --AGENT + operator: exists Core: Id: CORE-000111 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --AGENT is present in a dataset other than MS. Executability: Fully Executable Outcome: Message: --AGENT is present in a dataset other than MS. Output Variables: - - --AGENT + - --AGENT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000112/rule.yml b/Published/CORE-000112/rule.yml index b38d8d73d..a162e78fe 100644 --- a/Published/CORE-000112/rule.yml +++ b/Published/CORE-000112/rule.yml @@ -1,72 +1,73 @@ # Variable: --CONC -# Condition: +# Condition: # Rule: --CONC not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --CONC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0565 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. - These variables are for use only in a specific domain and will be identified in the - appropriate implementation guide. - Document: Model v1.7 - Item: MSCONC - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0565 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --CONC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0650 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --CONC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0565 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSCONC + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0565 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --CONC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0650 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --CONC - operator: exists + - name: --CONC + operator: exists Core: Id: CORE-000112 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --CONC is present in a dataset other than MS. Executability: Fully Executable Outcome: Message: --CONC is present in a dataset other than MS. Output Variables: - - --CONC + - --CONC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000113/rule.yml b/Published/CORE-000113/rule.yml index 07f40618c..ec2b7ca7f 100644 --- a/Published/CORE-000113/rule.yml +++ b/Published/CORE-000113/rule.yml @@ -1,72 +1,73 @@ # Variable: --CONCU -# Condition: +# Condition: # Rule: --CONCU not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MS Domain only - Document: Model v2.0 - Item: --CONCU - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0566 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. - These variables are for use only in a specific domain and will be identified in the - appropriate implementation guide. - Document: Model v1.7 - Item: MSCONCU - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0566 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MS Domain only. - Document: SDTM v2.1 - Item: --CONCU - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0651 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MS Domain only + Document: Model v2.0 + Item: --CONCU + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0566 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MSCONCU + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0566 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: MS Domain only. + Document: SDTM v2.1 + Item: --CONCU + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0651 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --CONCU - operator: exists + - name: --CONCU + operator: exists Core: Id: CORE-000113 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --CONCU is present in a dataset other than MS. Executability: Fully Executable Outcome: Message: --CONCU is present in a dataset other than MS. Output Variables: - - --CONCU + - --CONCU Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - MS + - MS Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000114/rule.yml b/Published/CORE-000114/rule.yml index 22f0fa310..7962e429d 100644 --- a/Published/CORE-000114/rule.yml +++ b/Published/CORE-000114/rule.yml @@ -1,73 +1,74 @@ # Variable: --EVDTYP -# Condition: +# Condition: # Rule: --EVDTYP not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MH Domain only - Document: Model v2.0 - Item: --EVDTYP - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0567 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The concept of domain-specific variables was first introduced in SDTM v1.5. - These variables are for use only in a specific domain and will be identified in the - appropriate implementation guide. - Document: Model v1.7 - Item: MHEVDTYP - Section: Table 2.2.12.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0567 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: MH Domain only - Document: SDTM v2.1 - Item: --EVDTYP - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0652 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MH Domain only + Document: Model v2.0 + Item: --EVDTYP + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0567 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The concept of domain-specific variables was first introduced in SDTM v1.5. + These variables are for use only in a specific domain and will be identified in the + appropriate implementation guide. + Document: Model v1.7 + Item: MHEVDTYP + Section: Table 2.2.12.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0567 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: MH Domain only + Document: SDTM v2.1 + Item: --EVDTYP + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0652 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --EVDTYP - operator: exists + - name: --EVDTYP + operator: exists Core: Id: CORE-000114 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --EVDTYP is present in a dataset other than MH. Executability: Fully Executable Outcome: Message: --EVDTYP is present in a dataset other than MH. Output Variables: - - --EVDTYP + - --EVDTYP Rule Type: Record Data Scope: Classes: Include: # - FINDINGS - - EVENTS + - EVENTS Domains: Exclude: - - MH + - MH Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000116/rule.yml b/Published/CORE-000116/rule.yml index 37eb0bc8e..cddd15991 100644 --- a/Published/CORE-000116/rule.yml +++ b/Published/CORE-000116/rule.yml @@ -1,50 +1,52 @@ # Variable: --SPCUFL -# Condition: +# Condition: # Rule: --SPCUFL = 'N' or null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the - specimen is usable. - Document: SDTM v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0619 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the - specimen is usable. - Document: SDTM v2.1 - Item: Specification - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0660 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The value will be "N" if the specimen is not usable, and null if the + specimen is usable. + Document: SDTM v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0619 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value will be "N" if the specimen is not usable, and null if the + specimen is usable. + Document: SDTM v2.1 + Item: Specification + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0660 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SPCUFL - operator: exists - - name: --SPCUFL - operator: not_equal_to - value: N - - name: --SPCUFL - operator: non_empty + - name: --SPCUFL + operator: exists + - name: --SPCUFL + operator: not_equal_to + value: N + - name: --SPCUFL + operator: non_empty Core: Id: CORE-000116 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SPCUFL is not null or equal to "N" Executability: Fully Executable Outcome: @@ -53,9 +55,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000117/rule.yml b/Published/CORE-000117/rule.yml index a5933368f..9e451b004 100644 --- a/Published/CORE-000117/rule.yml +++ b/Published/CORE-000117/rule.yml @@ -2,144 +2,152 @@ # Condition: --PRESP = 'Y' and --OCCUR = null # Rule: --STAT = 'NOT DONE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or detailed on the - CRF. - Document: Model v2.0 - Item: --PRESP - Section: Events - - Cited Guidance: An indication as to whether a prespecified event has occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Events - - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified - event was not answered. - Document: Model v2.0 - Item: STAT - Section: Events - - Cited Guidance: An indication that the intervention was prospectively stated or detailed on - the CRF. - Document: Model v2.0 - Item: --PRESP - Section: Interventions - - Cited Guidance: An indication as to whether a prespecified intervention has occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Interventions - - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified - intervention was not answered. Should be null or have a value of "NOT DONE". - Document: Model v2.0 - Item: STAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1.0' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value - is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously - reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information - about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question - about the occurrence of a pre-specified event was not answered . Should be null or hav a value - of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value - is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe - by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously - reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information - about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question - about the occurrence of a pre-specified event was not answered . Should be null or hav a value - of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0081 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][An indication that the event was prospectively stated or - detailed on the CRF.]|Events|[--OCCUR][An indication as to whether a prespecified event - has occurred.]|Events[--STAT][Used to indicate when a question about the occurrence of a - prespecified event was not answered.]|Interventions[--PRESP][An indication that the - intervention was prospectively stated or detailed on the CRF.]|Interventions[--OCCUR][An - indication as to whether a prespecified intervention has - occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of - a prespecified intervention was not answered. Should be null or have a value of "NOT - DONE".] - Document: SDTM v2.1 - Item: --PRESP|--OCCUR|STAT - Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0346 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + An indication that the event was prospectively stated or detailed on the + CRF. + Document: Model v2.0 + Item: --PRESP + Section: Events + - Cited Guidance: An indication as to whether a prespecified event has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Events + - Cited Guidance: + Used to indicate when a question about the occurrence of a prespecified + event was not answered. + Document: Model v2.0 + Item: STAT + Section: Events + - Cited Guidance: + An indication that the intervention was prospectively stated or detailed on + the CRF. + Document: Model v2.0 + Item: --PRESP + Section: Interventions + - Cited Guidance: An indication as to whether a prespecified intervention has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Interventions + - Cited Guidance: + Used to indicate when a question about the occurrence of a prespecified + intervention was not answered. Should be null or have a value of "NOT DONE". + Document: Model v2.0 + Item: STAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 + Version: "1.0" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value + is NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe + by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information + about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question + about the occurrence of a pre-specified event was not answered . Should be null or hav a value + of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be "Y" or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or hav a value of NOT DONE][--REASND: Used in conjunction with --STAT when value + is NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate whether the event describe + by --TERM was pre-specified on a CRF. Value is Y for pre-specified events, null for spontaneously + reported events.][--OCCUR: Used to record whether a pre-specified event occurred when information + about the occurrence of a specific event is solicited.][--STAT: Used to indicate when a question + about the occurrence of a pre-specified event was not answered . Should be null or hav a value + of NOT DONE][--REASND: Used in conjunction with --STAT when value is NOT DONE]' + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0081 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][An indication that the event was prospectively stated or + detailed on the CRF.]|Events|[--OCCUR][An indication as to whether a prespecified event + has occurred.]|Events[--STAT][Used to indicate when a question about the occurrence of a + prespecified event was not answered.]|Interventions[--PRESP][An indication that the + intervention was prospectively stated or detailed on the CRF.]|Interventions[--OCCUR][An + indication as to whether a prespecified intervention has + occurred.]|Interventions[--STAT][Used to indicate when a question about the occurrence of + a prespecified intervention was not answered. Should be null or have a value of "NOT + DONE".] + Document: SDTM v2.1 + Item: --PRESP|--OCCUR|STAT + Section: 3.1.1The Interventions Observation Class|3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0346 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --OCCUR - operator: empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --PRESP + operator: equal_to + value: Y + - name: --OCCUR + operator: empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000117 Status: Published - Version: '1' -Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is + Version: "1" +Description: + Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is null Executability: Fully Executable Outcome: Message: --STAT should equal 'NOT DONE' when --PRESP = 'Y' and --OCCUR = null Output Variables: - - --STAT - - --PRESP - - --OCCUR + - --STAT + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index 1fa4b99b7..5cfd842ea 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -2,148 +2,160 @@ # Condition: --PRESP = 'Y' and --OCCUR = null # Rule: --STAT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF - Document: SDTM v2.0 - Item: --PRESP - Section: Events - - Cited Guidance: An indication as to whether a prespecified event has occurred - Document: SDTM v2.0 - Item: --OCCUR - Section: Events - - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified - event was not answered. Should be null or have a value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Events - - Cited Guidance: An indication that the intervention was prospectively stated or detailed on - the CRF - Document: Model v2.0 - Item: --PRESP - Section: Interventions - - Cited Guidance: An indication as to whether a prespecified intervention has occurred. - Document: Model v2.0 - Item: --OCCUR - Section: Interventions - - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified - intervention was not answered. Should be null or have a value of 'NOT DONE' - Document: Model v2.0 - Item: --STAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: "2" - Version: "2.0" - Version: "3.4" - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or have a value of NOT DONE]" - Document: Model v1.4 - Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention - is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a - pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate - whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified - events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified - event occurred when information about the occurrence of a specific event is solicited.][--STAT: - Used to indicate when a question about the occurrence of a pre-specified event was not answered. - Should be null or have a value of NOT DONE]" - Document: Model v1.7 - Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0404 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF - | An indication that the intervention was prospectively stated or detailed on the CRF. - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings - Observation Class - - Cited Guidance: An indication as to whether a prespecified event has occurred. | An - indication as to whether a prespecified intervention has occurred - Document: SDTM v2.1 - Item: --OCCUR - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings - Observation Class - - Cited Guidance: Used to indicate when a question about the occurrence of a prespecified - event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate - when a question about the occurrence of a prespecified intervention was not answered. - Should be null or have a value of "NOT DONE". - Document: SDTM v2.1 - Item: --STAT - Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings - Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0562 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: An indication that the event was prospectively stated or detailed on the CRF + Document: SDTM v2.0 + Item: --PRESP + Section: Events + - Cited Guidance: An indication as to whether a prespecified event has occurred + Document: SDTM v2.0 + Item: --OCCUR + Section: Events + - Cited Guidance: + Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Events + - Cited Guidance: + An indication that the intervention was prospectively stated or detailed on + the CRF + Document: Model v2.0 + Item: --PRESP + Section: Interventions + - Cited Guidance: An indication as to whether a prespecified intervention has occurred. + Document: Model v2.0 + Item: --OCCUR + Section: Interventions + - Cited Guidance: + Used to indicate when a question about the occurrence of a prespecified + intervention was not answered. Should be null or have a value of 'NOT DONE' + Document: Model v2.0 + Item: --STAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Model v1.4[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.4[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.4 + Section: Model v1.4[2.2.1 (Interventions )]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Model v1.7[2.2.1 (Interventions )][--PRESP: Used when a specific intervention + is pre-specified on a CRF. Values should be 'Y' or null.][--OCCUR: Used to record whether a + pre-specified event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]|Model v1.7[2.2.2 (Events)][--PRESP: Used to indicate + whether the event describe by --TERM was pre-specified on a CRF. Value is Y for pre-specified + events; null for spontaneously reported events.][--OCCUR: Used to record whether a pre-specified + event occurred when information about the occurrence of a specific event is solicited.][--STAT: + Used to indicate when a question about the occurrence of a pre-specified event was not answered. + Should be null or have a value of NOT DONE]" + Document: Model v1.7 + Section: Model v1.7[2.2.1 (Interventions )]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0404 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + An indication that the event was prospectively stated or detailed on the CRF + | An indication that the intervention was prospectively stated or detailed on the CRF. + Document: SDTM v2.1 + Item: --PRESP + Section: + Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: + An indication as to whether a prespecified event has occurred. | An + indication as to whether a prespecified intervention has occurred + Document: SDTM v2.1 + Item: --OCCUR + Section: + Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + - Cited Guidance: + Used to indicate when a question about the occurrence of a prespecified + event was not answered. Should be null or have a value of "NOT DONE" | Used to indicate + when a question about the occurrence of a prespecified intervention was not answered. + Should be null or have a value of "NOT DONE". + Document: SDTM v2.1 + Item: --STAT + Section: + Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings + Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0562 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: equal_to - value: Y - - name: --OCCUR - operator: empty - - name: --STAT - operator: not_exists + - name: --PRESP + operator: equal_to + value: Y + - name: --OCCUR + operator: empty + - name: --STAT + operator: not_exists Core: Id: CORE-000118 Status: Published - Version: '1' -Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not + Version: "1" +Description: + Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not present in dataset. Executability: Fully Executable Outcome: Message: --STAT is not present in dataset when --PRESP is equal to "Y" and --OCCUR is blank Output Variables: - - --PRESP - - --OCCUR + - --PRESP + - --OCCUR Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000119/rule.yml b/Published/CORE-000119/rule.yml index 1d76bc25e..060ea5b3e 100644 --- a/Published/CORE-000119/rule.yml +++ b/Published/CORE-000119/rule.yml @@ -2,75 +2,78 @@ # Condition: ARMCD = null # Rule: ARM = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with - the reason ARMCD is null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0521 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with - the reason ARMCD is null. - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0521 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ARMCD is null, then ARM must be null and ARMNRS must be populated with - the reason ARMCD is null. - Document: TIG 1.0 - Item: Assumption 4.a.ii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0616 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: IG v3.4 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0521 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: IG v3.3 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0521 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If ARMCD is null, then ARM must be null and ARMNRS must be populated with + the reason ARMCD is null. + Document: TIG 1.0 + Item: Assumption 4.a.ii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0616 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: empty - - name: ARM - operator: non_empty + - name: ARMCD + operator: empty + - name: ARM + operator: non_empty Core: Id: CORE-000119 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ARM is not empty, but ARMCD is empty Executability: Fully Executable Outcome: Message: ARM is populated, when ARMCD is NULL Output Variables: - - ARMCD - - ARM + - ARMCD + - ARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000120/rule.yml b/Published/CORE-000120/rule.yml index 8b36fd043..1fd712287 100644 --- a/Published/CORE-000120/rule.yml +++ b/Published/CORE-000120/rule.yml @@ -2,77 +2,80 @@ # Condition: ACTARMCD = null # Rule: ACTARM = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated - with the reason ACTARMCD is null.\n Both ARMCD and ACTARMCD will be null for subjects who were - not assigned to treatment. \n The same reason will provide the reason that both are null.\"" - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0522 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated - with the reason ACTARMCD is null. - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0522 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated - with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who - were not assigned to an arm. The same reason will provide the reason that both are null. - Document: TIG 1.0 - Item: Assumption 4.a.ii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0617 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "\"If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null.\n Both ARMCD and ACTARMCD will be null for subjects who were + not assigned to treatment. \n The same reason will provide the reason that both are null.\"" + Document: IG v3.4 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0522 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null. + Document: IG v3.3 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0522 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If ACTARMCD is null, then ACTARM must be null and ARMNRS must be populated + with the reason ACTARMCD is null. Both ARMCD and ACTARMCD will be null for subjects who + were not assigned to an arm. The same reason will provide the reason that both are null. + Document: TIG 1.0 + Item: Assumption 4.a.ii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0617 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARMCD - operator: empty - - name: ACTARM - operator: non_empty + - name: ACTARMCD + operator: empty + - name: ACTARM + operator: non_empty Core: Id: CORE-000120 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ACTARM is not empty, but ACTARMCD is empty Executability: Fully Executable Outcome: Message: ACTARM is populated, when ACTARMCD is NULL Output Variables: - - ACTARMCD - - ACTARM + - ACTARMCD + - ACTARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000121/rule.yml b/Published/CORE-000121/rule.yml index b613f5445..94336c088 100644 --- a/Published/CORE-000121/rule.yml +++ b/Published/CORE-000121/rule.yml @@ -2,81 +2,84 @@ # Condition: ARMCD ^=null and ACTARMCD ^=null # Rule: ARMNRS = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"Specification [A coded reason that arm variables (ARM and ARMCD) and/or actual - arm variables (ACTARM and ACTARMCD) are null.]\n Assumption 4[ARMNRS may not be populated if - both ARMCD and ACTARMCD are populated]\"" - Document: IG v3.4 - Item: Specification|Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0520 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[A coded reason that arm variables (ARM and ARMCD) and/or - actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not be - populated if both ARMCD and ACTARMCD are populated] - Document: IG v3.3 - Item: Specification|Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0520 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification ARMNRS [A coded reason that arm variables (ARM and ARMCD) - and/or actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not - be populated if both ARMCD and ACTARMCD are populated] - Document: TIG 1.0 - Item: Specification|Assumption 4.a.iii - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0615 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "\"Specification [A coded reason that arm variables (ARM and ARMCD) and/or actual + arm variables (ACTARM and ACTARMCD) are null.]\n Assumption 4[ARMNRS may not be populated if + both ARMCD and ACTARMCD are populated]\"" + Document: IG v3.4 + Item: Specification|Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0520 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[A coded reason that arm variables (ARM and ARMCD) and/or + actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not be + populated if both ARMCD and ACTARMCD are populated] + Document: IG v3.3 + Item: Specification|Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0520 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Specification ARMNRS [A coded reason that arm variables (ARM and ARMCD) + and/or actual arm variables (ACTARM and ACTARMCD) are null.]|Assumption 4[ARMNRS may not + be populated if both ARMCD and ACTARMCD are populated] + Document: TIG 1.0 + Item: Specification|Assumption 4.a.iii + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0615 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: non_empty - - name: ACTARMCD - operator: non_empty - - name: ARMNRS - operator: non_empty + - name: ARMCD + operator: non_empty + - name: ACTARMCD + operator: non_empty + - name: ARMNRS + operator: non_empty Core: Id: CORE-000121 Status: Published - Version: '1' + Version: "1" Description: Verify the value for ARMNRS, when both ARMCD and ACTARMCD values are populated Executability: Fully Executable Outcome: Message: Value for ARMNRS is populated, when both ARMCD and ACTARMCD values are populated Output Variables: - - ARMCD - - ACTARMCD - - ARMNRS + - ARMCD + - ACTARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000122/rule.yml b/Published/CORE-000122/rule.yml index 59a03c490..94ecd3b5d 100644 --- a/Published/CORE-000122/rule.yml +++ b/Published/CORE-000122/rule.yml @@ -2,94 +2,94 @@ # Condition: AGEU ^= null and AGE = null # Rule: AGETXT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of AGE or AGETXT. - Document: Model v2.0 - Item: AGEU - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units associated with AGE or AGETXT. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units associated with AGE or AGETXT. - Document: Model v1.7 - Section: Table 2.2.6.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0434 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of AGE or AGETXT. - Document: SDTM v2.1 - Item: AGEU - Section: 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0586 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of AGE or AGETXT. + Document: Model v2.0 + Item: AGEU + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units associated with AGE or AGETXT. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units associated with AGE or AGETXT. + Document: Model v1.7 + Section: Table 2.2.6.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0434 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of AGE or AGETXT. + Document: SDTM v2.1 + Item: AGEU + Section: 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0586 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty - - name: AGETXT - operator: empty - - all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty - - name: AGETXT - operator: not_exists + - all: + - name: AGEU + operator: non_empty + - name: AGE + operator: empty + - name: AGETXT + operator: empty + - all: + - name: AGEU + operator: non_empty + - name: AGE + operator: empty + - name: AGETXT + operator: not_exists Core: Id: CORE-000122 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGEU is completed but both AGETXT and AGE are not completed. Executability: Fully Executable Outcome: Message: AGEU is completed, but both AGE and AGETXT are not completed. Output Variables: - - AGE - - AGEU - - AGETXT + - AGE + - AGEU + - AGETXT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000123/rule.yml b/Published/CORE-000123/rule.yml index 10bed53c8..f6e5ad35b 100644 --- a/Published/CORE-000123/rule.yml +++ b/Published/CORE-000123/rule.yml @@ -2,88 +2,89 @@ # Condition: --SCAN ^= null # Rule: --SCAN in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SCAN - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SCAN - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was the event associated with the development of cancer? Valid values are - 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0388 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N". - Document: SDTM v2.1 - Item: --SCAN - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0550 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SCAN + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SCAN + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Was the event associated with the development of cancer? Valid values are + 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0388 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N". + Document: SDTM v2.1 + Item: --SCAN + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0550 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESCAN - operator: non_empty - - name: AESCAN - operator: is_not_contained_by - value: - - Y - - N + - name: AESCAN + operator: non_empty + - name: AESCAN + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000123 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESCAN is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESCAN is completed, but not equal to "N" or "Y" Output Variables: - - AESCAN + - AESCAN Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000124/rule.yml b/Published/CORE-000124/rule.yml index 974e84239..4ad8100b6 100644 --- a/Published/CORE-000124/rule.yml +++ b/Published/CORE-000124/rule.yml @@ -2,88 +2,89 @@ # Condition: --SCONG ^= null # Rule: --SCONG in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SCONG - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SCONG - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was the event associated with congenital anomaly or birth defect? Valid - values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0389 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SCONG - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0551 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SCONG + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SCONG + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Was the event associated with congenital anomaly or birth defect? Valid + values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0389 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SCONG + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0551 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESCONG - operator: non_empty - - name: AESCONG - operator: is_not_contained_by - value: - - Y - - N + - name: AESCONG + operator: non_empty + - name: AESCONG + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000124 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESCONG is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESCONG is completed, but not equal to "N" or "Y" Output Variables: - - AESCONG + - AESCONG Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000125/rule.yml b/Published/CORE-000125/rule.yml index 1fc2247f2..7ea3e2e7c 100644 --- a/Published/CORE-000125/rule.yml +++ b/Published/CORE-000125/rule.yml @@ -2,88 +2,89 @@ # Condition: --SDISAB ^= null # Rule: --SDISAB in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SDISAB - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SDISAB - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event result in persistent or significant disability/incapacity? - Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0390 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SDISAB - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0552 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SDISAB + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SDISAB + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Did the event result in persistent or significant disability/incapacity? + Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0390 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SDISAB + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0552 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESDISAB - operator: non_empty - - name: AESDISAB - operator: is_not_contained_by - value: - - Y - - N + - name: AESDISAB + operator: non_empty + - name: AESDISAB + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000125 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESDISAB is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESDISAB is completed, but not equal to "N" or "Y" Output Variables: - - AESDISAB + - AESDISAB Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000126/rule.yml b/Published/CORE-000126/rule.yml index ce3e52760..5a94dc078 100644 --- a/Published/CORE-000126/rule.yml +++ b/Published/CORE-000126/rule.yml @@ -2,87 +2,87 @@ # Condition: --SDTH ^= null # Rule: --SDTH in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SDTH - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SDTH - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event result in death? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0391 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SDTH - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0553 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SDTH + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SDTH + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event result in death? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0391 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SDTH + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0553 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESDTH - operator: non_empty - - name: AESDTH - operator: is_not_contained_by - value: - - Y - - N + - name: AESDTH + operator: non_empty + - name: AESDTH + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000126 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESDTH is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESDTH is completed, but not equal to "N" or "Y" Output Variables: - - AESDTH + - AESDTH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000127/rule.yml b/Published/CORE-000127/rule.yml index 5419b72b6..ba2b7375e 100644 --- a/Published/CORE-000127/rule.yml +++ b/Published/CORE-000127/rule.yml @@ -2,88 +2,89 @@ # Condition: --SHOSP ^= null # Rule: --SHOSP in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SHOSP - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SHOSP - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event require or prolong hospitalization? Valid values are 'Y' and - 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0392 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SHOSP - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0554 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SHOSP + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SHOSP + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Did the event require or prolong hospitalization? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0392 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SHOSP + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0554 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESHOSP - operator: non_empty - - name: AESHOSP - operator: is_not_contained_by - value: - - Y - - N + - name: AESHOSP + operator: non_empty + - name: AESHOSP + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000127 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESHOSP is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESHOSP is completed, but not equal to "N" or "Y" Output Variables: - - AESHOSP + - AESHOSP Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000128/rule.yml b/Published/CORE-000128/rule.yml index ef131c84a..6285435b4 100644 --- a/Published/CORE-000128/rule.yml +++ b/Published/CORE-000128/rule.yml @@ -2,88 +2,89 @@ # Condition: --SLIFE ^= null # Rule: --SLIFE in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SLIFE - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SLIFE - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event require or prolong hospitalization? Valid values are 'Y' and - 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0393 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SLIFE - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0555 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SLIFE + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SLIFE + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Did the event require or prolong hospitalization? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0393 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SLIFE + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0555 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESLIFE - operator: non_empty - - name: AESLIFE - operator: is_not_contained_by - value: - - Y - - N + - name: AESLIFE + operator: non_empty + - name: AESLIFE + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000128 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESLIFE is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESLIFE is completed, but not equal to "N" or "Y" Output Variables: - - AESLIFE + - AESLIFE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000129/rule.yml b/Published/CORE-000129/rule.yml index 714a2c511..b67a688b5 100644 --- a/Published/CORE-000129/rule.yml +++ b/Published/CORE-000129/rule.yml @@ -2,87 +2,87 @@ # Condition: --SOD ^= null # Rule: --SOD in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SOD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SOD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0394 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SOD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0556 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SOD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SOD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Did the event occur with an overdose? Valid values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0394 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SOD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0556 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESOD - operator: non_empty - - name: AESOD - operator: is_not_contained_by - value: - - Y - - N + - name: AESOD + operator: non_empty + - name: AESOD + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000129 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESOD is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESOD is completed, but not equal to "N" or "Y" Output Variables: - - AESOD + - AESOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000130/rule.yml b/Published/CORE-000130/rule.yml index b5307e588..54b214a51 100644 --- a/Published/CORE-000130/rule.yml +++ b/Published/CORE-000130/rule.yml @@ -2,88 +2,89 @@ # Condition: --SMIE ^= null # Rule: --SMIE in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --SMIE - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v1.7 - Item: --SMIE - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do additional categories for seriousness apply? Valid values are 'Y' and - 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0395 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --SMIE - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0557 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --SMIE + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v1.7 + Item: --SMIE + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Do additional categories for seriousness apply? Valid values are 'Y' and + 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0395 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --SMIE + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0557 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESMIE - operator: non_empty - - name: AESMIE - operator: is_not_contained_by - value: - - Y - - N + - name: AESMIE + operator: non_empty + - name: AESMIE + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000130 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AESMIE is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AESMIE is completed, but not equal to "N" or "Y" Output Variables: - - AESMIE + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000131/rule.yml b/Published/CORE-000131/rule.yml index b2033fc9b..c370ff42b 100644 --- a/Published/CORE-000131/rule.yml +++ b/Published/CORE-000131/rule.yml @@ -2,89 +2,91 @@ # Condition: --CONTRT ^= null # Rule: --CONTRT in ('Y','N') Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: Model v2.0 - Item: --CONTRT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was another treatment given because of the occurrence of the event? Valid - values are "Y", "N", and null. - Document: Model v1.7 - Item: --CONTRT - Section: 2.2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Was another treatment given because of the occurrence of the event? Valid - values are 'Y' and 'N'. - Document: Model v1.4 - Item: '' - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0396 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Valid values are "Y" and "N" and null. - Document: SDTM v2.1 - Item: --CONTRT - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0558 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: Model v2.0 + Item: --CONTRT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Was another treatment given because of the occurrence of the event? Valid + values are "Y", "N", and null. + Document: Model v1.7 + Item: --CONTRT + Section: 2.2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Was another treatment given because of the occurrence of the event? Valid + values are 'Y' and 'N'. + Document: Model v1.4 + Item: "" + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0396 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Valid values are "Y" and "N" and null. + Document: SDTM v2.1 + Item: --CONTRT + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0558 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AECONTRT - operator: non_empty - - name: AECONTRT - operator: is_not_contained_by - value: - - Y - - N + - name: AECONTRT + operator: non_empty + - name: AECONTRT + operator: is_not_contained_by + value: + - Y + - N Core: Id: CORE-000131 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AECONTRT is completed and value is not 'Y' or 'N' Executability: Fully Executable Outcome: Message: AECONTRT is completed, but not equal to "N" or "Y" Output Variables: - - AECONTRT + - AECONTRT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000132/rule.yml b/Published/CORE-000132/rule.yml index ca0eab16a..3a07b4eac 100644 --- a/Published/CORE-000132/rule.yml +++ b/Published/CORE-000132/rule.yml @@ -2,308 +2,327 @@ # Condition: ELEMENT present in dataset and ETCD present in dataset # Rule: ELEMENT and ETCD have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have - special character restrictions. - Document: IG v3.4 - Item: Specification - Section: 5.3|7.2.1|7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have - special character restrictions. - Document: IG v3.2 - Item: Specification - Section: 5|7.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have - special character restrictions. - Document: IG v3.3 - Item: Specification - Section: 5.2|7.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0154 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.0 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND213 - Version: '1' - Version: '5.0' - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0914 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.4 + Item: Specification + Section: 5.3|7.2.1|7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.2 + Item: Specification + Section: 5|7.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. + Document: IG v3.3 + Item: Specification + Section: 5.2|7.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0154 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.0 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND213 + Version: "1" + Version: "5.0" + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0914 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: ETCD - operator: exists - - name: ELEMENT - operator: exists - - any: - name: ETCD - operator: is_not_unique_relationship - value: ELEMENT + operator: exists - name: ELEMENT - operator: is_not_unique_relationship - value: ETCD + operator: exists + - any: + - name: ETCD + operator: is_not_unique_relationship + value: ELEMENT + - name: ELEMENT + operator: is_not_unique_relationship + value: ETCD Core: Id: CORE-000132 Status: Published - Version: '1' + Version: "1" Description: ETCD and ELEMENT should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: ETCD and ELEMENT do not have a one-to-one relationship. Output Variables: - - ETCD - - ELEMENT + - ETCD + - ELEMENT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE - - TA - - SE + - TE + - TA + - SE Sensitivity: Record diff --git a/Published/CORE-000133/rule.yml b/Published/CORE-000133/rule.yml index 7417f23e8..c9cd9e7c1 100644 --- a/Published/CORE-000133/rule.yml +++ b/Published/CORE-000133/rule.yml @@ -1,75 +1,79 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unit of measure for the standardized result of the measurement, test, or - examination. Variable(s) Qualified, --STRESC and --STRESN and --STNRLO and --STNRHI and - --STREFC and --STREFN and --LLOQ and --ULOQ. - Document: Model v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. - Example: "mol/L".' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0426 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The unit of measure for the standardized result of the measurement, test, or - examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC - and --STREFN and --LLOQ and --ULOQ.' - Document: SDTM v2.1 - Item: --STRESU - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0580 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified, --STRESC and --STRESN and --STNRLO and --STNRHI and + --STREFC and --STREFN and --LLOQ and --ULOQ. + Document: Model v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "--STRESU: Standardized units used for --STRESC and --STRESN." + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '--STRESU: Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. + Example: "mol/L".' + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0426 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC + and --STREFN and --LLOQ and --ULOQ." + Document: SDTM v2.1 + Item: --STRESU + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0580 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --STRESC # Condition: --STRESU ^= null # Rule: --STRESC (in standard units) ^= null Check: all: - - name: --STRESU - operator: non_empty - - name: --STRESC - operator: empty + - name: --STRESU + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000133 Status: Published - Version: '1' -Description: When --STRESU is populated, --STRESC must also be populated. Please note that this + Version: "1" +Description: + When --STRESU is populated, --STRESC must also be populated. Please note that this rule, as executed, cannot check if --STRESC is populated with the standardized unit. Executability: Fully Executable Outcome: @@ -78,9 +82,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000134/rule.yml b/Published/CORE-000134/rule.yml index 0cc7e290f..f82d5f6a4 100644 --- a/Published/CORE-000134/rule.yml +++ b/Published/CORE-000134/rule.yml @@ -2,101 +2,105 @@ # Condition: RDOMAIN ^= 'DM' # Rule: IDVAR ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An - exception is SUPP-- dataset records that are related to Demographics (DM) records, where - both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and - USUBJID are sufficient to identify the unique parent record in DM (DM has one record per - USUBJID) - Document: SDTMIG v3.4 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is - SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent - To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and - IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has one record per USUBJID). - Document: SDTMIG v3.3 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is - SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent - To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and - IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has one record per USUBJID). - Document: SDTMIG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0203 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the - exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM. - Document: TIG 1.0 - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0423 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An + exception is SUPP-- dataset records that are related to Demographics (DM) records, where + both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and + USUBJID are sufficient to identify the unique parent record in DM (DM has one record per + USUBJID) + Document: SDTMIG v3.4 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.3 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN,and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0203 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM. + Document: TIG 1.0 + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0423 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: IDVAR - operator: empty + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: IDVAR + operator: empty Core: Id: CORE-000134 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RDOMAIN ^= 'DM' and IDVAR is empty. Executability: Fully Executable Outcome: Message: RDOMAIN is not 'DM' but IDVAR is empty. Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL - - QNAM + - RDOMAIN + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000135/rule.yml b/Published/CORE-000135/rule.yml index edea9f288..cfb68ed49 100644 --- a/Published/CORE-000135/rule.yml +++ b/Published/CORE-000135/rule.yml @@ -2,98 +2,102 @@ # Condition: IDVAR ^= null # Rule: IDVARVAL ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An - exception is SUPP-- dataset records that are related to Demographics (DM) records, where - both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and - USUBJID are sufficient to identify the unique parent record in DM (DM has one record per - USUBJID) - Document: SDTMIG v3.4 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is - SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent - To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and - IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has one record per USUBJID). - Document: SDTMIG v3.3 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A record in a SUPP-- dataset relates back to its parent record(s) via the - key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is - SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent - To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and - IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are - sufficient to identify the unique parent record in DM (DM has one record per USUBJID). - Document: SDTMIG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0204 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the - exception of SUPPDM. - Document: TIG 1.0 - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0424 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. An + exception is SUPP-- dataset records that are related to Demographics (DM) records, where + both IDVAR and IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and + USUBJID are sufficient to identify the unique parent record in DM (DM has one record per + USUBJID) + Document: SDTMIG v3.4 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.3 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A record in a SUPP-- dataset relates back to its parent record(s) via the + key identified by the STUDYID, RDOMAIN, and IDVAR/IDVARVAL variables. An exception is + SUPP-- dataset records that are related to Demographics (DM) records, such as the Intent + To Treat (ITT) and Safety (SAFETY) subject-level population flags, where both IDVAR and + IDVARVAL will be null because the key variables STUDYID, RDOMAIN, and USUBJID are + sufficient to identify the unique parent record in DM (DM has one record per USUBJID). + Document: SDTMIG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0204 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + exception of SUPPDM. + Document: TIG 1.0 + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0424 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVAR - operator: non_empty - - name: IDVARVAL - operator: empty + - name: IDVAR + operator: non_empty + - name: IDVARVAL + operator: empty Core: Id: CORE-000135 Status: Published - Version: '1' + Version: "1" Description: Raise an error when IDVAR is not empty and IDVARVAL is empty. Executability: Fully Executable Outcome: Message: IDVAR is not empty but IDVARVAL is empty. Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000136/rule.yml b/Published/CORE-000136/rule.yml index 1925cd4ee..e8d6d6f6b 100644 --- a/Published/CORE-000136/rule.yml +++ b/Published/CORE-000136/rule.yml @@ -2,99 +2,103 @@ # Condition: IDVARVAL = null and USUBJID = null # Rule: IDVAR ^= --SEQ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent related - information that is submitted as two datasets that have a one-to-many relationship. in the - example below all the records in one domain are being related to all of the records in - the other, so both USUBJID and IDVARVAL are null.... Since IDVAR identifies the keys that - can be used to merge/join records between the datasets, --SEQ cannot be used because - --SEQ only has meaning within a subject within a dataset, not across datasets. - Document: IG v3.4 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent related - information that is submitted as two datasets that have a one-to-many relationship. in the - example below all the records in one domain are being related to all of the records in the - other, so both USUBJID and IDVARVAL are null. - Document: IG v3.3 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This example shows how to use the RELREC dataset to represent related - information that is submitted as two datasets that have a one-to-many relationship. in the - example below all the records in one domain are being related to all of the records in the - other, so both USUBJID and IDVARVAL are null. - Document: IG v3.2 - Section: 8.3.1 RELREC Dataset Relationship Example - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0201 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Relationships between datasets are specified using the key variables - STUDYID, RDOMAIN, and IDVAR only. The values of variables USUBJID and IDVARVAL will be - null as relationships between specific subject records will not be identified. - Document: TIG 1.0 - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0422 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in + the other, so both USUBJID and IDVARVAL are null.... Since IDVAR identifies the keys that + can be used to merge/join records between the datasets, --SEQ cannot be used because + --SEQ only has meaning within a subject within a dataset, not across datasets. + Document: IG v3.4 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in the + other, so both USUBJID and IDVARVAL are null. + Document: IG v3.3 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This example shows how to use the RELREC dataset to represent related + information that is submitted as two datasets that have a one-to-many relationship. in the + example below all the records in one domain are being related to all of the records in the + other, so both USUBJID and IDVARVAL are null. + Document: IG v3.2 + Section: 8.3.1 RELREC Dataset Relationship Example + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0201 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Relationships between datasets are specified using the key variables + STUDYID, RDOMAIN, and IDVAR only. The values of variables USUBJID and IDVARVAL will be + null as relationships between specific subject records will not be identified. + Document: TIG 1.0 + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0422 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVARVAL - operator: empty - - name: USUBJID - operator: empty - - name: IDVAR - operator: ends_with - value: SEQ + - name: IDVARVAL + operator: empty + - name: USUBJID + operator: empty + - name: IDVAR + operator: ends_with + value: SEQ Core: Id: CORE-000136 Status: Published - Version: '1' + Version: "1" Description: Raise an error when IDVARVAL and USUBJID are empty and IDVAR = Sequence Number. Executability: Fully Executable Outcome: Message: IDVARVAL and USUBJID are not completed, but IDVAR equals Sequence Number. Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL - - RELID + - RDOMAIN + - IDVAR + - IDVARVAL + - RELID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000137/rule.yml b/Published/CORE-000137/rule.yml index 664feb533..25862d32a 100644 --- a/Published/CORE-000137/rule.yml +++ b/Published/CORE-000137/rule.yml @@ -2,172 +2,182 @@ # Condition: ECOCCUR ^= 'N' and ECSTAT = null and ECDOSTXT = null # Rule: ECDOSE > 0 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a - visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to - zero (0) as an alternative method for indicating doses not taken, not given, or missed. - Document: IG v3.4 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be - populated with positive (non-zero) values in cases where the sponsor feels it is necessary - and/or appropriate to represent specific dose amounts not taken, not given, or missed. - Document: IG v3.4 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a - visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to - zero (0) as an alternative method for indicating doses not taken, not given, or missed. - Document: IG v3.3 - Item: Assumption 4a - Section: 6.1.3.2 - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be - populated with positive (non-zero) values in cases where the sponsor feels it is necessary - and/or appropriate to represent specific dose amounts not taken, not given, or missed. - Document: IG v3.3 - Item: Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a - visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to - zero (0) as an alternative method for indicating doses not taken, not given, or missed. - Document: IG v3.2 - Item: Assumption 4a - Section: 6.1. - - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be - populated with positive (non-zero) values in cases where the sponsor feels it is necessary - and/or appropriate to represent specific dose amounts not taken, not given, or missed. - Document: IG v3.2 - Item: Assumption 4b - Section: 6.1. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0100 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating doses not taken, not given, - or missed.] - Document: TIG 1.0 - Item: Assumption 4a - Section: 2.8.10.11 - - Cited Guidance: Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose amounts not taken, not given, or - missed.] - Document: TIG 1.0 - Item: Assumption 4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0365 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: + Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.4 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.3 + Item: Assumption 4a + Section: 6.1.3.2 + - Cited Guidance: + Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.3 + Item: Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: IG v3.2 + Item: Assumption 4a + Section: 6.1. + - Cited Guidance: + Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + populated with positive (non-zero) values in cases where the sponsor feels it is necessary + and/or appropriate to represent specific dose amounts not taken, not given, or missed. + Document: IG v3.2 + Item: Assumption 4b + Section: 6.1. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0100 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.] + Document: TIG 1.0 + Item: Assumption 4a + Section: 2.8.10.11 + - Cited Guidance: + Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: TIG 1.0 + Item: Assumption 4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0365 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: not_exists - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 - - all: - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: not_exists - - name: ECDOSE - operator: less_than_or_equal_to - value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: not_exists + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 + - all: + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: not_exists + - name: ECDOSE + operator: less_than_or_equal_to + value: 0 Core: Id: CORE-000137 Status: Published - Version: '1' -Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but + Version: "1" +Description: + Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE less than or equal to 0. Executability: Fully Executable Outcome: - Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal + Message: + ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal to 0. Output Variables: - - ECOCCUR - - ECSTAT - - ECDOSTXT - - ECDOSE - - ECSTDTC + - ECOCCUR + - ECSTAT + - ECDOSTXT + - ECDOSE + - ECSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000138/rule.yml b/Published/CORE-000138/rule.yml index 13e2e0cef..2437d14c9 100644 --- a/Published/CORE-000138/rule.yml +++ b/Published/CORE-000138/rule.yml @@ -2,125 +2,131 @@ # Condition: --STDTC or DM.RFSTDTC does not contain complete values in their date portion # Rule: --STDY = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). - Document: IG v3.4 - Section: 4.4.4 - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, - --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This - algorithm should be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0221 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative - day of the observation starting with the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the - date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0435 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: IG v3.4 + Section: 4.4.4 + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, + --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This + algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0221 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains." + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0435 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: --STDTC - operator: is_incomplete_date - - name: --STDY - operator: non_empty - - all: - - name: RFSTDTC - operator: is_incomplete_date - - name: --STDY - operator: non_empty + - all: + - name: --STDTC + operator: is_incomplete_date + - name: --STDY + operator: non_empty + - all: + - name: RFSTDTC + operator: is_incomplete_date + - name: --STDY + operator: non_empty Core: Id: CORE-000138 Status: Published - Version: '1' + Version: "1" Description: If --STDTC or DM.RFSTDTC does not contain a complete values, --STDY must be null. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in + Message: + --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in their date portion Output Variables: - - --STDY - - --STDTC - - RFSTDTC + - --STDY + - --STDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000139/rule.yml b/Published/CORE-000139/rule.yml index 0f9e94b04..0125179f4 100644 --- a/Published/CORE-000139/rule.yml +++ b/Published/CORE-000139/rule.yml @@ -2,123 +2,129 @@ # Condition: --ENDTC or DM.RFSTDTC does not contain complete values in their date portion # Rule: --ENDY = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). All Study Day values are integers. Thus, to calculate Study - Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or - after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0223 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative - day of the observation starting with the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the - date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0437 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate Study + Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or + after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0223 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains." + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0437 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: --ENDTC - operator: is_incomplete_date - - name: --ENDY - operator: non_empty - - all: - - name: RFSTDTC - operator: is_incomplete_date - - name: --ENDY - operator: non_empty + - all: + - name: --ENDTC + operator: is_incomplete_date + - name: --ENDY + operator: non_empty + - all: + - name: RFSTDTC + operator: is_incomplete_date + - name: --ENDY + operator: non_empty Core: Id: CORE-000139 Status: Published - Version: '1' -Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date + Version: "1" +Description: + Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date portion, and --ENDY is not null. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in + Message: + --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in their date portion Output Variables: - - --ENDTC - - RFSTDTC - - --ENDY + - --ENDTC + - RFSTDTC + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000140/rule.yml b/Published/CORE-000140/rule.yml index 5f27cfcaf..a6736c0b7 100644 --- a/Published/CORE-000140/rule.yml +++ b/Published/CORE-000140/rule.yml @@ -2,96 +2,100 @@ # Condition: VISITNUM is NOT in TV.VISITNUM # Rule: VISITDY = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by - definition, the planned study day of visit, and since the actual study day of an unplanned - visit belongs in a --DY variable. - Document: IG v3.4 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by - definition, the planned study day of visit, and since the actual study day of an unplanned - visit belongs in a --DY variable. - Document: IG v3.3 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by - definition, the planned study day of visit, and since the actual study day of an unplanned - visit belongs in a --DY variable. - Document: IG v3.2 - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0225 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: VISITDY must not be populated for unplanned visits, since VISITDY is, by - definition, the planned study day of visit, and since the actual study day of an unplanned - visit belongs in a --DY variable. - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0438 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.4 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.3 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: IG v3.2 + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0225 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + VISITDY must not be populated for unplanned visits, since VISITDY is, by + definition, the planned study day of visit, and since the actual study day of an unplanned + visit belongs in a --DY variable. + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0438 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: VISITNUM - operator: is_not_contained_by - value: $tv_visitnum - - name: VISITDY - operator: non_empty + - name: VISITNUM + operator: is_not_contained_by + value: $tv_visitnum + - name: VISITDY + operator: non_empty Core: Id: CORE-000140 Status: Published - Version: '1' + Version: "1" Description: Trigger error if VISITDY is populated when VISITNUM is not in TV. Executability: Fully Executable Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITDY is not null when VISITNUM is not in TV.VISITNUM Output Variables: - - VISITNUM - - VISITDY + - VISITNUM + - VISITDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000141/rule.yml b/Published/CORE-000141/rule.yml index c6c96a6e3..13d1ab8ca 100644 --- a/Published/CORE-000141/rule.yml +++ b/Published/CORE-000141/rule.yml @@ -2,148 +2,156 @@ # Condition: VISITNUM and --TPTREF are not present in dataset # Rule: --TPT and --TPTNUM have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, which may - include domain, visit, and reference time point, there must be a one-to-relationship - between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time - point uniquely identify subject data, then if two subjects have records with the same - values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have - different time point descriptions in --TPT. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, which may - include domain, visit, and reference time point, there must be a one-to-relationship - between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time - point uniquely identify subject data, then if two subjects have records with the same - values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have - different time point descriptions in --TPT. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, which may - include domain, visit, and reference time point, there must be a one-to-relationship - between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time - point uniquely identify subject data, then if two subjects have records with the same - values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have - different time point descriptions in --TPT. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0240 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Timepoints will be represented using both --TPT and --TPTNUM. There will be - a one-to-one relationship between the values of --TPT and --TPTNUM. - Document: TIG 1.0 - Item: Sub Section Planned Timing Num 5 - Section: '2.8.7.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0448 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0922 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, which may + include domain, visit, and reference time point, there must be a one-to-relationship + between values of --TPT and --TPTNUM. in other words, if domain, visit, and reference time + point uniquely identify subject data, then if two subjects have records with the same + values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these records may not have + different time point descriptions in --TPT. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0240 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Timepoints will be represented using both --TPT and --TPTNUM. There will be + a one-to-one relationship between the values of --TPT and --TPTNUM. + Document: TIG 1.0 + Item: Sub Section Planned Timing Num 5 + Section: "2.8.7.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0448 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0922 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: VISITNUM - operator: not_exists - - name: --TPTREF - operator: not_exists - - name: --TPT - operator: is_not_unique_relationship - value: --TPTNUM + - name: VISITNUM + operator: not_exists + - name: --TPTREF + operator: not_exists + - name: --TPT + operator: is_not_unique_relationship + value: --TPTNUM Core: Id: CORE-000141 Status: Published - Version: '1' -Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one + Version: "1" +Description: + VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: --TPT and --TPTNUM do not have a one-to-one relationship. Output Variables: - - VISITNUM - - --TPTREF - - --TPT - - --TPTNUM + - VISITNUM + - --TPTREF + - --TPT + - --TPTNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000142/rule.yml b/Published/CORE-000142/rule.yml index 0ffbb4432..694edd647 100644 --- a/Published/CORE-000142/rule.yml +++ b/Published/CORE-000142/rule.yml @@ -2,120 +2,126 @@ # Condition: --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null # Rule: --ELTM is the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely - to be a one-to-one relationship between most values of --TPT and --ELTM. However, since - --ELTM can only be populated with ISO 8601 periods of time (as described in Section 4.4.3, - Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be populated - for all time points. For example, --ELTM is likely to be null for time points described by - text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if two subjects - have records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these - records may not have different values in --ELTM. - Document: IG v3.4 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely - to be a one-to-one relationship between most values of --TPT and --ELTM. However, since - --ELTM can only be populated with ISO 8601 periods of time (as described in Section - 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be - populated for all time points. For example, --ELTM is likely to be null for time points - described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if - two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and - --TPTNUM, then these records may not have different values in --ELTM. - Document: IG v3.3 - Section: 4.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Within the context that defines uniqueness for a time point, there is likely - to be a one-to-one relationship between most values of --TPT and --ELTM. However, since - --ELTM can only be populated with ISO 8601 periods of time (as described in Section - 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be - populated for all time points. For example, --ELTM is likely to be null for time points - described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if - two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and - --TPTNUM, then these records may not have different values in --ELTM. - Document: IG v3.2 - Section: 4.1.4.10 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0241 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Represents the planned elapsed time from the fixed timepoint reference to - the planned observation. The value of this variable is usually also reflected in the value - of variable --TPT. - Document: TIG 1.0 - Item: Sub Section Timing Relative to Reference Points Num 3 - Section: '2.8.7.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0449 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section 4.4.3, + Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be populated + for all time points. For example, --ELTM is likely to be null for time points described by + text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if two subjects + have records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM, then these + records may not have different values in --ELTM. + Document: IG v3.4 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section + 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be + populated for all time points. For example, --ELTM is likely to be null for time points + described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different values in --ELTM. + Document: IG v3.3 + Section: 4.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Within the context that defines uniqueness for a time point, there is likely + to be a one-to-one relationship between most values of --TPT and --ELTM. However, since + --ELTM can only be populated with ISO 8601 periods of time (as described in Section + 4.1.4.3, Intervals of Time and Use of Duration for --DUR Variables), --ELTM may not be + populated for all time points. For example, --ELTM is likely to be null for time points + described by text such as 'pre-dose' or 'before breakfast.' When --ELTM is populated, if + two subjects have records with the same values of DOMAIN, VISITNUM, --TPTREF, and + --TPTNUM, then these records may not have different values in --ELTM. + Document: IG v3.2 + Section: 4.1.4.10 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0241 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Represents the planned elapsed time from the fixed timepoint reference to + the planned observation. The value of this variable is usually also reflected in the value + of variable --TPT. + Document: TIG 1.0 + Item: Sub Section Timing Relative to Reference Points Num 3 + Section: "2.8.7.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0449 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: non_empty - - name: --ELTM - operator: non_empty - - name: --ELTM - operator: is_inconsistent_across_dataset - value: - - DOMAIN - - VISITNUM - - --TPTREF - - --TPTNUM + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: non_empty + - name: --ELTM + operator: non_empty + - name: --ELTM + operator: is_inconsistent_across_dataset + value: + - DOMAIN + - VISITNUM + - --TPTREF + - --TPTNUM Core: Id: CORE-000142 Status: Published - Version: '1' -Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM - does not have the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, + Version: "1" +Description: + Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM + does not have the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. Executability: Fully Executable Outcome: - Message: --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM, + Message: + --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. Output Variables: - - --TPT - - --TPTNUM - - --ELTM - - VISITNUM - - DOMAIN + - --TPT + - --TPTNUM + - --ELTM + - VISITNUM + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000143/rule.yml b/Published/CORE-000143/rule.yml index 262b0e0bd..a398a587b 100644 --- a/Published/CORE-000143/rule.yml +++ b/Published/CORE-000143/rule.yml @@ -1,204 +1,212 @@ # Variable: ETCD -# Condition: +# Condition: # Rule: ETCD value length <= 8 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: '5.3' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.4 - Item: Specification - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.3 - Item: Specification - Section: '5.2' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.3 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.2 - Item: Specification - Section: '5' - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0246 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND24 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters and does not have - special character restrictions. These values should be short for ease of use in - programming, but it is not expected that ETCD will need to serve as a variable name. - Document: TIG 1.0 - Item: Specification:ECTD - Section: 2.8.10.24|2.8.10.29|2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0450 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters, but do not have - special character restrictions. - Document: TIG v1.0 - Item: SE CDISC Notes - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0165 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: "5.3" + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.4 + Item: Specification + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.3 + Item: Specification + Section: "5.2" + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.3 + Item: Specification + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.2 + Item: Specification + Section: "5" + - Cited Guidance: ETCD (the companion to ELEMENT) is limited to 8 characters + Document: IG v3.2 + Item: Specification + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0246 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND24 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT) is limited to 8 characters and does not have + special character restrictions. These values should be short for ease of use in + programming, but it is not expected that ETCD will need to serve as a variable name. + Document: TIG 1.0 + Item: Specification:ECTD + Section: 2.8.10.24|2.8.10.29|2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0450 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT) is limited to 8 characters, but do not have + special character restrictions. + Document: TIG v1.0 + Item: SE CDISC Notes + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0165 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: ETCD - operator: longer_than - value: 8 + - name: ETCD + operator: longer_than + value: 8 Core: Id: CORE-000143 Status: Published - Version: '1' + Version: "1" Description: The length of ETCD should be no greater than 8 Executability: Fully Executable Outcome: Message: ETCD value is greater than 8 Output Variables: - - ETCD + - ETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - TA - - TE - - SE + - TA + - TE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000144/rule.yml b/Published/CORE-000144/rule.yml index 60efb0603..1c4f82f03 100644 --- a/Published/CORE-000144/rule.yml +++ b/Published/CORE-000144/rule.yml @@ -1,86 +1,86 @@ # Variable: TAETORD -# Condition: +# Condition: # Rule: TAETORD is unique within an ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.3 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0247 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Number that gives the order of the Element within the Arm. - Document: TIG 1.0 - Item: Specification;TAETORD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0451 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.3 + Item: Specification + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: IG v3.2 + Item: Specification + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0247 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Number that gives the order of the Element within the Arm. + Document: TIG 1.0 + Item: Specification;TAETORD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0451 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TAETORD - operator: is_not_unique_set - value: - - ARM + - name: TAETORD + operator: is_not_unique_set + value: + - ARM Core: Id: CORE-000144 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TAETORD is not unique within an ARM Executability: Fully Executable Outcome: Message: TAETORD is not unique within ARM Output Variables: - - TAETORD - - ARM + - TAETORD + - ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000147/rule.yml b/Published/CORE-000147/rule.yml index d789a03d1..e1012e2d9 100644 --- a/Published/CORE-000147/rule.yml +++ b/Published/CORE-000147/rule.yml @@ -1,193 +1,203 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not - have special character restrictions. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not - have special character restrictions. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not - have special character restrictions. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0257 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial - Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have - special character restrictions - Document: IG v3.1 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND26 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD. Value must be 8 characters or less. - Document: TIG v1.0 - Item: TSPARMCD CDISC Notes - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0178 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not - have special character restrictions. - Document: TIG 1.0 - Item: Specification:TSPARMCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0461 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0257 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ETCD (the companion to ELEMENT), SETCD (the short name of a specific Trial + Set), and TSPARMCD (the companion to TSPARM) are limited to 8 characters, but do not have + special character restrictions + Document: IG v3.1 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND26 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: TSPARMCD. Value must be 8 characters or less. + Document: TIG v1.0 + Item: TSPARMCD CDISC Notes + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0178 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not + have special character restrictions. + Document: TIG 1.0 + Item: Specification:TSPARMCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0461 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: TSPARMCD -# Condition: +# Condition: # Rule: TSPARMCD value length <= 8 Check: all: - - name: TSPARMCD - operator: longer_than - value: 8 + - name: TSPARMCD + operator: longer_than + value: 8 Core: Id: CORE-000147 Status: Published - Version: '1' + Version: "1" Description: Trigger error when length of TSPARMCD is greater than 8 Executability: Fully Executable Outcome: Message: Length of TSPARMCD is greater than 8 Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000148/rule.yml b/Published/CORE-000148/rule.yml index 3b332922a..eca4f3208 100644 --- a/Published/CORE-000148/rule.yml +++ b/Published/CORE-000148/rule.yml @@ -1,85 +1,85 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0258 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. - Document: TIG 1.0 - Item: Specification:TSPARM - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0462 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0258 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: The value in TSPARM cannot be longer than 40 characters. + Document: TIG 1.0 + Item: Specification:TSPARM + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0462 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: TSPARM -# Condition: +# Condition: # Rule: TSPARM value length <= 40 Check: all: - - name: TSPARM - operator: longer_than - value: 40 + - name: TSPARM + operator: longer_than + value: 40 Core: Id: CORE-000148 Status: Published - Version: '1' + Version: "1" Description: Trigger error when length of TSPARM value is greater than 40 Executability: Fully Executable Outcome: Message: Length of TSPARM is greater than 40 Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000151/rule.yml b/Published/CORE-000151/rule.yml index 07dfdfb15..347d6d9fa 100644 --- a/Published/CORE-000151/rule.yml +++ b/Published/CORE-000151/rule.yml @@ -2,142 +2,149 @@ # Condition: TSVAL1 ^= null # Rule: TSVAL ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0261 - Version: '1' - Version: '2.0' - Version: '3.3' - # Extended for SEND rule SEND281 by Jozef - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.0 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables - (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND281 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Text over 200 characters can be added to additional columns TSVAL1-TSVALn. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0261 + Version: "1" + Version: "2.0" + Version: + "3.3" + # Extended for SEND rule SEND281 by Jozef + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.0 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Trial Summary allows for one TSVAL value to span multiple variables + (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND281 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSVAL1 - operator: non_empty - - name: TSVAL - operator: empty + - name: TSVAL1 + operator: non_empty + - name: TSVAL + operator: empty Core: Id: CORE-000151 Status: Published - Version: '1' + Version: "1" Description: Trigger error when TSVAL1 is populated and TSVAL is null Executability: Fully Executable Outcome: @@ -146,8 +153,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000152/rule.yml b/Published/CORE-000152/rule.yml index 0d63168fe..7332d0931 100644 --- a/Published/CORE-000152/rule.yml +++ b/Published/CORE-000152/rule.yml @@ -2,89 +2,90 @@ # Condition: TSVAL ^= null and TSVALCD ^= null # Rule: TSVALCD and TSVAL have a one-to-one relationship. Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0265 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: This is the code of the term in TSVAL. - Document: TIG 1.0 - Item: Specification:TSVALCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0467 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0265 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: This is the code of the term in TSVAL. + Document: TIG 1.0 + Item: Specification:TSVALCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0467 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TSVAL - operator: non_empty - - name: TSVALCD - operator: non_empty - - name: TSVAL - operator: is_not_unique_relationship - value: TSVALCD + - name: TSVAL + operator: non_empty + - name: TSVALCD + operator: non_empty + - name: TSVAL + operator: is_not_unique_relationship + value: TSVALCD Core: Id: CORE-000152 Status: Published - Version: '1' -Description: When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between + Version: "1" +Description: + When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between TSVALCD and TSVAL Executability: Fully Executable Outcome: Message: There is not a one-to-one relationship between TSVAL and TSVALCD Output Variables: - - TSVAL - - TSVALCD + - TSVAL + - TSVALCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000154/rule.yml b/Published/CORE-000154/rule.yml index dde08a808..bf6bccf53 100644 --- a/Published/CORE-000154/rule.yml +++ b/Published/CORE-000154/rule.yml @@ -2,196 +2,205 @@ # Condition: TSPARMCD not unique # Rule: TSSEQ is unique for each distinct value of TSPARMCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows - inclusion of multiple records for the same TSPARMCD. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSSEQ has a different value for each record for the same parameter. - Document: IG v3.2 - Item: Assumption 5 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSSEQ has a different value for each record for the same parameter. - Document: IG v3.3 - Item: Assumption 5 - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0268 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.0 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is a unique identifier for each record and is Required to - identify each record as unique in cases where the same TSPARMCD is used within the dataset. - The TSSEQ variable must be populated for all records within the TS dataset.' - Document: IG v3.1.1 - Item: Assumption 7 - Section: '7.6.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND246 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The TSSEQ variable is required to identify each record as unique, in cases where - the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records - within the TS dataset.' - Document: TIG v1.0 - Item: Assumption 7 - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0167 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows - inclusion of multiple records for the same TSPARMCD. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0470 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Sequence number given to ensure uniqueness within a dataset. Allows + inclusion of multiple records for the same TSPARMCD. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSSEQ has a different value for each record for the same parameter. + Document: IG v3.2 + Item: Assumption 5 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSSEQ has a different value for each record for the same parameter. + Document: IG v3.3 + Item: Assumption 5 + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0268 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.0 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.1 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.1.1 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.1 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.1.1 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is a unique identifier for each record and is Required to + identify each record as unique in cases where the same TSPARMCD is used within the dataset. + The TSSEQ variable must be populated for all records within the TS dataset." + Document: IG v3.1.1 + Item: Assumption 7 + Section: "7.6.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND246 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The TSSEQ variable is required to identify each record as unique, in cases where + the same TSPARMCD is used within the dataset. The TSSEQ variable must be populated for all records + within the TS dataset." + Document: TIG v1.0 + Item: Assumption 7 + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0167 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Sequence number given to ensure uniqueness within a dataset. Allows + inclusion of multiple records for the same TSPARMCD. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0470 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN - - name: TSSEQ - operator: is_not_unique_set - value: TSPARMCD + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN + - name: TSSEQ + operator: is_not_unique_set + value: TSPARMCD Core: Id: CORE-000154 Status: Published - Version: '1' + Version: "1" Description: TSSEQ must be unique within TSPARMCD Executability: Fully Executable Outcome: Message: TSSEQ is not unique within TSPARMCD Output Variables: - - TSSEQ - - TSPARMCD + - TSSEQ + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000155/rule.yml b/Published/CORE-000155/rule.yml index 83d4d76bd..214d1ce48 100644 --- a/Published/CORE-000155/rule.yml +++ b/Published/CORE-000155/rule.yml @@ -2,94 +2,98 @@ # Condition: ARMCD ^= null # Rule: ARMCD in TA.ARMCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a - subject is in, then ARMCD should be null. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a - subject is in, then ARMCD should be null. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a - subject is in, then ARMCD should be null. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0293 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 2. If the timing of Visits for a trial does not depend on which ARM a - subject is in, then ARMCD should be null. - Document: TIG 1.0 - Item: Specification ARMCD - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0475 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0293 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + 2. If the timing of Visits for a trial does not depend on which ARM a + subject is in, then ARMCD should be null. + Document: TIG 1.0 + Item: Specification ARMCD + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0475 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000155 Status: Published - Version: '1' + Version: "1" Description: Trigger error when ARMCD is populated and ARMCD is not in TA.ARMCD Executability: Fully Executable Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not in TA.ARMCD Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000156/rule.yml b/Published/CORE-000156/rule.yml index 9533a3a67..5cf2beee3 100644 --- a/Published/CORE-000156/rule.yml +++ b/Published/CORE-000156/rule.yml @@ -2,93 +2,97 @@ # Condition: ARM ^= null # Rule: ARM in TA.ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of visits for a - trial does not depend on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a - trial does not depend on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a - trial does not depend on which Arm a subject is in, then Arm should be left blank. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0294 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 1. Name given to an Arm or Product Exposure Group. 2. If the timing of - Visits for a trial does not depend on which Arm a subject is in, then Arm should be left - blank. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0476 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 1. Name given to an Arm or Treatment Group. 2. If the timing of visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 1. Name given to an Arm or Treatment Group. 2. If the timing of Visits for a + trial does not depend on which Arm a subject is in, then Arm should be left blank. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0294 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + 1. Name given to an Arm or Product Exposure Group. 2. If the timing of + Visits for a trial does not depend on which Arm a subject is in, then Arm should be left + blank. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0476 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000156 Status: Published - Version: '1' + Version: "1" Description: Trigger error when ARM is populated and ARM is not in TA.ARM Executability: Fully Executable Operations: -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARM is not in TA.ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000157/rule.yml b/Published/CORE-000157/rule.yml index 8fd16cfca..feaf6a3f0 100644 --- a/Published/CORE-000157/rule.yml +++ b/Published/CORE-000157/rule.yml @@ -1,88 +1,92 @@ # Variable: ARMCD -# Condition: +# Condition: # Rule: ARMCD value length <= 20 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0297 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters and does not have special character - restrictions. - Document: TIG 1.0 - Item: Specification:ARMCD - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0479 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0297 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters and does not have special character + restrictions. + Document: TIG 1.0 + Item: Specification:ARMCD + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0479 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: longer_than - value: 20 + - name: ARMCD + operator: longer_than + value: 20 Core: Id: CORE-000157 Status: Published - Version: '1' + Version: "1" Description: The length of ARMCD is limited to 20 characters. Executability: Fully Executable Outcome: Message: Length of ARMCD is greater than 20 Output Variables: - - ARMCD + - ARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000158/rule.yml b/Published/CORE-000158/rule.yml index 91fb682ee..397e5f8f2 100644 --- a/Published/CORE-000158/rule.yml +++ b/Published/CORE-000158/rule.yml @@ -2,99 +2,103 @@ # Condition: Comment related to Domain Records and RDOMAIN not in (null, 'DM') # Rule: IDVAR ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. Null for comments collected on separate CRFs. - Document: IG v3.4 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. null for comments collected on separate CRFs. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. null for comments collected on separate CRFs. - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0163 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. Null for comments collected on separate CRFs. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0396 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: IG v3.4 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. null for comments collected on separate CRFs. + Document: IG v3.3 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0163 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0396 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: RDOMAIN - operator: non_empty - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: IDVAR - operator: empty + - all: + - name: RDOMAIN + operator: non_empty + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: IDVAR + operator: empty Core: Id: CORE-000158 Status: Published - Version: '1' + Version: "1" Description: IDVAR must be specified. Executability: Fully Executable Outcome: Message: IDVAR should not be missing when RDOMAIN is not in (empty, DM). Output Variables: - - RDOMAIN - - IDVAR + - RDOMAIN + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000159/rule.yml b/Published/CORE-000159/rule.yml index 940c066c4..0ffed3f31 100644 --- a/Published/CORE-000159/rule.yml +++ b/Published/CORE-000159/rule.yml @@ -1,94 +1,98 @@ # Variable: --TESTCD -# Condition: +# Condition: # Rule: --TESTCD ^= 'OTHER' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other, Specify" for tests may be handled similarly to Interventions. - --TESTCD and --TEST should be populated with the code and description of the test found in the - specified text. If specific tests are not prespecified on the CRF and the investigator has the - option of writing in tests, then the name of the test would have to be coded to ensure that - all --TESTCD and --TEST values are consistent with the test controlled terminology.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. - --TESTCD and --TEST should be populated with the code and description of the test found in the - specified text. If specific tests are not prespecified on the CRF and the investigator has the - option of writing in tests, then the name of the test would have to be coded to ensure that - all --TESTCD and --TEST values are consistent with the test controlled terminology.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. - --TESTCD and --TEST should be populated with the code and description of the test found in the - specified text. If specific tests are not prespecified on the CRF and the investigator has the - option of writing free text for tests; then the name of the test would have to be coded to ensure - that all --TESTCD and --TEST values are controlled terminology and are not free text.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0341 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Findings general observations class domains, each collected value will - be represented in --TESTCD and --TEST in its own record per controlled terminology. - Document: TIG 1.0 - Item: Num 3 - Section: '2.8.7.4' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0506 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Findings: "Other, Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing in tests, then the name of the test would have to be coded to ensure that + all --TESTCD and --TEST values are consistent with the test controlled terminology.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing in tests, then the name of the test would have to be coded to ensure that + all --TESTCD and --TEST values are consistent with the test controlled terminology.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Findings: "Other; Specify" for tests may be handled similarly to Interventions. + --TESTCD and --TEST should be populated with the code and description of the test found in the + specified text. If specific tests are not prespecified on the CRF and the investigator has the + option of writing free text for tests; then the name of the test would have to be coded to ensure + that all --TESTCD and --TEST values are controlled terminology and are not free text.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0341 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For Findings general observations class domains, each collected value will + be represented in --TESTCD and --TEST in its own record per controlled terminology. + Document: TIG 1.0 + Item: Num 3 + Section: "2.8.7.4" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0506 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TESTCD - operator: equal_to - value: OTHER + - name: --TESTCD + operator: equal_to + value: OTHER Core: Id: CORE-000159 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TESTCD = 'OTHER' Executability: Fully Executable Outcome: Message: --TESTCD is equal to 'OTHER' Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000160/rule.yml b/Published/CORE-000160/rule.yml index 99db2fe6c..df764d2ac 100644 --- a/Published/CORE-000160/rule.yml +++ b/Published/CORE-000160/rule.yml @@ -1,85 +1,89 @@ # Variable: --TRT -# Condition: +# Condition: # Rule: --TRT ^= 'OTHER' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, - Specify", --TRT should be populated with the name of the treatment found in the specified text.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, - Specify", --TRT should be populated with the name of the treatment found in the specified text.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Interventions: If a list of specific treatments is provided along with "Other, - Specify", --TRT should be populated with the name of the treatment found in the specified text.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0342 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Interventions general observations class domains, each collected value - will be represented in --TRT in its own record. - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0507 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Interventions: If a list of specific treatments is provided along with "Other, + Specify", --TRT should be populated with the name of the treatment found in the specified text.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0342 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For Interventions general observations class domains, each collected value + will be represented in --TRT in its own record. + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0507 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TRT - operator: equal_to - value: OTHER + - name: --TRT + operator: equal_to + value: OTHER Core: Id: CORE-000160 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TRT = 'OTHER' Executability: Fully Executable Outcome: Message: --TRT is equal to 'OTHER' Output Variables: - - --TRT + - --TRT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000161/rule.yml b/Published/CORE-000161/rule.yml index ba572f81b..69d7adabe 100644 --- a/Published/CORE-000161/rule.yml +++ b/Published/CORE-000161/rule.yml @@ -1,89 +1,93 @@ # Variable: --TERM -# Condition: +# Condition: # Rule: --TERM ^= 'OTHER' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. - --TERM should be populated with the description of the event found in the specified text and - --PRESP could be used to distinguish between prespecified and free text responses.' - Document: IG v3.4 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. - --TERM should be populated with the description of the event found in the specified text and - --PRESP could be used to distinguish between prespecified and free text responses.' - Document: IG v3.3 - Section: 4.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Events: "Other, Specify" for Events may be handled similarly to Interventions. - --TERM should be populated with the description of the event found in the specified text and - --PRESP could be used to distinguish between prespecified and free text responses.' - Document: IG v3.2 - Section: 4.1.2.7.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0343 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: For Events general observations class domains, each collected value will be - represented in --TERM in its own record. - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0508 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.4 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.3 + Section: 4.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Events: "Other, Specify" for Events may be handled similarly to Interventions. + --TERM should be populated with the description of the event found in the specified text and + --PRESP could be used to distinguish between prespecified and free text responses.' + Document: IG v3.2 + Section: 4.1.2.7.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0343 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For Events general observations class domains, each collected value will be + represented in --TERM in its own record. + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0508 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TERM - operator: equal_to - value: OTHER + - name: --TERM + operator: equal_to + value: OTHER Core: Id: CORE-000161 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TERM = 'OTHER' Executability: Fully Executable Outcome: Message: --TERM is equal to 'OTHER' Output Variables: - - --TERM + - --TERM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000162/rule.yml b/Published/CORE-000162/rule.yml index b27e7cbff..13e67e754 100644 --- a/Published/CORE-000162/rule.yml +++ b/Published/CORE-000162/rule.yml @@ -1,91 +1,95 @@ # Variable: --TESTCD -# Condition: +# Condition: # Rule: --TESTCD ^= 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings - class dataset, multiple records should be submitted for that --TESTCD. - Document: IG v3.4 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0344 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple result values (represented in --ORRES) are collected for a test, - then multiple records will be represented for the test (represented in --TESTCD) - Document: TIG 1.0 - Item: Num 2 - Section: 2.8.7.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0509 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple result values (--ORRES) are reported for a test in a Findings + class dataset, multiple records should be submitted for that --TESTCD. + Document: IG v3.4 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0344 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If multiple result values (represented in --ORRES) are collected for a test, + then multiple records will be represented for the test (represented in --TESTCD) + Document: TIG 1.0 + Item: Num 2 + Section: 2.8.7.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0509 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TESTCD - operator: equal_to - value: MULTIPLE + - name: --TESTCD + operator: equal_to + value: MULTIPLE Core: Id: CORE-000162 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TESTCD = 'MULTIPLE' Executability: Fully Executable Outcome: Message: --TESTCD is equal to 'MULTIPLE' Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000163/rule.yml b/Published/CORE-000163/rule.yml index 3a84d8dfc..76854627d 100644 --- a/Published/CORE-000163/rule.yml +++ b/Published/CORE-000163/rule.yml @@ -1,97 +1,101 @@ # Variable: --TRT -# Condition: +# Condition: # Rule: --TRT ^= 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset), it is expected that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity per the sponsor's data - management standard operating procedures. - Document: IG v3.4 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0345 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset), it is expected that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity per the sponsor's data - management standard operating procedures. - Document: TIG 1.0 - Item: Num 1, Num 2 - Section: '2.8.7.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0510 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: IG v3.4 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0345 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: TIG 1.0 + Item: Num 1, Num 2 + Section: "2.8.7.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0510 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TRT - operator: equal_to - value: MULTIPLE + - name: --TRT + operator: equal_to + value: MULTIPLE Core: Id: CORE-000163 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TRT = 'MULTIPLE' Executability: Fully Executable Outcome: Message: --TRT is equal to 'MULTIPLE' Output Variables: - - --TRT + - --TRT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000164/rule.yml b/Published/CORE-000164/rule.yml index bc6efe2b1..2fde53032 100644 --- a/Published/CORE-000164/rule.yml +++ b/Published/CORE-000164/rule.yml @@ -1,97 +1,101 @@ # Variable: --TERM -# Condition: +# Condition: # Rule: --TERM ^= 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset), it is expected that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity per the sponsor's data - management standard operating procedures. - Document: IG v3.4 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.3 - Section: 4.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e.; --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset); it is assumed that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity as per the sponsor's standard - data management procedures. - Document: IG v3.2 - Section: 4.1.2.8.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0346 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple values are reported for a topic variable (i.e., --TRT in an - Interventions general-observation-class dataset or --TERM in an Events - general-observation-class dataset), it is expected that the sponsor will split the values - into multiple records or otherwise resolve the multiplicity per the sponsor's data - management standard operating procedures. - Document: TIG 1.0 - Item: Num 1, Num 2 - Section: '2.8.7.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0511 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: IG v3.4 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.3 + Section: 4.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e.; --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset); it is assumed that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity as per the sponsor's standard + data management procedures. + Document: IG v3.2 + Section: 4.1.2.8.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0346 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If multiple values are reported for a topic variable (i.e., --TRT in an + Interventions general-observation-class dataset or --TERM in an Events + general-observation-class dataset), it is expected that the sponsor will split the values + into multiple records or otherwise resolve the multiplicity per the sponsor's data + management standard operating procedures. + Document: TIG 1.0 + Item: Num 1, Num 2 + Section: "2.8.7.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0511 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TERM - operator: equal_to - value: MULTIPLE + - name: --TERM + operator: equal_to + value: MULTIPLE Core: Id: CORE-000164 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TERM = 'MULTIPLE' Executability: Fully Executable Outcome: Message: --TERM is equal to 'MULTIPLE' Output Variables: - - --TERM + - --TERM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000165/rule.yml b/Published/CORE-000165/rule.yml index 621929f9a..6d0933e34 100644 --- a/Published/CORE-000165/rule.yml +++ b/Published/CORE-000165/rule.yml @@ -2,213 +2,217 @@ # Condition: --RFTDTC present in dataset # Rule: --TPTREF present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"The actual date or date and time of a time point that acts as a fixed reference - for a series of planned time points, represented in a standardized character format. The fixed - reference point is in --TPTREF"' - Document: Model v2.0 - Item: RFTDTC - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"Date/time for a fixed reference time point defined by --TPTREF."' - Document: Model v1.7 - Item: Table 2.2.5.1 --RFTDTC - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"(--RFTDTC) Date/time for a fixed reference time point defined by --TPTREF in - ISO 8601 character format."' - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0090 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a fixed - reference for a series of planned time points, represented in a standardized character - format. The fixed reference point is in --TPTREF. - Document: SDTM v2.1 - Item: --RFTDTC - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0355 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3701 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"The actual date or date and time of a time point that acts as a fixed reference + for a series of planned time points, represented in a standardized character format. The fixed + reference point is in --TPTREF"' + Document: Model v2.0 + Item: RFTDTC + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: '"Date/time for a fixed reference time point defined by --TPTREF."' + Document: Model v1.7 + Item: Table 2.2.5.1 --RFTDTC + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"(--RFTDTC) Date/time for a fixed reference time point defined by --TPTREF in + ISO 8601 character format."' + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0090 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF. + Document: SDTM v2.1 + Item: --RFTDTC + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0355 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3701 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --RFTDTC - operator: exists - - name: --TPTREF - operator: not_exists + - name: --RFTDTC + operator: exists + - name: --TPTREF + operator: not_exists Core: Id: CORE-000165 Status: Published - Version: '1' -Description: Time point reference (--TPTREF) should be present in the dataset, when reference time + Version: "1" +Description: + Time point reference (--TPTREF) should be present in the dataset, when reference time point (--RFTDTC) is also present in the dataset. Executability: Fully Executable Outcome: Message: --TPTREF is missing when --RFTDTC is present. Output Variables: - - --RFTDTC - - --TPTREF + - --RFTDTC + - --TPTREF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000166/rule.yml b/Published/CORE-000166/rule.yml index 93dcb9d4c..0033bfb15 100644 --- a/Published/CORE-000166/rule.yml +++ b/Published/CORE-000166/rule.yml @@ -1,59 +1,61 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"The description of the time when a protocol-defined activity is planned to occur, - used for study data tabulation."' - Document: Model v2.0 - Item: --TPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0091 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of the time when a protocol-defined activity is planned to - occur, used for study data tabulation. - Document: SDTM v2.1 - Item: --TPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0356 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"The description of the time when a protocol-defined activity is planned to occur, + used for study data tabulation."' + Document: Model v2.0 + Item: --TPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0091 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description of the time when a protocol-defined activity is planned to + occur, used for study data tabulation. + Document: SDTM v2.1 + Item: --TPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0356 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: not_exists + - name: --TPTNUM + operator: exists + - name: --TPT + operator: not_exists Core: Id: CORE-000166 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TPT is not present but --TPTNUM is present in dataset. Executability: Fully Executable Outcome: Message: --TPT is not present when --TPTNUM is present in a dataset Output Variables: - - --TPTNUM - - --TPT + - --TPTNUM + - --TPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000167/rule.yml b/Published/CORE-000167/rule.yml index 584a0bce9..168502f3d 100644 --- a/Published/CORE-000167/rule.yml +++ b/Published/CORE-000167/rule.yml @@ -2,102 +2,108 @@ # Condition: --ELTM present in dataset # Rule: --TPTREF present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference for a series - of planned time points, used for study data tabulation. Description of the fixed reference - point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: Model v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.4[2.2.5 Timing Variables for All Classes][Specification][(--TPTREF) - Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: - PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10 Representing Time Points][If the protocol describes - the scheduling of a dose using a reference intervention or assessment, then --TPTREF should - be populated, even if it does not contribute to uniqueness. The fact that time points are related - to a reference time point, and what that reference time point is, are important for interpreting - the data collected at the time point.]' - Document: Model v1.4|IG v3.2 - Item: Model v1.4[2.2.5 Timing Variables for All Classes][Specification] - Section: Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10 Representing - Time Points] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]Description - of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. Examples: - "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10 Representing Time Points][If the protocol - describes the scheduling of a dose using a reference intervention or assessment, then --TPTREF - should be populated, even if it does not contribute to uniqueness. The fact that time points - are related to a reference time point, and what that reference time point is, are important - for interpreting the data collected at the time point.]' - Document: Model v1.7|IG v3.3 - Item: 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]' - Section: Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10 Representing Time - Points] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0092 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description of a time point that acts as a fixed reference for a series - of planned time points, used for study data tabulation. Description of the fixed reference - point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. - Document: SDTM v2.1 - Item: --TPTREF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0357 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: Model v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Model v1.4[2.2.5 Timing Variables for All Classes][Specification][(--TPTREF) + Description of the fixed reference point referred to by --ELTM, --TPTNUM, and --TPT. Examples: + PREVIOUS DOSE, PREVIOUS MEAL.]|IG v3.2[4.1.4.10 Representing Time Points][If the protocol describes + the scheduling of a dose using a reference intervention or assessment, then --TPTREF should + be populated, even if it does not contribute to uniqueness. The fact that time points are related + to a reference time point, and what that reference time point is, are important for interpreting + the data collected at the time point.]" + Document: Model v1.4|IG v3.2 + Item: Model v1.4[2.2.5 Timing Variables for All Classes][Specification] + Section: + Model v1.4[2.2.5 Timing Variables for All Classes]|IG v3.2[4.1.4.10 Representing + Time Points] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]Description + of the fixed reference point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. Examples: + "PREVIOUS DOSE", "PREVIOUS MEAL".]|IG v3.3[4.4.10 Representing Time Points][If the protocol + describes the scheduling of a dose using a reference intervention or assessment, then --TPTREF + should be populated, even if it does not contribute to uniqueness. The fact that time points + are related to a reference time point, and what that reference time point is, are important + for interpreting the data collected at the time point.]' + Document: Model v1.7|IG v3.3 + Item: "Model v1.7[2.2.5 Timing Variables for All Classes][Table 2.2.5.1: --TPTREF]" + Section: + Model v1.7[2.2.5 Timing Variables for All Classes]|IG v3.3[4.4.10 Representing Time + Points] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0092 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description of a time point that acts as a fixed reference for a series + of planned time points, used for study data tabulation. Description of the fixed reference + point referred to by --ELTM, --TPTNUM, --TPT, --STINT, and --ENINT. + Document: SDTM v2.1 + Item: --TPTREF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0357 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ELTM - operator: exists - - name: --TPTREF - operator: not_exists + - name: --ELTM + operator: exists + - name: --TPTREF + operator: not_exists Core: Id: CORE-000167 Status: Published - Version: '1' + Version: "1" Description: Raise an error when--ELTM is present but --TPTREF is not present in dataset. Executability: Fully Executable Outcome: Message: --TPTREF must be present when --ELTM is present in a dataset Output Variables: - - --ELTM - - --TPTREF + - --ELTM + - --TPTREF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000168/rule.yml b/Published/CORE-000168/rule.yml index e7691af60..491e13f1e 100644 --- a/Published/CORE-000168/rule.yml +++ b/Published/CORE-000168/rule.yml @@ -2,97 +2,101 @@ # Condition: VISITNUM ^= null # Rule: VISITNUM in SV.VISITNUM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the timing of - subject visits that is otherwise spread over domains that include the visit variables - (VISITNUM and possibly VISIT and/or VISITDY). - Document: IG v3.4 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the timing of - subject visits that is otherwise spread over domains that include the visit variables - (VISITNUM and possibly VISIT and/or VISITDY). - Document: IG v3.3 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the timing of - subject visits that is otherwise spread over domains that include the visit variables - (VISITNUM and possibly VISIT and/or VISITDY). - Document: IG v3.2 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0034 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Subject Visits domain consolidates information about the timing of - subject visits that is otherwise spread over domains that include the visit variables - (VISITNUM and possibly VISIT and/or VISITDY). - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0315 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.4 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.3 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: IG v3.2 + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0034 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The Subject Visits domain consolidates information about the timing of + subject visits that is otherwise spread over domains that include the visit variables + (VISITNUM and possibly VISIT and/or VISITDY). + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0315 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: VISITNUM - operator: non_empty - - name: VISITNUM - operator: is_not_contained_by - value: $sv_visitnum + - name: VISITNUM + operator: non_empty + - name: VISITNUM + operator: is_not_contained_by + value: $sv_visitnum Core: Id: CORE-000168 Status: Published - Version: '1' + Version: "1" Description: If VISITNUM is not null then VISITNUM should be among SV.VISITNUM Executability: Fully Executable Operations: -- domain: SV - group: - - USUBJID - id: $sv_visitnum - name: VISITNUM - operator: distinct + - domain: SV + group: + - USUBJID + id: $sv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISITNUM is not among VISITNUM in SV domain. Output Variables: - - VISITNUM + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000169/rule.yml b/Published/CORE-000169/rule.yml index e30a57ee0..06d49382f 100644 --- a/Published/CORE-000169/rule.yml +++ b/Published/CORE-000169/rule.yml @@ -2,92 +2,96 @@ # Condition: Numeric scale used # Rule: LBTOXGR is a numeric value Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"If value is from a numeric scale, represent only the number (e.g., "2" and - not "Grade 2")."' - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If value is from a numeric scale, represent only the number (e.g., "2" and - not "Grade 2"). - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If value is from a numeric scale, represent only the number (e.g., "2" and - not "Grade 2"). - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0185 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Records toxicity grade value using a standard toxicity scale (such as the - NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not - "Grade 2"). - Document: TIG 1.0 - Item: Specification-LBTOXGR - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0414 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2")."' + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2"). + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If value is from a numeric scale, represent only the number (e.g., "2" and + not "Grade 2"). + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0185 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Records toxicity grade value using a standard toxicity scale (such as the + NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not + "Grade 2"). + Document: TIG 1.0 + Item: Specification-LBTOXGR + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0414 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: LBTOXGR - operator: matches_regex - value: .*[a-zA-Z].* # identifiers string contains characters - - name: LBTOXGR - operator: matches_regex - value: .*[0-9].* #identifies that string also contains a number + - name: LBTOXGR + operator: matches_regex + value: .*[a-zA-Z].* # identifiers string contains characters + - name: LBTOXGR + operator: matches_regex + value: .*[0-9].* #identifies that string also contains a number Core: Id: CORE-000169 Status: Published - Version: '1' + Version: "1" Description: Raise a warning when LBTOXGR is not numeric Executability: Fully Executable Outcome: Message: Verify that LBTOXGR value is not from a numeric scale Output Variables: - - LBTOXGR - - LBTOX + - LBTOXGR + - LBTOX Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000170/rule.yml b/Published/CORE-000170/rule.yml index dbe34f1a3..20ce88291 100644 --- a/Published/CORE-000170/rule.yml +++ b/Published/CORE-000170/rule.yml @@ -1,76 +1,76 @@ # Variable: --LOBXFL -# Condition: +# Condition: # Rule: Value must be 'Y' or null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: IG v3.4 - Item: Specification - Section: Various Findings Domains - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0541 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: IG v3.3 - Item: CDISC Notes - Section: Various Findings Domains - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0541 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value should be "Y" or null. - Document: TIG 1.0 - Item: Specification:--LOBXFL - Section: Various Finding Domains - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0634 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: IG v3.4 + Item: Specification + Section: Various Findings Domains + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0541 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: IG v3.3 + Item: CDISC Notes + Section: Various Findings Domains + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0541 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: The value should be "Y" or null. + Document: TIG 1.0 + Item: Specification:--LOBXFL + Section: Various Finding Domains + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0634 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --LOBXFL - operator: not_equal_to - value: Y - - name: --LOBXFL - operator: non_empty + - name: --LOBXFL + operator: not_equal_to + value: Y + - name: --LOBXFL + operator: non_empty Core: Id: CORE-000170 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --LOBXFL is not 'Y' or null Executability: Fully Executable Outcome: Message: Value of --LOBXFL must be 'Y' or null Output Variables: - - --CAT - - --TEST - - --TESTCD - - --LOBXFL + - --CAT + - --TEST + - --TESTCD + - --LOBXFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000171/rule.yml b/Published/CORE-000171/rule.yml index 64e187098..bdca7bc04 100644 --- a/Published/CORE-000171/rule.yml +++ b/Published/CORE-000171/rule.yml @@ -2,94 +2,99 @@ # Condition: --ENRTPT present in dataset # Rule: --ENTPT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the end of an observation. This is the sponsor-defined - reference point referred to by --ENRTPT. - Document: Model v2.0 - Item: --ENTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format of the - sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or "VISIT - 2". - Document: Model v1.7 - Item: Table 2.2.5.1, --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENTPT) Description or date/time in ISO 8601 or other character format of - the sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or - "VISIT 2". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0058 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the end of an observation. This is the sponsor-defined - reference point referred to by --ENRTPT. - Document: SDTM v2.1 - Item: --ENTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0332 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: Model v2.0 + Item: --ENTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or "VISIT + 2". + Document: Model v1.7 + Item: Table 2.2.5.1, --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--ENTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --ENRTPT. Examples "2003-12-25" or + "VISIT 2". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0058 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the end of an observation. This is the sponsor-defined + reference point referred to by --ENRTPT. + Document: SDTM v2.1 + Item: --ENTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0332 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --ENRTPT - operator: exists - - name: --ENTPT - operator: not_exists + - name: --ENRTPT + operator: exists + - name: --ENTPT + operator: not_exists Core: Id: CORE-000171 Status: Published - Version: '1' -Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in + Version: "1" +Description: + Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in dataset. Executability: Fully Executable Outcome: Message: --ENTPT should be present when --ENRTPT is present in a dataset Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000172/rule.yml b/Published/CORE-000172/rule.yml index 23a03f99e..2dd6bfef3 100644 --- a/Published/CORE-000172/rule.yml +++ b/Published/CORE-000172/rule.yml @@ -1,169 +1,174 @@ # Variable: STUDYID -# Condition: +# Condition: # Rule: STUDYID = DM.STUDYID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records that describe - that study. - Document: IG v3.4 - Item: 2.B.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records that describe - that study - Document: IG v3.3 - Item: 2.B.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records with the same STUDYID value are a group of records that describe - that study - Document: IG v3.2 - Item: 2.B.1 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0409 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - # IMPORTANT: Rule is different from SEND249, which is for SENDIG-3.0 ONLY, - # and which explicitely requires STUDYID=TS.STUDYID - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND249.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique identifier for a study. - Document: TIG v1.0 - Item: STUDYID CDISC Notes - Section: 2.8.9.32, and all domains - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0168 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique identifier that describe that study - Document: TIG 1.0 - Item: Specifications STUDYID - Section: All Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0565 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records with the same STUDYID value are a group of records that describe + that study. + Document: IG v3.4 + Item: 2.B.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records with the same STUDYID value are a group of records that describe + that study + Document: IG v3.3 + Item: 2.B.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records with the same STUDYID value are a group of records that describe + that study + Document: IG v3.2 + Item: 2.B.1 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0409 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: + SENDIG + # IMPORTANT: Rule is different from SEND249, which is for SENDIG-3.0 ONLY, + # and which explicitely requires STUDYID=TS.STUDYID + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The STUDYID in all domains must be the same in all records across the study. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND249.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Unique identifier for a study. + Document: TIG v1.0 + Item: STUDYID CDISC Notes + Section: 2.8.9.32, and all domains + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0168 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Unique identifier that describe that study + Document: TIG 1.0 + Item: Specifications STUDYID + Section: All Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0565 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: STUDYID - operator: is_not_contained_by - value: $dm_studyid + - name: STUDYID + operator: is_not_contained_by + value: $dm_studyid Core: Id: CORE-000172 Status: Published - Version: '1' -Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must + Version: "1" +Description: + Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must be the same in all records across the study. Executability: Fully Executable Operations: -- domain: DM - id: $dm_studyid - name: STUDYID - operator: distinct + - domain: DM + id: $dm_studyid + name: STUDYID + operator: distinct Outcome: Message: STUDYID is not equal to DM.STUDYID Output Variables: - - STUDYID + - STUDYID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000173/rule.yml b/Published/CORE-000173/rule.yml index 9dd9085c3..b158df342 100644 --- a/Published/CORE-000173/rule.yml +++ b/Published/CORE-000173/rule.yml @@ -2,111 +2,115 @@ # Condition: ETCD ^= 'UNPLAN' # Rule: ETCD = TE.ETCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of - the trial Elements a subject actually passed through in their participation in the trial. - Read Section 7.2.2, Trial Elements, on the Trial Elements (TE) dataset and Section 7.2.1, - Trial Arms, on the Trial Arms (TA) dataset, as these datasets define a trial's planned - Elements and describe the planned sequences of Elements for the Arms of the trial. - Document: IG V3.4 - Item: Assumptions - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of - the trial Elements a subject actually passed through in their participation in the trial. - Please read Section 7.2.2 - Experimental Design; Trial Elements (TE); on the Trial - Elements dataset and Section 7.2.1 - Experimental Design; Trial Arms (TA); on the Trial - Arms dataset; as these datasets define a trial's planned Elements; and describe the - planned sequences of lements for the Arms of the trial. - Document: IG V3.3 - Item: Assumptions - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of - the trial Elements a subject actually passed through in their participation in the trial. - Please read Section 7.2 - Experimental Design; Trial Elements (TE); on the Trial Elements - dataset and Section 7.2 - Experimental Design; Trial Arms (TA); on the Trial Arms dataset; - as these datasets define a trial's planned Elements; and describe the planned sequences of - lements for the Arms of the trial. - Document: IG V3.2 - Item: Assumptions 2 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0414 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Subject Elements domain allows the submission of data on the timing of - the trial Elements a subject actually passed through in their participation in the trial. - Section 10.8.30 Trial Elements and Section 10.8.29 Trial Arms, as these datasets define - a trial's planned Elements and describe the planned sequences of Elements for the Arms of - the trial. - Document: TIG 1.0 - Item: Assumptions - Section: 2.8.10.24|2.8.10.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0569 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Read Section 7.2.2, Trial Elements, on the Trial Elements (TE) dataset and Section 7.2.1, + Trial Arms, on the Trial Arms (TA) dataset, as these datasets define a trial's planned + Elements and describe the planned sequences of Elements for the Arms of the trial. + Document: IG V3.4 + Item: Assumptions + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Please read Section 7.2.2 - Experimental Design; Trial Elements (TE); on the Trial + Elements dataset and Section 7.2.1 - Experimental Design; Trial Arms (TA); on the Trial + Arms dataset; as these datasets define a trial's planned Elements; and describe the + planned sequences of lements for the Arms of the trial. + Document: IG V3.3 + Item: Assumptions + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Please read Section 7.2 - Experimental Design; Trial Elements (TE); on the Trial Elements + dataset and Section 7.2 - Experimental Design; Trial Arms (TA); on the Trial Arms dataset; + as these datasets define a trial's planned Elements; and describe the planned sequences of + lements for the Arms of the trial. + Document: IG V3.2 + Item: Assumptions 2 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0414 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The Subject Elements domain allows the submission of data on the timing of + the trial Elements a subject actually passed through in their participation in the trial. + Section 10.8.30 Trial Elements and Section 10.8.29 Trial Arms, as these datasets define + a trial's planned Elements and describe the planned sequences of Elements for the Arms of + the trial. + Document: TIG 1.0 + Item: Assumptions + Section: 2.8.10.24|2.8.10.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0569 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ETCD - operator: not_equal_to - value: UNPLAN - - name: ETCD - operator: is_not_contained_by - value: $te_etcd + - name: ETCD + operator: not_equal_to + value: UNPLAN + - name: ETCD + operator: is_not_contained_by + value: $te_etcd Core: Id: CORE-000173 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ETCD is not equal to 'UNPLAN' and not equal to TE.ETCD Executability: Fully Executable Operations: -- domain: TE - id: $te_etcd - name: ETCD - operator: distinct + - domain: TE + id: $te_etcd + name: ETCD + operator: distinct Outcome: Message: ETCD is not equal to 'UNPLAN' and not equal to TE.ETCD Output Variables: - - ETCD + - ETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - SE - - TA + - SE + - TA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000177/rule.yml b/Published/CORE-000177/rule.yml index 07d42ca30..b40ae79dc 100644 --- a/Published/CORE-000177/rule.yml +++ b/Published/CORE-000177/rule.yml @@ -2,99 +2,103 @@ # Condition: DM.RFENDTC = null # Rule: --ENRF = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: Model v2.0 - Item: --ENRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before, during or after the - sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENRF - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before, during or after the - sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0227 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --ENRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0440 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --ENRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before, during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENRF + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before, during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0227 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --ENRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0440 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RFENDTC - operator: empty - - name: --ENRF - operator: non_empty + - name: RFENDTC + operator: empty + - name: --ENRF + operator: non_empty Core: Id: CORE-000177 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DM.RFENDTC is empty and --ENRF is not empty. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: DM.RFENDTC is empty, but --ENRF is completed. Output Variables: - - --ENRF + - --ENRF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000179/rule.yml b/Published/CORE-000179/rule.yml index 22237728e..38479b436 100644 --- a/Published/CORE-000179/rule.yml +++ b/Published/CORE-000179/rule.yml @@ -1,227 +1,237 @@ # Variable: TSPARMCD AND TSPARM -# Condition: +# Condition: # Rule: TSPARM and TSPARMCD have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "'TSPARMCD (the companion to TSPARM)'" - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0307 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: TSPARMCD (the companion to TSPARM) - Document: TIG 1.0 - Item: Specification:TSPARMCD - Section: 2.8.10.30 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0482 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0916 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "'TSPARMCD (the companion to TSPARM)'" + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0307 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: TSPARMCD (the companion to TSPARM) + Document: TIG 1.0 + Item: Specification:TSPARMCD + Section: 2.8.10.30 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0482 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0916 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TSPARM - operator: is_not_unique_relationship - value: TSPARMCD + - name: TSPARM + operator: is_not_unique_relationship + value: TSPARMCD Core: Id: CORE-000179 Status: Published - Version: '1' + Version: "1" Description: TSPARMCD and TSPARM should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: TSPARM and TSPARMCD do not have a one-to-one relationship. Output Variables: - - TSPARM - - TSPARMCD + - TSPARM + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000180/rule.yml b/Published/CORE-000180/rule.yml index 807f4bf2f..78e1480a6 100644 --- a/Published/CORE-000180/rule.yml +++ b/Published/CORE-000180/rule.yml @@ -1,71 +1,72 @@ # Variable: DOMAIN -# Condition: +# Condition: # Rule: DOMAIN value length = 2 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code - Document: IG v3.4 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code - Document: IG v3.3 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0308 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Domain datasets based on the SDTM general observations classes will be named - using the two-character code for the domain or using the applicable four-character code - when a dataset is split. - Document: TIG 1.0 - Item: Num 2 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0483 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.4 + Section: "2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.2 + Section: "2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Each domain dataset is distinguished by a unique, two-character code + Document: IG v3.3 + Section: "2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0308 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Domain datasets based on the SDTM general observations classes will be named + using the two-character code for the domain or using the applicable four-character code + when a dataset is split. + Document: TIG 1.0 + Item: Num 2 + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0483 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DOMAIN - operator: longer_than - value: 2 + - name: DOMAIN + operator: longer_than + value: 2 Core: Id: CORE-000180 Status: Published - Version: '1' + Version: "1" Description: Raise an error when DOMAIN value length is not equal 2. Executability: Fully Executable Outcome: @@ -74,9 +75,9 @@ Rule Type: Record Data Scope: Classes: Exclude: - - RELATIONSHIP + - RELATIONSHIP Domains: Exclude: - - AP-- + - AP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000182/rule.yml b/Published/CORE-000182/rule.yml index d9351f271..2e2c11a01 100644 --- a/Published/CORE-000182/rule.yml +++ b/Published/CORE-000182/rule.yml @@ -1,164 +1,174 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable name length <= 8 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In some cases, the standard variable name will be shortened to meet the - 8-character variable name requirement... - Document: IG v3.4 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS - Transport format) - Document: IG v3.2 - Section: '2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In some cases, the standard variable name will be shortened to meet the - 8-character variable name requirement... - Document: IG v3.3 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0310 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: IG v1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND2 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable names will be 8 characters or less and upper case. - Document: TIG 1.0 - Item: 'Num 4' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0485 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Variable Name (limited to 8 characters for compatibility with the SAS v5 - Transport format). - Document: TIG v1.0 - Item: Text - Section: 2.6 Guidance for Datasets, tabulation table Num 4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0128 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In some cases, the standard variable name will be shortened to meet the + 8-character variable name requirement... + Document: IG v3.4 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS + Transport format) + Document: IG v3.2 + Section: "2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In some cases, the standard variable name will be shortened to meet the + 8-character variable name requirement... + Document: IG v3.3 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0310 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: IG v1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND2 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable names will be 8 characters or less and upper case. + Document: TIG 1.0 + Item: "Num 4" + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0485 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The Variable Name (limited to 8 characters for compatibility with the SAS v5 + Transport format). + Document: TIG v1.0 + Item: Text + Section: 2.6 Guidance for Datasets, tabulation table Num 4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0128 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: longer_than - value: 8 + - name: variable_name + operator: longer_than + value: 8 Core: Id: CORE-000182 Status: Published - Version: '1' + Version: "1" Description: Raise an error when variable name length is greater than 8. Executability: Fully Executable Outcome: @@ -167,9 +177,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000183/rule.yml b/Published/CORE-000183/rule.yml index 723f924c0..f79c5409f 100644 --- a/Published/CORE-000183/rule.yml +++ b/Published/CORE-000183/rule.yml @@ -2,87 +2,93 @@ # Condition: PP dataset present in study # Rule: PC dataset present in study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note, domain pairs have been modeled for microbiology data (MB/MS domains) - and PK data (PC/PP domains) to enable dataset-level relationships to be described using - RELREC. - Document: IG v3.4 - Item: '1' - Section: '2.6' - - Cited Guidance: A findings domain that contains pharmacokinetic parameters derived from - pharmacokinetic concentration-time (PC) data. - Document: IG v3.4 - Item: PP - Description/Overview - Section: 6.3.5.6.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to group parent - records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship - to be described in RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived from - pharmacokinetic concentration-time (PC) data.] - Document: IG v3.2 - Item: IG v3.2[2.6]|IG v3.2[6.3][PP] - Section: IG v3.2[2.6]|IG v3.2[6.3] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an Identifier - to group parent records (e.g., MB) from child records (e.g., MS) and enables a - dataset-level relationship to be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain - that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time - (PC) data.] - Document: IG v3.3 - Item: IG v3.3[2.6]|IG v3.3[6.3.11.2] - Section: IG v3.3[2.6]|IG v3.3[6.3.11.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0318 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A findings domain that contains pharmacokinetic parameters derived from - pharmacokinetic concentration-time (PC) data. - Document: TIG 1.0 - Item: Description - Section: 2.8.10.17 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0489 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Note, domain pairs have been modeled for microbiology data (MB/MS domains) + and PK data (PC/PP domains) to enable dataset-level relationships to be described using + RELREC. + Document: IG v3.4 + Item: "1" + Section: "2.6" + - Cited Guidance: + A findings domain that contains pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data. + Document: IG v3.4 + Item: PP - Description/Overview + Section: 6.3.5.6.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[2.6][The domain pair uses DOMAIN as an Identifier to group parent + records (e.g., MB) from child records (e.g., MS) and enables a dataset-level relationship + to be described in RELREC.]|IG v3.2[6.3][PP][Pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data.] + Document: IG v3.2 + Item: IG v3.2[2.6]|IG v3.2[6.3][PP] + Section: IG v3.2[2.6]|IG v3.2[6.3] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[2.6]|IG v3.3[6.3.11.2][The domain pair uses DOMAIN as an Identifier + to group parent records (e.g., MB) from child records (e.g., MS) and enables a + dataset-level relationship to be described in RELREC.]|IG v3.3[6.3.11.2][A findings domain + that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time + (PC) data.] + Document: IG v3.3 + Item: IG v3.3[2.6]|IG v3.3[6.3.11.2] + Section: IG v3.3[2.6]|IG v3.3[6.3.11.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0318 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A findings domain that contains pharmacokinetic parameters derived from + pharmacokinetic concentration-time (PC) data. + Document: TIG 1.0 + Item: Description + Section: 2.8.10.17 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0489 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: PP - operator: exists - - name: PC - operator: not_exists + - name: PP + operator: exists + - name: PC + operator: not_exists Core: Id: CORE-000183 Status: Published - Version: '1' -Description: Raise an error when a PP dataset is present in study, but a PC dataset is not present + Version: "1" +Description: + Raise an error when a PP dataset is present in study, but a PC dataset is not present in study. Executability: Fully Executable Outcome: @@ -91,10 +97,10 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC - - PP + - PC + - PP Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000184/rule.yml b/Published/CORE-000184/rule.yml index 1fdfef081..a32005a6f 100644 --- a/Published/CORE-000184/rule.yml +++ b/Published/CORE-000184/rule.yml @@ -1,131 +1,134 @@ # Variable: --BDSYCD -# Condition: +# Condition: # Rule: --BDSYCD and --BODSYS have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: Model v2.0 - Item: --BODSYS - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variable Qualifier of --BODSYS - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0083 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] - Document: SDTM v2.1 - Item: --BODSYS - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0348 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0910 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Variable Qualifier of --BODSYS + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0083 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: Events[--BODSYSCD][Variable Qualifier of BODSYS] + Document: SDTM v2.1 + Item: --BODSYS + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0348 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0910 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: --BDSYCD - operator: exists - - name: --BODSYS - operator: exists - - name: --BDSYCD - operator: is_not_unique_relationship - value: --BODSYS + - name: --BDSYCD + operator: exists + - name: --BODSYS + operator: exists + - name: --BDSYCD + operator: is_not_unique_relationship + value: --BODSYS Core: Id: CORE-000184 Status: Published - Version: '1' + Version: "1" Description: --BODSYS and --BDSYCD have a one-to-one relationship. Executability: Fully Executable Outcome: Message: --BODSYS and --BDSYCD do not have a one-to-one relationship. Output Variables: - - --BODSYS - - --BDSYCD + - --BODSYS + - --BDSYCD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000185/rule.yml b/Published/CORE-000185/rule.yml index e6b2e3192..61c796e15 100644 --- a/Published/CORE-000185/rule.yml +++ b/Published/CORE-000185/rule.yml @@ -1,88 +1,92 @@ # Variable: ACTARMCD -# Condition: +# Condition: # Rule: ACTARMCD value length <= 20 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject - to the character restrictions that apply to TESTCD. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: ACTARMCD is limited to 20 characters and does not have special character - restrictions. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject - to the character restrictions that apply to TESTCD. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0123 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject - to the character restrictions that apply to TESTCD. - Document: TIG 1.0 - Item: ACTARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0380 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + ACTARMCD is limited to 20 characters and does not have special character + restrictions. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0123 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Code of actual Arm. ACTARMCD is limited to 20 characters. It is not subject + to the character restrictions that apply to TESTCD. + Document: TIG 1.0 + Item: ACTARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0380 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARMCD - operator: longer_than - value: 20 + - name: ACTARMCD + operator: longer_than + value: 20 Core: Id: CORE-000185 Status: Published - Version: '1' + Version: "1" Description: Trigger error if length of ACTARMCD is greater than 20 characters Executability: Fully Executable Outcome: Message: Length of ACTARMCD is greater than 20 characters Output Variables: - - ACTARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000186/rule.yml b/Published/CORE-000186/rule.yml index eaced6b10..8121f4ff5 100644 --- a/Published/CORE-000186/rule.yml +++ b/Published/CORE-000186/rule.yml @@ -1,85 +1,85 @@ # Variable: SUBJID -# Condition: +# Condition: # Rule: SUBJID unique within a study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0150 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Subject identifier, which must be unique within the study. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0391 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0150 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Subject identifier, which must be unique within the study. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0391 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SUBJID - operator: is_not_unique_set - value: - - STUDYID + - name: SUBJID + operator: is_not_unique_set + value: + - STUDYID Core: Id: CORE-000186 Status: Published - Version: '1' + Version: "1" Description: Trigger error if SUBJID is not unique Executability: Fully Executable Outcome: Message: SUBJID is not unique within study Output Variables: - - SUBJID + - SUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000187/rule.yml b/Published/CORE-000187/rule.yml index d4faaf592..a325d0298 100644 --- a/Published/CORE-000187/rule.yml +++ b/Published/CORE-000187/rule.yml @@ -2,119 +2,124 @@ # Condition: IDVAR ^= null # Rule: CODTC = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of comment on dedicated comment form. Should be null if this is a - child record of another domain or if comment date was not collected. - Document: IG v3.4 - Item: Specification - Section: '5.1' - - Cited Guidance: Those related to a specific parent record or group of parent records, in - which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent - record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name - and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are - further described in Section 8.5, Relating Comments to a Parent Domain. CODTC should be - null because the timing of the parent record(s) is inherited by the comment record. See - example, Rows 3-5. - Document: IG v3.4 - Item: Assumption 2c - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null if this is a - child record of another domain or if comment date was not collected.][Those related to a specific - parent record or group of parent records, in which case the value of the variable RDOMAIN is - set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated - with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR - and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. - CODTC should be null because the timing of the parent record(s) is inherited by the comment - record. See example, Rows 3-5.]' - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Date/time of comment on dedicated comment form. Should be null if this is a - child record of another domain or if comment date was not collected.][Those related to a specific - parent record or group of parent records, in which case the value of the variable RDOMAIN is - set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated - with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR - and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. - CODTC should be null because the timing of the parent record(s) is inherited by the comment - record. See example, Rows 3-5.]' - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0168 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification[Date/time of comment on dedicated comment form. Should be null - if this is a child record of another domain or if comment date was not - collected.]|Assumption 2c[Those related to a specific parent record or group of parent - records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the - parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable - name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are - further described in Section 2.8.5.4 Relating Comments to a Domain. CODTC should be null - because the timing of the parent record(s) is inherited by the comment record - Document: TIG 1.0 - Item: Specification|Assumption 3c - Section: 2.8.10.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0400 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected. + Document: IG v3.4 + Item: Specification + Section: "5.1" + - Cited Guidance: + Those related to a specific parent record or group of parent records, in + which case the value of the variable RDOMAIN is set to the DOMAIN code of the parent + record(s) and the variables IDVAR and IDVARVAL are populated with the key variable name + and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are + further described in Section 8.5, Relating Comments to a Parent Domain. CODTC should be + null because the timing of the parent record(s) is inherited by the comment record. See + example, Rows 3-5. + Document: IG v3.4 + Item: Assumption 2c + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected.][Those related to a specific + parent record or group of parent records, in which case the value of the variable RDOMAIN is + set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated + with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR + and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. + CODTC should be null because the timing of the parent record(s) is inherited by the comment + record. See example, Rows 3-5.]" + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[Date/time of comment on dedicated comment form. Should be null if this is a + child record of another domain or if comment date was not collected.][Those related to a specific + parent record or group of parent records, in which case the value of the variable RDOMAIN is + set to the DOMAIN code of the parent record(s) and the variables IDVAR and IDVARVAL are populated + with the key variable name and value of the parent record(s).][Assumptions for populating IDVAR + and IDVARVAL are further described in Section 8: 8.5, Relating Comments To A Parent Domain. + CODTC should be null because the timing of the parent record(s) is inherited by the comment + record. See example, Rows 3-5.]" + Document: IG v3.3 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0168 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Specification[Date/time of comment on dedicated comment form. Should be null + if this is a child record of another domain or if comment date was not + collected.]|Assumption 2c[Those related to a specific parent record or group of parent + records, in which case the value of the variable RDOMAIN is set to the DOMAIN code of the + parent record(s) and the variables IDVAR and IDVARVAL are populated with the key variable + name and value of the parent record(s). Assumptions for populating IDVAR and IDVARVAL are + further described in Section 2.8.5.4 Relating Comments to a Domain. CODTC should be null + because the timing of the parent record(s) is inherited by the comment record + Document: TIG 1.0 + Item: Specification|Assumption 3c + Section: 2.8.10.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0400 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVAR - operator: non_empty - - name: CODTC - operator: non_empty + - name: IDVAR + operator: non_empty + - name: CODTC + operator: non_empty Core: Id: CORE-000187 Status: Published - Version: '1' + Version: "1" Description: Trigger error when IDVAR is not null and CODTC is not null Executability: Fully Executable Outcome: Message: CODTC is populated when IDVAR is also populated Output Variables: - - USUBJID - - IDVAR - - CODTC + - USUBJID + - IDVAR + - CODTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000189/rule.yml b/Published/CORE-000189/rule.yml index 4a38696fa..8c7b1a2b5 100644 --- a/Published/CORE-000189/rule.yml +++ b/Published/CORE-000189/rule.yml @@ -2,59 +2,59 @@ # Condition: AGE ^= null # Rule: AGEU ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' - Document: Model v2.0 - Item: AGEU|AGETXT - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0665 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' - Document: SDTM v2.1 - Item: AGEU|AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0699 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials." + Document: Model v2.0 + Item: AGEU|AGETXT + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0665 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials." + Document: SDTM v2.1 + Item: AGEU|AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0699 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AGE - operator: non_empty - - name: AGEU - operator: empty + - name: AGE + operator: non_empty + - name: AGEU + operator: empty Core: Id: CORE-000189 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGE is not blank and AGEU is blank. Executability: Fully Executable Outcome: Message: AGEU is missing when AGE is provided. Output Variables: - - AGE - - AGEU + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000190/rule.yml b/Published/CORE-000190/rule.yml index 57f625069..729935137 100644 --- a/Published/CORE-000190/rule.yml +++ b/Published/CORE-000190/rule.yml @@ -2,59 +2,59 @@ # Condition: AGEU ^= null # Rule: AGE ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' - Document: Model v2.0 - Item: AGEU|AGETXT - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0666 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials.' - Document: SDTM v2.1 - Item: AGEU|AGETXT - Section: Section 3.2.1 Demographics - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0700 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "[AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials." + Document: Model v2.0 + Item: AGEU|AGETXT + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0666 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: "AGEU]Variable Qualifier of AGE or AGETXT.|[AGETXT]Not in human clinical trials." + Document: SDTM v2.1 + Item: AGEU|AGETXT + Section: Section 3.2.1 Demographics + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0700 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AGEU - operator: non_empty - - name: AGE - operator: empty + - name: AGEU + operator: non_empty + - name: AGE + operator: empty Core: Id: CORE-000190 Status: Published - Version: '1' + Version: "1" Description: Raise an error when AGEU is not blank and AGE is blank. Executability: Fully Executable Outcome: Message: AGE is missing when AGEU is provided. Output Variables: - - AGE - - AGEU + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000191/rule.yml b/Published/CORE-000191/rule.yml index 68361d7e0..717b1677c 100644 --- a/Published/CORE-000191/rule.yml +++ b/Published/CORE-000191/rule.yml @@ -2,75 +2,78 @@ # Condition: ARM ^= null # Rule: RFENDTC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0529 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0529 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: TIG 1.0 - Item: Specification:RFENDTC - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0622 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0529 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0529 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: TIG 1.0 + Item: Specification:RFENDTC + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0622 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARM - operator: non_empty - - name: RFENDTC - operator: empty + - name: ARM + operator: non_empty + - name: RFENDTC + operator: empty Core: Id: CORE-000191 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ARM is not empty and RFENDTC is empty. Executability: Fully Executable Outcome: Message: RFENDTC is missing when ARM is provided. Output Variables: - - ARM - - RFENDTC + - ARM + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000192/rule.yml b/Published/CORE-000192/rule.yml index b2f536ccc..4dfa0c5de 100644 --- a/Published/CORE-000192/rule.yml +++ b/Published/CORE-000192/rule.yml @@ -2,75 +2,78 @@ # Condition: ARMNRS ^= null # Rule: RFENDTC = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0530 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0530 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Required for all randomized subjects; null for screen failures or unassigned - subjects. - Document: TIG 1.0 - Item: Specification:RFENDTC - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0623 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0530 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0530 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Required for all randomized subjects; null for screen failures or unassigned + subjects. + Document: TIG 1.0 + Item: Specification:RFENDTC + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0623 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMNRS - operator: non_empty - - name: RFENDTC - operator: non_empty + - name: ARMNRS + operator: non_empty + - name: RFENDTC + operator: non_empty Core: Id: CORE-000192 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ARMNRS is not blank and RFENDTC is provided. Executability: Fully Executable Outcome: Message: RFENDTC is not blank when ARMNRS is provided. Output Variables: - - ARMNRS - - RFENDTC + - ARMNRS + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000195/rule.yml b/Published/CORE-000195/rule.yml index ee8354775..11b2d94db 100644 --- a/Published/CORE-000195/rule.yml +++ b/Published/CORE-000195/rule.yml @@ -1,86 +1,90 @@ # Variable: --SCAT -# Condition: +# Condition: # Rule: --SCAT ^= --DECOD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0338 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0503 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0338 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0503 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: --DECOD + - name: --SCAT + operator: equal_to_case_insensitive + value: --DECOD Core: Id: CORE-000195 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SCAT = --DECOD. Executability: Fully Executable Outcome: Message: --SCAT is equal to --DECOD. Output Variables: - - --DECOD - - --SCAT + - --DECOD + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000196/rule.yml b/Published/CORE-000196/rule.yml index 7235f137c..413b06578 100644 --- a/Published/CORE-000196/rule.yml +++ b/Published/CORE-000196/rule.yml @@ -1,86 +1,90 @@ # Variable: --CAT -# Condition: +# Condition: # Rule: --CAT ^= --DECOD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0337 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0502 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0337 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0502 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: --DECOD + - name: --CAT + operator: equal_to_case_insensitive + value: --DECOD Core: Id: CORE-000196 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --CAT = --DECOD. Executability: Fully Executable Outcome: Message: --CAT is equal to --DECOD. Output Variables: - - --DECOD - - --CAT + - --DECOD + - --CAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000197/rule.yml b/Published/CORE-000197/rule.yml index f3a6db373..3812af893 100644 --- a/Published/CORE-000197/rule.yml +++ b/Published/CORE-000197/rule.yml @@ -1,87 +1,91 @@ # Variable: --CAT -# Condition: +# Condition: # Rule: --CAT ^= --BODSYS Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0339 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0504 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0339 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0504 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: --BODSYS + - name: --CAT + operator: equal_to_case_insensitive + value: --BODSYS Core: Id: CORE-000197 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --CAT = --BODSYS. Executability: Fully Executable Outcome: Message: --CAT is equal to --BODSYS. Output Variables: - - --TERM - - --CAT - - --BODSYS + - --TERM + - --CAT + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000198/rule.yml b/Published/CORE-000198/rule.yml index 94121e3c4..b586d3178 100644 --- a/Published/CORE-000198/rule.yml +++ b/Published/CORE-000198/rule.yml @@ -1,87 +1,91 @@ # Variable: --SCAT -# Condition: +# Condition: # Rule: --SCAT ^= --BODSYS Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0340 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0505 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0340 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0505 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: --BODSYS + - name: --SCAT + operator: equal_to_case_insensitive + value: --BODSYS Core: Id: CORE-000198 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SCAT = --BODSYS. Executability: Fully Executable Outcome: Message: --SCAT is equal to --BODSYS. Output Variables: - - --TERM - - --SCAT - - --BODSYS + - --TERM + - --SCAT + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000199/rule.yml b/Published/CORE-000199/rule.yml index 384329d14..2fee4724f 100644 --- a/Published/CORE-000199/rule.yml +++ b/Published/CORE-000199/rule.yml @@ -1,173 +1,183 @@ # Variable: --TEST -# Condition: +# Condition: # Rule: --TEST length <= 40 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since the --TEST variable is meant to serve as a label for a --TESTCD when a - Findings dataset is transposed to a more horizontal format, the length of --TEST is - limited to 40 characters (except as noted below) to conform to the limitations of the SAS - v5 Transport format currently used for submission datasets.... IETEST values in IE and TI - are exceptions to the above 40-character rule and are limited to 200 characters, since - they are not expected to be transformed to column labels. - Document: IG v3.4 - Section: 4.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The length of --TEST is normally limited to 40 characters to conform to the - limitations of the SAS V5 Transport format currently used for submission datasets. IETEST - values in IE and TI are exceptions to the above 40-character rule and are limited to 200 - characters since they are not expected to be transformed to a column labels. - Document: IG v3.3 - Section: 4.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The length of --TEST is normally limited to 40 characters to conform to the - limitations of the SAS V5 Transport format currently used for submission datasets. IETEST - values in IE and TI are exceptions to the above 40-character rule and are limited to 200 - characters since they are not expected to be transformed to a column labels. - Document: IG v3.2 - Section: 4.1.5.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0406 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because of limitations of SAS v5 Transport files, the lengths of data values - cannot exceed 200 characters. Because --TEST values may become column labels upon - transformation, the SDTM additionally restricts them to 40 characters. - Document: IG v3.0 - Section: 4.5.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Because --TEST values may become column labels upon transformation, the SDTM - additionally restricts them to 40 characters. - Document: IG v3.1.1 - Section: 4.5.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND64 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Since the --TEST variable is meant to serve as a label for a --TESTCD when a - Findings dataset is transposed to a more horizontal format, the length of --TEST is - limited to 40 characters (except as noted below) to conform to the limitations of the SAS - v5 Transport format currently used for submission datasets. - Document: TIG 1.0 - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0563 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Since the --TEST variable is meant to serve as a label for a --TESTCD when a + Findings dataset is transposed to a more horizontal format, the length of --TEST is + limited to 40 characters (except as noted below) to conform to the limitations of the SAS + v5 Transport format currently used for submission datasets.... IETEST values in IE and TI + are exceptions to the above 40-character rule and are limited to 200 characters, since + they are not expected to be transformed to column labels. + Document: IG v3.4 + Section: 4.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The length of --TEST is normally limited to 40 characters to conform to the + limitations of the SAS V5 Transport format currently used for submission datasets. IETEST + values in IE and TI are exceptions to the above 40-character rule and are limited to 200 + characters since they are not expected to be transformed to a column labels. + Document: IG v3.3 + Section: 4.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The length of --TEST is normally limited to 40 characters to conform to the + limitations of the SAS V5 Transport format currently used for submission datasets. IETEST + values in IE and TI are exceptions to the above 40-character rule and are limited to 200 + characters since they are not expected to be transformed to a column labels. + Document: IG v3.2 + Section: 4.1.5.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0406 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Because of limitations of SAS v5 Transport files, the lengths of data values + cannot exceed 200 characters. Because --TEST values may become column labels upon + transformation, the SDTM additionally restricts them to 40 characters. + Document: IG v3.0 + Section: 4.5.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Because --TEST values may become column labels upon transformation, the SDTM + additionally restricts them to 40 characters. + Document: IG v3.1.1 + Section: 4.5.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND64 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Since the --TEST variable is meant to serve as a label for a --TESTCD when a + Findings dataset is transposed to a more horizontal format, the length of --TEST is + limited to 40 characters (except as noted below) to conform to the limitations of the SAS + v5 Transport format currently used for submission datasets. + Document: TIG 1.0 + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0563 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --TEST - operator: longer_than - value: 40 + - name: --TEST + operator: longer_than + value: 40 Core: Id: CORE-000199 Status: Published - Version: '1' + Version: "1" Description: Raise an error when length of --TEST > 40. Executability: Fully Executable Outcome: Message: Value length of --TEST > 40. Output Variables: - - --TEST + - --TEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - IE + - IE Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000200/rule.yml b/Published/CORE-000200/rule.yml index ff96518c6..261fee582 100644 --- a/Published/CORE-000200/rule.yml +++ b/Published/CORE-000200/rule.yml @@ -2,117 +2,122 @@ # Condition: --STAT = null or --DRVFL ^= 'Y' # Rule: --ORRES ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "--ORRES variable contains the result of the measurement or finding as originally - received or collected. --ORRES is an expected variable and should always be populated, with - two exceptions':' When --STAT = \"NOT DONE\" since there is no result for such a record When - --DRVFL = \"Y\" since the distinction between an original result and a standard result is not - applicable for records for which --DRVFL = \"Y\" " - Document: IG v3.4 - Item: ' ' - Section: 4.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "The --ORRES variable contains the result of the measurement or finding as originally - received or collected. --ORRES is an expected variable and should always be populated; with - two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived - records." - Document: IG v3.2 - Section: 4.1.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "The --ORRES variable contains the result of the measurement or finding as originally - received or collected. --ORRES is an expected variable and should always be populated; with - two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived - records." - Document: IG v3.3 - Section: 4.5.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0348 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: In general observation class domains, --STAT will be populated with "NOT - DONE" when data are not collected for the topic of the observation. - Document: TIG 1.0 - Item: Findings table Num 5 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0513 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '--ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated, with + two exceptions'':'' When --STAT = "NOT DONE" since there is no result for such a record When + --DRVFL = "Y" since the distinction between an original result and a standard result is not + applicable for records for which --DRVFL = "Y" ' + Document: IG v3.4 + Item: " " + Section: 4.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The --ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated; with + two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived + records." + Document: IG v3.2 + Section: 4.1.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The --ORRES variable contains the result of the measurement or finding as originally + received or collected. --ORRES is an expected variable and should always be populated; with + two exceptions: When --STAT = 'NOT DONE'. --ORRES should generally not be populated for derived + records." + Document: IG v3.3 + Section: 4.5.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0348 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + In general observation class domains, --STAT will be populated with "NOT + DONE" when data are not collected for the topic of the observation. + Document: TIG 1.0 + Item: Findings table Num 5 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0513 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: --STAT - operator: empty - - name: --DRVFL - operator: not_equal_to - value: 'Y' - value_is_literal: true - - name: --ORRES - operator: empty - - all: - - name: --STAT - operator: empty - - name: --DRVFL - operator: not_exists - - name: --ORRES - operator: empty - - all: - - name: --STAT - operator: not_exists - - name: --DRVFL - operator: not_equal_to - value: 'Y' - value_is_literal: true - - name: --ORRES - operator: empty + - all: + - name: --STAT + operator: empty + - name: --DRVFL + operator: not_equal_to + value: "Y" + value_is_literal: true + - name: --ORRES + operator: empty + - all: + - name: --STAT + operator: empty + - name: --DRVFL + operator: not_exists + - name: --ORRES + operator: empty + - all: + - name: --STAT + operator: not_exists + - name: --DRVFL + operator: not_equal_to + value: "Y" + value_is_literal: true + - name: --ORRES + operator: empty Core: Id: CORE-000200 Status: Published - Version: '1' -Description: Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to + Version: "1" +Description: + Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to 'Y' Executability: Fully Executable Outcome: Message: --ORRES cannot be null when --STAT is null or --DRVFL not equal to 'Y' Output Variables: - - --STAT - - --DRVFL - - --ORRES + - --STAT + - --DRVFL + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000201/rule.yml b/Published/CORE-000201/rule.yml index bbe4e5579..e37a2e28a 100644 --- a/Published/CORE-000201/rule.yml +++ b/Published/CORE-000201/rule.yml @@ -2,199 +2,211 @@ # Condition: Domain Not in ('AP--') # Rule: USUBJID in DM.USUBJID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets - containing subject-level data. USUBJID values must be unique for each trial participant - (subject) across all trials in the submission. - Document: IG v3.4 - Section: 4.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets - containing subject-level data. USUBJID values must be unique for each trial participant - (subject) across all trials in the submission. - Document: IG v3.3 - Section: 4.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '... a unique identifier (USUBJID) should be assigned and included in all datasets. - The unique subject identifier (USUBJID) is required in all datasets containing subject-level - data.' - Document: IG v3.2 - Section: 4.1.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0029 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all - applications or submissions involving the product. This must be a unique value, and could - be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. - Document: TIG 1.0 - Item: Specification- USUBJID - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0311 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.0 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.5.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: To identify a subject uniquely across a submission, a unique identifier - (USUBJID) should be assigned and included in all subject-related datasets in the - submission. - Document: SENDIG v3.1.1 - Item: Assumption 1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND109 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all - applications or submissions involving the product. - Document: TIG 1.0 - Item: USUBJID CDISC Notes - Section: 2.8.9.6 SEND Demographics (DM) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0046 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) is required in all datasets + containing subject-level data. USUBJID values must be unique for each trial participant + (subject) across all trials in the submission. + Document: IG v3.4 + Section: 4.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) is required in all datasets + containing subject-level data. USUBJID values must be unique for each trial participant + (subject) across all trials in the submission. + Document: IG v3.3 + Section: 4.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "... a unique identifier (USUBJID) should be assigned and included in all datasets. + The unique subject identifier (USUBJID) is required in all datasets containing subject-level + data." + Document: IG v3.2 + Section: 4.1.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0029 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. This must be a unique value, and could + be a compound identifier formed by concatenating STUDYID-SITEID-SUBJID. + Document: TIG 1.0 + Item: Specification- USUBJID + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0311 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.0 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.5.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + To identify a subject uniquely across a submission, a unique identifier + (USUBJID) should be assigned and included in all subject-related datasets in the + submission. + Document: SENDIG v3.1.1 + Item: Assumption 1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND109 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: TIG 1.0 + Item: USUBJID CDISC Notes + Section: 2.8.9.6 SEND Demographics (DM) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0046 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: USUBJID - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid + - name: USUBJID + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid Core: Id: CORE-000201 Status: Published - Version: '1' -Description: Trigger error when domain is not an AP-- domain and USUBJID is not present in + Version: "1" +Description: + Trigger error when domain is not an AP-- domain and USUBJID is not present in DM.USUBJID Executability: Fully Executable Operations: -- domain: DM - id: $dm_usubjid - name: USUBJID - operator: distinct + - domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct Outcome: Message: USUBJID is not found in DM.USUBJID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - AP-- + - AP-- Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000202/rule.yml b/Published/CORE-000202/rule.yml index f961ae4df..6cf7f3471 100644 --- a/Published/CORE-000202/rule.yml +++ b/Published/CORE-000202/rule.yml @@ -2,106 +2,113 @@ # Condition: IDVAR populated with a --SEQ value # Rule: RELTYPE = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values - should be either ONE or MANY. Used only when identifying a relationship between datasets - (as described in Section 8.3, Relating Datasets). - Document: IG 3.4 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records - between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject - within a dataset, not across datasets. - Document: IG 3.4 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values - should be either ONE or MANY. Used only when identifying a relationship between datasets - (as described in Section 8.3, Relating Datasets). - Document: IG v3.2 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records - between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject - within a dataset, not across datasets. - Document: IG v3.2 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values - should be either ONE or MANY. Used only when identifying a relationship between datasets - (as described in Section 8.3, Relating Datasets). - Document: IG 3.3 - Section: 8.2.1 - - Cited Guidance: Since IDVAR identifies the keys that can be used to merge/join records - between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject - within a dataset, not across datasets. - Document: IG 3.3 - Section: 8.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0419 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifies the hierarchical level of the records in the relationship. Values - should be either ONE or MANY. Used only when identifying a relationship between datasets - (as described in Section 2.8.5.2. - Document: TIG 1.0 - Section: 2.8.5.2|2.8.10.21 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0574 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG 3.4 + Section: 8.2.1 + - Cited Guidance: + Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG 3.4 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG v3.2 + Section: 8.2.1 + - Cited Guidance: + Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG v3.2 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 8.3, Relating Datasets). + Document: IG 3.3 + Section: 8.2.1 + - Cited Guidance: + Since IDVAR identifies the keys that can be used to merge/join records + between the datasets, --SEQ cannot be used because --SEQ only has meaning within a subject + within a dataset, not across datasets. + Document: IG 3.3 + Section: 8.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0419 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifies the hierarchical level of the records in the relationship. Values + should be either ONE or MANY. Used only when identifying a relationship between datasets + (as described in Section 2.8.5.2. + Document: TIG 1.0 + Section: 2.8.5.2|2.8.10.21 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0574 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IDVAR - operator: suffix_matches_regex - suffix: 3 - value: SEQ - - name: RELTYPE - operator: non_empty + - name: IDVAR + operator: suffix_matches_regex + suffix: 3 + value: SEQ + - name: RELTYPE + operator: non_empty Core: Id: CORE-000202 Status: Published - Version: '1' + Version: "1" Description: When IDVAR is populated with a --SEQ value, RELTYPE must be null. Executability: Fully Executable Outcome: Message: RELTYPE is populated when IDVAR is populated with a 'SEQ' value. Output Variables: - - IDVAR - - RELTYPE + - IDVAR + - RELTYPE Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000203/rule.yml b/Published/CORE-000203/rule.yml index 0ef07d96f..840ffb0e3 100644 --- a/Published/CORE-000203/rule.yml +++ b/Published/CORE-000203/rule.yml @@ -1,109 +1,113 @@ # Variable: GEN -# Condition: +# Condition: # Rule: IDVAR, IDVARVAL, and QNAM a unique combination per parent subject record Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The combined set of values for the first six columns (STUDYID…QNAM) should - be unique for every record. That is, there should not be multiple records in a SUPP-- - dataset for the same QNAM value, as it relates to IDVAR/IDVARVAL for a USUBJID in a - domain. - Document: IG v3.4 - Section: '8.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per IDVAR, IDVARVAL, and QNAM value per subject - Document: IG v3.2 - Section: 8.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The combined set of values for the first six columns (STUDYID-QNAM) should - be unique for every record. That is; there should not be multiple records in a SUPP-- - dataset for the same QNAM value; as it relates to IDVAR/IDVARVAL for a USUBJID in a - domain. - Document: IG v3.3 - Section: '8.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0411 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A relationship dataset used to describe nonstandard variables and their - association to parent records in general-observation class datasets. - Document: TIG 1.0 - Item: Specifications IDVAR,IDVARVAL,QNAM|Description - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0567 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The combined set of values for the first six columns (STUDYID…QNAM) should + be unique for every record. That is, there should not be multiple records in a SUPP-- + dataset for the same QNAM value, as it relates to IDVAR/IDVARVAL for a USUBJID in a + domain. + Document: IG v3.4 + Section: "8.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per IDVAR, IDVARVAL, and QNAM value per subject + Document: IG v3.2 + Section: 8.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The combined set of values for the first six columns (STUDYID-QNAM) should + be unique for every record. That is; there should not be multiple records in a SUPP-- + dataset for the same QNAM value; as it relates to IDVAR/IDVARVAL for a USUBJID in a + domain. + Document: IG v3.3 + Section: "8.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0411 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A relationship dataset used to describe nonstandard variables and their + association to parent records in general-observation class datasets. + Document: TIG 1.0 + Item: Specifications IDVAR,IDVARVAL,QNAM|Description + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0567 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: RDOMAIN - operator: equal_to - value: DM - value_is_literal: true - - name: USUBJID - operator: is_not_unique_set - value: - - QNAM - - all: - - name: RDOMAIN - operator: not_equal_to - value: DM - value_is_literal: true - - name: USUBJID - operator: is_not_unique_set - value: - - IDVAR - - IDVARVAL - - QNAM + - all: + - name: RDOMAIN + operator: equal_to + value: DM + value_is_literal: true + - name: USUBJID + operator: is_not_unique_set + value: + - QNAM + - all: + - name: RDOMAIN + operator: not_equal_to + value: DM + value_is_literal: true + - name: USUBJID + operator: is_not_unique_set + value: + - IDVAR + - IDVARVAL + - QNAM Core: Id: CORE-000203 Status: Published - Version: '1' -Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per + Version: "1" +Description: + Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per parent subject record Executability: Fully Executable Outcome: Message: The combination of IDVAR, IDVARVAL, and QNAM is not unique per parent subject record Output Variables: - - USUBJID - - IDVAR - - IDVARVAL - - QNAM + - USUBJID + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000204/rule.yml b/Published/CORE-000204/rule.yml index e614de541..5fd7a3c96 100644 --- a/Published/CORE-000204/rule.yml +++ b/Published/CORE-000204/rule.yml @@ -2,108 +2,110 @@ # Condition: Scheduled or Contingent visit (exists in TV) # Rule: VISITNUM identifies unique record within subject Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: IG v3.4 - Item: 7.3.1.1 TV - Section: '5.5' - - Cited Guidance: Some data collection is contingent on the occurrence of a "trigger" event, - or disease milestone (see the Trial Disease Milestones (TM) dataset under Section 7.3, - Schedule for Assessments (TV, TD, and TM)). When such planned data collection involves an - additional clinic visit, a "contingent" Visit may be included in the trial visits table, - with start a rule that describes the circumstances under which it will take place. Since - values of VISITNUM must be assigned to all records in the Trial Visits dataset, a - contingent Visit included in the Trial Visits dataset must have a VISITNUM, but the - VISITNUM value may not be a "chronological" value, due to the uncertain timing of a - contingent Visit. If contingent visits are not included in the TV dataset, then they would - be treated as unplanned visits in the Subject Visits (SV) domain. - Document: IG v3.4 - Item: TV Issues 4 - Section: 7.3.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: IG v3.2 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[5.5 SV][One record per subject per actual visit.]|IG v3.3[7.3.1.1 - TV][TV Issues 4][Some data collection is contingent on the occurrence of a "trigger" - event; or disease milestone (see Section 7.3.3 Trial Disease Milestones). When such - planned data collection involves an additional clinic visit; a "contingent" Visit may be - included in the trial visits table;] - Document: IG v3.3 - Item: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV][TV Issues 4] - Section: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0410 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: One record per subject per actual visit. - Document: TIG v1.0 - Item: Assumption 1 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0566 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: IG v3.4 + Item: 7.3.1.1 TV + Section: "5.5" + - Cited Guidance: + Some data collection is contingent on the occurrence of a "trigger" event, + or disease milestone (see the Trial Disease Milestones (TM) dataset under Section 7.3, + Schedule for Assessments (TV, TD, and TM)). When such planned data collection involves an + additional clinic visit, a "contingent" Visit may be included in the trial visits table, + with start a rule that describes the circumstances under which it will take place. Since + values of VISITNUM must be assigned to all records in the Trial Visits dataset, a + contingent Visit included in the Trial Visits dataset must have a VISITNUM, but the + VISITNUM value may not be a "chronological" value, due to the uncertain timing of a + contingent Visit. If contingent visits are not included in the TV dataset, then they would + be treated as unplanned visits in the Subject Visits (SV) domain. + Document: IG v3.4 + Item: TV Issues 4 + Section: 7.3.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: IG v3.2 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[5.5 SV][One record per subject per actual visit.]|IG v3.3[7.3.1.1 + TV][TV Issues 4][Some data collection is contingent on the occurrence of a "trigger" + event; or disease milestone (see Section 7.3.3 Trial Disease Milestones). When such + planned data collection involves an additional clinic visit; a "contingent" Visit may be + included in the trial visits table;] + Document: IG v3.3 + Item: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV][TV Issues 4] + Section: IG v3.3[5.5 SV]|IG v3.3[7.3.1.1 TV] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0410 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: One record per subject per actual visit. + Document: TIG v1.0 + Item: Assumption 1 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0566 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISITNUM - operator: is_not_unique_set - value: USUBJID + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISITNUM + operator: is_not_unique_set + value: USUBJID Core: Id: CORE-000204 Status: Published - Version: '1' + Version: "1" Description: When VISITNUM is present in TV.VISITNUM, SV.VISITNUM must be unique within subject Executability: Fully Executable Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: Scheduled or Contingent visit is not unique within subject Output Variables: - - USUBJID - - VISITNUM + - USUBJID + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000206/rule.yml b/Published/CORE-000206/rule.yml index 1c50110ce..f6f6cb1bd 100644 --- a/Published/CORE-000206/rule.yml +++ b/Published/CORE-000206/rule.yml @@ -1,249 +1,260 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v2.0 - Item: IDVARVAL - Section: Comments - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v2.0 - Item: IDVARVAL - Section: Supplemental Qualifiers - - Cited Guidance: Value of identifying variable described in IDVAR. - Document: Model v2.0 - Item: IDVARVAL - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Value of identifying variable of the parent record(s). - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0371 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: SDTM v2.1 - Item: IDVARVAL - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVARVAL - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVARVAL - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0535 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of the parent record(s)to - which the comment applies.' and 'Value of identifying variable of the parent record(s).', respectively." - Document: SENDIG v3.0 - Item: Assumption 3.a - Section: 5.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described - in Section 8.2. - Document: SENDIG v3.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described - in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described - in Section 8.2. - Document: SENDIG v3.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described - in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described - in Section 8.2. - Document: SENDIG v3.1.1 - Item: Assumption 3.a - Section: 5.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND121 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Related to a specific parent record or group of parent records, in which - case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), - and the variables IDVAR and IDVARVAL are populated with the key variable name and value of - the parent record(s). - Document: TIG v1.0 - Item: Assumption 3.a - Section: 2.8.9.4 SEND Comments (CO) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0058 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v2.0 + Item: IDVARVAL + Section: Comments + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v2.0 + Item: IDVARVAL + Section: Supplemental Qualifiers + - Cited Guidance: Value of identifying variable described in IDVAR. + Document: Model v2.0 + Item: IDVARVAL + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Value of identifying variable of the parent record(s). + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0371 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVARVAL + Section: 3.2.2 Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVARVAL + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVARVAL + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0535 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "CDISC Notes for IDVAR and IDVARVAL: 'Identifiying variable of the parent record(s)to + which the comment applies.' and 'Value of identifying variable of the parent record(s).', respectively." + Document: SENDIG v3.0 + Item: Assumption 3.a + Section: 5.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). Assumptions for populating IDVAR and IDVARVAL are further described + in Section 8.2. + Document: SENDIG v3.1.1 + Item: Assumption 3.a + Section: 5.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND121 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Related to a specific parent record or group of parent records, in which + case the value of the variable RDOMAIN is set to the DOMAIN code of the parent record(s), + and the variables IDVAR and IDVARVAL are populated with the key variable name and value of + the parent record(s). + Document: TIG v1.0 + Item: Assumption 3.a + Section: 2.8.9.4 SEND Comments (CO) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0058 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" # Variable: IDVARVAL # Condition: IDVAR ^= null # Rule: IDVARVAL = value of variable = IDVAR in domain = RDOMAIN Check: all: - - name: IDVAR - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: IDVARVAL - operator: not_equal_to - type_insensitive: true - value: IDVAR - value_is_reference: true + - name: IDVAR + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: IDVARVAL + operator: not_equal_to + type_insensitive: true + value: IDVAR + value_is_reference: true Core: Id: CORE-000206 Status: Published - Version: '1' -Description: When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by + Version: "1" +Description: + When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by IDVAR within the domain referenced by RDOMAIN Executability: Fully Executable Match Datasets: -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: SUPP-- -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: CO -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: RELREC + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: SUPP-- + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: CO + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: RELREC Outcome: Message: IDVARVAL does not equal a value of the variable referenced by IDVAR in domain = RDOMAIN. Output Variables: - - RDOMAIN - - USUBJID - - IDVAR - - IDVARVAL + - RDOMAIN + - USUBJID + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - RELATIONSHIP + - SPECIAL PURPOSE + - RELATIONSHIP Domains: Include: - - CO - - SUPP-- - - RELREC + - CO + - SUPP-- + - RELREC Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000207/rule.yml b/Published/CORE-000207/rule.yml index 8146e75de..f920fb9aa 100644 --- a/Published/CORE-000207/rule.yml +++ b/Published/CORE-000207/rule.yml @@ -1,236 +1,248 @@ # Variable: --STDTC -# Condition: +# Condition: # Rule: --STDTC not present Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that --STDTC should not be used in the Findings general observation - class and is therefore blank in the following table. - Document: IG v3.4 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[4.1.1.3][Additional Timing variables can be added as needed to a - standard domain model based on the three general observation classes except where - discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be - added to special-purpose domains only where specified in the SDTMIG domain model - assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG - v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g., "2006-11-02"Date and Time - Reported in a Domain Based on Findings. When the date/time of collection is reported in - any domain, the date/time should go into the --DTC field (e.g., EGDTC for Date/Time of - ECG). For any domain based on the Findings general observation class, such as lab tests - which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data was - recorded. In order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. For example, in the LB domain the LBDTC variable would be used for all - single-point blood collections or spot urine collections. For timed lab collections (e.g., - 24-hour urine collections) the LBDTC variable would be used for the start date/time of the - collection and LBENDTC for the end date/time of the collection. This approach will allow - the single-point and interval collections to use the same date/time variables consistently - across all datasets for the Findings general observation class. The table below - illustrates the proper use of these variables. Note that --STDTC is not used for - collection dates over an interval, so is blank in the following table.] - Document: IG v3.2 - Section: IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[4.1.3][Additional Timing variables can be added as needed to a - standard domain model based on the three general observation classes except where - discouraged in Assumption 4.4.8 and specific domain assumptions. Timing variables can be - added to special-purpose domains only where specified in the SDTMIG domain model - assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG - v3.3[4.4.8][When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field (e.g., EGDTC for Date/Time of ECG). For any domain based on - the Findings general observation class, such as lab tests which are based on a specimen, - the collection date is likely to be tied to when the specimen or source of the finding was - captured, not necessarily when the data was recorded. In order to ensure that the critical - timing information is always represented in the same variable, the --DTC variable is used - to represent the time of specimen collection. For example, in the LB domain the LBDTC - variable would be used for all single-point blood collections or spot urine collections. - For timed lab collections (e.g., 24-hour urine collections) the LBDTC variable would be - used for the start date/time of the collection and LBENDTC for the end date/time of the - collection. This approach will allow the single-point and interval collections to use the - same date/time variables consistently across all datasets for the Findings general - observation class. The table below illustrates the proper use of these variables. Note - that --STDTC is not used for collection dates over an interval, so is blank in the - following table.] - Document: IG v3.3 - Section: IG v3.3[4.1.3]|IG v3.3[4.4.8] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0467 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.0 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval... - Document: IG v3.1.1 - Section: 4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND78 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in Findings class domains | Select variables for the domain from the - SDTM. Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--STDTC - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains | 2.8.3 - How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0597 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When the date/time of collection is reported in any domain, the date/time - should go into the --DTC field...In order to ensure that the critical timing information - is always represented in the same variable, the --DTC variable is used to represent the - time of specimen collection...Note that --STDTC is not used for collection dates over an - interval. - Document: TIG v1.0 - Item: text - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0276 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Note that --STDTC should not be used in the Findings general observation + class and is therefore blank in the following table. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[4.1.1.3][Additional Timing variables can be added as needed to a + standard domain model based on the three general observation classes except where + discouraged in Assumption 4.1.4.8 and specific domain assumptions. Timing variables can be + added to special-purpose domains only where specified in the SDTMIG domain model + assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG + v3.2[4.1.1.8][AEENTPT = final subject contact date, e.g., "2006-11-02"Date and Time + Reported in a Domain Based on Findings. When the date/time of collection is reported in + any domain, the date/time should go into the --DTC field (e.g., EGDTC for Date/Time of + ECG). For any domain based on the Findings general observation class, such as lab tests + which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. For example, in the LB domain the LBDTC variable would be used for all + single-point blood collections or spot urine collections. For timed lab collections (e.g., + 24-hour urine collections) the LBDTC variable would be used for the start date/time of the + collection and LBENDTC for the end date/time of the collection. This approach will allow + the single-point and interval collections to use the same date/time variables consistently + across all datasets for the Findings general observation class. The table below + illustrates the proper use of these variables. Note that --STDTC is not used for + collection dates over an interval, so is blank in the following table.] + Document: IG v3.2 + Section: IG v3.2[4.1.1.3]|IG v3.2[4.1.1.8] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[4.1.3][Additional Timing variables can be added as needed to a + standard domain model based on the three general observation classes except where + discouraged in Assumption 4.4.8 and specific domain assumptions. Timing variables can be + added to special-purpose domains only where specified in the SDTMIG domain model + assumptions. Timing variables cannot be added to SUPPQUAL datasets or to RELREC]|IG + v3.3[4.4.8][When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field (e.g., EGDTC for Date/Time of ECG). For any domain based on + the Findings general observation class, such as lab tests which are based on a specimen, + the collection date is likely to be tied to when the specimen or source of the finding was + captured, not necessarily when the data was recorded. In order to ensure that the critical + timing information is always represented in the same variable, the --DTC variable is used + to represent the time of specimen collection. For example, in the LB domain the LBDTC + variable would be used for all single-point blood collections or spot urine collections. + For timed lab collections (e.g., 24-hour urine collections) the LBDTC variable would be + used for the start date/time of the collection and LBENDTC for the end date/time of the + collection. This approach will allow the single-point and interval collections to use the + same date/time variables consistently across all datasets for the Findings general + observation class. The table below illustrates the proper use of these variables. Note + that --STDTC is not used for collection dates over an interval, so is blank in the + following table.] + Document: IG v3.3 + Section: IG v3.3[4.1.3]|IG v3.3[4.4.8] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0467 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.0 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval... + Document: IG v3.1.1 + Section: 4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND78 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in Findings class domains | Select variables for the domain from the + SDTM. Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--STDTC + Section: + Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains | 2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0597 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When the date/time of collection is reported in any domain, the date/time + should go into the --DTC field...In order to ensure that the critical timing information + is always represented in the same variable, the --DTC variable is used to represent the + time of specimen collection...Note that --STDTC is not used for collection dates over an + interval. + Document: TIG v1.0 + Item: text + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0276 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --STDTC - operator: exists + - name: --STDTC + operator: exists Core: Id: CORE-000207 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --STDTC is present in a Findings general observation class Executability: Fully Executable Outcome: Message: --STDTC is present in a Findings general observation class Output Variables: - - --STDTC + - --STDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000208/rule.yml b/Published/CORE-000208/rule.yml index d06967232..ffbde078b 100644 --- a/Published/CORE-000208/rule.yml +++ b/Published/CORE-000208/rule.yml @@ -2,87 +2,91 @@ # Condition: Study does not use multi-stage arm assignments and ACTARMCD ^= null # Rule: ACTARMCD in TA.ARMCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0512 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0512 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ACTARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0607 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0512 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0512 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ACTARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0607 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARMCD - operator: non_empty - - name: ACTARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ACTARMCD + operator: non_empty + - name: ACTARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000208 Status: Published - Version: '1' -Description: Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null, + Version: "1" +Description: + Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null, and ACTARMCD is not in TA.ARMCD Executability: Partially Executable - Possible Overreporting Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ACTARMCD is not in TA.ARMCD Output Variables: - - ACTARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000209/rule.yml b/Published/CORE-000209/rule.yml index 234801b61..fa970d831 100644 --- a/Published/CORE-000209/rule.yml +++ b/Published/CORE-000209/rule.yml @@ -2,91 +2,96 @@ # Condition: Study does not use multi-stage arm assignments and ACTARM ^= null # Rule: ACTARM in TA.ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARM is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0514 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0514 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ACTARM - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0609 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARM is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0514 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0514 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ACTARM + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0609 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARM - operator: non_empty - - name: ACTARM - operator: is_not_contained_by - value: $ta_arm + - name: ACTARM + operator: non_empty + - name: ACTARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000209 Status: Published - Version: '1' -Description: When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM - must be present in TA.ARM. This rule has been executed to identify all cases when ACTARM is not + Version: "1" +Description: + When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM + must be present in TA.ARM. This rule has been executed to identify all cases when ACTARM is not present in TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: - Message: ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset. - This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if + Message: + ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset. + This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage assignment study. Output Variables: - - ACTARM + - ACTARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000210/rule.yml b/Published/CORE-000210/rule.yml index ef643265d..5ad375b41 100644 --- a/Published/CORE-000210/rule.yml +++ b/Published/CORE-000210/rule.yml @@ -2,85 +2,89 @@ # Condition: Study does not use multi-stage arm assignments and ARMCD ^= null # Rule: ARMCD in TA.ARMCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, - ARMCD is null and ARMNRS is populated - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0516 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0516 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, - ARMCD is null and ARMNRS is populated - Document: TIG 1.0 - Item: Specification:ARMCD - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0611 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0516 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0516 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm, + ARMCD is null and ARMNRS is populated + Document: TIG 1.0 + Item: Specification:ARMCD + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0611 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000210 Status: Published - Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must - be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not - present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Partially Executable - Possible Overreporting Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000212/rule.yml b/Published/CORE-000212/rule.yml index e91d37704..490583df8 100644 --- a/Published/CORE-000212/rule.yml +++ b/Published/CORE-000212/rule.yml @@ -2,96 +2,101 @@ # Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' # Rule: DSSCAT must be present Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of - study participation or of a study treatment. It describes whether a subject completed - study participation or a study treatment, and if not, the reason they did not complete it. - Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout, - cross-over treatment, follow-up) or for the study as a whole. If disposition events for - both study participation and study treatment(s) are to be represented, then DSSCAT - provides this distinction. The value of DSSCAT is based on the sponsor's controlled - terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY - PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY - TREATMENT" can be used as a generic identifier when a study has only a single treatment. - If a study has multiple treatments, then DSSCAT should name the individual treatment. - Document: IG v3.4 - Item: DS – Assumption 2b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If separate disposition events for both study participation and study - treatment(s) are to be represented, then DSSCAT provides this distinction. - Document: IG v3.3 - Item: Assumption 2.b - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0535 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: An event with DSCAT = “DISPOSITION EVENT” describes either disposition of - study participation or of a product exposure. It describes whether a subject completed - study participation or a product exposure and, if not, the reason they did not complete - it. Dispositions may be described for each epoch (e.g., screening, initial exposure, - washout, cross-over, follow-up) or for the study as a whole. If disposition events for - both study participation and product exposure(s) are to be represented, then DSSCAT - provides this distinction. - Document: TIG 1.0 - Item: Assumption 2b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0628 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a study treatment. It describes whether a subject completed + study participation or a study treatment, and if not, the reason they did not complete it. + Dispositions may be described for each Epoch (e.g., screening, initial treatment, washout, + cross-over treatment, follow-up) or for the study as a whole. If disposition events for + both study participation and study treatment(s) are to be represented, then DSSCAT + provides this distinction. The value of DSSCAT is based on the sponsor's controlled + terminology, however for records with DSCAT = "DISPOSITION EVENT", DSSCAT = "STUDY + PARTICIPATION" is used to represent disposition of study participation. DSSCAT = "STUDY + TREATMENT" can be used as a generic identifier when a study has only a single treatment. + If a study has multiple treatments, then DSSCAT should name the individual treatment. + Document: IG v3.4 + Item: DS – Assumption 2b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If separate disposition events for both study participation and study + treatment(s) are to be represented, then DSSCAT provides this distinction. + Document: IG v3.3 + Item: Assumption 2.b + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0535 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + An event with DSCAT = “DISPOSITION EVENT” describes either disposition of + study participation or of a product exposure. It describes whether a subject completed + study participation or a product exposure and, if not, the reason they did not complete + it. Dispositions may be described for each epoch (e.g., screening, initial exposure, + washout, cross-over, follow-up) or for the study as a whole. If disposition events for + both study participation and product exposure(s) are to be represented, then DSSCAT + provides this distinction. + Document: TIG 1.0 + Item: Assumption 2b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0628 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - - name: DSSCAT - operator: not_exists + - name: DSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + - name: DSSCAT + operator: not_exists Core: Id: CORE-000212 Status: Published - Version: '1' -Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT + Version: "1" +Description: + When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT must be present. Executability: Fully Executable Outcome: - Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT = + Message: + DSSCAT is not present when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT'. Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000213/rule.yml b/Published/CORE-000213/rule.yml index 0293a6346..ad2d9b534 100644 --- a/Published/CORE-000213/rule.yml +++ b/Published/CORE-000213/rule.yml @@ -2,97 +2,101 @@ # Condition: DSCAT = 'DISPOSITION EVENT' and DSSCAT is present in dataset. # Rule: At most one record per subject per DSSCAT per epoch, including null values of DSSCAT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and study treatment(s) - are to be represented, then DSSCAT provides this distinction. - Document: IG v3.4 - Item: Assumption 2.b - Section: 6.2.3 - - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' - should be presented, and that summaries should be 'grouped by treatment and by major reason.' - The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) - per disposition event. If multiple reasons are reported, the sponsor should identify a primary - reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in - SUPPDS." - Document: IG v3.4 - Item: Assumption 5 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0536 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Assumption 2.b[If disposition events for both study participation and study treatment(s) - are to be represented, then DSSCAT provides this distinction.]|Assumption 2.b|Assumption 5[ICH - E3: Section 10.1 indicates that 'the specific reason for discontinuation' should be presented, - and that summaries should be 'grouped by treatment and by major reason.' The CDISC SDS Team - interprets this guidance as requiring one standardized disposition term (DSDECOD) per disposition - event. If multiple reasons are reported, the sponsor should identify a primary reason and use - that to populate DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" - Document: IG v3.3 - Item: Assumption 2.b|Assumption 5 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0536 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and product exposure(s) - are to be represented, then DSSCAT provides this distinction - Document: TIG 1.0 - Item: Assumption 2.b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0629 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction. + Document: IG v3.4 + Item: Assumption 2.b + Section: 6.2.3 + - Cited Guidance: + "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' + should be presented, and that summaries should be 'grouped by treatment and by major reason.' + The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) + per disposition event. If multiple reasons are reported, the sponsor should identify a primary + reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in + SUPPDS." + Document: IG v3.4 + Item: Assumption 5 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0536 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Assumption 2.b[If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction.]|Assumption 2.b|Assumption 5[ICH + E3: Section 10.1 indicates that 'the specific reason for discontinuation' should be presented, + and that summaries should be 'grouped by treatment and by major reason.' The CDISC SDS Team + interprets this guidance as requiring one standardized disposition term (DSDECOD) per disposition + event. If multiple reasons are reported, the sponsor should identify a primary reason and use + that to populate DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" + Document: IG v3.3 + Item: Assumption 2.b|Assumption 5 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0536 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If disposition events for both study participation and product exposure(s) + are to be represented, then DSSCAT provides this distinction + Document: TIG 1.0 + Item: Assumption 2.b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0629 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - value_is_literal: true - - name: DSSCAT - operator: exists - - name: EPOCH - operator: is_not_unique_set - value: - - USUBJID - - DSSCAT + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + value_is_literal: true + - name: DSSCAT + operator: exists + - name: EPOCH + operator: is_not_unique_set + value: + - USUBJID + - DSSCAT Core: Id: CORE-000213 Status: Published - Version: '1' + Version: "1" Description: Trigger error when there is more than one record per subject per DSSCAT per EPOCH Executability: Fully Executable Outcome: Message: More than one record per subject per DSSCAT per EPOCH Output Variables: - - DSSCAT - - EPOCH + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000214/rule.yml b/Published/CORE-000214/rule.yml index 734842fca..27fd1f49b 100644 --- a/Published/CORE-000214/rule.yml +++ b/Published/CORE-000214/rule.yml @@ -2,97 +2,102 @@ # Condition: Subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' # Rule: No more than 1 record per subject has DSSCAT = 'STUDY PARTICIPATION' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study - participation - Document: IG v3.4 - Item: Assumption 2.b.1 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0538 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study - participation. - Document: IG v3.3 - Item: Assumption 2.b.1 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0538 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study - participation. - Document: TIG 1.0 - Item: 2.b.i - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0631 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation + Document: IG v3.4 + Item: Assumption 2.b.1 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0538 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation. + Document: IG v3.3 + Item: Assumption 2.b.1 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0538 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + DSSCAT = "STUDY PARTICIPATION" is used to represent disposition of study + participation. + Document: TIG 1.0 + Item: 2.b.i + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0631 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $disposition_event_count - operator: greater_than - value: 1 - - name: DSSCAT - operator: equal_to - value: STUDY PARTICIPATION - value_is_literal: true - - name: DSSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH + - name: $disposition_event_count + operator: greater_than + value: 1 + - name: DSSCAT + operator: equal_to + value: STUDY PARTICIPATION + value_is_literal: true + - name: DSSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH Core: Id: CORE-000214 Status: Published - Version: '1' -Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION + Version: "1" +Description: + Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY PARTICIPATION' Executability: Fully Executable Operations: -- domain: DS - filter: - DSCAT: DISPOSITION EVENT - group: - - USUBJID - - EPOCH - id: $disposition_event_count - name: DSCAT - operator: record_count + - domain: DS + filter: + DSCAT: DISPOSITION EVENT + group: + - USUBJID + - EPOCH + id: $disposition_event_count + name: DSCAT + operator: record_count Outcome: - Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + Message: + More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'STUDY PARTICIPATION'. Output Variables: - - DSSCAT - - USUBJID - - EPOCH - - DSCAT + - DSSCAT + - USUBJID + - EPOCH + - DSCAT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml index d367cf211..1c4f24b36 100644 --- a/Published/CORE-000217/rule.yml +++ b/Published/CORE-000217/rule.yml @@ -2,153 +2,159 @@ # Condition: ECDOSE = null and ECOCCUR ^= 'N' and ECSTAT = null # Rule: ECDOSTXT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating doses not taken, not given, - or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose amounts not taken, not given, or - missed.] - Document: IG v3.4 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating doses not taken, not given, - or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose amounts not taken, not given, or - missed.] - Document: IG v3.3 - Item: Assumption 4a|Assumption 4b - Section: 6.1.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating doses not taken, not given, - or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose amounts not taken, not given, or - missed.] - Document: IG v3.2 - Item: Assumption 4a|Assumption 4b - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0462 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL - infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must - not be set to zero (0) as an alternative method for indicating doses not taken, not given, - or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) - may be populated with positive (non-zero) values in cases where the sponsor feels it is - necessary and/or appropriate to represent specific dose amounts not taken, not given, or - missed.] - Document: TIG 1.0 - Item: Assumption 4a|4b - Section: 2.8.10.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0592 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.4 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.3 + Item: Assumption 4a|Assumption 4b + Section: 6.1.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: IG v3.2 + Item: Assumption 4a|Assumption 4b + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0462 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Assumption 4a[For example, if 0 tablets are taken within a timeframe or 0 mL + infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected + doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must + not be set to zero (0) as an alternative method for indicating doses not taken, not given, + or missed.]|Assumption 4b[Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) + may be populated with positive (non-zero) values in cases where the sponsor feels it is + necessary and/or appropriate to represent specific dose amounts not taken, not given, or + missed.] + Document: TIG 1.0 + Item: Assumption 4a|4b + Section: 2.8.10.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0592 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_equal_to - value: N - value_is_literal: true - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: empty - - name: ECDOSTXT - operator: empty - - all: - - name: ECDOSE - operator: empty - - name: ECOCCUR - operator: not_exists - - name: ECSTAT - operator: not_exists - - name: ECDOSTXT - operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_equal_to + value: N + value_is_literal: true + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: empty + - name: ECDOSTXT + operator: empty + - all: + - name: ECDOSE + operator: empty + - name: ECOCCUR + operator: not_exists + - name: ECSTAT + operator: not_exists + - name: ECDOSTXT + operator: empty Core: Id: CORE-000217 Status: Published - Version: '1' -Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and + Version: "1" +Description: + Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and ECDOSTXT is empty Executability: Fully Executable Outcome: - Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also + Message: + ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also empty. Output Variables: - - ECDOSE - - ECOCCUR - - ECSTAT - - ECDOSTXT + - ECDOSE + - ECOCCUR + - ECSTAT + - ECDOSTXT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000218/rule.yml b/Published/CORE-000218/rule.yml index 992246afa..53581e3ff 100644 --- a/Published/CORE-000218/rule.yml +++ b/Published/CORE-000218/rule.yml @@ -2,196 +2,206 @@ # Condition: IDVAR = null # Rule: IDVARVAL = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Comments[Value of identifying variable of the parent - record(s).]|Supplemental Qualifiers[Value of identifying variable of the parent - record(s).] - Document: Model v2.0 - Item: IDVARVAL - Section: Comments|Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. Null for comments collected on separate CRFs. Value of - identifying variable of the parent record(s). Null for comments collected on separate - CRFs. - Document: Model v1.7 - Item: '' - Section: 2.2.7|5.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments - are related to domain records. Null for comments collected on separate CRFs. Value of - identifying variable of the parent record(s). Null for comments collected on separate - CRFs. - Document: Model v1.4 - Item: '' - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0465 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.0 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.1.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.1.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: IDVARVAL is used only when individual comments are related to domain - records. Cannot be populated if IDVAR is null. - Document: IG v3.1 - Item: Specification - Section: 5.2.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND118 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Specification IDVARVAL - Document: SDTM v2.1 - Item: IDVARVAL - Section: Section 3.2.2 Comments|Section 6.2 Supplemental Qualifiers - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0595 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used only when individual comments are related to domain records. Cannot be - populated if IDVAR is null. - Document: TIG v1.0 - Item: IDVARVAL CDISC Notes - Section: 2.8.9.4 SEND Comments (CO) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0055 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Comments[Value of identifying variable of the parent + record(s).]|Supplemental Qualifiers[Value of identifying variable of the parent + record(s).] + Document: Model v2.0 + Item: IDVARVAL + Section: Comments|Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. Value of + identifying variable of the parent record(s). Null for comments collected on separate + CRFs. + Document: Model v1.7 + Item: "" + Section: 2.2.7|5.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. Examples AESEQ or CMGRPID. Used only when individual comments + are related to domain records. Null for comments collected on separate CRFs. Value of + identifying variable of the parent record(s). Null for comments collected on separate + CRFs. + Document: Model v1.4 + Item: "" + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0465 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.0 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + IDVARVAL is used only when individual comments are related to domain + records. Cannot be populated if IDVAR is null. + Document: IG v3.1 + Item: Specification + Section: 5.2.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND118 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Specification IDVARVAL + Document: SDTM v2.1 + Item: IDVARVAL + Section: Section 3.2.2 Comments|Section 6.2 Supplemental Qualifiers + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0595 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Used only when individual comments are related to domain records. Cannot be + populated if IDVAR is null. + Document: TIG v1.0 + Item: IDVARVAL CDISC Notes + Section: 2.8.9.4 SEND Comments (CO) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0055 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: IDVAR - operator: empty - - name: IDVARVAL - operator: non_empty + - name: IDVAR + operator: empty + - name: IDVARVAL + operator: non_empty Core: Id: CORE-000218 Status: Published - Version: '1' + Version: "1" Description: Raise an error when IDVAR is empty and IDVARVAL is not empty Executability: Fully Executable Outcome: Message: IDVAR is empty but IDVARVAL is not empty Output Variables: - - IDVAR - - IDVARVAL + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - RELATIONSHIP + - SPECIAL PURPOSE + - RELATIONSHIP Domains: Include: - - CO - - SUPP-- + - CO + - SUPP-- Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000219/rule.yml b/Published/CORE-000219/rule.yml index bfe1e99a4..54f45c7f0 100644 --- a/Published/CORE-000219/rule.yml +++ b/Published/CORE-000219/rule.yml @@ -1,166 +1,176 @@ # Variable: --SCAT -# Condition: +# Condition: # Rule: --SCAT ^= Domain Name Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0350 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND44 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: '2.8.7.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0515 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0350 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND44 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: "2.8.7.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0515 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: equal_to_case_insensitive - value: $domain_label + - name: --SCAT + operator: equal_to_case_insensitive + value: $domain_label Core: Id: CORE-000219 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SCAT = domain dataset label. Executability: Fully Executable Operations: -- id: $domain_label - operator: domain_label + - id: $domain_label + operator: domain_label Outcome: Message: --SCAT is equal to domain dataset label. Output Variables: - - --SCAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000220/rule.yml b/Published/CORE-000220/rule.yml index bc0d3b869..4f018fbff 100644 --- a/Published/CORE-000220/rule.yml +++ b/Published/CORE-000220/rule.yml @@ -1,98 +1,106 @@ # Variable: --TESTCD -# Condition: +# Condition: # Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.3 - Section: 7.4.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start - with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; - numbers; or underscores. - Document: Model v1.7 - Section: 3.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.2 - Section: 4.1.2.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start - with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; - numbers; or underscores. - Document: Model v1.4 - Section: 3.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor can it start - with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than - letters, numbers, or underscores. - Document: TIG 1.0 - Item: Specifications --TESTCD - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0536 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.3 + Section: 7.4.1 + - Cited Guidance: + The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.7 + Section: 3.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.2 + Section: 4.1.2.1 + - Cited Guidance: + The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.4 + Section: 3.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value in --TESTCD cannot be longer than 8 characters, nor can it start + with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than + letters, numbers, or underscores. + Document: TIG 1.0 + Item: Specifications --TESTCD + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0536 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - name: --TESTCD - operator: not_matches_regex - value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ + - name: --TESTCD + operator: not_matches_regex + value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ Core: Id: CORE-000220 Status: Published - Version: '1' -Description: Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters, + Version: "1" +Description: + Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + Message: + --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts with a number. Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000221/rule.yml b/Published/CORE-000221/rule.yml index 8bf1abc2f..9061a9ee0 100644 --- a/Published/CORE-000221/rule.yml +++ b/Published/CORE-000221/rule.yml @@ -1,110 +1,117 @@ # Variable: QNAM -# Condition: +# Condition: # Rule: QNAM value length <=8 and cannot start with a number and cannot contain characters other than letters in upper case, numbers, or underscores Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with - a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or - underscores. - Document: Model v2.0 - Item: QNAM - Section: Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with - a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or - underscores. - Document: Model v1.7 - Item: QNAM - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with - a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or - underscores. - Document: Model v1.4 - Item: QNAM - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with - a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or - underscores. - Document: Model v1.4 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0417 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters; nor can it start with - a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or - underscores. - Document: SDTM v2.1 - Item: QNAM - Section: Section 6.2 Supplemental Qualifiers Data set - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0572 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v2.0 + Item: QNAM + Section: Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.7 + Item: QNAM + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.4 + Item: QNAM + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: Model v1.4 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0417 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters; nor can it start with + a number (e.g., '1TEST'). QNAM cannot contain characters other than letters; numbers; or + underscores. + Document: SDTM v2.1 + Item: QNAM + Section: Section 6.2 Supplemental Qualifiers Data set + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0572 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z_][A-Z0-9_]{0,7}$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z_][A-Z0-9_]{0,7}$ Core: Id: CORE-000221 Status: Published - Version: '1' -Description: Raise an error when QNAM > 8 chars or contains more than only letters in uppercase, + Version: "1" +Description: + Raise an error when QNAM > 8 chars or contains more than only letters in uppercase, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters, + Message: + QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters, numbers, underscores, or starts with a number. Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000222/rule.yml b/Published/CORE-000222/rule.yml index 5ed9e3bb9..c8dd70f35 100644 --- a/Published/CORE-000222/rule.yml +++ b/Published/CORE-000222/rule.yml @@ -1,92 +1,96 @@ # Variable: QLABEL -# Condition: +# Condition: # Rule: QLABEL value length <= 40 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL - cannot be longer than 40 characters. This will often be the column label in the sponsor's - original dataset. - Document: Model v2.0 - Item: QLABEL - Section: Supplemental Qualifiers - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL - cannot be longer than 40 characters. This will often be the column label in the sponsor's - original dataset. - Document: Model v1.7 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL - cannot be longer than 40 characters. This will often be the column label in the sponsor's - original dataset. - Document: Model v1.4 - Section: 4.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0416 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: This is the long name or label associated with QNAM. The value in QLABEL - cannot be longer than 40 characters. This will often be the column label in the sponsor's - original dataset. - Document: SDTM v2.1 - Item: QLABEL - Section: Section 6.2 Supplemental Qualifiers Data set - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0571 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v2.0 + Item: QLABEL + Section: Supplemental Qualifiers + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v1.7 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: Model v1.4 + Section: 4.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0416 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + This is the long name or label associated with QNAM. The value in QLABEL + cannot be longer than 40 characters. This will often be the column label in the sponsor's + original dataset. + Document: SDTM v2.1 + Item: QLABEL + Section: Section 6.2 Supplemental Qualifiers Data set + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0571 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: QLABEL - operator: longer_than - value: 40 + - name: QLABEL + operator: longer_than + value: 40 Core: Id: CORE-000222 Status: Published - Version: '1' + Version: "1" Description: Raise an error when QLABEL > 40 chars. Executability: Fully Executable Outcome: Message: QLABEL > 40 chars. Output Variables: - - IDVAR - - IDVARVAL - - QLABEL + - IDVAR + - IDVARVAL + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000223/rule.yml b/Published/CORE-000223/rule.yml index c56e689a4..0a0d8c09b 100644 --- a/Published/CORE-000223/rule.yml +++ b/Published/CORE-000223/rule.yml @@ -2,81 +2,84 @@ # Condition: ACTARMCD = null # Rule: ARMNRS^=null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0513 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0513 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0608 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0513 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0513 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0608 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARMCD - operator: empty - - name: ARMNRS - operator: empty + - name: ACTARMCD + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000223 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ACTARMCD is empty and ARMNRS is not completed. Executability: Fully Executable Outcome: Message: ACTARMCD is empty, but ARMNRS is not completed. Output Variables: - - ACTARMCD - - ARMNRS + - ACTARMCD + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000224/rule.yml b/Published/CORE-000224/rule.yml index 4ca4ba115..a0f34485a 100644 --- a/Published/CORE-000224/rule.yml +++ b/Published/CORE-000224/rule.yml @@ -2,81 +2,84 @@ # Condition: ACTARM = null # Rule: ARMNRS^=null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARM is null and ARMNRS is - populated. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0515 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or - followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is - populated. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0515 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be - a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or - followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is - populated. - Document: TIG 1.0 - Item: Specification:ARMNRS - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0610 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARM is null and ARMNRS is + populated. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0515 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or + followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is + populated. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0515 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + With the exception of studies which use multi-stage Arm assignments, must be + a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or + followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is + populated. + Document: TIG 1.0 + Item: Specification:ARMNRS + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0610 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARM - operator: empty - - name: ARMNRS - operator: empty + - name: ACTARM + operator: empty + - name: ARMNRS + operator: empty Core: Id: CORE-000224 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ACTARM is empty and ARMNRS is not completed. Executability: Fully Executable Outcome: Message: ACTARM is empty, but ARMNRS is not completed. Output Variables: - - ACTARM - - ARMNRS + - ACTARM + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000225/rule.yml b/Published/CORE-000225/rule.yml index bc915551b..50fc7d0e1 100644 --- a/Published/CORE-000225/rule.yml +++ b/Published/CORE-000225/rule.yml @@ -1,104 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The explanation for why requested information was not available. Used in - conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Interventions - - Cited Guidance: The explanation for why requested information was not available. Used in - conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Events - - Cited Guidance: The explanation for why requested information was not available. Used in - conjunction with --STAT when value is "NOT DONE". - Document: Model v2.0 - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is NOT DONE. - Document: Model v1.4 - Item: The Findings Observation Class - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is "NOT DONE". - Document: Model v1.7 - Item: 'Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND' - Section: 2.2.1|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0094 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[The explanation for why requested information was not available. Used - in conjunction with --STAT when value is "NOT DONE".]|Interventions[The explanation for - why requested information was not available. Used in conjunction with --STAT when value is - "NOT DONE".]|Findings[The explanation for why requested information was not available. - Used in conjunction with --STAT when value is "NOT DONE".] - Document: SDTM v2.1 - Item: --REASND - Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions - Observation Class|Section 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0359 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Interventions + - Cited Guidance: + The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Events + - Cited Guidance: + The explanation for why requested information was not available. Used in + conjunction with --STAT when value is "NOT DONE". + Document: Model v2.0 + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is NOT DONE. + Document: Model v1.4 + Item: The Findings Observation Class + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reason not done. Used in conjunction with --STAT when value is "NOT DONE". + Document: Model v1.7 + Item: "Table 2.2.1.1, 2.2.2.1, 2.2.3.1: --REASND" + Section: 2.2.1|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0094 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[The explanation for why requested information was not available. Used + in conjunction with --STAT when value is "NOT DONE".]|Interventions[The explanation for + why requested information was not available. Used in conjunction with --STAT when value is + "NOT DONE".]|Findings[The explanation for why requested information was not available. + Used in conjunction with --STAT when value is "NOT DONE".] + Document: SDTM v2.1 + Item: --REASND + Section: + Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Observation Class|Section 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0359 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --STAT # Condition: --REASND ^= null # Rule: --STAT = 'NOT DONE' Check: all: - - name: --REASND - operator: non_empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --REASND + operator: non_empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000225 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --REASND is provided and --STAT is not equal to "NOT DONE". Executability: Fully Executable Outcome: Message: --STAT should be "NOT DONE" when --REASND is provided. Output Variables: - - --STAT - - --REASND + - --STAT + - --REASND Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - EX - - AE - - DS - - DV - - IE + - EX + - AE + - DS + - DV + - IE Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000227/rule.yml b/Published/CORE-000227/rule.yml index 51e23bcc0..b1c5c7668 100644 --- a/Published/CORE-000227/rule.yml +++ b/Published/CORE-000227/rule.yml @@ -1,94 +1,98 @@ # Variable: IETEST -# Condition: +# Condition: # Rule: IETEST in TI.IETEST Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial - Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial - Inclusion/Exclusion Criteria. - Document: IG v3.4 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial - inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: - Trial Inclusion/Exclusion Criteria (TI).' - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial - inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: - Trial Inclusion/Exclusion Criteria (TI).' - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0178 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial - Inclusion/Exclusion Criteria (TI) dataset. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0407 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.4 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI)." + Document: IG v3.2 + Item: Assumption 2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI)." + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0178 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0407 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IETEST - operator: is_not_contained_by - value: $ti_ietest + - name: IETEST + operator: is_not_contained_by + value: $ti_ietest Core: Id: CORE-000227 Status: Published - Version: '1' + Version: "1" Description: Check if IETEST is not in TI.IETEST Executability: Fully Executable Operations: -- domain: TI - id: $ti_ietest - name: IETEST - operator: distinct + - domain: TI + id: $ti_ietest + name: IETEST + operator: distinct Outcome: Message: IETEST is not in TI.IETEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000228/rule.yml b/Published/CORE-000228/rule.yml index 4ce66b037..28a86e6e3 100644 --- a/Published/CORE-000228/rule.yml +++ b/Published/CORE-000228/rule.yml @@ -1,96 +1,100 @@ # Variable: IETESTCD -# Condition: +# Condition: # Rule: IETESTCD in TI.IETESTCD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial - Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial - Inclusion/Exclusion Criteria. - Document: IG v3.4 - Item: Specification - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The complete list of Inclusion/Exclusion criteria can be found in the TI trial - inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: - Trial Inclusion/Exclusion Criteria (TI).' - Document: IG v3.2 - Item: Assumption 2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial - Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial - Inclusion/Exclusion Criteria. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.3.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0179 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The complete list of Inclusion/Exclusion criteria can be found in the Trial - Inclusion/Exclusion Criteria (TI) dataset. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.13 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0408 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.4 + Item: Specification + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The complete list of Inclusion/Exclusion criteria can be found in the TI trial + inclusion/exclusion criteria dataset described in Section 7.4 - Trial Summary and Eligibility: + Trial Inclusion/Exclusion Criteria (TI)." + Document: IG v3.2 + Item: Assumption 2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial + Inclusion/Exclusion Criteria. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.3.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0179 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The complete list of Inclusion/Exclusion criteria can be found in the Trial + Inclusion/Exclusion Criteria (TI) dataset. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.13 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0408 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IETESTCD - operator: is_not_contained_by - value: $ti_ietestcd + - name: IETESTCD + operator: is_not_contained_by + value: $ti_ietestcd Core: Id: CORE-000228 Status: Published - Version: '1' + Version: "1" Description: Check if IETESTCD is present in TI.IETESTCD Executability: Fully Executable Operations: -- domain: TI - id: $ti_ietestcd - name: IETESTCD - operator: distinct + - domain: TI + id: $ti_ietestcd + name: IETESTCD + operator: distinct Outcome: Message: IETESTCD from IE domain does not exist in IETESTCD of TI domain. Output Variables: - - IETESTCD + - IETESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IE + - IE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000236/rule.yml b/Published/CORE-000236/rule.yml index 3a7d823cc..9faae4dbb 100644 --- a/Published/CORE-000236/rule.yml +++ b/Published/CORE-000236/rule.yml @@ -2,123 +2,130 @@ # Condition: MHSTDTC ^= null # Rule: MHSTDTC < DM.RFSTDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - Adverse Events and Medical History are an exception to this best practice because of - regulatory reporting needs. - Document: IG v3.4 - Item: '1' - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for - example, are conceptually the same data, the only differences being when the event started - relative to the study start and whether the event is considered a regulatory-reportable - adverse event in the study. - Document: SDTMIG v3.4 - Item: 3a - Section: 4.2.6 - - Cited Guidance: An events domain that contains data that includes the subject's prior - medical history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather - represent both prior and current observations in a domain (e.g., CM for all non-study medications). - Note that AE and MH are an exception to this best practice because of regulatory reporting needs.]|IG - v3.2[4.1.2.6][Section 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), - Medical History (MH) and Clinical Events (CE), for example, are conceptually the same data, - the only differences being when the event started relative to the study start and whether the - event is considered a regulatory reportable adverse event in the study.]|IG v3.2[6.2][Domain - Code Table: The medical history dataset includes the subject's prior history at the start of - the trial.][MH: The medical history dataset includes the subject's prior history at the start - of the trial.][Assumption 1:The Medical History dataset generally includes the subject's prior - and concomitant conditions at the start of the trial.]" - Document: IG v3.2 - Section: IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG v3.2[6.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "IG v3.3[2.6][Do not create separate domains based on time; rather, represent - both prior and current observations in a domain (e.g., CM for all non-study medications). Note - that AE and MH are an exception to this best practice because of regulatory reporting needs]|IG - v3.3[4.2.6][Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History - (MH), and Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is considered - a regulatory reportable adverse event in the study.]|IG v3.3[6.2][Domain Code Table: The medical - history dataset includes the subject's prior history at the start of the trial.][MH: The medical - history dataset includes the subject's prior history at the start of the trial.]" - Document: IG v3.3 - Section: IG v3.3[2.6]|IG v3.3[4.2.6]|IG v3.3[6.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0079 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Custom domains will be used to represent logically related observations - based on the scientific subject matter of the data and will not be created based on:The - timing of collected observations (e.g., all vital signs measurements will be represented - in domain Vital Signs (VS) irrespective of when measurements occurred). - Document: TIG 1.0 - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0345 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: IG v3.4 + Item: "1" + Section: "2.6" + - Cited Guidance: + Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 3a + Section: 4.2.6 + - Cited Guidance: + An events domain that contains data that includes the subject's prior + medical history at the start of the trial. + Document: SDTMIG v3.4 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.2[2.6][Section 2.6: Do not create separate domains based on time, rather + represent both prior and current observations in a domain (e.g., CM for all non-study medications). + Note that AE and MH are an exception to this best practice because of regulatory reporting needs.]|IG + v3.2[4.1.2.6][Section 4.1.2.6, Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), + Medical History (MH) and Clinical Events (CE), for example, are conceptually the same data, + the only differences being when the event started relative to the study start and whether the + event is considered a regulatory reportable adverse event in the study.]|IG v3.2[6.2][Domain + Code Table: The medical history dataset includes the subject's prior history at the start of + the trial.][MH: The medical history dataset includes the subject's prior history at the start + of the trial.][Assumption 1:The Medical History dataset generally includes the subject's prior + and concomitant conditions at the start of the trial.]" + Document: IG v3.2 + Section: IG v3.2[2.6]|IG v3.2[4.1.2.6]|IG v3.2[6.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.3[2.6][Do not create separate domains based on time; rather, represent + both prior and current observations in a domain (e.g., CM for all non-study medications). Note + that AE and MH are an exception to this best practice because of regulatory reporting needs]|IG + v3.3[4.2.6][Item 2.B.3.A (Discussion of --CAT/--SCAT): Adverse Events (AE), Medical History + (MH), and Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is considered + a regulatory reportable adverse event in the study.]|IG v3.3[6.2][Domain Code Table: The medical + history dataset includes the subject's prior history at the start of the trial.][MH: The medical + history dataset includes the subject's prior history at the start of the trial.]" + Document: IG v3.3 + Section: IG v3.3[2.6]|IG v3.3[4.2.6]|IG v3.3[6.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0079 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Custom domains will be used to represent logically related observations + based on the scientific subject matter of the data and will not be created based on:The + timing of collected observations (e.g., all vital signs measurements will be represented + in domain Vital Signs (VS) irrespective of when measurements occurred). + Document: TIG 1.0 + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0345 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: MHSTDTC - operator: non_empty - - name: MHSTDTC - operator: date_greater_than_or_equal_to - value: RFSTDTC + - name: MHSTDTC + operator: non_empty + - name: MHSTDTC + operator: date_greater_than_or_equal_to + value: RFSTDTC Core: Id: CORE-000236 Status: Published - Version: '1' + Version: "1" Description: Raise an issue if MHSTDTC has a non-empty date that later than DM.RFSTDTC Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset + Message: + MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset should include the subject's prior history at the start of the trial. Output Variables: - - MHSTDTC - - RFSTDTC + - MHSTDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - MH + - MH Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000237/rule.yml b/Published/CORE-000237/rule.yml index 59a2033f2..04a527481 100644 --- a/Published/CORE-000237/rule.yml +++ b/Published/CORE-000237/rule.yml @@ -2,166 +2,174 @@ # Condition: --SCAT ^= null # Rule: --SCAT ^= --CAT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.7 - Item: --SCAT - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Item: Table 2.2.1, --SCAT - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0027 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND43 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: --SCAT - Section: 3.1.4 Identifiers for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0309 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.7 + Item: --SCAT + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Item: Table 2.2.1, --SCAT + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0027 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND43 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: --SCAT + Section: 3.1.4 Identifiers for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0309 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SCAT - operator: non_empty - - name: --SCAT - operator: equal_to - value: --CAT + - name: --SCAT + operator: non_empty + - name: --SCAT + operator: equal_to + value: --CAT Core: Id: CORE-000237 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --SCAT is not null and --SCAT is equal to --CAT Executability: Fully Executable Outcome: Message: --SCAT is equal to --CAT Output Variables: - - --CAT - - --SCAT + - --CAT + - --SCAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000238/rule.yml b/Published/CORE-000238/rule.yml index edc0e7661..a6248bdb4 100644 --- a/Published/CORE-000238/rule.yml +++ b/Published/CORE-000238/rule.yml @@ -2,114 +2,119 @@ # Condition: EX records present for subject # Rule: RFXENDTC = latest value of EX.EXSTDTC or EX.EXENDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if - EXENDTC was not collected or is missing). - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if - EXENDTC was not collected or is missing). - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if - EXENDTC was not collected or is missing). - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0147 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified product, equal to the - latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is - missing). - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0388 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Equal to the latest value of EXENDTC (or the latest value of EXSTDTC if + EXENDTC was not collected or is missing). + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0147 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified product, equal to the + latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not collected or is + missing). + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0388 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exstdtc - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exendtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exstdtc + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exendtc Core: Id: CORE-000238 Status: Published - Version: '1' -Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the + Version: "1" +Description: + Raise an error when EX records are present for subject but RFXENDTC does not equal the latest value of EX.EXSTDTC or EX.EXENDTC Executability: Fully Executable Operations: -- domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct -- domain: EX - group: - - USUBJID - id: $max_ex_exstdtc - name: EXSTDTC - operator: max_date -- domain: EX - group: - - USUBJID - id: $max_ex_exendtc - name: EXENDTC - operator: max_date + - domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct + - domain: EX + group: + - USUBJID + id: $max_ex_exstdtc + name: EXSTDTC + operator: max_date + - domain: EX + group: + - USUBJID + id: $max_ex_exendtc + name: EXENDTC + operator: max_date Outcome: Message: RFXENDTC does not equal the latest value of EX.EXSTDTC or EX.EXENDTC Output Variables: - - RFXENDTC - - $max_ex_exstdtc - - $max_ex_exendtc + - RFXENDTC + - $max_ex_exstdtc + - $max_ex_exendtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000239/rule.yml b/Published/CORE-000239/rule.yml index 4008fb206..7b39ead43 100644 --- a/Published/CORE-000239/rule.yml +++ b/Published/CORE-000239/rule.yml @@ -2,104 +2,109 @@ # Condition: EX records present for subject # Rule: RFXSTDTC = earliest EX.EXSTDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date of exposure to any protocol-specified treatment or therapy, equal - to the earliest value of EXSTDTC. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + First date of exposure to any protocol-specified treatment or therapy, equal + to the earliest value of EXSTDTC. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: "2" + Version: "2.0" + Version: "3.4" - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date of exposure to any protocol-specified treatment or therapy, equal - to the earliest value of EXSTDTC. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0148 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified product, equal to the - earliest value of EXSTDTC. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0389 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + First date of exposure to any protocol-specified treatment or therapy, equal + to the earliest value of EXSTDTC. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0148 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified product, equal to the + earliest value of EXSTDTC. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0389 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXSTDTC - operator: not_equal_to - value: $min_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXSTDTC + operator: not_equal_to + value: $min_ex_exstdtc Core: Id: CORE-000239 Status: Published - Version: '1' -Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the + Version: "1" +Description: + Raise an error when EX records are present for subject but RFXSTDTC does not equal the earliest value of EX.EXSTDTC Executability: Fully Executable Operations: -- domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct -- domain: EX - group: - - USUBJID - id: $min_ex_exstdtc - name: EXSTDTC - operator: min_date + - domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct + - domain: EX + group: + - USUBJID + id: $min_ex_exstdtc + name: EXSTDTC + operator: min_date Outcome: Message: RFXSTDTC does not equal the earliest value of EX.EXSTDTC Output Variables: - - RFXSTDTC - - $min_ex_exstdtc + - RFXSTDTC + - $min_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000240/rule.yml b/Published/CORE-000240/rule.yml index f65b78609..03decfc98 100644 --- a/Published/CORE-000240/rule.yml +++ b/Published/CORE-000240/rule.yml @@ -2,96 +2,100 @@ # Condition: --OCCUR = 'N' # Rule: --STRF = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: Model v2.0 - Item: --STRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before; during; or after - the sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before; during; or after - the sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0420 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --STRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0575 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --STRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before; during; or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before; during; or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0420 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --STRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0575 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --OCCUR - operator: equal_to - value: N - - name: --STRF - operator: non_empty + - name: --OCCUR + operator: equal_to + value: N + - name: --STRF + operator: non_empty Core: Id: CORE-000240 Status: Published - Version: '1' + Version: "1" Description: When --OCCUR = 'N', --STRF must not be populated Executability: Fully Executable Outcome: Message: --STRF is populated when --OCCUR = "N" Output Variables: - - --STRF + - --STRF Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000241/rule.yml b/Published/CORE-000241/rule.yml index 9030f7b31..4614273eb 100644 --- a/Published/CORE-000241/rule.yml +++ b/Published/CORE-000241/rule.yml @@ -2,96 +2,100 @@ # Condition: --OCCUR = 'N' # Rule: --ENRF = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: Model v2.0 - Item: --ENRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before; during or after the - sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before; during or after the - sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0421 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --ENRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0576 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model v2.0 + Item: --ENRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before; during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before; during or after the + sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0421 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --ENRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0576 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --OCCUR - operator: equal_to - value: N - - name: --ENRF - operator: non_empty + - name: --OCCUR + operator: equal_to + value: N + - name: --ENRF + operator: non_empty Core: Id: CORE-000241 Status: Published - Version: '1' + Version: "1" Description: When --OCCUR = 'N', --ENRF must not be populated Executability: Fully Executable Outcome: Message: --ENRF is populated when --OCCUR = "N" Output Variables: - - --ENRF + - --ENRF Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000242/rule.yml b/Published/CORE-000242/rule.yml index 0be397e34..7ad23f78e 100644 --- a/Published/CORE-000242/rule.yml +++ b/Published/CORE-000242/rule.yml @@ -1,90 +1,95 @@ # Variable: --EXCLFL -# Condition: +# Condition: # Rule: --EXCLFL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) - --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0353 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--EXCLFL - Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to - Create New Specifications" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0518 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.4 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.2 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0353 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--EXCLFL + Section: + "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to + Create New Specifications" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0518 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --EXCLFL - operator: exists + - name: --EXCLFL + operator: exists Core: Id: CORE-000242 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --EXCLFL is present in dataset. Executability: Fully Executable Outcome: Message: --EXCLFL must never be used in SDTM-based human trials Output Variables: - - --EXCLFL + - --EXCLFL Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000243/rule.yml b/Published/CORE-000243/rule.yml index 71aeaa03c..5d2dc33aa 100644 --- a/Published/CORE-000243/rule.yml +++ b/Published/CORE-000243/rule.yml @@ -1,90 +1,95 @@ # Variable: --REASEX -# Condition: +# Condition: # Rule: --REASEX not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) - --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0354 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "Not in human clinical trials Select variables for the domain from the SDTM. Selection - of variables must align with SDTM Usage Restrictions. " - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--REASEX - Section: "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to - Create New Specifications" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0519 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.4 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.2 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0354 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "Not in human clinical trials Select variables for the domain from the SDTM. Selection + of variables must align with SDTM Usage Restrictions. " + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--REASEX + Section: + "Section 3.1.3 - The Findings Observation Class 2.8.2 How Extend Domains 2.8.3 How to + Create New Specifications" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0519 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --REASEX - operator: exists + - name: --REASEX + operator: exists Core: Id: CORE-000243 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --REASEX is present in dataset. Executability: Fully Executable Outcome: Message: --REASEX must never be used in SDTM-based human clinical trials Output Variables: - - --REASEX + - --REASEX Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000244/rule.yml b/Published/CORE-000244/rule.yml index 5577e1bd8..2f8045f77 100644 --- a/Published/CORE-000244/rule.yml +++ b/Published/CORE-000244/rule.yml @@ -1,90 +1,95 @@ # Variable: --DETECT -# Condition: +# Condition: # Rule: --DETECT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables, defined for use in non-clinical studies (SEND), - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.4 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL - (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)' - Document: IG v3.2 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) - --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0355 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--DETECT - Section: Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend Domains | 2.8.3 - How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0520 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables, defined for use in non-clinical studies (SEND), + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.4 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --DTHREL + (Findings) --EXCLFL (Findings) --REASEX (Findings) --DETECT (Findings)" + Document: IG v3.2 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions; Events; Findings) --DTHREL (Findings) --EXCLFL (Findings) --REASEX (Findings) + --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) --NOMDY (Timing Variables) + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0355 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--DETECT + Section: + Section 3.1.3 - The Findings Observation Class| 2.8.2 How Extend Domains | 2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0520 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DETECT - operator: exists + - name: --DETECT + operator: exists Core: Id: CORE-000244 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DETECT is present in dataset. Executability: Fully Executable Outcome: Message: --DETECT must never be used in SDTM-based human trials Output Variables: - - --DETECT + - --DETECT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000245/rule.yml b/Published/CORE-000245/rule.yml index 974b63041..bdf53e49c 100644 --- a/Published/CORE-000245/rule.yml +++ b/Published/CORE-000245/rule.yml @@ -1,92 +1,96 @@ # Variable: --NOMDY -# Condition: +# Condition: # Rule: --NOMDY not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies - (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials - --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) - --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) - --NOMDY (Timing Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0510 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), - --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0510 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--NOMDY - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 - How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0605 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --NOMDY is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0635 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --NOMDY - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0676 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0510 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0510 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--NOMDY + Section: + Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0605 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --NOMDY is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0635 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --NOMDY + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0676 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --NOMDY - operator: exists + - name: --NOMDY + operator: exists Core: Id: CORE-000245 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --NOMDY is present. Executability: Fully Executable Outcome: @@ -95,9 +99,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000246/rule.yml b/Published/CORE-000246/rule.yml index a536c1381..64cab3106 100644 --- a/Published/CORE-000246/rule.yml +++ b/Published/CORE-000246/rule.yml @@ -1,92 +1,96 @@ # Variable: --NOMLBL -# Condition: +# Condition: # Rule: --NOMLBL not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following SDTM variables, defined for use in non-clinical studies - (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials - --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) - --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) - --NOMDY (Timing Variables) --NOMLBL (Timing Variables) - Document: IG v3.4 - Item: SDTM Variables Not Allowed in SDTMIG - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0511 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following SDTM variables; defined for use in non-clinical studies (SEND); - must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL - (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), - --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), - --NOMLBL (Timing Variables)' - Document: IG v3.3 - Section: '2.7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0511 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. Select variables for the domain from the SDTM. - Selection of variables must align with SDTM Usage Restrictions. - Document: SDTM v2.1|TIG v1.0 - Item: Specification|--NOMLBL - Section: Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 - How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0606 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --NOMLBL is not be used in human clinical trials. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0636 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --NOMLBL - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0677 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following SDTM variables, defined for use in non-clinical studies + (SEND), must NEVER be used in the submission of SDTM-based data for human clinical trials + --USCHFL (Interventions, Events, Findings) --DTHREL (Findings) --EXCLFL (Findings) + --REASEX (Findings) --IMPLBL (Findings) FETUSID (Identifiers) --DETECT (Timing Variables) + --NOMDY (Timing Variables) --NOMLBL (Timing Variables) + Document: IG v3.4 + Item: SDTM Variables Not Allowed in SDTMIG + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0511 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following SDTM variables; defined for use in non-clinical studies (SEND); + must NEVER be used in the submission of SDTM-based data for human clinical trials: --USCHFL + (Interventions, Events, Findings), --DTHREL (Findings), --EXCLFL (Findings), --REASEX (Findings), + --IMPLBL (Findings), --FETUSID (Identifiers), --DETECT (Timing Variables), --NOMDY (Timing Variables), + --NOMLBL (Timing Variables)" + Document: IG v3.3 + Section: "2.7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0511 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Not in human clinical trials. Select variables for the domain from the SDTM. + Selection of variables must align with SDTM Usage Restrictions. + Document: SDTM v2.1|TIG v1.0 + Item: Specification|--NOMLBL + Section: + Section 3.1.5 - Timing Variables for All Classes | 2.8.2 How Extend Domains |2.8.3 + How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0606 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --NOMLBL is not be used in human clinical trials. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0636 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --NOMLBL + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0677 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --NOMLBL - operator: exists + - name: --NOMLBL + operator: exists Core: Id: CORE-000246 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --NOMLBL is present. Executability: Fully Executable Outcome: @@ -95,9 +99,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000247/rule.yml b/Published/CORE-000247/rule.yml index 21ac062ea..49878ec09 100644 --- a/Published/CORE-000247/rule.yml +++ b/Published/CORE-000247/rule.yml @@ -1,84 +1,84 @@ # Variable: --RESLOC -# Condition: +# Condition: # Rule: --RESLOC not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not be used in human clinical trials. - Document: Model v2.0 - Item: --RESLOC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0552 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not to be used with human clinical trials. - Document: Model v1.7 - Item: --RESLOC - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0552 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RESLOC - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0640 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: Model v2.0 - Item: --RESLOC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0626 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Not in human clinical trials. - Document: SDTM v2.1 - Item: --RESLOC - Section: Findings - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0667 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not be used in human clinical trials. + Document: Model v2.0 + Item: --RESLOC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0552 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not to be used with human clinical trials. + Document: Model v1.7 + Item: --RESLOC + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0552 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RESLOC + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0640 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: Model v2.0 + Item: --RESLOC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0626 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: Not in human clinical trials. + Document: SDTM v2.1 + Item: --RESLOC + Section: Findings + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0667 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --RESLOC - operator: exists + - name: --RESLOC + operator: exists Core: Id: CORE-000247 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --RESLOC is present. Executability: Fully Executable Outcome: @@ -87,9 +87,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000248/rule.yml b/Published/CORE-000248/rule.yml index fb44bd9f8..895453066 100644 --- a/Published/CORE-000248/rule.yml +++ b/Published/CORE-000248/rule.yml @@ -2,295 +2,305 @@ # Condition: --TPTREF = null # Rule: --RFTDTC = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a fixed - reference for a series of planned time points, represented in a standardized character - format. The fixed reference point is in --TPTREF - Document: Model v2.0 - Item: --RFTDTC - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF - Document: Model v1.7 - Item: --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 - character format. - Document: Model v1.4 - Item: Table 2.2.5, --RFTDTC - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0026 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be provided. - Document: IG v3.0 - Section: 4.4.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference - point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference - point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference - point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference - point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Since the --RFTDTC represents the actual date/time of the fixed reference - point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND63 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: "When instances of an activity are scheduled at planned time intervals relative - to a fixed reference point (e.g., an exposure), the following timing variables will be used - --TPTREF Represents a description of the fixed reference point from which the planned observation - will be made. --RFTDTC Represents the actual date/time of the value of --TPTREF" - Document: TIG v1.0 - Item: Timing Relative to Reference Points, Table Num 3 - Section: 2.8.7.6 Representing References and Relative Timing - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0265 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: The actual date or date and time of a time point that acts as a fixed - reference for a series of planned time points, represented in a standardized character - format. The fixed reference point is in --TPTREF. - Document: SDTM v2.1 - Item: --RFTDTC - Section: 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0308 - Version: "1" - Version: "1.0" - Substandard: SDTM - Version: "1.0" -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Time point reference should be provided, when reference time point is used. - Document: FDA - Section: FDAB037 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3702 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF + Document: Model v2.0 + Item: --RFTDTC + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Date/time for a fixed reference time point defined by --TPTREF + Document: Model v1.7 + Item: --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time for a fixed reference time point defined by --TPTREF in ISO 8601 + character format. + Document: Model v1.4 + Item: Table 2.2.5, --RFTDTC + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0026 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If an --RFTDTC entry is used, then the --TPTREF should be provided. + Document: IG v3.0 + Section: 4.4.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Since the --RFTDTC represents the actual date/time of the fixed reference + point (--TPTREF), the --TPTREF should be provided whenever --RFTDTC is populated. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND63 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "When instances of an activity are scheduled at planned time intervals relative + to a fixed reference point (e.g., an exposure), the following timing variables will be used + --TPTREF Represents a description of the fixed reference point from which the planned observation + will be made. --RFTDTC Represents the actual date/time of the value of --TPTREF" + Document: TIG v1.0 + Item: Timing Relative to Reference Points, Table Num 3 + Section: 2.8.7.6 Representing References and Relative Timing + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0265 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The actual date or date and time of a time point that acts as a fixed + reference for a series of planned time points, represented in a standardized character + format. The fixed reference point is in --TPTREF. + Document: SDTM v2.1 + Item: --RFTDTC + Section: 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0308 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Time point reference should be provided, when reference time point is used. + Document: FDA + Section: FDAB037 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3702 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --TPTREF - operator: empty - - name: --RFTDTC - operator: exists - - name: --RFTDTC - operator: non_empty + - name: --TPTREF + operator: empty + - name: --RFTDTC + operator: exists + - name: --RFTDTC + operator: non_empty Core: Id: CORE-000248 Status: Published - Version: '1' -Description: Time point reference (--TPTREF) should be populated when reference time point + Version: "1" +Description: + Time point reference (--TPTREF) should be populated when reference time point (--RFTDTC) is populated. Executability: Fully Executable Outcome: @@ -299,9 +309,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000249/rule.yml b/Published/CORE-000249/rule.yml index b7861c9e1..57e7ca13e 100644 --- a/Published/CORE-000249/rule.yml +++ b/Published/CORE-000249/rule.yml @@ -2,111 +2,115 @@ # Condition: VISITNUM is in TV.VISITNUM # Rule: VISITDY = TV.VISITDY Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). - Document: IG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset, - Document: IG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset, - Document: IG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0032 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned visits. There will be a - one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level - dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM - that appear in the TV dataset should also include the corresponding values of VISIT from - the TV dataset. - Document: TIG 1.0 - Item: 2.8.10.31 Assumption 6 - Section: 2.8.7.5 - - Cited Guidance: Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Specification VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0313 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: IG v3.4 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.3 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.2 + Item: "" + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0032 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. + Document: TIG 1.0 + Item: 2.8.10.31 Assumption 6 + Section: 2.8.7.5 + - Cited Guidance: Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Specification VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0313 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: VISITDY - operator: exists - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISITDY - operator: not_equal_to - value: TV.VISITDY + - name: VISITDY + operator: exists + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISITDY + operator: not_equal_to + value: TV.VISITDY Core: Id: CORE-000249 Status: Published - Version: '1' + Version: "1" Description: Verify that visitdy is planned and exists in TV Executability: Fully Executable Match Datasets: -- Keys: - - VISITNUM - Name: TV + - Keys: + - VISITNUM + Name: TV Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: Visit Day cannot be found in Trial Visit (TV) domain Output Variables: - - VISITDY - - VISITNUM + - VISITDY + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000250/rule.yml b/Published/CORE-000250/rule.yml index adf3bb565..938c40102 100644 --- a/Published/CORE-000250/rule.yml +++ b/Published/CORE-000250/rule.yml @@ -2,240 +2,269 @@ # Condition: MHENDTC ^= null # Rule: MHENDTC < DM.RFSTDTC Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - Adverse Events and Medical History are an exception to this best practice because of - regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for - example, are conceptually the same data, the only differences being when the event started - relative to the study start and whether the event is considered a regulatory-reportable - adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the subject's prior - history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial.][Assumption 1:The Medical History dataset generally includes - the subject's prior and concomitant conditions at the start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - Adverse Events and Medical History are an exception to this best practice because of - regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for - example, are conceptually the same data, the only differences being when the event started - relative to the study start and whether the event is considered a regulatory-reportable - adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the subject's prior - history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial.][Assumption 1:The Medical History dataset generally includes - the subject's prior and concomitant conditions at the start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - Adverse Events and Medical History are an exception to this best practice because of - regulatory reporting needs. - Document: SDTMIG v3.4 - Section: '2.6' - - Cited Guidance: Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for - example, are conceptually the same data, the only differences being when the event started - relative to the study start and whether the event is considered a regulatory-reportable - adverse event in the study. - Document: SDTMIG v3.4 - Item: 2.B.3.a - Section: 4.2.6 - - Cited Guidance: MH Description The medical history dataset includes the subject's prior - history at the start of the trial. - Document: SDTMIG v3.4 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time; rather, represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs - Document: SDTMIG v3.3 - Section: '2.6' - - Cited Guidance: (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.3 - Item: 2.B.3.A - Section: 4.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial. - Document: SDTMIG v3.3 - Section: '6.2' - - Cited Guidance: Do not create separate domains based on time, rather represent both prior - and current observations in a domain (e.g., CM for all non-study medications). Note that - AE and MH are an exception to this best practice because of regulatory reporting needs. - Document: SDTMIG v3.2 - Section: '2.6' - - Cited Guidance: Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and - Clinical Events (CE), for example, are conceptually the same data, the only differences - being when the event started relative to the study start and whether the event is - considered a regulatory reportable adverse event in the study. - Document: SDTMIG v3.2 - Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) - Section: 4.1.2.6 - - Cited Guidance: The medical history dataset includes the subject's prior history at the - start of the trial.][MH The medical history dataset includes the subject's prior history - at the start of the trial.][Assumption 1:The Medical History dataset generally includes - the subject's prior and concomitant conditions at the start of the trial.] - Document: SDTMIG v3.2 - Item: Domain Code Table | Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0078 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Custom domains will be used to represent logically related observations - based on the scientific subject matter of the data and will not be created based on:The - timing of collected observations (e.g., all vital signs measurements will be represented - in domain Vital Signs (VS) irrespective of when measurements occurred). - Document: TIG 1.0 - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0344 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: "2.6" + - Cited Guidance: + Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: + MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: "2.6" + - Cited Guidance: + (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: "2.6" + - Cited Guidance: + Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: "2.6" + - Cited Guidance: + Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: + MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: "2.6" + - Cited Guidance: + (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: "2.6" + - Cited Guidance: + Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + Adverse Events and Medical History are an exception to this best practice because of + regulatory reporting needs. + Document: SDTMIG v3.4 + Section: "2.6" + - Cited Guidance: + Adverse Events (AE), Medical History (MH), and Clinical Events (CE), for + example, are conceptually the same data, the only differences being when the event started + relative to the study start and whether the event is considered a regulatory-reportable + adverse event in the study. + Document: SDTMIG v3.4 + Item: 2.B.3.a + Section: 4.2.6 + - Cited Guidance: + MH Description The medical history dataset includes the subject's prior + history at the start of the trial. + Document: SDTMIG v3.4 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time; rather, represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs + Document: SDTMIG v3.3 + Section: "2.6" + - Cited Guidance: + (Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH), and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.3 + Item: 2.B.3.A + Section: 4.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial. + Document: SDTMIG v3.3 + Section: "6.2" + - Cited Guidance: + Do not create separate domains based on time, rather represent both prior + and current observations in a domain (e.g., CM for all non-study medications). Note that + AE and MH are an exception to this best practice because of regulatory reporting needs. + Document: SDTMIG v3.2 + Section: "2.6" + - Cited Guidance: + Discussion of --CAT/--SCAT) Adverse Events (AE), Medical History (MH) and + Clinical Events (CE), for example, are conceptually the same data, the only differences + being when the event started relative to the study start and whether the event is + considered a regulatory reportable adverse event in the study. + Document: SDTMIG v3.2 + Item: Item 2.B.3.A (Discussion of --CAT/--SCAT) + Section: 4.1.2.6 + - Cited Guidance: + The medical history dataset includes the subject's prior history at the + start of the trial.][MH The medical history dataset includes the subject's prior history + at the start of the trial.][Assumption 1:The Medical History dataset generally includes + the subject's prior and concomitant conditions at the start of the trial.] + Document: SDTMIG v3.2 + Item: Domain Code Table | Assumption 1 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0078 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Custom domains will be used to represent logically related observations + based on the scientific subject matter of the data and will not be created based on:The + timing of collected observations (e.g., all vital signs measurements will be represented + in domain Vital Signs (VS) irrespective of when measurements occurred). + Document: TIG 1.0 + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0344 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: MHENDTC - operator: non_empty - - name: MHENDTC - operator: date_greater_than_or_equal_to - value: RFSTDTC + - name: MHENDTC + operator: non_empty + - name: MHENDTC + operator: date_greater_than_or_equal_to + value: RFSTDTC Core: Id: CORE-000250 Status: Published - Version: '1' + Version: "1" Description: Raise an issue if MHENDTC has a non-empty date that is on or after DM.RFSTDTC Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset + Message: + MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset should include the subject's prior history at the start of the trial. Output Variables: - - MHENDTC - - RFSTDTC + - MHENDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - MH + - MH Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000252/rule.yml b/Published/CORE-000252/rule.yml index b693bb601..abcad815a 100644 --- a/Published/CORE-000252/rule.yml +++ b/Published/CORE-000252/rule.yml @@ -2,137 +2,145 @@ # Condition: DS record with DSDECOD= "DEATH" present for the subject # Rule: DTHFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0136 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even - when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0385 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0605 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0136 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0385 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0605 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: DSDECOD - operator: equal_to - value: DEATH - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: DSDECOD + operator: equal_to + value: DEATH + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000252 Status: Published - Version: '1' -Description: When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag + Version: "1" +Description: + When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DS + - Keys: + - USUBJID + Name: DS Outcome: Message: DSDECOD is 'DEATH' in DS dataset, but DTHFL in DM dataset is not "Y". Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000253/rule.yml b/Published/CORE-000253/rule.yml index d63f22ff9..a469c57d2 100644 --- a/Published/CORE-000253/rule.yml +++ b/Published/CORE-000253/rule.yml @@ -2,137 +2,145 @@ # Condition: AE record with AESDTH= "Y" present for the subject # Rule: DTHFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0135 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even - when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0384 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0604 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0135 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0384 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0604 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: AESDTH - operator: equal_to - value: Y - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: AESDTH + operator: equal_to + value: Y + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000253 Status: Published - Version: '1' -Description: When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL) + Version: "1" +Description: + When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: AE + - Keys: + - USUBJID + Name: AE Outcome: Message: AESDTH is 'Y' in AE dataset, but DTHFL in DM dataset is not "Y". Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000254/rule.yml b/Published/CORE-000254/rule.yml index 7d5dbca60..55a205f55 100644 --- a/Published/CORE-000254/rule.yml +++ b/Published/CORE-000254/rule.yml @@ -2,140 +2,148 @@ # Condition: AE record with AEOUT= "FATAL" present for the subject # Rule: DTHFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be Y or null. Should be populated even - when the death date is unknown. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0134 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Indicates the subject died. Should be "Y" or null. Should be populated even - when the death date is unknown. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0383 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All death information should be populated for subjects that died during the - study including any post treatment follow-up. - Document: FDA - Section: FDAB006 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0603 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be Y or null. Should be populated even + when the death date is unknown. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0134 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Indicates the subject died. Should be "Y" or null. Should be populated even + when the death date is unknown. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0383 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All death information should be populated for subjects that died during the + study including any post treatment follow-up. + Document: FDA + Section: FDAB006 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0603 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: AEOUT - operator: equal_to - value: FATAL - value_is_literal: true - - name: DTHFL - operator: not_equal_to - value: Y - value_is_literal: true + - name: AEOUT + operator: equal_to + value: FATAL + value_is_literal: true + - name: DTHFL + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000254 Status: Published - Version: '1' -Description: When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag + Version: "1" +Description: + When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: AE + - Keys: + - USUBJID + Name: AE Outcome: Message: AEOUT is 'FATAL' in AE dataset, but DTHFL in DM dataset is not "Y". Output Variables: - - DTHFL - - AEOUT + - DTHFL + - AEOUT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000255/rule.yml b/Published/CORE-000255/rule.yml index b576a44c6..a9151bbf3 100644 --- a/Published/CORE-000255/rule.yml +++ b/Published/CORE-000255/rule.yml @@ -1,109 +1,116 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND85.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND85.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --STAT - operator: not_equal_to - value: NOT DONE - - name: --ORRES - operator: empty + - name: --STAT + operator: not_equal_to + value: NOT DONE + - name: --ORRES + operator: empty Core: Id: CORE-000255 Status: Published - Version: '1' -Description: There should always be data presented in the --ORRES variable unless --STAT = "NOT + Version: "1" +Description: + There should always be data presented in the --ORRES variable unless --STAT = "NOT DONE". Executability: Fully Executable Outcome: Message: --ORRES must be populated as --STAT is not equal to 'NOT DONE' Output Variables: - - --STAT - - --ORRES + - --STAT + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000256/rule.yml b/Published/CORE-000256/rule.yml index 81a0857d1..150caf9f2 100644 --- a/Published/CORE-000256/rule.yml +++ b/Published/CORE-000256/rule.yml @@ -2,192 +2,202 @@ # Condition: SEUPDES = null # Rule: ETCD ^= 'UNPLAN' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular\ \ - period of time cannot be represented with one of the planned Elements, then\ \ that period - of time should be represented as an unplanned Element. The value\ \ of ETCD for an - unplanned Element is "UNPLAN" and SEUPDES should\ \ be populated with a description of the - unplanned Element. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element. The value of ETCD for an unplanned Element - is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element - only if ETCD has the value of "UNPLAN". - Document: IG v3.2 - Item: Assumption 6 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the sponsor decides that the subject's experience for a particular period - of time cannot be represented with one of the planned Elements, then that period of time - should be represented as an unplanned Element. The value of ETCD for an unplanned Element - is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element - only if ETCD has the value of "UNPLAN". - Document: IG v3.3 - Item: Assumption 4 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0210 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the applicant decides that the subject's experience for a particular - period of time cannot be represented with one of the planned elements, then that period of - time should be represented as an unplanned element. The value of ETCD for an unplanned - element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned - element. - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0429 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Description of what happened to the subject during this unplanned Element. - Document: SENDIG v3.0 - Item: Specification - Section: 5.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: SENDIG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: SENDIG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND125.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT - should be left blank, and SEUPDES should be populated with a description of the unplanned - Element. - Document: TIG v1.0 - Item: Assumption 5 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0062 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular\ \ + period of time cannot be represented with one of the planned Elements, then\ \ that period + of time should be represented as an unplanned Element. The value\ \ of ETCD for an + unplanned Element is "UNPLAN" and SEUPDES should\ \ be populated with a description of the + unplanned Element. + Document: IG v3.4 + Item: Assumption 4 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.2 + Item: Assumption 6 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the sponsor decides that the subject's experience for a particular period + of time cannot be represented with one of the planned Elements, then that period of time + should be represented as an unplanned Element. The value of ETCD for an unplanned Element + is "UNPLAN" and SEUPDES should be populated with a description of the unplanned Element + only if ETCD has the value of "UNPLAN". + Document: IG v3.3 + Item: Assumption 4 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0210 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If the applicant decides that the subject's experience for a particular + period of time cannot be represented with one of the planned elements, then that period of + time should be represented as an unplanned element. The value of ETCD for an unplanned + element is “UNPLAN” and SEUPDES should be populated with a description of the unplanned + element. + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0429 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Description of what happened to the subject during this unplanned Element. + Document: SENDIG v3.0 + Item: Specification + Section: 5.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with 'UNPLAN', ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: SENDIG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND125.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For unplanned Elements, ETCD should be populated with “UNPLAN”, ELEMENT + should be left blank, and SEUPDES should be populated with a description of the unplanned + Element. + Document: TIG v1.0 + Item: Assumption 5 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0062 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: SEUPDES - operator: empty - - name: ETCD - operator: equal_to - value: UNPLAN + - name: SEUPDES + operator: empty + - name: ETCD + operator: equal_to + value: UNPLAN Core: Id: CORE-000256 Status: Published - Version: '1' + Version: "1" Description: Raise an error when ETCD = 'UNPLAN', SEUPDES = null Executability: Fully Executable Outcome: @@ -196,9 +206,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000257/rule.yml b/Published/CORE-000257/rule.yml index 10a6965e5..09c3548b8 100644 --- a/Published/CORE-000257/rule.yml +++ b/Published/CORE-000257/rule.yml @@ -2,227 +2,242 @@ # Condition: --STRTPT ^= null # Rule: --STTPT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the start of an observation. This is the sponsor-defined - reference point referred to by --STRTPT. - Document: Model v2.0 - Item: --STTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format of the - sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT - 1". - Document: Model v1.7 - Item: Table 2.2.5.1 --STTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other character format of - the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or - "VISIT 1". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0061 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the start of an observation. This is the sponsor-defined - reference point referred to by --STRTPT. - Document: SDTM v2.1 - Item: --STTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0335 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - # FDA rule FB4401 is identical - added Jozef 2024-12-19 -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established - by --STTPT to characterize the start of an observation' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4401' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: Model v2.0 + Item: --STTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT + 1". + Document: Model v1.7 + Item: Table 2.2.5.1 --STTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--STTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or + "VISIT 1". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0061 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: SDTM v2.1 + Item: --STTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0335 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + # FDA rule FB4401 is identical - added Jozef 2024-12-19 + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When using --STRTPT, --STTPT must be defined. --STRTPT uses the time point established + by --STTPT to characterize the start of an observation" + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4401" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRTPT - operator: non_empty - - name: --STTPT - operator: empty + - name: --STRTPT + operator: non_empty + - name: --STTPT + operator: empty Core: Id: CORE-000257 Status: Published - Version: '1' -Description: 'When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time - Point (--STTPT) should also be populated.' + Version: "1" +Description: + "When Start Relative to Reference Time Point (--STRTPT) is populated, Start Reference Time + Point (--STTPT) should also be populated." Executability: Fully Executable Outcome: Message: --STRTPT is populated, but --STTPT is missing. Output Variables: - - --STRTPT - - --STTPT + - --STRTPT + - --STTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000258/rule.yml b/Published/CORE-000258/rule.yml index dc3991179..d235a3e40 100644 --- a/Published/CORE-000258/rule.yml +++ b/Published/CORE-000258/rule.yml @@ -2,93 +2,98 @@ # Condition: --STRTPT present in dataset # Rule: --STTPT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the start of an observation. This is the sponsor-defined - reference point referred to by --STRTPT. - Document: Model v2.0 - Item: --STTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Description or date/time in ISO 8601 or other character format of the - sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT - 1". - Document: Model v1.7 - Item: Table 2.2.5.1 --STTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STTPT) Description or date/time in ISO 8601 or other character format of - the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or - "VISIT 1". - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0062 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The description or date and/or time of a time point that acts as a fixed - reference for characterizing the start of an observation. This is the sponsor-defined - reference point referred to by --STRTPT. - Document: SDTM v2.1 - Item: --STTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0336 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: Model v2.0 + Item: --STTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Description or date/time in ISO 8601 or other character format of the + sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or "VISIT + 1". + Document: Model v1.7 + Item: Table 2.2.5.1 --STTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--STTPT) Description or date/time in ISO 8601 or other character format of + the sponsor-defined reference point referred to by --STRTPT. Examples; "2003-12-15" or + "VISIT 1". + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0062 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The description or date and/or time of a time point that acts as a fixed + reference for characterizing the start of an observation. This is the sponsor-defined + reference point referred to by --STRTPT. + Document: SDTM v2.1 + Item: --STTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0336 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --STRTPT - operator: exists - - name: --STTPT - operator: not_exists + - name: --STRTPT + operator: exists + - name: --STTPT + operator: not_exists Core: Id: CORE-000258 Status: Published - Version: '1' -Description: Raise an error when --STRTPT is present in dataset and --STTPT is not present in + Version: "1" +Description: + Raise an error when --STRTPT is present in dataset and --STTPT is not present in dataset. Executability: Fully Executable Outcome: Message: --STRTPT is present in dataset, but --STTPT is not present in dataset. Output Variables: - - --STRTPT + - --STRTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000260/rule.yml b/Published/CORE-000260/rule.yml index fad11b357..49e5ac3d4 100644 --- a/Published/CORE-000260/rule.yml +++ b/Published/CORE-000260/rule.yml @@ -1,98 +1,102 @@ # Variable: --PRESP -# Condition: +# Condition: # Rule: --PRESP in ('Y', null) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously - reported events.] Interventions[--PRESP][Values should be "Y" or null.] - Document: Model v2.0 - Item: --PRESP - Section: Events|Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] | - Model v1.7[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] - Document: Model v1.7 - Item: '' - Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] - |Model v1.4[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] - Document: Model v1.4 - Item: '' - Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0085 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously - reported events.] - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.2 The Events Observation Class - - Cited Guidance: Interventions[--PRESP][Values should be "Y" or null.] - Document: SDTM v2.1 - Item: --PRESP - Section: Section 3.1.1 The Interventions Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0350 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously + reported events.] Interventions[--PRESP][Values should be "Y" or null.] + Document: Model v2.0 + Item: --PRESP + Section: Events|Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Model v1.7[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] | + Model v1.7[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] + Document: Model v1.7 + Item: "" + Section: Model v1.7[2.2.1 (Interventions)]|Model v1.7[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Model v1.4[2.2.1 (Interventions )][--PRESP; Values should be "Y" or null.] + |Model v1.4[2.2.2 (Events)][--PRESP; Values should be "Y" or null.] + Document: Model v1.4 + Item: "" + Section: Model v1.4[2.2.1 (Interventions)]|Model v1.4[2.2.2 (Events)] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0085 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Events[--PRESP][Value is "Y" for prespecified events, null for spontaneously + reported events.] + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.2 The Events Observation Class + - Cited Guidance: Interventions[--PRESP][Values should be "Y" or null.] + Document: SDTM v2.1 + Item: --PRESP + Section: Section 3.1.1 The Interventions Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0350 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PRESP - operator: non_empty - - name: --PRESP - operator: not_equal_to - value: Y - value_is_literal: true + - name: --PRESP + operator: non_empty + - name: --PRESP + operator: not_equal_to + value: Y + value_is_literal: true Core: Id: CORE-000260 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --PRESP does not equal 'Y' or is not empty. Executability: Fully Executable Outcome: Message: --PRESP does not equal 'Y' or is not empty. Output Variables: - - --PRESP + - --PRESP Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - DS - - DV - - EX + - DS + - DV + - EX Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000261/rule.yml b/Published/CORE-000261/rule.yml index 236312311..ef7657a27 100644 --- a/Published/CORE-000261/rule.yml +++ b/Published/CORE-000261/rule.yml @@ -2,89 +2,94 @@ # Condition: --STTPT present in dataset # Rule: --STRTPT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to a reference - time point. The sponsor-defined reference time point is in --STTPT. - Document: Model v2.0 - Item: --STRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before or after the - sponsor-defined reference time point defined by variable --STTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --STRTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--STRTPT) Identifies the start of the observation as being before or after - the sponsor-defined reference time point defined by variable --STTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0060 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to a reference - time point. The sponsor-defined reference time point is in --STTPT. - Document: SDTM v2.1 - Item: --STRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0334 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: Model v2.0 + Item: --STRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before or after the + sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --STRTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--STRTPT) Identifies the start of the observation as being before or after + the sponsor-defined reference time point defined by variable --STTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0060 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to a reference + time point. The sponsor-defined reference time point is in --STTPT. + Document: SDTM v2.1 + Item: --STRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0334 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --STTPT - operator: exists - - name: --STRTPT - operator: not_exists + - name: --STTPT + operator: exists + - name: --STRTPT + operator: not_exists Core: Id: CORE-000261 Status: Published - Version: '1' -Description: Raise an error when --STTPT is present in dataset and --STRTPT is not present in + Version: "1" +Description: + Raise an error when --STTPT is present in dataset and --STRTPT is not present in dataset. Executability: Fully Executable Outcome: Message: --STTPT is present in dataset, but --STRTPT is not present in dataset. Output Variables: - - --STTPT + - --STTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000262/rule.yml b/Published/CORE-000262/rule.yml index 744db62fe..e51b19711 100644 --- a/Published/CORE-000262/rule.yml +++ b/Published/CORE-000262/rule.yml @@ -2,99 +2,103 @@ # Condition: DM.RFSTDTC = null # Rule: --STRF = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: Model 2.0 - Item: --STRF - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before, during, or after - the sponsor-defined reference period.The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model 1.7 - Item: 'Table 2.2.5.1: --STRF' - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the start of the observation as being before, during, or after - the sponsor-defined reference period. The sponsor-defined reference period is a continuous - period of time defined by a discrete starting point and a discrete ending point - represented by RFSTDTC and RFENDTC in Demographics. - Document: Model 1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0226 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the start of an observation relative to the study - reference period. The sponsor-defined reference period is a continuous period of time - defined by a discrete starting point and a discrete ending point represented by RFSTDTC - and RFENDTC in Demographics. - Document: SDTM v2.1 - Item: --STRF - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0439 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: Model 2.0 + Item: --STRF + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before, during, or after + the sponsor-defined reference period.The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model 1.7 + Item: "Table 2.2.5.1: --STRF" + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the start of the observation as being before, during, or after + the sponsor-defined reference period. The sponsor-defined reference period is a continuous + period of time defined by a discrete starting point and a discrete ending point + represented by RFSTDTC and RFENDTC in Demographics. + Document: Model 1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0226 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the start of an observation relative to the study + reference period. The sponsor-defined reference period is a continuous period of time + defined by a discrete starting point and a discrete ending point represented by RFSTDTC + and RFENDTC in Demographics. + Document: SDTM v2.1 + Item: --STRF + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0439 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RFSTDTC - operator: empty - - name: --STRF - operator: non_empty + - name: RFSTDTC + operator: empty + - name: --STRF + operator: non_empty Core: Id: CORE-000262 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RFSTDTC in DM is empty and --STRF is not empty. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: RFSTDTC in DM dataset is empty but --STRF is completed. Output Variables: - - --STRF + - --STRF Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000265/rule.yml b/Published/CORE-000265/rule.yml index 69a0043c1..395176951 100644 --- a/Published/CORE-000265/rule.yml +++ b/Published/CORE-000265/rule.yml @@ -2,223 +2,238 @@ # Condition: --ENRTPT ^= null # Rule: --ENTPT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a reference - time point. The sponsor-defined reference time point is in --ENTPT. - Document: Model v2.0 - Item: --ENRTPT - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifies the end of the observation as being before or after the - sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.7 - Item: Table 2.2.5.1 --ENTPT - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: (--ENRTPT) Identifies the end of the observation as being before or after - the sponsor-defined reference time point defined by variable --ENTPT. - Document: Model v1.4 - Item: Specification - Section: 2.2.5 Timing Variables for All Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0046 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The characterization of the end of an observation relative to a reference - time point. The sponsor-defined reference time point is in --ENTPT. - Document: SDTM v2.1 - Item: --ENRTPT - Section: Section 3.1.5 Timing Variables for All Classes - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0325 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established - by --ENTPT to characterize the start of an observation.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4402' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: Model v2.0 + Item: --ENRTPT + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifies the end of the observation as being before or after the + sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.7 + Item: Table 2.2.5.1 --ENTPT + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + (--ENRTPT) Identifies the end of the observation as being before or after + the sponsor-defined reference time point defined by variable --ENTPT. + Document: Model v1.4 + Item: Specification + Section: 2.2.5 Timing Variables for All Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0046 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The characterization of the end of an observation relative to a reference + time point. The sponsor-defined reference time point is in --ENTPT. + Document: SDTM v2.1 + Item: --ENRTPT + Section: Section 3.1.5 Timing Variables for All Classes + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0325 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When using --ENRTPT, --ENTPT must be defined. --ENRTPT uses the time point established + by --ENTPT to characterize the start of an observation." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4402" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --ENRTPT - operator: non_empty - - name: --ENTPT - operator: empty + - name: --ENRTPT + operator: non_empty + - name: --ENTPT + operator: empty Core: Id: CORE-000265 Status: Published - Version: '1' -Description: 'When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point - (--ENTPT) should also be populated.' + Version: "1" +Description: + "When End Relative to Reference Time Point (--ENRTPT) is populated, End Reference Time Point + (--ENTPT) should also be populated." Executability: Fully Executable Outcome: Message: --ENRTPT is populated, but --ENTPT is missing. Output Variables: - - --ENRTPT - - --ENTPT + - --ENRTPT + - --ENTPT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000266/rule.yml b/Published/CORE-000266/rule.yml index 1b0872b80..30aaca605 100644 --- a/Published/CORE-000266/rule.yml +++ b/Published/CORE-000266/rule.yml @@ -2,158 +2,164 @@ # Condition: AESCAN ^= 'Y' and AESCONG ^= 'Y' and AESDISAB ^= 'Y' and AESDTH ^= 'Y' and AESHOSP ^= 'Y' and AESLIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE ^= 'Y' # Rule: AESER = 'N' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If categories of serious events are collected secondarily to a leading question, - as in the example below, the values of the variables that capture reasons an event is considered - serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if Serious = \"No\", the values - for these variables may be null. However, if Serious = \"Yes\", at least one of them will have - a \"Y\" response.\n\n\n " - Document: IG v3.4 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question, as in the example below, the values of the variables that capture reasons an - event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No, " the values for these variables may be null. However, if Serious - is answered "Yes, " at least one of them will have a "Y" response. - Document: IG v3.2 - Item: Assumption 6a - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question, as in the example below, the values of the variables that capture reasons an - event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if - Serious is answered "No, " the values for these variables may be null. However, if Serious - is answered "Yes, " at least one of them will have a "Y" response. - Document: IG v3.3 - Item: Assumption 6a - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0042 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If categories of serious events are collected secondarily to a leading - question the values of the variables that capture reasons an event is considered serious - (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a - response is collected for each seriousness category, all category variables (e.g., AESDTH, - AESHOSP) would be populated and AESER would be derived. - Document: TIG 1.0 - Item: Assumption 7a - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0321 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If categories of serious events are collected secondarily to a leading question, + as in the example below, the values of the variables that capture reasons an event is considered + serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if Serious = \"No\", the values + for these variables may be null. However, if Serious = \"Yes\", at least one of them will have + a \"Y\" response.\n\n\n " + Document: IG v3.4 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No, " the values for these variables may be null. However, if Serious + is answered "Yes, " at least one of them will have a "Y" response. + Document: IG v3.2 + Item: Assumption 6a + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question, as in the example below, the values of the variables that capture reasons an + event is considered serious (i.e., AESCAN, AESCONG, etc.) may be null. For example, if + Serious is answered "No, " the values for these variables may be null. However, if Serious + is answered "Yes, " at least one of them will have a "Y" response. + Document: IG v3.3 + Item: Assumption 6a + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0042 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If categories of serious events are collected secondarily to a leading + question the values of the variables that capture reasons an event is considered serious + (e.g., AESCAN, AESCONG) may be null. On the other hand, if the CRF is structured so that a + response is collected for each seriousness category, all category variables (e.g., AESDTH, + AESHOSP) would be populated and AESER would be derived. + Document: TIG 1.0 + Item: Assumption 7a + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0321 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: AESER - operator: not_equal_to - value: N - - all: - - any: - - name: AESCAN - operator: not_exists - - name: AESCAN - operator: not_equal_to - value: Y - - any: - - name: AESCONG - operator: not_exists - - name: AESCONG - operator: not_equal_to - value: Y - - any: - - name: AESDISAB - operator: not_exists - - name: AESDISAB - operator: not_equal_to - value: Y - - any: - - name: AESDTH - operator: not_exists - - name: AESDTH - operator: not_equal_to - value: Y - - any: - - name: AESHOSP - operator: not_exists - - name: AESHOSP - operator: not_equal_to - value: Y - - any: - - name: AESLIFE - operator: not_exists - - name: AESLIFE - operator: not_equal_to - value: Y - - any: - - name: AESOD - operator: not_exists - - name: AESOD - operator: not_equal_to - value: Y - - any: - - name: AESMIE - operator: not_exists - - name: AESMIE - operator: not_equal_to - value: Y + - name: AESER + operator: not_equal_to + value: N + - all: + - any: + - name: AESCAN + operator: not_exists + - name: AESCAN + operator: not_equal_to + value: Y + - any: + - name: AESCONG + operator: not_exists + - name: AESCONG + operator: not_equal_to + value: Y + - any: + - name: AESDISAB + operator: not_exists + - name: AESDISAB + operator: not_equal_to + value: Y + - any: + - name: AESDTH + operator: not_exists + - name: AESDTH + operator: not_equal_to + value: Y + - any: + - name: AESHOSP + operator: not_exists + - name: AESHOSP + operator: not_equal_to + value: Y + - any: + - name: AESLIFE + operator: not_exists + - name: AESLIFE + operator: not_equal_to + value: Y + - any: + - name: AESOD + operator: not_exists + - name: AESOD + operator: not_equal_to + value: Y + - any: + - name: AESMIE + operator: not_exists + - name: AESMIE + operator: not_equal_to + value: Y Core: Id: CORE-000266 Status: Published - Version: '1' -Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE + Version: "1" +Description: + Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE and AESOD and AESMIE ^= "Y" However, AESER ^= "N" Executability: Fully Executable Outcome: - Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, + Message: + If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y". Output Variables: - - AESER - - AESCAN - - AESCONG - - AESDISAB - - AESDTH - - AESHOSP - - AESLIFE - - AESOD - - AESMIE + - AESER + - AESCAN + - AESCONG + - AESDISAB + - AESDTH + - AESHOSP + - AESLIFE + - AESOD + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000267/rule.yml b/Published/CORE-000267/rule.yml index 9663e8d34..6647880d8 100644 --- a/Published/CORE-000267/rule.yml +++ b/Published/CORE-000267/rule.yml @@ -2,88 +2,89 @@ # Condition: --PTCD ^= null # Rule: --DECOD ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The preferred term code assigned to the event from MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0050 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the description of an - event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The - preferred term code assigned to the event from MedDRA.] - Document: SDTM v2.1 - Item: --PTCD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0328 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0050 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + --DECOD[Standardized or dictionary-derived text for the description of an + event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The + preferred term code assigned to the event from MedDRA.] + Document: SDTM v2.1 + Item: --PTCD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0328 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --PTCD - operator: non_empty - - name: --DECOD - operator: empty + - name: --PTCD + operator: non_empty + - name: --DECOD + operator: empty Core: Id: CORE-000267 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DECOD is not populated but --PTCD is populated Executability: Fully Executable Outcome: Message: --DECOD should be populated when --PTCD is populated Output Variables: - - --TERM - - --PTCD - - --DECOD + - --TERM + - --PTCD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000268/rule.yml b/Published/CORE-000268/rule.yml index 32ed61b78..203902fa9 100644 --- a/Published/CORE-000268/rule.yml +++ b/Published/CORE-000268/rule.yml @@ -1,152 +1,159 @@ # Variable: --PTCD -# Condition: +# Condition: # Rule: --DECOD and --PTCD have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized or dictionary-derived text for the description of an event or - intervention. Equivalent to the Preferred Term (PT in MedDRA). - Document: Model v2.0 - Item: --DECOD - Section: Events - - Cited Guidance: The preferred term code assigned to the event from MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic - variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to - the Preferred Term (PT in MedDRA). - Document: Model v1.7 - Item: --DECOD - Section: 2.2.2 - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic - variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to - the Preferred Term (PT in MedDRA). - Document: Model v1.4 - Item: --DECOD - Section: 2.2.2 - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Item: --PTCD - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0049 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: --DECOD[Standardized or dictionary-derived text for the description of an - event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The - preferred term code assigned to the event from MedDRA.] - Document: SDTM v2.1 - Item: --DECOD|--PTCD - Section: 3.1.2 The Events Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0327 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0909 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standardized or dictionary-derived text for the description of an event or + intervention. Equivalent to the Preferred Term (PT in MedDRA). + Document: Model v2.0 + Item: --DECOD + Section: Events + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Dictionary or sponsor-defined derived text description of the topic + variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.7 + Item: --DECOD + Section: 2.2.2 + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Dictionary or sponsor-defined derived text description of the topic + variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.4 + Item: --DECOD + Section: 2.2.2 + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Item: --PTCD + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0049 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + --DECOD[Standardized or dictionary-derived text for the description of an + event or intervention. Equivalent to the Preferred Term (PT in MedDRA).]|--PTCD[The + preferred term code assigned to the event from MedDRA.] + Document: SDTM v2.1 + Item: --DECOD|--PTCD + Section: 3.1.2 The Events Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0327 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0909 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: --DECOD - operator: exists - - name: --PTCD - operator: exists - - name: --PTCD - operator: is_not_unique_relationship - value: --DECOD + - name: --DECOD + operator: exists + - name: --PTCD + operator: exists + - name: --PTCD + operator: is_not_unique_relationship + value: --DECOD Core: Id: CORE-000268 Status: Published - Version: '1' + Version: "1" Description: --DECOD and --PTCD should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: --DECOD and --PTCD do not have a one-to-one relationship. Output Variables: - - --PTCD - - --DECOD + - --PTCD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000269/rule.yml b/Published/CORE-000269/rule.yml index 55380c4ad..574d147d5 100644 --- a/Published/CORE-000269/rule.yml +++ b/Published/CORE-000269/rule.yml @@ -2,114 +2,120 @@ # Condition: VISIT ^= null and is planned # Rule: VISIT in TV.VISIT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). - Document: IG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset, - Document: IG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset, - Document: IG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0031 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned visits. There will be a - one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level - dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM - that appear in the TV dataset should also include the corresponding values of VISIT from - the TV dataset. - Document: TIG 1.0 - Item: 2.8.10.31 Assumption 6 - Section: 2.8.7.5 - - Cited Guidance: Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Specification VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0312 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: IG v3.4 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.3 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset, + Document: IG v3.2 + Item: "" + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0031 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. + Document: TIG 1.0 + Item: 2.8.10.31 Assumption 6 + Section: 2.8.7.5 + - Cited Guidance: Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Specification VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0312 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: VISIT - operator: non_empty - - name: SVPRESP - operator: equal_to - value: Y - - name: VISIT - operator: is_not_contained_by - value: $tv_visit + - name: VISIT + operator: non_empty + - name: SVPRESP + operator: equal_to + value: Y + - name: VISIT + operator: is_not_contained_by + value: $tv_visit Core: Id: CORE-000269 Status: Published - Version: '1' -Description: Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'), + Version: "1" +Description: + Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISIT. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - - VISIT - Name: SV + - Keys: + - USUBJID + - VISIT + Name: SV Operations: -- domain: TV - id: $tv_visit - name: VISIT - operator: distinct + - domain: TV + id: $tv_visit + name: VISIT + operator: distinct Outcome: - Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present + Message: + For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present in TV.VISIT. Output Variables: - - VISIT - - VISITNUM + - VISIT + - VISITNUM Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000270/rule.yml b/Published/CORE-000270/rule.yml index f212bc408..bf9a1b055 100644 --- a/Published/CORE-000270/rule.yml +++ b/Published/CORE-000270/rule.yml @@ -2,108 +2,114 @@ # Condition: VISITNUM ^= null and is planned # Rule: VISITNUM in TV.VISITNUM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). - Document: SDTMIG v3.4 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset. - Document: SDTMIG v3.3 - Item: '' - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For planned visits, values of VISIT, VISITNUM, and VISITDY must be those - defined in the Trial Visits dataset. - Document: SDTMIG v3.2 - Item: '' - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0033 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of VISITNUM in the TV dataset are the valid values of VISITNUM - for planned visits. Any values of VISITNUM that appear in subject-level datasets that are - not in the TV dataset are assumed to correspond to unplanned visits. There will be a - one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level - dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM - that appear in the TV dataset should also include the corresponding values of VISIT from - the TV dataset. Specification VISITDY Planned study day of VISIT. - Document: TIG 1.0 - Item: Assumption 6 |Specifications VISITDY - Section: 2.8.10.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0314 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits (TV) dataset (Section 7.3.1, Trial Visits). + Document: SDTMIG v3.4 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset. + Document: SDTMIG v3.3 + Item: "" + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For planned visits, values of VISIT, VISITNUM, and VISITDY must be those + defined in the Trial Visits dataset. + Document: SDTMIG v3.2 + Item: "" + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0033 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The values of VISITNUM in the TV dataset are the valid values of VISITNUM + for planned visits. Any values of VISITNUM that appear in subject-level datasets that are + not in the TV dataset are assumed to correspond to unplanned visits. There will be a + one-to-one relationship between values of VISIT and VISITNUM in TV. If a subject-level + dataset includes both VISITNUM and VISIT, then records that include values of VISITNUM + that appear in the TV dataset should also include the corresponding values of VISIT from + the TV dataset. Specification VISITDY Planned study day of VISIT. + Document: TIG 1.0 + Item: Assumption 6 |Specifications VISITDY + Section: 2.8.10.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0314 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SVPRESP - operator: equal_to - value: Y - - name: VISITNUM - operator: is_not_contained_by - value: $TV_VISITNUM + - name: SVPRESP + operator: equal_to + value: Y + - name: VISITNUM + operator: is_not_contained_by + value: $TV_VISITNUM Core: Id: CORE-000270 Status: Published - Version: '1' -Description: Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP = + Version: "1" +Description: + Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISITNUM. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - - VISITNUM - Name: SV + - Keys: + - USUBJID + - VISITNUM + Name: SV Operations: -- domain: TV - id: $TV_VISITNUM - name: VISITNUM - operator: distinct + - domain: TV + id: $TV_VISITNUM + name: VISITNUM + operator: distinct Outcome: - Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those + Message: + For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those present in TV.VISITNUM. in TV.VISITNUM Output Variables: - - VISITNUM - - SVPRESP + - VISITNUM + - SVPRESP Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TV + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000271/rule.yml b/Published/CORE-000271/rule.yml index a99a8c698..a97e6ce3b 100644 --- a/Published/CORE-000271/rule.yml +++ b/Published/CORE-000271/rule.yml @@ -1,99 +1,103 @@ # Variable: EPOCH -# Condition: +# Condition: # Rule: EPOCH in TA.EPOCH Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other - general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH - are drawn from the Trial Arms(TA) dataset (Section 7.2.1, Trial Arms). - Document: SDTMIG v3.4 - Item: DS, Assumption 4.c - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other - general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH - are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms). - Document: SDTMIG v3.3 - Item: DS, Assumption 4.c - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '...EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC - or --DTC falls. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2 - Experimental - Design Trial Arms (TA)' - Document: SDTMIG v3.2 - Item: DS, Assumption 3.c - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0009 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: EPOCH may be included as a timing variable as in other general - observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn - from the Trial Arms (TA) dataset. - Document: TIG 1.0 - Item: Assumption 4.c - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0294 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + EPOCH may be included as a timing variable as in other + general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH + are drawn from the Trial Arms(TA) dataset (Section 7.2.1, Trial Arms). + Document: SDTMIG v3.4 + Item: DS, Assumption 4.c + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + EPOCH may be included as a timing variable as in other + general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH + are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms). + Document: SDTMIG v3.3 + Item: DS, Assumption 4.c + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "...EPOCH, as a Timing variable, is the name of the Epoch during which --STDTC + or --DTC falls. The values of EPOCH are drawn from the Trial Arms domain, Section 7.2 - Experimental + Design Trial Arms (TA)" + Document: SDTMIG v3.2 + Item: DS, Assumption 3.c + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0009 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + EPOCH may be included as a timing variable as in other general + observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn + from the Trial Arms (TA) dataset. + Document: TIG 1.0 + Item: Assumption 4.c + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0294 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: EPOCH - operator: is_not_contained_by - value: $ta_epoch - - name: EPOCH - operator: non_empty + - name: EPOCH + operator: is_not_contained_by + value: $ta_epoch + - name: EPOCH + operator: non_empty Core: Id: CORE-000271 Status: Published - Version: '1' + Version: "1" Description: Raise an error when EPOCH is not in TA.EPOCH Executability: Fully Executable Operations: -- domain: TA - id: $ta_epoch - name: EPOCH - operator: distinct + - domain: TA + id: $ta_epoch + name: EPOCH + operator: distinct Outcome: Message: EPOCH is not in TA.EPOCH Output Variables: - - EPOCH + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000272/rule.yml b/Published/CORE-000272/rule.yml index b867e060f..6445a3ce0 100644 --- a/Published/CORE-000272/rule.yml +++ b/Published/CORE-000272/rule.yml @@ -1,166 +1,176 @@ # Variable: --CAT -# Condition: +# Condition: # Rule: --CAT ^= Domain Name Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.4 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.3 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain name or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v3.2 - Section: 4.1.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0336 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND46 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT will not be the domain name or dictionary - classification represented in --DECOD and --BODSYS. - Document: TIG 1.0 - Item: General Conventions table NUM 7 - Section: '2.8.7.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0501 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.4 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.3 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain name or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v3.2 + Section: 4.1.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0336 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND46 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT will not be the domain name or dictionary + classification represented in --DECOD and --BODSYS. + Document: TIG 1.0 + Item: General Conventions table NUM 7 + Section: "2.8.7.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0501 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --CAT - operator: equal_to_case_insensitive - value: $domain_label + - name: --CAT + operator: equal_to_case_insensitive + value: $domain_label Core: Id: CORE-000272 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --CAT = DOMAIN. Executability: Fully Executable Operations: -- id: $domain_label - operator: domain_label + - id: $domain_label + operator: domain_label Outcome: Message: --CAT is equal to DOMAIN. Output Variables: - - --CAT + - --CAT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000273/rule.yml b/Published/CORE-000273/rule.yml index b6a618255..bc59ee2ec 100644 --- a/Published/CORE-000273/rule.yml +++ b/Published/CORE-000273/rule.yml @@ -1,134 +1,142 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND19 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: TIG v1.0 - Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) - Section: 2.8.9.14 (and all other domains with --TESTCD) - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0118 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND19 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) + Section: 2.8.9.14 (and all other domains with --TESTCD) + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0118 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - name: --TESTCD - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: --TESTCD + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000273 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TESTCD contains anything else than a letter, number or underscore Executability: Fully Executable Outcome: Message: --TESTCD value cannot contain characters other than letters, numbers or underscores Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000274/rule.yml b/Published/CORE-000274/rule.yml index a82f62f2c..965d1ae11 100644 --- a/Published/CORE-000274/rule.yml +++ b/Published/CORE-000274/rule.yml @@ -1,134 +1,142 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND17 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: TIG v1.0 - Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) - Section: 2.8.9.14 (and all other domains with --TESTCD) - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0099 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND17 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: LBTESTCD CDISC Notes (and in all CDISC Notes for --TESTCD in all TIG Domains) + Section: 2.8.9.14 (and all other domains with --TESTCD) + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0099 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - name: --TESTCD - operator: longer_than - value: 8 + - name: --TESTCD + operator: longer_than + value: 8 Core: Id: CORE-000274 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TESTCD > 8 chars Executability: Fully Executable Outcome: Message: --TESTCD > 8 chars Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000289/rule.yml b/Published/CORE-000289/rule.yml index 78197baf9..e5063b039 100644 --- a/Published/CORE-000289/rule.yml +++ b/Published/CORE-000289/rule.yml @@ -2,86 +2,92 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBORNRHI = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement in original units. - Should be populated only for continuous results. - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0181 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement in original units. - Should be populated only for continuous results. - Document: TIG 1.0 - Item: Specification-LBORNRHI - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0410 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0181 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBORNRHI + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0410 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - # value: ^-?(0|[1-9]\d*)(\.\d+)?$ - # Change by Jozef Aerts to allow values starting with a dot, e.g. ".25" - # Also see Github ticket https://github.com/cdisc-org/cdisc-rules-engine/issues/520 - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBORNRHI - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: + not_matches_regex + # value: ^-?(0|[1-9]\d*)(\.\d+)?$ + # Change by Jozef Aerts to allow values starting with a dot, e.g. ".25" + # Also see Github ticket https://github.com/cdisc-org/cdisc-rules-engine/issues/520 + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBORNRHI + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000289 Status: Published - Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty. + Version: "1" +Description: + Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: @@ -90,9 +96,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000290/rule.yml b/Published/CORE-000290/rule.yml index de04b0fee..d74cbf849 100644 --- a/Published/CORE-000290/rule.yml +++ b/Published/CORE-000290/rule.yml @@ -2,83 +2,88 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBORNRLO = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0180 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurement in original units. - Should be populated only for continuous results. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0409 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0180 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurement in original units. + Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0409 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBORNRLO - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBORNRLO + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000290 Status: Published - Version: '1' -Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The + Version: "1" +Description: + Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: @@ -87,9 +92,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000291/rule.yml b/Published/CORE-000291/rule.yml index 2e34656eb..6ba2500d9 100644 --- a/Published/CORE-000291/rule.yml +++ b/Published/CORE-000291/rule.yml @@ -2,102 +2,106 @@ # Condition: EC domain is present # Rule: EXVAMT not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '"When the EC domain is implemented in conjunction with the EX domain, EXVAMT - and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE - and ECDOSU."' - Document: IG v3.4 - Item: Assumption 6c - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the EC domain is implemented in conjunction with the EX domain, EXVAMT - and EXVAMTU should not be used in EX; collected values instead would be represented in - ECDOSE and ECDOSU. - Document: IG v3.3 - Item: Assumption 6c - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the EC domain (See Section 6.1.2.3) is implemented in conjunction with - the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would - be represented in ECDOSE and ECDOSU - Document: IG v3.2 - Item: Assumption 6c - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0105 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: When the EC domain is implemented in conjunction with the EX domain, EXVAMT - and EXVAMTU should not be used in EX; collected values instead would be represented in - ECDOSE and ECDOSU. - Document: TIG 1.0 - Item: Assumption 6c - Section: 2.8.10.10 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0370 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in ECDOSE + and ECDOSU."' + Document: IG v3.4 + Item: Assumption 6c + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in + ECDOSE and ECDOSU. + Document: IG v3.3 + Item: Assumption 6c + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the EC domain (See Section 6.1.2.3) is implemented in conjunction with + the EX domain, EXVAMT and EXVAMTU should not be used in EX; collected values instead would + be represented in ECDOSE and ECDOSU + Document: IG v3.2 + Item: Assumption 6c + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0105 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When the EC domain is implemented in conjunction with the EX domain, EXVAMT + and EXVAMTU should not be used in EX; collected values instead would be represented in + ECDOSE and ECDOSU. + Document: TIG 1.0 + Item: Assumption 6c + Section: 2.8.10.10 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0370 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $EXVAMT_EXISTS - operator: equal_to - value: true - - name: EC - operator: exists + - name: $EXVAMT_EXISTS + operator: equal_to + value: true + - name: EC + operator: exists Core: Id: CORE-000291 Status: Published - Version: '1' + Version: "1" Description: When EC exists, EXVAMT should not be used. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: EX + - Keys: + - USUBJID + Name: EX Operations: -- id: $EXVAMT_EXISTS - name: EXVAMT - operator: variable_exists + - id: $EXVAMT_EXISTS + name: EXVAMT + operator: variable_exists Outcome: Message: EXVAMT is present when EC exists. Output Variables: - - $EXVAMT_EXISTS + - $EXVAMT_EXISTS Rule Type: Domain Presence Check Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000293/rule.yml b/Published/CORE-000293/rule.yml index 6bc3b424d..dfb618f1d 100644 --- a/Published/CORE-000293/rule.yml +++ b/Published/CORE-000293/rule.yml @@ -1,85 +1,89 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Suppqual dataset names <= 8 characters Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"When data have been split into multiple datasets (see Section 4.1.7, Splitting - Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated - Persons (see Associated Persons Implementation Guide) have been collected, Supplemental Qualifiers - for Findings About events or interventions for an associated person may need to be represented. - A dataset name with the SUPP fragment, e.g., SUPPAPFAMH, would be too long. In this case only, - the 'SUPP' portion should be shortened to 'SQ', resulting in a dataset name such as SQAPFAMH.\"" - Document: IG v3.4 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting - Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated - Persons (see Associated Persons Implementation Guide) have been collected, an associated person - with Supplemental Qualifiers for Findings About their medical history, the resulting dataset - name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be - shortened to "SQ". resulting in a dataset name of SQAPFAMH.' - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting - Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated - Persons (see Associated Persons Implementation Guide) have been collected, an associated person - with Supplemental Qualifiers for Findings About their medical history, the resulting dataset - name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be - shortened to "SQ". resulting in a dataset name of SQAPFAMH.' - Document: IG v3.3 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0205 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets will be named using convention SUPP - concatenated with the two-character domain code or four-character code when a dataset is - split (e.g., SUPPDM, SUPPFA, SUPPFACM). - Document: TIG 1.0 - Item: Tabulation table NUM 2 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0425 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '"When data have been split into multiple datasets (see Section 4.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, Supplemental Qualifiers + for Findings About events or interventions for an associated person may need to be represented. + A dataset name with the SUPP fragment, e.g., SUPPAPFAMH, would be too long. In this case only, + the ''SUPP'' portion should be shortened to ''SQ'', resulting in a dataset name such as SQAPFAMH."' + Document: IG v3.4 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, an associated person + with Supplemental Qualifiers for Findings About their medical history, the resulting dataset + name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be + shortened to "SQ". resulting in a dataset name of SQAPFAMH.' + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'When data have been split into multiple datasets (see Section 4: 4.1.1.7, Splitting + Domains), longer names such as SUPPFAMH may be needed. In cases where data about Associated + Persons (see Associated Persons Implementation Guide) have been collected, an associated person + with Supplemental Qualifiers for Findings About their medical history, the resulting dataset + name SUPPAPFAMH) would be too long so that, in this case only, the "SUPP" portion should be + shortened to "SQ". resulting in a dataset name of SQAPFAMH.' + Document: IG v3.3 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0205 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets will be named using convention SUPP + concatenated with the two-character domain code or four-character code when a dataset is + split (e.g., SUPPDM, SUPPFA, SUPPFACM). + Document: TIG 1.0 + Item: Tabulation table NUM 2 + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0425 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: dataset_name - operator: longer_than - value: 8 + - name: dataset_name + operator: longer_than + value: 8 Core: Id: CORE-000293 Status: Published - Version: '1' + Version: "1" Description: Trigger error if length of dataset name is greater than 8 Executability: Fully Executable Outcome: @@ -88,9 +92,9 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000294/rule.yml b/Published/CORE-000294/rule.yml index d91430b58..174a5adbb 100644 --- a/Published/CORE-000294/rule.yml +++ b/Published/CORE-000294/rule.yml @@ -2,82 +2,87 @@ # Condition: TSPARMCD = 'AGEMAX' and TSVAL ^= null # Rule: TSVAL conforms to ISO 8601 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the trial summary parameter is AGEMAX, then TSVAL should have a value - expressed as an ISO8601 time duration (e.g., P43Y for 43 years old or P6M for 6 months - old). - Document: IG v3.4 - Section: 7.4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included Appendix C1, Trial - Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. - Conditions for including parameters are included in Appendix C1, Trial Summary Codes. - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0270 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or - times, intervals of time, and durations of time in ISO 8601 format as defined by the - International Organization for Standardization (ISO) (http://www.iso.org). - Document: TIG 1.0 - Item: '' - Section: '2.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0471 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the trial summary parameter is AGEMAX, then TSVAL should have a value + expressed as an ISO8601 time duration (e.g., P43Y for 43 years old or P6M for 6 months + old). + Document: IG v3.4 + Section: 7.4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial + Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. + Conditions for including parameters are included in Appendix C1, Trial Summary Codes. + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0270 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). + Document: TIG 1.0 + Item: "" + Section: "2.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0471 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: AGEMAX - - name: TSVAL - operator: non_empty - - name: TSVAL - negative: false - operator: invalid_duration + - name: TSPARMCD + operator: equal_to + value: AGEMAX + - name: TSVAL + operator: non_empty + - name: TSVAL + negative: false + operator: invalid_duration Core: Id: CORE-000294 Status: Published - Version: '1' -Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to + Version: "1" +Description: + Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to ISO 8601 Executability: Fully Executable Outcome: @@ -86,9 +91,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000295/rule.yml b/Published/CORE-000295/rule.yml index 65f5cebff..03c497abb 100644 --- a/Published/CORE-000295/rule.yml +++ b/Published/CORE-000295/rule.yml @@ -2,61 +2,64 @@ # Condition: --STREFC ^= null # Rule: --STREFN ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in standard - format or in standard units. --STREFN uses the same units as --STRESN, if applicable. - Document: SDTM v2.0 - Item: --STREFN - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0550 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in standard - format or in standard units. --STREFN uses the same units as --STRESN, if applicable - Document: Model v1.7 - Item: --STREFN - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0550 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in standard - format or in standard units. --STREFN uses the same units as --STRESN, if applicable. - Document: SDTM v2.1 - Item: --STREFN - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0638 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: SDTM v2.0 + Item: --STREFN + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0550 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable + Document: Model v1.7 + Item: --STREFN + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0550 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: SDTM v2.1 + Item: --STREFN + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0638 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --STREFC - operator: non_empty - - name: --STREFN - operator: empty + - name: --STREFC + operator: non_empty + - name: --STREFN + operator: empty Core: Id: CORE-000295 Status: Published - Version: '1' + Version: "1" Description: When --STREFC is populated, --STREFN should also be populated. Executability: Fully Executable Outcome: @@ -65,9 +68,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000296/rule.yml b/Published/CORE-000296/rule.yml index 769fe89ad..665052976 100644 --- a/Published/CORE-000296/rule.yml +++ b/Published/CORE-000296/rule.yml @@ -2,88 +2,91 @@ # Condition: DM.ACTARMCD not null # Rule: DS records present for subject Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Disposition dataset provides an accounting for all subjects who entered - the study and may include protocol milestones, such as randomization, as well as the - subject's completion status or reason for discontinuation for the entire study or each - phase or segment of the study, including screening and post-treatment follow-up. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0540 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Disposition dataset provides an accounting for all subjects who entered - the study and may include protocol milestones, such as randomization, as well as the - subject's completion status or reason for discontinuation for the entire study or each - phase or segment of the study, including screening and post-treatment follow-up. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0540 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Disposition (DS) dataset provides an accounting for all subjects who - entered the study and may include protocol milestones, such as randomization, as well as - the subject's completion status or reason for discontinuation for the entire study or each - phase or segment of the study, including screening and follow-up. Applicants may choose - which disposition events and milestones to submit for a study in alignment with regulatory - requirements. - Document: TIG 1.0 - Item: Assumption 1 - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0633 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Disposition dataset provides an accounting for all subjects who entered + the study and may include protocol milestones, such as randomization, as well as the + subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and post-treatment follow-up. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0540 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Disposition dataset provides an accounting for all subjects who entered + the study and may include protocol milestones, such as randomization, as well as the + subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and post-treatment follow-up. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0540 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The Disposition (DS) dataset provides an accounting for all subjects who + entered the study and may include protocol milestones, such as randomization, as well as + the subject's completion status or reason for discontinuation for the entire study or each + phase or segment of the study, including screening and follow-up. Applicants may choose + which disposition events and milestones to submit for a study in alignment with regulatory + requirements. + Document: TIG 1.0 + Item: Assumption 1 + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0633 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ACTARMCD - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $ds_usubjid + - name: ACTARMCD + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $ds_usubjid Core: Id: CORE-000296 Status: Published - Version: '1' + Version: "1" Description: When ACTARMCD is populated, disposition data for subject must be present Executability: Fully Executable Operations: -- domain: DS - id: $ds_usubjid - name: USUBJID - operator: distinct + - domain: DS + id: $ds_usubjid + name: USUBJID + operator: distinct Outcome: Message: There are no DS records for subject who was assigned treatment Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000298/rule.yml b/Published/CORE-000298/rule.yml index fd947757f..4d3bfd583 100644 --- a/Published/CORE-000298/rule.yml +++ b/Published/CORE-000298/rule.yml @@ -2,83 +2,88 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBSTNRLO = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN - in standardized units. Should be populated only for continuous results. ' - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0182 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. - Document: TIG 1.0 - Item: Specification-LBSTNRLO - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0411 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN + in standardized units. Should be populated only for continuous results. " + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0182 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBSTNRLO + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0411 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRLO - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRLO + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000298 Status: Published - Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty. + Version: "1" +Description: + Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: @@ -87,9 +92,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000299/rule.yml b/Published/CORE-000299/rule.yml index 1fdc1f9ae..5530a6b55 100644 --- a/Published/CORE-000299/rule.yml +++ b/Published/CORE-000299/rule.yml @@ -2,82 +2,87 @@ # Condition: LBORRES ^= continuous measurement # Rule: LBSTNRHI = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Upper end of reference range for continuous measurements in standardized units. - Should be populated only for continuous results. ' - Document: SDTMIG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Should be populated only for continuous results. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0183 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in standardized - units. Should be populated only for continuous results. - Document: TIG 1.0 - Item: Specification-LBSTNRHI - Section: 2.8.10.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0412 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Upper end of reference range for continuous measurements in standardized units. + Should be populated only for continuous results. " + Document: SDTMIG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in original units. + Should be populated only for continuous results. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0183 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in standardized + units. Should be populated only for continuous results. + Document: TIG 1.0 + Item: Specification-LBSTNRHI + Section: 2.8.10.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0412 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: # Changed by Marcelina Hungria on 2025-05-29 # Fixed the regex and the LBORRES non-empty condition per revised Description. # Changed to Fully Executable. See Jira ticket: CORERULES-156 (CG0180) all: - - name: LBORRES - operator: not_matches_regex - value: ^-?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRHI - operator: non_empty - - name: LBORRES - operator: non_empty + - name: LBORRES + operator: not_matches_regex + value: ^-?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRHI + operator: non_empty + - name: LBORRES + operator: non_empty Core: Id: CORE-000299 Status: Published - Version: '1' -Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty. + Version: "1" +Description: + Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: @@ -86,9 +91,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000302/rule.yml b/Published/CORE-000302/rule.yml index e406d3db6..ef7dbb2f2 100644 --- a/Published/CORE-000302/rule.yml +++ b/Published/CORE-000302/rule.yml @@ -1,168 +1,178 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0920 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0920 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: QLABEL - operator: is_not_unique_relationship - value: QNAM + - name: QLABEL + operator: is_not_unique_relationship + value: QNAM Core: Id: CORE-000302 Status: Published - Version: '1' + Version: "1" Description: QNAM and QLABEL should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: QNAM and QLABEL do not have a one-to-one relationship. Output Variables: - - QNAM - - QLABEL + - QNAM + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000303/rule.yml b/Published/CORE-000303/rule.yml index e3fad7ca0..1e2d66d3e 100644 --- a/Published/CORE-000303/rule.yml +++ b/Published/CORE-000303/rule.yml @@ -1,169 +1,179 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0901 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0901 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --TEST - operator: is_not_unique_relationship - value: --TESTCD + - name: --TEST + operator: is_not_unique_relationship + value: --TESTCD Core: Id: CORE-000303 Status: Published - Version: '1' + Version: "1" Description: --TESTCD and --TEST should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: --TESTCD and --TEST do not have a one-to-one relationship. Output Variables: - - --TESTCD - - --TEST + - --TESTCD + - --TEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000305/rule.yml b/Published/CORE-000305/rule.yml index 4b3ffb60b..1c74a7c7e 100644 --- a/Published/CORE-000305/rule.yml +++ b/Published/CORE-000305/rule.yml @@ -1,157 +1,157 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4005 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4005 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DUR - operator: non_empty - - name: --DUR - operator: contains - value: '-' + - name: --DUR + operator: non_empty + - name: --DUR + operator: contains + value: "-" Core: Id: CORE-000305 Status: Published - Version: '1' + Version: "1" Description: Collected Duration (--DUR) value should not be negative. Executability: Fully Executable Outcome: @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000308/rule.yml b/Published/CORE-000308/rule.yml index 7e4aab943..56da1ec85 100644 --- a/Published/CORE-000308/rule.yml +++ b/Published/CORE-000308/rule.yml @@ -1,157 +1,157 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4002 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4002 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DOSE - operator: non_empty - - name: --DOSE - operator: less_than - value: 0 + - name: --DOSE + operator: non_empty + - name: --DOSE + operator: less_than + value: 0 Core: Id: CORE-000308 Status: Published - Version: '1' + Version: "1" Description: Dose (--DOSE) value should not be negative Executability: Fully Executable Outcome: @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000310/rule.yml b/Published/CORE-000310/rule.yml index d96341c18..d20a46f10 100644 --- a/Published/CORE-000310/rule.yml +++ b/Published/CORE-000310/rule.yml @@ -1,155 +1,155 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4001 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4001 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: AGE - operator: less_than - value: 0 + - name: AGE + operator: less_than + value: 0 Core: Id: CORE-000310 Status: Published - Version: '1' + Version: "1" Description: Age (AGE) value should not be negative Executability: Fully Executable Outcome: @@ -158,8 +158,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000318/rule.yml b/Published/CORE-000318/rule.yml index 69fcfa5c5..da7f6c031 100644 --- a/Published/CORE-000318/rule.yml +++ b/Published/CORE-000318/rule.yml @@ -1,171 +1,181 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0902 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0902 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: ARM - operator: is_not_unique_relationship - value: ARMCD + - name: ARM + operator: is_not_unique_relationship + value: ARMCD Core: Id: CORE-000318 Status: Published - Version: '1' + Version: "1" Description: ARMCD and ARM should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: ARMCD and ARM do not have a one-to-one relationship. Output Variables: - - ARMCD - - ARM + - ARMCD + - ARM Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - TA - - TV - - DM + - TA + - TV + - DM Sensitivity: Record diff --git a/Published/CORE-000321/rule.yml b/Published/CORE-000321/rule.yml index 14fb71070..9b46f9754 100644 --- a/Published/CORE-000321/rule.yml +++ b/Published/CORE-000321/rule.yml @@ -1,158 +1,170 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3201 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3201 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DY - operator: not_exists - - name: --DTC - operator: exists + - name: --DY + operator: not_exists + - name: --DTC + operator: exists Core: Id: CORE-000321 Status: Published - Version: '1' -Description: When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of + Version: "1" +Description: + When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of Visit/Collection/Exam (--DY) should also present in the dataset. Executability: Fully Executable Outcome: - Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of + Message: + Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of Collection (--DTC) is present. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000324/rule.yml b/Published/CORE-000324/rule.yml index a4b59e6f2..5c8f4b0a8 100644 --- a/Published/CORE-000324/rule.yml +++ b/Published/CORE-000324/rule.yml @@ -1,122 +1,126 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection. - If the reference time point is prior to the date of collection or assessment: Start values: - an observation can start BEFORE the reference point, can start COINCIDENT with the reference - point, can start AFTER the reference point, or it may not be known (U) when it started. End - values: an observation can end BEFORE the reference point, can end COINCIDENT with the reference - point, can end AFTER the reference point, can be known that it didn't end but was ONGOING, - or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0234 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection." - Document: TIG 1.0 - Item: Num 2 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0443 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection. + If the reference time point is prior to the date of collection or assessment: Start values: + an observation can start BEFORE the reference point, can start COINCIDENT with the reference + point, can start AFTER the reference point, or it may not be known (U) when it started. End + values: an observation can end BEFORE the reference point, can end COINCIDENT with the reference + point, can end AFTER the reference point, can be known that it didn't end but was ONGOING, + or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0234 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: TIG 1.0 + Item: Num 2 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0443 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --ENRTPT # Condition: --ENTPT corresponds to the date of collection or assessment. # Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --ENTPT - operator: date_equal_to - value: --DTC - - name: --ENRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - ONGOING - - UNKNOWN + - name: --ENTPT + operator: non_empty + - name: --ENTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --ENTPT + operator: date_equal_to + value: --DTC + - name: --ENRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - ONGOING + - UNKNOWN Core: Id: CORE-000324 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Executability: Partially Executable Outcome: Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'UNKNOWN') Output Variables: - - --ENTPT - - --ENRTPT - - --DTC + - --ENTPT + - --ENRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000325/rule.yml b/Published/CORE-000325/rule.yml index 3fbd366ef..cda32fa83 100644 --- a/Published/CORE-000325/rule.yml +++ b/Published/CORE-000325/rule.yml @@ -1,117 +1,123 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: SENDIG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: SENDIG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: SENDIG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARMCD is limited to 20 characters, but does not have special character - restrictions. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND27.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: SENDIG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ARMCD is limited to 20 characters, but does not have special character + restrictions. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND27.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - name: ARMCD - operator: longer_than - value: 20 - - all: - - name: TXPARMCD - operator: equal_to - value: ARMCD - - name: TXVAL + - name: ARMCD operator: longer_than value: 20 + - all: + - name: TXPARMCD + operator: equal_to + value: ARMCD + - name: TXVAL + operator: longer_than + value: 20 Core: Id: CORE-000325 Status: Published - Version: '1' + Version: "1" Description: Verify ARMCD value length is <= 20 Executability: Fully Executable Outcome: Message: ARMCD value length is greater than 20 Output Variables: - - ARMCD - - TXPARMCD - - TXVAL + - ARMCD + - TXPARMCD + - TXVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TA - - TX + - DM + - TA + - TX Sensitivity: Record diff --git a/Published/CORE-000328/rule.yml b/Published/CORE-000328/rule.yml index 1300f0978..ffb53a6b8 100644 --- a/Published/CORE-000328/rule.yml +++ b/Published/CORE-000328/rule.yml @@ -1,162 +1,174 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3202 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3202 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STDY - operator: not_exists - - name: --STDTC - operator: exists + - name: --STDY + operator: not_exists + - name: --STDTC + operator: exists Core: Id: CORE-000328 Status: Published - Version: '1' -Description: Study Day of Start (--STDY) variable should be included into dataset, when Start Study + Version: "1" +Description: + Study Day of Start (--STDY) variable should be included into dataset, when Start Study Date/Time (--STDTC) variable is present. Executability: Fully Executable Outcome: - Message: The Study Day of Start of Observation (--STDY) is not present in the dataset when Start + Message: + The Study Day of Start of Observation (--STDY) is not present in the dataset when Start Date/Time of Observation (--STDTC) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000334/rule.yml b/Published/CORE-000334/rule.yml index 74c853dbd..cdd5cb5c8 100644 --- a/Published/CORE-000334/rule.yml +++ b/Published/CORE-000334/rule.yml @@ -2,205 +2,215 @@ # Condition: Variable Core Status = Expected # Rule: Variable present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When the study does not include the data item for an expected variable, however, - a null column must still be included in the dataset, and a comment must be included in the Define-XML - document to state that the study does not include the data item." - Document: SDTM v1.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When no data has been collected for an expected variable, however, a null column - must still be included in the dataset, and a comment must be included in the define.xml to state - that data was not collected." - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "When no data has been collected for an expected variable however, a null column - must still be included in the dataset, and a comment must be included in the define.xml to state - that data was not collected." - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0016 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as columns - Document: TIG v1.0 - Item: Table 2 Num - Section: 2.5. - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0301 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: An Expected variable is any variable necessary to make a record useful in - the context of a specific domain. Columns for Expected variables must be present in each - submitted dataset even if all values are null. Expected variables may contain some null - values, but in most cases will not contain null values for every record. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND13 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Exp for variables which are Expected to be included in the resulting - dataset, even if all values are null. Such variables are considered necessary to make the - data record useful in the context of the domain. - Document: TIG v1.0 - Item: Table Row 7 - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0065 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When the study does not include the data item for an expected variable, however, + a null column must still be included in the dataset, and a comment must be included in the Define-XML + document to state that the study does not include the data item." + Document: SDTM v1.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When no data has been collected for an expected variable, however, a null column + must still be included in the dataset, and a comment must be included in the define.xml to state + that data was not collected." + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When no data has been collected for an expected variable however, a null column + must still be included in the dataset, and a comment must be included in the define.xml to state + that data was not collected." + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0016 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: All Required and Expected tabulation variables are included as columns + Document: TIG v1.0 + Item: Table 2 Num + Section: 2.5. + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0301 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + An Expected variable is any variable necessary to make a record useful in + the context of a specific domain. Columns for Expected variables must be present in each + submitted dataset even if all values are null. Expected variables may contain some null + values, but in most cases will not contain null values for every record. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND13 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Exp for variables which are Expected to be included in the resulting + dataset, even if all values are null. Such variables are considered necessary to make the + data record useful in the context of the domain. + Document: TIG v1.0 + Item: Table Row 7 + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0065 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: not_contains_all - value: - - $expected_variables + - name: variable_name + operator: not_contains_all + value: + - $expected_variables Core: Id: CORE-000334 Status: Published - Version: '1' + Version: "1" Description: Raise an error when an expected variable is not present in the dataset. Executability: Fully Executable Operations: -- id: $expected_variables - operator: expected_variables -- id: $dataset_variables - operator: get_column_order_from_dataset + - id: $expected_variables + operator: expected_variables + - id: $dataset_variables + operator: get_column_order_from_dataset Outcome: Message: At least one expected variable is missing from dataset Output Variables: - - $dataset_variables - - $expected_variables + - $dataset_variables + - $expected_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000337/rule.yml b/Published/CORE-000337/rule.yml index 4895da31c..2ab50e73a 100644 --- a/Published/CORE-000337/rule.yml +++ b/Published/CORE-000337/rule.yml @@ -2,103 +2,108 @@ # Condition: Multiple records in SUPPDM where RACE captured # Rule: RACE = 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' - and the additional information will be included in the Supplemental Qualifiers dataset. - Document: IG v3.2 - Item: Assumption 6 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' - and the additional information will be included in the Supplemental Qualifiers dataset. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' - and the additional information will be included in the Supplemental Qualifiers dataset. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0140 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: If multiple races are collected then the value of RACE should be 'MULTIPLE' - and the additional information will be included in the Supplemental Qualifiers dataset. - Document: TIG 1.0 - Item: Assumption 6 - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0386 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.2 + Item: Assumption 6 + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.3 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.4 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0140 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If multiple races are collected then the value of RACE should be 'MULTIPLE' + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: TIG 1.0 + Item: Assumption 6 + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0386 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RACE - operator: not_equal_to - value: MULTIPLE - - name: QNAM - operator: starts_with - value: RACE - value_is_literal: true - - name: QNAM - operator: suffix_matches_regex - suffix: 1 - value: ^[A-Z0-9] - - name: QNAM - operator: not_suffix_matches_regex - suffix: 3 - value: (OTH) + - name: RACE + operator: not_equal_to + value: MULTIPLE + - name: QNAM + operator: starts_with + value: RACE + value_is_literal: true + - name: QNAM + operator: suffix_matches_regex + suffix: 1 + value: ^[A-Z0-9] + - name: QNAM + operator: not_suffix_matches_regex + suffix: 3 + value: (OTH) Core: Id: CORE-000337 Status: Published - Version: '1' -Description: 'Raise an error when multiple races are collected in SUPPDM but RACE in DM does not equal + Version: "1" +Description: + 'Raise an error when multiple races are collected in SUPPDM but RACE in DM does not equal "MULTIPLE".' Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: 'Multiple races are collected in SUPPDM but RACE in DM does not equal "MULTIPLE".' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPPDM + - SUPPDM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000341/rule.yml b/Published/CORE-000341/rule.yml index fdd6e0e75..6ea8d10e5 100644 --- a/Published/CORE-000341/rule.yml +++ b/Published/CORE-000341/rule.yml @@ -1,123 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND87 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When --ORRES is populated, --STRESC must also be populated, regardless of - whether the data values are character or numeric. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0279 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND87 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When --ORRES is populated, --STRESC must also be populated, regardless of + whether the data values are character or numeric. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0279 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: non_empty - - name: --STRESC - operator: empty + - name: --ORRES + operator: non_empty + - name: --STRESC + operator: empty Core: Id: CORE-000341 Status: Published - Version: '1' + Version: "1" Description: When --ORRES is populated, --STRESC must also be populated. Executability: Fully Executable Outcome: Message: --STRESC must be populated as --ORRES is populated. Output Variables: - - --ORRES - - --STRESC + - --ORRES + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000342/rule.yml b/Published/CORE-000342/rule.yml index 4bf15d1e9..deb605c82 100644 --- a/Published/CORE-000342/rule.yml +++ b/Published/CORE-000342/rule.yml @@ -1,213 +1,227 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD which is unique within the - trial. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND233 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each Trial Set must be identified by a SETCD that is unique within the - trial. - Document: TIG v1.0 - Item: Assumption 2 - Section: 2.8.9.28 Assumption 2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0161 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - # FDA BUsiness Rule metadata added as both have the same logic -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Trial set parameter code should be unique for each study set for nonclinical - data. - Document: FDA - Section: FDAB050 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5001 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD which is unique within the + trial. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND233 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Each Trial Set must be identified by a SETCD that is unique within the + trial. + Document: TIG v1.0 + Item: Assumption 2 + Section: 2.8.9.28 Assumption 2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0161 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + # FDA BUsiness Rule metadata added as both have the same logic + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Trial set parameter code should be unique for each study set for nonclinical + data. + Document: FDA + Section: FDAB050 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5001 + Version: "1" + Version: "1.5" + Version: "1.0" Check: # SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET all: - - name: SETCD - operator: is_not_unique_set - value: - - TXPARMCD - - TXPARM - - TXVAL - - SET + - name: SETCD + operator: is_not_unique_set + value: + - TXPARMCD + - TXPARM + - TXVAL + - SET Core: Id: CORE-000342 Status: Published - Version: '1' + Version: "1" Description: SETCD must be unique for the combination of value in TXPARMCD, TXPARM, TXVAL, and SET Executability: Fully Executable Outcome: @@ -216,9 +230,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000351/rule.yml b/Published/CORE-000351/rule.yml index 460066613..b0c20c981 100644 --- a/Published/CORE-000351/rule.yml +++ b/Published/CORE-000351/rule.yml @@ -1,179 +1,182 @@ # Variable: USUBJID -# Condition: +# Condition: # Rule: USUBJID unique within a submission Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all - applications or submissions involving the product. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0151 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifier used to uniquely identify a subject across all studies for all - applications or submissions involving the product. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0392 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.0 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: No more than one animal may have the same USUBJID within a submission. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND37 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a subject across all - studies for all applications or submissions involving the product. - Document: TIG v1.0 - Item: Text - Section: SDTM v2.1, Identifiers for All Classes, USUBJID - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0255 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to uniquely identify a subject across all studies + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0151 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifier used to uniquely identify a subject across all studies for all + applications or submissions involving the product. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0392 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.0 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: No more than one animal may have the same USUBJID within a submission. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND37 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A sequence of characters used to uniquely identify a subject across all + studies for all applications or submissions involving the product. + Document: TIG v1.0 + Item: Text + Section: SDTM v2.1, Identifiers for All Classes, USUBJID + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0255 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: USUBJID - operator: is_not_unique_set - value: DOMAIN + - name: USUBJID + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000351 Status: Published - Version: '1' + Version: "1" Description: USUBJID must be unique across all studies Executability: Partially Executable Outcome: Message: USUBJID is not unique within study Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000352/rule.yml b/Published/CORE-000352/rule.yml index a4027fb71..b85377dfc 100644 --- a/Published/CORE-000352/rule.yml +++ b/Published/CORE-000352/rule.yml @@ -2,95 +2,100 @@ # Condition: Next ELEMENT present in dataset # Rule: SEENDTC = SESTDTC of next ELEMENT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of - SEENDTC for one Element will always be the same as the value of SESTDTC for the next - Element. - Document: IG v3.4 - Item: Assumption 8 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of - SEENDTC for one Element will always be the same as the value of SESTDTC for the next - Element - Document: IG v3.2 - Item: Assumption 10 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of - SEENDTC for one Element will always be the same as the value of SESTDTC for the next - Element - Document: IG v3.3 - Item: Assumption 8 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0207 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC value for one - element will always be the same as the SESTDTC value for the next Element. - Document: IG v3.0 - Item: Assumption 1 - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND126 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of - SEENDTC for one Element will always be the same as the value of SESTDTC for the next - Element. Because there are, by definition, no gaps between elements, the value of SEENDTC - for one element will always be the same as the value of SESTDTC for the next element. - Document: TIG 1.0 - Item: Assumption 7 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0427 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. + Document: IG v3.4 + Item: Assumption 8 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element + Document: IG v3.2 + Item: Assumption 10 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element + Document: IG v3.3 + Item: Assumption 8 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0207 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Because there are no time gaps between Elements, the SEENDTC value for one + element will always be the same as the SESTDTC value for the next Element. + Document: IG v3.0 + Item: Assumption 1 + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND126 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. Because there are, by definition, no gaps between elements, the value of SEENDTC + for one element will always be the same as the value of SESTDTC for the next element. + Document: TIG 1.0 + Item: Assumption 7 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0427 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SEENDTC - operator: does_not_have_next_corresponding_record - ordering: SESEQ - value: SESTDTC - within: USUBJID + - name: SEENDTC + operator: does_not_have_next_corresponding_record + ordering: SESEQ + value: SESTDTC + within: USUBJID Core: Id: CORE-000352 Status: Published - Version: '1' + Version: "1" Description: Trigger error where SEENDTC is not equal to SESTDTC of the next element. Executability: Fully Executable Outcome: @@ -99,9 +104,9 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000353/rule.yml b/Published/CORE-000353/rule.yml index c24e8af5c..139779895 100644 --- a/Published/CORE-000353/rule.yml +++ b/Published/CORE-000353/rule.yml @@ -1,188 +1,194 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.0 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 - format. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND248.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.0 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Dates or durations represented in TSVAL must be in the appropriate ISO 8601 + format. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND248.1 + Version: "1" + Version: "5.0" + Version: "1.0" # Applies for: # date/datetime: TSVAL = EXPENDTC, EXPSTDTC, STSTENDTC, DOSENDTC, DOSSTDTC, or STENDTC # duration: TRMSAC, INTSAC, SLENGTH, RECSAC Check: any: # Date/datetime parameter values - - all: - - name: TSPARMCD - operator: equal_to - value: EXPENDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: EXPSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: STSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: DOSENDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: DOSSTDTC - - name: TSVAL - operator: invalid_date - - all: - - name: TSPARMCD - operator: equal_to - value: STENDTC - - name: TSVAL - operator: invalid_date - # Duration parameter values - P.S. negative durations are allowed - - all: - - name: TSPARMCD - operator: equal_to - value: DOSDUR - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: TRMSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: INTSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: SLENGTH - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: TSPARMCD - operator: equal_to - value: RECSAC - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: TSVAL - operator: not_matches_regex - value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: EXPENDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: EXPSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: STSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: DOSENDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: DOSSTDTC + - name: TSVAL + operator: invalid_date + - all: + - name: TSPARMCD + operator: equal_to + value: STENDTC + - name: TSVAL + operator: invalid_date + # Duration parameter values - P.S. negative durations are allowed + - all: + - name: TSPARMCD + operator: equal_to + value: DOSDUR + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: TRMSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: INTSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: SLENGTH + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: TSPARMCD + operator: equal_to + value: RECSAC + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: TSVAL + operator: not_matches_regex + value: ^-?P([0-9]+W)$ Core: Id: CORE-000353 Status: Published - Version: '1' + Version: "1" Description: Dates or durations represented in TSVAL must be in the appropriate ISO 8601 format. Executability: Fully Executable Outcome: @@ -191,8 +197,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000354/rule.yml b/Published/CORE-000354/rule.yml index aa8201077..e7574413c 100644 --- a/Published/CORE-000354/rule.yml +++ b/Published/CORE-000354/rule.yml @@ -2,104 +2,110 @@ # Condition: The date portion of --DTC ^= complete date or the date portion of DM.RFSTDTC ^= complete date # Rule: --DY = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain) - Document: SDTMIG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). - Document: SDTMIG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). - Document: SDTMIG v3.2 - Section: 4.1.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0007 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Variables --DY, --STDY, and --ENDY represent the timing of observations in - days relative to the reference start date in RFSTDTC where the value of --DY is the - relative day of the date populated in --DTC for the observation,--STDTC is the relative - day of the date populated in --STDTC for the observation; an--ENDY is the relative day of - the of the date populated in --ENDTC for the observation. - Document: TIG 1.0 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0292 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain) + Document: SDTMIG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: SDTMIG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) . . . are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). + Document: SDTMIG v3.2 + Section: 4.1.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0007 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Variables --DY, --STDY, and --ENDY represent the timing of observations in + days relative to the reference start date in RFSTDTC where the value of --DY is the + relative day of the date populated in --DTC for the observation,--STDTC is the relative + day of the date populated in --STDTC for the observation; an--ENDY is the relative day of + the of the date populated in --ENDTC for the observation. + Document: TIG 1.0 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0292 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DY - operator: non_empty - - any: - - name: --DTC - operator: is_incomplete_date - - name: RFSTDTC - operator: is_incomplete_date + - name: --DY + operator: non_empty + - any: + - name: --DTC + operator: is_incomplete_date + - name: RFSTDTC + operator: is_incomplete_date Core: Id: CORE-000354 Status: Published - Version: '1' -Description: Raise an error when the date portion of --DTC is an incomplete date or the date portion + Version: "1" +Description: + Raise an error when the date portion of --DTC is an incomplete date or the date portion of DM.RFSTDTC is an incomplete date, but --DY is not empty Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not + Message: + The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not complete date, but --DY is not empty Output Variables: - - --DY - - --DTC - - RFSTDTC + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000355/rule.yml b/Published/CORE-000355/rule.yml index e29ce0a58..95706e528 100644 --- a/Published/CORE-000355/rule.yml +++ b/Published/CORE-000355/rule.yml @@ -2,185 +2,196 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as columns in - the dataset. Required tabulation variables are populated for all records in the dataset. - Document: TIG 1.0 - Item: Table 2 Num 6 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0299 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Req for variables which are Required and must be included in the resulting - dataset and cannot be null for any record. Such variables are basic to the identification - of a data record or are necessary to make the record meaningful. - Document: TIG 1.0 - Item: Text - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0057 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + All Required and Expected tabulation variables are included as columns in + the dataset. Required tabulation variables are populated for all records in the dataset. + Document: TIG 1.0 + Item: Table 2 Num 6 + Section: "2.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0299 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Req for variables which are Required and must be included in the resulting + dataset and cannot be null for any record. Such variables are basic to the identification + of a data record or are necessary to make the record meaningful. + Document: TIG 1.0 + Item: Text + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0057 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: not_contains_all - value: - - $required_variables + - name: variable_name + operator: not_contains_all + value: + - $required_variables Core: Id: CORE-000355 Status: Published - Version: '1' -Description: 'Part A: Raise an error when a Required variable is not present in the dataset.' + Version: "1" +Description: "Part A: Raise an error when a Required variable is not present in the dataset." Executability: Fully Executable Operations: -- id: $required_variables - operator: required_variables -- id: $dataset_variables - operator: get_column_order_from_dataset + - id: $required_variables + operator: required_variables + - id: $dataset_variables + operator: get_column_order_from_dataset Outcome: Message: At least one required variable is missing from dataset Output Variables: - - $dataset_variables - - $required_variables + - $dataset_variables + - $required_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000356/rule.yml b/Published/CORE-000356/rule.yml index b0bc4029a..19423d949 100644 --- a/Published/CORE-000356/rule.yml +++ b/Published/CORE-000356/rule.yml @@ -2,186 +2,197 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0014 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Required variables must always be included in the dataset and cannot be null - for any record. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND12 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Required and Expected tabulation variables are included as columns in - the dataset. Required tabulation variables are populated for all records in the dataset. - Document: TIG 1.0 - Item: Table 2 Num 6 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0299 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Req for variables which are Required and must be included in the resulting - dataset and cannot be null for any record. Such variables are basic to the identification - of a data record or are necessary to make the record meaningful. - Document: TIG 1.0 - Item: Text - Section: 2.8.1 How to Read Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0057 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0014 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Required variables must always be included in the dataset and cannot be null + for any record. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND12 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + All Required and Expected tabulation variables are included as columns in + the dataset. Required tabulation variables are populated for all records in the dataset. + Document: TIG 1.0 + Item: Table 2 Num 6 + Section: "2.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0299 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Req for variables which are Required and must be included in the resulting + dataset and cannot be null for any record. Such variables are basic to the identification + of a data record or are necessary to make the record meaningful. + Document: TIG 1.0 + Item: Text + Section: 2.8.1 How to Read Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0057 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: $required_variables - operator: exists - - name: variable_name - operator: is_contained_by - value: $required_variables - - name: variable_value - operator: empty + - name: $required_variables + operator: exists + - name: variable_name + operator: is_contained_by + value: $required_variables + - name: variable_value + operator: empty Core: Id: CORE-000356 Status: Published - Version: '1' -Description: 'Part B: Raise an error when a Required variable is null.' + Version: "1" +Description: "Part B: Raise an error when a Required variable is null." Executability: Fully Executable Operations: -- id: $required_variables - operator: required_variables + - id: $required_variables + operator: required_variables Outcome: Message: At least one Required variable has a null value Output Variables: - - variable_name - - variable_value + - variable_name + - variable_value Rule Type: Value Check with Dataset Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000357/rule.yml b/Published/CORE-000357/rule.yml index f7dde4e25..464c1e722 100644 --- a/Published/CORE-000357/rule.yml +++ b/Published/CORE-000357/rule.yml @@ -2,92 +2,98 @@ # Condition: Supplemental Qualifier datasets # Rule: Split dataset names length <= 8 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset. - Document: IG v3.4 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset. - Document: IG v3.2 - Item: Rule 7 - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset. - Document: IG v3.3 - Item: Rule 7 - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0018 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature will include the additional one to two characters used to identify the split - dataset (e.g., SUPPLBHM, SUPPFACM). - Document: TIG 1.0 - Item: Num 9.3.ii - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0303 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.4 + Item: "7" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.2 + Item: Rule 7 + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset. + Document: IG v3.3 + Item: Rule 7 + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0018 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature will include the additional one to two characters used to identify the split + dataset (e.g., SUPPLBHM, SUPPFACM). + Document: TIG 1.0 + Item: Num 9.3.ii + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0303 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: dataset_name - operator: longer_than - value: 8 + - name: dataset_name + operator: longer_than + value: 8 Core: Id: CORE-000357 Status: Published - Version: '1' -Description: When a supplemental qualifier dataset is associated with a split dataset, the dataset + Version: "1" +Description: + When a supplemental qualifier dataset is associated with a split dataset, the dataset name length must not be greater than 8 characters. Executability: Fully Executable Outcome: - Message: Supplemental qualifier dataset associated with a split dataset is greater than 8 + Message: + Supplemental qualifier dataset associated with a split dataset is greater than 8 characters in length Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- include_split_datasets: true Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000358/rule.yml b/Published/CORE-000358/rule.yml index cf1770a5e..e73bae9ae 100644 --- a/Published/CORE-000358/rule.yml +++ b/Published/CORE-000358/rule.yml @@ -2,104 +2,109 @@ # Condition: --LNKGRP present in a domain # Rule: --LNKGRP present in another domain Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of records in one - domain that is related to a record in another domain, often forming a many-to-one - relationship. - Document: SDTMIG v3.4 - Item: 2.E.2 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKGRP is a grouping identifier used to identify a group of records in one - domain that is related to a record in another domain, often forming a many-to-one - relationship. - Document: SDTMIG v3.3 - Item: 2.E.2 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to link related, grouped records across domains. - Document: SDTMIG v3.2 - Item: Specification - Section: 6.1. - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0022 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a group of records, for a - subject, in one domain and link it to 1 or more records for that subject in another - domain. - Document: SDTM v2.1 - Item: --LNKGRP, Definition column - Section: SDTM- 3.1.4 Identifiers for All Classes - - Cited Guidance: Groups of records can be related by using grouping variables such as --LNKID - or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of - representing relationships in RELREC when relating a single or group of records in one - dataset to a group of records in another dataset. - Document: SDTM v2.1 - Item: --LNKGRP, Definition column - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0306 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --LNKGRP is a grouping identifier used to identify a group of records in one + domain that is related to a record in another domain, often forming a many-to-one + relationship. + Document: SDTMIG v3.4 + Item: 2.E.2 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --LNKGRP is a grouping identifier used to identify a group of records in one + domain that is related to a record in another domain, often forming a many-to-one + relationship. + Document: SDTMIG v3.3 + Item: 2.E.2 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to link related, grouped records across domains. + Document: SDTMIG v3.2 + Item: Specification + Section: 6.1. + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0022 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A sequence of characters used to uniquely identify a group of records, for a + subject, in one domain and link it to 1 or more records for that subject in another + domain. + Document: SDTM v2.1 + Item: --LNKGRP, Definition column + Section: SDTM- 3.1.4 Identifiers for All Classes + - Cited Guidance: + Groups of records can be related by using grouping variables such as --LNKID + or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of + representing relationships in RELREC when relating a single or group of records in one + dataset to a group of records in another dataset. + Document: SDTM v2.1 + Item: --LNKGRP, Definition column + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0306 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --LNKGRP - operator: exists - - name: $VARIABLE_COUNT - operator: less_than - value: 2 + - name: --LNKGRP + operator: exists + - name: $VARIABLE_COUNT + operator: less_than + value: 2 Core: Id: CORE-000358 Status: Published - Version: '1' -Description: Verify that when --LNKGRP is present in one domain it is also present in another + Version: "1" +Description: + Verify that when --LNKGRP is present in one domain it is also present in another domain. Executability: Fully Executable Operations: -- id: $VARIABLE_COUNT - name: --LNKGRP - operator: variable_count + - id: $VARIABLE_COUNT + name: --LNKGRP + operator: variable_count Outcome: Message: LNKGRP variable is not found in any of the other domains. Output Variables: - - --LNKGRP - - $VARIABLE_COUNT + - --LNKGRP + - $VARIABLE_COUNT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000359/rule.yml b/Published/CORE-000359/rule.yml index d03ea0f7e..bf9df5a1c 100644 --- a/Published/CORE-000359/rule.yml +++ b/Published/CORE-000359/rule.yml @@ -1,82 +1,87 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot - be used for DSSTDTC. - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot - be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot - be used for DSSTDTC. - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot - be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The use of an interval of uncertainty, as described in Section 4.4.2, cannot - be used for DSSTDTC. - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND317' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND317" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND317" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND317" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND317" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The use of an interval of uncertainty, as described in Section 4.4.2, cannot + be used for DSSTDTC. + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND317" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: DSSTDTC - operator: non_empty - - name: DSSTDTC - operator: contains - value: / + - name: DSSTDTC + operator: non_empty + - name: DSSTDTC + operator: contains + value: / Core: Id: CORE-000359 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the value of DSSTDTC contains a slash Executability: Fully Executable Outcome: @@ -85,8 +90,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000361/rule.yml b/Published/CORE-000361/rule.yml index e98b9667b..91185d08f 100644 --- a/Published/CORE-000361/rule.yml +++ b/Published/CORE-000361/rule.yml @@ -2,143 +2,152 @@ # Condition: VISITNUM in TV.VISITNUM # Rule: VISIT and VISITNUM have a one-to-one relationship Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of VISIT and - VISITNUM. - Document: IG v3.4 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of VISIT and - VISITNUM. - Document: IG v3.3 - Section: 4.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There should be a one-to-one relationship between values of VISIT and - VISITNUM. - Document: IG v3.2 - Section: 4.1.4.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0035 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: There will be a one-to-one relationship between values of VISIT and VISITNUM - in TV. - Document: TIG 1.0 - Item: Assumption 6 - Section: 2.8.10.31 - - Cited Guidance: Values of VISIT, VISITNUM, and VISITDY will be represented as defined in the - Trial Visits (TV) dataset. - Document: TIG 1.0 - Item: Planned Timing table NUM 1 - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0316 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0919 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.4 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.3 + Section: 4.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There should be a one-to-one relationship between values of VISIT and + VISITNUM. + Document: IG v3.2 + Section: 4.1.4.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0035 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + There will be a one-to-one relationship between values of VISIT and VISITNUM + in TV. + Document: TIG 1.0 + Item: Assumption 6 + Section: 2.8.10.31 + - Cited Guidance: + Values of VISIT, VISITNUM, and VISITDY will be represented as defined in the + Trial Visits (TV) dataset. + Document: TIG 1.0 + Item: Planned Timing table NUM 1 + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0316 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0919 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: VISITNUM - operator: is_contained_by - value: $tv_visitnum - - name: VISIT - operator: is_not_unique_relationship - value: VISITNUM + - name: VISITNUM + operator: is_contained_by + value: $tv_visitnum + - name: VISIT + operator: is_not_unique_relationship + value: VISITNUM Core: Id: CORE-000361 Status: Published - Version: '1' -Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one + Version: "1" +Description: + When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one relationship. Executability: Fully Executable Operations: -- domain: TV - id: $tv_visitnum - name: VISITNUM - operator: distinct + - domain: TV + id: $tv_visitnum + name: VISITNUM + operator: distinct Outcome: Message: VISIT and VISITNUM do not have a one-to-one relationship. Output Variables: - - VISITNUM - - VISIT + - VISITNUM + - VISIT Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000363/rule.yml b/Published/CORE-000363/rule.yml index 2f4704a8b..22ab5f5e4 100644 --- a/Published/CORE-000363/rule.yml +++ b/Published/CORE-000363/rule.yml @@ -1,116 +1,121 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the - same as the date of informed consent in the Disposition domain, if that protocol milestone - is documented. - Document: IG v3.4 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the - same as the date of informed consent in the Disposition domain, if that protocol milestone - is documented. - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the - same as the date of informed consent in the Disposition domain, if that protocol milestone - is documented. - Document: IG v3.3 - Item: Specification - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0068 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Date/time of informed consent in ISO 8601 character format. This will be the - same as the date of informed consent in the Disposition domain, if that protocol milestone - is documented. - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0338 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.4 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: IG v3.3 + Item: Specification + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0068 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Date/time of informed consent in ISO 8601 character format. This will be the + same as the date of informed consent in the Disposition domain, if that protocol milestone + is documented. + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0338 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: DSSTDTC # Condition: Multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT OBTAINED' # Rule: For each subject, earliest DSSTDTC = DM.RFICDTC Check: all: - - name: DSDECOD - operator: present_on_multiple_rows_within - within: USUBJID - - name: DSDECOD - operator: equal_to - value: INFORMED CONSENT OBTAINED - - name: $min_ds_dsstdtc - operator: not_equal_to - value: RFICDTC - - name: $min_ds_dsstdtc - operator: equal_to - value: DSSTDTC + - name: DSDECOD + operator: present_on_multiple_rows_within + within: USUBJID + - name: DSDECOD + operator: equal_to + value: INFORMED CONSENT OBTAINED + - name: $min_ds_dsstdtc + operator: not_equal_to + value: RFICDTC + - name: $min_ds_dsstdtc + operator: equal_to + value: DSSTDTC Core: Id: CORE-000363 Status: Published - Version: '1' -Description: When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT + Version: "1" +Description: + When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT OBTAINED', the earliest DSSTDTC for each subject should be equal to DM.RFICDTC. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- domain: DS - group: - - USUBJID - id: $min_ds_dsstdtc - name: DSSTDTC - operator: min_date + - domain: DS + group: + - USUBJID + id: $min_ds_dsstdtc + name: DSSTDTC + operator: min_date Outcome: Message: The earliest disposition date for "INFORMED CONSENT OBTAINED" is not equal to DM.RFICDTC Output Variables: - - RFICDTC - - $min_ds_dsstdtc - - DSDECOD - - DSSTDTC + - RFICDTC + - $min_ds_dsstdtc + - DSDECOD + - DSSTDTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000370/rule.yml b/Published/CORE-000370/rule.yml index df3c6e0f2..55d66767b 100644 --- a/Published/CORE-000370/rule.yml +++ b/Published/CORE-000370/rule.yml @@ -1,127 +1,134 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This will be the same as the date of informed consent in the Disposition - domain, if that protocol milestone is documented. Would be null only in studies not - collecting the date of informed consent. - Document: SDTMIG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: "RFICDTC should correspond to the date of the informed consent protocol milestone - in DS, if that protocol milestone is documented in DS.\n In the event that there are multiple - informed consents, this will be the date of the first one." - Document: SDTMIG v3.4 - Item: Assumption 10c - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[This will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. Would be null only in - studies not collecting the date of informed consent.]|Assumption 13[RFICDTC should - correspond to the date of the informed . . . In the event that there are multiple informed - consents, this will be the date of the first one.] - Document: IG v3.2 - Item: Specification|Assumption 13 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[This will be the same as the date of informed consent in the - Disposition domain, if that protocol milestone is documented. Would be null only in - studies not collecting the date of informed consent.]|Assumption 10c[In the event that - there are multiple informed consents, this will be the date of the first one.] - Document: IG v3.3 - Item: Specification|Assumption 10c - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0143 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: RFICDTC should correspond to the date of the informed consent protocol - milestone in Disposition (DS), if that protocol milestone is documented in DS. In the - event that there are multiple informed consents, this will be the date of the first. - RFPENDTC will be the last date of participation for a subject for data included in a - submission. This should be the last date of any record for the subject in the database at - the time it is locked for submission. As such, it may not be the last date of - participation in the study if the submission includes interim data. - Document: TIG 1.0 - Item: Specification|Assumption 10c - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0387 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This will be the same as the date of informed consent in the Disposition + domain, if that protocol milestone is documented. Would be null only in studies not + collecting the date of informed consent. + Document: SDTMIG v3.4 + Item: Specification + Section: "5.2" + - Cited Guidance: + "RFICDTC should correspond to the date of the informed consent protocol milestone + in DS, if that protocol milestone is documented in DS.\n In the event that there are multiple + informed consents, this will be the date of the first one." + Document: SDTMIG v3.4 + Item: Assumption 10c + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[This will be the same as the date of informed consent in the + Disposition domain, if that protocol milestone is documented. Would be null only in + studies not collecting the date of informed consent.]|Assumption 13[RFICDTC should + correspond to the date of the informed . . . In the event that there are multiple informed + consents, this will be the date of the first one.] + Document: IG v3.2 + Item: Specification|Assumption 13 + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[This will be the same as the date of informed consent in the + Disposition domain, if that protocol milestone is documented. Would be null only in + studies not collecting the date of informed consent.]|Assumption 10c[In the event that + there are multiple informed consents, this will be the date of the first one.] + Document: IG v3.3 + Item: Specification|Assumption 10c + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0143 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + RFICDTC should correspond to the date of the informed consent protocol + milestone in Disposition (DS), if that protocol milestone is documented in DS. In the + event that there are multiple informed consents, this will be the date of the first. + RFPENDTC will be the last date of participation for a subject for data included in a + submission. This should be the last date of any record for the subject in the database at + the time it is locked for submission. As such, it may not be the last date of + participation in the study if the submission includes interim data. + Document: TIG 1.0 + Item: Specification|Assumption 10c + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0387 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: RFICDTC # Condition: DS.DSTERM indicates informed consent obtained # Rule: RFICDTC = earliest DS.DSSTDTC Check: all: - - name: DSTERM - operator: contains - value: INFORMED CONSENT - - name: RFICDTC - operator: date_not_equal_to - value: $min_ds_dsstdtc - - name: $min_ds_dsstdtc - operator: equal_to - value: DSSTDTC + - name: DSTERM + operator: contains + value: INFORMED CONSENT + - name: RFICDTC + operator: date_not_equal_to + value: $min_ds_dsstdtc + - name: $min_ds_dsstdtc + operator: equal_to + value: DSSTDTC Core: Id: CORE-000370 Status: Published - Version: '1' -Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent + Version: "1" +Description: + DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent obtained. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- domain: DS - group: - - USUBJID - id: $min_ds_dsstdtc - name: DSSTDTC - operator: min_date + - domain: DS + group: + - USUBJID + id: $min_ds_dsstdtc + name: DSSTDTC + operator: min_date Outcome: - Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent + Message: + DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent obtained. Output Variables: - - DSDECOD - - RFICDTC - - DSSTDTC - - $min_ds_dsstdtc + - DSDECOD + - RFICDTC + - DSSTDTC + - $min_ds_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000374/rule.yml b/Published/CORE-000374/rule.yml index b76781648..4922d8d9a 100644 --- a/Published/CORE-000374/rule.yml +++ b/Published/CORE-000374/rule.yml @@ -2,99 +2,103 @@ # Condition: DSCAT = 'DISPOSITION EVENT' and DSSCAT is NOT present in dataset. # Rule: At most one record per subject per epoch Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If disposition events for both study participation and study treatment(s) - are to be represented, then DSSCAT provides this distinction. - Document: IG v3.4 - Item: Assumption 2.b - Section: 6.2.3 - - Cited Guidance: "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' - should be presented, and that summaries should be 'grouped by treatment and by major reason.' - The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) - per disposition event. If multiple reasons are reported, the sponsor should identify a primary - reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in - SUPPDS." - Document: IG v3.4 - Item: Assumption 5 - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0537 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "Assumption 2.b[If disposition events for both study participation and study treatment(s) - are to be represented, then DSSCAT provides this distinction]|Assumption 5[ICH E3: Section 10.1 - indicates that 'the specific reason for discontinuation' should be presented, and that summaries - should be 'grouped by treatment and by major reason.' The CDISC SDS Team interprets this guidance - as requiring one standardized disposition term (DSDECOD) per disposition event. If multiple - reasons are reported, the sponsor should identify a primary reason and use that to populate - DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" - Document: IG v3.3 - Item: Assumption 2.b|Assumption 5 - Section: 6.2.3 DS - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0537 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY - PARTICIPATION"" is used to represent disposition of study participation. DSSCAT = - ""PRODUCT EXPOSURE"" is used when a study has only a single product. If a study has - multiple products, then DSSCAT should name the individual product." - Document: TIG 1.0 - Item: Assumption 2b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0630 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction. + Document: IG v3.4 + Item: Assumption 2.b + Section: 6.2.3 + - Cited Guidance: + "ICH E3: Section 10.1 indicates that 'the specific reason for discontinuation' + should be presented, and that summaries should be 'grouped by treatment and by major reason.' + The CDISC SDS Team interprets this guidance as requiring one standardized disposition term (DSDECOD) + per disposition event. If multiple reasons are reported, the sponsor should identify a primary + reason and use that to populate DSTERM and DSDECOD. Additional reasons should be submitted in + SUPPDS." + Document: IG v3.4 + Item: Assumption 5 + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0537 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Assumption 2.b[If disposition events for both study participation and study treatment(s) + are to be represented, then DSSCAT provides this distinction]|Assumption 5[ICH E3: Section 10.1 + indicates that 'the specific reason for discontinuation' should be presented, and that summaries + should be 'grouped by treatment and by major reason.' The CDISC SDS Team interprets this guidance + as requiring one standardized disposition term (DSDECOD) per disposition event. If multiple + reasons are reported, the sponsor should identify a primary reason and use that to populate + DSTERM and DSDECOD. Additional reasons should be submitted in SUPPDS.]" + Document: IG v3.3 + Item: Assumption 2.b|Assumption 5 + Section: 6.2.3 DS + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0537 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY + PARTICIPATION"" is used to represent disposition of study participation. DSSCAT = + ""PRODUCT EXPOSURE"" is used when a study has only a single product. If a study has + multiple products, then DSSCAT should name the individual product." + Document: TIG 1.0 + Item: Assumption 2b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0630 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DSCAT - operator: equal_to - value: DISPOSITION EVENT - value_is_literal: true - - name: DSSCAT - operator: not_exists - - name: DSCAT - operator: is_not_unique_set - value: - - EPOCH - - USUBJID + - name: DSCAT + operator: equal_to + value: DISPOSITION EVENT + value_is_literal: true + - name: DSSCAT + operator: not_exists + - name: DSCAT + operator: is_not_unique_set + value: + - EPOCH + - USUBJID Core: Id: CORE-000374 Status: Published - Version: '1' + Version: "1" Description: Trigger error when there is more than one record per subject per EPOCH Executability: Fully Executable Outcome: Message: There is more than one record per subject per EPOCH Output Variables: - - DSCAT - - DSSCAT - - EPOCH + - DSCAT + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000376/rule.yml b/Published/CORE-000376/rule.yml index a67eb3939..05fdcf710 100644 --- a/Published/CORE-000376/rule.yml +++ b/Published/CORE-000376/rule.yml @@ -2,140 +2,146 @@ # Condition: Custom domain and variable name is not STUDYID, DOMAIN, USUBJID, POOLID, SPDEVID, VISIT, VISITNUM, VISITDY, ELEMENT, TAETORD, EPOCH. # Rule: First 2 characters of the Variable Name = the 2-character domain code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following variables are exceptions to the philosophy that all variable names - are prefixed with the Domain Identifier: -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly - used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY) All Demographics domain (DM) variables - other than DMDTC and DMDY -All variables in RELREC and SUPPQUAL, and some variables in Comments - and Trial Design datasets. Required Identifiers are not prefixed because they are usually used - as keys when merging/joining observations. The --SEQ and the optional Identifiers --GRPID and - --REFID are prefixed because they may be used as keys when relating observations across domains.' - Document: IG v3.4 - Section: 4.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The philosophy applied to determine which variable names use a prefix was that - all variable names are prefixed with the Domain Identifier in which they originate except the - following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID). b. Commonly used grouping and - merge Keys (VISIT; VISITNUM; VISITDY); and many of the variables in trial design (such as ELEMENT - and ARM). c. All Demographics domain (DM) variables other than DMDTC and DMDY. d. All variables - in RELREC and SUPPQUAL; and some variables in Comments and Trial Design datasets.' - Document: IG v3.2 - Section: 4.1.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The following variables are exceptions to the philosophy that all variable names - are prefixed with the Domain Identifier: - Required Identifiers (STUDYID; DOMAIN; USUBJID). - -Commonly used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY). -All Demographics domain - (DM) variables other than DMDTC and DMDY. -All variables in RELREC and SUPPQUAL; and some variables - in Comments and Trial Design datasets. Required Identifiers are not prefixed because they are - usually used as keys when merging/joining observations. The --SEQ and the optional Identifiers - --GRPID and --REFID are prefixed because they may be used as keys when relating observations - across domains.' - Document: IG v3.3 - Section: 4.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0349 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'Apply the domain code to the appropriate variables in the domain by replacing - all variable prefixes (shown in the SDTM as “--“) with the domain code.' - Document: TIG 1.0 - Item: 5a - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0514 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following variables are exceptions to the philosophy that all variable names + are prefixed with the Domain Identifier: -Required Identifiers (STUDYID, DOMAIN, USUBJID) -Commonly + used grouping and merge Keys (e.g., VISIT, VISITNUM, VISITDY) All Demographics domain (DM) variables + other than DMDTC and DMDY -All variables in RELREC and SUPPQUAL, and some variables in Comments + and Trial Design datasets. Required Identifiers are not prefixed because they are usually used + as keys when merging/joining observations. The --SEQ and the optional Identifiers --GRPID and + --REFID are prefixed because they may be used as keys when relating observations across domains." + Document: IG v3.4 + Section: 4.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The philosophy applied to determine which variable names use a prefix was that + all variable names are prefixed with the Domain Identifier in which they originate except the + following: a. Required Identifiers (STUDYID; DOMAIN; USUBJID). b. Commonly used grouping and + merge Keys (VISIT; VISITNUM; VISITDY); and many of the variables in trial design (such as ELEMENT + and ARM). c. All Demographics domain (DM) variables other than DMDTC and DMDY. d. All variables + in RELREC and SUPPQUAL; and some variables in Comments and Trial Design datasets." + Document: IG v3.2 + Section: 4.1.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The following variables are exceptions to the philosophy that all variable names + are prefixed with the Domain Identifier: - Required Identifiers (STUDYID; DOMAIN; USUBJID). + -Commonly used grouping and merge Keys (e.g.,VISIT; VISITNUM; VISITDY). -All Demographics domain + (DM) variables other than DMDTC and DMDY. -All variables in RELREC and SUPPQUAL; and some variables + in Comments and Trial Design datasets. Required Identifiers are not prefixed because they are + usually used as keys when merging/joining observations. The --SEQ and the optional Identifiers + --GRPID and --REFID are prefixed because they may be used as keys when relating observations + across domains." + Document: IG v3.3 + Section: 4.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0349 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "Apply the domain code to the appropriate variables in the domain by replacing + all variable prefixes (shown in the SDTM as “--“) with the domain code." + Document: TIG 1.0 + Item: 5a + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0514 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $domain_is_custom - operator: equal_to - value: true - - name: variable_name - operator: is_not_contained_by - value: - - STUDYID - - DOMAIN - - USUBJID - - POOLID - - SPDEVID - - VISIT - - VISITNUM - - VISITDY - - ELEMENT - - TAETORD - - EPOCH - - NHOID - - FOCID - - SPTOBID - - STOCONID - - IGDCMPID - - MIDS - - RELMIDS - - MIDSDTC - - RSUBJID - - RDEVID - - SREL - - APID - - name: variable_name - operator: prefix_is_not_contained_by - prefix: 2 - value: $domain_list + - name: $domain_is_custom + operator: equal_to + value: true + - name: variable_name + operator: is_not_contained_by + value: + - STUDYID + - DOMAIN + - USUBJID + - POOLID + - SPDEVID + - VISIT + - VISITNUM + - VISITDY + - ELEMENT + - TAETORD + - EPOCH + - NHOID + - FOCID + - SPTOBID + - STOCONID + - IGDCMPID + - MIDS + - RELMIDS + - MIDSDTC + - RSUBJID + - RDEVID + - SREL + - APID + - name: variable_name + operator: prefix_is_not_contained_by + prefix: 2 + value: $domain_list Core: Id: CORE-000376 Status: Published - Version: '1' -Description: Raise an error when the two first characters of a prefixed variable within a custom + Version: "1" +Description: + Raise an error when the two first characters of a prefixed variable within a custom domain do not match the DOMAIN value. Executability: Fully Executable Operations: -- id: $domain_list - name: DOMAIN - operator: distinct -- id: $domain_is_custom - operator: domain_is_custom + - id: $domain_list + name: DOMAIN + operator: distinct + - id: $domain_is_custom + operator: domain_is_custom Outcome: - Message: First 2 characters of prefixed variable within custom domain do not match the DOMAIN + Message: + First 2 characters of prefixed variable within custom domain do not match the DOMAIN value. Output Variables: - - $domain_list - - variable_name + - $domain_list + - variable_name Rule Type: Variable Metadata Check Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS - - EVENTS + - FINDINGS + - INTERVENTIONS + - EVENTS Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000381/rule.yml b/Published/CORE-000381/rule.yml index 0e05b7fd0..9a3ad9bc0 100644 --- a/Published/CORE-000381/rule.yml +++ b/Published/CORE-000381/rule.yml @@ -1,111 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND18 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND18 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --TESTCD - operator: matches_regex - value: ^[0-9] + - name: --TESTCD + operator: matches_regex + value: ^[0-9] Core: Id: CORE-000381 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --TESTCD starts with a number Executability: Fully Executable Outcome: Message: --TESTCD may not start with a number Output Variables: - - --TESTCD + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000382/rule.yml b/Published/CORE-000382/rule.yml index eecadf6c1..07ff1f4fb 100644 --- a/Published/CORE-000382/rule.yml +++ b/Published/CORE-000382/rule.yml @@ -1,111 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: dm.xpt, Demographics - Special-Purpose Domains. One record per subject, - Tabulation. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND97 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + dm.xpt, Demographics - Special-Purpose Domains. One record per subject, + Tabulation. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND97 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: USUBJID - operator: is_not_unique_set - value: DOMAIN + - name: USUBJID + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000382 Status: Published - Version: '1' + Version: "1" Description: DM - One record per subject Executability: Fully Executable Outcome: Message: USUBJID is not unique within DM Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000383/rule.yml b/Published/CORE-000383/rule.yml index d04e594f5..cbfb43fa8 100644 --- a/Published/CORE-000383/rule.yml +++ b/Published/CORE-000383/rule.yml @@ -1,84 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission containing - this dataset. Only a single record should be provided in the Trial Summary dataset. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission containing - this dataset. Only a single record should be provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission containing - this dataset. Only a single record should be provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission containing - this dataset. Only a single record should be provided in the Trial Summary dataset. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SEND Implementation Guide version used for the submission containing - this dataset. Only a single record should be provided in the Trial Summary dataset. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND341 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The SEND Implementation Guide version used for the submission containing + this dataset. Only a single record should be provided in the Trial Summary dataset. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND341 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: TSPARMCD - operator: equal_to - value: SNDIGVER - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SNDIGVER + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000383 Status: Published - Version: '1' + Version: "1" Description: Raise an error when there is more than one record with TSPARMCD=SNDIGVER Executability: Fully Executable Outcome: @@ -87,8 +92,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000384/rule.yml b/Published/CORE-000384/rule.yml index d732b6583..b8dface81 100644 --- a/Published/CORE-000384/rule.yml +++ b/Published/CORE-000384/rule.yml @@ -2,86 +2,86 @@ # Condition: RELREC dataset present in study # Rule: Dataset present in study with DOMAIN = RELREC.RDOMAIN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Two-character abbreviation for the domain of the parent record(s). ' - Document: Model v2.0 - Item: RDOMAIN - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). - Document: Model v1.4 - Item: RDOMAIN Description - Section: 4.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 2-character abbreviation for the domain of the parent record(s). - Document: Model v1.7 - Item: RDOMAIN Description - Section: 4.1.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0374 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). - Document: SDTM v2.1 - Item: RDOMAIN - Section: 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0538 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "Two-character abbreviation for the domain of the parent record(s). " + Document: Model v2.0 + Item: RDOMAIN + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). + Document: Model v1.4 + Item: RDOMAIN Description + Section: 4.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 2-character abbreviation for the domain of the parent record(s). + Document: Model v1.7 + Item: RDOMAIN Description + Section: 4.1.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0374 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: Two-character abbreviation for the domain of the parent record(s). + Document: SDTM v2.1 + Item: RDOMAIN + Section: 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0538 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000384 Status: Published - Version: '1' + Version: "1" Description: RELREC.RDOMAIN must represent a dataset that is present in the study. Executability: Fully Executable Operations: -- id: $study_domains - operator: study_domains + - id: $study_domains + operator: study_domains Outcome: Message: RELREC.RDOMAIN does not represent a dataset present in the study Output Variables: - - RDOMAIN + - RDOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000385/rule.yml b/Published/CORE-000385/rule.yml index 5f6b346af..ed137ca91 100644 --- a/Published/CORE-000385/rule.yml +++ b/Published/CORE-000385/rule.yml @@ -1,107 +1,112 @@ Authorities: # REMARK: not applicable to SENDIG-3.0 -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. In the Events or Interventions general - observation class, this could be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per subject per administration site - (as identified in FOCID). A constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated with a specific lot at a - constant dose level. - Document: IG v3.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. In the Events or Interventions general - observation class, this could be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per subject per administration site - (as identified in FOCID). A constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated with a specific lot at a - constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. In the Events or Interventions general - observation class, this could be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per subject per administration site - (as identified in FOCID). A constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated with a specific lot at a - constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. In the Events or Interventions general - observation class, this could be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per subject per administration site - (as identified in FOCID). A constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated with a specific lot at a - constant dose level. - Document: IG v3.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. In the Events or Interventions general - observation class, this could be the start date of the event or intervention…This domain - should contain one record per constant dosing interval per subject per administration site - (as identified in FOCID). A constant dosing interval is sponsor defined and represents a - specific period of time during which a subject was treated with a specific lot at a - constant dose level. - Document: IG v3.1.1 - Section: 4.4|6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND291' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND291" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND291" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND291" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND291" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. In the Events or Interventions general + observation class, this could be the start date of the event or intervention…This domain + should contain one record per constant dosing interval per subject per administration site + (as identified in FOCID). A constant dosing interval is sponsor defined and represents a + specific period of time during which a subject was treated with a specific lot at a + constant dose level. + Document: IG v3.1.1 + Section: 4.4|6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND291" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: --STDTC - operator: empty - - name: --STDY - operator: empty + - name: --STDTC + operator: empty + - name: --STDY + operator: empty Core: Id: CORE-000385 Status: Published - Version: '1' + Version: "1" Description: Either --STDTC or --STDY must be populated. Executability: Fully Executable Outcome: @@ -110,8 +115,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000386/rule.yml b/Published/CORE-000386/rule.yml index 3d0d14849..28bfd947f 100644 --- a/Published/CORE-000386/rule.yml +++ b/Published/CORE-000386/rule.yml @@ -1,69 +1,73 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The values of SJSTDTC provide the chronological order of the actual subject Stages. - SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. - Note: The requirement that SJSEQ be consistent with chronological order is more stringent than - in most other domains where --SEQ values need only be unique within subject." - Document: IG-DART v1.1 - Item: Assumption 7 - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND354 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The values of SJSTDTC provide the chronological order of the actual subject Stages. - SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. - Note: The requirement that SJSEQ be consistent with chronological order is more stringent than - in most other domains where --SEQ values need only be unique within subject." - Document: IG-DART v1.2 - Item: Assumption 7 - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND354 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The values of SJSTDTC provide the chronological order of the actual subject Stages. + SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. + Note: The requirement that SJSEQ be consistent with chronological order is more stringent than + in most other domains where --SEQ values need only be unique within subject." + Document: IG-DART v1.1 + Item: Assumption 7 + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND354 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The values of SJSTDTC provide the chronological order of the actual subject Stages. + SJSEQ should be assigned to be consistent with the chronological order of the Stages per subject. + Note: The requirement that SJSEQ be consistent with chronological order is more stringent than + in most other domains where --SEQ values need only be unique within subject." + Document: IG-DART v1.2 + Item: Assumption 7 + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND354 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: SJSEQ - operator: target_is_not_sorted_by - value: - - name: SJSTDTC - # What is "null_position" doing? - null_position: last - sort_order: asc - within: USUBJID + - name: SJSEQ + operator: target_is_not_sorted_by + value: + - name: + SJSTDTC + # What is "null_position" doing? + null_position: last + sort_order: asc + within: USUBJID Core: Id: CORE-000386 Status: Published - Version: '1' -Description: Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within + Version: "1" +Description: + Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within USUBJID Executability: Fully Executable Outcome: Message: SJSEQ is not chronologically (based on SJSTDTC) within USUBJID Output Variables: - - USUBJID - - SJSEQ - - SJSTDTC + - USUBJID + - SJSEQ + - SJSTDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000387/rule.yml b/Published/CORE-000387/rule.yml index b4d2904af..2f17022f0 100644 --- a/Published/CORE-000387/rule.yml +++ b/Published/CORE-000387/rule.yml @@ -1,98 +1,103 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND311 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND311 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # case that USUBJID ("expected") is populated all: - - name: USUBJID - operator: non_empty - - name: COSEQ - operator: is_not_unique_set - value: USUBJID - # case that USUBJID is not populated - #- all: - # - name: USUBJID - # operator: empty - # - name: POOLID - # operator: non_empty - # - name: COSEQ - # operator: is_not_unique_set - # value: POOLID + - name: USUBJID + operator: non_empty + - name: COSEQ + operator: is_not_unique_set + value: USUBJID + # case that USUBJID is not populated + #- all: + # - name: USUBJID + # operator: empty + # - name: POOLID + # operator: non_empty + # - name: COSEQ + # operator: is_not_unique_set + # value: POOLID Core: Id: CORE-000387 Status: Published - Version: '1' + Version: "1" Description: Raise an error when COSEQ is not unique within USUBJID Executability: Fully Executable Outcome: @@ -101,8 +106,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000388/rule.yml b/Published/CORE-000388/rule.yml index 4ca56c130..b7ad0e7c9 100644 --- a/Published/CORE-000388/rule.yml +++ b/Published/CORE-000388/rule.yml @@ -1,132 +1,141 @@ Authorities: -- Organization: CDISC - # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule 121) - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: SENDIG v3.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: SENDIG v3.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: SENDIG v3.1.1 - Item: Assumption 3 - Section: '8.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND286' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are - populated; RELTYPE is null) - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0202 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: + CDISC + # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule 121) + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1 + Item: Assumption 3 + Section: "8.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND286" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: "8.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND286" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: "8.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND286" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1 + Item: Assumption 3 + Section: "8.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND286" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: SENDIG v3.1.1 + Item: Assumption 3 + Section: "8.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND286" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + populated; RELTYPE is null) + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0202 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: RELTYPE - operator: non_empty - - all: - - name: POOLID - operator: non_empty - - name: IDVARVAL - operator: non_empty - - name: RELTYPE - operator: non_empty + - all: + - name: USUBJID + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: RELTYPE + operator: non_empty + - all: + - name: POOLID + operator: non_empty + - name: IDVARVAL + operator: non_empty + - name: RELTYPE + operator: non_empty Core: Id: CORE-000388 Status: Published - Version: '1' -Description: When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be + Version: "1" +Description: + When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be null. Executability: Fully Executable Outcome: - Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is + Message: + RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is populated Output Variables: - - RDOMAIN - - USUBJID - - POOLID - - IDVAR - - IDVARVAL - - RELTYPE + - RDOMAIN + - USUBJID + - POOLID + - IDVAR + - IDVARVAL + - RELTYPE Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000389/rule.yml b/Published/CORE-000389/rule.yml index d113e0b48..1452a59aa 100644 --- a/Published/CORE-000389/rule.yml +++ b/Published/CORE-000389/rule.yml @@ -1,89 +1,94 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sequence number must be unique for each record within a USUBJID or - POOLID, whichever applies for the record. - Document: IG v3.1 - Item: COSEQ CDISC Notes - Section: '5.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND312 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The sequence number must be unique for each record within a USUBJID or + POOLID, whichever applies for the record. + Document: IG v3.1 + Item: COSEQ CDISC Notes + Section: "5.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND312 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # case that POOLID ("permissible") is populated all: - - name: POOLID - operator: non_empty - - name: COSEQ - operator: is_not_unique_set - value: POOLID + - name: POOLID + operator: non_empty + - name: COSEQ + operator: is_not_unique_set + value: POOLID Core: Id: CORE-000389 Status: Published - Version: '1' + Version: "1" Description: Raise an error when COSEQ is not unique within POOLID Executability: Fully Executable Outcome: @@ -92,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000390/rule.yml b/Published/CORE-000390/rule.yml index a1ea93c96..189d897f1 100644 --- a/Published/CORE-000390/rule.yml +++ b/Published/CORE-000390/rule.yml @@ -1,99 +1,100 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.17 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND336 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.17 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND336 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # Implemented as that combination of USUBJID, CVTESTCD and CVDTC must be unique all: - - name: CVTESTCD - operator: is_not_unique_set - value: - - USUBJID - - CVDTC + - name: CVTESTCD + operator: is_not_unique_set + value: + - USUBJID + - CVDTC Core: Id: CORE-000390 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular + Version: "1" +Description: + Raise an error when there is more than one record present for any particular cardiovascular test for a subject and measurement date/time Executability: Fully Executable Outcome: Message: The cardiovascular test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - CVTESTCD - - CVDTC + - USUBJID + - CVTESTCD + - CVDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CV + - CV Sensitivity: Record diff --git a/Published/CORE-000391/rule.yml b/Published/CORE-000391/rule.yml index b0bfff76c..a0f0379f6 100644 --- a/Published/CORE-000391/rule.yml +++ b/Published/CORE-000391/rule.yml @@ -1,23 +1,23 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in DDTESTCD...In this domain the value should always be DEATHD. - Document: IG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND164 - Version: "1" - Version: "5.0" - Version: "3.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in DDTESTCD...In this domain the value should always be DEATHD. + Document: IG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND164 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: DDTESTCD - operator: not_equal_to - value: DEATHD + - name: DDTESTCD + operator: not_equal_to + value: DEATHD Core: Id: CORE-000391 Status: Published @@ -27,13 +27,13 @@ Executability: Fully Executable Outcome: Message: The value of DDTESTCD is not 'DEATHD' Output Variables: - - DDTESTCD + - DDTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000392/rule.yml b/Published/CORE-000392/rule.yml index 99a12dc8b..1ce3b6c3c 100644 --- a/Published/CORE-000392/rule.yml +++ b/Published/CORE-000392/rule.yml @@ -1,23 +1,23 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in DDTEST should always be 'Death Diagnosis'. - Document: IG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND165 - Version: "1" - Version: "5.0" - Version: "3.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value in DDTEST should always be 'Death Diagnosis'. + Document: IG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND165 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: DDTEST - operator: not_equal_to - value: Death Diagnosis + - name: DDTEST + operator: not_equal_to + value: Death Diagnosis Core: Id: CORE-000392 Status: Published @@ -27,13 +27,13 @@ Executability: Fully Executable Outcome: Message: The value of DDTESTCD is not 'Death Diagnosis' Output Variables: - - DDTEST + - DDTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000393/rule.yml b/Published/CORE-000393/rule.yml index f58ce8a6a..b4a69c163 100644 --- a/Published/CORE-000393/rule.yml +++ b/Published/CORE-000393/rule.yml @@ -1,125 +1,132 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points can be represented using the time point variables, --TPT, - --TPTNUM, --ELTM, and the time point anchors, --TPTREF (text description) and --RFTDTC - (the date/time).; See also --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed - time (in ISO 8601) format relative to the planned fixed reference (EXTPTREF).") - Document: IG v3.0 - Item: Specification - Section: 4.4.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which - the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from - the fixed reference point event (e.g., a dose) to the planned observation." - Document: IG v3.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which - the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from - the fixed reference point event (e.g., a dose) to the planned observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which - the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from - the fixed reference point event (e.g., a dose) to the planned observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which - the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from - the fixed reference point event (e.g., a dose) to the planned observation." - Document: IG v3.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "--TPTREF: the description of the fixed reference point event or anchor from which - the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from - the fixed reference point event (e.g., a dose) to the planned observation." - Document: IG v3.1.1 - Item: Specification - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND279.1" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: >- - When instances of an activity are scheduled at planned time - intervals relative to a fixed reference point (e.g., an - exposure), the following timing variables will be - used:… --TPTREF Represents a description of the fixed - reference point from which the planned observation will be - made. --ELTM Represents the planned elapsed time from the - fixed timepoint reference to the planned observation. - Document: TIG v1.0 - Item: Table Num 3 - Section: 2.8.7.6 Representing References and Relative Timing, Timing Relative to Reference - Points - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0195 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Time points can be represented using the time point variables, --TPT, + --TPTNUM, --ELTM, and the time point anchors, --TPTREF (text description) and --RFTDTC + (the date/time).; See also --ELTM CDISC Notes in Domain Tables (e.g., "Planned elapsed + time (in ISO 8601) format relative to the planned fixed reference (EXTPTREF).") + Document: IG v3.0 + Item: Specification + Section: 4.4.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "--TPTREF: the description of the fixed reference point event or anchor from which + the planned observation will be made, usually the dose ...--ELTM: the planned elapsed time from + the fixed reference point event (e.g., a dose) to the planned observation." + Document: IG v3.1.1 + Item: Specification + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND279.1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: >- + When instances of an activity are scheduled at planned time + intervals relative to a fixed reference point (e.g., an + exposure), the following timing variables will be + used:… --TPTREF Represents a description of the fixed + reference point from which the planned observation will be + made. --ELTM Represents the planned elapsed time from the + fixed timepoint reference to the planned observation. + Document: TIG v1.0 + Item: Table Num 3 + Section: + 2.8.7.6 Representing References and Relative Timing, Timing Relative to Reference + Points + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0195 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --TPTREF - operator: empty - - name: --ELTM - operator: non_empty + - name: --TPTREF + operator: empty + - name: --ELTM + operator: non_empty Core: Id: CORE-000393 Status: Published @@ -129,16 +136,16 @@ Executability: Fully Executable Outcome: Message: --TPTREF is empty and --ELTM is not empty Output Variables: - - --TPTREF - - --ELTM + - --TPTREF + - --ELTM Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS + - FINDINGS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000394/rule.yml b/Published/CORE-000394/rule.yml index be26f37ed..0f9a55aa2 100644 --- a/Published/CORE-000394/rule.yml +++ b/Published/CORE-000394/rule.yml @@ -1,85 +1,90 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall conduct of - the nonclinical study. The parameter contains the name of the specific individual, e.g. - 'Dr. William Spock.' - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall conduct of - the nonclinical study. The parameter contains the name of the specific individual, e.g. - 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall conduct of - the nonclinical study. The parameter contains the name of the specific individual, e.g. - 'Dr. William Spock.' - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall conduct of - the nonclinical study. The parameter contains the name of the specific individual, e.g. - 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Study Director is the individual responsible for the overall conduct of - the nonclinical study. The parameter contains the name of the specific individual, e.g. - 'Dr. William Spock.' - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND346 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The Study Director is the individual responsible for the overall conduct of + the nonclinical study. The parameter contains the name of the specific individual, e.g. + 'Dr. William Spock.' + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND346 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: STDIR - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: STDIR + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000394 Status: Published @@ -92,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000395/rule.yml b/Published/CORE-000395/rule.yml index 438316e7b..452b8e02b 100644 --- a/Published/CORE-000395/rule.yml +++ b/Published/CORE-000395/rule.yml @@ -1,81 +1,87 @@ Authorities: -- Organization: CDISC - # REMARK: not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND344" - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: + CDISC + # REMARK: not applicable to SENDIG-3.0 + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND344" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: STCAT - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: STCAT + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000395 Status: Published @@ -88,8 +94,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000396/rule.yml b/Published/CORE-000396/rule.yml index 8603d34a4..6bd2e955e 100644 --- a/Published/CORE-000396/rule.yml +++ b/Published/CORE-000396/rule.yml @@ -1,80 +1,85 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND345 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND345 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SSTYP - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SSTYP + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000396 Status: Published @@ -87,8 +92,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000397/rule.yml b/Published/CORE-000397/rule.yml index 97a79e968..3e91399cb 100644 --- a/Published/CORE-000397/rule.yml +++ b/Published/CORE-000397/rule.yml @@ -1,75 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Only a single record should be provided in the Trial Summary. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND343" - Version: "1" - Version: "5.0" - Version: "1.2" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Only a single record should be provided in the Trial Summary. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND343" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: TSPARMCD - operator: equal_to - value: SNDCTVER - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SNDCTVER + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000397 Status: Published @@ -82,8 +82,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000398/rule.yml b/Published/CORE-000398/rule.yml index f9752f7ff..62f3d230c 100644 --- a/Published/CORE-000398/rule.yml +++ b/Published/CORE-000398/rule.yml @@ -1,129 +1,136 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified variable labels for all standard domains - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0303 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.0 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Sponsors must use the predefined SENDIG-standard labels in all standard - domains - Document: SENDIG v3.1.1 - Section: "4.2.1" - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND276 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified variable labels for all standard domains + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0303 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.0 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Sponsors must use the predefined SENDIG-standard labels in all standard + domains + Document: SENDIG v3.1.1 + Section: "4.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND276 + Version: "1" + Version: "5.0" + Version: "1.0" # The implementation successfully skips invalid variables (e.g. VSINVALID) # and skips variables that are not in the IG, but come from the model (e.g. VSLOBXFL) Check: all: # Precondition: variable (label) is in the IG - - name: variable_name - operator: equal_to - value: library_variable_name - - name: library_variable_label - operator: non_empty - # variable label must be equal to that in the CDISC-library - - name: variable_label - operator: not_equal_to - value: library_variable_label + - name: variable_name + operator: equal_to + value: library_variable_name + - name: library_variable_label + operator: non_empty + # variable label must be equal to that in the CDISC-library + - name: variable_label + operator: not_equal_to + value: library_variable_label Core: Id: CORE-000398 Status: Published Version: "1" -Description: Raise an error when the variable label for an IG-variable does not correspond to the +Description: + Raise an error when the variable label for an IG-variable does not correspond to the variable label in the Implementation Guide. Executability: Fully Executable Outcome: Message: The label of the variable does not correspond to the label in the IG Output Variables: - - variable_name - - variable_label - - library_variable_label + - variable_name + - variable_label + - library_variable_label Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000400/rule.yml b/Published/CORE-000400/rule.yml index c4af0d92f..5aab093a0 100644 --- a/Published/CORE-000400/rule.yml +++ b/Published/CORE-000400/rule.yml @@ -1,58 +1,61 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute - reasonDurationWillVary) must be given and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00004' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If duration will vary (attribute durationWillVary is True) then a reason (attribute + reasonDurationWillVary) must be given and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00004" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'AdministrationDuration' - - any: - - name: durationWillVary - operator: not_equal_to - value: false - - name: reasonDurationWillVary - operator: non_empty - - not: - all: - - name: durationWillVary - operator: equal_to - value: true - - name: reasonDurationWillVary - operator: non_empty + - name: instanceType + operator: equal_to + value: "AdministrationDuration" + - any: + - name: durationWillVary + operator: not_equal_to + value: false + - name: reasonDurationWillVary + operator: non_empty + - not: + all: + - name: durationWillVary + operator: equal_to + value: true + - name: reasonDurationWillVary + operator: non_empty Core: - Id: 'CORE-000400' + Id: "CORE-000400" Status: Published - Version: '1' -Description: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) - must be given and vice versa.' + Version: "1" +Description: + "If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) + must be given and vice versa." Executability: Fully Executable Outcome: - Message: The administration duration will vary (durationWillVary is not 'false' or - reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not + Message: + The administration duration will vary (durationWillVary is not 'false' or + reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - durationWillVary - - reasonDurationWillVary + - parent_entity + - parent_id + - parent_rel + - id + - description + - durationWillVary + - reasonDurationWillVary Rule Type: Record Data Scope: Entities: Include: - - AdministrationDuration + - AdministrationDuration Sensitivity: Record diff --git a/Published/CORE-000401/rule.yml b/Published/CORE-000401/rule.yml index 77741a3d2..bf82a915d 100644 --- a/Published/CORE-000401/rule.yml +++ b/Published/CORE-000401/rule.yml @@ -1,66 +1,69 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have exactly one study identifier with an identifier - scope that references a clinical study sponsor organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00005' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Every study version must have exactly one study identifier with an identifier + scope that references a clinical study sponsor organization." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00005" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $num_sponsor_ids - operator: empty - - name: $num_sponsor_ids - operator: not_equal_to - value: 1 + - name: instanceType + operator: equal_to + value: "StudyVersion" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: $num_sponsor_ids + operator: empty + - name: $num_sponsor_ids + operator: not_equal_to + value: 1 Core: - Id: 'CORE-000401' + Id: "CORE-000401" Status: Published - Version: '1' -Description: 'Every study version must have exactly one study identifier with an identifier scope that - references a clinical study sponsor organization.' + Version: "1" +Description: + "Every study version must have exactly one study identifier with an identifier scope that + references a clinical study sponsor organization." Executability: Fully Executable Operations: -- domain: StudyIdentifier - filter: - parent_entity: 'StudyVersion' - parent_rel: 'studyIdentifiers' - rel_type: 'definition' - studyIdentifierScope.organizationType.code: 'C70793' - studyIdentifierScope.organizationType.codeSystem: 'http://www.cdisc.org' - group: - - parent_id - group_aliases: - - id - id: $num_sponsor_ids - operator: record_count + - domain: StudyIdentifier + filter: + parent_entity: "StudyVersion" + parent_rel: "studyIdentifiers" + rel_type: "definition" + studyIdentifierScope.organizationType.code: "C70793" + studyIdentifierScope.organizationType.codeSystem: "http://www.cdisc.org" + group: + - parent_id + group_aliases: + - id + id: $num_sponsor_ids + operator: record_count Outcome: - Message: 'The study version does not have exactly one sponsor identifier (i.e., a study identifier whose + Message: + 'The study version does not have exactly one sponsor identifier (i.e., a study identifier whose scope is an organization with an type code system of "http://www.cdisc.org" and a type code of "C70793")' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $num_sponsor_ids + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $num_sponsor_ids Rule Type: Record Data Scope: Entities: Include: - - StudyVersion + - StudyVersion Sensitivity: Record diff --git a/Published/CORE-000402/rule.yml b/Published/CORE-000402/rule.yml index 62b6a9e99..a70ff3f09 100644 --- a/Published/CORE-000402/rule.yml +++ b/Published/CORE-000402/rule.yml @@ -1,75 +1,78 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Timing windows must be fully defined, if one of the window attributes (i.e., - window label, window lower, and window upper) is defined then all must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00006' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Timing windows must be fully defined, if one of the window attributes (i.e., - window label, window lower, and window upper) is defined then all must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00006' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Timing windows must be fully defined, if one of the window attributes (i.e., + window label, window lower, and window upper) is defined then all must be specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00006" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Timing windows must be fully defined, if one of the window attributes (i.e., + window label, window lower, and window upper) is defined then all must be specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00006" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty - - not: - all: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty + - name: instanceType + operator: equal_to + value: "Timing" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty + - not: + all: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty Core: - Id: 'CORE-000402' + Id: "CORE-000402" Status: Published - Version: '1' -Description: 'Timing windows must be fully defined, if one of the window attributes (i.e., window label, - window lower, and window upper) is defined then all must be specified.' + Version: "1" +Description: + "Timing windows must be fully defined, if one of the window attributes (i.e., window label, + window lower, and window upper) is defined then all must be specified." Executability: Fully Executable Outcome: - Message: 'One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing.' + Message: "One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - valueLabel - - windowLabel - - windowLower - - windowUpper + - parent_entity + - parent_id + - parent_rel + - id + - name + - valueLabel + - windowLabel + - windowLower + - windowUpper Rule Type: Record Data Scope: Entities: Include: - - Timing + - Timing Sensitivity: Record diff --git a/Published/CORE-000403/rule.yml b/Published/CORE-000403/rule.yml index 89bdce043..7e6364299 100644 --- a/Published/CORE-000403/rule.yml +++ b/Published/CORE-000403/rule.yml @@ -1,73 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only one scheduled - instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance - or it must be missing).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00007' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then it must point to only one scheduled - instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance - or it must be missing).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00007' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is "Fixed Reference" then it must point to only one scheduled + instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance + or it must be missing).' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00007" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is "Fixed Reference" then it must point to only one scheduled + instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance + or it must be missing).' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00007" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: C201358 - - not: - any: - - name: relativeToScheduledInstanceId - operator: empty - - name: relativeToScheduledInstanceId - operator: not_exists - - name: relativeToScheduledInstanceId - operator: equal_to - value: relativeFromScheduledInstanceId + - name: rel_type + operator: equal_to + value: "definition" + - name: type.code + operator: equal_to + value: C201358 + - not: + any: + - name: relativeToScheduledInstanceId + operator: empty + - name: relativeToScheduledInstanceId + operator: not_exists + - name: relativeToScheduledInstanceId + operator: equal_to + value: relativeFromScheduledInstanceId Core: - Id: 'CORE-000403' + Id: "CORE-000403" Status: Published - Version: '1' -Description: 'If timing type is "Fixed Reference" then it must point to only one scheduled instance (e.g. + Version: "1" +Description: + 'If timing type is "Fixed Reference" then it must point to only one scheduled instance (e.g. attribute relativeToScheduledInstance must be equal to relativeFromScheduledInstance or it must be missing).' Executability: Fully Executable Outcome: - Message: 'The Timing type is "Fixed Reference" (type.code=C201358) but it does not point to only one + Message: + 'The Timing type is "Fixed Reference" (type.code=C201358) but it does not point to only one scheduled instance - relativeToScheduledInstanceId is not missing and does not contain the same value as relativeFromScheduledInstanceId.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - relativeToScheduledInstanceId + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - relativeToScheduledInstanceId Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000404/rule.yml b/Published/CORE-000404/rule.yml index e257fe5e8..92911d7e5 100644 --- a/Published/CORE-000404/rule.yml +++ b/Published/CORE-000404/rule.yml @@ -1,69 +1,72 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must refer to either a default condition or a timeline - exit, but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00008' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must refer to either a default condition or a timeline - exit, but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00008' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must refer to either a default condition or a timeline + exit, but not both." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00008" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must refer to either a default condition or a timeline + exit, but not both." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00008" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - any: - - all: - - name: defaultConditionId - operator: empty - - name: timelineExitId - operator: empty - - all: - - name: defaultConditionId - operator: non_empty - - name: timelineExitId - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: instanceType + operator: equal_to + value: "ScheduledActivityInstance" + - any: + - all: + - name: defaultConditionId + operator: empty + - name: timelineExitId + operator: empty + - all: + - name: defaultConditionId + operator: non_empty + - name: timelineExitId + operator: non_empty Core: - Id: 'CORE-000404' + Id: "CORE-000404" Status: Published - Version: '1' -Description: 'A scheduled activity instance must refer to either a default condition or a timeline exit, - but not both.' + Version: "1" +Description: + "A scheduled activity instance must refer to either a default condition or a timeline exit, + but not both." Executability: Fully Executable Outcome: - Message: 'The defaultConditionId and timelineExitId attributes are either both populated or both empty.' + Message: "The defaultConditionId and timelineExitId attributes are either both populated or both empty." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId - - timelineExitId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId + - timelineExitId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance + - ScheduledActivityInstance Sensitivity: Record diff --git a/Published/CORE-000407/rule.yml b/Published/CORE-000407/rule.yml index 3942505f9..3c7ff3e9c 100644 --- a/Published/CORE-000407/rule.yml +++ b/Published/CORE-000407/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, there must be exactly one scheduled timeline which identifies - as the main Timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00012' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, there must be exactly one scheduled timeline which identifies - as the main Timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00012' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, there must be exactly one scheduled timeline which identifies + as the main Timeline." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00012" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, there must be exactly one scheduled timeline which identifies + as the main Timeline." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00012" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.versions.studyDesigns. { @@ -37,23 +39,24 @@ Check: |- ~> $map(function($v){$v.id & ($v.name ? " [" & $v.name & "]")}) }[`# Main timelines` != 1][] Core: - Id: 'CORE-000407' + Id: "CORE-000407" Status: Published - Version: '1' -Description: 'Within a study design, there must be exactly one scheduled timeline which identifies as - the main Timeline.' + Version: "1" +Description: + "Within a study design, there must be exactly one scheduled timeline which identifies as + the main Timeline." Executability: Fully Executable Outcome: - Message: 'The study design does not have exactly one main timeline.' + Message: "The study design does not have exactly one main timeline." Output Variables: - - name - - '# Main timelines' - - 'Main timelines' + - name + - "# Main timelines" + - "Main timelines" Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000408/rule.yml b/Published/CORE-000408/rule.yml index bb7ba1c5f..d7aa310f3 100644 --- a/Published/CORE-000408/rule.yml +++ b/Published/CORE-000408/rule.yml @@ -1,71 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept property is required then it must also be enabled, while - if it is not enabled then it must not be required.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00013' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept property is required then it must also be enabled, while - if it is not enabled then it must not be required.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00013' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a biomedical concept property is required then it must also be enabled, while + if it is not enabled then it must not be required." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00013" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a biomedical concept property is required then it must also be enabled, while + if it is not enabled then it must not be required." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00013" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptProperty' - - any: - - all: - - name: isRequired - operator: equal_to - value: true - - name: isEnabled - operator: not_equal_to - value: true - - all: - - name: isEnabled - operator: equal_to - value: false - - name: isRequired - operator: not_equal_to - value: false + - name: instanceType + operator: equal_to + value: "BiomedicalConceptProperty" + - any: + - all: + - name: isRequired + operator: equal_to + value: true + - name: isEnabled + operator: not_equal_to + value: true + - all: + - name: isEnabled + operator: equal_to + value: false + - name: isRequired + operator: not_equal_to + value: false Core: - Id: 'CORE-000408' + Id: "CORE-000408" Status: Published - Version: '1' -Description: 'If a biomedical concept property is required then it must also be enabled, while if it is - not enabled then it must not be required.' + Version: "1" +Description: + "If a biomedical concept property is required then it must also be enabled, while if it is + not enabled then it must not be required." Executability: Fully Executable Outcome: - Message: 'A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not + Message: + "A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not true), or a disabled biomedical concept property (isEnabled=false) is required (isRequired is not - false).' + false)." Output Variables: - - parent_entity - - parent_id - - id - - name - - isRequired - - isEnabled + - parent_entity + - parent_id + - id + - name + - isRequired + - isEnabled Rule Type: Record Data Scope: Entities: Include: - - BiomedicalConceptProperty + - BiomedicalConceptProperty Sensitivity: Record diff --git a/Published/CORE-000413/rule.yml b/Published/CORE-000413/rule.yml index 5daa27896..d04e4001a 100644 --- a/Published/CORE-000413/rule.yml +++ b/Published/CORE-000413/rule.yml @@ -1,59 +1,62 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'USDM' - Document: 'USDM v2.6' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00020' - Version: '1' - Validator Rule Message: If the reason for a study amendment is 'Other' then this must be - specified (attribute otherReason must be completed), and vice versa. - Version: '1.0' - Version: '4.0' + - Organization: "CDISC" + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "USDM" + Document: "USDM v2.6" + Origin: USDM Conformance Rules + Rule Identifier: + Id: "DDF00020" + Version: "1" + Validator Rule Message: + If the reason for a study amendment is 'Other' then this must be + specified (attribute otherReason must be completed), and vice versa. + Version: "1.0" + Version: "4.0" Check: any: - - all: - - name: code.code - operator: equal_to - value: 'C17649' - - any: - - name: otherReason - operator: not_exists - - name: otherReason - operator: empty - - all: - - name: code.code - operator: not_equal_to - value: 'C17649' - - name: otherReason - operator: exists - - name: otherReason - operator: non_empty + - all: + - name: code.code + operator: equal_to + value: "C17649" + - any: + - name: otherReason + operator: not_exists + - name: otherReason + operator: empty + - all: + - name: code.code + operator: not_equal_to + value: "C17649" + - name: otherReason + operator: exists + - name: otherReason + operator: non_empty Core: - Id: 'CORE-000413' + Id: "CORE-000413" Status: Published - Version: '1' -Description: If the reason for a study amendment is 'Other' then this must be specified (attribute + Version: "1" +Description: + If the reason for a study amendment is 'Other' then this must be specified (attribute otherReason must be completed), and vice versa. Executability: Fully Executable Outcome: - Message: Population of otherReason is not consistent with code - code.code is C17649 ('Other') but + Message: + Population of otherReason is not consistent with code - code.code is C17649 ('Other') but otherReason is blank, or otherReason is present but code.code is not C17649 ('Other'). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code.code - - code.decode - - otherReason + - parent_entity + - parent_id + - parent_rel + - id + - code.code + - code.decode + - otherReason Rule Type: Record Data Scope: Entities: Include: - - StudyAmendmentReason + - StudyAmendmentReason Sensitivity: Record diff --git a/Published/CORE-000414/rule.yml b/Published/CORE-000414/rule.yml index f331fa2c1..9b5197441 100644 --- a/Published/CORE-000414/rule.yml +++ b/Published/CORE-000414/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its previous instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00021' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its previous instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00021' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not refer to itself as its previous instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00021" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not refer to itself as its previous instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00021" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: previousId - operator: exists - - name: previousId - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: "definition" + - name: previousId + operator: exists + - name: previousId + operator: equal_to + value: id Core: Id: CORE-000414 Status: Published - Version: '1' -Description: 'An instance of a class must not refer to itself as its previous instance.' + Version: "1" +Description: "An instance of a class must not refer to itself as its previous instance." Executability: Fully Executable Outcome: - Message: 'An instance of a class is referencing itself as its previous instance.' + Message: "An instance of a class is referencing itself as its previous instance." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000416/rule.yml b/Published/CORE-000416/rule.yml index c4ab8bb60..4e698be28 100644 --- a/Published/CORE-000416/rule.yml +++ b/Published/CORE-000416/rule.yml @@ -1,78 +1,82 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, when both previous and next attributes are available - within an entity the previous id value must match the next id value of the referred instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00023' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, when both previous and next attributes are available - within an entity the previous id value must match the next id value of the referred instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00023' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "To ensure consistent ordering, when both previous and next attributes are available + within an entity the previous id value must match the next id value of the referred instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00023" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "To ensure consistent ordering, when both previous and next attributes are available + within an entity the previous id value must match the next id value of the referred instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00023" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: previousId - operator: exists - - name: nextId - operator: exists - - name: rel_type - operator: equal_to - value: 'reference' - - any: - - all: - - name: parent_rel - operator: equal_to - value: 'previousId' - value_is_literal: true - - name: nextId - operator: not_equal_to - value: parent_id - - all: - - name: parent_rel - operator: equal_to - value: 'nextId' - value_is_literal: true - - name: previousId - operator: not_equal_to - value: parent_id + - name: previousId + operator: exists + - name: nextId + operator: exists + - name: rel_type + operator: equal_to + value: "reference" + - any: + - all: + - name: parent_rel + operator: equal_to + value: "previousId" + value_is_literal: true + - name: nextId + operator: not_equal_to + value: parent_id + - all: + - name: parent_rel + operator: equal_to + value: "nextId" + value_is_literal: true + - name: previousId + operator: not_equal_to + value: parent_id Core: - Id: 'CORE-000416' + Id: "CORE-000416" Status: Published - Version: '1' -Description: 'To ensure consistent ordering, when both previous and next attributes are available within - an entity the previous id value must match the next id value of the referred instance.' + Version: "1" +Description: + "To ensure consistent ordering, when both previous and next attributes are available within + an entity the previous id value must match the next id value of the referred instance." Executability: Fully Executable Outcome: - Message: 'The next and previous relationships are not reciprocal - the instance is the "previous" instance + Message: + 'The next and previous relationships are not reciprocal - the instance is the "previous" instance (parent_rel is "previousId") for an instance that is not its "next" instance (nextId is not the same as parent_id), or vice versa.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000417/rule.yml b/Published/CORE-000417/rule.yml index d17e83697..f2d937b24 100644 --- a/Published/CORE-000417/rule.yml +++ b/Published/CORE-000417/rule.yml @@ -1,66 +1,67 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00025' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00025' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00025" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00025" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: windowLabel - operator: non_empty - - name: windowLower - operator: non_empty - - name: windowUpper - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type.code + operator: equal_to + value: "C201358" + - any: + - name: windowLabel + operator: non_empty + - name: windowLower + operator: non_empty + - name: windowUpper + operator: non_empty Core: Id: CORE-000417 Status: Published - Version: '1' + Version: "1" Description: 'A window must not be defined for an anchor timing (i.e., type is "Fixed Reference").' Executability: Fully Executable Outcome: - Message: 'One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value - for a Fixed Reference timing (type.code=C201358).' + Message: + "One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value + for a Fixed Reference timing (type.code=C201358)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - windowLabel - - windowLower - - windowUpper + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - windowLabel + - windowLower + - windowUpper Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000419/rule.yml b/Published/CORE-000419/rule.yml index 190791008..ce3ff1119 100644 --- a/Published/CORE-000419/rule.yml +++ b/Published/CORE-000419/rule.yml @@ -1,75 +1,79 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, the same instance must not be referenced more - than once as previous or next.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00027' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'To ensure consistent ordering, the same instance must not be referenced more - than once as previous or next.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00027' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "To ensure consistent ordering, the same instance must not be referenced more + than once as previous or next." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00027" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "To ensure consistent ordering, the same instance must not be referenced more + than once as previous or next." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00027" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - all: - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - all: + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel Core: - Id: 'CORE-000419' + Id: "CORE-000419" Status: Published - Version: '1' -Description: 'To ensure consistent ordering, the same instance must not be referenced more than once as - previous or next.' + Version: "1" +Description: + "To ensure consistent ordering, the same instance must not be referenced more than once as + previous or next." Executability: Fully Executable Outcome: - Message: 'The same instance is referenced more than once as previous or next - nextId or previousId - values are not unique.' + Message: + "The same instance is referenced more than once as previous or next - nextId or previousId + values are not unique." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - nextId - - previousId + - parent_entity + - parent_id + - parent_rel + - id + - name + - nextId + - previousId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000423/rule.yml b/Published/CORE-000423/rule.yml index fc1a1bd2a..43b53490c 100644 --- a/Published/CORE-000423/rule.yml +++ b/Published/CORE-000423/rule.yml @@ -1,75 +1,79 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances - (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not - be missing and must not be equal to each other).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00031' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances - (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not - be missing and must not be equal to each other).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00031' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is not "Fixed Reference" then it must point to two scheduled instances + (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not + be missing and must not be equal to each other).' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00031" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is not "Fixed Reference" then it must point to two scheduled instances + (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not + be missing and must not be equal to each other).' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00031" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: not_equal_to - value: C201358 - - any: - - name: relativeFromScheduledInstanceId - operator: empty - - name: relativeToScheduledInstanceId - operator: not_exists - - name: relativeToScheduledInstanceId - operator: empty - - name: relativeFromScheduledInstanceId + - name: rel_type operator: equal_to - value: relativeToScheduledInstanceId + value: "definition" + - name: type.code + operator: not_equal_to + value: C201358 + - any: + - name: relativeFromScheduledInstanceId + operator: empty + - name: relativeToScheduledInstanceId + operator: not_exists + - name: relativeToScheduledInstanceId + operator: empty + - name: relativeFromScheduledInstanceId + operator: equal_to + value: relativeToScheduledInstanceId Core: - Id: 'CORE-000423' + Id: "CORE-000423" Status: Published - Version: '1' -Description: 'If timing type is not "Fixed Reference" then it must point to two scheduled instances (e.g. + Version: "1" +Description: + 'If timing type is not "Fixed Reference" then it must point to two scheduled instances (e.g. the relativeFromScheduledInstance and relativeToScheduledInstance attributes must not be missing and must not be equal to each other).' Executability: Fully Executable Outcome: - Message: 'The Timing type is not "Fixed Reference" (type.code is not C201358) but it does not point + Message: + 'The Timing type is not "Fixed Reference" (type.code is not C201358) but it does not point to two different scheduled instances - relativeFromScheduledInstanceId and/or relativeToScheduledInstanceId is missing, or they both contain the same value.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - relativeToScheduledInstanceId + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - relativeToScheduledInstanceId Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000424/rule.yml b/Published/CORE-000424/rule.yml index f24205689..95cfa20ca 100644 --- a/Published/CORE-000424/rule.yml +++ b/Published/CORE-000424/rule.yml @@ -1,71 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if more than 1 business therapeutic area is defined then - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00032' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if more than 1 business therapeutic area is defined then - they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00032' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study version, if more than 1 business therapeutic area is defined then + they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00032" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study version, if more than 1 business therapeutic area is defined then + they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00032" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyVersion' - - name: parent_rel - operator: equal_to - value: 'businessTherapeuticAreas' - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyVersion" + - name: parent_rel + operator: equal_to + value: "businessTherapeuticAreas" + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - codeSystem + - codeSystemVersion Core: Id: CORE-000424 Status: Published - Version: '1' -Description: 'Within a study version, if more than 1 business therapeutic area is defined then they must - be distinct.' + Version: "1" +Description: + "Within a study version, if more than 1 business therapeutic area is defined then they must + be distinct." Executability: Fully Executable Outcome: - Message: 'The business therapeutic areas of the study version are not unique - the same code is used - more than once with the same codeSystem and codeSystemVersion.' + Message: + "The business therapeutic areas of the study version are not unique - the same code is used + more than once with the same codeSystem and codeSystemVersion." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000427/rule.yml b/Published/CORE-000427/rule.yml index 6a7ba5c3f..15d23b3e0 100644 --- a/Published/CORE-000427/rule.yml +++ b/Published/CORE-000427/rule.yml @@ -1,84 +1,88 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a code system and corresponding version, a one-to-one relationship between - code and decode is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00035' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a code system and corresponding version, a one-to-one relationship between - code and decode is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00035' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a code system and corresponding version, a one-to-one relationship between + code and decode is expected." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00035" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a code system and corresponding version, a one-to-one relationship between + code and decode is expected." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00035" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - any: - - name: $num_records_in_codesystemversion_with_code - operator: not_equal_to - value: $num_records_in_codesystemversion_with_code_decode - - name: $num_records_in_codesystemversion_with_decode - operator: not_equal_to - value: $num_records_in_codesystemversion_with_code_decode + - name: instanceType + operator: equal_to + value: "Code" + - any: + - name: $num_records_in_codesystemversion_with_code + operator: not_equal_to + value: $num_records_in_codesystemversion_with_code_decode + - name: $num_records_in_codesystemversion_with_decode + operator: not_equal_to + value: $num_records_in_codesystemversion_with_code_decode Core: Id: CORE-000427 Status: Published - Version: '1' -Description: 'Within a code system and corresponding version, a one-to-one relationship between code and - decode is expected.' + Version: "1" +Description: + "Within a code system and corresponding version, a one-to-one relationship between code and + decode is expected." Executability: Partially Executable - Possible Overreporting Operations: -- group: - - codeSystem - - codeSystemVersion - - code - id: $num_records_in_codesystemversion_with_code - operator: record_count -- group: - - codeSystem - - codeSystemVersion - - decode - id: $num_records_in_codesystemversion_with_decode - operator: record_count -- group: - - codeSystem - - codeSystemVersion - - code - - decode - id: $num_records_in_codesystemversion_with_code_decode - operator: record_count + - group: + - codeSystem + - codeSystemVersion + - code + id: $num_records_in_codesystemversion_with_code + operator: record_count + - group: + - codeSystem + - codeSystemVersion + - decode + id: $num_records_in_codesystemversion_with_decode + operator: record_count + - group: + - codeSystem + - codeSystemVersion + - code + - decode + id: $num_records_in_codesystemversion_with_code_decode + operator: record_count Outcome: - Message: 'There is not a one-to-one relationship between code and decode within a codeSytem and corresponding - codeSystemVersion' + Message: + "There is not a one-to-one relationship between code and decode within a codeSytem and corresponding + codeSystemVersion" Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - codeSystem - - codeSystemVersion - - code - - decode + - parent_entity + - parent_id + - parent_rel + - id + - codeSystem + - codeSystemVersion + - code + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000428/rule.yml b/Published/CORE-000428/rule.yml index 397db8f8d..5375c6b38 100644 --- a/Published/CORE-000428/rule.yml +++ b/Published/CORE-000428/rule.yml @@ -1,67 +1,71 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom - must be filled with "Start to Start".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00036' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom - must be filled with "Start to Start".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00036' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom + must be filled with "Start to Start".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00036" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom + must be filled with "Start to Start".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00036" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: relativeToFrom.code - operator: empty - - name: relativeToFrom.code - operator: not_equal_to - value: 'C201355' + - name: rel_type + operator: equal_to + value: "definition" + - name: type.code + operator: equal_to + value: "C201358" + - any: + - name: relativeToFrom.code + operator: empty + - name: relativeToFrom.code + operator: not_equal_to + value: "C201355" Core: Id: CORE-000428 Status: Published - Version: '1' -Description: 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom must + Version: "1" +Description: + 'If timing type is "Fixed Reference" then the corresponding attribute relativeToFrom must be filled with "Start to Start".' Executability: Fully Executable Outcome: - Message: 'Type is "Fixed Reference" (type.code=C201358) for the timing but relativeToFrom is not "Start + Message: + 'Type is "Fixed Reference" (type.code=C201358) for the timing but relativeToFrom is not "Start to Start" (relativeToFrom.code is not C201355).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeToFrom.code - - relativeToFrom.decode + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeToFrom.code + - relativeToFrom.decode Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000429/rule.yml b/Published/CORE-000429/rule.yml index 5c7687924..a73f6b0d1 100644 --- a/Published/CORE-000429/rule.yml +++ b/Published/CORE-000429/rule.yml @@ -1,34 +1,36 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Only applies to SENDIG-3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN - must be null and not populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND329' - Version: '1' - Version: '5.0' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN + must be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND329" + Version: "1" + Version: "5.0" + Version: "3.1.1" Check: all: - - name: PCORRES - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' - # report an error when either PCORRES does not represent a number - all: - # and PCSTRESN is populated - - name: PCSTRESN - operator: non_empty + - name: PCORRES + operator: not_matches_regex + value: "[+-]?([0-9]*[.])?[0-9]+$" + # report an error when either PCORRES does not represent a number - all: + # and PCSTRESN is populated + - name: PCSTRESN + operator: non_empty Core: Id: CORE-000429 Status: Published - Version: '1' -Description: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null + Version: "1" +Description: + If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null and not populated with the value of zero (0). Executability: Fully Executable Outcome: @@ -37,8 +39,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000430/rule.yml b/Published/CORE-000430/rule.yml index c7711cf2b..0e3f1e962 100644 --- a/Published/CORE-000430/rule.yml +++ b/Published/CORE-000430/rule.yml @@ -1,111 +1,118 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.0 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: WThe variable, --STRESC, is derived either by the conversion of values in - --ORRES to values with standard units, or by the assignment of the value of --ORRES. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND264 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Derived by the conversion of numeric values in --ORRES to numeric values - with standard units. The assigned of the value of --ORRES. - Document: TIG v1.0 - Item: Second Table, Num 2 - Section: 2.8.7.1 General Guidance - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0183 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.0 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + WThe variable, --STRESC, is derived either by the conversion of values in + --ORRES to values with standard units, or by the assignment of the value of --ORRES. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND264 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Derived by the conversion of numeric values in --ORRES to numeric values + with standard units. The assigned of the value of --ORRES. + Document: TIG v1.0 + Item: Second Table, Num 2 + Section: 2.8.7.1 General Guidance + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0183 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: empty - - name: --STRESC - operator: non_empty + - name: --ORRES + operator: empty + - name: --STRESC + operator: non_empty Core: Id: CORE-000430 Status: Published @@ -115,15 +122,15 @@ Executability: Fully Executable Outcome: Message: --STRESC must be be null as --ORRES is null. Output Variables: - - --ORRES - - --STRESC + - --ORRES + - --STRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000431/rule.yml b/Published/CORE-000431/rule.yml index cd0887c0d..e61dbe8e3 100644 --- a/Published/CORE-000431/rule.yml +++ b/Published/CORE-000431/rule.yml @@ -1,90 +1,90 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.0 - Item: Assumption 1.b - Section: 8.7.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A pool must consist of at least one subject. - Document: IG v3.1.1 - Item: Assumption 1.b - Section: 8.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND263 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.0 + Item: Assumption 1.b + Section: 8.7.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: A pool must consist of at least one subject. + Document: IG v3.1.1 + Item: Assumption 1.b + Section: 8.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND263 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: POOLID - operator: non_empty - - name: USUBJID - operator: empty + - name: POOLID + operator: non_empty + - name: USUBJID + operator: empty Core: Id: CORE-000431 Status: Published @@ -97,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Published/CORE-000432/rule.yml b/Published/CORE-000432/rule.yml index e84d7395e..c084714d5 100644 --- a/Published/CORE-000432/rule.yml +++ b/Published/CORE-000432/rule.yml @@ -1,115 +1,123 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TXPARMCD Short character value for the Trial Set parameter described in - TXPARM. Maximum 8 characters. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND232 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Short character value for the Trial Set parameter described in TXPARM. - Maximum 8 characters. - Document: TIG v1.0 - Item: TXPARMCD CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0160 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + TXPARMCD Short character value for the Trial Set parameter described in + TXPARM. Maximum 8 characters. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND232 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Short character value for the Trial Set parameter described in TXPARM. + Maximum 8 characters. + Document: TIG v1.0 + Item: TXPARMCD CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0160 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXPARMCD - operator: longer_than - value: 8 + - name: TXPARMCD + operator: longer_than + value: 8 Core: Id: CORE-000432 Status: Published Version: "1" -Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum +Description: + TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. Executability: Fully Executable Outcome: @@ -118,9 +126,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000433/rule.yml b/Published/CORE-000433/rule.yml index cd60b1255..776de468e 100644 --- a/Published/CORE-000433/rule.yml +++ b/Published/CORE-000433/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND231 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Unique number for this record within this dataset. (This sequence should be - unique within the entire dataset because there is no USUBJID.) - Document: TIG v1.0 - Item: TXSEQ CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0159 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND231 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Unique number for this record within this dataset. (This sequence should be + unique within the entire dataset because there is no USUBJID.) + Document: TIG v1.0 + Item: TXSEQ CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0159 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXSEQ - operator: is_not_unique_set - value: DOMAIN + - name: TXSEQ + operator: is_not_unique_set + value: DOMAIN Core: Id: CORE-000433 Status: Published @@ -117,9 +124,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000436/rule.yml b/Published/CORE-000436/rule.yml index bffcd553b..ea0e1058c 100644 --- a/Published/CORE-000436/rule.yml +++ b/Published/CORE-000436/rule.yml @@ -1,140 +1,149 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0275 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0275 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY # checking failure criteria - operator: not_equal_to - value: $val_dy # this is created in the operations statement that follows + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY # checking failure criteria + operator: not_equal_to + value: $val_dy # this is created in the operations statement that follows Core: Id: CORE-000436 Status: Published - Version: '1' -Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero - integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a + Version: "1" +Description: + Raise an error when --DY is not calculated as per the study day algorithm as a non-zero + integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not empty Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- id: $val_dy # ex in devops 2538 used -- but that threw an error - name: --DTC - operator: dy # does dy op take into acct +1? + - id: $val_dy # ex in devops 2538 used -- but that threw an error + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: - Message: --DY is not calculated correctly even though the date portion of --DTC is complete, the + Message: + --DY is not calculated correctly even though the date portion of --DTC is complete, the date portion of DM.RFSTDTC is a complete date, and --DY is not empty. Output Variables: - - --DY - - --DTC - - RFSTDTC + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000438/rule.yml b/Published/CORE-000438/rule.yml index 5449526d4..a0353ec7f 100644 --- a/Published/CORE-000438/rule.yml +++ b/Published/CORE-000438/rule.yml @@ -1,121 +1,122 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.0 - Item: Specification - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. - Document: IG v3.1.1 - Item: Specification - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND257 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Result of, response to, or value associated with QNAM. A value for this - column is required; no records can be in SUPP-- with a null value for QVAL. - Document: TIG v1.0 - Item: QVAL CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (SUPP--) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0175 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.0 + Item: Specification + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1 + Item: Specification + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1 + Item: Specification + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All records in the SUPP-- datasets must have a value for QVAL. + Document: IG v3.1.1 + Item: Specification + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND257 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Result of, response to, or value associated with QNAM. A value for this + column is required; no records can be in SUPP-- with a null value for QVAL. + Document: TIG v1.0 + Item: QVAL CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (SUPP--) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0175 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QVAL - operator: empty + - name: QVAL + operator: empty Core: Id: CORE-000438 Status: Published - Version: '1' + Version: "1" Description: All records in the SUPP-- datasets must have a value for QVAL. Executability: Fully Executable Outcome: Message: The record does not have a value for QVAL Output Variables: - - QNAM - - QLABEL + - QNAM + - QLABEL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000440/rule.yml b/Published/CORE-000440/rule.yml index 664f15849..75a2e255a 100644 --- a/Published/CORE-000440/rule.yml +++ b/Published/CORE-000440/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.0 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as scheduled in the study plan - Document: IG v3.1.1 - Section: 6.3.8.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND280' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not - completing the evaluation as described in the study plan. - Document: TIG v1.0 - Item: Assumption 4.h.ii - Section: 2.8.9.16 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0196 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.0 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as scheduled in the study plan + Document: IG v3.1.1 + Section: 6.3.8.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND280" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Whenever MISTAT is “NOT DONE”; MIREASND should provide the reason for not + completing the evaluation as described in the study plan. + Document: TIG v1.0 + Item: Assumption 4.h.ii + Section: 2.8.9.16 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0196 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - - name: --REASND - operator: empty + - name: --STAT + operator: equal_to + value: NOT DONE + - name: --REASND + operator: empty Core: Id: CORE-000440 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --STAT="NOT DONE" and --REASND is not populated Executability: Fully Executable Outcome: @@ -113,10 +120,10 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - MI + - LB + - MI Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000441/rule.yml b/Published/CORE-000441/rule.yml index 89a59f51a..214cc85f2 100644 --- a/Published/CORE-000441/rule.yml +++ b/Published/CORE-000441/rule.yml @@ -1,35 +1,36 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TFDTHREL must be "Y", "N", or "U" - Document: SENDIG v3.0 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND201 - Version: '1' - Version: '5.0' - # ATTENTION: for SENDIG 3.0 only - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TFDTHREL must be "Y", "N", or "U" + Document: SENDIG v3.0 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND201 + Version: "1" + Version: + "5.0" + # ATTENTION: for SENDIG 3.0 only + Version: "3.0" Check: all: # Remark: TFTDTREL cannot be null - - name: TFDTHREL - operator: not_equal_to - value: Y - - name: TFDTHREL - operator: not_equal_to - value: N - - name: TFDTHREL - operator: not_equal_to - value: U + - name: TFDTHREL + operator: not_equal_to + value: Y + - name: TFDTHREL + operator: not_equal_to + value: N + - name: TFDTHREL + operator: not_equal_to + value: U Core: Id: CORE-000441 Status: Published - Version: '1' + Version: "1" Description: Raise an error when record is TFDTHREL is not 'N', 'Y' or 'U' Executability: Fully Executable Outcome: @@ -38,8 +39,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Published/CORE-000442/rule.yml b/Published/CORE-000442/rule.yml index 0e1d5b77f..0d9bd47c5 100644 --- a/Published/CORE-000442/rule.yml +++ b/Published/CORE-000442/rule.yml @@ -1,43 +1,44 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'VSTPTNUM: Numerical version of VSTPT to aid in sorting; required if time points - are included within the domain.' - Document: IG v3.0 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND207 - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "VSTPTNUM: Numerical version of VSTPT to aid in sorting; required if time points + are included within the domain." + Document: IG v3.0 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND207 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: VSTPT - operator: non_empty - - name: VSTPTNUM - operator: empty + - name: VSTPT + operator: non_empty + - name: VSTPTNUM + operator: empty Core: Id: CORE-000442 Status: Published - Version: '1' + Version: "1" Description: When VSTPT is populated, VSTPTNUM must be populated Executability: Fully Executable Outcome: Message: VSTPTNUM is not populated although VSTPT is populated Output Variables: - - VSTPT - - VSTPTNUM + - VSTPT + - VSTPTNUM Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - VS + - VS Sensitivity: Record diff --git a/Published/CORE-000444/rule.yml b/Published/CORE-000444/rule.yml index b3d391387..bf6ab6085 100644 --- a/Published/CORE-000444/rule.yml +++ b/Published/CORE-000444/rule.yml @@ -1,74 +1,79 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Does not apply to SENDIG-3.0 and SENDIG-3.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with the term - "BLQ" for results below the limit and "ALQ" for results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with the term - "BLQ" for results below the limit and "ALQ" for results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Results beyond limits of quantitation should be represented with the term - "BLQ" for results below the limit and "ALQ" for results above the limit. - Document: IG v3.1.1 - Section: 6.3.11. - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND324' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND324" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND324" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Results beyond limits of quantitation should be represented with the term + "BLQ" for results below the limit and "ALQ" for results above the limit. + Document: IG v3.1.1 + Section: 6.3.11. + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND324" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: PCORRES - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' - # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ" - - name: PCSTRESC - operator: not_equal_to - value: 'BLQ' - - name: PCSTRESC - operator: not_equal_to - value: 'ALQ' + - name: PCORRES + operator: not_matches_regex + value: "[+-]?([0-9]*[.])?[0-9]+$" + # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ" + - name: PCSTRESC + operator: not_equal_to + value: "BLQ" + - name: PCSTRESC + operator: not_equal_to + value: "ALQ" Core: Id: CORE-000444 Status: Published - Version: '1' -Description: When Result is outside the Limit of Quantification, i.e. it is not a number (e.g. + Version: "1" +Description: + When Result is outside the Limit of Quantification, i.e. it is not a number (e.g. <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ" Executability: Fully Executable Outcome: - Message: The value in PCORRES is not a number (so represents a value outside the Limit of + Message: + The value in PCORRES is not a number (so represents a value outside the Limit of Quantification), in which case PCSTRESC must be either "BLQ" or "ALQ" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000445/rule.yml b/Published/CORE-000445/rule.yml index 18a0be0f2..462abd691 100644 --- a/Published/CORE-000445/rule.yml +++ b/Published/CORE-000445/rule.yml @@ -1,58 +1,61 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as a number - and populated in EXDOSE, this field is used to describe the amount of treatment - administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as a number - and populated in EXDOSE, this field is used to describe the amount of treatment - administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the amount of treatment administered cannot be represented as a number - and populated in EXDOSE, this field is used to describe the amount of treatment - administered. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND314' - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND314" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND314" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the amount of treatment administered cannot be represented as a number + and populated in EXDOSE, this field is used to describe the amount of treatment + administered. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND314" + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: EXDOSTXT - operator: non_empty - - name: EXDOSE - operator: non_empty + - name: EXDOSTXT + operator: non_empty + - name: EXDOSE + operator: non_empty Core: Id: CORE-000445 Status: Published - Version: '1' + Version: "1" Description: Raise an error when EXDOSE is populated when EXDOSTXT is populated Executability: Fully Executable Outcome: @@ -61,8 +64,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000446/rule.yml b/Published/CORE-000446/rule.yml index 710b084b9..04cb47f5c 100644 --- a/Published/CORE-000446/rule.yml +++ b/Published/CORE-000446/rule.yml @@ -1,107 +1,113 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.0 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --DTHREL Describes the relationship of a particular finding to the death of - a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not - available. - Document: SENDIG v3.1.1 - Section: Section 6.3.7-6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND183 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.0 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + --DTHREL Describes the relationship of a particular finding to the death of + a subject (Y=caused death, N=did not cause death, U=unknown). May be left null if not + available. + Document: SENDIG v3.1.1 + Section: Section 6.3.7-6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND183 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --DTHREL - operator: non_empty - - name: --DTHREL - operator: not_equal_to - value: Y - - name: --DTHREL - operator: not_equal_to - value: U - - name: --DTHREL - operator: not_equal_to - value: N + - name: --DTHREL + operator: non_empty + - name: --DTHREL + operator: not_equal_to + value: Y + - name: --DTHREL + operator: not_equal_to + value: U + - name: --DTHREL + operator: not_equal_to + value: N Core: Id: CORE-000446 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DTHREL is neither null nor 'Y', 'N' or 'U' Executability: Fully Executable Outcome: @@ -110,9 +116,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA - - MI + - MA + - MI Sensitivity: Record diff --git a/Published/CORE-000447/rule.yml b/Published/CORE-000447/rule.yml index 69db57dc7..c238e2375 100644 --- a/Published/CORE-000447/rule.yml +++ b/Published/CORE-000447/rule.yml @@ -1,101 +1,107 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.0 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND178 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.0 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND178 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: MATEST - operator: equal_to - value: Clinical Signs Follow-up - - name: MASPEC - operator: non_empty + - name: MATEST + operator: equal_to + value: Clinical Signs Follow-up + - name: MASPEC + operator: non_empty Core: Id: CORE-000447 Status: Published - Version: '1' + Version: "1" Description: When MATEST is 'Clinical Signs Follow-up' MASPEC should not be used. Executability: Fully Executable Outcome: @@ -104,8 +110,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Sensitivity: Record diff --git a/Published/CORE-000449/rule.yml b/Published/CORE-000449/rule.yml index 1a711d0e7..9185b57e0 100644 --- a/Published/CORE-000449/rule.yml +++ b/Published/CORE-000449/rule.yml @@ -1,68 +1,68 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study element must be referenced by at least one study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00040' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study element must be referenced by at least one study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00040' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Each study element must be referenced by at least one study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00040" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Each study element must be referenced by at least one study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00040" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyElement' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $num_el_refs - operator: empty - - name: $num_el_refs + - name: instanceType operator: equal_to - value: 0 + value: "StudyElement" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: $num_el_refs + operator: empty + - name: $num_el_refs + operator: equal_to + value: 0 Core: Id: "CORE-000449" Status: Published - Version: '1' -Description: 'Each study element must be referenced by at least one study cell.' + Version: "1" +Description: "Each study element must be referenced by at least one study cell." Executability: Fully Executable Operations: -- filter: - parent_entity: 'StudyCell' - parent_rel: 'elementIds' - rel_type: 'reference' - group: - - id - id: $num_el_refs - operator: record_count + - filter: + parent_entity: "StudyCell" + parent_rel: "elementIds" + rel_type: "reference" + group: + - id + id: $num_el_refs + operator: record_count Outcome: - Message: 'The study element is not referenced by any study cell.' + Message: "The study element is not referenced by any study cell." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - StudyElement + - StudyElement Sensitivity: Record diff --git a/Published/CORE-000451/rule.yml b/Published/CORE-000451/rule.yml index 727430957..c2c625b4a 100644 --- a/Published/CORE-000451/rule.yml +++ b/Published/CORE-000451/rule.yml @@ -1,228 +1,242 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of a specific Trial Set. SET: Long description of a specific - Trial Set, as defined by the sponsor.' - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND237' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'SETCD: Short name of the Trial Set. SET: Long description of a specific Trial - Set, as defined by the sponsor.' - Document: TIG v1.0 - Item: SETCD CDISC Notes | SET CDISC Notes - Section: 2.8.9.31 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0163 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0921 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of a specific Trial Set. SET: Long description of a specific + Trial Set, as defined by the sponsor." + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND237" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "SETCD: Short name of the Trial Set. SET: Long description of a specific Trial + Set, as defined by the sponsor." + Document: TIG v1.0 + Item: SETCD CDISC Notes | SET CDISC Notes + Section: 2.8.9.31 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0163 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0921 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: SETCD - operator: is_not_unique_relationship - value: SET + - name: SETCD + operator: is_not_unique_relationship + value: SET Core: Id: CORE-000451 Status: Published - Version: '1' + Version: "1" Description: SET and SETCD should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: SET and SETCD do not have a one-to-one relationship. Output Variables: - - SET - - SETCD + - SET + - SETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000454/rule.yml b/Published/CORE-000454/rule.yml index 7c18a6706..19966d6a4 100644 --- a/Published/CORE-000454/rule.yml +++ b/Published/CORE-000454/rule.yml @@ -1,129 +1,136 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, - equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not - collected or is missing). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, - equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not - collected or is missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, - equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not - collected or is missing). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, - equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not - collected or is missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Last date/time of exposure to any protocol-specified treatment or therapy, - equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not - collected or is missing). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND306 - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Last date/time of exposure to any protocol-specified treatment or therapy, + equal to the latest value of EXENDTC (or the latest value of EXSTDTC if EXENDTC was not + collected or is missing). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND306 + Version: "2" + Version: "5.0" + Version: "1.0" Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exendtc - - name: RFXENDTC - operator: not_equal_to - value: $max_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exendtc + - name: RFXENDTC + operator: not_equal_to + value: $max_ex_exstdtc Core: Id: CORE-000454 Status: Published - Version: '1' -Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the + Version: "1" +Description: + Raise an error when EX records are present for subject but RFXENDTC does not equal the latest value of EX.EXENDTC Executability: Fully Executable Operations: -- domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct -- domain: EX - group: - - USUBJID - id: $max_ex_exstdtc - name: EXSTDTC - operator: max_date -- domain: EX - group: - - USUBJID - id: $max_ex_exendtc - name: EXENDTC - operator: max_date + - domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct + - domain: EX + group: + - USUBJID + id: $max_ex_exstdtc + name: EXSTDTC + operator: max_date + - domain: EX + group: + - USUBJID + id: $max_ex_exendtc + name: EXENDTC + operator: max_date Outcome: - Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC + Message: + RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC if EX.EXENDTC is not present or not populated. Output Variables: - - RFXSTDTC - - $max_ex_exendtc - - $max_ex_exstdtc + - RFXSTDTC + - $max_ex_exendtc + - $max_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000455/rule.yml b/Published/CORE-000455/rule.yml index fbf6a8768..45b6320a9 100644 --- a/Published/CORE-000455/rule.yml +++ b/Published/CORE-000455/rule.yml @@ -1,113 +1,119 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: First date/time of exposure to any protocol-specified treatment or therapy, - equal to the earliest value of EXSTDTC. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND305 - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + First date/time of exposure to any protocol-specified treatment or therapy, + equal to the earliest value of EXSTDTC. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND305 + Version: "2" + Version: "5.0" + Version: "1.0" Check: all: - - name: USUBJID - operator: is_contained_by - value: $ex_usubjid - - name: RFXSTDTC - operator: not_equal_to - value: $min_ex_exstdtc + - name: USUBJID + operator: is_contained_by + value: $ex_usubjid + - name: RFXSTDTC + operator: not_equal_to + value: $min_ex_exstdtc Core: Id: CORE-000455 Status: Published - Version: '1' -Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the + Version: "1" +Description: + Raise an error when EX records are present for subject but RFXSTDTC does not equal the earliest value of EX.EXSTDTC Executability: Fully Executable Operations: -- domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct -- domain: EX - group: - - USUBJID - id: $min_ex_exstdtc - name: EXSTDTC - operator: min_date + - domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct + - domain: EX + group: + - USUBJID + id: $min_ex_exstdtc + name: EXSTDTC + operator: min_date Outcome: Message: RFXSTDTC does not equal the earliest value of EX.EXSTDTC Output Variables: - - RFXSTDTC - - $min_ex_exstdtc + - RFXSTDTC + - $min_ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000456/rule.yml b/Published/CORE-000456/rule.yml index e81d60f07..f166bc2e1 100644 --- a/Published/CORE-000456/rule.yml +++ b/Published/CORE-000456/rule.yml @@ -1,107 +1,113 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.0 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: MASPEC defines the base organ or tissue examined and is required when MATEST - is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs - Follow-up'. - Document: SENDIG v3.1.1 - Item: Assumption 4.b - Section: Section 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND177 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.0 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + MASPEC defines the base organ or tissue examined and is required when MATEST + is 'Gross Pathological Examination'. It should not be used when MATEST is 'Clinical Signs + Follow-up'. + Document: SENDIG v3.1.1 + Item: Assumption 4.b + Section: Section 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND177 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: MATEST - operator: equal_to - value: Gross Pathological Examination - - name: MASPEC - operator: empty + - name: MATEST + operator: equal_to + value: Gross Pathological Examination + - name: MASPEC + operator: empty Core: Id: CORE-000456 Status: Published - Version: '1' + Version: "1" Description: When MATEST is "Gross Pathological Examination" MASPEC is required. Executability: Fully Executable Outcome: @@ -110,8 +116,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Sensitivity: Record diff --git a/Published/CORE-000457/rule.yml b/Published/CORE-000457/rule.yml index 83baea898..d322007de 100644 --- a/Published/CORE-000457/rule.yml +++ b/Published/CORE-000457/rule.yml @@ -2,98 +2,102 @@ # Condition: SUPP-- dataset present in study # Rule: Dataset present in study with DOMAIN = SUPP--.RDOMAIN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset and it's - Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The - single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The - set of Supplemental Qualifiers for each domain is included in a separate dataset with the - name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers relate - back to. - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset and it's - Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The - single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The - set of Supplemental Qualifiers for each domain is included in a separate dataset with the - name SUPP-- where '--' denotes the source domain which the supplemental Qualifiers relate - back to. - Document: IG v3.2 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There is a one-to-one correspondence between a domain dataset and its - Supplemental Qualifier dataset. The single SUPPQUAL dataset option that was introduced in - SDTMIG v3.1 was deprecated. The set of Supplemental Qualifiers for each domain is included - in a separate dataset with the name SUPP-- where "--" denotes the source domain which the - Supplemental Qualifiers relate back to. - Document: IG v3.3 - Section: 8.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0373 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: There will be only one SUPP-- dataset for a parent dataset. Relationships - between records in the SUPP-- dataset and observations in the parent dataset are specified - using the key variables STUDYID, RDOMAIN (the domain code of the observation in the - relationship), USUBJID - Document: TIG 1.0 - Item: '' - Section: 2.8.5.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0537 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There is a one-to-one correspondence between a domain dataset and it's + Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The + single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The + set of Supplemental Qualifiers for each domain is included in a separate dataset with the + name SUPP-- where “--“ denotes the source domain which the supplemental Qualifiers relate + back to. + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There is a one-to-one correspondence between a domain dataset and it's + Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The + single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The + set of Supplemental Qualifiers for each domain is included in a separate dataset with the + name SUPP-- where '--' denotes the source domain which the supplemental Qualifiers relate + back to. + Document: IG v3.2 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There is a one-to-one correspondence between a domain dataset and its + Supplemental Qualifier dataset. The single SUPPQUAL dataset option that was introduced in + SDTMIG v3.1 was deprecated. The set of Supplemental Qualifiers for each domain is included + in a separate dataset with the name SUPP-- where "--" denotes the source domain which the + Supplemental Qualifiers relate back to. + Document: IG v3.3 + Section: 8.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0373 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + There will be only one SUPP-- dataset for a parent dataset. Relationships + between records in the SUPP-- dataset and observations in the parent dataset are specified + using the key variables STUDYID, RDOMAIN (the domain code of the observation in the + relationship), USUBJID + Document: TIG 1.0 + Item: "" + Section: 2.8.5.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0537 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000457 Status: Published - Version: '1' + Version: "1" Description: Trigger error when SUPP--.RDOMAIN does not represent a dataset present in the study Executability: Fully Executable Operations: -- id: $study_domains - operator: study_domains + - id: $study_domains + operator: study_domains Outcome: Message: SUPP--.RDOMAIN does not represent a dataset present in the study Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000458/rule.yml b/Published/CORE-000458/rule.yml index 77dfdc31d..ee8c34d58 100644 --- a/Published/CORE-000458/rule.yml +++ b/Published/CORE-000458/rule.yml @@ -1,140 +1,147 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness of subject records within a - domain. May be any valid number. - Document: SENDIG v3.0 - Item: EXSEQ CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a - given USUBJID within a domain. - Document: SENDIG v3.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a - given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a - given USUBJID within a domain. - Document: SENDIG v3.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a - given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Sequence Number (--SEQ) variable uniquely identifies a record for a - given USUBJID within a domain. - Document: SENDIG v3.1.1 - Item: Text - Section: '8' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND138 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: --SEQ Values uniquely identify records for subjects within a domain - Document: TIG v1.0 - Item: Table Row 4 - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0074 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sequence number given to ensure uniqueness of subject records within a + domain. May be any valid number. + Document: SENDIG v3.0 + Item: EXSEQ CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1 + Item: Text + Section: "8" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: "8" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1 + Item: Text + Section: "8" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: "8" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The Sequence Number (--SEQ) variable uniquely identifies a record for a + given USUBJID within a domain. + Document: SENDIG v3.1.1 + Item: Text + Section: "8" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND138 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: --SEQ Values uniquely identify records for subjects within a domain + Document: TIG v1.0 + Item: Table Row 4 + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0074 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: is_not_unique_set - value: USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: is_not_unique_set - value: POOLID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: is_not_unique_set + value: USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: is_not_unique_set + value: POOLID Core: Id: CORE-000458 Status: Published - Version: '1' -Description: Sequence number given to ensure uniqueness of subject records within a domain. May be + Version: "1" +Description: + Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Executability: Fully Executable Outcome: Message: --SEQ is not unique within USUBJID or POOLID Output Variables: - - USUBJID - - POOLID - - --SEQ + - USUBJID + - POOLID + - --SEQ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000459/rule.yml b/Published/CORE-000459/rule.yml index 8428fa372..49947ac2c 100644 --- a/Published/CORE-000459/rule.yml +++ b/Published/CORE-000459/rule.yml @@ -1,110 +1,116 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The units associated with the environmental temperature; only "C" or "F" is - acceptable. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND244.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The units associated with the environmental temperature; only "C" or "F" is + acceptable. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND244.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TXPARMCD - operator: equal_to - value: ENVTEMPU - # addition Jozef 2024-03-16 - # pre-condition is that TXVAL is not null - - name: TXVAL - operator: non_empty - # end of addition - - name: TXVAL - operator: not_equal_to - value: C - - name: TXVAL - operator: not_equal_to - value: F + - name: TXPARMCD + operator: equal_to + value: ENVTEMPU + # addition Jozef 2024-03-16 + # pre-condition is that TXVAL is not null + - name: TXVAL + operator: non_empty + # end of addition + - name: TXVAL + operator: not_equal_to + value: C + - name: TXVAL + operator: not_equal_to + value: F Core: Id: CORE-000459 Status: Published - Version: '1' + Version: "1" Description: The units associated with the environmental temperature; only "C" or "F" is acceptable. Executability: Fully Executable Outcome: @@ -113,8 +119,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000460/rule.yml b/Published/CORE-000460/rule.yml index e869076a2..ae6561fe8 100644 --- a/Published/CORE-000460/rule.yml +++ b/Published/CORE-000460/rule.yml @@ -1,106 +1,113 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Trial Set Parameters that include dates are required to be presented - according to the international standard ISO 8601 - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND243.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Trial Set Parameters that include dates are required to be presented + according to the international standard ISO 8601 + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND243.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - any: - - name: TXPARMCD - operator: equal_to - value: DOSENDTC - - name: TXPARMCD - operator: equal_to - value: DOSSTDTC - - name: TXVAL - operator: invalid_date + - any: + - name: TXPARMCD + operator: equal_to + value: DOSENDTC + - name: TXPARMCD + operator: equal_to + value: DOSSTDTC + - name: TXVAL + operator: invalid_date Core: Id: CORE-000460 Status: Published - Version: '1' -Description: Trial Set Parameters that include dates are required to be presented according to the + Version: "1" +Description: + Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Executability: Fully Executable Outcome: @@ -109,8 +116,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000461/rule.yml b/Published/CORE-000461/rule.yml index bd8d6d29d..9e6ef1420 100644 --- a/Published/CORE-000461/rule.yml +++ b/Published/CORE-000461/rule.yml @@ -1,31 +1,33 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.0 - Section: 6.3.7 | 6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182 - Version: '1' - Version: '5.0' - # ATTENTION: for SENDIG 3.0, only applicable to MA, MI. Not to LB, PC. - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.0 + Section: 6.3.7 | 6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182 + Version: "1" + Version: + "5.0" + # ATTENTION: for SENDIG 3.0, only applicable to MA, MI. Not to LB, PC. + Version: "3.0" Check: all: - - name: --SPCUFL - operator: non_empty - - name: --SPCUFL - operator: not_equal_to - value: N + - name: --SPCUFL + operator: non_empty + - name: --SPCUFL + operator: not_equal_to + value: N Core: Id: CORE-000461 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SPCUFL is not null and is not equal to 'N' Executability: Fully Executable Outcome: @@ -34,9 +36,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA - - MI + - MA + - MI Sensitivity: Record diff --git a/Published/CORE-000462/rule.yml b/Published/CORE-000462/rule.yml index 2ead0a713..91f1495c5 100644 --- a/Published/CORE-000462/rule.yml +++ b/Published/CORE-000462/rule.yml @@ -1,82 +1,87 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --SPCUFL describes the usability of the specimen for the test. Example, N = - the specimen is not usable; otherwise null. - Document: SENDIG v3.1.1 - Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND182.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + --SPCUFL describes the usability of the specimen for the test. Example, N = + the specimen is not usable; otherwise null. + Document: SENDIG v3.1.1 + Section: 6.3.6 | 6.3.7 | 6.3.8 | 6.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND182.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --SPCUFL - operator: non_empty - - name: --SPCUFL - operator: not_equal_to - value: N + - name: --SPCUFL + operator: non_empty + - name: --SPCUFL + operator: not_equal_to + value: N Core: Id: CORE-000462 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --SPCUFL is not null and is not equal to 'N' Executability: Fully Executable Outcome: @@ -85,11 +90,11 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - MA - - MI - - PC + - LB + - MA + - MI + - PC Sensitivity: Record diff --git a/Published/CORE-000463/rule.yml b/Published/CORE-000463/rule.yml index cfdd91f71..94db17fb7 100644 --- a/Published/CORE-000463/rule.yml +++ b/Published/CORE-000463/rule.yml @@ -1,103 +1,103 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG v3.0 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG v3.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG v3.1.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG-DART v1.1 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG-DART v1.2 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: SENDIG-GENETOX v1.0 - Section: Section 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND172 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record. The value should be Y or null. - Document: TIG v1.0 - Item: LBDRVFL CDISC Notes - Section: 2.8.9.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0102 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.0 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG v3.1.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-DART v1.1 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-DART v1.2 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: SENDIG-GENETOX v1.0 + Section: Section 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND172 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Used to indicate a derived record. The value should be Y or null. + Document: TIG v1.0 + Item: LBDRVFL CDISC Notes + Section: 2.8.9.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0102 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --DRVFL - operator: non_empty - - name: --DRVFL - operator: not_equal_to - value: Y + - name: --DRVFL + operator: non_empty + - name: --DRVFL + operator: not_equal_to + value: Y Core: Id: CORE-000463 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --DRVFL is not null and is not equal to 'Y' Executability: Fully Executable Outcome: @@ -106,9 +106,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000465/rule.yml b/Published/CORE-000465/rule.yml index 39b2c03b6..71e12f806 100644 --- a/Published/CORE-000465/rule.yml +++ b/Published/CORE-000465/rule.yml @@ -1,64 +1,67 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND295' - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND295" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND295" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND295" + Version: "1" + Version: "5.0" + Version: "1.1" Check: any: - - all: - - name: --STINT - operator: empty - - name: --ENINT - operator: non_empty - - all: - - name: --ENINT - operator: empty - - name: --STINT - operator: non_empty + - all: + - name: --STINT + operator: empty + - name: --ENINT + operator: non_empty + - all: + - name: --ENINT + operator: empty + - name: --STINT + operator: non_empty Core: Id: CORE-000465 Status: Published - Version: '1' + Version: "1" Description: WHEN --STINT ^= null OR --ENINT ^= null THEN --STINT ^= null AND --ENINT ^= null Executability: Fully Executable Outcome: @@ -67,8 +70,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000466/rule.yml b/Published/CORE-000466/rule.yml index e349dc73d..33f8b9380 100644 --- a/Published/CORE-000466/rule.yml +++ b/Published/CORE-000466/rule.yml @@ -1,79 +1,83 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a - performed test or observation was not driven by the study schedule. | Expected values are - Y or null. - Document: IG v3.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a - performed test or observation was not driven by the study schedule. | Expected values are - Y or null. - Document: IG v3.1.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a - performed test or observation was not driven by the study schedule. | Expected values are - Y or null. - Document: IG v3.1 - Section: '4.2.9|6.2.1 ' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND303' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: TIG - References: - - Citations: - - Cited Guidance: The Unscheduled Flag (--USCHFL) variable is populated when the timing of a - performed test or observation was not driven by the study schedule. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.5 - - Cited Guidance: Expected values are Y or null. - Document: TIG v1.0 - Item: DSUSCHFL CDISC Notes - Section: 2.8.7.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0215 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1 + Section: "4.2.9|6.2.1 " + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND303" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1.1 + Section: "4.2.9|6.2.1 " + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND303" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. | Expected values are + Y or null. + Document: IG v3.1 + Section: "4.2.9|6.2.1 " + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND303" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The Unscheduled Flag (--USCHFL) variable is populated when the timing of a + performed test or observation was not driven by the study schedule. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.5 + - Cited Guidance: Expected values are Y or null. + Document: TIG v1.0 + Item: DSUSCHFL CDISC Notes + Section: 2.8.7.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0215 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --USCHFL - operator: non_empty - - name: --USCHFL - operator: not_equal_to - value: Y + - name: --USCHFL + operator: non_empty + - name: --USCHFL + operator: not_equal_to + value: Y Core: Id: CORE-000466 Status: Published - Version: '1' + Version: "1" Description: --USCHFL must be either Y or null Executability: Fully Executable Outcome: @@ -82,11 +86,11 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - EVENTS - - INTERVENTIONS + - FINDINGS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000471/rule.yml b/Published/CORE-000471/rule.yml index fded2c069..11b1cf6a8 100644 --- a/Published/CORE-000471/rule.yml +++ b/Published/CORE-000471/rule.yml @@ -1,100 +1,106 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records - that contain collected or derived data.' - Document: IG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records - that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records - that contain collected or derived data.' - Document: IG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records - that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'EGEVAL: Role of the person who provided the evaluation. Should be null for records - that contain collected or derived data.' - Document: IG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND334' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data." + Document: IG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND334" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data." + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND334" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data." + Document: IG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND334" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data." + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND334" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "EGEVAL: Role of the person who provided the evaluation. Should be null for records + that contain collected or derived data." + Document: IG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND334" + Version: "1" + Version: "5.0" + Version: "1.0" Check: - # After discussion with SEND team: implemented as that + # After discussion with SEND team: implemented as that # - When EGCAT = MEASUREMENT then EGEVAL is null - # - When EGORRESU is not null then EGEVAL is null - # - P.S. Reason for taking EGORRESU (and not EGORRES) - # is that a value with a unit is not expected to be a subjective value + # - When EGORRESU is not null then EGEVAL is null + # - P.S. Reason for taking EGORRESU (and not EGORRES) + # is that a value with a unit is not expected to be a subjective value any: # report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated # Q: shouldn't be "case-sensitive" as it is under controlled terminology (which is uppercase) - - all: - - name: EGCAT - operator: equal_to_case_insensitive - value: 'MEASUREMENT' - - name: EGEVAL - operator: non_empty - # report an error when EGORRESU is not null and EGEVAL is populated - # the idea is that evaluations do not have a unit - - all: - - name: EGORRESU - operator: non_empty - - name: EGEVAL - operator: non_empty + - all: + - name: EGCAT + operator: equal_to_case_insensitive + value: "MEASUREMENT" + - name: EGEVAL + operator: non_empty + # report an error when EGORRESU is not null and EGEVAL is populated + # the idea is that evaluations do not have a unit + - all: + - name: EGORRESU + operator: non_empty + - name: EGEVAL + operator: non_empty Core: Id: CORE-000471 Status: Published - Version: '1' -Description: 'Report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated, or when - EGORRESU is not null and EGEVAL is populated' + Version: "1" +Description: + "Report an error when EGCAT=MEASUREMENT (case-insensitive) and EGEVAL is populated, or when + EGORRESU is not null and EGEVAL is populated" Executability: Partially Executable Outcome: Message: EGEVAL must be null for results that are collected or derived @@ -102,8 +108,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - EG + - EG Sensitivity: Record diff --git a/Published/CORE-000472/rule.yml b/Published/CORE-000472/rule.yml index e4d6e85d7..0f3706739 100644 --- a/Published/CORE-000472/rule.yml +++ b/Published/CORE-000472/rule.yml @@ -1,107 +1,108 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND150 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND150 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: BGDTC - operator: non_empty - - name: BGTESTCD - operator: is_not_unique_set - value: - - USUBJID - - BGDTC + - name: BGDTC + operator: non_empty + - name: BGTESTCD + operator: is_not_unique_set + value: + - USUBJID + - BGDTC Core: Id: CORE-000472 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular Body + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Body Weight Gain test, in the BG Domain, for a subject on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where BGDTC is null Outcome: Message: The Body Weight Gain test is not unique for this subject and date/time. Output Variables: - - USUBJID - - BGTESTCD - - BGDTC + - USUBJID + - BGTESTCD + - BGDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000474/rule.yml b/Published/CORE-000474/rule.yml index 41b6bb149..869af77be 100644 --- a/Published/CORE-000474/rule.yml +++ b/Published/CORE-000474/rule.yml @@ -1,104 +1,105 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.16 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND208.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.16 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND208.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: EGTESTCD - operator: is_not_unique_set - value: - - USUBJID - - EGDTC + - name: EGTESTCD + operator: is_not_unique_set + value: + - USUBJID + - EGDTC Core: Id: CORE-000474 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular ECG test + Version: "1" +Description: + Raise an error when there is more than one record present for any particular ECG test for a subject and measurement date/time. Executability: Partially Executable - Possible Underreporting Outcome: Message: The ECG test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - EGTESTCD - - EGDTC + - USUBJID + - EGTESTCD + - EGDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - EG + - EG Sensitivity: Record diff --git a/Published/CORE-000475/rule.yml b/Published/CORE-000475/rule.yml index d93d72ec3..6dd4aa445 100644 --- a/Published/CORE-000475/rule.yml +++ b/Published/CORE-000475/rule.yml @@ -1,124 +1,126 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.0 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per specimen per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.11 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND192 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.0 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per specimen per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.11 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND192 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: - - name: PCDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: PCTESTCD - operator: is_not_unique_set - value: - - USUBJID - - PCSPEC - - PCDTC - - all: - - name: PCDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: PCTESTCD - operator: is_not_unique_set - value: - - POOLID - - PCSPEC - - PCDTC + - all: + - name: PCDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: PCTESTCD + operator: is_not_unique_set + value: + - USUBJID + - PCSPEC + - PCDTC + - all: + - name: PCDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: PCTESTCD + operator: is_not_unique_set + value: + - POOLID + - PCSPEC + - PCDTC Core: Id: CORE-000475 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Pharmacokinetics Concentration, in the PC Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: - Message: The Pharmacokinetics Concentration test is not unique for this subject or pool and + Message: + The Pharmacokinetics Concentration test is not unique for this subject or pool and specimen and date/time. Output Variables: - - USUBJID - - POOLID - - PCTESTCD - - PCSPEC - - PCDTC + - USUBJID + - POOLID + - PCTESTCD + - PCSPEC + - PCDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000476/rule.yml b/Published/CORE-000476/rule.yml index 0d2140097..f95b18f12 100644 --- a/Published/CORE-000476/rule.yml +++ b/Published/CORE-000476/rule.yml @@ -1,45 +1,49 @@ Authorities: -- Organization: CDISC - # Remark: not applicable to SENDIG-3.1.1, which excludes PC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: IG v3.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: IG v3.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289' - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: + CDISC + # Remark: not applicable to SENDIG-3.1.1, which excludes PC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1 + Section: "4.4" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND289" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1 + Section: "4.4" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND289" + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty Core: Id: CORE-000476 Status: Published - Version: '1' -Description: When a domain belongs to the Findings General Observation Class, and the domain is one - in which data are usually collected at multiple study days, at least --DTC or --DY must be + Version: "1" +Description: + When a domain belongs to the Findings General Observation Class, and the domain is one + in which data are usually collected at multiple study days, at least --DTC or --DY must be populated. Executability: Fully Executable Outcome: @@ -48,19 +52,19 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW - - BG - - CL - - FW - - LB - - OM - - PM - - PC - - VS - - EG - - CV - - RE + - BW + - BG + - CL + - FW + - LB + - OM + - PM + - PC + - VS + - EG + - CV + - RE Sensitivity: Record diff --git a/Published/CORE-000477/rule.yml b/Published/CORE-000477/rule.yml index a8010f1d5..36847e26d 100644 --- a/Published/CORE-000477/rule.yml +++ b/Published/CORE-000477/rule.yml @@ -1,58 +1,63 @@ Authorities: -- Organization: CDISC - # Remark: This is the version for SENDIG-3.1.1, which excludes PC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In the Findings observation class, where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: IG v3.1.1 - Section: '4.4' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND289.1' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: + CDISC + # Remark: This is the version for SENDIG-3.1.1, which excludes PC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: "4.4" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND289.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: "4.4" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND289.1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + In the Findings observation class, where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: IG v3.1.1 + Section: "4.4" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND289.1" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty Core: Id: CORE-000477 Status: Published - Version: '1' -Description: When a domain belongs to the Findings General Observation Class, and the domain is one - in which data are usually collected at multiple study days, at least --DTC or --DY must be + Version: "1" +Description: + When a domain belongs to the Findings General Observation Class, and the domain is one + in which data are usually collected at multiple study days, at least --DTC or --DY must be populated. Executability: Fully Executable Outcome: @@ -61,19 +66,19 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW - - BG - - CL - - FW - - LB - - OM - - PM - # REMARK that for SENDIG-3.1.1, PC is not in the list anymore - - VS - - EG - - CV - - RE + - BW + - BG + - CL + - FW + - LB + - OM + - PM + # REMARK that for SENDIG-3.1.1, PC is not in the list anymore + - VS + - EG + - CV + - RE Sensitivity: Record diff --git a/Published/CORE-000478/rule.yml b/Published/CORE-000478/rule.yml index a88c6bcb9..ee962c1ae 100644 --- a/Published/CORE-000478/rule.yml +++ b/Published/CORE-000478/rule.yml @@ -1,89 +1,94 @@ Authorities: # ATTENTION: Not applicable to SENDIG-3.0 -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Time points with collections over a duration also typically include the - --STINT and --ENINT variables, which specify the start and end of the period over which - the assessment was evaluated, based on the --TPTREF anchor. - Document: IG v3.1.1 - Section: 4.4.7.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND294' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND294" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND294" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND294" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND294" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Time points with collections over a duration also typically include the + --STINT and --ENINT variables, which specify the start and end of the period over which + the assessment was evaluated, based on the --TPTREF anchor. + Document: IG v3.1.1 + Section: 4.4.7.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND294" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --STINT - operator: non_empty - - name: --ENINT - operator: non_empty - - name: --TPTREF - operator: empty + - name: --STINT + operator: non_empty + - name: --ENINT + operator: non_empty + - name: --TPTREF + operator: empty Core: Id: CORE-000478 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --STINT and -ENINT are populated but --TPTREF is not populated. Executability: Fully Executable Outcome: @@ -92,8 +97,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000479/rule.yml b/Published/CORE-000479/rule.yml index e5f885712..e8c2f0181 100644 --- a/Published/CORE-000479/rule.yml +++ b/Published/CORE-000479/rule.yml @@ -1,95 +1,95 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.0 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.1 - Item: Specification - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". - Document: IG v3.1.1 - Item: Specification - Section: 7.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND251" - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.0 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1 + Item: Specification + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: TSVAL values associated with TSPARMCD=SRANDOM would be "Y" or "N". + Document: IG v3.1.1 + Item: Specification + Section: 7.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND251" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SRANDOM - - name: TSVAL - operator: not_equal_to - value: Y - - name: TSVAL - operator: not_equal_to - value: N + - name: TSPARMCD + operator: equal_to + value: SRANDOM + - name: TSVAL + operator: not_equal_to + value: Y + - name: TSVAL + operator: not_equal_to + value: N Core: Id: CORE-000479 Status: Published @@ -102,8 +102,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000480/rule.yml b/Published/CORE-000480/rule.yml index 3633ed919..4f0131b49 100644 --- a/Published/CORE-000480/rule.yml +++ b/Published/CORE-000480/rule.yml @@ -1,104 +1,105 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per measurement per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.15 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND206 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per measurement per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.15 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND206 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: VSTESTCD - operator: is_not_unique_set - value: - - USUBJID - - VSDTC + - name: VSTESTCD + operator: is_not_unique_set + value: + - USUBJID + - VSDTC Core: Id: CORE-000480 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular Vital + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Vital Signs test for a subject and measurement date/time. Executability: Fully Executable Outcome: Message: The Vital Signs test is not unique for this subject and measurement datetime. Output Variables: - - USUBJID - - VSTESTCD - - VSDTC + - USUBJID + - VSTESTCD + - VSDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - VS + - VS Sensitivity: Record diff --git a/Published/CORE-000481/rule.yml b/Published/CORE-000481/rule.yml index 629d5929a..8ceb4eaa8 100644 --- a/Published/CORE-000481/rule.yml +++ b/Published/CORE-000481/rule.yml @@ -1,95 +1,101 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The reason the result should be excluded from all calculations. Used only - when BWEXCLFL is Y. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND149 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The reason the result should be excluded from all calculations. Used only + when BWEXCLFL is Y. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND149 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --EXCLFL - operator: not_equal_to - value: Y - - name: --REASEX - operator: non_empty + - name: --EXCLFL + operator: not_equal_to + value: Y + - name: --REASEX + operator: non_empty Core: Id: CORE-000481 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --REASEX is populated and --EXCLFL is not 'Y' Executability: Fully Executable Outcome: @@ -98,8 +104,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000482/rule.yml b/Published/CORE-000482/rule.yml index f19e79203..19c0c909f 100644 --- a/Published/CORE-000482/rule.yml +++ b/Published/CORE-000482/rule.yml @@ -1,109 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.0 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: SENDIG v3.1.1 - Item: BWEXCLFL Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND148 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. - Document: TIG v1.0 - Item: BWEXCLFL CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0084 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.0 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: SENDIG v3.1.1 + Item: BWEXCLFL Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND148 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Y if the result should be excluded from all calculations, otherwise null. + Document: TIG v1.0 + Item: BWEXCLFL CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0084 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --EXCLFL - operator: non_empty - - name: --EXCLFL - operator: not_equal_to - value: Y + - name: --EXCLFL + operator: non_empty + - name: --EXCLFL + operator: not_equal_to + value: Y Core: Id: CORE-000482 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --EXCLFL is populated and the value is different from "Y" Executability: Fully Executable Outcome: @@ -112,9 +112,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000484/rule.yml b/Published/CORE-000484/rule.yml index 9466ab1b8..c5347ee29 100644 --- a/Published/CORE-000484/rule.yml +++ b/Published/CORE-000484/rule.yml @@ -1,88 +1,92 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are considered - "related/associated." - Document: IG v3.4 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are considered - "related/associated." - Document: IG v3.2 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are considered - "related/associated." - Document: IG v3.3 - Item: Specification - Section: 8.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0200 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: All records for the same USUBJID that have the same RELID are considered - "related/associated." - Document: TIG 1.0 - Item: Specification-RELID - Section: 2.8.10.21 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0421 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.4 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.2 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: IG v3.3 + Item: Specification + Section: 8.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0200 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + All records for the same USUBJID that have the same RELID are considered + "related/associated." + Document: TIG 1.0 + Item: Specification-RELID + Section: 2.8.10.21 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0421 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: RELID -# Condition: +# Condition: # Rule: Within a subject each unique RELID is present on multiple RELREC records Check: all: - - name: RELID - operator: not_present_on_multiple_rows_within - within: USUBJID + - name: RELID + operator: not_present_on_multiple_rows_within + within: USUBJID Core: Id: CORE-000484 Status: Published - Version: '1' + Version: "1" Description: Within a subject, each unique RELID should be present on multiple RELREC records Executability: Fully Executable Outcome: Message: Unique RELID is NOT present on multiple RELREC records within a subject. Output Variables: - - RELID + - RELID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000485/rule.yml b/Published/CORE-000485/rule.yml index 59dd20c00..35f3608bb 100644 --- a/Published/CORE-000485/rule.yml +++ b/Published/CORE-000485/rule.yml @@ -1,129 +1,136 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND20 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it start with a - number (e.g., "1TEST" is not valid). - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0129 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND20 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters nor can it start with a + number (e.g., "1TEST" is not valid). + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0129 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QNAM - operator: longer_than - value: 8 + - name: QNAM + operator: longer_than + value: 8 Core: Id: CORE-000485 Status: Published - Version: '1' + Version: "1" Description: Raise an error when QNAM > 8 chars Executability: Fully Executable Outcome: Message: The value of QNAM has more than 8 chars Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000486/rule.yml b/Published/CORE-000486/rule.yml index caeb48142..01d09a749 100644 --- a/Published/CORE-000486/rule.yml +++ b/Published/CORE-000486/rule.yml @@ -1,102 +1,103 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.0 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per characteristic per subject - Document: SENDIG v3.1.1 - Section: 6.3.13 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND199 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.0 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per characteristic per subject + Document: SENDIG v3.1.1 + Section: 6.3.13 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND199 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: SCTESTCD - operator: is_not_unique_set - value: - - USUBJID + - name: SCTESTCD + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000486 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular Subject + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Subject Characteristics test for a subject. Executability: Fully Executable Outcome: Message: The Subject Characteristics test is not unique for this subject. Output Variables: - - USUBJID - - SCTESTCD + - USUBJID + - SCTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - SC + - SC Sensitivity: Record diff --git a/Published/CORE-000487/rule.yml b/Published/CORE-000487/rule.yml index 08896cd07..4a76b947b 100644 --- a/Published/CORE-000487/rule.yml +++ b/Published/CORE-000487/rule.yml @@ -1,105 +1,111 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The two-character domain code is limited to A to Z for the first character, - and A-Z, 0 to 9 for the second character and is always represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND33 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The two-character domain code is limited to A to Z for the first character, + and A-Z, 0 to 9 for the second character and is always represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND33 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000487 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the value of DOMAIN contains non-uppercase characters Executability: Fully Executable Outcome: Message: DOMAIN value must be uppercase Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000490/rule.yml b/Published/CORE-000490/rule.yml index a2e100228..098ed6c53 100644 --- a/Published/CORE-000490/rule.yml +++ b/Published/CORE-000490/rule.yml @@ -1,156 +1,164 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.0' -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.1' -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '3.1.1' -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.1' -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.2' -- Organization: CDISC - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND23' - Version: '1' - Version: '5.0' - Version: '1.0' -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: QNAM serves the same purpose as --TESTCD within supplemental qualifier - datasets, and so values of QNAM are subject to the same restrictions as values of --TESTCD - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 4 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0157 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: When extending a controlled terminology list, the case-sensitivity - convention of that list should be followed. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0157 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "3.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "3.1" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "1.1" + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "1.2" + - Organization: CDISC + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND23" + Version: "1" + Version: "5.0" + Version: "1.0" + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + QNAM serves the same purpose as --TESTCD within supplemental qualifier + datasets, and so values of QNAM are subject to the same restrictions as values of --TESTCD + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 4 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0157 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When extending a controlled terminology list, the case-sensitivity + convention of that list should be followed. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0157 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000490 Status: Published - Version: '1' + Version: "1" Description: Raise an error when QNAM has lowercase characters Executability: Partially Executable - Possible Overreporting Outcome: Message: --QNAM value must be uppercase Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000491/rule.yml b/Published/CORE-000491/rule.yml index aa21c9688..2736254df 100644 --- a/Published/CORE-000491/rule.yml +++ b/Published/CORE-000491/rule.yml @@ -1,113 +1,119 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND22 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND22 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: QNAM - operator: not_matches_regex - value: ^[A-Z0-9_]*$ + - name: QNAM + operator: not_matches_regex + value: ^[A-Z0-9_]*$ Core: Id: CORE-000491 Status: Published - Version: '1' + Version: "1" Description: Raise an error when QNAM contains anything else than a letter, number or underscore Executability: Fully Executable Outcome: Message: QNAM value cannot contain characters other than letters, numbers or underscores Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000492/rule.yml b/Published/CORE-000492/rule.yml index 2f33bd1eb..ebc55f44f 100644 --- a/Published/CORE-000492/rule.yml +++ b/Published/CORE-000492/rule.yml @@ -1,130 +1,137 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values of --TESTCD and QNAM values must be limited to 8 characters, and - cannot start with a number, nor can they contain characters other than letters, numbers, - or underscores. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND21 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in QNAM cannot be longer than 8 characters nor can it start with a - number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, - numbers, or underscores. - Document: TIG v1.0 - Item: QNAM CDISC Notes - Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0137 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values of --TESTCD and QNAM values must be limited to 8 characters, and + cannot start with a number, nor can they contain characters other than letters, numbers, + or underscores. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND21 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value in QNAM cannot be longer than 8 characters nor can it start with a + number (e.g., "1TEST" is not valid). QNAM cannot contain characters other than letters, + numbers, or underscores. + Document: TIG v1.0 + Item: QNAM CDISC Notes + Section: 2.8.9.27 SEND Supplemental Qualifiers (--SUPP) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0137 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QNAM - operator: matches_regex - value: ^[0-9] + - name: QNAM + operator: matches_regex + value: ^[0-9] Core: Id: CORE-000492 Status: Published - Version: '1' + Version: "1" Description: Raise an error when QNAM starts with a number Executability: Fully Executable Outcome: Message: QNAM may not start with a number Output Variables: - - IDVAR - - IDVARVAL - - QNAM + - IDVAR + - IDVARVAL + - QNAM Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000493/rule.yml b/Published/CORE-000493/rule.yml index 1ef9e0ae1..366930512 100644 --- a/Published/CORE-000493/rule.yml +++ b/Published/CORE-000493/rule.yml @@ -1,163 +1,168 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. It should be presented in number-number format.. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. It should be presented in number-number format.. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. It should be presented in number-number format.. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. It should be presented in number-number format.. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND102 - Version: '1' - Version: '5.0' - Version: '1.1' - # FDA Business rule FB5301 is identical, so extending the scope here - # FB5301 as of SEND 3.1 -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5301' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. It should be presented in number-number format.. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND102 + Version: "1" + Version: "5.0" + Version: "1.1" + # FDA Business rule FB5301 is identical, so extending the scope here + # FB5301 as of SEND 3.1 + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5301" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: AGETXT - operator: non_empty - - name: AGETXT - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: AGETXT + operator: non_empty + - name: AGETXT + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000493 Status: Published - Version: '1' -Description: Age Range (AGETXT) should be populated with a number-number format when age range is + Version: "1" +Description: + Age Range (AGETXT) should be populated with a number-number format when age range is supplied. Executability: Fully Executable Outcome: Message: AGETXT is not in number - number format. Output Variables: - - USUBJID - - AGETXT + - USUBJID + - AGETXT Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000494/rule.yml b/Published/CORE-000494/rule.yml index cfbea0475..257d2c941 100644 --- a/Published/CORE-000494/rule.yml +++ b/Published/CORE-000494/rule.yml @@ -1,137 +1,145 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.0 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Role of the variable, which determines how the variable is used in the dataset. - For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, - Topic, Timing, or the five types of Qualifiers" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND9.1 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.0 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Role of the variable, which determines how the variable is used in the dataset. + For SEND Domain. Models, Roles are used to represent the categories of variables such as Identifier, + Topic, Timing, or the five types of Qualifiers" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND9.1 + Version: "1" + Version: "5.0" + Version: "1.0" # REMARK: this will ONLY validate the define.xml dataset definitions # for which a dataset is actually being provided Check: all: - - name: define_variable_name - operator: equal_to - value: library_variable_name - - name: define_variable_role - operator: not_equal_to - value: library_variable_role + - name: define_variable_name + operator: equal_to + value: library_variable_name + - name: define_variable_role + operator: not_equal_to + value: library_variable_role Core: Id: CORE-000494 Status: Published Version: "1" -Description: Raise an error when the role provided in the define.xml does not correspond to the role +Description: + Raise an error when the role provided in the define.xml does not correspond to the role in the IG Executability: Fully Executable Outcome: - Message: The Role of the variable in the define.xml does not correspond to the Role given by the + Message: + The Role of the variable in the define.xml does not correspond to the Role given by the Implementation Guide Output Variables: - - define_variable_label - - define_variable_name - - define_variable_role - - library_variable_name - - library_variable_role + - define_variable_label + - define_variable_name + - define_variable_role + - library_variable_name + - library_variable_role # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000495/rule.yml b/Published/CORE-000495/rule.yml index 9c066c492..9d543053c 100644 --- a/Published/CORE-000495/rule.yml +++ b/Published/CORE-000495/rule.yml @@ -1,126 +1,128 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND175 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ma.xpt, Macroscopic Findings - Findings. One record per finding per specimen - per subject, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.15 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0104 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND175 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ma.xpt, Macroscopic Findings - Findings. One record per finding per specimen + per subject, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.15 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0104 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: MAORRES - operator: non_empty - - name: MASPEC - operator: non_empty - - name: MAORRES - operator: is_not_unique_set - value: - - USUBJID - - MATESTCD - - MASPEC + - name: MAORRES + operator: non_empty + - name: MASPEC + operator: non_empty + - name: MAORRES + operator: is_not_unique_set + value: + - USUBJID + - MATESTCD + - MASPEC Core: Id: CORE-000495 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Macroscopic Finding test and result in the MA Domain, within a subject. Executability: Fully Executable Outcome: Message: The Macroscopic Finding test result is not unique for this subject and test. Output Variables: - - USUBJID - - MATESTCD - - MAORRES - - MASPEC + - USUBJID + - MATESTCD + - MAORRES + - MASPEC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MA + - MA Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000496/rule.yml b/Published/CORE-000496/rule.yml index 1259aab61..8dfd8204d 100644 --- a/Published/CORE-000496/rule.yml +++ b/Published/CORE-000496/rule.yml @@ -1,150 +1,165 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.0' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.1.1' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.1.1' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Food and Water Consumption - Findings. One record per test per interval per subject - or pool' - Document: 'IG v.3.1' - Item: 'Domain table header' - Section: '6.3.5' - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND168' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: fw.xpt, Food and Water Consumption - Findings. One record per test per - interval per subject or pool, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.12 - # REMARK: Both FWDTC and FWENDTC are "expected" variables - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0097 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.0" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.1" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.1.1" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.1" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.1.1" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "Food and Water Consumption - Findings. One record per test per interval per subject + or pool" + Document: "IG v.3.1" + Item: "Domain table header" + Section: + "6.3.5" + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND168" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + fw.xpt, Food and Water Consumption - Findings. One record per test per + interval per subject or pool, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: + 2.8.9.12 + # REMARK: Both FWDTC and FWENDTC are "expected" variables + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0097 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - all: + - all: # we must first test on USUBJID being populated - - name: USUBJID - operator: non_empty - - name: FWTESTCD - operator: 'is_not_unique_set' - value: - - USUBJID - - FWDTC - - FWENDTC - - all: + - name: USUBJID + operator: non_empty + - name: FWTESTCD + operator: "is_not_unique_set" + value: + - USUBJID + - FWDTC + - FWENDTC + - all: # we must first test on POOLID being populated - - name: POOLID - operator: non_empty - - name: FWTESTCD - operator: 'is_not_unique_set' - value: - - POOLID - - FWDTC - - FWENDTC + - name: POOLID + operator: non_empty + - name: FWTESTCD + operator: "is_not_unique_set" + value: + - POOLID + - FWDTC + - FWENDTC Core: Id: CORE-000496 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'Structure must be one record per test per interval (as defined by FWDTC and FWENDTC) per subject - or pool' + Message: + "Structure must be one record per test per interval (as defined by FWDTC and FWENDTC) per subject + or pool" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - FW + - FW Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000498/rule.yml b/Published/CORE-000498/rule.yml index 679929cb5..54075af29 100644 --- a/Published/CORE-000498/rule.yml +++ b/Published/CORE-000498/rule.yml @@ -1,125 +1,132 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGETXT is used to present the age range in situations where the exact - birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be - populated. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND103 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + AGETXT is used to present the age range in situations where the exact + birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be + populated. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND103 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: AGETXT - operator: non_empty - - any: - - name: BRTHDTC - operator: non_empty - - name: AGE + - name: AGETXT operator: non_empty + - any: + - name: BRTHDTC + operator: non_empty + - name: AGE + operator: non_empty Core: Id: CORE-000498 Status: Published - Version: '1' -Description: AGETXT is used to present the age range in situations where the exact birthdate is not + Version: "1" +Description: + AGETXT is used to present the age range in situations where the exact birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be populated. Executability: Fully Executable Outcome: Message: AGETXT is populated, so neither BRTHDTC nor AGE may be populated Output Variables: - - USUBJID - - AGETXT - - BRTHDTC - - AGE + - USUBJID + - AGETXT + - BRTHDTC + - AGE Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000499/rule.yml b/Published/CORE-000499/rule.yml index 068cbc791..43ba227f9 100644 --- a/Published/CORE-000499/rule.yml +++ b/Published/CORE-000499/rule.yml @@ -1,114 +1,121 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.0 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: om.xpt, Organ Measurements - Findings. One record per test per specimen per - subject, Tabulation. - Document: SENDIG v3.1.1 - Section: 6.3.9 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND188 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.0 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + om.xpt, Organ Measurements - Findings. One record per test per specimen per + subject, Tabulation. + Document: SENDIG v3.1.1 + Section: 6.3.9 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND188 + Version: "1" + Version: "5.0" + Version: "1.0" # IMPORTANT REMARK: after discussion with the SEND team, it was decided to NOT include other variables # like OMLAT, OMDIR, OMDTC, as these relate to very unusual situations. Check: all: - - name: OMSPEC - operator: non_empty - - name: OMSPEC - operator: is_not_unique_set - value: - - USUBJID - - OMTESTCD + - name: OMSPEC + operator: non_empty + - name: OMSPEC + operator: is_not_unique_set + value: + - USUBJID + - OMTESTCD Core: Id: CORE-000499 Status: Published Version: "1" -Description: Raise an error when there is more than one record present per subject for any +Description: + Raise an error when there is more than one record present per subject for any particular Organ Measurement test in the OM Domain Executability: Fully Executable Outcome: Message: The Organ Measurement test is not unique for this subject. Output Variables: - - USUBJID - - OMTESTCD - - OMSPEC + - USUBJID + - OMTESTCD + - OMSPEC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Published/CORE-000500/rule.yml b/Published/CORE-000500/rule.yml index d885e725b..a62be0a05 100644 --- a/Published/CORE-000500/rule.yml +++ b/Published/CORE-000500/rule.yml @@ -1,81 +1,81 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set - Document: IG v3.0 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set - Document: IG v3.1 - Item: Specification - Section: 7.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND230 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: TIG - References: - - Citations: - - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0158 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.0 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set + Document: IG v3.1 + Item: Specification + Section: 7.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND230 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: TIG + References: + - Citations: + - Cited Guidance: Trial Sets - Trial Design. One record per Trial Set parameter per Trial Set. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0158 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXPARMCD - operator: is_not_unique_set - value: SETCD + - name: TXPARMCD + operator: is_not_unique_set + value: SETCD Core: Id: CORE-000500 Status: Published - Version: '1' + Version: "1" Description: Combination of SETCD and TXPARMCD must be unique Executability: Fully Executable Outcome: @@ -84,9 +84,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000502/rule.yml b/Published/CORE-000502/rule.yml index 8f61fd7a2..437657a93 100644 --- a/Published/CORE-000502/rule.yml +++ b/Published/CORE-000502/rule.yml @@ -2,107 +2,113 @@ # Condition: RDOMAIN ^= null # Rule: RDOMAIN is dataset in study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include 1 standardized set of observations in a specific - structure; this is the Demographics domain described here. - Document: Model v2.0 - Item: RDOMAIN - Section: Comments - - Cited Guidance: Each study must include 1 standardized set of observations in a specific - structure; this is the Demographics domain described here. - Document: Model v2.0 - Item: RDOMAIN - Section: Supplemental Qualifiers - - Cited Guidance: Each study must incude 1 standardized set of observations in a specific - structure; this is the Demographics domain described here. - Document: Model v2.0 - Item: RDOMAIN - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Domain Abbreviation of the parent record(s). - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Domain Abbreviation of the parent record(s). - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0369 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Comments[Each study must include 1 standardized set of observations in a - specific structure; this is the Demographics domain described here.]|Supplemental - Qualifiers[Each study must include 1 standardized set of observations in a specific - structure; this is the Demographics domain described here.]|Related Records[Each study - must include 1 standardized set of observations in a specific structure; this is the - Demographics domain described here.] - Document: SDTM v2.1 - Item: RDOMAIN - Section: 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1 Related Records - Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0533 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Comments + - Cited Guidance: + Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Supplemental Qualifiers + - Cited Guidance: + Each study must incude 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Item: RDOMAIN + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Domain Abbreviation of the parent record(s). + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Domain Abbreviation of the parent record(s). + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0369 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Comments[Each study must include 1 standardized set of observations in a + specific structure; this is the Demographics domain described here.]|Supplemental + Qualifiers[Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here.]|Related Records[Each study + must include 1 standardized set of observations in a specific structure; this is the + Demographics domain described here.] + Document: SDTM v2.1 + Item: RDOMAIN + Section: + 3.2.2 Comments| 6.2 Supplemental Qualifiers Datasets | Section 6.1 Related Records + Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0533 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: non_empty - - name: RDOMAIN - operator: is_not_contained_by - value: $study_domains + - name: RDOMAIN + operator: non_empty + - name: RDOMAIN + operator: is_not_contained_by + value: $study_domains Core: Id: CORE-000502 Status: Published - Version: '1' -Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a + Version: "1" +Description: + Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a dataset in the present study Executability: Fully Executable Operations: -- id: $study_domains - operator: study_domains + - id: $study_domains + operator: study_domains Outcome: Message: RDOMAIN does not represent a dataset present in the study. Output Variables: - - RDOMAIN - - $study_domains + - RDOMAIN + - $study_domains Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - CO - - RELREC - - SUPP-- + - CO + - RELREC + - SUPP-- Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000503/rule.yml b/Published/CORE-000503/rule.yml index cd922a879..02905cf31 100644 --- a/Published/CORE-000503/rule.yml +++ b/Published/CORE-000503/rule.yml @@ -1,150 +1,159 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.0 - Item: QORIG CDISC Notes - Section: "8.5" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: SENDIG v3.1.1 - Item: QORIG CDISC Notes - Section: "8.3" - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND255" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: QORIG is used to indicate the origin of the data. Possible values are - COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. - Document: TIG v1.0 - Item: QORIG CDISC Notes - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0173 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.0 + Item: QORIG CDISC Notes + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: SENDIG v3.1.1 + Item: QORIG CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND255" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + QORIG is used to indicate the origin of the data. Possible values are + COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. + Document: TIG v1.0 + Item: QORIG CDISC Notes + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0173 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: QORIG - operator: exists - - name: QORIG - operator: non_empty - - name: QORIG - operator: not_equal_to - value: COLLECTED - - name: QORIG - operator: not_equal_to - value: DERIVED - - name: QORIG - operator: not_equal_to - value: OTHER - - name: QORIG - operator: not_equal_to - value: NOT AVAILABLE - # Simplification 2024-05-21 - # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation - # see e.g. CG0118 - # - name: QORIG - # operator: is_not_contained_by - # value: - # - COLLECTED - # - DERIVED - # - OTHER - # - NOT AVAILABLE + - name: QORIG + operator: exists + - name: QORIG + operator: non_empty + - name: QORIG + operator: not_equal_to + value: COLLECTED + - name: QORIG + operator: not_equal_to + value: DERIVED + - name: QORIG + operator: not_equal_to + value: OTHER + - name: QORIG + operator: not_equal_to + value: NOT AVAILABLE + # Simplification 2024-05-21 + # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation + # see e.g. CG0118 + # - name: QORIG + # operator: is_not_contained_by + # value: + # - COLLECTED + # - DERIVED + # - OTHER + # - NOT AVAILABLE Core: Id: CORE-000503 Status: Published Version: "1" -Description: QORIG is used to indicate the origin of the data. Possible values are COLLECTED, +Description: + QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. Executability: Fully Executable Outcome: - Message: When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER, + Message: + When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000505/rule.yml b/Published/CORE-000505/rule.yml index 8a585c89b..8a83ca494 100644 --- a/Published/CORE-000505/rule.yml +++ b/Published/CORE-000505/rule.yml @@ -2,193 +2,206 @@ # Condition: TSPARMCD = SSTDTC (Study Start Date) # Rule: TSVAL conforms to ISO 8601 date Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0285 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included Appendix C1, Trial - Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. - Conditions for including parameters are included in Appendix C1, Trial Summary Codes. - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0285 - Version: '1' - Version: '2.0' - Version: '3.3' - ##CGO285 is similar to TRC1734c. Added FDA Business rule. -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734c - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0285 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included Appendix C1, Trial + Summary Codes. TSVAL may have controlled terminology depending on the value of TSPARMCD. + Conditions for including parameters are included in Appendix C1, Trial Summary Codes. + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0285 + Version: "1" + Version: "2.0" + Version: "3.3" + ##CGO285 is similar to TRC1734c. Added FDA Business rule. + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734c + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SSTDTC - - name: TSVAL - operator: invalid_date + - name: TSPARMCD + operator: equal_to + value: SSTDTC + - name: TSVAL + operator: invalid_date Core: Id: CORE-000505 Status: Published - Version: '1' -Description: Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601 + Version: "1" +Description: + Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601 format. Executability: Fully Executable Outcome: @@ -197,8 +210,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000507/rule.yml b/Published/CORE-000507/rule.yml index 3e7c85b22..6083cfdf1 100644 --- a/Published/CORE-000507/rule.yml +++ b/Published/CORE-000507/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.0 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.0 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # IMPORTANT: Order is important ... - - name: variable_label - operator: not_equal_to - value: define_variable_label + - name: variable_label + operator: not_equal_to + value: define_variable_label Core: Id: CORE-000507 Status: Published - Version: '1' -Description: 'Raise an error when the variable label in the define.xml does not correspond to the variable + Version: "1" +Description: + "Raise an error when the variable label in the define.xml does not correspond to the variable label dataset. NOTE: This rule has been split in two parts: A. check define variable label against IG - label B. check define variable label against the label in the dataset ' + label B. check define variable label against the label in the dataset " Executability: Fully Executable Outcome: Message: The label of the variable is incorrect Output Variables: - - define_variable_name - - define_variable_label - - variable_label + - define_variable_name + - define_variable_label + - variable_label Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000508/rule.yml b/Published/CORE-000508/rule.yml index 4e0b10e83..8ccd85d44 100644 --- a/Published/CORE-000508/rule.yml +++ b/Published/CORE-000508/rule.yml @@ -1,108 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.0 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND191' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.0 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND191" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: PMDTC - operator: non_empty - - name: PMDTC - operator: is_not_unique_set - value: - - USUBJID - - PMTESTCD - - PMORRES + - name: PMDTC + operator: non_empty + - name: PMDTC + operator: is_not_unique_set + value: + - USUBJID + - PMTESTCD + - PMORRES Core: Id: CORE-000508 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular Palpable + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Palpable Mass test per Palpable Mass test in the PM Domain, for a subject on a particular date. Executability: Fully Executable Outcome: Message: The palpable mass test and result is not unique for this subject and date/time. Output Variables: - - USUBJID - - PMTESTCD - - PMORRES - - PMDTC + - USUBJID + - PMTESTCD + - PMORRES + - PMDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PM + - PM Sensitivity: Record diff --git a/Published/CORE-000509/rule.yml b/Published/CORE-000509/rule.yml index 0e95de5ff..4b7cd5857 100644 --- a/Published/CORE-000509/rule.yml +++ b/Published/CORE-000509/rule.yml @@ -1,133 +1,135 @@ # Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.0 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Either the AGE or the AGETXT variable should be populated. - Document: IG v3.1.1 - Section: 3.7.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND250 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.0 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Either the AGE or the AGETXT variable should be populated. + Document: IG v3.1.1 + Section: 3.7.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND250 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: + - all: # count # record for which TSPARMCD=AGETXT and for which TXPARMCD=AGE # throw error when both counts >= 1 - - name: $record_count_AGETXT - operator: greater_than_or_equal_to - value: 1 - - name: $record_count_AGE - operator: greater_than_or_equal_to - value: 1 - # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present - # Both counts are 0 - - all: - - name: $record_count_AGETXT - operator: equal_to - value: 0 - - name: $record_count_AGE - operator: equal_to - value: 0 + - name: $record_count_AGETXT + operator: greater_than_or_equal_to + value: 1 + - name: $record_count_AGE + operator: greater_than_or_equal_to + value: 1 + # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present + # Both counts are 0 + - all: + - name: $record_count_AGETXT + operator: equal_to + value: 0 + - name: $record_count_AGE + operator: equal_to + value: 0 Core: Id: CORE-000509 Status: Published - Version: '1' -Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not + Version: "1" +Description: + Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Executability: Fully Executable Operations: # Record count for TSPARMCD=AGE (for reporting reasons) -- filter: - TSPARMCD: AGE - id: $record_count_AGE - operator: record_count - # Record count for TSPARMCD=AGETXT -- filter: - TSPARMCD: AGETXT - id: $record_count_AGETXT - operator: record_count + - filter: + TSPARMCD: AGE + id: $record_count_AGE + operator: record_count + # Record count for TSPARMCD=AGETXT + - filter: + TSPARMCD: AGETXT + id: $record_count_AGETXT + operator: record_count Outcome: - Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not + Message: + Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Output Variables: #- TSPARMCD #- TSVAL - - $record_count_AGE - - $record_count_AGETXT + - $record_count_AGE + - $record_count_AGETXT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS # IMPORTANT: Sensitivity=Dataset Sensitivity: Dataset diff --git a/Published/CORE-000511/rule.yml b/Published/CORE-000511/rule.yml index f5abd94f7..67d6dfcbf 100644 --- a/Published/CORE-000511/rule.yml +++ b/Published/CORE-000511/rule.yml @@ -1,115 +1,116 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # ATTENTION: Rules 189 and 189.1 have been combined as only the "cited guidance" differs. - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight will be recorded in the BW domain and this is indicated - by the test code (BWTESTCD) of TERMBW. - Document: IG v3.0 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. - Document: IG v3.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. - Document: IG v3.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. - Document: IG v3.1.1 - Item: Assumption 2 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND189.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Terminal Body Weight will be recorded in the BW domain and this is indicated + by the test code (BWTESTCD) of TERMBW. + Document: IG v3.0 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Terminal Body Weight belongs in the BW domain, not in the OM domain. + Document: IG v3.1.1 + Item: Assumption 2 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND189.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # implemented as that --TESTCD=TERMBW may only appear for DOMAIN=BWn(in Findings) - - name: DOMAIN - operator: not_equal_to - value: BW - - name: --TESTCD - operator: equal_to - value: TERMBW + - name: DOMAIN + operator: not_equal_to + value: BW + - name: --TESTCD + operator: equal_to + value: TERMBW Core: Id: CORE-000511 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --TESTCD=TERMBW is used in another findings domain than BW Executability: Fully Executable Outcome: Message: --TESTCD=TERMBW may only be used in the BW domain Output Variables: - - DOMAIN - - --TESTCD + - DOMAIN + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000513/rule.yml b/Published/CORE-000513/rule.yml index 24947f7ab..5a975fca6 100644 --- a/Published/CORE-000513/rule.yml +++ b/Published/CORE-000513/rule.yml @@ -1,43 +1,44 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: BGENDTC must be populated when BGTESTCD is representing Average Body Weight - Gain (BWGAINA) - Document: IG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND152.1 - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + BGENDTC must be populated when BGTESTCD is representing Average Body Weight + Gain (BWGAINA) + Document: IG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND152.1 + Version: "1" + Version: "5.0" + Version: "3.0" # REMARK: this rule is only applicable to SENDIG-3.0, not to later versions Check: all: - - name: BGTESTCD - operator: equal_to - value: BWGAINA - - name: BGENDTC - operator: empty + - name: BGTESTCD + operator: equal_to + value: BWGAINA + - name: BGENDTC + operator: empty Core: Id: CORE-000513 Status: Published - Version: '1' + Version: "1" Description: Raise an error when BGENDTC is empty when BGTESTCD=BWGAINA Executability: Fully Executable Outcome: Message: BGENDTC is empty for BGTESTCD=BWGAINA Output Variables: - - BGTESTCD + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000514/rule.yml b/Published/CORE-000514/rule.yml index fa5ad0dd1..3ff3ceaa4 100644 --- a/Published/CORE-000514/rule.yml +++ b/Published/CORE-000514/rule.yml @@ -1,43 +1,44 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Date/time of the end of the weight interval in ISO 8601 format. This must - be populated when BGTESTCD is BWGAINA. - Document: IG v3.0 - Section: 6.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND151.1 - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Date/time of the end of the weight interval in ISO 8601 format. This must + be populated when BGTESTCD is BWGAINA. + Document: IG v3.0 + Section: 6.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND151.1 + Version: "1" + Version: "5.0" + Version: "3.0" # REMARK: this rule is only applicable to SENDIG-3.0, not to later versions Check: all: - - name: BGTESTCD - operator: equal_to - value: BWGAINA - - name: BGDTC - operator: empty + - name: BGTESTCD + operator: equal_to + value: BWGAINA + - name: BGDTC + operator: empty Core: Id: CORE-000514 Status: Published - Version: '1' + Version: "1" Description: Raise an error when both BGDTC is empty when BGTESTCD=BWGAINA Executability: Fully Executable Outcome: Message: BGDTC is empty for BGTESTCD=BWGAINA Output Variables: - - BGTESTCD + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Published/CORE-000516/rule.yml b/Published/CORE-000516/rule.yml index 89a5a4f48..6d7e01e03 100644 --- a/Published/CORE-000516/rule.yml +++ b/Published/CORE-000516/rule.yml @@ -1,153 +1,154 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: The value for study day should not be negative for exposure treatments. - Document: FDA - Section: FDAB036 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3601 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: The value for study day should not be negative for exposure treatments. + Document: FDA + Section: FDAB036 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3601 + Version: "1" + Version: "1.5" + Version: "1.0" Check: any: - - name: --STDY - operator: less_than - value: 0 - - name: --ENDY - operator: less_than - value: 0 + - name: --STDY + operator: less_than + value: 0 + - name: --ENDY + operator: less_than + value: 0 Core: Id: CORE-000516 Status: Published - Version: '1' -Description: 'Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should - not be negative for exposure treatments.' + Version: "1" +Description: + "Study Day of Start of Treatment (--STDY) and Study Day of End of Treatment (--ENDY) should + not be negative for exposure treatments." Executability: Fully Executable Outcome: Message: Negative value of Study Day variable. Output Variables: - - --STDY - - --ENDY + - --STDY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Published/CORE-000517/rule.yml b/Published/CORE-000517/rule.yml index 5dd91d4b5..f820578ce 100644 --- a/Published/CORE-000517/rule.yml +++ b/Published/CORE-000517/rule.yml @@ -1,157 +1,157 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4003 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4003 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DOSTOT - operator: non_empty - - name: --DOSTOT - operator: less_than - value: 0 + - name: --DOSTOT + operator: non_empty + - name: --DOSTOT + operator: less_than + value: 0 Core: - Id: 'CORE-000517' + Id: "CORE-000517" Status: Published - Version: '1' + Version: "1" Description: Total Daily Dose (--DOSTOT) value should not be negative. Executability: Fully Executable Outcome: @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000518/rule.yml b/Published/CORE-000518/rule.yml index 0eda83345..d34a77247 100644 --- a/Published/CORE-000518/rule.yml +++ b/Published/CORE-000518/rule.yml @@ -1,157 +1,157 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: >- - Values for the following should not be negative: age, dose, - and duration of event, exposure or observation. - Document: FDA - Section: FDAB040 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4004 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: >- + Values for the following should not be negative: age, dose, + and duration of event, exposure or observation. + Document: FDA + Section: FDAB040 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4004 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --VAMT - operator: non_empty - - name: --VAMT - operator: less_than - value: 0 + - name: --VAMT + operator: non_empty + - name: --VAMT + operator: less_than + value: 0 Core: Id: CORE-000518 Status: Published - Version: '1' + Version: "1" Description: Value for Treatment Vehicle Amount (--VAMT) should not be negative. Executability: Fully Executable Outcome: @@ -160,8 +160,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000519/rule.yml b/Published/CORE-000519/rule.yml index 269e0d874..97b2f609c 100644 --- a/Published/CORE-000519/rule.yml +++ b/Published/CORE-000519/rule.yml @@ -1,106 +1,113 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z for the first character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND31 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z for the first character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND31 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z].* + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z].* Core: Id: CORE-000519 Status: Published - Version: '1' -Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first + Version: "1" +Description: + Raise an error when the value of DOMAIN has a character other than A-Z as the first character Executability: Fully Executable Outcome: Message: First character of DOMAIN value must be in the range A-Z Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000520/rule.yml b/Published/CORE-000520/rule.yml index ebace34b7..5edd1f202 100644 --- a/Published/CORE-000520/rule.yml +++ b/Published/CORE-000520/rule.yml @@ -1,108 +1,114 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND146 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Describes why BWSTAT is NOT DONE. - Document: TIG v1.0 - Item: BWREASND CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0082 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND146 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Describes why BWSTAT is NOT DONE. + Document: TIG v1.0 + Item: BWREASND CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0082 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --STAT - operator: empty - - name: --REASND - operator: non_empty + - name: --STAT + operator: empty + - name: --REASND + operator: non_empty Core: Id: CORE-000520 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --STAT is not populated and --REASND is populated Executability: Fully Executable Outcome: @@ -111,9 +117,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000521/rule.yml b/Published/CORE-000521/rule.yml index 786248da3..533475191 100644 --- a/Published/CORE-000521/rule.yml +++ b/Published/CORE-000521/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND147 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A baseline indicator may be used to calculate differences or changes from - baseline. Value should be Y or null. The baseline flag is sponsor-defined. - Document: TIG v1.0 - Item: BWBLFL CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0083 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND147 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A baseline indicator may be used to calculate differences or changes from + baseline. Value should be Y or null. The baseline flag is sponsor-defined. + Document: TIG v1.0 + Item: BWBLFL CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0083 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --BLFL - operator: non_empty - - name: --BLFL - operator: not_equal_to - value: Y + - name: --BLFL + operator: non_empty + - name: --BLFL + operator: not_equal_to + value: Y Core: Id: CORE-000521 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --BLFL is populated and the value is different from "Y" Executability: Fully Executable Outcome: @@ -113,9 +120,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000523/rule.yml b/Published/CORE-000523/rule.yml index ff321fea4..82a3651ed 100644 --- a/Published/CORE-000523/rule.yml +++ b/Published/CORE-000523/rule.yml @@ -1,107 +1,115 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.0 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Two character domain identifier used as a prefix in the variable is limited - to A to Z, 0-9 for the second character - Document: IG v3.1.1 - Section: 4.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND32 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.0 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Two character domain identifier used as a prefix in the variable is limited + to A to Z, 0-9 for the second character + Document: IG v3.1.1 + Section: 4.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND32 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: DOMAIN - operator: not_matches_regex - value: ^[A-Z][A-Z0-9].* + - name: DOMAIN + operator: not_matches_regex + value: ^[A-Z][A-Z0-9].* Core: Id: CORE-000523 Status: Published - Version: '1' -Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first + Version: "1" +Description: + Raise an error when the value of DOMAIN has a character other than A-Z as the first character or a character A-Z, 0-9 for the second character Executability: Fully Executable Outcome: - Message: First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9 + Message: + First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9 for the second Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000524/rule.yml b/Published/CORE-000524/rule.yml index 751b93c39..eb59cd5a3 100644 --- a/Published/CORE-000524/rule.yml +++ b/Published/CORE-000524/rule.yml @@ -1,124 +1,131 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.0 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will - be null and if a USUBJID is recorded, the POOLID will be null. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND132 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.11 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0068 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.0 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + POOLID and USUBJID are mutually exclusive. When POOLID is used, USUBJID will + be null and if a USUBJID is recorded, the POOLID will be null. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND132 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.11 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0068 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: POOLID - operator: non_empty - - name: USUBJID - operator: non_empty + - name: POOLID + operator: non_empty + - name: USUBJID + operator: non_empty Core: Id: CORE-000524 Status: Published - Version: '1' + Version: "1" Description: Raise an error when both USUBJID and POOLID are populated Executability: Fully Executable Outcome: Message: When POOLID is populated, USUBJID may not be populated Output Variables: - - USUBJID - - POOLID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000526/rule.yml b/Published/CORE-000526/rule.yml index 8fb6da449..cf08029db 100644 --- a/Published/CORE-000526/rule.yml +++ b/Published/CORE-000526/rule.yml @@ -1,126 +1,133 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject or pool, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject or pool, Tabulation. - Document: IG v3.0 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject or pool, Tabulation. - Document: IG v3.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject or pool, Tabulation. - Document: IG v3.1.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Pharmacokinetics Parameters - Findings. One record per pharmacokinetic - parameter per time-concentration profile per specimen per subject or pool, Tabulation. - Document: IG v3.1.1 - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND195.1 - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195 + Version: "2" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.0 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Pharmacokinetics Parameters - Findings. One record per pharmacokinetic + parameter per time-concentration profile per specimen per subject or pool, Tabulation. + Document: IG v3.1.1 + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND195.1 + Version: "2" + Version: "5.0" + Version: "1.0" Check: # "time-concentration profile" is defined the combination of PPCAT and PPTPTREF # "pharmacokinetic parameter" is defined by PPTESTCD # but we also need PPSPEC any: # Implementation with USUBJID - - name: PPTESTCD - operator: is_not_unique_set - value: - - USUBJID - - PPCAT - - PPSPEC - - PPTPTREF - # Implementation with POOLID - - name: PPTESTCD - operator: is_not_unique_set - value: - - POOLID - - PPCAT - - PPSPEC - - PPTPTREF + - name: PPTESTCD + operator: is_not_unique_set + value: + - USUBJID + - PPCAT + - PPSPEC + - PPTPTREF + # Implementation with POOLID + - name: PPTESTCD + operator: is_not_unique_set + value: + - POOLID + - PPCAT + - PPSPEC + - PPTPTREF Core: Id: CORE-000526 Status: Published - Version: '1' -Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be + Version: "1" +Description: + The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be unique. Executability: Fully Executable Outcome: Message: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF is not unique Output Variables: - - POOLID - - PPTESTCD - - PPCAT - - PPSPEC - - PPTPTREF + - POOLID + - PPTESTCD + - PPCAT + - PPSPEC + - PPTPTREF Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000527/rule.yml b/Published/CORE-000527/rule.yml index a52cee6a7..432f74d57 100644 --- a/Published/CORE-000527/rule.yml +++ b/Published/CORE-000527/rule.yml @@ -2,123 +2,129 @@ # Condition: Not last record # Rule: SEENDTC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Since there are, by definition, no gaps between Elements, the value of SEENDTC - for one Element will always be the same as the value of SESTDTC for the next Element. ' - Document: IG v3.4 - Item: Assumption 8 - Section: '5.3' - - Cited Guidance: '"Note that SESTDTC is required, although --STDTC is not required in any other - subject-level dataset. The purpose of the dataset is to record the Elements a subject actually - passed through. We assume that if it is known that a subject passed through a particular Element, - then there must be some information on when it started, even if that information is imprecise. - Thus, SESTDTC may not be null, although some records may not have all the components (e.g., - year, month, day, hour, minute) of the date/time value collected."' - Document: IG v3.4 - Item: Assumption 9 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 10[Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as the value of SESTDTC for the - next Element.]|Assumption 11[Note that SESTDTC is required, although --STDTC is not - required in any other subject-level dataset. The purpose of the dataset is to record the - Elements a subject actually passed through. We assume that if it is known that a subject - passed through a particular Element, then there must be some information on when it - started, even if that information is imprecise. Thus, SESTDTC may not be null, although - some records may not have all the components (e.g., year, month, day, hour, minute) of the - date/time value collected.] - Document: IG v3.2 - Item: Assumption 10|Assumption 11 - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Assumption 8[Since there are, by definition, no gaps between Elements, the - value of SEENDTC for one Element will always be the same as the value of SESTDTC for the - next Element.]|Assumption 9[Note that SESTDTC is required, although --STDTC is not - required in any other subject-level dataset. The purpose of the dataset is to record the - Elements a subject actually passed through. We assume that if it is known that a subject - passed through a particular Element, then there must be some information on when it - started, even if that information is imprecise. Thus, SESTDTC may not be null, although - some records may not have all the components (e.g., year, month, day, hour, minute) of the - date/time value collected.] - Document: IG v3.3 - Item: Assumption 8|Assumption 9 - Section: '5.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0209 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Since there are, by definition, no gaps between Elements, the value of - SEENDTC for one Element will always be the same as the value of SESTDTC for the next - Element. - Document: TIG 1.0 - Item: Assumption 7 - Section: 2.8.10.24 - - Cited Guidance: Note that SESTDTC is required, although --STDTC is not required in any other - subject-level dataset. The purpose of the dataset is to record the Elements a subject - actually passed through. We assume that if it is known that a subject passed through a - particular Element, then there must be some information on when it started, even if that - information is imprecise. Thus, SESTDTC may not be null, although some records may not - have all the components (e.g., year, month, day, hour, minute) of the date/time value - collected. - Document: TIG 1.0 - Item: Assumption 8 - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0428 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Since there are, by definition, no gaps between Elements, the value of SEENDTC + for one Element will always be the same as the value of SESTDTC for the next Element. " + Document: IG v3.4 + Item: Assumption 8 + Section: "5.3" + - Cited Guidance: + '"Note that SESTDTC is required, although --STDTC is not required in any other + subject-level dataset. The purpose of the dataset is to record the Elements a subject actually + passed through. We assume that if it is known that a subject passed through a particular Element, + then there must be some information on when it started, even if that information is imprecise. + Thus, SESTDTC may not be null, although some records may not have all the components (e.g., + year, month, day, hour, minute) of the date/time value collected."' + Document: IG v3.4 + Item: Assumption 9 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Assumption 10[Since there are, by definition, no gaps between Elements, the + value of SEENDTC for one Element will always be the same as the value of SESTDTC for the + next Element.]|Assumption 11[Note that SESTDTC is required, although --STDTC is not + required in any other subject-level dataset. The purpose of the dataset is to record the + Elements a subject actually passed through. We assume that if it is known that a subject + passed through a particular Element, then there must be some information on when it + started, even if that information is imprecise. Thus, SESTDTC may not be null, although + some records may not have all the components (e.g., year, month, day, hour, minute) of the + date/time value collected.] + Document: IG v3.2 + Item: Assumption 10|Assumption 11 + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Assumption 8[Since there are, by definition, no gaps between Elements, the + value of SEENDTC for one Element will always be the same as the value of SESTDTC for the + next Element.]|Assumption 9[Note that SESTDTC is required, although --STDTC is not + required in any other subject-level dataset. The purpose of the dataset is to record the + Elements a subject actually passed through. We assume that if it is known that a subject + passed through a particular Element, then there must be some information on when it + started, even if that information is imprecise. Thus, SESTDTC may not be null, although + some records may not have all the components (e.g., year, month, day, hour, minute) of the + date/time value collected.] + Document: IG v3.3 + Item: Assumption 8|Assumption 9 + Section: "5.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0209 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Since there are, by definition, no gaps between Elements, the value of + SEENDTC for one Element will always be the same as the value of SESTDTC for the next + Element. + Document: TIG 1.0 + Item: Assumption 7 + Section: 2.8.10.24 + - Cited Guidance: + Note that SESTDTC is required, although --STDTC is not required in any other + subject-level dataset. The purpose of the dataset is to record the Elements a subject + actually passed through. We assume that if it is known that a subject passed through a + particular Element, then there must be some information on when it started, even if that + information is imprecise. Thus, SESTDTC may not be null, although some records may not + have all the components (e.g., year, month, day, hour, minute) of the date/time value + collected. + Document: TIG 1.0 + Item: Assumption 8 + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0428 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SEENDTC - operator: empty_within_except_last_row - ordering: SESTDTC - value: USUBJID + - name: SEENDTC + operator: empty_within_except_last_row + ordering: SESTDTC + value: USUBJID Core: Id: CORE-000527 Status: Published - Version: '1' + Version: "1" Description: Trigger error where element is not the last element and SEENDTC is null. Executability: Fully Executable Outcome: Message: SEENDTC is null when element is not the last. Output Variables: - - SESTDTC - - SEENDTC + - SESTDTC + - SEENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000529/rule.yml b/Published/CORE-000529/rule.yml index 1310391b9..689ab274b 100644 --- a/Published/CORE-000529/rule.yml +++ b/Published/CORE-000529/rule.yml @@ -1,448 +1,478 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Study Day value is incremented by 1 for each date following RFSTDTC. - Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated as - Study Day -1 (there is no Study Day 0)....All Study Day values are integers. Thus to - calculate Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if - --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) - if --DTC precedes RFSTDTC. This algorithm should be used across all domains. - Document: SDTMIG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for each date following - RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated - as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]IG v3.2[4.1.4.4][Thus, - to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC - is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes - RFSTDTC This algorithm should be used across all domains.]' - Document: IG v3.2 - Section: 4.1.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.3[4.4.4][The Study Day value is incremented by 1 for each date following - RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated - as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]''IG v3.3[4.4.4][ - Thus, to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + - 1 if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) - if --DTC precedes RFSTDTC This algorithm should be used across all domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0006 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: All relative day values will be integers and there will be no study day 0. - The reference start date is considered day 1 and the study day value is increased by 1 for - each date following the reference start date and decreased by 1 for each date prior to the - reference start date, e.g.; --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 - if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) - if --DTC precedes RFSTDTC - Document: TIG v1.0 - Item: Table 1 Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0291 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.0 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day --DY = (date - portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND73 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date - portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0274 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.0 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. Thus, to calculate Study Day. --DY = - (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND74 - Version: '2' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date - portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0275 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1603 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Study Day value is incremented by 1 for each date following RFSTDTC. + Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated as + Study Day -1 (there is no Study Day 0)....All Study Day values are integers. Thus to + calculate Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if + --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC. This algorithm should be used across all domains. + Document: SDTMIG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.2[4.1.4.4][The Study Day value is incremented by 1 for each date following + RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated + as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]IG v3.2[4.1.4.4][Thus, + to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC + is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes + RFSTDTC This algorithm should be used across all domains.]" + Document: IG v3.2 + Section: 4.1.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.3[4.4.4][The Study Day value is incremented by 1 for each date following + RFSTDTC. Dates prior to RFSTDTC are decreased by 1, with the date preceding RFSTDTC designated + as Study Day -1 (there is no Study Day 0). . . . All Study Day values are integers.]'IG v3.3[4.4.4][ + Thus, to calculate Study Day: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + + 1 if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC This algorithm should be used across all domains.]" + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0006 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + All relative day values will be integers and there will be no study day 0. + The reference start date is considered day 1 and the study day value is increased by 1 for + each date following the reference start date and decreased by 1 for each date prior to the + reference start date, e.g.; --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 + if --DTC is on or after RFSTDTC --DY = (date portion of --DTC) - (date portion of RFSTDTC) + if --DTC precedes RFSTDTC + Document: TIG v1.0 + Item: Table 1 Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0291 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.0 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day --DY = (date + portion of --DTC) minus (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND73 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0274 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.0 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All Study Day values are integers. Thus, to calculate Study Day. --DY = + (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND74 + Version: "2" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "All Study Day values are integers. Thus, to calculate Study Day: --DY = (date + portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC" + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0275 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1603 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY # checking failure criteria - operator: not_equal_to - value: $val_dy # this is created in the operations statement that follows + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY # checking failure criteria + operator: not_equal_to + value: $val_dy # this is created in the operations statement that follows Core: Id: CORE-000529 Status: Published - Version: '1' -Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero - integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a + Version: "1" +Description: + Raise an error when --DY is not calculated as per the study day algorithm as a non-zero + integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not empty Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- id: $val_dy # ex in devops 2538 used -- but that threw an error - name: --DTC - operator: dy # does dy op take into acct +1? + - id: $val_dy # ex in devops 2538 used -- but that threw an error + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: - Message: --DY is not correctly calculated even though the date portion of --DTC is complete, the + Message: + --DY is not correctly calculated even though the date portion of --DTC is complete, the date portion of RFSTDTC is complete, and --DY is not empty. Output Variables: - - $val_dy - - --DY - - --DTC - - RFSTDTC + - $val_dy + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000534/rule.yml b/Published/CORE-000534/rule.yml index 36a7c4314..b82259beb 100644 --- a/Published/CORE-000534/rule.yml +++ b/Published/CORE-000534/rule.yml @@ -1,170 +1,170 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.4 - Item: Assumption 1 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.2 - Item: Assumption 1 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: IG v3.3 - Item: Assumption 1 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0248 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.0 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: TAETORD value should be an integer. - Document: IG v3.1.1 - Section: 7.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND221 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: TAETORD is an integer. - Document: TIG 1.0 - Item: Specification;TAETORD - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0452 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: This value should be an integer. - Document: TIG 1.0 - Item: TAETORD CDISC Notes - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0148 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.4 + Item: Assumption 1 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.2 + Item: Assumption 1 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: IG v3.3 + Item: Assumption 1 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0248 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.0 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: TAETORD value should be an integer. + Document: IG v3.1.1 + Section: 7.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND221 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: TAETORD is an integer. + Document: TIG 1.0 + Item: Specification;TAETORD + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0452 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: This value should be an integer. + Document: TIG 1.0 + Item: TAETORD CDISC Notes + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0148 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" # Variable: TAETORD -# Condition: +# Condition: # Rule: TAETORD is an integer Check: all: - - name: TAETORD - operator: not_matches_regex - value: ^(-?[1-9]\d*|0)$ + - name: TAETORD + operator: not_matches_regex + value: ^(-?[1-9]\d*|0)$ Core: Id: CORE-000534 Status: Published - Version: '1' + Version: "1" Description: TAETORD must be an integer Executability: Fully Executable Outcome: Message: TAETORD is not an integer Output Variables: - - TAETORD + - TAETORD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000535/rule.yml b/Published/CORE-000535/rule.yml index 0038e9c96..bb03e2958 100644 --- a/Published/CORE-000535/rule.yml +++ b/Published/CORE-000535/rule.yml @@ -1,198 +1,210 @@ # Variable: --SEQ -# Condition: +# Condition: # Rule: --SEQ is in a consistent chronological order Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sequence Number given to ensure uniqueness of subject records within a - domain. Should be assigned to be consistent chronological order. - Document: IG v3.2 - Item: Specification - Section: 5 SE - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0662 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of subject - records within a domain. Should be assigned to be consistent chronological - order.]5.4[Specification][Sequence number to ensure uniqueness of subject records. Should - be assigned to be consistent chronological order.] - Document: IG v3.3 - Item: Specification - Section: 5.3|5.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0620 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 5.3[Specification][Sequence number given to ensure uniqueness of subject - records within a domain. Should be assigned to be consistent chronological - order]|5.4[Specification][Sequence number to ensure uniqueness of subject records. Should - be assigned to be consistent chronological order.] - Document: IG v3.4 - Item: Specification - Section: 5.3|5.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0620 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - Elements. SESEQ should be assigned to be consistent with the chronological order. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND130.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The values of SESTDTC provide the chronological order of the actual subject - elements. SESEQ should be assigned to be consistent with the chronological order. - Document: TIG v1.0 - Item: Assumption 7 - Section: 2.8.9.26 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0066 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Sequence number given to ensure uniqueness of subject records within a - domain. Should be assigned to be consistent chronological order. - Document: TIG v1.0 - Item: Specifications - Section: 2.8.10.24 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0661 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Sequence Number given to ensure uniqueness of subject records within a + domain. Should be assigned to be consistent chronological order. + Document: IG v3.2 + Item: Specification + Section: 5 SE + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0662 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 5.3[Specification][Sequence number given to ensure uniqueness of subject + records within a domain. Should be assigned to be consistent chronological + order.]5.4[Specification][Sequence number to ensure uniqueness of subject records. Should + be assigned to be consistent chronological order.] + Document: IG v3.3 + Item: Specification + Section: 5.3|5.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0620 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 5.3[Specification][Sequence number given to ensure uniqueness of subject + records within a domain. Should be assigned to be consistent chronological + order]|5.4[Specification][Sequence number to ensure uniqueness of subject records. Should + be assigned to be consistent chronological order.] + Document: IG v3.4 + Item: Specification + Section: 5.3|5.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0620 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + Elements. SESEQ should be assigned to be consistent with the chronological order. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND130.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The values of SESTDTC provide the chronological order of the actual subject + elements. SESEQ should be assigned to be consistent with the chronological order. + Document: TIG v1.0 + Item: Assumption 7 + Section: 2.8.9.26 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0066 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Sequence number given to ensure uniqueness of subject records within a + domain. Should be assigned to be consistent chronological order. + Document: TIG v1.0 + Item: Specifications + Section: 2.8.10.24 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0661 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --SEQ - operator: target_is_not_sorted_by - value: - - name: --STDTC - null_position: last - sort_order: asc - within: USUBJID + - name: --SEQ + operator: target_is_not_sorted_by + value: + - name: --STDTC + null_position: last + sort_order: asc + within: USUBJID Core: Id: CORE-000535 Status: Published - Version: '1' -Description: Trigger error when the order of --SEQ is not chronological (based on --STDTC) within + Version: "1" +Description: + Trigger error when the order of --SEQ is not chronological (based on --STDTC) within USUBJID Executability: Fully Executable Outcome: Message: --SEQ is not chronological (based on --STDTC) within USUBJID Output Variables: - - --SEQ - - --STDTC + - --SEQ + - --STDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SM - - SE + - SM + - SE Use Case: NONCLIN, INDH Sensitivity: Record diff --git a/Published/CORE-000537/rule.yml b/Published/CORE-000537/rule.yml index 6e3cd5e1e..0208dfefe 100644 --- a/Published/CORE-000537/rule.yml +++ b/Published/CORE-000537/rule.yml @@ -1,85 +1,91 @@ Authorities: -- Organization: CDISC - # REMARK: Rule 342 is not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The most appropriate single value, as defined by the sponsor, should be - included for Trial Summary purposes. - Document: IG v3.1.1 - Section: 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND342' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: + CDISC + # REMARK: Rule 342 is not applicable to SENDIG-3.0 + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND342" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND342" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND342" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND342" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The most appropriate single value, as defined by the sponsor, should be + included for Trial Summary purposes. + Document: IG v3.1.1 + Section: 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND342" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: SDESIGN - - name: TSPARMCD - operator: is_not_unique_set - value: - - DOMAIN + - name: TSPARMCD + operator: equal_to + value: SDESIGN + - name: TSPARMCD + operator: is_not_unique_set + value: + - DOMAIN Core: Id: CORE-000537 Status: Published - Version: '1' + Version: "1" Description: Raise an error when there is more than record with TSPARMCD=SDESIGN Executability: Fully Executable Outcome: @@ -88,8 +94,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000538/rule.yml b/Published/CORE-000538/rule.yml index 8a6a5c4b3..fdd4c1905 100644 --- a/Published/CORE-000538/rule.yml +++ b/Published/CORE-000538/rule.yml @@ -1,100 +1,105 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be - the two-character domain code (e.g., QS, FA). - Document: IG v3.4 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be - the two-character domain code (e.g., QS; FA). - Document: IG v3.2 - Item: '7' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains would also be split. The - nomenclature would include the additional one-to-two characters used to identify the split - dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be - the two-character domain code (e.g., QS; FA). - Document: IG v3.3 - Item: '7' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0334 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Supplemental Qualifier datasets for split domains will also be split. The - nomenclature will include the additional one to two characters used to identify the split - dataset (e.g., SUPPLBHM, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be - the two-character domain code (e.g., LB, FA). - Document: TIG 1.0 - Item: 'Num 9.e.ii' - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0500 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS, FA). + Document: IG v3.4 + Item: "7" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS; FA). + Document: IG v3.2 + Item: "7" + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains would also be split. The + nomenclature would include the additional one-to-two characters used to identify the split + dataset (e.g., SUPPQS36; SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., QS; FA). + Document: IG v3.3 + Item: "7" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0334 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Supplemental Qualifier datasets for split domains will also be split. The + nomenclature will include the additional one to two characters used to identify the split + dataset (e.g., SUPPLBHM, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be + the two-character domain code (e.g., LB, FA). + Document: TIG 1.0 + Item: "Num 9.e.ii" + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0500 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: does_not_equal_string_part - regex: .{4}(..).* - value: $dataset_name + - name: RDOMAIN + operator: does_not_equal_string_part + regex: .{4}(..).* + value: $dataset_name Core: Id: CORE-000538 Status: Published - Version: '1' -Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary + Version: "1" +Description: + Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary dataset name Executability: Fully Executable Operations: -- id: $dataset_name - name: dataset_name - operator: extract_metadata + - id: $dataset_name + name: dataset_name + operator: extract_metadata Outcome: Message: RDOMAIN does not match characters 5 and 6 of the dataset name Output Variables: - - $dataset_name - - RDOMAIN + - $dataset_name + - RDOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000539/rule.yml b/Published/CORE-000539/rule.yml index 52f24ade6..5a0cdc91a 100644 --- a/Published/CORE-000539/rule.yml +++ b/Published/CORE-000539/rule.yml @@ -2,115 +2,120 @@ # Condition: Dataset name length = 3 or 4 and dataset name does not begin with 'AP' or 'FA' # Rule: The first two characters of the dataset name must equal a domain that is present in the study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'For domains with two-letter domain codes (i.e., other than SUPPxx and RELREC), - split dataset names can be up to four characters in length. For example, if splitting by --CAT, - then dataset names would be the domain name plus up to two additional characters (e.g., QS36 - for SF-36). If splitting Findings About by parent domain, then the dataset name would be the - domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). - The four-character dataset-name limitation allows the use of a Supplemental Qualifier dataset - associated with the split dataset. ' - Document: IG v3.4 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For example; if - splitting by --CAT; then dataset names would be the domain name plus up to two additional - characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the - dataset name would be the domain name plus the two-character domain code describing the - parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use - of a Supplemental Qualifier dataset associated with the split dataset. - Document: IG v3.2 - Item: '6' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For example; if - splitting by --CAT; then dataset names would be the domain name plus up to two additional - characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the - dataset name would be the domain name plus the two-character domain code describing the - parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use - of a Supplemental Qualifier dataset associated with the split dataset. - Document: IG v3.3 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0332 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For domains with 2-letter domain codes, split dataset names can be up to 4 - characters in length - Document: TIG 1.0 - Item: Num 9.e.i - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0498 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'For domains with two-letter domain codes (i.e., other than SUPPxx and RELREC), + split dataset names can be up to four characters in length. For example, if splitting by --CAT, + then dataset names would be the domain name plus up to two additional characters (e.g., QS36 + for SF-36). If splitting Findings About by parent domain, then the dataset name would be the + domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). + The four-character dataset-name limitation allows the use of a Supplemental Qualifier dataset + associated with the split dataset. ' + Document: IG v3.4 + Item: "6" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.2 + Item: "6" + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.3 + Item: "6" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0332 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For domains with 2-letter domain codes, split dataset names can be up to 4 + characters in length + Document: TIG 1.0 + Item: Num 9.e.i + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0498 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: dataset_name - operator: matches_regex - value: ^[a-z(?-i)]{2}[a-z0-9(?-i)]{1,2} - - name: dataset_name - operator: not_prefix_matches_regex - prefix: 2 - value: (AP|FA) - - name: dataset_name - operator: prefix_is_not_contained_by - prefix: 2 - value: $list_dataset_names + - name: dataset_name + operator: matches_regex + value: ^[a-z(?-i)]{2}[a-z0-9(?-i)]{1,2} + - name: dataset_name + operator: not_prefix_matches_regex + prefix: 2 + value: (AP|FA) + - name: dataset_name + operator: prefix_is_not_contained_by + prefix: 2 + value: $list_dataset_names Core: Id: CORE-000539 Status: Published - Version: '1' -Description: Raise an error when split domains (i.e three/four-letter domain name) do not have a + Version: "1" +Description: + Raise an error when split domains (i.e three/four-letter domain name) do not have a two-letter parent domain present in the study. Executability: Fully Executable Operations: -- id: $list_dataset_names - operator: dataset_names + - id: $list_dataset_names + operator: dataset_names Outcome: Message: Split dataset is present but the two-Letter parent domain is missing. Output Variables: - - dataset_name - - $list_dataset_names + - dataset_name + - $list_dataset_names Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - RELREC - - RELSUB - - SUPP-- + - RELREC + - RELSUB + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000540/rule.yml b/Published/CORE-000540/rule.yml index 7757a33fb..0de944473 100644 --- a/Published/CORE-000540/rule.yml +++ b/Published/CORE-000540/rule.yml @@ -2,111 +2,116 @@ # Condition: Dataset split by parent domain and dataset name length > 2 and dataset name begins with 'FA' # Rule: The characters of the dataset name after 'FA' equal a domain that present in the study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'If splitting Findings About by parent domain, then the dataset name would be - the domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). ' - Document: IG v3.4 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For example; if - splitting by --CAT; then dataset names would be the domain name plus up to two additional - characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the - dataset name would be the domain name plus the two-character domain code describing the - parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use - of a Supplemental Qualifier dataset associated with the split dataset. - Document: IG v3.2 - Item: '6' - Section: 4.1.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Split dataset names can be up to four characters in length. For example; if - splitting by --CAT; then dataset names would be the domain name plus up to two additional - characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the - dataset name would be the domain name plus the two-character domain code describing the - parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use - of a Supplemental Qualifier dataset associated with the split dataset. - Document: IG v3.3 - Item: '6' - Section: 4.1.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0333 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If splitting Findings About by parent domain, then the dataset name would be - the domain code, "FA", plus the two-character domain code for parent domain code (e.g., - "FACM"). The four-character dataset-name limitation allows the use of a Supplemental - Qualifier dataset associated with the split dataset. - Document: TIG 1.0 - Item: Num 9.e.i - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0499 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 'If splitting Findings About by parent domain, then the dataset name would be + the domain code, "FA", plus the two-character domain code for parent domain code (e.g., "FACM"). ' + Document: IG v3.4 + Item: "6" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.2 + Item: "6" + Section: 4.1.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Split dataset names can be up to four characters in length. For example; if + splitting by --CAT; then dataset names would be the domain name plus up to two additional + characters (e.g., QS36 for SF-36). If splitting Findings About by parent domain; then the + dataset name would be the domain name plus the two-character domain code describing the + parent domain code (e.g., FACM). The four-character dataset-name limitation allows the use + of a Supplemental Qualifier dataset associated with the split dataset. + Document: IG v3.3 + Item: "6" + Section: 4.1.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0333 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If splitting Findings About by parent domain, then the dataset name would be + the domain code, "FA", plus the two-character domain code for parent domain code (e.g., + "FACM"). The four-character dataset-name limitation allows the use of a Supplemental + Qualifier dataset associated with the split dataset. + Document: TIG 1.0 + Item: Num 9.e.i + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0499 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: dataset_name - operator: matches_regex - value: ^[a-z(?-i)]{2}[a-z(?-i)]{1,2} - - name: dataset_name - operator: prefix_equal_to - prefix: 2 - value: 'FA' - - name: dataset_name - operator: suffix_is_not_contained_by - suffix: 2 - value: $list_dataset_names + - name: dataset_name + operator: matches_regex + value: ^[a-z(?-i)]{2}[a-z(?-i)]{1,2} + - name: dataset_name + operator: prefix_equal_to + prefix: 2 + value: "FA" + - name: dataset_name + operator: suffix_is_not_contained_by + suffix: 2 + value: $list_dataset_names Core: Id: CORE-000540 Status: Published - Version: '1' -Description: Raise an error when parent domain referenced in Findings About dataset name is not + Version: "1" +Description: + Raise an error when parent domain referenced in Findings About dataset name is not present in the study. Executability: Fully Executable Operations: -- id: $list_dataset_names - operator: dataset_names + - id: $list_dataset_names + operator: dataset_names Outcome: Message: Parent domain referenced in Findings About dataset name is not present in the study Output Variables: - - dataset_name - - $list_dataset_names + - dataset_name + - $list_dataset_names Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000541/rule.yml b/Published/CORE-000541/rule.yml index cf9836452..01cfdd88c 100644 --- a/Published/CORE-000541/rule.yml +++ b/Published/CORE-000541/rule.yml @@ -1,98 +1,106 @@ # Variable: --TESTCD -# Condition: +# Condition: # Rule: --TESTCD <= 8 chars and contains only letters, numbers, and underscores and can not start with a number Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.4 - Section: 4.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.3 - Section: 7.4.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start - with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; - numbers; or underscores. - Document: Model v1.7 - Section: 3.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Values of --TESTCD must be limited to 8 characters; and cannot start with a - number; nor can they contain characters other than letters; numbers; or underscores - Document: IG v3.2 - Section: 4.1.2.1 - - Cited Guidance: The value in IETESTCD cannot be longer than 8 characters; nor can it start - with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; - numbers; or underscores. - Document: Model v1.4 - Section: 3.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0372 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: The value in --TESTCD cannot be longer than 8 characters, nor can it start - with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than - letters, numbers, or underscores. - Document: TIG 1.0 - Item: Specifications --TESTCD - Section: Finding Domain Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0536 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.4 + Section: 4.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.3 + Section: 7.4.1 + - Cited Guidance: + The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.7 + Section: 3.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Values of --TESTCD must be limited to 8 characters; and cannot start with a + number; nor can they contain characters other than letters; numbers; or underscores + Document: IG v3.2 + Section: 4.1.2.1 + - Cited Guidance: + The value in IETESTCD cannot be longer than 8 characters; nor can it start + with a number (e.g., '1TEST'). IETESTCD cannot contain characters other than letters; + numbers; or underscores. + Document: Model v1.4 + Section: 3.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0372 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The value in --TESTCD cannot be longer than 8 characters, nor can it start + with a number (e.g., "1TEST" is not valid). --TESTCD cannot contain characters other than + letters, numbers, or underscores. + Document: TIG 1.0 + Item: Specifications --TESTCD + Section: Finding Domain Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0536 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - name: IETESTCD - operator: not_matches_regex - value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ + - name: IETESTCD + operator: not_matches_regex + value: ^[a-zA-Z_][a-zA-Z0-9_]{0,7}$ Core: Id: "CORE-000541" Status: Published - Version: '1' -Description: Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters, + Version: "1" +Description: + Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + Message: + IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts with a number. Output Variables: - - IETESTCD + - IETESTCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000542/rule.yml b/Published/CORE-000542/rule.yml index a38a36a2e..077bf55c6 100644 --- a/Published/CORE-000542/rule.yml +++ b/Published/CORE-000542/rule.yml @@ -1,258 +1,266 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.0 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.1 - Item: Text - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: SENDIG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND88 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further step is necessary when --STRESC contains numeric values. These are - converted to numeric type and written to --STRESN. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0280 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3102' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.0 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1 + Item: Text + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: SENDIG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND88 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A further step is necessary when --STRESC contains numeric values. These are + converted to numeric type and written to --STRESN. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0280 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3102" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRESC - operator: non_empty - - name: --STRESC - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - any: - - name: --STRESN - operator: empty - name: --STRESC - operator: not_equal_to - type_insensitive: true - value: --STRESN + operator: non_empty + - name: --STRESC + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - any: + - name: --STRESN + operator: empty + - name: --STRESC + operator: not_equal_to + type_insensitive: true + value: --STRESN Core: Id: CORE-000542 Status: Published - Version: '1' -Description: Raise an error when --STRESC is populated with a numeric value, but --STRESN is not + Version: "1" +Description: + Raise an error when --STRESC is populated with a numeric value, but --STRESN is not populated, or --STRESN is not equal to --STRESC. Executability: Fully Executable Outcome: Message: --STRESC is numeric but --STRESN is not populated or not equal to --STRESC. Output Variables: - - --STRESC - - --STRESN - - --TESTCD + - --STRESC + - --STRESN + - --TESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN, INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000545/rule.yml b/Published/CORE-000545/rule.yml index c00766bb9..bb794dec0 100644 --- a/Published/CORE-000545/rule.yml +++ b/Published/CORE-000545/rule.yml @@ -1,125 +1,132 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values presented in - --STRESC are numeric values - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values presented in - --STRESC are numeric values - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --STRESN will only contain data values if the data values presented in - --STRESC are numeric values - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND45 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + --STRESN will only contain data values if the data values presented in + --STRESC are numeric values + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND45 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: #- name: --SCAT # operator: non_empty - - all: - - name: --SCAT - operator: non_empty - - name: --DECOD - operator: non_empty - - name: --SCAT - operator: equal_to - value: --DECOD - - all: - - name: --SCAT - operator: non_empty - - name: --BODSYS - operator: non_empty - - name: --SCAT - operator: equal_to - value: --BODSYS + - all: + - name: --SCAT + operator: non_empty + - name: --DECOD + operator: non_empty + - name: --SCAT + operator: equal_to + value: --DECOD + - all: + - name: --SCAT + operator: non_empty + - name: --BODSYS + operator: non_empty + - name: --SCAT + operator: equal_to + value: --BODSYS Core: Id: CORE-000545 Status: Published - Version: '1' -Description: Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal + Version: "1" +Description: + Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal to --BODSYS Executability: Fully Executable Outcome: Message: --SCAT is equal to --DECOD, or --SCAT is equal to --BODSYS Output Variables: - - --CAT - - --SCAT - - --DECOD - - --BODSYS + - --CAT + - --SCAT + - --DECOD + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000546/rule.yml b/Published/CORE-000546/rule.yml index 2fe752ac1..5816d5e1e 100644 --- a/Published/CORE-000546/rule.yml +++ b/Published/CORE-000546/rule.yml @@ -1,123 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.0 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Values for --CAT and --SCAT should not be redundant with the domain or - dictionary classification provided by --DECOD and --BODSYS. - Document: IG v.3.1.1 - Section: 4.2.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND47 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.0 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Values for --CAT and --SCAT should not be redundant with the domain or + dictionary classification provided by --DECOD and --BODSYS. + Document: IG v.3.1.1 + Section: 4.2.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND47 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: # - name: --CAT # operator: non_empty - - all: - - name: --CAT - operator: non_empty - - name: --DECOD - operator: non_empty - - name: --CAT - operator: equal_to - value: --DECOD - - all: - - name: --CAT - operator: non_empty - - name: --BODSYS - operator: non_empty - - name: --CAT - operator: equal_to - value: --BODSYS + - all: + - name: --CAT + operator: non_empty + - name: --DECOD + operator: non_empty + - name: --CAT + operator: equal_to + value: --DECOD + - all: + - name: --CAT + operator: non_empty + - name: --BODSYS + operator: non_empty + - name: --CAT + operator: equal_to + value: --BODSYS Core: Id: CORE-000546 Status: Published - Version: '1' -Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to + Version: "1" +Description: + Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to --BODSYS Executability: Fully Executable Outcome: Message: --CAT is equal to --DECOD, or --CAT is equal to --BODSYS Output Variables: - - --CAT - - --DECOD - - --BODSYS + - --CAT + - --DECOD + - --BODSYS Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000547/rule.yml b/Published/CORE-000547/rule.yml index 30377fddf..da3904ef8 100644 --- a/Published/CORE-000547/rule.yml +++ b/Published/CORE-000547/rule.yml @@ -1,339 +1,362 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # SEND66 added here as code for SEND67 also covers SEND66 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.0 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The SENDIG requires dates and times of day to be stored according to the - international standard ISO 8601 (http://www.iso.org). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4|4.4.3|4.4.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND66 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SDTM and SENDIG require use of the ISO 8601 Extended format, which - requires hyphen delimiters for date components and colon delimiters for time components. - The ISO 8601 basic format, which does not require delimiters, should not be used in SDTM - datasets. - Document: SENDIG v3.0 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be - used. - Document: SENDIG v3.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be - used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be - used. - Document: SENDIG v3.1 - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be - used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The ISO 8601 basic format, which does not require delimiters, should not be - used. - Document: SENDIG v3.1.1 - Item: Text - Section: '4.4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND67 - Version: '1' - Version: '5.0' - Version: '1.0' - # SEND68 added here as code for SEND66 and SEND67 also covers SEND68 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.0 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a date is stored with a time in the same variable (as a date/time), the - date is written in front of the time and the time is preceded with "T" using the notation - YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND68 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or - times, intervals of time, and durations of time in ISO 8601 format as defined by the - International Organization for Standardization (ISO) (http://www.iso.org). The appropriate - date and/or time ISO format must be used when specified. - Document: TIG v1.0 - Item: Text - Section: '2.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0267 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or - times, intervals of time, and durations of time in ISO 8601 format as defined by the - International Organization for Standardization (ISO) (http://www.iso.org). The appropriate - date and/or time ISO format must be used when specified. - Document: TIG v1.0 - Item: Text - Section: 2.3 Controlled Terminology and Formats - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0268 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Standards for tabulation and analysis require representation of dates and/or - times, intervals of time, and durations of time in ISO 8601 format as defined by the - International Organization for Standardization (ISO) (http://www.iso.org). The appropriate - date and/or time ISO format must be used when specified. - Document: TIG v1.0 - Item: Text - Section: 2.3 Controlled Terminology and Formats - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0269 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.0 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The SENDIG requires dates and times of day to be stored according to the + international standard ISO 8601 (http://www.iso.org). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4|4.4.3|4.4.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND66 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The SDTM and SENDIG require use of the ISO 8601 Extended format, which + requires hyphen delimiters for date components and colon delimiters for time components. + The ISO 8601 basic format, which does not require delimiters, should not be used in SDTM + datasets. + Document: SENDIG v3.0 + Item: Text + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1 + Item: Text + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1 + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The ISO 8601 basic format, which does not require delimiters, should not be + used. + Document: SENDIG v3.1.1 + Item: Text + Section: "4.4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND67 + Version: "1" + Version: "5.0" + Version: + "1.0" + # SEND68 added here as code for SEND66 and SEND67 also covers SEND68 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.0 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a date is stored with a time in the same variable (as a date/time), the + date is written in front of the time and the time is preceded with "T" using the notation + YYYY-MM-DDThh:mm:ss (e.g., 2001-12-26T00:00:01). + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND68 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: "2.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0267 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: 2.3 Controlled Terminology and Formats + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0268 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Standards for tabulation and analysis require representation of dates and/or + times, intervals of time, and durations of time in ISO 8601 format as defined by the + International Organization for Standardization (ISO) (http://www.iso.org). The appropriate + date and/or time ISO format must be used when specified. + Document: TIG v1.0 + Item: Text + Section: 2.3 Controlled Terminology and Formats + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0269 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - name: RFSTDTC - operator: invalid_date - - name: RFENDTC - operator: invalid_date - - name: BRTHDTC - operator: invalid_date - - name: --STDTC - operator: invalid_date - - name: --ENDTC - operator: invalid_date - - name: --DTC - operator: invalid_date - - name: --RFTDTC - operator: invalid_date + - name: RFSTDTC + operator: invalid_date + - name: RFENDTC + operator: invalid_date + - name: BRTHDTC + operator: invalid_date + - name: --STDTC + operator: invalid_date + - name: --ENDTC + operator: invalid_date + - name: --DTC + operator: invalid_date + - name: --RFTDTC + operator: invalid_date Core: Id: CORE-000547 Status: Published - Version: '1' -Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must + Version: "1" +Description: + Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must be correct ISO-8601 dates / datetimes Executability: Fully Executable Outcome: @@ -346,9 +369,9 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000548/rule.yml b/Published/CORE-000548/rule.yml index d414225eb..5e0b4bdff 100644 --- a/Published/CORE-000548/rule.yml +++ b/Published/CORE-000548/rule.yml @@ -1,175 +1,182 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Other variables that represent durations or elapsed times include --EVLINT - and --ELTM. These should be represented in accordance with the ISO 8601 standard. Both - duration and duration units can be represented in a single --DUR variable, in accordance - with the ISO 8601 standard as follows... For the purposes of data submission, an - additional format is allowed to represent "negative" intervals of time (intervals of time - preceding a reference point). - Document: IG v3.0 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the duration timing - variable (--DUR) should generally be used in a domain if it was collected in lieu of a - start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are - collected, durations can be calculated by the difference in these two values and need not - be in the submission dataset. Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as follows...For the purposes of data - submission, an additional format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the duration timing - variable (--DUR) should generally be used in a domain if it was collected in lieu of a - start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are - collected, durations can be calculated by the difference in these two values and need not - be in the submission dataset. Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as follows...For the purposes of data - submission, an additional format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the duration timing - variable (--DUR) should generally be used in a domain if it was collected in lieu of a - start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are - collected, durations can be calculated by the difference in these two values and need not - be in the submission dataset. Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as follows...For the purposes of data - submission, an additional format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the duration timing - variable (--DUR) should generally be used in a domain if it was collected in lieu of a - start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are - collected, durations can be calculated by the difference in these two values and need not - be in the submission dataset. Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as follows...For the purposes of data - submission, an additional format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Duration is frequently used during a review; however, the duration timing - variable (--DUR) should generally be used in a domain if it was collected in lieu of a - start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are - collected, durations can be calculated by the difference in these two values and need not - be in the submission dataset. Durations and associated units can be provided in a single - variable, in accordance with the ISO 8601 standard as follows...For the purposes of data - submission, an additional format is allowed to represent "negative" intervals of time - (intervals of time preceding a reference point). - Document: IG v3.1.1 - Item: Specification - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND59.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Other variables that represent durations or elapsed times include --EVLINT + and --ELTM. These should be represented in accordance with the ISO 8601 standard. Both + duration and duration units can be represented in a single --DUR variable, in accordance + with the ISO 8601 standard as follows... For the purposes of data submission, an + additional format is allowed to represent "negative" intervals of time (intervals of time + preceding a reference point). + Document: IG v3.0 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Duration is frequently used during a review; however, the duration timing + variable (--DUR) should generally be used in a domain if it was collected in lieu of a + start date/time (--DTC) and end date/time (--ENDTC). If both --DTC and --ENDTC are + collected, durations can be calculated by the difference in these two values and need not + be in the submission dataset. Durations and associated units can be provided in a single + variable, in accordance with the ISO 8601 standard as follows...For the purposes of data + submission, an additional format is allowed to represent "negative" intervals of time + (intervals of time preceding a reference point). + Document: IG v3.1.1 + Item: Specification + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND59.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: - - name: --DUR - operator: non_empty - - name: --DUR - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --DUR - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: --EVLINT - operator: non_empty - - name: --EVLINT - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --EVLINT - operator: not_matches_regex - value: ^-?P([0-9]+W)$ - - all: - - name: --ELTM - operator: non_empty - - name: --ELTM - operator: not_matches_regex - value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - - name: --ELTM - operator: not_matches_regex - value: ^-?P([0-9]+W)$ + - all: + - name: --DUR + operator: non_empty + - name: --DUR + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --DUR + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: --EVLINT + operator: non_empty + - name: --EVLINT + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --EVLINT + operator: not_matches_regex + value: ^-?P([0-9]+W)$ + - all: + - name: --ELTM + operator: non_empty + - name: --ELTM + operator: not_matches_regex + value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + - name: --ELTM + operator: not_matches_regex + value: ^-?P([0-9]+W)$ Core: Id: CORE-000548 Status: Published - Version: '1' -Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional + Version: "1" +Description: + --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional format that allows the representation of "negative" intervals of time. Executability: Fully Executable Outcome: Message: --DUR, --EVLINT or --ELTM is not in ISO 8601 Duration format Output Variables: - - USUBJID - - --ELTM - - --EVLINT - - --DUR + - USUBJID + - --ELTM + - --EVLINT + - --DUR Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000549/rule.yml b/Published/CORE-000549/rule.yml index 6d4402a26..dde181a9b 100644 --- a/Published/CORE-000549/rule.yml +++ b/Published/CORE-000549/rule.yml @@ -1,45 +1,47 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: TODO: Add SENDIG-DART 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be - populated with a description of the unplanned Stage. - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND352 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be - populated with a description of the unplanned Stage. - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND352 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be + populated with a description of the unplanned Stage. + Document: IG-DART v1.1 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND352 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The value of RSTGCD for an unplanned Stage is 'UNPLAN' and SJUPDES should be + populated with a description of the unplanned Stage. + Document: IG-DART v1.2 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND352 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: RSTGCD - operator: not_equal_to - value: UNPLAN - - name: SJUPDES - operator: non_empty + - name: RSTGCD + operator: not_equal_to + value: UNPLAN + - name: SJUPDES + operator: non_empty Core: Id: CORE-000549 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RSTGCD is not 'UNPLAN' and SJUPDES is populated Executability: Fully Executable Outcome: @@ -48,8 +50,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000550/rule.yml b/Published/CORE-000550/rule.yml index a11f1d8d7..329217d55 100644 --- a/Published/CORE-000550/rule.yml +++ b/Published/CORE-000550/rule.yml @@ -1,153 +1,160 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable = Model List of Allowed Variables for Observation Class # # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here, -# as SDTMIG has "domain-specific" variables: +# as SDTMIG has "domain-specific" variables: # which are NOT in the "SDTM Model" Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Sponsors may not add any variables other than those described in the - preceding three bullets. . . . Standard variables must not be renamed or modified for - novel usage. - Document: IG v3.4 - Section: '2.5' - - Cited Guidance: Each observation consists of a series of named variables. - Document: Model v2.0 - Section: Model Concepts and Terms --Variables - - Cited Guidance: Domain-specific variables, a concept introduced in SDTM v1.5, are for use in - a limited number of designated domains and will be identified in the appropriate - implementation guide.] - Document: Model v2.0 - Section: The General Observation Classes - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0013 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[2.5][Sponsors may not add any other variables. . . . Standard - variables must not be renamed or modified for novel usage. Using SDTM-specified standard - variable names.]|Model v1.4[3.2.22][Each observation can be described by a series of named - variables.] - Document: IG v3.2|Model v1.4 - Section: IG v3.2[2.5]|Model v1.4[3.2.22] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0013 - Version: '1' - Version: '2.0' - Version: '3.2' - # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here, - # as SDTMIG has "domain-specific" variables: - # which are NOT in the "SDTM Model" - # For SDTMIG-3-2 there are none such "domain-specific" variables - # and for SDTMIG-3-4 they are also present in the "SDTM Model". - #- Name: SDTMIG - # References: - # - Citations: - # - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . . - # Standard variables must not be renamed or modified for novel - # usage]|IG v3.3[2.5][[Using SDTM-specified standard variable - # names]|Model v1.7[3.2.2 2.1][Each observation can be described - # by a series of named variables. Domain-specific variables, a - # concept introduced in SDTM v1.5, are for use in a limited - # number of designated domains and will be identified in the - # appropriate implementation guide.] - # Document: IG v3.3|Model v1.7 - # Section: IG v3.3[2.5]|Model v1.7[3.2.2 2.1] - # Origin: SDTM and SDTMIG Conformance Rules - # Rule Identifier: - # Id: CG0013 - # Version: '1' - # Version: '2.0' - # Version: '3.3' - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A dataset is created using a domain specification in this guide when the - scientific nature or role of the data is within the scope of a domain. Domains are - extended or custom domain specifications are only used when data are different in nature - and are not in scope for domains in this guide. - Document: TIG 1.0 - Item: Table 2 Num 2 - Section: 2.8.5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0298 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard variable names - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0351 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard variable names - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0351 - Version: '1' - Version: '2.0' - Version: '3.2' - #- Name: SDTMIG - # References: - # - Citations: - # - Cited Guidance: Using SDTM-specified standard variable names - # Document: IG v3.3 - # Section: 3.2.2 - # Origin: SDTM and SDTMIG Conformance Rules - # Rule Identifier: - # Id: CG0351 - # Version: '1' - # Version: '2.0' - # Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Sponsors may not add any variables other than those described in the + preceding three bullets. . . . Standard variables must not be renamed or modified for + novel usage. + Document: IG v3.4 + Section: "2.5" + - Cited Guidance: Each observation consists of a series of named variables. + Document: Model v2.0 + Section: Model Concepts and Terms --Variables + - Cited Guidance: + Domain-specific variables, a concept introduced in SDTM v1.5, are for use in + a limited number of designated domains and will be identified in the appropriate + implementation guide.] + Document: Model v2.0 + Section: The General Observation Classes + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0013 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[2.5][Sponsors may not add any other variables. . . . Standard + variables must not be renamed or modified for novel usage. Using SDTM-specified standard + variable names.]|Model v1.4[3.2.22][Each observation can be described by a series of named + variables.] + Document: IG v3.2|Model v1.4 + Section: IG v3.2[2.5]|Model v1.4[3.2.22] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0013 + Version: "1" + Version: "2.0" + Version: + "3.2" + # 2025-11-18: SDTMIG-3-3 is implemented in a separate rule, and thus commented out here, + # as SDTMIG has "domain-specific" variables: + # which are NOT in the "SDTM Model" + # For SDTMIG-3-2 there are none such "domain-specific" variables + # and for SDTMIG-3-4 they are also present in the "SDTM Model". + #- Name: SDTMIG + # References: + # - Citations: + # - Cited Guidance: IG v3.3[2.5][Sponsors may not add any other variables. . . . + # Standard variables must not be renamed or modified for novel + # usage]|IG v3.3[2.5][[Using SDTM-specified standard variable + # names]|Model v1.7[3.2.2 2.1][Each observation can be described + # by a series of named variables. Domain-specific variables, a + # concept introduced in SDTM v1.5, are for use in a limited + # number of designated domains and will be identified in the + # appropriate implementation guide.] + # Document: IG v3.3|Model v1.7 + # Section: IG v3.3[2.5]|Model v1.7[3.2.2 2.1] + # Origin: SDTM and SDTMIG Conformance Rules + # Rule Identifier: + # Id: CG0013 + # Version: '1' + # Version: '2.0' + # Version: '3.3' + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + A dataset is created using a domain specification in this guide when the + scientific nature or role of the data is within the scope of a domain. Domains are + extended or custom domain specifications are only used when data are different in nature + and are not in scope for domains in this guide. + Document: TIG 1.0 + Item: Table 2 Num 2 + Section: 2.8.5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0298 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard variable names + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0351 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard variable names + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0351 + Version: "1" + Version: "2.0" + Version: + "3.2" + #- Name: SDTMIG + # References: + # - Citations: + # - Cited Guidance: Using SDTM-specified standard variable names + # Document: IG v3.3 + # Section: 3.2.2 + # Origin: SDTM and SDTMIG Conformance Rules + # Rule Identifier: + # Id: CG0351 + # Version: '1' + # Version: '2.0' + # Version: '3.3' Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CORE-000550 Status: Published - Version: '1' + Version: "1" Description: Raise an error when a variable is not an allowed variable for an Observation Class Executability: Partially Executable - Possible Underreporting Operations: -- id: $allowed_variables - operator: get_model_column_order + - id: $allowed_variables + operator: get_model_column_order Outcome: - Message: Variables not listed in the Model List of Allowed Variables for Observation Class should + Message: + Variables not listed in the Model List of Allowed Variables for Observation Class should be in SUPPQUAL. Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000551/rule.yml b/Published/CORE-000551/rule.yml index 4515ea063..1380ac6f4 100644 --- a/Published/CORE-000551/rule.yml +++ b/Published/CORE-000551/rule.yml @@ -1,160 +1,174 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # SENDIG-3.0: rule 254 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, - Tabulation. - Document: IG v3.0 - Item: Domain Table Header - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254' - Version: '1' - Version: '5.0' - Version: '3.0' - # SENDIG-3.1: rule 254.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per supplemental qualifier per related parent domain record(s), - Tabulation. - Document: IG v3.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '3.1' - # SENDIG-3.1: rule 254.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per supplemental qualifier per related parent domain record(s), - Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' - # SENDIG-DART-1.1: rule 254.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per supplemental qualifier per related parent domain record(s), - Tabulation. - Document: IG v3.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.1' - # SENDIG-DART-1.2: rule 254.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per supplemental qualifier per related parent domain record(s), - Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.2' - # SENDIG-GENETOX-1.0: rule 254.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship - Datasets. One record per supplemental qualifier per related parent domain record(s), - Tabulation. - Document: IG v3.1.1 - Item: Domain Table Header - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND254.1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: supp--.xpt, Supplemental Qualifiers for [domain name] — Relationship. One - record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0172 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, + Tabulation. + Document: IG v3.0 + Item: Domain Table Header + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254" + Version: "1" + Version: "5.0" + Version: + "3.0" + # SENDIG-3.1: rule 254.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1 + Item: Domain Table Header + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254.1" + Version: "1" + Version: "5.0" + Version: + "3.1" + # SENDIG-3.1: rule 254.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254.1" + Version: "1" + Version: "5.0" + Version: + "3.1.1" + # SENDIG-DART-1.1: rule 254.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1 + Item: Domain Table Header + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254.1" + Version: "1" + Version: "5.0" + Version: + "1.1" + # SENDIG-DART-1.2: rule 254.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254.1" + Version: "1" + Version: "5.0" + Version: + "1.2" + # SENDIG-GENETOX-1.0: rule 254.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + Datasets. One record per supplemental qualifier per related parent domain record(s), + Tabulation. + Document: IG v3.1.1 + Item: Domain Table Header + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND254.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + supp--.xpt, Supplemental Qualifiers for [domain name] — Relationship. One + record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0172 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: QNAM - operator: is_not_unique_set - value: - - USUBJID - - RDOMAIN - - IDVAR - - IDVARVAL - - all: - - name: POOLID - operator: non_empty - - name: QNAM - operator: is_not_unique_set - value: - - POOLID - - RDOMAIN - - IDVAR - - IDVARVAL + - all: + - name: USUBJID + operator: non_empty + - name: QNAM + operator: is_not_unique_set + value: + - USUBJID + - RDOMAIN + - IDVAR + - IDVARVAL + - all: + - name: POOLID + operator: non_empty + - name: QNAM + operator: is_not_unique_set + value: + - POOLID + - RDOMAIN + - IDVAR + - IDVARVAL Core: Id: CORE-000551 Status: Published - Version: '1' -Description: There may be only be one record in a SUPP-- dataset with the same QNAM value within + Version: "1" +Description: + There may be only be one record in a SUPP-- dataset with the same QNAM value within USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL. Executability: Fully Executable Outcome: - Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with + Message: + Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with QNAM Output Variables: - - RDOMAIN - - IDVAR - - IDVARVAL + - RDOMAIN + - IDVAR + - IDVARVAL Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000552/rule.yml b/Published/CORE-000552/rule.yml index 0c6f64b8b..b1236140c 100644 --- a/Published/CORE-000552/rule.yml +++ b/Published/CORE-000552/rule.yml @@ -2,124 +2,128 @@ # Condition: --STDTC and DM.RFSTDTC both contain complete values in their date portion # Rule: --STDY is properly calculated per study day algorithm Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). All Study Day values are integers. Thus, to calculate - Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on - or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0220 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative - day of the observation starting with the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the - date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0434 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate + Study Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on + or after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0220 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains." + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0434 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --STDTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --STDY # checking failure criteria - operator: not_equal_to - value: $val_stdy # this is created in the operations statement that follows + - name: --STDTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --STDY # checking failure criteria + operator: not_equal_to + value: $val_stdy # this is created in the operations statement that follows Core: Id: CORE-000552 Status: Published - Version: '1' + Version: "1" Description: Study day must be calculated using the algorithm detailed in the SDTMIG. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: #domain: DM -- id: $val_stdy - name: --STDTC - operator: dy + - id: $val_stdy + name: --STDTC + operator: dy Outcome: Message: --STDY is not properly calculated per study day algorithm Output Variables: - - --STDY - - --STDTC - - $val_stdy - - RFSTDTC + - --STDY + - --STDTC + - $val_stdy + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000553/rule.yml b/Published/CORE-000553/rule.yml index 3510cbaa7..b09517abe 100644 --- a/Published/CORE-000553/rule.yml +++ b/Published/CORE-000553/rule.yml @@ -2,125 +2,129 @@ # Condition: --ENDTC and DM.RFSTDTC both contain complete values in their date portion # Rule: --ENDY is properly calculated per study day algorithm Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are - determined by comparing the date portion of the respective date/time variables (--DTC, - --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC - from the Demographics domain). All Study Day values are integers. Thus, to calculate Study - Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or - after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC - precedes RFSTDTC. This algorithm should be used across all domains. - Document: IG v3.4 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. They are determined - by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) - to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.]' - Document: IG v3.3 - Section: 4.4.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0222 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative - day of the observation starting with the reference date as Day 1. They are determined by comparing - the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the - date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All - Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) - - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) - - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across - all domains.' - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0436 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are + determined by comparing the date portion of the respective date/time variables (--DTC, + --STDTC, and --ENDTC) to the date portion of the Subject Reference Start Date (RFSTDTC + from the Demographics domain). All Study Day values are integers. Thus, to calculate Study + Day, --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or + after RFSTDTC, --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC + precedes RFSTDTC. This algorithm should be used across all domains. + Document: IG v3.4 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. They are determined + by comparing the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) + to the date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day: --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains.]" + Document: IG v3.3 + Section: 4.4.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0222 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The permissible Study Day variables (--DY, --STDY, and --ENDY) describe the relative + day of the observation starting with the reference date as Day 1. They are determined by comparing + the date portion of the respective date/time variables (--DTC, --STDTC, and --ENDTC) to the + date portion of the Subject Reference Start Date (RFSTDTC from the Demographics domain).][All + Study Day values are integers. Thus, to calculate Study Day; --DY = (date portion of --DTC) + - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC, --DY = (date portion of --DTC) + - (date portion of RFSTDTC) if --DTC precedes RFSTDTC. This algorithm should be used across + all domains." + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0436 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: # - name: --ENDY # operator: non_empty - - name: --ENDTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --ENDY # checking failure criteria - operator: not_equal_to - value: $val_endy # this is created in the operations statement that follows + - name: --ENDTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --ENDY # checking failure criteria + operator: not_equal_to + value: $val_endy # this is created in the operations statement that follows Core: Id: CORE-000553 Status: Published - Version: '1' + Version: "1" Description: Study day must be calculated using the algorithm detailed in the SDTMIG. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- id: $val_endy - name: --ENDTC - operator: dy + - id: $val_endy + name: --ENDTC + operator: dy Outcome: Message: --ENDY is not properly calculated per study day algorithm Output Variables: - - --ENDY - - --ENDTC - - $val_endy - - RFSTDTC + - --ENDY + - --ENDTC + - $val_endy + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000554/rule.yml b/Published/CORE-000554/rule.yml index 62af26113..9e03ed382 100644 --- a/Published/CORE-000554/rule.yml +++ b/Published/CORE-000554/rule.yml @@ -1,42 +1,42 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND350 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND350 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. + Document: IG-DART v1.1 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND350 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If RSTGCD has the value of UNPLAN, then RSTAGE should be null. + Document: IG-DART v1.2 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND350 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: RSTGCD - operator: equal_to - value: UNPLAN - - name: RSTAGE - operator: non_empty + - name: RSTGCD + operator: equal_to + value: UNPLAN + - name: RSTAGE + operator: non_empty Core: Id: CORE-000554 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RSTGCD is 'UNPLAN' and RPHASE is populated Executability: Fully Executable Outcome: @@ -45,8 +45,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000555/rule.yml b/Published/CORE-000555/rule.yml index e1426ffd8..f04782401 100644 --- a/Published/CORE-000555/rule.yml +++ b/Published/CORE-000555/rule.yml @@ -1,112 +1,114 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.0 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) - Document: SENDIG v3.1.1 - Section: 6.3.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND163 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.0 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per diagnosis per subject (for unscheduled deaths only) + Document: SENDIG v3.1.1 + Section: 6.3.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND163 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # Implemented as uniqueness of DDORRES and/or DDSTRESC per USUBJID # as decided by the SEND team any: - - name: DDORRES - operator: is_not_unique_set - value: - - USUBJID - - name: DDSTRESC - operator: is_not_unique_set - value: - - USUBJID + - name: DDORRES + operator: is_not_unique_set + value: + - USUBJID + - name: DDSTRESC + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000555 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present the combination of USUBJID + Version: "1" +Description: + Raise an error when there is more than one record present the combination of USUBJID and DDORRES or for the combination of USUBJID and DDSTRESC. Executability: Fully Executable Outcome: - Message: There is more than one for the combination of USUBJID and DDORRES or the combination of + Message: + There is more than one for the combination of USUBJID and DDORRES or the combination of USUBJID and DDSTRESC Output Variables: - - USUBJID - - DDORRES - - DDSTRESC + - USUBJID + - DDORRES + - DDSTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000556/rule.yml b/Published/CORE-000556/rule.yml index 4537d6d02..2a6fb074a 100644 --- a/Published/CORE-000556/rule.yml +++ b/Published/CORE-000556/rule.yml @@ -1,103 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.0 - Section: 8.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: pooldef.xpt, Pooled Definition - Relationship Datasets. One record per - subject per pool, - Document: IG v3.1.1 - Section: 8.5.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND262.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.0 + Section: 8.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + pooldef.xpt, Pooled Definition - Relationship Datasets. One record per + subject per pool, + Document: IG v3.1.1 + Section: 8.5.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND262.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: POOLID - operator: is_not_unique_set - value: USUBJID + - name: POOLID + operator: is_not_unique_set + value: USUBJID Core: Id: CORE-000556 Status: Published - Version: '1' -Description: 'Generate a message when the there are duplicate combinations of USUBJID and POOLID' + Version: "1" +Description: "Generate a message when the there are duplicate combinations of USUBJID and POOLID" Executability: Fully Executable Outcome: - Message: 'A duplicate combination of USUBJID and POOLID was found' + Message: "A duplicate combination of USUBJID and POOLID was found" Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Published/CORE-000557/rule.yml b/Published/CORE-000557/rule.yml index 1288cde11..ea98b22d2 100644 --- a/Published/CORE-000557/rule.yml +++ b/Published/CORE-000557/rule.yml @@ -1,157 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: RELTYPE; Identifies the hierarchical level of the records in the - relationship. Values should be either ONE or MANY, only when --SPID is used. However, - values are only necessary when identifying a relationship between datasets. - Document: SENDIG v3.0 - Item: RELTYPE CDISC Notes - Section: 8.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; - RELTYPE is populated) - Document: SENDIG v3.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; - RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; - RELTYPE is populated) - Document: SENDIG v3.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; - RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; - RELTYPE is populated) - Document: SENDIG v3.1.1 - Item: Assumption 4 - Section: 8.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND253.1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: The variable RELTYPE will identify the type of relationship between the - datasets (e.g., a one-to-one or parent-child relationship). The allowable values for - RELYPE are ONE and MANY per CDISC Controlled Terminology. - Document: TIG v1.0 - Item: Text - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0171 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + RELTYPE; Identifies the hierarchical level of the records in the + relationship. Values should be either ONE or MANY, only when --SPID is used. However, + values are only necessary when identifying a relationship between datasets. + Document: SENDIG v3.0 + Item: RELTYPE CDISC Notes + Section: 8.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253.1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Domain-to-domain relationships (USUBJID, POOLID, and IDVARVAL are null; + RELTYPE is populated) + Document: SENDIG v3.1.1 + Item: Assumption 4 + Section: 8.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND253.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The variable RELTYPE will identify the type of relationship between the + datasets (e.g., a one-to-one or parent-child relationship). The allowable values for + RELYPE are ONE and MANY per CDISC Controlled Terminology. + Document: TIG v1.0 + Item: Text + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0171 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" # We must take into account that POOLID is "permissible" and may be absent # USUBJID is "expected" and the column must then always be present Check: any: # Case that the POOLID column is not present - - all: - - name: USUBJID - operator: empty - - name: POOLID - operator: not_exists - - name: IDVARVAL - operator: empty - - name: RELTYPE - operator: not_equal_to - value: ONE - - name: RELTYPE - operator: not_equal_to - value: MANY - # Case that the POOLID column is present - - all: - - name: USUBJID - operator: empty - - name: POOLID - operator: exists - - name: POOLID - operator: empty - - name: IDVARVAL - operator: empty - - name: RELTYPE - operator: not_equal_to - value: ONE - - name: RELTYPE - operator: not_equal_to - value: MANY + - all: + - name: USUBJID + operator: empty + - name: POOLID + operator: not_exists + - name: IDVARVAL + operator: empty + - name: RELTYPE + operator: not_equal_to + value: ONE + - name: RELTYPE + operator: not_equal_to + value: MANY + # Case that the POOLID column is present + - all: + - name: USUBJID + operator: empty + - name: POOLID + operator: exists + - name: POOLID + operator: empty + - name: IDVARVAL + operator: empty + - name: RELTYPE + operator: not_equal_to + value: ONE + - name: RELTYPE + operator: not_equal_to + value: MANY Core: Id: CORE-000557 Status: Published - Version: '1' + Version: "1" Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be "ONE" or "MANY" Executability: Fully Executable Outcome: - Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are + Message: + For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are null Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000558/rule.yml b/Published/CORE-000558/rule.yml index b219fdd1e..198775de1 100644 --- a/Published/CORE-000558/rule.yml +++ b/Published/CORE-000558/rule.yml @@ -1,129 +1,129 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND72.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0273 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND72.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0273 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: #- name: --DY # operator: equal_to # value: 0 - - name: --DY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: --STDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: --ENDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ - - name: VISITDY - operator: not_matches_regex - value: ^-?[1-9]{1}\d*$ + - name: --DY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: --STDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: --ENDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ + - name: VISITDY + operator: not_matches_regex + value: ^-?[1-9]{1}\d*$ Core: Id: CORE-000558 Status: Published - Version: '1' + Version: "1" Description: --DY must be a non-zero integer Executability: Fully Executable Outcome: Message: Study day variable (--DY/--STDY/--ENDY/VISITDY) is not a non-zero integer Output Variables: - - --DY - - --STDY - - --ENDY - - VISITDY + - --DY + - --STDY + - --ENDY + - VISITDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000559/rule.yml b/Published/CORE-000559/rule.yml index a34c24a1e..27e1bfaf9 100644 --- a/Published/CORE-000559/rule.yml +++ b/Published/CORE-000559/rule.yml @@ -1,130 +1,137 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND224 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND224 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd - - all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - all: + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd + - all: + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CORE-000559 Status: Published - Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must - be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not - present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Fully Executable Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000560/rule.yml b/Published/CORE-000560/rule.yml index cab9b36f6..f1d98c28c 100644 --- a/Published/CORE-000560/rule.yml +++ b/Published/CORE-000560/rule.yml @@ -1,86 +1,94 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL contains one record per subject, regardless of the type of clinical - trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a - study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its - name is ADSL. - Document: ADaM IG v1.3 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL contains one record per subject, regardless of the type of clinical - trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a - study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its - name is ADSL. - Document: ADaM IG v1.2 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: ADaM IG v1.1 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: Model v2.1 - Section: '6' - - Cited Guidance: ADSL and its related metadata are required in a CDISC-based submission of - data from a clinical trial even if no other analysis datasets are submitted. - Document: ADaM IG v1.0 - Section: 2.3.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '1' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: "6" + - Cited Guidance: + ADSL contains one record per subject, regardless of the type of clinical + trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a + study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its + name is ADSL. + Document: ADaM IG v1.3 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "1" + Version: "1" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: "6" + - Cited Guidance: + ADSL contains one record per subject, regardless of the type of clinical + trial design. The label of the ADSL dataset is "Subject-Level Analysis Dataset." In a + study, there is only one dataset in the class of "SUBJECT LEVEL ANALYSIS DATASET", and its + name is ADSL. + Document: ADaM IG v1.2 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: "6" + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: ADaM IG v1.1 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: Model v2.1 + Section: "6" + - Cited Guidance: + ADSL and its related metadata are required in a CDISC-based submission of + data from a clinical trial even if no other analysis datasets are submitted. + Document: ADaM IG v1.0 + Section: 2.3.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "1" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: ADSL - operator: not_exists + - name: ADSL + operator: not_exists Core: Id: CORE-000560 Status: Published - Version: '1' + Version: "1" Description: The ADSL dataset must exist Executability: Fully Executable Outcome: @@ -89,8 +97,8 @@ Rule Type: Domain Presence Check Scope: Data Structures: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000561/rule.yml b/Published/CORE-000561/rule.yml index 77bf3130a..5c9539560 100644 --- a/Published/CORE-000561/rule.yml +++ b/Published/CORE-000561/rule.yml @@ -1,78 +1,78 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per tumor per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND200 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per tumor per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND200 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # REMARK 2024-03-20: This may be "overreporting" # (after having discussed with Christy Kubin, on occasion of Tatiana's remark), @@ -80,46 +80,47 @@ Check: # TFANTREG is however "permissible" and not always used. # We will first develop some test files. any: - - all: - - name: TFANTREG - operator: exists - - name: TFORRES - operator: is_not_unique_set - value: - - USUBJID - - TFSPEC - - TFANTREG - # case that TFANTREG is not present - - all: - - name: TFANTREG - operator: not_exists - - name: TFORRES - operator: is_not_unique_set - value: - - USUBJID - - TFSPEC + - all: + - name: TFANTREG + operator: exists + - name: TFORRES + operator: is_not_unique_set + value: + - USUBJID + - TFSPEC + - TFANTREG + # case that TFANTREG is not present + - all: + - name: TFANTREG + operator: not_exists + - name: TFORRES + operator: is_not_unique_set + value: + - USUBJID + - TFSPEC Core: Id: CORE-000561 Status: Published Version: "1" -Description: Raise an error when there is more than one record present for any particular tumor test +Description: + Raise an error when there is more than one record present for any particular tumor test result for a subject and specimen. Executability: Fully Executable Outcome: Message: The Tumor Findings test result is not unique for this subject and specimen. Output Variables: - - USUBJID - - TFTESTCD - - TFORRES - - TFSPEC - - TFANTREG + - USUBJID + - TFTESTCD + - TFORRES + - TFSPEC + - TFANTREG Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Published/CORE-000567/rule.yml b/Published/CORE-000567/rule.yml index eab67dcf9..4d10c82fe 100644 --- a/Published/CORE-000567/rule.yml +++ b/Published/CORE-000567/rule.yml @@ -1,104 +1,105 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND143 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: (ND) codelist is referenced in the domain table - Document: TIG v1.0 - Item: BWSTAT Controlled Terms, Codelist, or Format - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0079 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND143 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: (ND) codelist is referenced in the domain table + Document: TIG v1.0 + Item: BWSTAT Controlled Terms, Codelist, or Format + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0079 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --STAT - operator: non_empty - - name: --STAT - operator: not_equal_to - value: NOT DONE + - name: --STAT + operator: non_empty + - name: --STAT + operator: not_equal_to + value: NOT DONE Core: Id: CORE-000567 Status: Published - Version: '1' -Description: Trigger error when --STAT is non-empty and does not contain a value from the ND + Version: "1" +Description: + Trigger error when --STAT is non-empty and does not contain a value from the ND codelist Executability: Fully Executable Outcome: @@ -107,9 +108,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000568/rule.yml b/Published/CORE-000568/rule.yml index 8eb622ad1..84c018181 100644 --- a/Published/CORE-000568/rule.yml +++ b/Published/CORE-000568/rule.yml @@ -1,109 +1,116 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.0 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: IG v3.1.1 - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND145 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: TIG v1.0 - Item: BWSTAT CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0081 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.0 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: IG v3.1.1 + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND145 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: TIG v1.0 + Item: BWSTAT CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0081 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: non_empty - - name: --STAT - operator: non_empty + - name: --ORRES + operator: non_empty + - name: --STAT + operator: non_empty Core: Id: CORE-000568 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --ORRES is populated and --STAT is populated Executability: Fully Executable Outcome: @@ -112,9 +119,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000569/rule.yml b/Published/CORE-000569/rule.yml index 2c9eb109d..9a18af75b 100644 --- a/Published/CORE-000569/rule.yml +++ b/Published/CORE-000569/rule.yml @@ -1,101 +1,101 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND30 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Variable names should be represented in uppercase. - Document: TIG v1.0 - Item: Text - Section: "2.6, 2.8.3 (5.c)" - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0212 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND30 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: Variable names should be represented in uppercase. + Document: TIG v1.0 + Item: Text + Section: "2.6, 2.8.3 (5.c)" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0212 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: not_matches_regex - value: ^[A-Z0-9]*$ + - name: variable_name + operator: not_matches_regex + value: ^[A-Z0-9]*$ Core: Id: CORE-000569 Status: Published - Version: '1' + Version: "1" Description: Raise an error when variable name is not in uppercase Executability: Fully Executable Outcome: @@ -104,9 +104,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000570/rule.yml b/Published/CORE-000570/rule.yml index d7f40d1d9..66e6f0dfb 100644 --- a/Published/CORE-000570/rule.yml +++ b/Published/CORE-000570/rule.yml @@ -1,109 +1,115 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.0 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The unique subject identifier (USUBJID) or pool identifier (POOLID) is - Required in all datasets containing subject-level or pool-level data, respectively. - Document: IG v3.1.1 - Section: 4.2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND36 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.0 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The unique subject identifier (USUBJID) or pool identifier (POOLID) is + Required in all datasets containing subject-level or pool-level data, respectively. + Document: IG v3.1.1 + Section: 4.2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND36 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: USUBJID - operator: empty - - name: POOLID - operator: empty + - name: USUBJID + operator: empty + - name: POOLID + operator: empty Core: Id: CORE-000570 Status: Published - Version: '1' + Version: "1" Description: Raise an error when both USUBJID and POOLID are empty Executability: Fully Executable Outcome: Message: Both USUBJID and POOID are empty Output Variables: - - USUBJID - - POOLID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - EVENTS + - INTERVENTIONS + - FINDINGS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000571/rule.yml b/Published/CORE-000571/rule.yml index 077acdef2..a8a5d3d93 100644 --- a/Published/CORE-000571/rule.yml +++ b/Published/CORE-000571/rule.yml @@ -2,97 +2,101 @@ # Condition: --LNKID present in a domain # Rule: --LNKID present in another domain Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKID is a grouping identifier used to identify a record in one domain - that is related to records in another domain, often forming a one-to-many relationship. - Document: IG v3.4 - Item: 2.E.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --LNKID is a grouping identifier used to identify a record in one domain - that is related to records in another domain, often forming a one-to-many relationship. - Document: IG v3.3 - Item: 2.E.1 - Section: 4.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier used to link related records across domains. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0024 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A sequence of characters used to uniquely identify a record, for a subject, - in one domain and link it to 1 or more records for that subject in another domain. - Document: SDTM v2.1 - Item: -LNKID, Definition column - Section: SDTM 3.1.4 Identifiers for All Classes - - Cited Guidance: Groups of records can be related by using grouping variables such as --LNKID - or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of - representing relationships in RELREC when relating a single or group of records in one - dataset to a group of records in another dataset. - Document: TIG v1.0 - Item: -LNKID, Definition column - Section: 2.8.5.2 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0307 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --LNKID is a grouping identifier used to identify a record in one domain + that is related to records in another domain, often forming a one-to-many relationship. + Document: IG v3.4 + Item: 2.E.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + --LNKID is a grouping identifier used to identify a record in one domain + that is related to records in another domain, often forming a one-to-many relationship. + Document: IG v3.3 + Item: 2.E.1 + Section: 4.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Identifier used to link related records across domains. + Document: IG v3.2 + Item: Specification + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0024 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A sequence of characters used to uniquely identify a record, for a subject, + in one domain and link it to 1 or more records for that subject in another domain. + Document: SDTM v2.1 + Item: -LNKID, Definition column + Section: SDTM 3.1.4 Identifiers for All Classes + - Cited Guidance: + Groups of records can be related by using grouping variables such as --LNKID + or --LNKGRP in IDVAR. Using --LNKID or --LNKGRP can be a more efficient method of + representing relationships in RELREC when relating a single or group of records in one + dataset to a group of records in another dataset. + Document: TIG v1.0 + Item: -LNKID, Definition column + Section: 2.8.5.2 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0307 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --LNKID - operator: exists - - name: $VARIABLE_COUNT - operator: less_than - value: 2 + - name: --LNKID + operator: exists + - name: $VARIABLE_COUNT + operator: less_than + value: 2 Core: Id: "CORE-000571" Status: Published - Version: '1' + Version: "1" Description: Verify that when --LNKID is present in one domain it is also present in another domain. Executability: Fully Executable Operations: -- id: $VARIABLE_COUNT - name: --LNKID - operator: variable_count + - id: $VARIABLE_COUNT + name: --LNKID + operator: variable_count Outcome: Message: "LNKID variable is only found in one domain." Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Dataset diff --git a/Published/CORE-000572/rule.yml b/Published/CORE-000572/rule.yml index 874a8a064..f4175b019 100644 --- a/Published/CORE-000572/rule.yml +++ b/Published/CORE-000572/rule.yml @@ -1,118 +1,123 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0235 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment; - Start values; an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values; an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0444 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0235 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment; + Start values; an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values; an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0444 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --ENRTPT # Condition: --ENTPT is prior to the date of collection or assessment. # Rule: --ENRTPT in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Check: all: - - name: --ENTPT - operator: non_empty - - name: --ENTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --ENTPT - operator: date_less_than - value: --DTC - - name: --ENRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - ONGOING - - AFTER - - UNKNOWN + - name: --ENTPT + operator: non_empty + - name: --ENTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --ENTPT + operator: date_less_than + value: --DTC + - name: --ENRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - ONGOING + - AFTER + - UNKNOWN Core: Id: CORE-000572 Status: Published - Version: '1' -Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', + Version: "1" +Description: + Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Executability: Partially Executable Outcome: Message: --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Output Variables: - - --ENTPT - - --ENRTPT - - --DTC + - --ENTPT + - --ENRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000573/rule.yml b/Published/CORE-000573/rule.yml index cc6d36002..d00b62873 100644 --- a/Published/CORE-000573/rule.yml +++ b/Published/CORE-000573/rule.yml @@ -1,110 +1,116 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND278 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.0 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND278 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: $record_count - operator: equal_to - value: 0 + - name: $record_count + operator: equal_to + value: 0 Core: Id: CORE-000573 Status: Published - Version: '1' + Version: "1" Description: Trigger error when a dataset has no records Executability: Fully Executable Operations: -- id: $record_count - operator: record_count + - id: $record_count + operator: record_count Outcome: Message: Dataset may not be empty, it must contain records Output Variables: - - dataset_name - - dataset_label - - $record_count + - dataset_name + - dataset_label + - $record_count Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000575/rule.yml b/Published/CORE-000575/rule.yml index f41f4e749..6d164bb37 100644 --- a/Published/CORE-000575/rule.yml +++ b/Published/CORE-000575/rule.yml @@ -1,227 +1,239 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class, this could be the start date of the event or - intervention. In the Findings observation class, where data are usually collected at - multiple visits, at least one Timing variable must be used. - Document: IG v3.4 - Section: '4.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, all domains based on the three general observation classes - should have at least one Timing variable. in the Events or Interventions general - observation class this could be the start date of the event or intervention. in the - Findings observation class where data are usually collected at multiple visits, at least - one Timing variable must be used. - Document: IG v3.2 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class, this could be the start date of the event or - intervention. In the Findings observation class, where data are usually collected at - multiple visits, at least one Timing variable must be used. - Document: IG v3.3 - Section: '4.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0219 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all - SDTM subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must beused. - Document: SENDIG v3.0 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: SENDIG v3.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: SENDIG v3.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM - subject-level domain datasets. In general, all domains based on the three general - observation classes should have at least one Timing variable. In the Events or - Interventions general observation class this could be the start date of the event or - intervention. In the Findings observation class where data are usually collected at - multiple study days, either --DTC or --DY must be used. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.4. - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND65 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Include the applicable SDTM Timing variables. In general, the domain must - have at least one timing variable. - Document: TIG v1.0 - Item: 4d - Section: 2.8.3 How to Create New Specifications - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0266 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Include the applicable SDTM Timing variables. In general, the domain must - have at least one timing variable. - Document: TIG v1.0 - Item: 4d - Section: 2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0433 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class, this could be the start date of the event or + intervention. In the Findings observation class, where data are usually collected at + multiple visits, at least one Timing variable must be used. + Document: IG v3.4 + Section: "4.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In general, all domains based on the three general observation classes + should have at least one Timing variable. in the Events or Interventions general + observation class this could be the start date of the event or intervention. in the + Findings observation class where data are usually collected at multiple visits, at least + one Timing variable must be used. + Document: IG v3.2 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class, this could be the start date of the event or + intervention. In the Findings observation class, where data are usually collected at + multiple visits, at least one Timing variable must be used. + Document: IG v3.3 + Section: "4.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0219 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all + SDTM subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must beused. + Document: SENDIG v3.0 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Timing variables (SDTM Table 2.2.5) are an essential component of all SDTM + subject-level domain datasets. In general, all domains based on the three general + observation classes should have at least one Timing variable. In the Events or + Interventions general observation class this could be the start date of the event or + intervention. In the Findings observation class where data are usually collected at + multiple study days, either --DTC or --DY must be used. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.4. + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND65 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Include the applicable SDTM Timing variables. In general, the domain must + have at least one timing variable. + Document: TIG v1.0 + Item: 4d + Section: 2.8.3 How to Create New Specifications + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0266 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Include the applicable SDTM Timing variables. In general, the domain must + have at least one timing variable. + Document: TIG v1.0 + Item: 4d + Section: 2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0433 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $dataset_variables - operator: shares_no_elements_with - value: $timing_variables + - name: $dataset_variables + operator: shares_no_elements_with + value: $timing_variables Core: Id: CORE-000575 Status: Published - Version: '1' -Description: There must be at least one timing variable for any of the domains based on the three + Version: "1" +Description: + There must be at least one timing variable for any of the domains based on the three general observation classes Executability: Partially Executable - Possible Underreporting Operations: -- id: $dataset_variables - operator: get_column_order_from_dataset -- id: $timing_variables - key_name: role - key_value: Timing - operator: get_model_filtered_variables + - id: $dataset_variables + operator: get_column_order_from_dataset + - id: $timing_variables + key_name: role + key_value: Timing + operator: get_model_filtered_variables Outcome: Message: No timing variable is provided Output Variables: - - $dataset_variables - - $timing_variables + - $dataset_variables + - $timing_variables Rule Type: Variable Metadata Check Scope: Classes: Include: - - FINDINGS - - INTERVENTIONS - - EVENTS + - FINDINGS + - INTERVENTIONS + - EVENTS Domains: Exclude: - - IE - - SC + - IE + - SC Use Case: NONCLIN, INDH Sensitivity: Dataset diff --git a/Published/CORE-000576/rule.yml b/Published/CORE-000576/rule.yml index 1f78ae6bc..8d18eb7fe 100644 --- a/Published/CORE-000576/rule.yml +++ b/Published/CORE-000576/rule.yml @@ -1,135 +1,144 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Numeric representation of the planned test article dose level. For dose - levels that vary over time within a set, a semicolon-delimited string without spaces can - be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE - PROTOCOL". - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND240.1' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Numeric representation of the planned test article dose level. For dose + levels that vary over time within a set, a semicolon-delimited string without spaces can + be used (e.g., 100;150;7). For more complex dosing regimens, sponsor should enter "SEE + PROTOCOL". + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND240.1" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: TXPARMCD - operator: equal_to - value: TRTDOS - # check whether value is a number - - name: TXVAL - operator: not_matches_regex - value: '[+-]?([0-9]*[.])?[0-9]+$' - # check whether a comma-separated list of values - - name: TXVAL - operator: not_matches_regex - # see https://stackoverflow.com/questions/44374088/regex-to-match-comma-separated-numbers-or-stop-full-match-only - value: ^(\s*-?\d+(\.\d+)?)(\s*;\s*-?\d+(\.\d+)?)*$ - - name: TXVAL - operator: not_equal_to - value: SEE PROTOCOL + - name: TXPARMCD + operator: equal_to + value: TRTDOS + # check whether value is a number + - name: TXVAL + operator: not_matches_regex + value: "[+-]?([0-9]*[.])?[0-9]+$" + # check whether a comma-separated list of values + - name: TXVAL + operator: + not_matches_regex + # see https://stackoverflow.com/questions/44374088/regex-to-match-comma-separated-numbers-or-stop-full-match-only + value: ^(\s*-?\d+(\.\d+)?)(\s*;\s*-?\d+(\.\d+)?)*$ + - name: TXVAL + operator: not_equal_to + value: SEE PROTOCOL Core: Id: CORE-000576 Status: Published - Version: '1' -Description: The value of TRTDOS is either a number, a semicolon-delimited string containing numbers + Version: "1" +Description: + The value of TRTDOS is either a number, a semicolon-delimited string containing numbers without spaces, or "SEE PROTOCOL" for more complex dosing regimens. Executability: Fully Executable Outcome: - Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string + Message: + The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string containing numbers without spaces, or "SEE PROTOCOL" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000577/rule.yml b/Published/CORE-000577/rule.yml index a6d03a033..25e7221ca 100644 --- a/Published/CORE-000577/rule.yml +++ b/Published/CORE-000577/rule.yml @@ -1,41 +1,41 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per actual Repro Stage per subject - Document: IG-DART v1.1 - Section: '4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND349 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per actual Repro Stage per subject - Document: IG-DART v1.2 - Section: '4.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND349 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per actual Repro Stage per subject + Document: IG-DART v1.1 + Section: "4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND349 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per actual Repro Stage per subject + Document: IG-DART v1.2 + Section: "4.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND349 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: RSTGCD - operator: is_not_unique_set - value: - - USUBJID + - name: RSTGCD + operator: is_not_unique_set + value: + - USUBJID Core: Id: CORE-000577 Status: Published - Version: '1' + Version: "1" Description: Raise an error when RSTGCD is not unique within USUBJID Executability: Fully Executable Outcome: @@ -45,8 +45,8 @@ Scope: Classes: Include: # P.S. "SJ" is not recognized as "SPECIAL PURPOSE", Github ticket 586 - - ALL + - ALL Domains: Include: - - SJ + - SJ Sensitivity: Record diff --git a/Published/CORE-000578/rule.yml b/Published/CORE-000578/rule.yml index a23e13f15..babac4242 100644 --- a/Published/CORE-000578/rule.yml +++ b/Published/CORE-000578/rule.yml @@ -1,79 +1,84 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Only applies to SENDIG-3.1.1 and SENDIG-GENETOX 1.0 and SENDIG-DART 1.2 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as - indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with - the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as - indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with - the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the test result in PCORRES is below the Lower Limit of Quantitation as - indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with - the appropriate unit - Document: IG v3.1.1 - Item: Assumption 7.c - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND331' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND331" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND331" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the test result in PCORRES is below the Lower Limit of Quantitation as + indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with + the appropriate unit + Document: IG v3.1.1 + Item: Assumption 7.c + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND331" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: PCSTRESC - operator: equal_to - value: 'BLQ' - # report an error when either PCLLOQ is not populated or PCSTRESU is not populated - - any: - - name: PCLLOQ - operator: empty - - name: PCSTRESU - operator: empty + - name: PCSTRESC + operator: equal_to + value: "BLQ" + # report an error when either PCLLOQ is not populated or PCSTRESU is not populated + - any: + - name: PCLLOQ + operator: empty + - name: PCSTRESU + operator: empty Core: Id: CORE-000578 Status: Published - Version: '1' -Description: If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in + Version: "1" +Description: + If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with the appropriate unit Executability: Fully Executable Outcome: - Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must + Message: + PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must be populated Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000580/rule.yml b/Published/CORE-000580/rule.yml index 18ef11334..ee7822700 100644 --- a/Published/CORE-000580/rule.yml +++ b/Published/CORE-000580/rule.yml @@ -1,129 +1,133 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that Elements that have different start and end rules are different - Elements and must have different values of ELEMENT and ETCD. - Document: IG v3.4 - Item: Assumption 13 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Expresses rule for ending Element. Either TEENRL or TEDUR must - be present for each Element.]|Assumption 15[Note that Elements that have different start - and end rules are different Elements and must have different values of ELEMENT and ETCD.] - Document: IG v3.2 - Item: Specification|Assumption 15 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that Elements that have different start and end rules are different - Elements and must have different values of ELEMENT and ETCD. - Document: IG v3.3 - Item: Assumption 15 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0325 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Note that elements that have different start and end rules are different - elements and must have different values of ELEMENT and ETCD. - Document: TIG 1.0 - Item: Assumption 15 - Section: 2.8.10.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0495 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Note that Elements that have different start and end rules are different + Elements and must have different values of ELEMENT and ETCD. + Document: IG v3.4 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Expresses rule for ending Element. Either TEENRL or TEDUR must + be present for each Element.]|Assumption 15[Note that Elements that have different start + and end rules are different Elements and must have different values of ELEMENT and ETCD.] + Document: IG v3.2 + Item: Specification|Assumption 15 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Note that Elements that have different start and end rules are different + Elements and must have different values of ELEMENT and ETCD. + Document: IG v3.3 + Item: Assumption 15 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0325 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Note that elements that have different start and end rules are different + elements and must have different values of ELEMENT and ETCD. + Document: TIG 1.0 + Item: Assumption 15 + Section: 2.8.10.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0495 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: ETCD -# Condition: +# Condition: # Rule: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is unique for each ETCD Check: any: - - name: ETCD - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR - - all: - name: ETCD - operator: is_unique_set - value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR - - name: ELEMENT - operator: is_not_unique_set - value: - - TESTRL - - TEENRL - - TEDUR - - name: TESTRL operator: is_not_unique_set value: - - ELEMENT - - TEENRL - - TEDUR - - name: TEENRL - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEDUR - - name: TEDUR - operator: is_not_unique_set - value: - - ELEMENT - - TEENRL - - TESTRL + - ELEMENT + - TESTRL + - TEENRL + - TEDUR + - all: + - name: ETCD + operator: is_unique_set + value: + - ELEMENT + - TESTRL + - TEENRL + - TEDUR + - name: ELEMENT + operator: is_not_unique_set + value: + - TESTRL + - TEENRL + - TEDUR + - name: TESTRL + operator: is_not_unique_set + value: + - ELEMENT + - TEENRL + - TEDUR + - name: TEENRL + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEDUR + - name: TEDUR + operator: is_not_unique_set + value: + - ELEMENT + - TEENRL + - TESTRL Core: Id: CORE-000580 Status: Published - Version: '1' + Version: "1" Description: The combination of TESTRL, TEENRL, and TEDUR must be unique for each ETCD. Executability: Fully Executable Outcome: Message: The combination of TESTRL, TEENRL, and TEDUR is not unique for each ETCD. Output Variables: - - ETCD - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ETCD + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000581/rule.yml b/Published/CORE-000581/rule.yml index ec6cc5dbf..18b5953f5 100644 --- a/Published/CORE-000581/rule.yml +++ b/Published/CORE-000581/rule.yml @@ -2,212 +2,226 @@ # Condition: Study on human subjects # Rule: DM dataset present in study Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include 1 standardized set of observations in a specific - structure; this is the Demographics domain described here. - Document: Model v2.0 - Section: Demographics - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include one standardized set of observations in a specific - structure; this is the Demographics domain described in Table 2.2.6. - Document: Model v1.4 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study must include one standardized set of observations in a specific - structure; this is the Demographics domain described in Table 2.2.6. - Document: Model v1.7 - Section: 2.2.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0368 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: For studies that assess the impact of tobacco products on the health of - individuals, DM is required even if no other datasets are generated. - Document: TIG 1.0 - Item: Table 2 Num 3 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0532 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml - must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, - 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml - must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, - 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml - must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, - 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736a - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic - (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, - 4.2.3.4 - Document: FDA - Section: TRC1736 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1736c - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Each study must include 1 standardized set of observations in a specific + structure; this is the Demographics domain described here. + Document: Model v2.0 + Section: Demographics + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Each study must include one standardized set of observations in a specific + structure; this is the Demographics domain described in Table 2.2.6. + Document: Model v1.4 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Each study must include one standardized set of observations in a specific + structure; this is the Demographics domain described in Table 2.2.6. + Document: Model v1.7 + Section: 2.2.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0368 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + For studies that assess the impact of tobacco products on the health of + individuals, DM is required even if no other datasets are generated. + Document: TIG 1.0 + Item: Table 2 Num 3 + Section: "2.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0532 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For Study Data Tabulation Model (SDTM) data, a DM dataset and define.xml + must be submitted in Module 5, sections 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, + 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736a + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + For Standard for Exchange of Nonclinical Data (SEND) data, a Demographic + (DM) dataset and define.xml must be submitted in Module 4, sections 4.2.3.1, 4.2.3.2, + 4.2.3.4 + Document: FDA + Section: TRC1736 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1736c + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: DM - operator: not_exists + - name: DM + operator: not_exists Core: Id: CORE-000581 Status: Published - Version: '1' + Version: "1" Description: DM dataset should be present. Executability: Fully Executable Outcome: @@ -216,9 +230,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000583/rule.yml b/Published/CORE-000583/rule.yml index 14ff23464..8fb6d1cfb 100644 --- a/Published/CORE-000583/rule.yml +++ b/Published/CORE-000583/rule.yml @@ -1,111 +1,119 @@ Authorities: -- Organization: CDISC - # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule xxx) - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND288" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: TIG - References: - - Citations: - - Cited Guidance: Null flavor for the value of the TSPARMs, which should be included according - to the trial summary code table below if and only if TSVAL is null. - Document: TIG v1.0 - Item: TSVALNF CDISC Notes - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0204 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: + CDISC + # REMARK: NOT applicable to SENDIG-3.0 (which has similar rule xxx) + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND288" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Null flavor for the value of the TSPARMs, which should be included according + to the trial summary code table below if and only if TSVAL is null. + Document: TIG v1.0 + Item: TSVALNF CDISC Notes + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0204 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: - # 2024-11-19: after discussion with SEND team, also raise an error + # 2024-11-19: after discussion with SEND team, also raise an error # when NONE of TSVAL and TSVALNF are populated any: - - all: - - name: TSVAL - operator: non_empty - - name: TSVALNF - operator: non_empty - - all: - - name: TSVAL - operator: empty - - name: TSVALNF - operator: empty + - all: + - name: TSVAL + operator: non_empty + - name: TSVALNF + operator: non_empty + - all: + - name: TSVAL + operator: empty + - name: TSVALNF + operator: empty Core: Id: CORE-000583 Status: Published Version: "1" -Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and +Description: + Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and TSVALNF are populated, or when both variables are empty. Executability: Fully Executable Outcome: @@ -114,9 +122,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000584/rule.yml b/Published/CORE-000584/rule.yml index 1b5104dc9..6abc09c5f 100644 --- a/Published/CORE-000584/rule.yml +++ b/Published/CORE-000584/rule.yml @@ -1,150 +1,158 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.0 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per - observation time per subject or pool, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 6.3.6 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND169' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: lb.xpt, Laboratory Test Results — Findings. One record per test per specimen - per observation time per subject or pool, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.14 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0098 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.0 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory - Findings. One record per test per specimen per + observation time per subject or pool, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 6.3.6 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND169" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + lb.xpt, Laboratory Test Results — Findings. One record per test per specimen + per observation time per subject or pool, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.14 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0098 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: any: - - all: - - name: LBDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: LBTESTCD - operator: is_not_unique_set - value: - - USUBJID - - LBSPEC - - LBDTC - - all: - - name: LBDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: LBTESTCD - operator: is_not_unique_set - value: - - POOLID - - LBSPEC - - LBDTC + - all: + - name: LBDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: LBTESTCD + operator: is_not_unique_set + value: + - USUBJID + - LBSPEC + - LBDTC + - all: + - name: LBDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: LBTESTCD + operator: is_not_unique_set + value: + - POOLID + - LBSPEC + - LBDTC Core: Id: CORE-000584 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present per test per specimen, in the + Version: "1" +Description: + Raise an error when there is more than one record present per test per specimen, in the LB Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: Message: The LB test result is not unique per specimen per subject or pool and date/time. Output Variables: - - POOLID - - LBTESTCD - - LBSPEC - - LBDTC + - POOLID + - LBTESTCD + - LBSPEC + - LBDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000590/rule.yml b/Published/CORE-000590/rule.yml index f4d4e6cea..9f56031a3 100644 --- a/Published/CORE-000590/rule.yml +++ b/Published/CORE-000590/rule.yml @@ -2,34 +2,36 @@ # Condition: Study of tobacco product(s) # Rule: TO dataset is required in all studies of tobacco products Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: 'TO is a study reference dataset that provides a consistent identifier, the Applicant-defined - Tobacco Product Identifier (SPTOBID), for a tobacco product in a study. It contains the identifying - and descriptive characteristics of a tobacco product and merges those characteristics on this - single identifier. This dataset is required for studies of tobacco products.' - Document: 'TIG 1.0' - Item: 'assumption 1' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0001' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + "TO is a study reference dataset that provides a consistent identifier, the Applicant-defined + Tobacco Product Identifier (SPTOBID), for a tobacco product in a study. It contains the identifying + and descriptive characteristics of a tobacco product and merges those characteristics on this + single identifier. This dataset is required for studies of tobacco products." + Document: "TIG 1.0" + Item: "assumption 1" + Section: "2.8.8.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0001" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TO - operator: not_exists + - name: TO + operator: not_exists Core: Id: CORE-000590 Status: Published - Version: '1' -Description: Raise an error when the study is a study of tobacco product(s) but the TO dataset is + Version: "1" +Description: + Raise an error when the study is a study of tobacco product(s) but the TO dataset is not present. Executability: Fully Executable Outcome: @@ -38,9 +40,9 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: PROD Sensitivity: Dataset diff --git a/Published/CORE-000591/rule.yml b/Published/CORE-000591/rule.yml index 19ad92e58..9faf5f3af 100644 --- a/Published/CORE-000591/rule.yml +++ b/Published/CORE-000591/rule.yml @@ -1,56 +1,58 @@ # Variable: TOPARMCD # Rule: TOPARMCD=TBPRDCAT present in dataset Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A minimally meaningful TO dataset must include at least the parameter for - tobacco product category (TOPARMCD = TPRDCAT) - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0003' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + A minimally meaningful TO dataset must include at least the parameter for + tobacco product category (TOPARMCD = TPRDCAT) + Document: "TIG 1.0" + Item: "assumption 2" + Section: "2.8.8.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0003" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $tbprdcat_count - operator: equal_to - value: 0 + - name: $tbprdcat_count + operator: equal_to + value: 0 Core: Id: CORE-000591 Status: Published - Version: '1' -Description: Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals + Version: "1" +Description: + Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals TBPRDCAT. Executability: Fully Executable Operations: -- domain: TO - filter: - TOPARMCD: TBPRDCAT - group: - - SPTOBID - id: $tbprdcat_count - name: TOPARMCD - operator: record_count + - domain: TO + filter: + TOPARMCD: TBPRDCAT + group: + - SPTOBID + id: $tbprdcat_count + name: TOPARMCD + operator: record_count Outcome: Message: TO dataset does not include a record for each SPTOBID where TOPARMCD = TBPRDCAT. Output Variables: - - SPTOBID - - $tbprdcat_count + - SPTOBID + - $tbprdcat_count Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000592/rule.yml b/Published/CORE-000592/rule.yml index ef9161c43..d2f9e0259 100644 --- a/Published/CORE-000592/rule.yml +++ b/Published/CORE-000592/rule.yml @@ -2,48 +2,49 @@ # Condition: TOPARMCD = TBPRDCAT # Rule: TOVAL ^= null Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: A minimally meaningful TO dataset must include at least the parameter for - tobacco product category (TOPARMCD = TPRDCAT) - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0004' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + A minimally meaningful TO dataset must include at least the parameter for + tobacco product category (TOPARMCD = TPRDCAT) + Document: "TIG 1.0" + Item: "assumption 2" + Section: "2.8.8.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0004" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TOPARMCD - operator: equal_to - value: TBPRDCAT - - name: TOVAL - operator: empty + - name: TOPARMCD + operator: equal_to + value: TBPRDCAT + - name: TOVAL + operator: empty Core: Id: CORE-000592 Status: Published - Version: '1' + Version: "1" Description: Raise an error when TOVAL is not completed for records where TOPARMCD equals TBPRDCAT. Executability: Fully Executable Outcome: Message: TOVAL is not completed when TOPARMCD = TBPRDCAT. Output Variables: - - TOPARMCD - - TOVAL + - TOPARMCD + - TOVAL Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000593/rule.yml b/Published/CORE-000593/rule.yml index 291c95b29..7d29aa788 100644 --- a/Published/CORE-000593/rule.yml +++ b/Published/CORE-000593/rule.yml @@ -2,69 +2,71 @@ # Condition: PTMETHOD = null / PTXFN = null # Rule: PTXFN ^= null / PTMETHOD ^= null Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When lab methodology is too complex for the single PTMETHOD variable, PTXFN - should be used to reference a file name or path to a file in the application that - describes the methodology used. One or the other of PTMETHOD or PTXFN should be included - in the data. - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0006' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When lab methodology is too complex for the single PTMETHOD variable, PTXFN - should be used to reference a file name or path to a file in the application that - describes the methodology used. One or the other of PTMETHOD or PTXFN should be included - in the data. - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0007' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + When lab methodology is too complex for the single PTMETHOD variable, PTXFN + should be used to reference a file name or path to a file in the application that + describes the methodology used. One or the other of PTMETHOD or PTXFN should be included + in the data. + Document: "TIG 1.0" + Item: "assumption 6" + Section: "2.8.8.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0006" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + When lab methodology is too complex for the single PTMETHOD variable, PTXFN + should be used to reference a file name or path to a file in the application that + describes the methodology used. One or the other of PTMETHOD or PTXFN should be included + in the data. + Document: "TIG 1.0" + Item: "assumption 6" + Section: "2.8.8.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0007" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: PTMETHOD - operator: empty - - name: PTXFN - operator: empty + - name: PTMETHOD + operator: empty + - name: PTXFN + operator: empty Core: Id: CORE-000593 Status: Published - Version: '1' + Version: "1" Description: Raise an error when PTMETHOD and PTXFN are both not populated. Executability: Fully Executable Outcome: Message: At least one of PTMETHOD and PTXFN variables should be populated. Output Variables: - - SPTOBID - - PTMETHOD - - PTXFN + - SPTOBID + - PTMETHOD + - PTXFN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PT + - PT Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000594/rule.yml b/Published/CORE-000594/rule.yml index eb9d721bd..91d7c3c33 100644 --- a/Published/CORE-000594/rule.yml +++ b/Published/CORE-000594/rule.yml @@ -1,175 +1,186 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable labels are in title case Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize the first - letter of every word except for articles, prepositions, and conjunctions). - Document: IG v3.4 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize the first - letter of every word except for articles; prepositions; and conjunctions). - Document: IG v3.2 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Use title case for all labels (title case means to capitalize the first - letter of every word except for articles; prepositions; and conjunctions). - Document: IG v3.3 - Item: 3h - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0359 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.0 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Variable descriptive names (labels), up to 40 characters in title case, - should be provided as data variable labels. - Document: IG v3.1.1 - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND29 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as - data variable labels for all variables, including Supplemental Qualifier variables. Use - title case for all labels - Document: TIG 1.0 - Item: Tabulation Datasets table NUM 5 - Section: 2.6|2.8.2|2.8.3 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0524 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as - data variable labels for all variables, including Supplemental Qualifier variables. - Document: TIG 1.0 - Item: Tabulation Datasets table, Num 5 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0205 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Use title case for all labels (title case means to capitalize the first + letter of every word except for articles, prepositions, and conjunctions). + Document: IG v3.4 + Item: 3h + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Use title case for all labels (title case means to capitalize the first + letter of every word except for articles; prepositions; and conjunctions). + Document: IG v3.2 + Item: 3h + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Use title case for all labels (title case means to capitalize the first + letter of every word except for articles; prepositions; and conjunctions). + Document: IG v3.3 + Item: 3h + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0359 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.0 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Variable descriptive names (labels), up to 40 characters in title case, + should be provided as data variable labels. + Document: IG v3.1.1 + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND29 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. Use + title case for all labels + Document: TIG 1.0 + Item: Tabulation Datasets table NUM 5 + Section: 2.6|2.8.2|2.8.3 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0524 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables. + Document: TIG 1.0 + Item: Tabulation Datasets table, Num 5 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0205 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_label - operator: not_matches_regex - # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|([A-Z]\S*))\s*)*$ - # Updated by Jozef Aerts, added "and/or", "is", "within" and "from" - # as these appear in existing labels in SDTM Model 2.0 (I did not check in earlier model versions) - # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|and/or|is|within|from|([A-Z]\S*))\s*)*$ - # update 2025-07-24: - value: - ^\s*[A-Z]\S*\s*((a|an|the|as|and|per|to|but|or|for|in|is|of|on|with|and\/or|is|within|from|([A-Z]\S*))\s*)*$ + - name: variable_label + operator: + not_matches_regex + # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|([A-Z]\S*))\s*)*$ + # Updated by Jozef Aerts, added "and/or", "is", "within" and "from" + # as these appear in existing labels in SDTM Model 2.0 (I did not check in earlier model versions) + # value: ^\s*[A-Z]\S*\s*((a|an|the|and|per|to|but|or|for|in|of|on|with|and/or|is|within|from|([A-Z]\S*))\s*)*$ + # update 2025-07-24: + value: ^\s*[A-Z]\S*\s*((a|an|the|as|and|per|to|but|or|for|in|is|of|on|with|and\/or|is|within|from|([A-Z]\S*))\s*)*$ Core: Id: CORE-000594 Status: Published - Version: '1' + Version: "1" Description: Raise an error when a variable label is not in title case Executability: Fully Executable Outcome: @@ -178,9 +189,9 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000595/rule.yml b/Published/CORE-000595/rule.yml index 6e35f042f..7b1970976 100644 --- a/Published/CORE-000595/rule.yml +++ b/Published/CORE-000595/rule.yml @@ -2,81 +2,84 @@ # Condition: CASNO = null / UNII = null # Rule: UNII ^= null / CASNO ^= null Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: At least one of the two permissible variables CASNO or UNII should also be - provided if available. - Document: 'TIG 1.0' - Item: 'assumption 3.d.ii' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0010' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: At least one of the two permissible variables CASNO or UNII should also be - provided if available. - Document: 'TIG 1.0' - Item: 'assumption 3.d.ii' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0011' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + At least one of the two permissible variables CASNO or UNII should also be + provided if available. + Document: "TIG 1.0" + Item: "assumption 3.d.ii" + Section: "2.8.8.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0010" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + At least one of the two permissible variables CASNO or UNII should also be + provided if available. + Document: "TIG 1.0" + Item: "assumption 3.d.ii" + Section: "2.8.8.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0011" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: UNII - operator: empty - - name: CASNO - operator: empty - - all: - - name: UNII - operator: not_exists - - name: CASNO - operator: not_exists - - all: - - name: UNII - operator: not_exists - - name: CASNO - operator: empty - - all: - - name: CASNO - operator: not_exists - - name: UNII - operator: empty + - all: + - name: UNII + operator: empty + - name: CASNO + operator: empty + - all: + - name: UNII + operator: not_exists + - name: CASNO + operator: not_exists + - all: + - name: UNII + operator: not_exists + - name: CASNO + operator: empty + - all: + - name: CASNO + operator: not_exists + - name: UNII + operator: empty Core: Id: CORE-000595 Status: Published - Version: '1' + Version: "1" Description: Raise an error when UNII and CASNO are both not populated. Executability: Fully Executable Outcome: - Message: At least one of the UNII and CASNO variables should be present and populated for each + Message: + At least one of the UNII and CASNO variables should be present and populated for each ingredient if available. Output Variables: - - UNII - - CASNO + - UNII + - CASNO Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000596/rule.yml b/Published/CORE-000596/rule.yml index cee818bff..188a49f77 100644 --- a/Published/CORE-000596/rule.yml +++ b/Published/CORE-000596/rule.yml @@ -2,58 +2,60 @@ # Condition: INGRADE = null AND INPURITY = null # Rule: TPMF ^= null Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA - rule, at least one of these two attributes must be included. If the data are proprietary - and only available via the TPMF, then TPMF should be populated. - Document: 'TIG 1.0' - Item: 'assumption 3.f' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0012' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA + rule, at least one of these two attributes must be included. If the data are proprietary + and only available via the TPMF, then TPMF should be populated. + Document: "TIG 1.0" + Item: "assumption 3.f" + Section: "2.8.8.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0012" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: INGRADE - operator: empty - - name: INPURITY - operator: empty - - any: - - name: TPMF + - name: INGRADE operator: empty - - name: TPMF - operator: not_exists + - name: INPURITY + operator: empty + - any: + - name: TPMF + operator: empty + - name: TPMF + operator: not_exists Core: Id: CORE-000596 Status: Published - Version: '1' + Version: "1" Description: Raise an error when INGRADE, INPURITY and TPMF are all not populated. Executability: Fully Executable Outcome: - Message: At least one of INGRADE or INPURITY should be populated. If neither is available due to + Message: + At least one of INGRADE or INPURITY should be populated. If neither is available due to the ingredient being proprietary and originating from a third-party supplier, populate TPMF with the Tobacco Product Master File number provided by the supplier. Output Variables: - - INGRADE - - INPURITY - - TPMF - - IGDCMPID - - SPTOBID + - INGRADE + - INPURITY + - TPMF + - IGDCMPID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000597/rule.yml b/Published/CORE-000597/rule.yml index 383a3ed8e..82b5ac047 100644 --- a/Published/CORE-000597/rule.yml +++ b/Published/CORE-000597/rule.yml @@ -2,100 +2,104 @@ # Condition: Record present in SUPPAE where SUPPAE.QNAM=AESOSP # Rule: AESMIE = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse Events - category is collected on a CRF, sponsors should place the description in the SUPPAE - dataset using the standard supplemental qualifier name code AESOSP. - Document: IG v3.4 - Item: Asumtpion 6c - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse Events - category is collected on a CRF, sponsors should place the description in the SUPPAE - dataset using the standard supplemental qualifier name code AESOSP. - Document: IG v3.2 - Item: Assumption 6c - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a description of Other Medically Important Serious Adverse Events - category is collected on a CRF, sponsors should place the description in the SUPPAE - dataset using the standard supplemental qualifier name code AESOSP. - Document: IG v3.3 - Item: Assumption 6c - Section: 6.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0043 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: When a description of "Other Medically Important Serious Adverse Events" - category is collected on a CRF, applicants should place the description in the SUPPAE - dataset using the standard supplemental qualifier name code AESOSP. - Document: TIG 1.0 - Item: Assumption 7c - Section: 2.8.10.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0322 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.4 + Item: Asumtpion 6c + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.2 + Item: Assumption 6c + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a description of Other Medically Important Serious Adverse Events + category is collected on a CRF, sponsors should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: IG v3.3 + Item: Assumption 6c + Section: 6.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0043 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When a description of "Other Medically Important Serious Adverse Events" + category is collected on a CRF, applicants should place the description in the SUPPAE + dataset using the standard supplemental qualifier name code AESOSP. + Document: TIG 1.0 + Item: Assumption 7c + Section: 2.8.10.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0322 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: QNAM - operator: equal_to - value: AESOSP - value_is_literal: true - - name: AESMIE - operator: not_equal_to - value: Y + - name: QNAM + operator: equal_to + value: AESOSP + value_is_literal: true + - name: AESMIE + operator: not_equal_to + value: Y Core: Id: CORE-000597 Status: Published - Version: '1' + Version: "1" Description: When SUPPAE.QNAM=AESOSP is present, a record with AESMIE=Y should be present Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: SUPPAE + - Keys: + - USUBJID + Name: SUPPAE Outcome: Message: Missing AESMIE=Y where SUPPAE.QNAM=AESOSP Output Variables: - - QNAM - - AESMIE + - QNAM + - AESMIE Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000598/rule.yml b/Published/CORE-000598/rule.yml index 736f4096d..a3d304e50 100644 --- a/Published/CORE-000598/rule.yml +++ b/Published/CORE-000598/rule.yml @@ -1,179 +1,184 @@ # Variable: DOMAIN -# Condition: +# Condition: # Rule: Dataset name begins with DOMAIN value Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Each study subject domain dataset is distinguished by a unique, 2-character - code that should be used consistently throughout the submission. This code, which is - stored in the SDTM variable named DOMAIN, is used in the dataset name, as the value of the - DOMAIN variable in that dataset, and as a prefix for most variable names in that dataset. - Document: Model v2.0 - Section: Study Subject Data - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'This code; which is stored in the SDTM variable named DOMAIN; is used in four - ways: as the dataset name; the value of the DOMAIN variable in that dataset; as a prefix for - most variable names in that dataset; and as a value in the RDOMAIN variable in relationship - tables.' - Document: Model v1.4 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Each domain dataset is distinguished by a unique; 2-character code that should - be used consistently throughout the submission. This code; which is stored in the SDTM variable - named DOMAIN; is used in 4 ways: as the dataset name; as the value of the DOMAIN variable in - that dataset; as a prefix for most variable names in that dataset; and as a value in the RDOMAIN - variable in relationship tables.' - Document: Model v1.7 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0413 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each study subject domain dataset is distinguished by a unique 2-character - code. This code, which is stored in the SDTM variable named DOMAIN, is used in the dataset - name, as the value of the DOMAIN variable in that dataset, and as a prefix for most - variable names in that dataset. - Document: SDTM v2.1 - Item: DOMAIN - Section: Section 3 Study Subject Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0568 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Domain datasets based on the SDTM general observations classes will be named - using the two-character code for the domain or using the applicable four-character code - when a dataset is split. Supplemental Qualifier datasets will be named using convention - SUPP concatenated with the two-character domain code or four-character code when a dataset - is split (e.g., SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named using the code - for the domain or dataset and (e.g., DM, RELREC). - Document: TIG v1.0 - Item: Tabulation Datasets Table, Num 2 - Section: 2.6 Guidance for Datasets - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0037 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Each study subject domain dataset is distinguished by a unique, 2-character + code that should be used consistently throughout the submission. This code, which is + stored in the SDTM variable named DOMAIN, is used in the dataset name, as the value of the + DOMAIN variable in that dataset, and as a prefix for most variable names in that dataset. + Document: Model v2.0 + Section: Study Subject Data + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "This code; which is stored in the SDTM variable named DOMAIN; is used in four + ways: as the dataset name; the value of the DOMAIN variable in that dataset; as a prefix for + most variable names in that dataset; and as a value in the RDOMAIN variable in relationship + tables." + Document: Model v1.4 + Section: "2.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Each domain dataset is distinguished by a unique; 2-character code that should + be used consistently throughout the submission. This code; which is stored in the SDTM variable + named DOMAIN; is used in 4 ways: as the dataset name; as the value of the DOMAIN variable in + that dataset; as a prefix for most variable names in that dataset; and as a value in the RDOMAIN + variable in relationship tables." + Document: Model v1.7 + Section: "2.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0413 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Each study subject domain dataset is distinguished by a unique 2-character + code. This code, which is stored in the SDTM variable named DOMAIN, is used in the dataset + name, as the value of the DOMAIN variable in that dataset, and as a prefix for most + variable names in that dataset. + Document: SDTM v2.1 + Item: DOMAIN + Section: Section 3 Study Subject Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0568 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Domain datasets based on the SDTM general observations classes will be named + using the two-character code for the domain or using the applicable four-character code + when a dataset is split. Supplemental Qualifier datasets will be named using convention + SUPP concatenated with the two-character domain code or four-character code when a dataset + is split (e.g., SUPPDM, SUPPFA, SUPPFACM). All other datasets will be named using the code + for the domain or dataset and (e.g., DM, RELREC). + Document: TIG v1.0 + Item: Tabulation Datasets Table, Num 2 + Section: 2.6 Guidance for Datasets + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0037 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: dataset_name - operator: prefix_not_equal_to - prefix: 2 - value: DOMAIN + - name: dataset_name + operator: prefix_not_equal_to + prefix: 2 + value: DOMAIN Core: Id: CORE-000598 Status: Published - Version: '1' + Version: "1" Description: The dataset name must begin with the DOMAIN value. Executability: Fully Executable Outcome: @@ -182,12 +187,12 @@ Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - SUPP-- - - RELREC - - RELREF - - POOLDEF + - SUPP-- + - RELREC + - RELREF + - POOLDEF Use Case: INDH, PROD, NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000599/rule.yml b/Published/CORE-000599/rule.yml index dc5b12043..bf03b778f 100644 --- a/Published/CORE-000599/rule.yml +++ b/Published/CORE-000599/rule.yml @@ -1,105 +1,106 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.0 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If no test article was administered, EXLOT should be null. - Document: IG v3.1.1 - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND134 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.0 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: If no test article was administered, EXLOT should be null. + Document: IG v3.1.1 + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND134 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # Remark: In SEND, "no test article (as described in EXTRT) is administered", is depicted as EXDOSE=0 # and NOT by EXDOSE being empty. Information from Christy Kubin 2023-03-20 - - name: EXDOSE - operator: equal_to - value: 0 - - name: EXLOT - operator: non_empty + - name: EXDOSE + operator: equal_to + value: 0 + - name: EXLOT + operator: non_empty Core: Id: CORE-000599 Status: Published - Version: '1' -Description: If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT + Version: "1" +Description: + If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT is null. Executability: Fully Executable Outcome: Message: EXDOSE is 0, EXLOT may not be populated Output Variables: - - EXDOSE - - EXLOT + - EXDOSE + - EXLOT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Published/CORE-000600/rule.yml b/Published/CORE-000600/rule.yml index 7e24ffddd..2022b0609 100644 --- a/Published/CORE-000600/rule.yml +++ b/Published/CORE-000600/rule.yml @@ -1,66 +1,68 @@ # Variable: PARENT # Rule: For each value in PARENT there must exist one record with REFID value = PARENT value. Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Every value of PARENT must be defined once and only once. Every PARENT must - have a unique REFID which may be referenced by multiple records with the same PARENT. - (Each REFID with a PARENT, has only one PARENT and that PARENT is described in a unique - PARENT record.). - Document: 'TIG 1.0' - Item: 'assumption 4' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0030' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Every value of PARENT must be defined once and only once. Every PARENT must + have a unique REFID which may be referenced by multiple records with the same PARENT. + (Each REFID with a PARENT, has only one PARENT and that PARENT is described in a unique + PARENT record.). + Document: "TIG 1.0" + Item: "assumption 4" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0030" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: LEVEL - operator: not_equal_to - value: 1 - - any: - - name: PARENT - operator: is_not_contained_by - value: $relref_refid - within: SETCD - - name: PARENT - operator: equal_to - value: REFID + - name: LEVEL + operator: not_equal_to + value: 1 + - any: + - name: PARENT + operator: is_not_contained_by + value: $relref_refid + within: SETCD + - name: PARENT + operator: equal_to + value: REFID Core: Id: CORE-000600 Status: Published - Version: '1' -Description: Raise an error when a record has a PARENT value but no other record exists with REFID + Version: "1" +Description: + Raise an error when a record has a PARENT value but no other record exists with REFID value = PARENT value. Executability: Fully Executable Operations: -- domain: RELREF - group: - - SETCD - id: $relref_refid - name: REFID - operator: distinct + - domain: RELREF + group: + - SETCD + id: $relref_refid + name: REFID + operator: distinct Outcome: Message: Value for PARENT does not equal a REFID value from another record. Output Variables: - - LEVEL - - PARENT - - SETCD - - $relref_refid + - LEVEL + - PARENT + - SETCD + - $relref_refid Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000601/rule.yml b/Published/CORE-000601/rule.yml index 1b4e9e79e..b9dcad422 100644 --- a/Published/CORE-000601/rule.yml +++ b/Published/CORE-000601/rule.yml @@ -1,65 +1,68 @@ # Variable: IQPARENT # Rule: IQPARENT in IGDCMPID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IQPARENT must equal the IDGCMPID of another record in IQ (i.e., the parent - ingredient/component must be listed in IQ). - Document: 'TIG 1.0' - Item: 'assumption 4.a.i.' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0015' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + IQPARENT must equal the IDGCMPID of another record in IQ (i.e., the parent + ingredient/component must be listed in IQ). + Document: "TIG 1.0" + Item: "assumption 4.a.i." + Section: "2.8.8.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0015" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IQLEVEL - operator: not_equal_to - value: 1 - - any: - - name: IQPARENT - operator: is_not_contained_by - value: $iq_igdcmpid - within: SPTOBID - - name: IQPARENT - operator: equal_to - value: IGDCMPID + - name: IQLEVEL + operator: not_equal_to + value: 1 + - any: + - name: IQPARENT + operator: is_not_contained_by + value: $iq_igdcmpid + within: SPTOBID + - name: IQPARENT + operator: equal_to + value: IGDCMPID Core: Id: CORE-000601 Status: Published - Version: '1' -Description: Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value + Version: "1" +Description: + Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value of another record. Executability: Fully Executable Operations: -- domain: IQ - group: - - SPTOBID - id: $iq_igdcmpid - name: IGDCMPID - operator: distinct + - domain: IQ + group: + - SPTOBID + id: $iq_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IQPARENT value does not match an ingredient represented in another records IGDCMPID + Message: + IQPARENT value does not match an ingredient represented in another records IGDCMPID value. Output Variables: - - SPTOBID - - IGDCMPID - - IQPARENT - - $iq_igdcmpid + - SPTOBID + - IGDCMPID + - IQPARENT + - $iq_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000602/rule.yml b/Published/CORE-000602/rule.yml index 760c90e26..e2e0a3acd 100644 --- a/Published/CORE-000602/rule.yml +++ b/Published/CORE-000602/rule.yml @@ -2,50 +2,52 @@ # Condition: Record does not have associated PARENT records # Rule: Value for LEVEL = 1 Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: The value for LEVEL must be 1 for a record without a PARENT record. This - record may or may not have a child record. - Document: 'TIG 1.0' - Item: 'assumption 5' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0032' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + The value for LEVEL must be 1 for a record without a PARENT record. This + record may or may not have a child record. + Document: "TIG 1.0" + Item: "assumption 5" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0032" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: PARENT - operator: empty - - name: LEVEL - operator: not_equal_to - value: 1 + - name: PARENT + operator: empty + - name: LEVEL + operator: not_equal_to + value: 1 Core: Id: CORE-000602 Status: Published - Version: '1' -Description: Raise an error when a record does not have associated PARENT records but the value for + Version: "1" +Description: + Raise an error when a record does not have associated PARENT records but the value for LEVEL does not equal '1'. Executability: Fully Executable Outcome: Message: Record has no PARENT record in RELREF but LEVEL value does not equal '1'. Output Variables: - - LEVEL - - PARENT - - SETCD + - LEVEL + - PARENT + - SETCD Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000603/rule.yml b/Published/CORE-000603/rule.yml index 157047ece..57f14fb0f 100644 --- a/Published/CORE-000603/rule.yml +++ b/Published/CORE-000603/rule.yml @@ -1,45 +1,45 @@ # Variable: REFID # Rule: REFID value is unique Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: One record per Reference ID - Document: 'TIG 1.0' - Item: 'Domain Table Header' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0034' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: One record per Reference ID + Document: "TIG 1.0" + Item: "Domain Table Header" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0034" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: REFID - operator: is_not_unique_set - value: STUDYID + - name: REFID + operator: is_not_unique_set + value: STUDYID Core: Id: CORE-000603 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the REFID value is not unique. Executability: Fully Executable Outcome: Message: REFID value is not unique. Output Variables: - - STUDYID - - REFID + - STUDYID + - REFID Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000604/rule.yml b/Published/CORE-000604/rule.yml index 9048ac0f8..3b465e91a 100644 --- a/Published/CORE-000604/rule.yml +++ b/Published/CORE-000604/rule.yml @@ -2,65 +2,68 @@ # Condition: TOPARMCD where TOCAT="NEW PRODUCT" and TOSCAT="PRODUCT DESCRIPTOR" # Rule: TOPARMCD in PDPARMCD Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Design parameter data must be included for all new tobacco products in the - application - Document: 'TIG 1.0' - Item: 'assumption 4' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0005' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Design parameter data must be included for all new tobacco products in the + application + Document: "TIG 1.0" + Item: "assumption 4" + Section: "2.8.8.2" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0005" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TOCAT - operator: equal_to - value: NEW PRODUCT - value_is_literal: true - - name: TOSCAT - operator: equal_to - value: PRODUCT DESCRIPTOR - value_is_literal: true - - name: TOPARMCD - operator: is_not_contained_by - value: $distinct_pdparmcd - within: SPTOBID + - name: TOCAT + operator: equal_to + value: NEW PRODUCT + value_is_literal: true + - name: TOSCAT + operator: equal_to + value: PRODUCT DESCRIPTOR + value_is_literal: true + - name: TOPARMCD + operator: is_not_contained_by + value: $distinct_pdparmcd + within: SPTOBID Core: Id: CORE-000604 Status: Published - Version: '1' -Description: Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and + Version: "1" +Description: + Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR does not have a matching PDPARMCD in the PD dataset. Executability: Fully Executable Operations: -- domain: PD - group: - - SPTOBID - id: $distinct_pdparmcd - name: PDPARMCD - operator: distinct + - domain: PD + group: + - SPTOBID + id: $distinct_pdparmcd + name: PDPARMCD + operator: distinct Outcome: - Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but + Message: + TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but does not have a matching PDPARMCD per SPTOBID in PD. Output Variables: - - SPTOBID - - TOPARMCD - - $distinct_pdparmcd + - SPTOBID + - TOPARMCD + - $distinct_pdparmcd Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TO + - TO Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000605/rule.yml b/Published/CORE-000605/rule.yml index 0bfdc6087..112b268dd 100644 --- a/Published/CORE-000605/rule.yml +++ b/Published/CORE-000605/rule.yml @@ -2,76 +2,79 @@ # Condition: IQ domain present in study # Rule: IGDCMPID in IQ.IGDCMPID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of - IGDCMPID in IT) must be accounted for in IQ (see IQ domain specification and assumptions - for more information). - Document: 'TIG 1.0' - Item: 'assumption 2b' - Section: '2.8.8.4' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0008' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of - IGDCMPID in IN) must be accounted for in IQ (see IQ domain specification and assumptions - for more information). - Document: 'TIG 1.0' - Item: 'assumption 2b' - Section: '2.8.8.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0009' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + When quantifying ingredients in IQ, every ingredient (every value of + IGDCMPID in IT) must be accounted for in IQ (see IQ domain specification and assumptions + for more information). + Document: "TIG 1.0" + Item: "assumption 2b" + Section: "2.8.8.4" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0008" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + When quantifying ingredients in IQ, every ingredient (every value of + IGDCMPID in IN) must be accounted for in IQ (see IQ domain specification and assumptions + for more information). + Document: "TIG 1.0" + Item: "assumption 2b" + Section: "2.8.8.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0009" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IGDCMPID - operator: is_not_contained_by - value: $iq_igdcmpid - within: SPTOBID + - name: IGDCMPID + operator: is_not_contained_by + value: $iq_igdcmpid + within: SPTOBID Core: Id: CORE-000605 Status: Published - Version: '1' -Description: Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the + Version: "1" +Description: + Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the IQ dataset per SPTOBID. Executability: Fully Executable Operations: -- domain: IQ - group: - - SPTOBID - id: $iq_igdcmpid - name: IGDCMPID - operator: distinct + - domain: IQ + group: + - SPTOBID + id: $iq_igdcmpid + name: IGDCMPID + operator: distinct Outcome: Message: IGDCMPID does not have a matching IGDCMPID per SPTOBID in IQ. Output Variables: - - SPTOBID - - IGDCMPID - - $iq_igdcmpid + - SPTOBID + - IGDCMPID + - $iq_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IT - - IN + - IT + - IN Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000606/rule.yml b/Published/CORE-000606/rule.yml index cc17e2e4d..381ecb59b 100644 --- a/Published/CORE-000606/rule.yml +++ b/Published/CORE-000606/rule.yml @@ -2,63 +2,66 @@ # Condition: IQCAT = TOBACCO INGREDIENT # Rule: IGDCMPID in IT.IGDCMPID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IGDCMPID represents the unique ingredient name established in either the - Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, - every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0013' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + IGDCMPID represents the unique ingredient name established in either the + Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, + every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN + Document: "TIG 1.0" + Item: "assumption 2" + Section: "2.8.8.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0013" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IQCAT - operator: equal_to - value: TOBACCO INGREDIENT - value_is_literal: true - - name: IGDCMPID - operator: is_not_contained_by - value: $it_igdcmpid - within: SPTOBID + - name: IQCAT + operator: equal_to + value: TOBACCO INGREDIENT + value_is_literal: true + - name: IGDCMPID + operator: is_not_contained_by + value: $it_igdcmpid + within: SPTOBID Core: Id: CORE-000606 Status: Published - Version: '1' -Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT = + Version: "1" +Description: + Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT = TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IT dataset Executability: Fully Executable Operations: -- domain: IT - group: - - SPTOBID - id: $it_igdcmpid - name: IGDCMPID - operator: distinct + - domain: IT + group: + - SPTOBID + id: $it_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching + Message: + IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching IGDCMPID per SPTOBID in IT. Output Variables: - - SPTOBID - - IGDCMPID - - IQCAT - - $it_igdcmpid + - SPTOBID + - IGDCMPID + - IQCAT + - $it_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000607/rule.yml b/Published/CORE-000607/rule.yml index 2d9fe7f4d..37f9b941c 100644 --- a/Published/CORE-000607/rule.yml +++ b/Published/CORE-000607/rule.yml @@ -1,53 +1,55 @@ # Variable: STOCONID # Rule: STOCONID in ES.STOCONID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Applicant-defined identifier for a set of storage conditions that are - represented in the ES domain, where this identifier originates. - Document: 'TIG 1.0' - Item: 'STOCONID, CDISC Notes column' - Section: '2.8.8.3' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0017' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + Applicant-defined identifier for a set of storage conditions that are + represented in the ES domain, where this identifier originates. + Document: "TIG 1.0" + Item: "STOCONID, CDISC Notes column" + Section: "2.8.8.3" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0017" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: STOCONID - operator: is_not_contained_by - value: $es_stoconid + - name: STOCONID + operator: is_not_contained_by + value: $es_stoconid Core: Id: CORE-000607 Status: Published - Version: '1' -Description: Raise an error when value for STOCONID in the PT dataset does not match a STOCONID + Version: "1" +Description: + Raise an error when value for STOCONID in the PT dataset does not match a STOCONID specified in the ES dataset. Executability: Fully Executable Operations: -- domain: ES - id: $es_stoconid - name: STOCONID - operator: distinct + - domain: ES + id: $es_stoconid + name: STOCONID + operator: distinct Outcome: Message: STOCONID does not have a matching STOCONID in ES. Output Variables: - - SPTOBID - - STOCONID - - $es_stoconid + - SPTOBID + - STOCONID + - $es_stoconid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PT + - PT Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000608/rule.yml b/Published/CORE-000608/rule.yml index 890b29949..e1739143f 100644 --- a/Published/CORE-000608/rule.yml +++ b/Published/CORE-000608/rule.yml @@ -1,100 +1,102 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time or evaluation interval per subject - Document: SENDIG v3.1.1 - Section: 6.3.18.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND338 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time or evaluation interval per subject + Document: SENDIG v3.1.1 + Section: 6.3.18.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND338 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: RETESTCD - operator: is_not_unique_set - value: - - USUBJID - - REDTC - - name: RETESTCD - operator: is_not_unique_set - value: - - USUBJID - - REDTC - - RESTINT + - name: RETESTCD + operator: is_not_unique_set + value: + - USUBJID + - REDTC + - name: RETESTCD + operator: is_not_unique_set + value: + - USUBJID + - REDTC + - RESTINT Core: Id: CORE-000608 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular + Version: "1" +Description: + Raise an error when there is more than one record present for any particular respiratory test for a subject and measurement date/time or evaluation interval. Executability: Fully Executable Outcome: - Message: The respiratory test is not unique for this subject and measurement datetime and/or + Message: + The respiratory test is not unique for this subject and measurement datetime and/or evaluation interval. Output Variables: - - USUBJID - - RETESTCD - - REDTC - - RESTINT + - USUBJID + - RETESTCD + - REDTC + - RESTINT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - RE + - RE Sensitivity: Record diff --git a/Published/CORE-000609/rule.yml b/Published/CORE-000609/rule.yml index a79f167ca..727e24f30 100644 --- a/Published/CORE-000609/rule.yml +++ b/Published/CORE-000609/rule.yml @@ -1,50 +1,50 @@ # Variable: SETCD # Rule: RELREF.SETCD = TX.SETCD for a given TX record Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: The SETCD column value must match a SETCD value in the TX dataset - Document: 'TIG 1.0' - Item: 'assumption 7' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0033' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: The SETCD column value must match a SETCD value in the TX dataset + Document: "TIG 1.0" + Item: "assumption 7" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0033" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: SETCD - operator: is_not_contained_by - value: $tx_setcd + - name: SETCD + operator: is_not_contained_by + value: $tx_setcd Core: Id: CORE-000609 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the SETCD value doesn't match a SETCD value in the TX dataset. Executability: Fully Executable Operations: -- domain: TX - id: $tx_setcd - name: SETCD - operator: distinct + - domain: TX + id: $tx_setcd + name: SETCD + operator: distinct Outcome: Message: SETCD value doesn't match a SETCD value in the TX dataset. Output Variables: - - SETCD - - $tx_setcd + - SETCD + - $tx_setcd Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000610/rule.yml b/Published/CORE-000610/rule.yml index 74ac71ec7..4057cbadf 100644 --- a/Published/CORE-000610/rule.yml +++ b/Published/CORE-000610/rule.yml @@ -2,51 +2,52 @@ # Condition: REFID value exists in GT domain # Rule: REFID value exists in RELREF domain Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the RELREF dataset. - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0035' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: Each GTREFID that exists in the GT dataset must exist in the RELREF dataset. + Document: "TIG 1.0" + Item: "assumption 2" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0035" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: GTREFID - operator: is_not_contained_by - value: $relref_refid + - name: GTREFID + operator: is_not_contained_by + value: $relref_refid Core: Id: CORE-000610 Status: Published - Version: '1' -Description: Raise an error when a REFID value in the GT dataset does not exist in the RELREF + Version: "1" +Description: + Raise an error when a REFID value in the GT dataset does not exist in the RELREF dataset. Executability: Fully Executable Operations: -- domain: RELREF - id: $relref_refid - name: REFID - operator: distinct + - domain: RELREF + id: $relref_refid + name: REFID + operator: distinct Outcome: Message: REFID value in GT does not exist in RELREF. Output Variables: - - GTREFID - - $relref_refid + - GTREFID + - $relref_refid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GT + - GT Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000611/rule.yml b/Published/CORE-000611/rule.yml index c3b23f640..8a993c90b 100644 --- a/Published/CORE-000611/rule.yml +++ b/Published/CORE-000611/rule.yml @@ -2,51 +2,52 @@ # Condition: REFID value exists in RELREF domain # Rule: REFID value exists in GT domain Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the GT dataset. - Document: 'TIG 1.0' - Item: 'assumption 3' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0036' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: Each REFID that exists in the RELREF dataset must exist in the GT dataset. + Document: "TIG 1.0" + Item: "assumption 3" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0036" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: REFID - operator: is_not_contained_by - value: $gt_refid + - name: REFID + operator: is_not_contained_by + value: $gt_refid Core: Id: CORE-000611 Status: Published - Version: '1' -Description: Raise an error when a REFID value in the RELREF dataset does not exist in the GT + Version: "1" +Description: + Raise an error when a REFID value in the RELREF dataset does not exist in the GT dataset. Executability: Fully Executable Operations: -- domain: GT - id: $gt_refid - name: GTREFID - operator: distinct + - domain: GT + id: $gt_refid + name: GTREFID + operator: distinct Outcome: Message: REFID value in RELREF does not exist in GT. Output Variables: - - REFID - - $gt_refid + - REFID + - $gt_refid Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000612/rule.yml b/Published/CORE-000612/rule.yml index 6df6a275c..91f9e1d5a 100644 --- a/Published/CORE-000612/rule.yml +++ b/Published/CORE-000612/rule.yml @@ -1,158 +1,169 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Standardized units should be consistent for a given drug or metabolite - across pharmacokinetic datasets within a submission. - Document: FDA - Section: FDAB070 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7001 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Standardized units should be consistent for a given drug or metabolite + across pharmacokinetic datasets within a submission. + Document: FDA + Section: FDAB070 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7001 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: # ONLY for PPSTRESU/PPTESTCD and PCSTRESU/PCTESTCD - - name: --STRESU - operator: is_inconsistent_across_dataset - value: --TESTCD + - name: --STRESU + operator: is_inconsistent_across_dataset + value: --TESTCD Core: Id: CORE-000612 Status: Published - Version: '1' -Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug + Version: "1" +Description: + Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug or metabolite across pharmacokinetic datasets within a submission. Executability: Fully Executable Outcome: - Message: '--STRESU is not consistent per --TESTCD.' + Message: "--STRESU is not consistent per --TESTCD." Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP - - PC + - PP + - PC Sensitivity: Record diff --git a/Published/CORE-000613/rule.yml b/Published/CORE-000613/rule.yml index 38fc82a02..51c81d0eb 100644 --- a/Published/CORE-000613/rule.yml +++ b/Published/CORE-000613/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5139 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5139 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--ENTPT' - operator: exists + - name: "--ENTPT" + operator: exists Core: Id: CORE-000613 Status: Published - Version: '1' -Description: '--ENTPT must not be in SEND dataset' + Version: "1" +Description: "--ENTPT must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--ENTPT must not be in SEND dataset' + Message: "--ENTPT must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000614/rule.yml b/Published/CORE-000614/rule.yml index e65fcc703..b259d0d31 100644 --- a/Published/CORE-000614/rule.yml +++ b/Published/CORE-000614/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5138 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5138 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--STRTPT' - operator: exists + - name: "--STRTPT" + operator: exists Core: Id: CORE-000614 Status: Published - Version: '1' -Description: '--STRTPT must not be in SEND dataset' + Version: "1" +Description: "--STRTPT must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--STRTPT must not be in SEND dataset' + Message: "--STRTPT must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000615/rule.yml b/Published/CORE-000615/rule.yml index ce814ee5f..d00921423 100644 --- a/Published/CORE-000615/rule.yml +++ b/Published/CORE-000615/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5137 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5137 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--STTPT' - operator: exists + - name: "--STTPT" + operator: exists Core: Id: CORE-000615 Status: Published - Version: '1' -Description: '--STTPT must not be in SEND dataset' + Version: "1" +Description: "--STTPT must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--STTPT must not be in SEND dataset' + Message: "--STTPT must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000616/rule.yml b/Published/CORE-000616/rule.yml index 348329099..8abc1e47a 100644 --- a/Published/CORE-000616/rule.yml +++ b/Published/CORE-000616/rule.yml @@ -1,129 +1,139 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.4' - # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4403' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: + "3.4" + # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4403" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # REMARK: --TPTNUM and --STINT both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--STINT' - operator: exists - - name: '--STINT' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: "--TPTREF" + operator: exists + - name: "--STINT" + operator: exists + - name: "--STINT" + operator: "non_empty" + - name: "--TPTREF" + operator: "empty" Core: Id: CORE-000616 Status: Published - Version: '1' -Description: 'When Planned Start of Assessment Interval (--STINT) is populated, Time Point Reference (--TPTREF) - should also be populated.' + Version: "1" +Description: + "When Planned Start of Assessment Interval (--STINT) is populated, Time Point Reference (--TPTREF) + should also be populated." Executability: Fully Executable Outcome: Message: --STINT is populated, but --TPTREF is missing. @@ -132,8 +142,8 @@ Scope: Classes: # TODO? Should we limit to "Findings" here? Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000617/rule.yml b/Published/CORE-000617/rule.yml index d2ee64148..a258d90ae 100644 --- a/Published/CORE-000617/rule.yml +++ b/Published/CORE-000617/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5136 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5136 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--ENRF' - operator: exists + - name: "--ENRF" + operator: exists Core: Id: CORE-000617 Status: Published - Version: '1' -Description: '--ENRF must not be in SEND dataset' + Version: "1" +Description: "--ENRF must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--ENRF must not be in SEND dataset' + Message: "--ENRF must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000618/rule.yml b/Published/CORE-000618/rule.yml index 1e2ecafb7..2840ae4b1 100644 --- a/Published/CORE-000618/rule.yml +++ b/Published/CORE-000618/rule.yml @@ -1,122 +1,130 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy - status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. ' - Document: 'FDA' - Section: 'FDAB085' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB8501' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "For findings in MISTRESC using the NEOPLASM controlled terminology list, malignancy + status in MIRESCAT should align with any benign or malignant designation in NEOPLASM. " + Document: "FDA" + Section: "FDAB085" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB8501" + Version: "1" + Version: "1.5" + Version: "1.0" Check: any: - - all: - - name: 'MISTRESC' - # 'contains' means 'contains the word' - operator: contains - value: 'BENIGN' - - name: 'MIRESCAT' - operator: not_equal_to - value: 'BENIGN' - # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN - - all: - - name: 'MISTRESC' - operator: contains - value: 'MALIGNANT' - - name: 'MIRESCAT' - operator: is_not_contained_by - value: - - 'MALIGNANT' - - 'METASTATIC' + - all: + - name: + "MISTRESC" + # 'contains' means 'contains the word' + operator: contains + value: "BENIGN" + - name: "MIRESCAT" + operator: not_equal_to + value: "BENIGN" + # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN + - all: + - name: "MISTRESC" + operator: contains + value: "MALIGNANT" + - name: "MIRESCAT" + operator: is_not_contained_by + value: + - "MALIGNANT" + - "METASTATIC" Core: Id: CORE-000618 Status: Published - Version: '1' -Description: 'When value of MISTRESC is using the NEOPLASM CT, it should align with the value in MIRESCAT.' + Version: "1" +Description: "When value of MISTRESC is using the NEOPLASM CT, it should align with the value in MIRESCAT." Executability: Fully Executable Outcome: # Or should the message be the other way? I.e. that value in MIRESCAT does not match the value in MISTRESC @@ -125,8 +133,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Published/CORE-000619/rule.yml b/Published/CORE-000619/rule.yml index 03b407396..a7f4f6fe6 100644 --- a/Published/CORE-000619/rule.yml +++ b/Published/CORE-000619/rule.yml @@ -1,91 +1,92 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5303' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5303" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TXPARMCD - operator: equal_to - value: 'AGETXT' - - name: TXVAL - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: TXPARMCD + operator: equal_to + value: "AGETXT" + - name: TXVAL + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000619 Status: Published - Version: '1' -Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a + Version: "1" +Description: + Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a number-number format when age range is supplied. Executability: Fully Executable Outcome: @@ -94,8 +95,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000620/rule.yml b/Published/CORE-000620/rule.yml index 6d68b3be2..b57485d33 100644 --- a/Published/CORE-000620/rule.yml +++ b/Published/CORE-000620/rule.yml @@ -1,160 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.0 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. - Document: IG v3.1 - Item: Specification - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND113.1 - Version: '1' - Version: '5.0' - Version: '1.1' - # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Set code should match trial sets for nonclinical data.' - Document: FDA - Section: FDAB049 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4901 - Version: '1' - Version: '1.5' - Version: '1.2' - # P.S. NOT applicable to SENDIG-AR + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.0 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Subject (animal) may belong to one and only one Trial Set. + Document: IG v3.1 + Item: Specification + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND113.1 + Version: "1" + Version: "5.0" + Version: "1.1" + # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Set code should match trial sets for nonclinical data." + Document: FDA + Section: FDAB049 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4901 + Version: "1" + Version: "1.5" + Version: + "1.2" + # P.S. NOT applicable to SENDIG-AR Check: all: - - name: SETCD - operator: non_empty - - name: SETCD - operator: is_not_contained_by - value: $tx_setcd + - name: SETCD + operator: non_empty + - name: SETCD + operator: is_not_contained_by + value: $tx_setcd Core: Id: CORE-000620 Status: Published - Version: '1' + Version: "1" Description: SETCD value in the DM dataset should match one of the SETCD values in the TX dataset. Executability: Fully Executable Operations: -- domain: TX - id: $tx_setcd - name: SETCD - operator: distinct + - domain: TX + id: $tx_setcd + name: SETCD + operator: distinct Outcome: Message: SETCD value does not match a SETCD value in the TX dataset. Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000621/rule.yml b/Published/CORE-000621/rule.yml index b78cf0876..fa3b97915 100644 --- a/Published/CORE-000621/rule.yml +++ b/Published/CORE-000621/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5123 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5123 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SDISAB' - operator: exists + - name: "--SDISAB" + operator: exists Core: Id: CORE-000621 Status: Published - Version: '1' -Description: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset' + Version: "1" +Description: "--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset' + Message: "--SDISAB (Persist or Signif Disability/Incapacity) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000622/rule.yml b/Published/CORE-000622/rule.yml index c9ddfef76..d482139b1 100644 --- a/Published/CORE-000622/rule.yml +++ b/Published/CORE-000622/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5124 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5124 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SDTH' - operator: exists + - name: "--SDTH" + operator: exists Core: Id: CORE-000622 Status: Published - Version: '1' -Description: '--SDTH (Results in Death) must not be in SEND dataset' + Version: "1" +Description: "--SDTH (Results in Death) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SDTH (Results in Death) must not be in SEND dataset' + Message: "--SDTH (Results in Death) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000623/rule.yml b/Published/CORE-000623/rule.yml index 1b9b46f91..01c7f763e 100644 --- a/Published/CORE-000623/rule.yml +++ b/Published/CORE-000623/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5125 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5125 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SHOSP' - operator: exists + - name: "--SHOSP" + operator: exists Core: Id: CORE-000623 Status: Published - Version: '1' -Description: '--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset' + Version: "1" +Description: "--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset' + Message: "--SHOSP (Requires or Prolongs Hospitalization) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000624/rule.yml b/Published/CORE-000624/rule.yml index acd493c54..3eeb2c368 100644 --- a/Published/CORE-000624/rule.yml +++ b/Published/CORE-000624/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5126 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5126 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SLIFE' - operator: exists + - name: "--SLIFE" + operator: exists Core: Id: CORE-000624 Status: Published - Version: '1' -Description: '--SLIFE (Is Life Threatening) must not be in SEND dataset' + Version: "1" +Description: "--SLIFE (Is Life Threatening) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SLIFE (Is Life Threatening) must not be in SEND dataset' + Message: "--SLIFE (Is Life Threatening) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000625/rule.yml b/Published/CORE-000625/rule.yml index 9ebf6d55d..0da826e55 100644 --- a/Published/CORE-000625/rule.yml +++ b/Published/CORE-000625/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5127 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5127 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SOD' - operator: exists + - name: "--SOD" + operator: exists Core: Id: CORE-000625 Status: Published - Version: '1' -Description: '--SOD (Occurred with Overdose) must not be in SEND dataset' + Version: "1" +Description: "--SOD (Occurred with Overdose) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SOD (Occurred with Overdose) must not be in SEND dataset' + Message: "--SOD (Occurred with Overdose) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000626/rule.yml b/Published/CORE-000626/rule.yml index a2e8f7f8d..ff158849a 100644 --- a/Published/CORE-000626/rule.yml +++ b/Published/CORE-000626/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5128 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5128 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SMIE' - operator: exists + - name: "--SMIE" + operator: exists Core: Id: CORE-000626 Status: Published - Version: '1' -Description: '--SMIE (Other Medically Important Serious Event) must not be in SEND dataset' + Version: "1" +Description: "--SMIE (Other Medically Important Serious Event) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SMIE (Other Medically Important Serious Event) must not be in SEND dataset' + Message: "--SMIE (Other Medically Important Serious Event) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000627/rule.yml b/Published/CORE-000627/rule.yml index bd99cce7c..762150491 100644 --- a/Published/CORE-000627/rule.yml +++ b/Published/CORE-000627/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5129 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5129 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SOC' - operator: exists + - name: "--SOC" + operator: exists Core: Id: CORE-000627 Status: Published - Version: '1' -Description: '--SOC (Primary System Organ Class) must not be in SEND dataset' + Version: "1" +Description: "--SOC (Primary System Organ Class) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SOC (Primary System Organ Class) must not be in SEND dataset) must not be in SEND dataset' + Message: "--SOC (Primary System Organ Class) must not be in SEND dataset) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000628/rule.yml b/Published/CORE-000628/rule.yml index 7b58f43c2..4d4da7f4a 100644 --- a/Published/CORE-000628/rule.yml +++ b/Published/CORE-000628/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5130 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5130 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SOCCD' - operator: exists + - name: "--SOCCD" + operator: exists Core: Id: CORE-000628 Status: Published - Version: '1' -Description: '--SOCCD (Primary System Organ Class Code) must not be in SEND dataset' + Version: "1" +Description: "--SOCCD (Primary System Organ Class Code) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SOCCD (Primary System Organ Class Code) must not be in SEND dataset' + Message: "--SOCCD (Primary System Organ Class Code) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000629/rule.yml b/Published/CORE-000629/rule.yml index 7a88ff636..74c60d439 100644 --- a/Published/CORE-000629/rule.yml +++ b/Published/CORE-000629/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5131 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5131 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--PRESP' - operator: exists + - name: "--PRESP" + operator: exists Core: Id: CORE-000629 Status: Published - Version: '1' -Description: '--PRESP (Pre-specified) must not be in SEND dataset' + Version: "1" +Description: "--PRESP (Pre-specified) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--PRESP (Pre-specified) must not be in SEND dataset' + Message: "--PRESP (Pre-specified) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000630/rule.yml b/Published/CORE-000630/rule.yml index 4c3127bc9..2081484b0 100644 --- a/Published/CORE-000630/rule.yml +++ b/Published/CORE-000630/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5140 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5140 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--ENRTPT' - operator: exists + - name: "--ENRTPT" + operator: exists Core: Id: CORE-000630 Status: Published - Version: '1' -Description: '--ENRTPT must not be in SEND dataset' + Version: "1" +Description: "--ENRTPT must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--ENRTPT must not be in SEND dataset' + Message: "--ENRTPT must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000631/rule.yml b/Published/CORE-000631/rule.yml index 7c427ad07..b8b7f38ca 100644 --- a/Published/CORE-000631/rule.yml +++ b/Published/CORE-000631/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5110 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5110 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'RFICDTC' - operator: exists + - name: "RFICDTC" + operator: exists Core: Id: CORE-000631 Status: Published - Version: '1' -Description: 'RFICDTC must not be present in SEND dataset' + Version: "1" +Description: "RFICDTC must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'RFICDTC must not be present in SEND dataset' + Message: "RFICDTC must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000632/rule.yml b/Published/CORE-000632/rule.yml index afb03089e..fdf9305f6 100644 --- a/Published/CORE-000632/rule.yml +++ b/Published/CORE-000632/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5111 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5111 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'RFPENDTC' - operator: exists + - name: "RFPENDTC" + operator: exists Core: Id: CORE-000632 Status: Published - Version: '1' -Description: 'RFPENDTC must not be present in SEND dataset' + Version: "1" +Description: "RFPENDTC must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'RFPENDTC must not be present in SEND dataset' + Message: "RFPENDTC must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000633/rule.yml b/Published/CORE-000633/rule.yml index 62fbe2970..f2538f623 100644 --- a/Published/CORE-000633/rule.yml +++ b/Published/CORE-000633/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5109 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5109 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'RACE' - operator: exists + - name: "RACE" + operator: exists Core: Id: CORE-000633 Status: Published - Version: '1' -Description: 'RACE must not be present in SEND dataset' + Version: "1" +Description: "RACE must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'RACE must not be present in SEND dataset' + Message: "RACE must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000634/rule.yml b/Published/CORE-000634/rule.yml index d9c030de0..22e53e852 100644 --- a/Published/CORE-000634/rule.yml +++ b/Published/CORE-000634/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5108 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5108 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'INVNAM' - operator: exists + - name: "INVNAM" + operator: exists Core: Id: CORE-000634 Status: Published - Version: '1' -Description: 'INVNAM must not be present in SEND dataset' + Version: "1" +Description: "INVNAM must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'INVNAM must not be present in SEND dataset' + Message: "INVNAM must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000635/rule.yml b/Published/CORE-000635/rule.yml index 1a1dbfd5a..268357c42 100644 --- a/Published/CORE-000635/rule.yml +++ b/Published/CORE-000635/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5107 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5107 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'INVID' - operator: exists + - name: "INVID" + operator: exists Core: Id: CORE-000635 Status: Published - Version: '1' -Description: 'INVID must not be present in SEND dataset' + Version: "1" +Description: "INVID must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'INVID must not be present in SEND dataset' + Message: "INVID must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000636/rule.yml b/Published/CORE-000636/rule.yml index d415e7698..861f74fa1 100644 --- a/Published/CORE-000636/rule.yml +++ b/Published/CORE-000636/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5106 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5106 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'ETHNIC' - operator: exists + - name: "ETHNIC" + operator: exists Core: Id: CORE-000636 Status: Published - Version: '1' -Description: 'ETHNIC must not be present in SEND dataset' + Version: "1" +Description: "ETHNIC must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'ETHNIC must not be present in SEND dataset' + Message: "ETHNIC must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000637/rule.yml b/Published/CORE-000637/rule.yml index 474a885fb..9f8359bcd 100644 --- a/Published/CORE-000637/rule.yml +++ b/Published/CORE-000637/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5105 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5105 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'DTHFL' - operator: exists + - name: "DTHFL" + operator: exists Core: Id: CORE-000637 Status: Published - Version: '1' -Description: 'DTHFL must not be present in SEND dataset' + Version: "1" +Description: "DTHFL must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'DTHFL must not be present in SEND dataset' + Message: "DTHFL must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000638/rule.yml b/Published/CORE-000638/rule.yml index d48f96a2a..654c80acd 100644 --- a/Published/CORE-000638/rule.yml +++ b/Published/CORE-000638/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5104 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5104 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'DTHDTC' - operator: exists + - name: "DTHDTC" + operator: exists Core: Id: CORE-000638 Status: Published - Version: '1' -Description: 'DTHDTC must not be present in SEND dataset' + Version: "1" +Description: "DTHDTC must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'DTHDTC must not be present in SEND dataset' + Message: "DTHDTC must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000639/rule.yml b/Published/CORE-000639/rule.yml index ed171b016..9693dce2a 100644 --- a/Published/CORE-000639/rule.yml +++ b/Published/CORE-000639/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5103 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5103 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'COUNTRY' - operator: exists + - name: "COUNTRY" + operator: exists Core: Id: CORE-000639 Status: Published - Version: '1' -Description: 'COUNTRY must not be present in SEND dataset' + Version: "1" +Description: "COUNTRY must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'COUNTRY must not be present in SEND dataset' + Message: "COUNTRY must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000640/rule.yml b/Published/CORE-000640/rule.yml index c1e74b9d9..431f6c371 100644 --- a/Published/CORE-000640/rule.yml +++ b/Published/CORE-000640/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5102 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5102 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'ACTARM' - operator: exists + - name: "ACTARM" + operator: exists Core: Id: CORE-000640 Status: Published - Version: '1' -Description: 'ACTARM must not be present in SEND dataset' + Version: "1" +Description: "ACTARM must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'ACTARM must not be present in SEND dataset' + Message: "ACTARM must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000641/rule.yml b/Published/CORE-000641/rule.yml index 34413146a..d42a6a297 100644 --- a/Published/CORE-000641/rule.yml +++ b/Published/CORE-000641/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5101 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5101 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'ACTARMCD' - operator: exists + - name: "ACTARMCD" + operator: exists Core: Id: CORE-000641 Status: Published - Version: '1' -Description: 'ACTARMCD must not be present in SEND dataset' + Version: "1" +Description: "ACTARMCD must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'ACTARMCD must not be present in SEND dataset' + Message: "ACTARMCD must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000642/rule.yml b/Published/CORE-000642/rule.yml index 03516dfe2..27083a923 100644 --- a/Published/CORE-000642/rule.yml +++ b/Published/CORE-000642/rule.yml @@ -1,129 +1,139 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.4' - # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4404' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: + "3.4" + # REMARK: SENDIG: NOT applicable to SEND 3.0 and 3.1 + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4404" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # REMARK: --TPTNUM and --ENINT both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--ENINT' - operator: exists - - name: '--ENINT' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: "--TPTREF" + operator: exists + - name: "--ENINT" + operator: exists + - name: "--ENINT" + operator: "non_empty" + - name: "--TPTREF" + operator: "empty" Core: Id: CORE-000642 Status: Published - Version: '1' -Description: 'When Planned End of Assessment Interval (--ENINT) is populated, Time Point Reference (--TPTREF) - should also be populated.' + Version: "1" +Description: + "When Planned End of Assessment Interval (--ENINT) is populated, Time Point Reference (--TPTREF) + should also be populated." Executability: Fully Executable Outcome: Message: --ENINT is populated, but --TPTREF is missing. @@ -131,10 +141,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000643/rule.yml b/Published/CORE-000643/rule.yml index f212f66a5..525486d6e 100644 --- a/Published/CORE-000643/rule.yml +++ b/Published/CORE-000643/rule.yml @@ -1,150 +1,161 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Records with a baseline flag should have a corresponding standard result with - a standardized unit where available.' - Document: FDA - Section: FDAB026 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2601 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Records with a baseline flag should have a corresponding standard result with + a standardized unit where available." + Document: FDA + Section: FDAB026 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2601 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --BLFL - operator: equal_to - value: 'Y' - - name: --STRESC - operator: empty + - name: --BLFL + operator: equal_to + value: "Y" + - name: --STRESC + operator: empty Core: - Id: 'CORE-000643' + Id: "CORE-000643" Status: Published - Version: '1' -Description: 'Records with a baseline flag (--BLFL) have a non missing value in character standard result - variable (--STRESC)' + Version: "1" +Description: + "Records with a baseline flag (--BLFL) have a non missing value in character standard result + variable (--STRESC)" Executability: Fully Executable Outcome: Message: 'BLFL is set to "Y", but no value for STRESC is provided' @@ -152,8 +163,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000645/rule.yml b/Published/CORE-000645/rule.yml index 69251805c..7898a2675 100644 --- a/Published/CORE-000645/rule.yml +++ b/Published/CORE-000645/rule.yml @@ -1,102 +1,102 @@ Authorities: -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8601 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8601 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: # throw an error when both AGE and AGETXT are not present in DM - - name: AGE - operator: not_exists - - name: AGETXT - operator: not_exists + - name: AGE + operator: not_exists + - name: AGETXT + operator: not_exists Core: Id: CORE-000645 Status: Published - Version: '1' + Version: "1" Description: At least one of variables AGE or AGETXT is present in the DM dataset. Executability: Fully Executable Outcome: @@ -105,8 +105,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Published/CORE-000648/rule.yml b/Published/CORE-000648/rule.yml index f749255d0..213a4ebf4 100644 --- a/Published/CORE-000648/rule.yml +++ b/Published/CORE-000648/rule.yml @@ -1,90 +1,90 @@ Authorities: -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Age or age range should be provided for all animals. - Document: FDA - Section: FDAB086 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8602 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Age or age range should be provided for all animals. + Document: FDA + Section: FDAB086 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8602 + Version: "1" + Version: "1.5" + Version: "1.0" Check: any: # Commented out 2025-05-05: See Jora comment Nick de Donder https://jira.cdisc.org/browse/CORERULES-9331 @@ -94,17 +94,17 @@ Check: # operator: non_empty # - name: AGETXT # operator: non_empty - - all: + - all: # Case 2: throw an error when none of AGE and AGETXT is populated - - name: AGE - operator: empty - - name: AGETXT - operator: empty + - name: AGE + operator: empty + - name: AGETXT + operator: empty Core: Id: CORE-000648 Status: Published - Version: '1' + Version: "1" Description: AGE or AGETXT should be populated in the DM dataset. Executability: Fully Executable Outcome: @@ -113,8 +113,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000649/rule.yml b/Published/CORE-000649/rule.yml index 364feae72..36a5f3407 100644 --- a/Published/CORE-000649/rule.yml +++ b/Published/CORE-000649/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5112 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5112 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--BDSYCD' - operator: exists + - name: "--BDSYCD" + operator: exists Core: Id: CORE-000649 Status: Published - Version: '1' -Description: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset' + Version: "1" +Description: "--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: '--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset' + Message: "--BDSYCD (Body System or Organ Class Code) must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000650/rule.yml b/Published/CORE-000650/rule.yml index fecb4d164..8d8324800 100644 --- a/Published/CORE-000650/rule.yml +++ b/Published/CORE-000650/rule.yml @@ -1,108 +1,114 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: --ORRES is an Expected variable and should always be populated except when - --STAT = 'NOT DONE' - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND86.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + --ORRES is an Expected variable and should always be populated except when + --STAT = 'NOT DONE' + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND86.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - - name: --ORRES - operator: non_empty + - name: --STAT + operator: equal_to + value: NOT DONE + - name: --ORRES + operator: non_empty Core: Id: CORE-000650 Status: Published - Version: '1' + Version: "1" Description: Data should not be presented in the --ORRES variable if --STAT = "NOT DONE". Executability: Fully Executable Outcome: Message: --ORRES may not populated as --STAT is equal to 'NOT DONE' Output Variables: - - --STAT - - --ORRES + - --STAT + - --ORRES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000651/rule.yml b/Published/CORE-000651/rule.yml index af5512369..86538589a 100644 --- a/Published/CORE-000651/rule.yml +++ b/Published/CORE-000651/rule.yml @@ -1,210 +1,223 @@ Authorities: -- Organization: CDISC - # REMARK: not applicable to SENDIG-3.0 - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: '4.4.7.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND290' - Version: '1' - Version: '5.0' - Version: '1.0' -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0926 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0926 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0913 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: + CDISC + # REMARK: not applicable to SENDIG-3.0 + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: "4.4.7.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND290" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: "4.4.7.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND290" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: "4.4.7.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND290" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: "4.4.7.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND290" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: "4.4.7.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND290" + Version: "1" + Version: "5.0" + Version: "1.0" + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0926 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0926 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0913 + Version: "1" + Version: "1.5" + Version: "1.0" # The implementation only checks 1:1 relationship between --TPT and --TPTNUM Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: exists - - name: --TPTNUM - operator: non_empty - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: is_not_unique_relationship - value: --TPT + - name: --TPTNUM + operator: exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: non_empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: is_not_unique_relationship + value: --TPT Core: Id: CORE-000651 Status: Published - Version: '1' + Version: "1" Description: --TPT and --TPTNUM should have a one-to-one relationship. Executability: Fully Executable Outcome: @@ -213,8 +226,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000652/rule.yml b/Published/CORE-000652/rule.yml index 625ac1fdb..cea51f4a7 100644 --- a/Published/CORE-000652/rule.yml +++ b/Published/CORE-000652/rule.yml @@ -1,57 +1,60 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Only animals on the study are included, negative and/or positive controls - from another study are not included in the domain. Study data are not typically directly - compared against the positive control data. - Document: SENDIG-GENETOX - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND410 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Only animals on the study are included, negative and/or positive controls + from another study are not included in the domain. Study data are not typically directly + compared against the positive control data. + Document: SENDIG-GENETOX + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND410 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid - - all: - - name: USUBJID - operator: is_not_contained_by - value: $ex_usubjid - # TODO?: no record in EX is expected when the subject is an "Untreated Control", - # i.e. DM.SETCD has a value from TX.TXVAL='Untreated Control' for TXPARMCD=TCNTRL - # After discussion with SEND team: we will NOT implement the second part "except when the subject is an untreated control", as this may cause false positives. + - all: + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid + - all: + - name: USUBJID + operator: is_not_contained_by + value: + $ex_usubjid + # TODO?: no record in EX is expected when the subject is an "Untreated Control", + # i.e. DM.SETCD has a value from TX.TXVAL='Untreated Control' for TXPARMCD=TCNTRL + # After discussion with SEND team: we will NOT implement the second part "except when the subject is an untreated control", as this may cause false positives. Core: Id: CORE-000652 Status: Published - Version: '1' -Description: 'Only animals on the study are included, negative and/or positive controls from another study - are not included in the domain' + Version: "1" +Description: + "Only animals on the study are included, negative and/or positive controls from another study + are not included in the domain" Executability: Partially Executable - Possible Overreporting Operations: -- domain: DM - id: $dm_usubjid - name: USUBJID - operator: distinct -- domain: EX - id: $ex_usubjid - name: USUBJID - operator: distinct + - domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct + - domain: EX + id: $ex_usubjid + name: USUBJID + operator: distinct Outcome: - Message: 'No record for USUBJID is found in DM or EC' + Message: "No record for USUBJID is found in DM or EC" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Published/CORE-000653/rule.yml b/Published/CORE-000653/rule.yml index 69d84200a..15730e638 100644 --- a/Published/CORE-000653/rule.yml +++ b/Published/CORE-000653/rule.yml @@ -1,127 +1,134 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.0 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If both --DTC and --ENDTC are collected, durations can be calculated by the - difference in these two values... - Document: IG v3.1.1 - Section: 4.4.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND58 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: "The length of time an observation continues, i.e., the duration of the observation, - is represented using variables - --DTC or --STDTC for the start of the observation and --ENDTC - for the end of the observation when date/times are collected." - Document: TIG v1.0 - Item: Text - Section: 2.8.7.5 Representing Planned and Actual Timing - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0264 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.0 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If both --DTC and --ENDTC are collected, durations can be calculated by the + difference in these two values... + Document: IG v3.1.1 + Section: 4.4.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND58 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "The length of time an observation continues, i.e., the duration of the observation, + is represented using variables - --DTC or --STDTC for the start of the observation and --ENDTC + for the end of the observation when date/times are collected." + Document: TIG v1.0 + Item: Text + Section: 2.8.7.5 Representing Planned and Actual Timing + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0264 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ENDTC - operator: non_empty - - name: --DTC - operator: non_empty - - name: --DTC - operator: date_greater_than - value: --ENDTC + - name: --ENDTC + operator: non_empty + - name: --DTC + operator: non_empty + - name: --DTC + operator: date_greater_than + value: --ENDTC Core: Id: CORE-000653 Status: Published - Version: '1' + Version: "1" Description: Raise an error when --ENDTC before --DTC Executability: Fully Executable Outcome: Message: --ENDTC must be greater than or equal to --DTC Output Variables: - - --ENDTC - - --DTC + - --ENDTC + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000654/rule.yml b/Published/CORE-000654/rule.yml index 870892e19..3f9961474 100644 --- a/Published/CORE-000654/rule.yml +++ b/Published/CORE-000654/rule.yml @@ -1,109 +1,114 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND292' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND292" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND292" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND292" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND292" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND292" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: --TPTNUM - operator: exists - - name: --TPT - operator: exists - - name: --TPTNUM - operator: non_empty - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: is_not_unique_relationship - value: --TPT + - name: --TPTNUM + operator: exists + - name: --TPT + operator: exists + - name: --TPTNUM + operator: non_empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: is_not_unique_relationship + value: --TPT Core: Id: CORE-000654 Status: Published - Version: '1' + Version: "1" Description: There must be a one-to-one relationship between the values of --TPT and --TPTNUM Executability: Fully Executable Outcome: @@ -112,8 +117,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000660/rule.yml b/Published/CORE-000660/rule.yml index b1336d043..420090108 100644 --- a/Published/CORE-000660/rule.yml +++ b/Published/CORE-000660/rule.yml @@ -1,55 +1,57 @@ # Variable: SPTOBID # Rule: SPTOBID in TO.SPTOBID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), - Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well - as any domain in the general observation classes where there are records pertaining to the - tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset - must correspond to a product described in the TO dataset. - Document: 'TIG 1.0' - Item: 'assumption 1b' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0002' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), + Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well + as any domain in the general observation classes where there are records pertaining to the + tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset + must correspond to a product described in the TO dataset. + Document: "TIG 1.0" + Item: "assumption 1b" + Section: "2.8.8.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0002" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SPTOBID - operator: is_not_contained_by - value: $to_sptobid + - name: SPTOBID + operator: is_not_contained_by + value: $to_sptobid Core: Id: CORE-000660 Status: Published - Version: '1' -Description: Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to + Version: "1" +Description: + Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to a SPTOBID value present in TO. Executability: Fully Executable Operations: -- domain: TO - id: $to_sptobid - name: SPTOBID - operator: distinct + - domain: TO + id: $to_sptobid + name: SPTOBID + operator: distinct Outcome: Message: SPTOBID value in the dataset does not correspond to a SPTOBID value in TO. Output Variables: - - SPTOBID - - $to_sptobid + - SPTOBID + - $to_sptobid Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000661/rule.yml b/Published/CORE-000661/rule.yml index 47577f500..18c9fb732 100644 --- a/Published/CORE-000661/rule.yml +++ b/Published/CORE-000661/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5113 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5113 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--HLT' - operator: exists + - name: "--HLT" + operator: exists Core: Id: CORE-000661 Status: Published - Version: '1' -Description: '--HLT (High Level Term) must not be present in SEND dataset' + Version: "1" +Description: "--HLT (High Level Term) must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: '--HLT (High Level Term) must not be present in SEND dataset' + Message: "--HLT (High Level Term) must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000662/rule.yml b/Published/CORE-000662/rule.yml index 486ae735e..03153aef2 100644 --- a/Published/CORE-000662/rule.yml +++ b/Published/CORE-000662/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5114 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5114 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--HLTCD' - operator: exists + - name: "--HLTCD" + operator: exists Core: Id: CORE-000662 Status: Published - Version: '1' -Description: '--HLTCD (High Level Term Code) must not be in SEND dataset' + Version: "1" +Description: "--HLTCD (High Level Term Code) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--HLTCD (High Level Term Code) must not be in SEND dataset' + Message: "--HLTCD (High Level Term Code) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000663/rule.yml b/Published/CORE-000663/rule.yml index e61da096f..a9f25d6d3 100644 --- a/Published/CORE-000663/rule.yml +++ b/Published/CORE-000663/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5115 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5115 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--HLGT' - operator: exists + - name: "--HLGT" + operator: exists Core: Id: CORE-000663 Status: Published - Version: '1' -Description: '--HLGT (High Level Group Term) must not be in SEND dataset' + Version: "1" +Description: "--HLGT (High Level Group Term) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--HLGT (High Level Group Term) must not be in SEND dataset' + Message: "--HLGT (High Level Group Term) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000664/rule.yml b/Published/CORE-000664/rule.yml index 2ecdad4b0..c2dcb28f8 100644 --- a/Published/CORE-000664/rule.yml +++ b/Published/CORE-000664/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5116 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5116 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--LLT' - operator: exists + - name: "--LLT" + operator: exists Core: Id: CORE-000664 Status: Published - Version: '1' -Description: '--LLT (Lower Level Term) must not be in SEND dataset' + Version: "1" +Description: "--LLT (Lower Level Term) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--LLT (Lower Level Term) must not be in SEND dataset' + Message: "--LLT (Lower Level Term) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000665/rule.yml b/Published/CORE-000665/rule.yml index 20418bba7..5d6cd0876 100644 --- a/Published/CORE-000665/rule.yml +++ b/Published/CORE-000665/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5117 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5117 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--LLTCD' - operator: exists + - name: "--LLTCD" + operator: exists Core: Id: CORE-000665 Status: Published - Version: '1' -Description: '--LLTCD (Lower Level Term Code) must not be in SEND dataset' + Version: "1" +Description: "--LLTCD (Lower Level Term Code) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--LLTCD (Lower Level Term Code) must not be in SEND dataset' + Message: "--LLTCD (Lower Level Term Code) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000667/rule.yml b/Published/CORE-000667/rule.yml index a4da0566b..e4a61b120 100644 --- a/Published/CORE-000667/rule.yml +++ b/Published/CORE-000667/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5118 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5118 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--PARTY' - operator: exists + - name: "--PARTY" + operator: exists Core: Id: CORE-000667 Status: Published - Version: '1' -Description: '--PARTY (Accountable Party) must not be in SEND dataset' + Version: "1" +Description: "--PARTY (Accountable Party) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--PARTY (Accountable Party) must not be in SEND dataset' + Message: "--PARTY (Accountable Party) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000668/rule.yml b/Published/CORE-000668/rule.yml index 309143bed..4829c7196 100644 --- a/Published/CORE-000668/rule.yml +++ b/Published/CORE-000668/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5119 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5119 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--PRTYID' - operator: exists + - name: "--PRTYID" + operator: exists Core: Id: CORE-000668 Status: Published - Version: '1' -Description: '--PRTYID (Identification of Accountable Party) must not be in SEND dataset' + Version: "1" +Description: "--PRTYID (Identification of Accountable Party) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--PRTYID (Identification of Accountable Party) must not be in SEND dataset' + Message: "--PRTYID (Identification of Accountable Party) must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000669/rule.yml b/Published/CORE-000669/rule.yml index c5a9426eb..4569a563b 100644 --- a/Published/CORE-000669/rule.yml +++ b/Published/CORE-000669/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5135 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5135 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--STRF' - operator: exists + - name: "--STRF" + operator: exists Core: Id: CORE-000669 Status: Published - Version: '1' -Description: '--STRF must not be in SEND dataset' + Version: "1" +Description: "--STRF must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--STRF must not be in SEND dataset' + Message: "--STRF must not be in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000670/rule.yml b/Published/CORE-000670/rule.yml index 96e5d540a..b2652d8a9 100644 --- a/Published/CORE-000670/rule.yml +++ b/Published/CORE-000670/rule.yml @@ -1,65 +1,67 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.0 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.0' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.0 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "3.0" Check: all: - - name: 'DDTESTCD' - operator: non_empty - # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD - # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE - # for "unscheduled" - - name: 'DSDECOD' - # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'" - # WHY? - #operator: is_not_contained_by - #value: - # - 'ACCIDENTAL DEATH' - # - 'FOUND DEAD' - # - 'MORIBUND SACRIFICE' - # - 'NON-MORIBUND SACRIFICE' - operator: not_equal_to - value: 'ACCIDENTAL DEATH' - - name: 'DSDECOD' - operator: not_equal_to - value: 'FOUND DEAD' - - name: 'DSDECOD' - operator: not_equal_to - value: 'MORIBUND SACRIFICE' - - name: 'DSDECOD' - operator: not_equal_to - value: 'NON-MORIBUND SACRIFICE' + - name: "DDTESTCD" + operator: non_empty + # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD + # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE + # for "unscheduled" + - name: + "DSDECOD" + # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'" + # WHY? + #operator: is_not_contained_by + #value: + # - 'ACCIDENTAL DEATH' + # - 'FOUND DEAD' + # - 'MORIBUND SACRIFICE' + # - 'NON-MORIBUND SACRIFICE' + operator: not_equal_to + value: "ACCIDENTAL DEATH" + - name: "DSDECOD" + operator: not_equal_to + value: "FOUND DEAD" + - name: "DSDECOD" + operator: not_equal_to + value: "MORIBUND SACRIFICE" + - name: "DSDECOD" + operator: not_equal_to + value: "NON-MORIBUND SACRIFICE" Core: Id: CORE-000670 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DS + - Keys: + - USUBJID + Name: DS Outcome: - Message: 'Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND SACRIFICE,NON-MORIBUND - SACRIFICE indicating unscheduled death' + Message: + "Record does not have DDSTRESC=ACCIDENTAL DEATH,FOUND DEAD,MORIBUND SACRIFICE,NON-MORIBUND + SACRIFICE indicating unscheduled death" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000671/rule.yml b/Published/CORE-000671/rule.yml index 45c062f58..a7aae5323 100644 --- a/Published/CORE-000671/rule.yml +++ b/Published/CORE-000671/rule.yml @@ -1,96 +1,96 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'The DD domain should only be utilized for subjects with an unscheduled death' - Document: SENDIG v3.1.1 - Section: '6.3.4.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND167' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.1 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.1.1 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.1 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.1.1 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "The DD domain should only be utilized for subjects with an unscheduled death" + Document: SENDIG v3.1.1 + Section: "6.3.4.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND167" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: 'DDTESTCD' - operator: non_empty - - name: 'DSUSCHFL' - operator: not_equal_to - value: 'Y' + - name: "DDTESTCD" + operator: non_empty + - name: "DSUSCHFL" + operator: not_equal_to + value: "Y" Core: Id: CORE-000671 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DS + - Keys: + - USUBJID + Name: DS Outcome: - Message: 'Record does not have DSUSCHFL=Y in DS' + Message: "Record does not have DSUSCHFL=Y in DS" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - DD + - DD Sensitivity: Record diff --git a/Published/CORE-000672/rule.yml b/Published/CORE-000672/rule.yml index 1eb9e0263..41e3e90ee 100644 --- a/Published/CORE-000672/rule.yml +++ b/Published/CORE-000672/rule.yml @@ -1,164 +1,175 @@ Authorities: -- Organization: FDA - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3901' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3901" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STNRHI - operator: non_empty - - name: --STNRLO - operator: non_empty - - name: --STNRHI - operator: less_than_or_equal_to - value: --STNRLO + - name: --STNRHI + operator: non_empty + - name: --STNRLO + operator: non_empty + - name: --STNRHI + operator: less_than_or_equal_to + value: --STNRLO Core: Id: CORE-000672 Status: Published - Version: '1' -Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal + Version: "1" +Description: + Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal Range Lower Limit-Standard Units (--STNRLO). Executability: Fully Executable Outcome: Message: --STNRHI is less than or equal to --STNRLO. Output Variables: - - --TESTCD - - --STNRLO - - --STNRHI + - --TESTCD + - --STNRLO + - --STNRHI Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000673/rule.yml b/Published/CORE-000673/rule.yml index deb1ea404..524e79d3e 100644 --- a/Published/CORE-000673/rule.yml +++ b/Published/CORE-000673/rule.yml @@ -2,54 +2,55 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016a' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: "TIG 1.0" + Item: "Specification Table: IQVALTRG | IQVALMIN | IQVALMAX" + Section: "2.8.8.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0016a" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMIN - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: less_than - value: --VALMIN + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMIN + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: less_than + value: --VALMIN Core: Id: CORE-000673 Status: Published - Version: '1' -Description: Part A - Raise an error when --VALTRG is a number and is less than the specified + Version: "1" +Description: + Part A - Raise an error when --VALTRG is a number and is less than the specified --VALMIN value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or greater than the --VALMIN value. Output Variables: - - IGDCMPID - - SPTOBID - - --VALTRG - - --VALMIN + - IGDCMPID + - SPTOBID + - --VALTRG + - --VALMIN Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000674/rule.yml b/Published/CORE-000674/rule.yml index 7b86f5e04..f2948b0b2 100644 --- a/Published/CORE-000674/rule.yml +++ b/Published/CORE-000674/rule.yml @@ -2,54 +2,55 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: IQVALTRG | IQVALMIN | IQVALMAX' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016a' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: "TIG 1.0" + Item: "Specification Table: IQVALTRG | IQVALMIN | IQVALMAX" + Section: "2.8.8.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0016a" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMAX - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: greater_than - value: --VALMAX + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMAX + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: greater_than + value: --VALMAX Core: Id: CORE-000674 Status: Published - Version: '1' -Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified + Version: "1" +Description: + Part B - Raise an error when --VALTRG is a number and is greater than the specified --VALMAX value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or less than the --VALMAX value. Output Variables: - - IGDCMPID - - SPTOBID - - --VALTRG - - --VALMAX + - IGDCMPID + - SPTOBID + - --VALTRG + - --VALMAX Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000675/rule.yml b/Published/CORE-000675/rule.yml index 86414ace1..bd9af453f 100644 --- a/Published/CORE-000675/rule.yml +++ b/Published/CORE-000675/rule.yml @@ -1,162 +1,173 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Origin: FDA Business Rules - Rule Identifier: - Id: FB4201 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Origin: FDA Business Rules + Rule Identifier: + Id: FB4201 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - value_is_literal: true - - any: - - name: --ORRES - operator: non_empty - - name: --STRESC - operator: non_empty - - name: --STRESN - operator: non_empty + - name: --STAT + operator: equal_to + value: NOT DONE + value_is_literal: true + - any: + - name: --ORRES + operator: non_empty + - name: --STRESC + operator: non_empty + - name: --STRESN + operator: non_empty Core: Id: CORE-000675 Status: Published - Version: '1' -Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and + Version: "1" +Description: + When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and --STRESC) should not be populated. Executability: Fully Executable Outcome: - Message: '--STAT = NOT DONE, but a result variable (--ORRES, --STRESC and/or --STRESN) is populated.' + Message: "--STAT = NOT DONE, but a result variable (--ORRES, --STRESC and/or --STRESN) is populated." Output Variables: - - --TESTCD - - --ORRES - - --STRESC - - --STRESN - - --STAT + - --TESTCD + - --ORRES + - --STRESC + - --STRESN + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000676/rule.yml b/Published/CORE-000676/rule.yml index 8cf358073..ce7c68d1f 100644 --- a/Published/CORE-000676/rule.yml +++ b/Published/CORE-000676/rule.yml @@ -1,60 +1,63 @@ # Variable: SPTOBID # Rule: SPTOBID in TO.SPTOBID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), - Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well - as any domain in the general observation classes where there are records pertaining to the - tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset - must correspond to a product described in the TO dataset. - Document: 'TIG 1.0' - Item: 'assumption 1b' - Section: '2.8.8.1' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0002' - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + SPTOBID is used in the Product Design (PD), Tobacco Ingredients (IT), + Non-Tobacco Ingredients (IN), and Ingredient Quantities by Component (IQ) domains, as well + as any domain in the general observation classes where there are records pertaining to the + tobacco product it identifies/describes (e.g., PT). Every value of SPTOBID in any dataset + must correspond to a product described in the TO dataset. + Document: "TIG 1.0" + Item: "assumption 1b" + Section: "2.8.8.1" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0002" + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TXPARMCD - operator: equal_to - value: SPTOBID - value_is_literal: true - - name: TXVAL - operator: is_not_contained_by - value: $to_sptobid + - name: TXPARMCD + operator: equal_to + value: SPTOBID + value_is_literal: true + - name: TXVAL + operator: is_not_contained_by + value: $to_sptobid Core: Id: CORE-000676 Status: Published - Version: '1' -Description: Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX + Version: "1" +Description: + Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID value present in TO. Executability: Fully Executable Operations: -- domain: TO - id: $to_sptobid - name: SPTOBID - operator: distinct + - domain: TO + id: $to_sptobid + name: SPTOBID + operator: distinct Outcome: - Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID + Message: + Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID value in TO. Output Variables: - - TXVAL - - $to_sptobid + - TXVAL + - $to_sptobid Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000677/rule.yml b/Published/CORE-000677/rule.yml index a2e2d9c80..f9cf1f44e 100644 --- a/Published/CORE-000677/rule.yml +++ b/Published/CORE-000677/rule.yml @@ -1,131 +1,138 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.0 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.22 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0075 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.0 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.22 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0075 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: $poolid_exists - operator: equal_to - value: true - - name: POOLDEF - operator: not_exists + - name: $poolid_exists + operator: equal_to + value: true + - name: POOLDEF + operator: not_exists Core: Id: CORE-000677 Status: Published - Version: '1' + Version: "1" Description: Part A - Raise error when POOLID exists in the dataset but POOLDEF does not exist. Executability: Fully Executable Operations: -- id: $poolid_exists - name: POOLID - operator: variable_exists + - id: $poolid_exists + name: POOLID + operator: variable_exists Outcome: Message: POOLID variable exists in the dataset but POOLDEF dataset does not exist. Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Dataset diff --git a/Published/CORE-000678/rule.yml b/Published/CORE-000678/rule.yml index 5090c5a70..2cc6dc7f1 100644 --- a/Published/CORE-000678/rule.yml +++ b/Published/CORE-000678/rule.yml @@ -1,136 +1,144 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.0 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: SENDIG v3.1.1 - Item: POOLID CDISC Notes - Section: 6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND139 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: If POOLID is entered, POOLDEF records must exist for each subject and the - USUBJID must be null. - Document: TIG v1.0 - Item: POOLID CDISC Notes - Section: 2.8.9.22 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0075 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.0 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: SENDIG v3.1.1 + Item: POOLID CDISC Notes + Section: 6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND139 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If POOLID is entered, POOLDEF records must exist for each subject and the + USUBJID must be null. + Document: TIG v1.0 + Item: POOLID CDISC Notes + Section: 2.8.9.22 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0075 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: POOLID - operator: non_empty - - name: POOLID - operator: is_not_contained_by - value: $pooldef_poolid + - name: POOLID + operator: non_empty + - name: POOLID + operator: is_not_contained_by + value: $pooldef_poolid Core: Id: CORE-000678 Status: Published - Version: '1' -Description: Part B - Raise error when value for POOLID in the dataset is not a POOLID value in + Version: "1" +Description: + Part B - Raise error when value for POOLID in the dataset is not a POOLID value in POOLDEF. Executability: Fully Executable Operations: -- domain: POOLDEF - id: $pooldef_poolid - name: POOLID - operator: distinct + - domain: POOLDEF + id: $pooldef_poolid + name: POOLID + operator: distinct Outcome: Message: POOLID value in the dataset does not correspond to a POOLID value in POOLDEF. Output Variables: - - POOLID - - $pooldef_poolid + - POOLID + - $pooldef_poolid Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000680/rule.yml b/Published/CORE-000680/rule.yml index 29add310a..ec93f4306 100644 --- a/Published/CORE-000680/rule.yml +++ b/Published/CORE-000680/rule.yml @@ -1,60 +1,61 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned enrollment number or a planned completion - number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00043' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A unit must not be specified for a planned enrollment number or a planned completion + number." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00043" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: is_contained_by - value: - - 'plannedCompletionNumber' - - 'plannedEnrollmentNumber' - - not: - any: - - name: unit - operator: equal_to - value: false - - name: unit - operator: empty - - name: unit - operator: not_exists + - name: instanceType + operator: equal_to + value: "Range" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_rel + operator: is_contained_by + value: + - "plannedCompletionNumber" + - "plannedEnrollmentNumber" + - not: + any: + - name: unit + operator: equal_to + value: false + - name: unit + operator: empty + - name: unit + operator: not_exists Core: - Id: 'CORE-000680' + Id: "CORE-000680" Status: Published - Version: '1' -Description: 'A unit must not be specified for a planned enrollment number or a planned completion number.' + Version: "1" +Description: "A unit must not be specified for a planned enrollment number or a planned completion number." Executability: Fully Executable Outcome: - Message: 'A unit is specified for a planned enrollment number or a planned completion number.' + Message: "A unit is specified for a planned enrollment number or a planned completion number." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - minValue - - maxValue - - unit - - unit.decode + - parent_entity + - parent_id + - parent_rel + - id + - minValue + - maxValue + - unit + - unit.decode Rule Type: Record Data Scope: Entities: Include: - - Range + - Range Sensitivity: Record diff --git a/Published/CORE-000681/rule.yml b/Published/CORE-000681/rule.yml index f070d52d5..ac9ed17e6 100644 --- a/Published/CORE-000681/rule.yml +++ b/Published/CORE-000681/rule.yml @@ -1,86 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one attribute must be specified for an address.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00045' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "At least one attribute must be specified for an address." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00045" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Address' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: text - operator: not_exists - - name: text - operator: empty - - any: - - name: line - operator: not_exists - - name: line - operator: empty - - any: - - name: district - operator: not_exists - - name: district - operator: empty - - any: - - name: city - operator: not_exists - - name: city - operator: empty - - any: - - name: postalCode - operator: not_exists - - name: postalCode - operator: empty - - any: - - name: state - operator: not_exists - - name: state - operator: empty - - any: - - name: country - operator: not_exists - - name: country - operator: empty - - name: country + - name: instanceType operator: equal_to - value: false + value: "Address" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: text + operator: not_exists + - name: text + operator: empty + - any: + - name: line + operator: not_exists + - name: line + operator: empty + - any: + - name: district + operator: not_exists + - name: district + operator: empty + - any: + - name: city + operator: not_exists + - name: city + operator: empty + - any: + - name: postalCode + operator: not_exists + - name: postalCode + operator: empty + - any: + - name: state + operator: not_exists + - name: state + operator: empty + - any: + - name: country + operator: not_exists + - name: country + operator: empty + - name: country + operator: equal_to + value: false Core: - Id: 'CORE-000681' + Id: "CORE-000681" Status: Published - Version: '1' -Description: 'At least one attribute must be specified for an address.' + Version: "1" +Description: "At least one attribute must be specified for an address." Executability: Fully Executable Outcome: - Message: 'All attributes of the address are blank.' + Message: "All attributes of the address are blank." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - line - - district - - city - - postalCode - - state - - country + - parent_entity + - parent_id + - parent_rel + - id + - text + - line + - district + - city + - postalCode + - state + - country Rule Type: Record Data Scope: Entities: Include: - - Address + - Address Sensitivity: Record diff --git a/Published/CORE-000682/rule.yml b/Published/CORE-000682/rule.yml index f58f7c91a..10fd94888 100644 --- a/Published/CORE-000682/rule.yml +++ b/Published/CORE-000682/rule.yml @@ -1,49 +1,49 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is not expected to refer to a timeline exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00064' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A scheduled decision instance is not expected to refer to a timeline exit." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00064" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - not: - any: - - name: timelineExitId - operator: not_exists - - name: timelineExitId - operator: empty + - name: instanceType + operator: equal_to + value: "ScheduledDecisionInstance" + - name: rel_type + operator: equal_to + value: "definition" + - not: + any: + - name: timelineExitId + operator: not_exists + - name: timelineExitId + operator: empty Core: - Id: 'CORE-000682' + Id: "CORE-000682" Status: Published - Version: '1' -Description: 'A scheduled decision instance is not expected to refer to a timeline exit.' + Version: "1" +Description: "A scheduled decision instance is not expected to refer to a timeline exit." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The scheduled decision instance refers to a timeline exit.' + Message: "The scheduled decision instance refers to a timeline exit." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineExitId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineExitId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-000683/rule.yml b/Published/CORE-000683/rule.yml index e42ff86c3..751598c24 100644 --- a/Published/CORE-000683/rule.yml +++ b/Published/CORE-000683/rule.yml @@ -1,49 +1,49 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is not expected to have a sub-timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00065' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A scheduled decision instance is not expected to have a sub-timeline." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00065" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - not: - any: - - name: timelineId - operator: not_exists - - name: timelineId - operator: empty + - name: instanceType + operator: equal_to + value: "ScheduledDecisionInstance" + - name: rel_type + operator: equal_to + value: "definition" + - not: + any: + - name: timelineId + operator: not_exists + - name: timelineId + operator: empty Core: - Id: 'CORE-000683' + Id: "CORE-000683" Status: Published - Version: '1' -Description: 'A scheduled decision instance is not expected to have a sub-timeline.' + Version: "1" +Description: "A scheduled decision instance is not expected to have a sub-timeline." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The scheduled decision instance has a sub-timeline.' + Message: "The scheduled decision instance has a sub-timeline." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-000684/rule.yml b/Published/CORE-000684/rule.yml index 079a32f21..2c9278b44 100644 --- a/Published/CORE-000684/rule.yml +++ b/Published/CORE-000684/rule.yml @@ -1,47 +1,48 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The minimum value of a range must be less than or equal to the maximum value - of the range.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00070' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The minimum value of a range must be less than or equal to the maximum value + of the range." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00070" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: minValue - operator: greater_than - value: maxValue + - name: instanceType + operator: equal_to + value: "Range" + - name: rel_type + operator: equal_to + value: "definition" + - name: minValue + operator: greater_than + value: maxValue Core: - Id: 'CORE-000684' + Id: "CORE-000684" Status: Published - Version: '1' -Description: 'The minimum value of a range must be less than or equal to the maximum value of the range.' + Version: "1" +Description: "The minimum value of a range must be less than or equal to the maximum value of the range." Executability: Fully Executable Outcome: - Message: 'The minimum value of the range is not less than or equal to the maximum value.' + Message: "The minimum value of the range is not less than or equal to the maximum value." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - minValue - - maxValue + - parent_entity + - parent_id + - parent_rel + - id + - minValue + - maxValue Rule Type: Record Data Scope: Entities: Include: - - 'Range' + - "Range" Sensitivity: Record diff --git a/Published/CORE-000690/rule.yml b/Published/CORE-000690/rule.yml index 97a55d74a..3133700ed 100644 --- a/Published/CORE-000690/rule.yml +++ b/Published/CORE-000690/rule.yml @@ -1,128 +1,135 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.0 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A descriptive Variable Label, using up to 40 characters, which should be - unique for each variable in the dataset. - Document: SENDIG v3.1.1 - Item: Text - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND273 - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: TIG - References: - - Citations: - - Cited Guidance: Descriptive labels per this guide, up to 40 characters, will be provided as - data variable labels for all variables, including Supplemental Qualifier variables - Document: TIG v1.0 - Item: Text - Section: 2.6 Guidance for Datasets, Tabulation Dataset, Num 5 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0192 - Version: "1" - Version: "1.0" - Substandard: SEND - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.0 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A descriptive Variable Label, using up to 40 characters, which should be + unique for each variable in the dataset. + Document: SENDIG v3.1.1 + Item: Text + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND273 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Descriptive labels per this guide, up to 40 characters, will be provided as + data variable labels for all variables, including Supplemental Qualifier variables + Document: TIG v1.0 + Item: Text + Section: 2.6 Guidance for Datasets, Tabulation Dataset, Num 5 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0192 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: variable_name - operator: is_not_unique_relationship - value: variable_label + - name: variable_name + operator: is_not_unique_relationship + value: variable_label Core: Id: CORE-000690 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the variable label is not unique for each variable in the dataset Executability: Fully Executable Outcome: Message: Variable label is not unique for each variable in the dataset. Output Variables: - - variable_label - - variable_name + - variable_label + - variable_name Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000691/rule.yml b/Published/CORE-000691/rule.yml index 6d092a42d..16079a851 100644 --- a/Published/CORE-000691/rule.yml +++ b/Published/CORE-000691/rule.yml @@ -1,65 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate environmental settings.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00053' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within an encounter there must be no duplicate environmental settings." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00053" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'environmentalSetting' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "Encounter" + - name: parent_rel + operator: equal_to + value: "environmentalSetting" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000691" Status: Published - Version: '1' -Description: 'Within an encounter there must be no duplicate environmental settings.' + Version: "1" +Description: "Within an encounter there must be no duplicate environmental settings." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The environmental settings of the encounter are not unique - the same code is used more than - once with the same codeSystem and codeSystemVersion.' + Message: + "The environmental settings of the encounter are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000692/rule.yml b/Published/CORE-000692/rule.yml index e9fbb1b66..e4eca406e 100644 --- a/Published/CORE-000692/rule.yml +++ b/Published/CORE-000692/rule.yml @@ -1,65 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more trial types are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00055' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more trial types are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00055" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'trialTypes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: parent_rel + operator: equal_to + value: "trialTypes" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000692" Status: Published - Version: '1' -Description: 'Within a study design, if more trial types are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more trial types are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The trial types of the study design are not unique - the same code is used more than once - with the same codeSystem and codeSystemVersion.' + Message: + "The trial types of the study design are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000693/rule.yml b/Published/CORE-000693/rule.yml index fa30779cd..0e71fcd6d 100644 --- a/Published/CORE-000693/rule.yml +++ b/Published/CORE-000693/rule.yml @@ -1,65 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00056' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more therapeutic areas are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00056" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'therapeuticAreas' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: parent_rel + operator: equal_to + value: "therapeuticAreas" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000693" Status: Published - Version: '1' -Description: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more therapeutic areas are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The therapeutic areas of the study design are not unique - the same code is used more than - once with the same codeSystem and codeSystemVersion.' + Message: + "The therapeutic areas of the study design are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000694/rule.yml b/Published/CORE-000694/rule.yml index 120178793..65d009049 100644 --- a/Published/CORE-000694/rule.yml +++ b/Published/CORE-000694/rule.yml @@ -1,65 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more trial intent types are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00057' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more trial intent types are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00057" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'trialIntentTypes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: parent_rel + operator: equal_to + value: "trialIntentTypes" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000694" Status: Published - Version: '1' -Description: 'Within a study design, if more trial intent types are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more trial intent types are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The trial intent types of the study design are not unique - the same code is used more than - once with the same codeSystem and codeSystemVersion.' + Message: + "The trial intent types of the study design are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000695/rule.yml b/Published/CORE-000695/rule.yml index 20026ee37..467b0d1d3 100644 --- a/Published/CORE-000695/rule.yml +++ b/Published/CORE-000695/rule.yml @@ -1,65 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more characteristics are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00134' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more characteristics are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00134" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: parent_rel - operator: equal_to - value: 'characteristics' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: parent_rel + operator: equal_to + value: "characteristics" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000695" Status: Published - Version: '1' -Description: 'Within a study design, if more characteristics are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more characteristics are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyDesign + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyDesign Outcome: - Message: 'The characteristics of the study design are not unique - the same code is used more than once - with the same codeSystem and codeSystemVersion.' + Message: + "The characteristics of the study design are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000696/rule.yml b/Published/CORE-000696/rule.yml index b1b623002..83eb76df7 100644 --- a/Published/CORE-000696/rule.yml +++ b/Published/CORE-000696/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every identifier must be unique within the scope of an identified organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00138' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Every identifier must be unique within the scope of an identified organization." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00138" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyIdentifier' - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyIdentifier - operator: is_not_unique_set - value: - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - name: instanceType + operator: equal_to + value: "StudyIdentifier" + - name: rel_type + operator: equal_to + value: "definition" + - name: studyIdentifier + operator: is_not_unique_set + value: + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Core: - Id: 'CORE-000696' + Id: "CORE-000696" Status: Published - Version: '1' -Description: 'Every identifier must be unique within the scope of an identified organization.' + Version: "1" +Description: "Every identifier must be unique within the scope of an identified organization." Executability: Fully Executable Outcome: - Message: 'The identifier is not unique within the scope of the identified organization.' + Message: "The identifier is not unique within the scope of the identified organization." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - studyIdentifier - - studyIdentifierScope.name - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - parent_entity + - parent_id + - parent_rel + - id + - studyIdentifier + - studyIdentifierScope.name + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Rule Type: Record Data Scope: Entities: Include: - - 'StudyIdentifier' + - "StudyIdentifier" Sensitivity: Record diff --git a/Published/CORE-000697/rule.yml b/Published/CORE-000697/rule.yml index 185df688e..3e1e1ea95 100644 --- a/Published/CORE-000697/rule.yml +++ b/Published/CORE-000697/rule.yml @@ -1,51 +1,52 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An identified organization is not expected to have more than one identifier for - the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00139' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An identified organization is not expected to have more than one identifier for + the study." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00139" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyIdentifier' - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyIdentifierScope.identifier - operator: is_not_unique_set - value: - - parent_id - - studyIdentifierScope.identifierScheme + - name: instanceType + operator: equal_to + value: "StudyIdentifier" + - name: rel_type + operator: equal_to + value: "definition" + - name: studyIdentifierScope.identifier + operator: is_not_unique_set + value: + - parent_id + - studyIdentifierScope.identifierScheme Core: - Id: 'CORE-000697' + Id: "CORE-000697" Status: Published - Version: '1' -Description: 'An identified organization is not expected to have more than one identifier for the study.' + Version: "1" +Description: "An identified organization is not expected to have more than one identifier for the study." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The identified organization has more than one identifier for the study.' + Message: "The identified organization has more than one identifier for the study." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - studyIdentifier - - studyIdentifierScope.name - - studyIdentifierScope.identifierScheme - - studyIdentifierScope.identifier + - parent_entity + - parent_id + - parent_rel + - id + - studyIdentifier + - studyIdentifierScope.name + - studyIdentifierScope.identifierScheme + - studyIdentifierScope.identifier Rule Type: Record Data Scope: Entities: Include: - - 'StudyIdentifier' + - "StudyIdentifier" Sensitivity: Record diff --git a/Published/CORE-000698/rule.yml b/Published/CORE-000698/rule.yml index ba0339067..a4d7410c6 100644 --- a/Published/CORE-000698/rule.yml +++ b/Published/CORE-000698/rule.yml @@ -2,54 +2,55 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: "TIG 1.0" + Item: "Specification Table: PDVALTRG | PDVALMIN | PDVALMAX" + Section: "2.8.8.2" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0016" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMIN - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: less_than - value: --VALMIN + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMIN + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: less_than + value: --VALMIN Core: Id: CORE-000698 Status: Published - Version: '1' -Description: Part A - Raise an error when --VALTRG is a number and is less than the specified + Version: "1" +Description: + Part A - Raise an error when --VALTRG is a number and is less than the specified --VALMIN value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or greater than the --VALMIN value. Output Variables: - - SPTOBID - - --VALTRG - - --VALMIN - - PDPARMCD + - SPTOBID + - --VALTRG + - --VALMIN + - PDPARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - PD + - PD Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000699/rule.yml b/Published/CORE-000699/rule.yml index 552f938e0..0a9585dff 100644 --- a/Published/CORE-000699/rule.yml +++ b/Published/CORE-000699/rule.yml @@ -1,172 +1,184 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Standard units should be consistent within the same assessment (having the - same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). - Document: FDA - Section: FDAB030 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3001 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Standard units should be consistent within the same assessment (having the + same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values). + Document: FDA + Section: FDAB030 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3001 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRESU - operator: is_inconsistent_across_dataset - value: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --STAT + - name: --STRESU + operator: is_inconsistent_across_dataset + value: + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --STAT Core: Id: CORE-000699 Status: Published - Version: '1' -Description: Standard units should be consistent within the same assessment (having the same + Version: "1" +Description: + Standard units should be consistent within the same assessment (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values) Executability: Fully Executable Outcome: - Message: Standards units are inconsistent within the same test (category, sub-category, specimen + Message: + Standards units are inconsistent within the same test (category, sub-category, specimen and method) Output Variables: - - --STRESU - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --STAT + - --STRESU + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --STAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000700/rule.yml b/Published/CORE-000700/rule.yml index 095a0ed7e..045c7ea3e 100644 --- a/Published/CORE-000700/rule.yml +++ b/Published/CORE-000700/rule.yml @@ -1,162 +1,173 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3204 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3204 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DY - operator: exists - - name: --DTC - operator: not_exists + - name: --DY + operator: exists + - name: --DTC + operator: not_exists Core: Id: CORE-000700 Status: Published - Version: '1' -Description: When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the + Version: "1" +Description: + When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the Date/Time of Collection (--DTC) should also be present in the dataset Executability: Fully Executable Outcome: - Message: Date/Time of Collection (--DTC) variable is missing when Study Day of + Message: Date/Time of Collection (--DTC) variable is missing when Study Day of Visit/Collection/Exam (--DY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000702/rule.yml b/Published/CORE-000702/rule.yml index 2a06869e8..e48c807b6 100644 --- a/Published/CORE-000702/rule.yml +++ b/Published/CORE-000702/rule.yml @@ -1,48 +1,48 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance is expected to refer to a default condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00066' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A scheduled decision instance is expected to refer to a default condition." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00066" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: defaultConditionId - operator: not_exists - - name: defaultConditionId - operator: empty + - name: instanceType + operator: equal_to + value: "ScheduledDecisionInstance" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: defaultConditionId + operator: not_exists + - name: defaultConditionId + operator: empty Core: - Id: 'CORE-000702' + Id: "CORE-000702" Status: Published - Version: '1' -Description: 'A scheduled decision instance is expected to refer to a default condition.' + Version: "1" +Description: "A scheduled decision instance is expected to refer to a default condition." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The scheduled decision instance does not refer to a default condition.' + Message: "The scheduled decision instance does not refer to a default condition." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-000703/rule.yml b/Published/CORE-000703/rule.yml index 1a5d68e5d..57ababddd 100644 --- a/Published/CORE-000703/rule.yml +++ b/Published/CORE-000703/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must refer to at least one element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00067' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study cell must refer to at least one element." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00067" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyCell' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: elementIds - operator: not_exists - - name: elementIds - operator: empty - - name: elementIds + - name: instanceType operator: equal_to - value: false + value: "StudyCell" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: elementIds + operator: not_exists + - name: elementIds + operator: empty + - name: elementIds + operator: equal_to + value: false Core: - Id: 'CORE-000703' + Id: "CORE-000703" Status: Published - Version: '1' -Description: 'A study cell must refer to at least one element.' + Version: "1" +Description: "A study cell must refer to at least one element." Executability: Fully Executable Outcome: - Message: 'The study cell does not refer to any elements.' + Message: "The study cell does not refer to any elements." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - elementIds + - parent_entity + - parent_id + - parent_rel + - id + - elementIds Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - "StudyCell" Sensitivity: Record diff --git a/Published/CORE-000704/rule.yml b/Published/CORE-000704/rule.yml index 9f74498cb..a97d2fecd 100644 --- a/Published/CORE-000704/rule.yml +++ b/Published/CORE-000704/rule.yml @@ -2,54 +2,55 @@ # Condition: --VALTRG is a number # Rule: --VALMIN <= --VALTRG <= --VALMAX Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: No specific guidance; this is a simple mathematical definition - Document: 'TIG 1.0' - Item: 'Specification Table: PDVALTRG | PDVALMIN | PDVALMAX' - Section: '2.8.8.2' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0016' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: No specific guidance; this is a simple mathematical definition + Document: "TIG 1.0" + Item: "Specification Table: PDVALTRG | PDVALMIN | PDVALMAX" + Section: "2.8.8.2" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0016" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --VALTRG - operator: matches_regex - value: ^-?([1-9]\d*|0)(\.\d+)?$ - - name: --VALMAX - operator: matches_regex - value: ^.+$ - - name: --VALTRG - operator: greater_than - value: --VALMAX + - name: --VALTRG + operator: matches_regex + value: ^-?([1-9]\d*|0)(\.\d+)?$ + - name: --VALMAX + operator: matches_regex + value: ^.+$ + - name: --VALTRG + operator: greater_than + value: --VALMAX Core: Id: CORE-000704 Status: Published - Version: '1' -Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified + Version: "1" +Description: + Part B - Raise an error when --VALTRG is a number and is greater than the specified --VALMAX value. Executability: Fully Executable Outcome: Message: --VALTRG is not equal to or less than the --VALMAX value. Output Variables: - - SPTOBID - - --VALTRG - - --VALMAX - - PDPARMCD + - SPTOBID + - --VALTRG + - --VALMAX + - PDPARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - PD + - PD Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000707/rule.yml b/Published/CORE-000707/rule.yml index 13b778f57..50081628b 100644 --- a/Published/CORE-000707/rule.yml +++ b/Published/CORE-000707/rule.yml @@ -2,169 +2,180 @@ # Condition: --DY ^= Null and --ENDY ^= Null # Rule: --DY <= --ENDY Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3208 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3208 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DY - operator: exists - - name: --ENDY - operator: exists - - name: --DY - operator: non_empty - - name: --ENDY - operator: non_empty - - name: --DY - operator: greater_than - value: --ENDY + - name: --DY + operator: exists + - name: --ENDY + operator: exists + - name: --DY + operator: non_empty + - name: --ENDY + operator: non_empty + - name: --DY + operator: greater_than + value: --ENDY Core: Id: CORE-000707 Status: Published - Version: '1' -Description: Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of + Version: "1" +Description: + Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of End of Observation (--ENDY). Executability: Fully Executable Outcome: Message: --DY is greater than --ENDY. Output Variables: - - --DY - - --ENDY + - --DY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000708/rule.yml b/Published/CORE-000708/rule.yml index 7411c3d36..2b4d1074c 100644 --- a/Published/CORE-000708/rule.yml +++ b/Published/CORE-000708/rule.yml @@ -2,167 +2,178 @@ # Condition: --STDY ^= Null and --ENDY ^= Null # Rule: --STDY <= --ENDY Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3207 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3207 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STDY - operator: non_empty - - name: --ENDY - operator: non_empty - - name: --STDY - operator: greater_than - value: --ENDY + - name: --STDY + operator: non_empty + - name: --ENDY + operator: non_empty + - name: --STDY + operator: greater_than + value: --ENDY Core: Id: CORE-000708 Status: Published - Version: '1' -Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End + Version: "1" +Description: + When Study Day of End of Observation (--ENDY) is present in the dataset, then the End Date/Time of Observation (--ENDTC) should also be present in the dataset. Executability: Fully Executable Outcome: Message: --STDY is greater than --ENDY. Output Variables: - - --STDY - - --ENDY + - --STDY + - --ENDY Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000710/rule.yml b/Published/CORE-000710/rule.yml index 55ce161b9..840c6d449 100644 --- a/Published/CORE-000710/rule.yml +++ b/Published/CORE-000710/rule.yml @@ -1,116 +1,121 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT with - the reference point, can start AFTER the reference point, or it may not be known (U) when it - started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with - the reference point, can end AFTER the reference point, can be known that it didn't end but - was ONGOING, or it is unknown (U) when it ended or if it was ongoing." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0233 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: 'If the reference time point is prior to the date of collection or assessment: - Start values: an observation can start BEFORE the reference point, can start COINCIDENT - with the reference point, can start AFTER the reference point, or it may not be known (U) when - it started. End values: an observation can end BEFORE the reference point, can end COINCIDENT - with the reference point, can end AFTER the reference point, can be known that it didn''t end - but was ONGOING, or it is unknown (U) when it ended or if it was ongoing.' - Document: TIG 1.0 - Item: Num 3 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0442 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT with + the reference point, can start AFTER the reference point, or it may not be known (U) when it + started. End values: an observation can end BEFORE the reference point, can end COINCIDENT with + the reference point, can end AFTER the reference point, can be known that it didn't end but + was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0233 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + "If the reference time point is prior to the date of collection or assessment: + Start values: an observation can start BEFORE the reference point, can start COINCIDENT + with the reference point, can start AFTER the reference point, or it may not be known (U) when + it started. End values: an observation can end BEFORE the reference point, can end COINCIDENT + with the reference point, can end AFTER the reference point, can be known that it didn't end + but was ONGOING, or it is unknown (U) when it ended or if it was ongoing." + Document: TIG 1.0 + Item: Num 3 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0442 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --STRTPT # Condition: --STTPT is prior to the date of collection or assessment. # Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') Check: all: - - name: --STTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --STTPT - operator: date_less_than - value: --DTC - - name: --STRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - AFTER - - UNKNOWN + - name: --STTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --STTPT + operator: date_less_than + value: --DTC + - name: --STRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - AFTER + - UNKNOWN Core: Id: CORE-000710 Status: Published - Version: '1' + Version: "1" -Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and +Description: + Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and --STTPT is prior to the date of collection or assessment. Executability: Partially Executable Outcome: Message: --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') Output Variables: - - --STTPT - - --STRTPT - - --DTC + - --STTPT + - --STRTPT + - --DTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000711/rule.yml b/Published/CORE-000711/rule.yml index 62d1fb341..f92bb1d36 100644 --- a/Published/CORE-000711/rule.yml +++ b/Published/CORE-000711/rule.yml @@ -2,155 +2,156 @@ # Condition: DM.RFSTDTC ^= Null and DM.RFENDTC ^= Null # Rule: DM.RFSTDTC <= DM.RFENDTC (Note: When comparing values that contain missing date/time components, the comparison is based on the most detailed level of specificity shared by both values. If components such as day, month, or time are missing in either value, these components are excluded from the comparison. Interval components are not included in the comparison.) Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3404 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3404 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: RFSTDTC - operator: non_empty - - name: RFENDTC - operator: non_empty - - name: RFSTDTC - operator: date_greater_than - value: RFENDTC + - name: RFSTDTC + operator: non_empty + - name: RFENDTC + operator: non_empty + - name: RFSTDTC + operator: date_greater_than + value: RFENDTC Core: Id: CORE-000711 Status: Published - Version: '1' -Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject + Version: "1" +Description: + Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject Reference End Date/Time (RFENDTC). Executability: Fully Executable Outcome: Message: RFSTDTC falls after RFENDTC. Output Variables: - - RFSTDTC - - RFENDTC + - RFSTDTC + - RFENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000712/rule.yml b/Published/CORE-000712/rule.yml index 0597dec05..6a120c303 100644 --- a/Published/CORE-000712/rule.yml +++ b/Published/CORE-000712/rule.yml @@ -2,124 +2,134 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000712 Status: Published - Version: '1' -Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable + Version: "1" +Description: + Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: SUPP-- + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: SUPP-- Operations: -- domain: SUPP-- - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true + - domain: SUPP-- + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced + Message: + Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000714/rule.yml b/Published/CORE-000714/rule.yml index c939491c4..d2592e777 100644 --- a/Published/CORE-000714/rule.yml +++ b/Published/CORE-000714/rule.yml @@ -2,143 +2,144 @@ # Condition: DM.RFXSTDTC ^= Null and DM.RFXENDTC ^= Null # Rule: DM.RFXSTDTC <= DM.RFXENDTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3408 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3408 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: RFXSTDTC - operator: non_empty - - name: RFXENDTC - operator: non_empty - - name: RFXSTDTC - operator: date_greater_than - value: RFXENDTC + - name: RFXSTDTC + operator: non_empty + - name: RFXENDTC + operator: non_empty + - name: RFXSTDTC + operator: date_greater_than + value: RFXENDTC Core: Id: CORE-000714 Status: Published - Version: '1' -Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal + Version: "1" +Description: + Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal to the Date/Time of Last Study Treatment (RFXENDTC). Executability: Fully Executable Outcome: Message: RFXSTDTC falls after RFXENDTC. Output Variables: - - RFXSTDTC - - RFXENDTC + - RFXSTDTC + - RFXENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000715/rule.yml b/Published/CORE-000715/rule.yml index 69c192759..b50c4ec42 100644 --- a/Published/CORE-000715/rule.yml +++ b/Published/CORE-000715/rule.yml @@ -1,115 +1,122 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.0 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: SENDIG v3.1.1 - Item: BWSTAT CDISC Notes - Section: 6.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND144 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Used to indicate when a test is not done or result is missing. Should be - null if a result exists in BWORRES. - Document: TIG v1.0 - Item: BWSTAT CDISC Notes - Section: 2.8.9.9 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0080 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.0 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: SENDIG v3.1.1 + Item: BWSTAT CDISC Notes + Section: 6.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND144 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Used to indicate when a test is not done or result is missing. Should be + null if a result exists in BWORRES. + Document: TIG v1.0 + Item: BWSTAT CDISC Notes + Section: 2.8.9.9 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0080 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: empty - - name: --STAT - operator: empty + - name: --ORRES + operator: empty + - name: --STAT + operator: empty Core: Id: CORE-000715 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --ORRES is not populated and --STAT is not populated Executability: Fully Executable Outcome: @@ -118,9 +125,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Exclude: - - SC + - SC Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000718/rule.yml b/Published/CORE-000718/rule.yml index 24aaee728..066205567 100644 --- a/Published/CORE-000718/rule.yml +++ b/Published/CORE-000718/rule.yml @@ -2,167 +2,178 @@ # Condition: --STDTC ^= Null and --ENDTC ^= Null # Rule: --STDTC <= --ENDTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3209 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3209 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STDTC - operator: non_empty - - name: --ENDTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: --ENDTC + - name: --STDTC + operator: non_empty + - name: --ENDTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: --ENDTC Core: Id: CORE-000718 Status: Published - Version: '1' -Description: Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time + Version: "1" +Description: + Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time of Observation (--ENDTC). Executability: Fully Executable Outcome: Message: --STDTC falls after --ENDTC. Output Variables: - - --STDTC - - --ENDTC + - --STDTC + - --ENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Exclude: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000721/rule.yml b/Published/CORE-000721/rule.yml index da0368085..dbbb32446 100644 --- a/Published/CORE-000721/rule.yml +++ b/Published/CORE-000721/rule.yml @@ -1,52 +1,54 @@ # Variable: ARM -# Condition: +# Condition: # Rule: ARM not in ('Screen Failure', 'Not Assigned', 'Unplanned Product Exposure', 'Not Exposed to Product') Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: The trial arms table describes each planned arm in the trial. - Document: TIG 1.0 - Item: Specification:ARM - Section: 2.8.6.1|2.8.10.27|2.8.9.29 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0654 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: The trial arms table describes each planned arm in the trial. + Document: TIG 1.0 + Item: Specification:ARM + Section: 2.8.6.1|2.8.10.27|2.8.9.29 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0654 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARM - operator: is_contained_by_case_insensitive - value: - - Screen Failure - - Not Assigned - - Not Exposed to Product - - Unplanned Product Exposure + - name: ARM + operator: is_contained_by_case_insensitive + value: + - Screen Failure + - Not Assigned + - Not Exposed to Product + - Unplanned Product Exposure Core: Id: "CORE-000721" Status: Published - Version: '1' -Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product + Version: "1" +Description: + Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure', or 'Not Exposed to Product' Executability: Fully Executable Outcome: - Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or + Message: + ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or 'Not Exposed to Product'. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN - - SPECIAL PURPOSE + - TRIAL DESIGN + - SPECIAL PURPOSE Domains: Include: - - DM - - TA - - TV + - DM + - TA + - TV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000722/rule.yml b/Published/CORE-000722/rule.yml index 255d8262c..18491896b 100644 --- a/Published/CORE-000722/rule.yml +++ b/Published/CORE-000722/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.0 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If the PCORRES result is less than the Lower Limit of Quantification (LLQ), - then PCSTRESN should be null and not populated with the value of zero (0). - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND194 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.0 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If the PCORRES result is less than the Lower Limit of Quantification (LLQ), + then PCSTRESN should be null and not populated with the value of zero (0). + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND194 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # Attention: -ORRES is "char", -STRESN is "num" - - name: PCORRES - operator: less_than - value: PCLLOQ - - name: PCSTRESN - operator: non_empty + - name: PCORRES + operator: less_than + value: PCLLOQ + - name: PCSTRESN + operator: non_empty Core: Id: CORE-000722 Status: Published - Version: '1' -Description: If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN + Version: "1" +Description: + If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN should be null and not populated with the value of zero (0). Executability: Fully Executable Outcome: Message: PCSTRESN may not be populated as PCORRES is less than PCLLOQ Output Variables: - - PCORRES - - PCSTRESN + - PCORRES + - PCSTRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Published/CORE-000727/rule.yml b/Published/CORE-000727/rule.yml index 1821433f0..cd2cfb644 100644 --- a/Published/CORE-000727/rule.yml +++ b/Published/CORE-000727/rule.yml @@ -2,63 +2,66 @@ # Condition: IQCAT = NON-TOBACCO INGREDIENT # Rule: IGDCMPID in IN.IGDCMPID Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: IGDCMPID represents the unique ingredient name established in either the - Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, - every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN - Document: 'TIG 1.0' - Item: 'assumption 2' - Section: '2.8.8.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0014' - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + IGDCMPID represents the unique ingredient name established in either the + Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, + every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN + Document: "TIG 1.0" + Item: "assumption 2" + Section: "2.8.8.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0014" + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IQCAT - operator: equal_to - value: NON-TOBACCO INGREDIENT - value_is_literal: true - - name: IGDCMPID - operator: is_not_contained_by - value: $in_igdcmpid - within: SPTOBID + - name: IQCAT + operator: equal_to + value: NON-TOBACCO INGREDIENT + value_is_literal: true + - name: IGDCMPID + operator: is_not_contained_by + value: $in_igdcmpid + within: SPTOBID Core: Id: CORE-000727 Status: Published - Version: '1' -Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT = + Version: "1" +Description: + Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT = NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IN dataset. Executability: Fully Executable Operations: -- domain: IN - group: - - SPTOBID - id: $in_igdcmpid - name: IGDCMPID - operator: distinct + - domain: IN + group: + - SPTOBID + id: $in_igdcmpid + name: IGDCMPID + operator: distinct Outcome: - Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching + Message: + IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching IGDCMPID per SPTOBID in IN. Output Variables: - - SPTOBID - - IGDCMPID - - IQCAT - - $in_igdcmpid + - SPTOBID + - IGDCMPID + - IQCAT + - $in_igdcmpid Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IQ + - IQ Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000732/rule.yml b/Published/CORE-000732/rule.yml index 543890f53..e9410f132 100644 --- a/Published/CORE-000732/rule.yml +++ b/Published/CORE-000732/rule.yml @@ -2,154 +2,154 @@ # Condition: # Rule: --STRESC is not populated with a numeric value, but --STRESN is not empty Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3103' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3103" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRESC - operator: non_empty - - name: --STRESC - operator: not_matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --STRESN - operator: non_empty + - name: --STRESC + operator: non_empty + - name: --STRESC + operator: not_matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --STRESN + operator: non_empty Core: Id: CORE-000732 Status: Published - Version: '1' -Description: '--STRESC is not populated with a numeric value, but --STRESN is not empty.' + Version: "1" +Description: "--STRESC is not populated with a numeric value, but --STRESN is not empty." Executability: Fully Executable Outcome: - Message: '--STRESC is not numeric but --STRESN is not empty' + Message: "--STRESC is not numeric but --STRESN is not empty" Output Variables: - - --STRESC - - --STRESN + - --STRESC + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000736/rule.yml b/Published/CORE-000736/rule.yml index 045fd4dca..6b9410c2f 100644 --- a/Published/CORE-000736/rule.yml +++ b/Published/CORE-000736/rule.yml @@ -1,167 +1,168 @@ # Variable: TSPARMCD -# Condition: +# Condition: # Rule: Either 'AGE' or 'AGETXT' is in the list of TSPARAMCDs with TSVAL populated, not both. Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.4' - # SEND-IGs added Jozef - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1116' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: + "3.4" + # SEND-IGs added Jozef + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1116" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - any: - - name: TSPARMCD - operator: equal_to - value: AGE - - name: TSPARMCD - operator: equal_to - value: AGETXT - - name: $age_count - operator: greater_than_or_equal_to - value: 1 - - name: $agetxt_count - operator: greater_than_or_equal_to - value: 1 - - name: TSVAL - operator: non_empty + - any: + - name: TSPARMCD + operator: equal_to + value: AGE + - name: TSPARMCD + operator: equal_to + value: AGETXT + - name: $age_count + operator: greater_than_or_equal_to + value: 1 + - name: $agetxt_count + operator: greater_than_or_equal_to + value: 1 + - name: TSVAL + operator: non_empty Core: Id: CORE-000736 Status: Published - Version: '1' -Description: 'Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL populated, not both.' + Version: "1" +Description: "Either AGE or AGETXT is in the list of TSPARMCDs with TSVAL populated, not both." Executability: Fully Executable Operations: -- domain: TS - filter: - TSPARMCD: AGE - id: $age_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: AGETXT - id: $agetxt_count - name: TSPARMCD - operator: record_count + - domain: TS + filter: + TSPARMCD: AGE + id: $age_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: AGETXT + id: $agetxt_count + name: TSPARMCD + operator: record_count Outcome: - Message: 'AGE and AGETXT are in the list of TSPARAMCDs with TSVAL populated.' + Message: "AGE and AGETXT are in the list of TSPARAMCDs with TSVAL populated." Output Variables: - - TSPARMCD - - TSVAL - - $age_count - - $agetxt_count + - TSPARMCD + - TSVAL + - $age_count + - $agetxt_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000744/rule.yml b/Published/CORE-000744/rule.yml index cbea1fd92..792a4464b 100644 --- a/Published/CORE-000744/rule.yml +++ b/Published/CORE-000744/rule.yml @@ -2,102 +2,108 @@ # Condition: Related record present in parent domain dataset # Rule: FAOBJ in (--TERM, --TRT, --DECOD) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If an FA record does have a parent record, the value in FAOBJ should match - the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to - controlled terminology, in which case FAOBJ should match the value in --DECOD. - Document: IG v3.4 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM or --TRT, - unless the parent domain is dictionary coded or subject to controlled terminology, in - which case FAOBJ should then match the value in --DECOD. - Document: IG v3.3 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In general, the value in FAOBJ should match the value in --TERM or --TRT, - unless the parent domain is dictionary coded or subject to controlled terminology, in - which case FAOBJ should then match the value in --DECOD. - Document: IG v3.2 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0174 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: A record in FA may or may not have a parent record in an events or - interventions domain. If an FA record does have a parent record, the value in FAOBJ should - match the value in --TERM or --TRT, unless the parent domain is dictionary coded or - subject to controlled terminology. In such cases, the value represented in FAOBJ will - match the value represented in --DECOD. - Document: TIG 1.0 - Section: 2.8.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0403 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If an FA record does have a parent record, the value in FAOBJ should match + the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to + controlled terminology, in which case FAOBJ should match the value in --DECOD. + Document: IG v3.4 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In general, the value in FAOBJ should match the value in --TERM or --TRT, + unless the parent domain is dictionary coded or subject to controlled terminology, in + which case FAOBJ should then match the value in --DECOD. + Document: IG v3.3 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In general, the value in FAOBJ should match the value in --TERM or --TRT, + unless the parent domain is dictionary coded or subject to controlled terminology, in + which case FAOBJ should then match the value in --DECOD. + Document: IG v3.2 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0174 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A record in FA may or may not have a parent record in an events or + interventions domain. If an FA record does have a parent record, the value in FAOBJ should + match the value in --TERM or --TRT, unless the parent domain is dictionary coded or + subject to controlled terminology. In such cases, the value represented in FAOBJ will + match the value represented in --DECOD. + Document: TIG 1.0 + Section: 2.8.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0403 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: FAOBJ - operator: not_equal_to - value: RELREC.**TERM - - name: FAOBJ - operator: not_equal_to - value: RELREC.**TRT - - name: FAOBJ - operator: not_equal_to_case_insensitive - value: RELREC.**DECOD + - name: FAOBJ + operator: not_equal_to + value: RELREC.**TERM + - name: FAOBJ + operator: not_equal_to + value: RELREC.**TRT + - name: FAOBJ + operator: not_equal_to_case_insensitive + value: RELREC.**DECOD Core: Id: CORE-000744 Status: Published - Version: '1' -Description: Raise an error when a related record is present in the parent domain dataset but FAOBJ + Version: "1" +Description: + Raise an error when a related record is present in the parent domain dataset but FAOBJ is not equal to the --TERM, --TRT or --DECOD of the parent domain. Executability: Fully Executable Match Datasets: -- Name: RELREC + - Name: RELREC Outcome: - Message: Related record is present in the parent domain dataset but FAOBJ is not equal to the + Message: + Related record is present in the parent domain dataset but FAOBJ is not equal to the "TERM", "TRT" or "DECOD" of the parent domain. Output Variables: - - FAOBJ - - RELREC.**TERM - - RELREC.**TRT - - RELREC.**DECOD + - FAOBJ + - RELREC.**TERM + - RELREC.**TRT + - RELREC.**DECOD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - FA + - FA Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000749/rule.yml b/Published/CORE-000749/rule.yml index 2cb47fc4d..3a000aa09 100644 --- a/Published/CORE-000749/rule.yml +++ b/Published/CORE-000749/rule.yml @@ -1,128 +1,135 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.0 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: SENDIG v3.1.1 - Item: Domain Table Header - Section: 7.6.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND245 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter - value, Tabulation. - Document: TIG v1.0 - Item: Domain Table Header - Section: 2.8.9.32 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0166 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.0 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: SENDIG v3.1.1 + Item: Domain Table Header + Section: 7.6.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND245 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + ts.xpt, Trial Summary - Trial Design. One record per Trial Summary parameter + value, Tabulation. + Document: TIG v1.0 + Item: Domain Table Header + Section: 2.8.9.32 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0166 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: TSVAL - operator: is_not_unique_set - value: TSPARMCD + - name: TSVAL + operator: is_not_unique_set + value: TSPARMCD Core: Id: CORE-000749 Status: Published - Version: '1' + Version: "1" Description: TSVAL must be unique within each distinct value of TSPARMCD Executability: Fully Executable Outcome: Message: The value of TSVAL is not unique within the value for TSPARMCD Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000750/rule.yml b/Published/CORE-000750/rule.yml index 8ef2c6e6c..5caf10407 100644 --- a/Published/CORE-000750/rule.yml +++ b/Published/CORE-000750/rule.yml @@ -2,68 +2,71 @@ # Condition: Variable is not TS.TSSEQ # Rule: --SEQ is a unique number per USUBJID per domain, or a unique number per POOLID per domain, including when the domain is split into multiple files Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within a domain. - The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to - ensure uniqueness within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: "3.1.4 Identifiers for All Classes" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - POOLID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - POOLID Core: Id: "CORE-000750" Status: Published - Version: '1' -Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per - USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is + Version: "1" +Description: + Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per + USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is split into multiple files. Executability: Fully Executable Outcome: - Message: --SEQ is not a unique number per one of the following identifier variables, per domain; + Message: + --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID or POOLID. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - TS - - EM - - DU - - DO - - DI + - TS + - EM + - DU + - DO + - DI Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000751/rule.yml b/Published/CORE-000751/rule.yml index 23c2da7f6..0ee460567 100644 --- a/Published/CORE-000751/rule.yml +++ b/Published/CORE-000751/rule.yml @@ -1,77 +1,80 @@ Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within a domain. - The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to - ensure uniqueness within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: "3.1.4 Identifiers for All Classes" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: any: - - all: - - name: SPDEVID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPDEVID - - all: - - name: USUBJID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - USUBJID - - all: - - name: POOLID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - POOLID + - all: + - name: SPDEVID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPDEVID + - all: + - name: USUBJID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - USUBJID + - all: + - name: POOLID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - POOLID Core: Id: CORE-000751 Status: Published - Version: '1' -Description: Part B - Raise an error when --SEQ is not a unique number per one of the following + Version: "1" +Description: + Part B - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID. Executability: Fully Executable Outcome: - Message: --SEQ is not a unique number per one of the following identifier variables, per domain; + Message: + --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID. Output Variables: - - SPDEVID - - USUBJID - - POOLID + - SPDEVID + - USUBJID + - POOLID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - DU - - DI - - DO + - DU + - DI + - DO Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000752/rule.yml b/Published/CORE-000752/rule.yml index 0dc032417..5319c1a2b 100644 --- a/Published/CORE-000752/rule.yml +++ b/Published/CORE-000752/rule.yml @@ -1,51 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within a domain. - The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to - ensure uniqueness within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: "3.1.4 Identifiers for All Classes" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SPTOBID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPTOBID + - name: SPTOBID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPTOBID Core: Id: CORE-000752 Status: Published - Version: '1' -Description: Part C - Raise an error when --SEQ is not a unique number per one of the following + Version: "1" +Description: + Part C - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per SPTOBID per domain. Output Variables: - - SPTOBID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - EM + - EM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000753/rule.yml b/Published/CORE-000753/rule.yml index f4111bc67..490038516 100644 --- a/Published/CORE-000753/rule.yml +++ b/Published/CORE-000753/rule.yml @@ -1,51 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within a domain. - The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to - ensure uniqueness within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: "3.1.4 Identifiers for All Classes" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: SPTOBID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - SPTOBID + - name: SPTOBID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - SPTOBID Core: Id: CORE-000753 Status: Published - Version: '1' -Description: Part D - Raise an error when --SEQ is not a unique number per one of the following + Version: "1" +Description: + Part D - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per SPTOBID per domain. Output Variables: - - SPTOBID + - SPTOBID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - ES + - ES Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000754/rule.yml b/Published/CORE-000754/rule.yml index 161c97368..b15d09238 100644 --- a/Published/CORE-000754/rule.yml +++ b/Published/CORE-000754/rule.yml @@ -1,51 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: A number used to uniquely identify records for a subject within a domain. - The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to - ensure uniqueness within the dataset. - Document: SDTM v2.1 - Item: --SEQ - Section: '3.1.4 Identifiers for All Classes' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0310 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + A number used to uniquely identify records for a subject within a domain. + The Trial Summary domain does not contain subject data, and TSSEQ is a sequence number to + ensure uniqueness within the dataset. + Document: SDTM v2.1 + Item: --SEQ + Section: "3.1.4 Identifiers for All Classes" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0310 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: STOCONID - operator: non_empty - - name: --SEQ - operator: exists - - name: --SEQ - operator: is_not_unique_set - value: - - DOMAIN - - STOCONID + - name: STOCONID + operator: non_empty + - name: --SEQ + operator: exists + - name: --SEQ + operator: is_not_unique_set + value: + - DOMAIN + - STOCONID Core: Id: CORE-000754 Status: Published - Version: '1' -Description: Part E - Raise an error when --SEQ is not a unique number per one of the following + Version: "1" +Description: + Part E - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: Message: --SEQ is not a unique number per STOCONID per domain. Output Variables: - - STOCONID + - STOCONID Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - ES + - ES Use Case: PROD Sensitivity: Record diff --git a/Published/CORE-000755/rule.yml b/Published/CORE-000755/rule.yml index 89f25a16d..e627ca396 100644 --- a/Published/CORE-000755/rule.yml +++ b/Published/CORE-000755/rule.yml @@ -1,40 +1,42 @@ # Variable: GEN -# Condition: +# Condition: # Rule: STUDYID, DOMAIN, and --SEQ exist and at least one of USUBJID, APID, SPDEVID, or POOLID Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 - general observation classes. Each general class domain must also include at least one of - the following subject identifiers - SUBJID, SPDEVID, or POOLID. - Document: SDTM v2.1 - Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP - datasets, and will identify records as AP data. - Document: SDTM v2.1 - Section: Section 4.0 Associated Persons Data - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0642 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + STUDYID, DOMAIN, and --SEQ are required in all domains based on one of the 3 + general observation classes. Each general class domain must also include at least one of + the following subject identifiers - SUBJID, SPDEVID, or POOLID. + Document: SDTM v2.1 + Section: Section 3.1.4 Identifiers For All Classes + - Cited Guidance: + The Associated Persons Identifier (APID) will be required in all AP + datasets, and will identify records as AP data. + Document: SDTM v2.1 + Section: Section 4.0 Associated Persons Data + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0642 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: DOMAIN - operator: exists - - name: STUDYID - operator: exists - - name: SPTOBID - operator: not_exists + - name: DOMAIN + operator: exists + - name: STUDYID + operator: exists + - name: SPTOBID + operator: not_exists Core: Id: "CORE-000755" Status: Published - Version: '1' + Version: "1" Description: Raise an error when STUDYID and DOMAIN exist but SPTOBID does not exist. Executability: Fully Executable Outcome: @@ -43,11 +45,11 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - IN - - IQ - - IT + - IN + - IQ + - IT Use Case: PROD Sensitivity: Dataset diff --git a/Published/CORE-000756/rule.yml b/Published/CORE-000756/rule.yml index 824cefec4..559025028 100644 --- a/Published/CORE-000756/rule.yml +++ b/Published/CORE-000756/rule.yml @@ -1,146 +1,154 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.0 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: IG v3.1.1 - Section: 4.5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND91 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: Occasionally data that are intended to be numeric are collected with - characters attached that cause the character-to numeric conversion to fail. For example, - numeric cell counts in the source data may be specified with a greater than (>) or less - than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in - the --STRESN column since only numeric values can be represented in the --STRESN field. - Document: TIG v1.0 - Item: Text - Section: 2.8.7.1 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0281 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.0 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: IG v3.1.1 + Section: 4.5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND91 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Occasionally data that are intended to be numeric are collected with + characters attached that cause the character-to numeric conversion to fail. For example, + numeric cell counts in the source data may be specified with a greater than (>) or less + than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in + the --STRESN column since only numeric values can be represented in the --STRESN field. + Document: TIG v1.0 + Item: Text + Section: 2.8.7.1 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0281 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: --ORRES - operator: not_matches_regex - value: ^(?:[+-]?(\d+(\.\d+)?|\.\d+)|[a-zA-Z]+|[^\d\s\w]+)$ - - name: --STRESN - operator: non_empty + - name: --ORRES + operator: not_matches_regex + value: ^(?:[+-]?(\d+(\.\d+)?|\.\d+)|[a-zA-Z]+|[^\d\s\w]+)$ + - name: --STRESN + operator: non_empty Core: Id: CORE-000756 Status: Published - Version: '1' -Description: When --ORRES is representing numeric data with special characters like '<' and '>', , + Version: "1" +Description: + When --ORRES is representing numeric data with special characters like '<' and '>', , --STRESN may not be populated. Executability: Partially Executable # See JIRA Outcome: Message: --STRESN may not be populated as --ORRES does not represent a pure numeric value. Output Variables: - - --ORRES - - --STRESN + - --ORRES + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: NONCLIN Sensitivity: Record diff --git a/Published/CORE-000757/rule.yml b/Published/CORE-000757/rule.yml index 217534300..787cd0c41 100644 --- a/Published/CORE-000757/rule.yml +++ b/Published/CORE-000757/rule.yml @@ -1,69 +1,72 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and the name of - the event or intervention is collected in an "Other, specify" CRF field, the value in - --OBJ variable depends on whether the FA record has a parent record and whether the - "Other, specify" value was coded. - Document: IG v3.4 - Section: '4.2.7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0602 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and the name of - the event or intervention is collected in an "Other, specify" CRF field, the value in - --OBJ variable depends on whether the FA record has a parent record and whether the - "Other, specify" value was coded. - Document: TIG 1.0 - Section: 2.8.7.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0656 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: "4.2.7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0602 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: TIG 1.0 + Section: 2.8.7.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0656 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --DECOD - operator: empty - - name: RELREC.FAOBJ - operator: non_empty - - name: --TRT - operator: not_equal_to - value: RELREC.FAOBJ + - name: --DECOD + operator: empty + - name: RELREC.FAOBJ + operator: non_empty + - name: --TRT + operator: not_equal_to + value: RELREC.FAOBJ Core: Id: CORE-000757 Status: Published - Version: '1' -Description: When findings are collected about an intervention, and the interventions parent record + Version: "1" +Description: + When findings are collected about an intervention, and the interventions parent record exists and --DECOD = null, FAOBJ should be equal to --TRT. Executability: Fully Executable Match Datasets: -- Name: RELREC - Wildcard: FA + - Name: RELREC + Wildcard: FA Outcome: Message: Interventions parent record exists and --DECOD = null, but FAOBJ is not equal to --TRT. Output Variables: - - RELREC.FAOBJ - - --TRT - - --DECOD + - RELREC.FAOBJ + - --TRT + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000758/rule.yml b/Published/CORE-000758/rule.yml index 757352eed..34329c55c 100644 --- a/Published/CORE-000758/rule.yml +++ b/Published/CORE-000758/rule.yml @@ -2,123 +2,131 @@ # Condition: Milestone associated with RFSTDTC is start of treatment and ARMNRS ^=null and ARMNRS ^='UNPLANNED TREATMENT'. # Rule: RFSTDTC = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character format. - Usually equivalent to date/time when subject was first exposed to study treatment. See - Assumption 9 for additional detail on when RFSTDTC may be null. - Document: IG v3.3 - Item: Specification - Section: '5.2' - - Cited Guidance: ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should be populated - with a description of the unplanned treatment received. - Document: IG v3.3 - Item: Assumption 4.a.4 - Section: '5.2' - - Cited Guidance: As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to - calculate study day variables. RFSTDTC is usually defined as the date/time when a subject - was first exposed to study drug. This definition applies for most interventional studies, - when the start of treatment is the natural and preferred starting point for study day - variables and thus the logical value for RFSTDTC. In such studies, when data are submitted - for subjects who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN - FAILURE"), subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT - ASSIGNED"), or subjects who were randomized but not treated (e.g., ARMNRS = "NOT - TREATED"), RFSTDTC will be null. For studies with designs that include a substantial - portion of subjects who are not expected to be treated, a different protocol milestone may - be chosen as the starting point for study day variables. Some examples include - non-interventional or observational studies, studies with a no-treatment arm, or studies - where there is a delay between randomization and treatment. - Document: IG v3.3 - Item: Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0534 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Start Date/time for the subject in ISO 8601 character format. - Usually equivalent to date/time when subject was first exposed to study treatment. See - Assumption 9 for additional detail on when RFSTDTC may be null. - Document: IG v3.4 - Item: Specification - Section: '5.2' - - Cited Guidance: RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined - as the date/time when a subject was first exposed to study drug. This definition applies - for most interventional studies, when the start of treatment is the natural and preferred - starting point for study day variables and thus the logical value for RFSTDTC. In such - studies, when data are submitted for subjects who are ineligible for treatment (e.g., - screen failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not - assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but - not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs - that include a substantial portion of subjects who are not expected to be treated, a - different protocol milestone may be chosen as the starting point for study day variables. - Some examples include non-interventional or observational studies, studies with a - no-treatment Arm, or studies where there is a delay between randomization and treatment. - Document: IG v3.4 - Item: Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0534 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: RFSTDTC Reference start date/time for the subject in ISO 8601 character - format. Usually equivalent to date/time when subject was first exposed to study product - Document: TIG 1.0 - Item: Specification - Section: 2.8.10.4 - - Cited Guidance: RFSTDTC is used to calculate study day variables - Document: TIG 1.0 - Item: Assumption 9 - Section: 2.8.10.4 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0627 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference Start Date/time for the subject in ISO 8601 character format. + Usually equivalent to date/time when subject was first exposed to study treatment. See + Assumption 9 for additional detail on when RFSTDTC may be null. + Document: IG v3.3 + Item: Specification + Section: "5.2" + - Cited Guidance: + ARMNRS is populated with "UNPLANNED TREATMENT", ACTARMUD should be populated + with a description of the unplanned treatment received. + Document: IG v3.3 + Item: Assumption 4.a.4 + Section: "5.2" + - Cited Guidance: + As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to + calculate study day variables. RFSTDTC is usually defined as the date/time when a subject + was first exposed to study drug. This definition applies for most interventional studies, + when the start of treatment is the natural and preferred starting point for study day + variables and thus the logical value for RFSTDTC. In such studies, when data are submitted + for subjects who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN + FAILURE"), subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT + ASSIGNED"), or subjects who were randomized but not treated (e.g., ARMNRS = "NOT + TREATED"), RFSTDTC will be null. For studies with designs that include a substantial + portion of subjects who are not expected to be treated, a different protocol milestone may + be chosen as the starting point for study day variables. Some examples include + non-interventional or observational studies, studies with a no-treatment arm, or studies + where there is a delay between randomization and treatment. + Document: IG v3.3 + Item: Assumption 9 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0534 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference Start Date/time for the subject in ISO 8601 character format. + Usually equivalent to date/time when subject was first exposed to study treatment. See + Assumption 9 for additional detail on when RFSTDTC may be null. + Document: IG v3.4 + Item: Specification + Section: "5.2" + - Cited Guidance: + RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined + as the date/time when a subject was first exposed to study drug. This definition applies + for most interventional studies, when the start of treatment is the natural and preferred + starting point for study day variables and thus the logical value for RFSTDTC. In such + studies, when data are submitted for subjects who are ineligible for treatment (e.g., + screen failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not + assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but + not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs + that include a substantial portion of subjects who are not expected to be treated, a + different protocol milestone may be chosen as the starting point for study day variables. + Some examples include non-interventional or observational studies, studies with a + no-treatment Arm, or studies where there is a delay between randomization and treatment. + Document: IG v3.4 + Item: Assumption 9 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0534 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + RFSTDTC Reference start date/time for the subject in ISO 8601 character + format. Usually equivalent to date/time when subject was first exposed to study product + Document: TIG 1.0 + Item: Specification + Section: 2.8.10.4 + - Cited Guidance: RFSTDTC is used to calculate study day variables + Document: TIG 1.0 + Item: Assumption 9 + Section: 2.8.10.4 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0627 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: ARMNRS - operator: non_empty - - name: ARMNRS - operator: not_equal_to - value: 'UNPLANNED TREATMENT' - value_is_literal: true - - name: RFSTDTC - operator: non_empty + - name: ARMNRS + operator: non_empty + - name: ARMNRS + operator: not_equal_to + value: "UNPLANNED TREATMENT" + value_is_literal: true + - name: RFSTDTC + operator: non_empty Core: - Id: 'CORE-000758' + Id: "CORE-000758" Status: Published - Version: '1' -Description: 'Raise an error when milestone associated with RFSTDTC is start of treatment and ARMNRS is - not null and different from ''UNPLANNED TREATMENT'', but RFSTDTC is not null.' + Version: "1" +Description: + "Raise an error when milestone associated with RFSTDTC is start of treatment and ARMNRS is + not null and different from 'UNPLANNED TREATMENT', but RFSTDTC is not null." Executability: Partially Executable Outcome: - Message: 'Milestone associated with RFSTDTC is start of treatment and ARMNRS is not null and different - from ''UNPLANNED TREATMENT'', but RFSTDTC is not empty.' + Message: + "Milestone associated with RFSTDTC is start of treatment and ARMNRS is not null and different + from 'UNPLANNED TREATMENT', but RFSTDTC is not empty." Output Variables: - - ARMNRS - - RFSTDTC + - ARMNRS + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000760/rule.yml b/Published/CORE-000760/rule.yml index d8d28ec90..69be4d4b7 100644 --- a/Published/CORE-000760/rule.yml +++ b/Published/CORE-000760/rule.yml @@ -2,59 +2,60 @@ # Condition: DM.RFCSTDTC ^= Null and DM.RFCENDTC ^= Null # Rule: DM.RFCSTDTC <= DM.RFCENDTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3413 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3413 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3413 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3413 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: RFCSTDTC - operator: non_empty - - name: RFCENDTC - operator: non_empty - - name: RFCSTDTC - operator: date_greater_than - value: RFCENDTC + - name: RFCSTDTC + operator: non_empty + - name: RFCENDTC + operator: non_empty + - name: RFCSTDTC + operator: date_greater_than + value: RFCENDTC Core: Id: CORE-000760 Status: Published - Version: '1' -Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the + Version: "1" +Description: + Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the Date/Time of Last Challenge Agent Admin (RFCENDTC). Executability: Fully Executable Outcome: Message: RFCSTDTC falls after RFCENDTC. Output Variables: - - RFCSTDTC - - RFCENDTC + - RFCSTDTC + - RFCENDTC Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000762/rule.yml b/Published/CORE-000762/rule.yml index ee7aa8eeb..ce29b0869 100644 --- a/Published/CORE-000762/rule.yml +++ b/Published/CORE-000762/rule.yml @@ -1,102 +1,109 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.2" - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: "Variables intended only for human studies should not be included in nonclinical - data." - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5141 - Version: "1" - Version: "1.5" - Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5141 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: "--HLGTCD" - operator: exists + - name: "--HLGTCD" + operator: exists Core: Id: "CORE-000762" Status: Published @@ -109,8 +116,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000763/rule.yml b/Published/CORE-000763/rule.yml index 9a7844959..5944c8fce 100644 --- a/Published/CORE-000763/rule.yml +++ b/Published/CORE-000763/rule.yml @@ -1,113 +1,118 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not - a valid value in this case because it would represent an event after the date of collection." - Document: IG v3.4 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection." - Document: IG v3.2 - Section: 4.1.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "If the reference time point corresponds to the date of collection or assessment: - Start values: an observation can start BEFORE that time point, can start COINCIDENT with that - time point, or it is unknown (U) when it started. End values: an observation can end BEFORE - that time point, can end COINCIDENT with that time point, can be known that it didn't end but - was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a - valid value in this case because it would represent an event after the date of collection." - Document: IG v3.3 - Section: 4.4.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0232 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If the reference time point corresponds to the date of collection or - assessment; Start values; an observation can start BEFORE that time point, can start - COINCIDENT with that time point, or it is unknown (U) when it started. End values; an - observation can end BEFORE that time point, can end COINCIDENT with that time point, can - be known that it didn't end but was ONGOING, or it is unknown (U) at all when it ended or - if it was ongoing. AFTER is not a valid value in this case because it would represent an - event after the date of collection. - Document: TIG 1.0 - Item: Num 1 - Section: 2.8.7.6 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0441 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not + a valid value in this case because it would represent an event after the date of collection." + Document: IG v3.4 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.2 + Section: 4.1.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If the reference time point corresponds to the date of collection or assessment: + Start values: an observation can start BEFORE that time point, can start COINCIDENT with that + time point, or it is unknown (U) when it started. End values: an observation can end BEFORE + that time point, can end COINCIDENT with that time point, can be known that it didn't end but + was ONGOING, or it is unknown (U) at all when it ended or if it was ongoing. AFTER is not a + valid value in this case because it would represent an event after the date of collection." + Document: IG v3.3 + Section: 4.4.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0232 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If the reference time point corresponds to the date of collection or + assessment; Start values; an observation can start BEFORE that time point, can start + COINCIDENT with that time point, or it is unknown (U) when it started. End values; an + observation can end BEFORE that time point, can end COINCIDENT with that time point, can + be known that it didn't end but was ONGOING, or it is unknown (U) at all when it ended or + if it was ongoing. AFTER is not a valid value in this case because it would represent an + event after the date of collection. + Document: TIG 1.0 + Item: Num 1 + Section: 2.8.7.6 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0441 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" # Variable: --STRTPT # Condition: --STTPT corresponds to the date of collection or assessment. # Rule: --STRTPT in ('BEFORE', 'COINCIDENT', 'UNKNOWN') Check: all: - - name: --STTPT - operator: non_empty - - name: --STTPT - operator: is_complete_date - - name: --DTC - operator: exists - - name: --STTPT - operator: date_equal_to - value: --DTC - - name: --STRTPT - operator: is_not_contained_by - value: - - BEFORE - - COINCIDENT - - UNKNOWN + - name: --STTPT + operator: non_empty + - name: --STTPT + operator: is_complete_date + - name: --DTC + operator: exists + - name: --STTPT + operator: date_equal_to + value: --DTC + - name: --STRTPT + operator: is_not_contained_by + value: + - BEFORE + - COINCIDENT + - UNKNOWN Core: Id: CORE-000763 Status: Published - Version: '1' + Version: "1" Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN') Executability: Partially Executable Outcome: - Message: --STTPT is equal to the date of collection or assessment but --STRTPT is not in + Message: + --STTPT is equal to the date of collection or assessment but --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN'). Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000764/rule.yml b/Published/CORE-000764/rule.yml index 4db492f76..70e74391b 100644 --- a/Published/CORE-000764/rule.yml +++ b/Published/CORE-000764/rule.yml @@ -1,68 +1,71 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single - product|2.b.iii If a study has multiple products, then DSSCAT should name the individual - product. - Document: TIG v1.0 - Item: 2.b.ii - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0632 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single + product|2.b.iii If a study has multiple products, then DSSCAT should name the individual + product. + Document: TIG v1.0 + Item: 2.b.ii + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0632 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: $disposition_event_count - operator: greater_than - value: 1 - - name: DSSCAT - operator: equal_to - value: PRODUCT EXPOSURE - value_is_literal: true - - name: DSSCAT - operator: is_not_unique_set - value: - - USUBJID - - EPOCH + - name: $disposition_event_count + operator: greater_than + value: 1 + - name: DSSCAT + operator: equal_to + value: PRODUCT EXPOSURE + value_is_literal: true + - name: DSSCAT + operator: is_not_unique_set + value: + - USUBJID + - EPOCH Core: Id: CORE-000764 Status: Published - Version: '1' -Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION + Version: "1" +Description: + Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = PRODUCT EXPOSURE' Executability: Fully Executable Operations: -- domain: DS - filter: - DSCAT: DISPOSITION EVENT - group: - - USUBJID - - EPOCH - id: $disposition_event_count - name: DSCAT - operator: record_count + - domain: DS + filter: + DSCAT: DISPOSITION EVENT + group: + - USUBJID + - EPOCH + id: $disposition_event_count + name: DSCAT + operator: record_count Outcome: - Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + Message: + More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'PRODUCT EXPOSURE'. Output Variables: - - USUBJID - - DSCAT - - DSSCAT - - EPOCH + - USUBJID + - DSCAT + - DSSCAT + - EPOCH Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000765/rule.yml b/Published/CORE-000765/rule.yml index c951cf9e6..42aced21e 100644 --- a/Published/CORE-000765/rule.yml +++ b/Published/CORE-000765/rule.yml @@ -1,164 +1,174 @@ # Variable: dataset_size -# Condition: +# Condition: # Rule: dataset_size is not greater than 5GB Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Large datasets should be split into smaller datasets no larger than 5 GB in - size. - Document: FDA - Section: FDAB024 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2401 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Large datasets should be split into smaller datasets no larger than 5 GB in + size. + Document: FDA + Section: FDAB024 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2401 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: $dataset_size - operator: greater_than - value: 5368709120 + - name: $dataset_size + operator: greater_than + value: 5368709120 Core: Id: CORE-000765 Status: Published - Version: '1' + Version: "1" Description: The submitted dataset is larger than 5 GB Executability: Fully Executable Operations: -- id: $dataset_size - name: dataset_size - operator: extract_metadata + - id: $dataset_size + name: dataset_size + operator: extract_metadata Outcome: Message: The submitted dataset is larger than 5 GB Output Variables: - - $dataset_size + - $dataset_size Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000768/rule.yml b/Published/CORE-000768/rule.yml index e8279dd11..f36cd76b2 100644 --- a/Published/CORE-000768/rule.yml +++ b/Published/CORE-000768/rule.yml @@ -1,122 +1,123 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Every Trial Set should have only one ARMCD. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND235 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Every Trial Set should have only one ARMCD. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND235 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # There may be only 1 record for TXPARMCD=ARMCD per group of SETCD values # REMARK: 2025-03-13: works, but currently only the first violation is reported, the following ones are not - - name: $armcd_count - operator: not_equal_to - value: 1 + - name: $armcd_count + operator: not_equal_to + value: 1 Core: Id: CORE-000768 Status: Published - Version: '1' + Version: "1" Description: Every Trial Set should have only one ARMCD. Executability: Fully Executable Operations: -- domain: TX - # only keep the records with TXPARMCD=ARMCD - filter: - TXPARMCD: ARMCD - # group the records by value of TXSETCD - group: - - SETCD - # within the filtered and grouped records, count the number of TXVAL records - id: $armcd_count - name: TXVAL - operator: record_count + - domain: + TX + # only keep the records with TXPARMCD=ARMCD + filter: + TXPARMCD: ARMCD + # group the records by value of TXSETCD + group: + - SETCD + # within the filtered and grouped records, count the number of TXVAL records + id: $armcd_count + name: TXVAL + operator: record_count Outcome: Message: There may be only 1 record for TXPARMCD=ARMCD per group of SETCD values Output Variables: - - SETCD - - $armcd_count + - SETCD + - $armcd_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When Sensitivity is set to Dataset, only the first set that violates the rule is reported # When Sensitivity is set to Record, a violation is reported for EACH record in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000769/rule.yml b/Published/CORE-000769/rule.yml index 25b118246..efabda69c 100644 --- a/Published/CORE-000769/rule.yml +++ b/Published/CORE-000769/rule.yml @@ -1,91 +1,91 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'If an age range is supplied, it should be in number-number format.' - Document: 'FDA' - Section: 'FDAB053' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB5302' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "If an age range is supplied, it should be in number-number format." + Document: "FDA" + Section: "FDAB053" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB5302" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TSPARMCD - operator: equal_to - value: 'AGETXT' - - name: TSVAL - operator: not_matches_regex - value: ^[0-9]+-[0-9]+$ + - name: TSPARMCD + operator: equal_to + value: "AGETXT" + - name: TSVAL + operator: not_matches_regex + value: ^[0-9]+-[0-9]+$ Core: Id: CORE-000769 Status: Published - Version: '1' -Description: 'The value of TSVAL for TSPARMCD=AGETXT must be in number-number format' + Version: "1" +Description: "The value of TSVAL for TSPARMCD=AGETXT must be in number-number format" Executability: Fully Executable Outcome: Message: TSVAL value when TSPARMCD = AGETXT is not in number - number format. @@ -93,8 +93,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Published/CORE-000770/rule.yml b/Published/CORE-000770/rule.yml index 7f7dad5c6..39d78bfc9 100644 --- a/Published/CORE-000770/rule.yml +++ b/Published/CORE-000770/rule.yml @@ -1,211 +1,218 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD value assigned in TXPARMCD. - Document: IG v3.0 - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND234 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: TIG - References: - - Citations: - - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding - parameter value under TXVAL. - Document: TIG v1.0 - Item: Assumption 3 - Section: 2.8.9.28 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0162 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' - # FDA rule FB4602 added (SEND-only) -- Organization: FDA - Standards: + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Each Trial Set should have a SPGRPCD value assigned in TXPARMCD. + Document: IG v3.0 + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND234 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + parameter value under TXVAL. + Document: TIG v1.0 + Item: Assumption 3 + Section: 2.8.9.28 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0162 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" + # FDA rule FB4602 added (SEND-only) + - Organization: FDA + Standards: # Applicable to SENDIG as of version 3.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: FDA - Section: FDAB046 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4602 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: FDA + Section: FDAB046 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4602 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: # 2025-03-13: REMARK that only the first violation is reported when Sensitivity is set to "Dataset" # See Github issue https://github.com/cdisc-org/cdisc-rules-engine/issues/831 - - name: '$txgroupsbysetcd' - operator: 'does_not_contain' - value: 'SPGRPCD' - # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule + - name: "$txgroupsbysetcd" + operator: "does_not_contain" + value: "SPGRPCD" + # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule Core: Id: CORE-000770 Status: Published - Version: '1' -Description: 'For each Trial Set (SETCD) in the TX dataset exactly one Sponsor-Defined Group Code (SPGRPCD) - record should be included.' + Version: "1" +Description: + "For each Trial Set (SETCD) in the TX dataset exactly one Sponsor-Defined Group Code (SPGRPCD) + record should be included." Executability: Fully Executable Operations: -- domain: TX - group: - - SETCD - id: $txgroupsbysetcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txgroupsbysetcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'SPGRPCD' record per SETCD. Output Variables: - - SETCD - - TXPARMCD - - $txgroupsbysetcd + - SETCD + - TXPARMCD + - $txgroupsbysetcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Use Case: NONCLIN # CAVEAT: When Sensitivity set to "Dataset" only the an issue is reported for the FIRST "set" for which the rule is violate # When Sensitivity is set to "Record", an issue is reported for EACH record in the set that violates the rule diff --git a/Published/CORE-000771/rule.yml b/Published/CORE-000771/rule.yml index e9b8bfa29..d11b43baf 100644 --- a/Published/CORE-000771/rule.yml +++ b/Published/CORE-000771/rule.yml @@ -1,122 +1,123 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.0 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per finding per observation time per subject or pool - Document: SENDIG v3.1 - Section: 6.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND156 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.0 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per finding per observation time per subject or pool + Document: SENDIG v3.1 + Section: 6.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND156 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: - - all: - - name: CLDTC - operator: non_empty - - name: USUBJID - operator: non_empty - - name: CLORRES - operator: is_not_unique_set - value: - - USUBJID - - CLDTC - - all: - - name: CLDTC - operator: non_empty - - name: POOLID - operator: non_empty - - name: CLORRES - operator: is_not_unique_set - value: - - POOLID - - CLDTC + - all: + - name: CLDTC + operator: non_empty + - name: USUBJID + operator: non_empty + - name: CLORRES + operator: is_not_unique_set + value: + - USUBJID + - CLDTC + - all: + - name: CLDTC + operator: non_empty + - name: POOLID + operator: non_empty + - name: CLORRES + operator: is_not_unique_set + value: + - POOLID + - CLDTC Core: Id: CORE-000771 Status: Published - Version: '1' -Description: Raise an error when there is more than one record present for any particular Result or + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Result or Findings as Collected, in the CL Domain, for a subject or pool on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where CLDTC is null Outcome: Message: The Clinical Observation test result is not unique for this subject and date/time. Output Variables: - - USUBJID - - POOLID - - CLTESTCD - - CLORRES - - CLDTC + - USUBJID + - POOLID + - CLTESTCD + - CLORRES + - CLDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL + - CL Sensitivity: Record diff --git a/Published/CORE-000772/rule.yml b/Published/CORE-000772/rule.yml index 69c4d7062..630cca3ad 100644 --- a/Published/CORE-000772/rule.yml +++ b/Published/CORE-000772/rule.yml @@ -1,124 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ARMCD parameter should be used to associate each Trial Set with a Trial - Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD - parameter, but more than one Trial Set may have the same value of the ARMCD parameter. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND236.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ARMCD parameter should be used to associate each Trial Set with a Trial + Arm as defined in the Trial Arms table. Each Trial Set should only have one ARMCD + parameter, but more than one Trial Set may have the same value of the ARMCD parameter. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND236.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: TXPARMCD - operator: equal_to - value: ARMCD - value_is_literal: true - - name: TXVAL - operator: is_not_contained_by - value: $ta_armcd + - name: TXPARMCD + operator: equal_to + value: ARMCD + value_is_literal: true + - name: TXVAL + operator: is_not_contained_by + value: $ta_armcd Core: Id: CORE-000772 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: - Message: 'The value of TXVAL for TXPARMCD=ARMCD cannot be found in the TA dataset' + Message: "The value of TXVAL for TXPARMCD=ARMCD cannot be found in the TA dataset" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000773/rule.yml b/Published/CORE-000773/rule.yml index 9e2314b1c..f72de3acd 100644 --- a/Published/CORE-000773/rule.yml +++ b/Published/CORE-000773/rule.yml @@ -1,105 +1,110 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of - subject disposition in ISO 8601 format - Document: IG v3.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of - subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of - subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of - subject disposition in ISO 8601 format - Document: IG v3.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For a specimen collected or observed post mortem, this is the date/time of - subject disposition in ISO 8601 format - Document: IG v3.1.1 - Section: 6.3.7 | 6.3.8 | 6.3.14 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND320' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND320" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND320" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND320" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND320" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For a specimen collected or observed post mortem, this is the date/time of + subject disposition in ISO 8601 format + Document: IG v3.1.1 + Section: 6.3.7 | 6.3.8 | 6.3.14 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND320" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: date_greater_than - value: $dsstdtc + - name: --DTC + operator: non_empty + - name: --DTC + operator: date_greater_than + value: $dsstdtc Core: Id: CORE-000773 Status: Published - Version: '1' + Version: "1" Description: --DTC may not be later than DS.DSSTDTC Executability: Fully Executable Operations: # Though there should be only one record per subject in DS -- domain: DS - group: - - USUBJID - id: $dsstdtc - name: DSSTDTC - operator: max_date + - domain: DS + group: + - USUBJID + id: $dsstdtc + name: DSSTDTC + operator: max_date Outcome: Message: --DTC may not be later than DS.DSSTDTC (date/time of death) Output Variables: - - --DTC - - $dsstdtc + - --DTC + - $dsstdtc Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI - - MA - - TF + - MI + - MA + - TF Sensitivity: Record diff --git a/Published/CORE-000774/rule.yml b/Published/CORE-000774/rule.yml index 9120c122b..5416d23af 100644 --- a/Published/CORE-000774/rule.yml +++ b/Published/CORE-000774/rule.yml @@ -1,167 +1,178 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: When a test is not done, the result variable should not be populated, and - the reason not done should be provided in the appropriate variable. - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4202 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + When a test is not done, the result variable should not be populated, and + the reason not done should be provided in the appropriate variable. + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4202 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STAT - operator: equal_to - value: NOT DONE - value_is_literal: true - - any: - - name: --REASND - operator: empty - - name: --REASND - operator: not_exists + - name: --STAT + operator: equal_to + value: NOT DONE + value_is_literal: true + - any: + - name: --REASND + operator: empty + - name: --REASND + operator: not_exists Core: Id: CORE-000774 Status: Published - Version: '1' -Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be + Version: "1" +Description: + When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be populated. Executability: Partially Executable - Possible Overreporting Outcome: Message: --STAT = NOT DONE, but --REASND is missing. Output Variables: - - --TESTCD - - --STAT - - --REASND + - --TESTCD + - --STAT + - --REASND Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - FINDINGS ABOUT + - FINDINGS + - FINDINGS ABOUT Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000775/rule.yml b/Published/CORE-000775/rule.yml index fc3007ab0..11e02abf9 100644 --- a/Published/CORE-000775/rule.yml +++ b/Published/CORE-000775/rule.yml @@ -1,143 +1,150 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "TRTDOSU: For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' - to match the associated TRTDOS value." - Document: IG v3.0 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match - the associated TRTDOS value." - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match - the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match - the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match - the associated TRTDOS value." - Document: IG v3.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match - the associated TRTDOS value." - Document: IG v3.1.1 - Item: Specification - Section: 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND241.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "TRTDOSU: For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' + to match the associated TRTDOS value." + Document: IG v3.0 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "For more complex dosing regimens, sponsor should enter 'SEE PROTOCOL' to match + the associated TRTDOS value." + Document: IG v3.1.1 + Item: Specification + Section: 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND241.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: - # With thanks to Richard Marshall 2025-03-16 + # With thanks to Richard Marshall 2025-03-16 all: - - name: TXPARMCD - operator: is_contained_by - value: - - TRTDOS - - TRTDOSU - - name: $num_trtdos_see_protocol - operator: equal_to - value: 1 - - name: $num_trtdosu_see_protocol - operator: not_equal_to - value: 1 + - name: TXPARMCD + operator: is_contained_by + value: + - TRTDOS + - TRTDOSU + - name: $num_trtdos_see_protocol + operator: equal_to + value: 1 + - name: $num_trtdosu_see_protocol + operator: not_equal_to + value: 1 Core: Id: CORE-000775 Status: Published - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable # Group by value of SETCD Operations: - # With thanks to Richard Marshall 2025-03-16 + # With thanks to Richard Marshall 2025-03-16 # counts the records with TRTDOS='SEE PROTOCOL' within the group -- filter: - TXPARMCD: TRTDOS - TXVAL: 'SEE PROTOCOL' - group: - - SETCD - id: $num_trtdos_see_protocol - operator: record_count - # counts the records with TRTDOSU='SEE PROTOCOL' within the group -- filter: - TXPARMCD: TRTDOSU - TXVAL: 'SEE PROTOCOL' - group: - - SETCD - id: $num_trtdosu_see_protocol - operator: record_count + - filter: + TXPARMCD: TRTDOS + TXVAL: "SEE PROTOCOL" + group: + - SETCD + id: $num_trtdos_see_protocol + operator: record_count + # counts the records with TRTDOSU='SEE PROTOCOL' within the group + - filter: + TXPARMCD: TRTDOSU + TXVAL: "SEE PROTOCOL" + group: + - SETCD + id: $num_trtdosu_see_protocol + operator: record_count Outcome: - Message: "Within a single set, when TXPARMCD='TRTDOS' with the value for TXVAL='SEE PROTOCOL', then + Message: + "Within a single set, when TXPARMCD='TRTDOS' with the value for TXVAL='SEE PROTOCOL', then for the record with TXPARMCD=TRTDOSU in the same set, the value for TXVAL must also be 'SEE PROTOCOL'" Output Variables: - - STUDYID - - $num_trtdos_see_protocol - - $num_trtdosu_see_protocol + - STUDYID + - $num_trtdos_see_protocol + - $num_trtdosu_see_protocol Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # Keeping Sensitivity to "Record" as otherwise only the first violation is reported Sensitivity: Record diff --git a/Published/CORE-000776/rule.yml b/Published/CORE-000776/rule.yml index d14bfb474..dd952ad00 100644 --- a/Published/CORE-000776/rule.yml +++ b/Published/CORE-000776/rule.yml @@ -1,162 +1,174 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3203 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3203 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --ENDY - operator: not_exists - - name: --ENDTC - operator: exists + - name: --ENDY + operator: not_exists + - name: --ENDTC + operator: exists Core: Id: CORE-000776 Status: Published - Version: '1' -Description: When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study + Version: "1" +Description: + When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study Day of End of Observation (--ENDY) should also be present in the dataset Executability: Fully Executable Outcome: - Message: Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of + Message: + Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of Observation (--ENDTC) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000780/rule.yml b/Published/CORE-000780/rule.yml index 61163a7ed..dfb415011 100644 --- a/Published/CORE-000780/rule.yml +++ b/Published/CORE-000780/rule.yml @@ -1,96 +1,102 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.0' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn.' - Document: 'IG v.3.1.1' - Item: 'Specification' - Section: '5.2.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND119' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.0" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.1" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.1.1" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.1.1" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.1" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn." + Document: "IG v.3.1.1" + Item: "Specification" + Section: "5.2.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND119" + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: #- all: @@ -100,23 +106,23 @@ Check: # operator: non_empty # - name: COVAL # operator: empty - - all: - - name: --VAL - operator: inconsistent_enumerated_columns + - all: + - name: --VAL + operator: inconsistent_enumerated_columns Core: Id: CORE-000780 Status: Published - Version: '1' -Description: 'Correct order of population in COVALn variables check' + Version: "1" +Description: "Correct order of population in COVALn variables check" Executability: Partially Executable - Possible Underreporting Outcome: - Message: 'Correct order of population in COVAL variables must be COVAL, COVAL1, COVAL2 ...' + Message: "Correct order of population in COVAL variables must be COVAL, COVAL1, COVAL2 ..." Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Published/CORE-000781/rule.yml b/Published/CORE-000781/rule.yml index 0ecdb3491..ce18a896a 100644 --- a/Published/CORE-000781/rule.yml +++ b/Published/CORE-000781/rule.yml @@ -2,107 +2,113 @@ # Condition: TXPARMCD = SPECIES # Rule: One Trail Set cannot contain more than one species Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND307' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND307" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND307" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND307" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND307" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND307" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: $species_count - operator: greater_than - value: 1 + - name: $species_count + operator: greater_than + value: 1 Core: Id: CORE-000781 Status: Published - Version: '1' -Description: 'Trial Sets (TX) can have multiple species and/or strains if they are different by set.' + Version: "1" +Description: "Trial Sets (TX) can have multiple species and/or strains if they are different by set." Executability: Fully Executable Operations: -- domain: TX - # only keep the records with TXPARMCD=SPECIES - filter: - TXPARMCD: SPECIES - # group the records by value of TXSETCD - group: - - SETCD - # within the filtered and grouped records, count the number of records - id: $species_count - operator: record_count + - domain: + TX + # only keep the records with TXPARMCD=SPECIES + filter: + TXPARMCD: SPECIES + # group the records by value of TXSETCD + group: + - SETCD + # within the filtered and grouped records, count the number of records + id: $species_count + operator: record_count Outcome: - Message: 'One Trial Set cannot contain more than one species for the same SETCD.' + Message: "One Trial Set cannot contain more than one species for the same SETCD." Output Variables: - - SETCD - - $species_count - - TXPARMCD + - SETCD + - $species_count + - TXPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000782/rule.yml b/Published/CORE-000782/rule.yml index 40e76d479..55bdbe5ba 100644 --- a/Published/CORE-000782/rule.yml +++ b/Published/CORE-000782/rule.yml @@ -2,107 +2,113 @@ # Condition: TXPARMCD = STRAIN # Rule: One Trail Set cannot contain more than one strain Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND308' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND308" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND308" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND308" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND308" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND308" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: $strain_count - operator: greater_than - value: 1 + - name: $strain_count + operator: greater_than + value: 1 Core: Id: CORE-000782 Status: Published - Version: '1' -Description: 'Trial Sets (TX) can have multiple species and/or strains if they are different by set.' + Version: "1" +Description: "Trial Sets (TX) can have multiple species and/or strains if they are different by set." Executability: Fully Executable Operations: -- domain: TX - # only keep the records with TXPARMCD=STRAIN - filter: - TXPARMCD: STRAIN - # group the records by value of TXSETCD - group: - - SETCD - # within the filtered and grouped records, count the number of records - id: $strain_count - operator: record_count + - domain: + TX + # only keep the records with TXPARMCD=STRAIN + filter: + TXPARMCD: STRAIN + # group the records by value of TXSETCD + group: + - SETCD + # within the filtered and grouped records, count the number of records + id: $strain_count + operator: record_count Outcome: - Message: 'One Trial Set cannot contain more than one strain.' + Message: "One Trial Set cannot contain more than one strain." Output Variables: - - SETCD - - $strain_count - - TXPARMCD + - SETCD + - $strain_count + - TXPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Published/CORE-000783/rule.yml b/Published/CORE-000783/rule.yml index a2ec34c2a..4ea3e9b01 100644 --- a/Published/CORE-000783/rule.yml +++ b/Published/CORE-000783/rule.yml @@ -1,166 +1,178 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM variables using - the Supplemental Qualifiers special-purpose dataset structure - Document: IG v3.4 - Item: NA - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The SDTM allows for the inclusion of the sponsors non-SDTM variables using the - Supplemental Qualifiers special-purpose dataset structure, described in Section 8; 8.4, Relating - Non-Standard Variables Values To A Parent Domain.' - Document: IG v3.2 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The SDTM allows for the inclusion of a sponsor's non-SDTM variables using - the Supplemental Qualifiers special purpose dataset structure, described in Section 8.4, - Relating Non-Standard Variables Values to a Parent Domain. - Document: IG v3.3 - Section: '2.5' - - Cited Guidance: New sponsor-defined variables must not be added, and existing variables must - not be renamed or modified for novel usage. - Document: Model v1.7 - Section: '2.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0314 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.0 - Item: QNAM CDISC Notes - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value in QNAM may not be the same as any variable name defined in - another domain or the SDTM. - Document: SENDIG v3.1.1 - Item: QNAM CDISC Notes - Section: '8.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND274.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The SDTM allows for the inclusion of a sponsor's non-SDTM variables using + the Supplemental Qualifiers special-purpose dataset structure + Document: IG v3.4 + Item: NA + Section: "2.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The SDTM allows for the inclusion of the sponsors non-SDTM variables using the + Supplemental Qualifiers special-purpose dataset structure, described in Section 8; 8.4, Relating + Non-Standard Variables Values To A Parent Domain." + Document: IG v3.2 + Section: "2.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The SDTM allows for the inclusion of a sponsor's non-SDTM variables using + the Supplemental Qualifiers special purpose dataset structure, described in Section 8.4, + Relating Non-Standard Variables Values to a Parent Domain. + Document: IG v3.3 + Section: "2.5" + - Cited Guidance: + New sponsor-defined variables must not be added, and existing variables must + not be renamed or modified for novel usage. + Document: Model v1.7 + Section: "2.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0314 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.0 + Item: QNAM CDISC Notes + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1 + Item: QNAM CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1 + Item: QNAM CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The value in QNAM may not be the same as any variable name defined in + another domain or the SDTM. + Document: SENDIG v3.1.1 + Item: QNAM CDISC Notes + Section: "8.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND274.1 + Version: "1" + Version: "5.0" + Version: "1.2" # Variable: QNAM # Condition: SUPP--.QNAM present in dataset # Rule: Value of SUPP--.QNAM ^= any variable name defined in the corresponding SDTM version Check: all: - - name: QNAM - operator: is_contained_by - value: $model_variables + - name: QNAM + operator: is_contained_by + value: $model_variables Core: Id: CORE-000783 Status: Published - Version: '1' -Description: Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is + Version: "1" +Description: + Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is equal to a variable name defined in the corresponding SDTM version. Executability: Fully Executable Operations: -- id: $model_variables - operator: get_parent_model_column_order + - id: $model_variables + operator: get_parent_model_column_order Outcome: - Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable + Message: + SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable name defined in the corresponding SDTM version. Output Variables: - - QNAM - - $model_variables + - QNAM + - $model_variables Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Record diff --git a/Published/CORE-000784/rule.yml b/Published/CORE-000784/rule.yml index 6c98afd5a..3980bf6a4 100644 --- a/Published/CORE-000784/rule.yml +++ b/Published/CORE-000784/rule.yml @@ -2,109 +2,115 @@ # Condition: TAETORD present in dataset and SESTDTC <= SVSTDTC and SVSTDTC <= SEENDTC # Rule: TAETORD = SE.TAETORD Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit. - Document: IG v3.4 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit.It would be inappropriate to add the variables that support time points - (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.2 - Item: Assumption 11 - Section: 5 SV - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit.It would be inappropriate to add the variables that support time points - (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is - visits. - Document: IG v3.3 - Item: Assumption 11 - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0217 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: If TAETORD and/or EPOCH are added, then the values must be those at the - start of the visit. - Document: TIG 1.0 - Item: Assumption 11 - Section: 2.8.10.25 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0431 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: IG v3.4 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.2 + Item: Assumption 11 + Section: 5 SV + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit.It would be inappropriate to add the variables that support time points + (--TPT, --TPTNUM, --ELTM, --TPTREF, and --RFTDTC), since the topic of this dataset is + visits. + Document: IG v3.3 + Item: Assumption 11 + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0217 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + If TAETORD and/or EPOCH are added, then the values must be those at the + start of the visit. + Document: TIG 1.0 + Item: Assumption 11 + Section: 2.8.10.25 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0431 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: TAETORD - operator: exists - - name: SVSTDTC - operator: date_greater_than_or_equal_to - value: SESTDTC - - name: SVSTDTC - operator: date_less_than_or_equal_to - value: SEENDTC - - name: TAETORD - operator: not_equal_to - value: SE.TAETORD + - name: TAETORD + operator: exists + - name: SVSTDTC + operator: date_greater_than_or_equal_to + value: SESTDTC + - name: SVSTDTC + operator: date_less_than_or_equal_to + value: SEENDTC + - name: TAETORD + operator: not_equal_to + value: SE.TAETORD Core: Id: CORE-000784 Status: Published - Version: '1' -Description: Raise an error when variable TAETORD values don't match between Subject Visits (SV) and + Version: "1" +Description: + Raise an error when variable TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: SE + - Keys: + - USUBJID + Name: SE Outcome: - Message: TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) + Message: + TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Output Variables: - - SESTDTC - - SEENDTC - - SVSTDTC - - TAETORD - - SE.TAETORD + - SESTDTC + - SEENDTC + - SVSTDTC + - TAETORD + - SE.TAETORD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SV + - SV Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000785/rule.yml b/Published/CORE-000785/rule.yml index 5c07c47a8..63b65308a 100644 --- a/Published/CORE-000785/rule.yml +++ b/Published/CORE-000785/rule.yml @@ -2,103 +2,109 @@ # Condition: --SCAT ^= null # Rule: --CAT ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table - 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used - to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0429 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Interventions[A further grouping or classification of the category for the - topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further - grouping or classification of the category for the topic of the finding, event, or - intervention. The category is in --CAT.]|Findings[A further grouping or classification of - the category for the topic of the finding, event, or intervention. The category is in - --CAT.] - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events - Observation Class Section|3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0583 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "2.2.1[Table 3.2.1 --SCAT][Used to define a further categorization of --CAT values.]|2.2.2[Table + 3.2.2 --SCAT][Used to define a further categorization of --CAT values.]|2.2.3[Table 3.2.3 --SCAT][Used + to define a further categorization of --CAT values.]" + Document: Model v1.7 + Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]" + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0429 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Interventions[A further grouping or classification of the category for the + topic of the finding, event, or intervention. The category is in --CAT.]|Events[A further + grouping or classification of the category for the topic of the finding, event, or + intervention. The category is in --CAT.]|Findings[A further grouping or classification of + the category for the topic of the finding, event, or intervention. The category is in + --CAT.] + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: + Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Observation Class Section|3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0583 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IESCAT - operator: non_empty - - name: IECAT - operator: empty + - name: IESCAT + operator: non_empty + - name: IECAT + operator: empty Core: Id: CORE-000785 Status: Published - Version: '1' + Version: "1" Description: Part B - Raise an error when IESCAT is not empty, but IECAT is empty. Executability: Fully Executable Outcome: Message: IECAT should not be null when IESCAT is populated Output Variables: - - IECAT - - IESCAT + - IECAT + - IESCAT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-000786/rule.yml b/Published/CORE-000786/rule.yml index 14d6a20ef..fcf6db017 100644 --- a/Published/CORE-000786/rule.yml +++ b/Published/CORE-000786/rule.yml @@ -2,106 +2,112 @@ # Condition: --SCAT present in dataset # Rule: --CAT present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Interventions - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Events - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: Model v2.0 - Item: --SCAT - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values. - Document: Model v1.4 - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to define a further categorization of --CAT values.]' - Document: Model v1.7 - Item: '2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]' - Section: 2.2.1|2.2.2|2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0430 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.1 The Interventions Observation Class - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: Section 3.1.2 The Events Observation Class Section - - Cited Guidance: A further grouping or classification of the category for the topic of the - finding, event, or intervention. The category is in --CAT. - Document: SDTM v2.1 - Item: Specifications --SCAT - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0584 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Interventions + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Events + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: Model v2.0 + Item: --SCAT + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values. + Document: Model v1.4 + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used to define a further categorization of --CAT values.]' + Document: Model v1.7 + Item: "2.2.1[Table 3.2.1: --SCAT]|2.2.2[Table 3.2.2: --SCAT]|2.2.3[Table 3.2.3: --SCAT]" + Section: 2.2.1|2.2.2|2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0430 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.1 The Interventions Observation Class + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: Section 3.1.2 The Events Observation Class Section + - Cited Guidance: + A further grouping or classification of the category for the topic of the + finding, event, or intervention. The category is in --CAT. + Document: SDTM v2.1 + Item: Specifications --SCAT + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0584 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: IESCAT - operator: exists - - name: IECAT - operator: not_exists + - name: IESCAT + operator: exists + - name: IECAT + operator: not_exists Core: Id: CORE-000786 Status: Published - Version: '1' + Version: "1" Description: Part B - Raise an error when IESCAT exists in a dataset, but IECAT does not exist. Executability: Fully Executable Outcome: Message: IESCAT exists in a dataset, but IECAT does not exist. Output Variables: - - IECAT - - IESCAT + - IECAT + - IESCAT Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Use Case: INDH Sensitivity: Dataset diff --git a/Published/CORE-000788/rule.yml b/Published/CORE-000788/rule.yml index b37e62ead..0626fdb51 100644 --- a/Published/CORE-000788/rule.yml +++ b/Published/CORE-000788/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5133 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5133 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'TSVCDREF' - operator: exists + - name: "TSVCDREF" + operator: exists Core: Id: CORE-000788 Status: Published - Version: '1' -Description: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset' + Version: "1" +Description: "TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset' + Message: "TSVCDREF (Name of Reference Terminology) must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Published/CORE-000789/rule.yml b/Published/CORE-000789/rule.yml index 479403afc..bf8b282e8 100644 --- a/Published/CORE-000789/rule.yml +++ b/Published/CORE-000789/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5134 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5134 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'TSVCDVER' - operator: exists + - name: "TSVCDVER" + operator: exists Core: Id: CORE-000789 Status: Published - Version: '1' -Description: 'TSVCDVER (Version of the Reference Terminology) must not be present in SEND dataset' + Version: "1" +Description: "TSVCDVER (Version of the Reference Terminology) must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: 'TSVCDVER must not be present in SEND dataset' + Message: "TSVCDVER must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Published/CORE-000791/rule.yml b/Published/CORE-000791/rule.yml index a532f82f7..fcf536526 100644 --- a/Published/CORE-000791/rule.yml +++ b/Published/CORE-000791/rule.yml @@ -1,168 +1,178 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All paired variables should have a one-to-one relationship. Examples include - short name and name of test; parameter name and parameter code or number; variable name - and variable label, etc. - Document: FDA - Section: FDAB009 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0903 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All paired variables should have a one-to-one relationship. Examples include + short name and name of test; parameter name and parameter code or number; variable name + and variable label, etc. + Document: FDA + Section: FDAB009 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0903 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: ACTARM - operator: is_not_unique_relationship - value: ACTARMCD + - name: ACTARM + operator: is_not_unique_relationship + value: ACTARMCD Core: Id: CORE-000791 Status: Published - Version: '1' + Version: "1" Description: ACTARMCD and ACTARM should have a one-to-one relationship. Executability: Fully Executable Outcome: Message: ACTARMCD and ACTARM do not have a one-to-one relationship. Output Variables: - - ACTARM - - ACTARMCD + - ACTARM + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000793/rule.yml b/Published/CORE-000793/rule.yml index 89937405b..8ffccfab2 100644 --- a/Published/CORE-000793/rule.yml +++ b/Published/CORE-000793/rule.yml @@ -1,149 +1,159 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1601 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1601 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: --DY - operator: not_exists + - name: --DTC + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: --DY + operator: not_exists Core: Id: CORE-000793 Status: Published - Version: '1' -Description: 'Collection study day (--DY) should be present when date/time of collection (--DTC) is populated' + Version: "1" +Description: "Collection study day (--DY) should be present when date/time of collection (--DTC) is populated" Executability: Fully Executable Outcome: Message: Collection study day (--DY) is missing when date/time of collection (--DTC) is populated. @@ -151,8 +161,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000794/rule.yml b/Published/CORE-000794/rule.yml index 846111317..9cc163710 100644 --- a/Published/CORE-000794/rule.yml +++ b/Published/CORE-000794/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5120 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5120 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--PTCD' - operator: exists + - name: "--PTCD" + operator: exists Core: Id: CORE-000794 Status: Published - Version: '1' -Description: '--PTCD (Preferred Term Code) must not be in SEND dataset' + Version: "1" +Description: "--PTCD (Preferred Term Code) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--PTCD (Preferred Term Code) must not be present in SEND dataset' + Message: "--PTCD (Preferred Term Code) must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000796/rule.yml b/Published/CORE-000796/rule.yml index 6de3f0a2e..29b652f6d 100644 --- a/Published/CORE-000796/rule.yml +++ b/Published/CORE-000796/rule.yml @@ -1,49 +1,52 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A specified condition for assessments must apply to at least to a procedure, - biomedical concept, biomedical concept surrogate, biomedical concept category or a whole activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00016' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A specified condition for assessments must apply to at least to a procedure, + biomedical concept, biomedical concept surrogate, biomedical concept category or a whole activity." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00016" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Condition' - - any: - - name: appliesToIds - operator: not_exists - - name: appliesToIds - operator: not_equal_to - value: true + - name: instanceType + operator: equal_to + value: "Condition" + - any: + - name: appliesToIds + operator: not_exists + - name: appliesToIds + operator: not_equal_to + value: true Core: - Id: 'CORE-000796' + Id: "CORE-000796" Status: Published - Version: '1' -Description: 'A specified condition for assessments must apply to at least to a procedure, biomedical - concept, biomedical concept surrogate, biomedical concept category or a whole activity.' + Version: "1" +Description: + "A specified condition for assessments must apply to at least to a procedure, biomedical + concept, biomedical concept surrogate, biomedical concept category or a whole activity." Executability: Fully Executable Outcome: - Message: 'The condition does not apply to a procedure, biomedical concept, biomedical concept surrogate, - biomedical concept category or a whole activity.' + Message: + "The condition does not apply to a procedure, biomedical concept, biomedical concept surrogate, + biomedical concept category or a whole activity." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - appliesToIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - appliesToIds Rule Type: Record Data Scope: Entities: Include: - - Condition + - Condition Sensitivity: Record diff --git a/Published/CORE-000797/rule.yml b/Published/CORE-000797/rule.yml index 04470c2ca..615afad08 100644 --- a/Published/CORE-000797/rule.yml +++ b/Published/CORE-000797/rule.yml @@ -1,78 +1,78 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each StudyArm must have one StudyCell for each StudyEpoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00068' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Each StudyArm must have one StudyCell for each StudyEpoch." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00068" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyArm' - - name: id.StudyEpoch - operator: is_unique_set - value: id - - any: - - all: - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'arms' - - name: parent_rel.StudyEpoch - operator: equal_to - value: 'epochs' - - all: - - name: parent_entity - operator: equal_to - value: 'StudyCell' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'armId' - - name: parent_rel.StudyEpoch - operator: equal_to - value: 'epochId' + - name: instanceType + operator: equal_to + value: "StudyArm" + - name: id.StudyEpoch + operator: is_unique_set + value: id + - any: + - all: + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_rel + operator: equal_to + value: "arms" + - name: parent_rel.StudyEpoch + operator: equal_to + value: "epochs" + - all: + - name: parent_entity + operator: equal_to + value: "StudyCell" + - name: rel_type + operator: equal_to + value: "reference" + - name: parent_rel + operator: equal_to + value: "armId" + - name: parent_rel.StudyEpoch + operator: equal_to + value: "epochId" Core: - Id: 'CORE-000797' + Id: "CORE-000797" Status: Published - Version: '1' -Description: 'Each StudyArm must have one StudyCell for each StudyEpoch.' + Version: "1" +Description: "Each StudyArm must have one StudyCell for each StudyEpoch." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - parent_entity - - parent_id - - rel_type - Name: StudyEpoch + - Join Type: left + Keys: + - parent_entity + - parent_id + - rel_type + Name: StudyEpoch Outcome: - Message: 'The StudyArm does not have a StudyCell for the StudyEpoch.' + Message: "The StudyArm does not have a StudyCell for the StudyEpoch." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - id.StudyEpoch - - name.StudyEpoch + - parent_entity + - parent_id + - parent_rel + - id + - name + - id.StudyEpoch + - name.StudyEpoch Rule Type: Record Data Scope: Entities: Include: - - 'StudyArm' + - "StudyArm" Sensitivity: Record diff --git a/Published/CORE-000798/rule.yml b/Published/CORE-000798/rule.yml index 85051a005..3bb98a729 100644 --- a/Published/CORE-000798/rule.yml +++ b/Published/CORE-000798/rule.yml @@ -1,68 +1,71 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A procedure must only reference a study intervention that is defined within the - same study design as the activity within which the procedure is defined.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00048' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A procedure must only reference a study intervention that is defined within the + same study design as the activity within which the procedure is defined." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00048" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Procedure' - - name: rel_type - operator: equal_to - value: 'definition' - - name: rel_type.StudyIntervention - operator: equal_to - value: 'definition' - - name: rel_type.Activity - operator: equal_to - value: 'definition' - - name: parent_id.StudyIntervention - operator: not_equal_to - value: parent_id.Activity + - name: instanceType + operator: equal_to + value: "Procedure" + - name: rel_type + operator: equal_to + value: "definition" + - name: rel_type.StudyIntervention + operator: equal_to + value: "definition" + - name: rel_type.Activity + operator: equal_to + value: "definition" + - name: parent_id.StudyIntervention + operator: not_equal_to + value: parent_id.Activity Core: - Id: 'CORE-000798' + Id: "CORE-000798" Status: Published - Version: '1' -Description: 'A procedure must only reference a study intervention that is defined within the same study - design as the activity within which the procedure is defined.' + Version: "1" +Description: + "A procedure must only reference a study intervention that is defined within the same study + design as the activity within which the procedure is defined." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: studyInterventionId - Right: id - Name: StudyIntervention -- Join Type: left - Keys: - - Left: parent_id - Right: id - Name: Activity + - Join Type: left + Keys: + - Left: studyInterventionId + Right: id + Name: StudyIntervention + - Join Type: left + Keys: + - Left: parent_id + Right: id + Name: Activity Outcome: - Message: 'The procedure references a study intervention that is not defined within the same study design + Message: + "The procedure references a study intervention that is not defined within the same study design as the activity within which the procedure is defined: the parent_id of the study intervention (parent_id.StudyIntervention) - is not the same as the parent_id of the activity (parent_id.Activity).' + is not the same as the parent_id of the activity (parent_id.Activity)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyIntervention - - parent_id.Activity + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyIntervention + - parent_id.Activity Rule Type: Record Data Scope: Entities: Include: - - Procedure + - Procedure Sensitivity: Record diff --git a/Published/CORE-000799/rule.yml b/Published/CORE-000799/rule.yml index 8e708b1aa..a831be822 100644 --- a/Published/CORE-000799/rule.yml +++ b/Published/CORE-000799/rule.yml @@ -1,73 +1,76 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference populations that are defined within the same - study design as the study arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00049' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study arm must only reference populations that are defined within the same + study design as the study arm." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00049" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'populationIds' - value_is_literal: true - - name: rel_type.StudyArm - operator: equal_to - value: 'definition' - - name: parent_id.StudyArm - operator: is_not_contained_by - value: $parent_of_population + - name: instanceType + operator: equal_to + value: "StudyDesignPopulation" + - name: rel_type + operator: equal_to + value: "reference" + - name: parent_rel + operator: equal_to + value: "populationIds" + value_is_literal: true + - name: rel_type.StudyArm + operator: equal_to + value: "definition" + - name: parent_id.StudyArm + operator: is_not_contained_by + value: $parent_of_population Core: - Id: 'CORE-000799' + Id: "CORE-000799" Status: Published - Version: '1' -Description: 'A study arm must only reference populations that are defined within the same study design - as the study arm.' + Version: "1" +Description: + "A study arm must only reference populations that are defined within the same study design + as the study arm." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - Name: StudyArm + - Keys: + - Left: parent_id + Right: id + Name: StudyArm Operations: -- group: - - id - - rel_type - group_aliases: - - id - - rel_type.StudyArm - id: $parent_of_population - name: parent_id - operator: distinct + - group: + - id + - rel_type + group_aliases: + - id + - rel_type.StudyArm + id: $parent_of_population + name: parent_id + operator: distinct Outcome: - Message: 'The study population is referenced by a study arm but was not defined within the same study + Message: + "The study population is referenced by a study arm but was not defined within the same study design as the study arm: the parent_id of the study population ($parent_of_population) is not the - same as parent_id of the study arm (parent_id.StudyArm).' + same as parent_id of the study arm (parent_id.StudyArm)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyArm - - $parent_of_population + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyArm + - $parent_of_population Rule Type: Record Data Scope: Entities: Include: - - StudyDesignPopulation + - StudyDesignPopulation Sensitivity: Record diff --git a/Published/CORE-000800/rule.yml b/Published/CORE-000800/rule.yml index f22c6bb23..4db484238 100644 --- a/Published/CORE-000800/rule.yml +++ b/Published/CORE-000800/rule.yml @@ -1,73 +1,76 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then no codes are expected to specify the - specific area within scope while if it is not global then at least one code is expected to specify - the specific area within scope.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00077' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If geographic scope type is global then no codes are expected to specify the + specific area within scope while if it is not global then at least one code is expected to specify + the specific area within scope." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00077" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: type.code - operator: equal_to - value: 'C68846' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - all: - - name: type.code - operator: not_equal_to - value: 'C68846' - - any: - - name: code - operator: not_exists - - name: code - operator: empty - - name: code - operator: equal_to - value: false + - name: instanceType + operator: equal_to + value: "GeographicScope" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: type.code + operator: equal_to + value: "C68846" + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - all: + - name: type.code + operator: not_equal_to + value: "C68846" + - any: + - name: code + operator: not_exists + - name: code + operator: empty + - name: code + operator: equal_to + value: false Core: - Id: 'CORE-000800' + Id: "CORE-000800" Status: Published - Version: '1' -Description: 'If geographic scope type is global then no codes are expected to specify the specific area + Version: "1" +Description: + "If geographic scope type is global then no codes are expected to specify the specific area within scope while if it is not global then at least one code is expected to specify the specific area - within scope.' + within scope." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The geographic scope is global (type.code = C68846) and a code has been specified or the geographic - scope is not global (type.code is not C68846) and no code has been specified.' + Message: + "The geographic scope is global (type.code = C68846) and a code has been specified or the geographic + scope is not global (type.code is not C68846) and no code has been specified." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - type.code - - type.decode - - code - - code.standardCode.code - - code.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - type.code + - type.decode + - code + - code.standardCode.code + - code.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - "GeographicScope" Sensitivity: Record diff --git a/Published/CORE-000801/rule.yml b/Published/CORE-000801/rule.yml index 861235a83..64d875490 100644 --- a/Published/CORE-000801/rule.yml +++ b/Published/CORE-000801/rule.yml @@ -1,91 +1,94 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study protocol document version, if a date of a specific type exists - with a global geographic scope then no other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00095' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study protocol document version, if a date of a specific type exists + with a global geographic scope then no other dates are expected with the same type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00095" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code + - name: instanceType operator: equal_to - value: 'C68846' - - name: type.decode - operator: equal_to_case_insensitive - value: 'Global' - - any: - - name: $num_geographic_scopes_for_this_date - operator: greater_than - value: 1 - - name: $num_dates_of_this_type - operator: greater_than - value: 1 + value: "GeographicScope" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: type.code + operator: equal_to + value: "C68846" + - name: type.decode + operator: equal_to_case_insensitive + value: "Global" + - any: + - name: $num_geographic_scopes_for_this_date + operator: greater_than + value: 1 + - name: $num_dates_of_this_type + operator: greater_than + value: 1 Core: - Id: 'CORE-000801' + Id: "CORE-000801" Status: Published - Version: '1' -Description: 'Within a study protocol document version, if a date of a specific type exists with a global - geographic scope then no other dates are expected with the same type.' + Version: "1" +Description: + "Within a study protocol document version, if a date of a specific type exists with a global + geographic scope then no other dates are expected with the same type." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: GovernanceDate -- Keys: - - Left: parent_id.GovernanceDate - Right: id - - rel_type - Name: StudyProtocolDocumentVersion + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: GovernanceDate + - Keys: + - Left: parent_id.GovernanceDate + Right: id + - rel_type + Name: StudyProtocolDocumentVersion Operations: -- group: - - parent_id - id: $num_geographic_scopes_for_this_date - operator: record_count -- domain: GovernanceDate - group: - - parent_id - - type.code - group_aliases: - - id.StudyProtocolDocumentVersion - - type.code.GovernanceDate - id: $num_dates_of_this_type - operator: record_count + - group: + - parent_id + id: $num_geographic_scopes_for_this_date + operator: record_count + - domain: GovernanceDate + group: + - parent_id + - type.code + group_aliases: + - id.StudyProtocolDocumentVersion + - type.code.GovernanceDate + id: $num_dates_of_this_type + operator: record_count Outcome: - Message: 'The study protocol document version has a type of governance date with a global geographic - scope and either another date of the same type or additional geographic scope(s) defined for the date.' + Message: + "The study protocol document version has a type of governance date with a global geographic + scope and either another date of the same type or additional geographic scope(s) defined for the date." Output Variables: - - parent_entity.StudyProtocolDocumentVersion - - parent_id.StudyProtocolDocumentVersion - - parent_rel.StudyProtocolDocumentVersion - - id.StudyProtocolDocumentVersion - - protocolVersion - - type.code.GovernanceDate - - type.decode.GovernanceDate - - dateValue - - type.code - - type.decode - - $num_dates_of_this_type - - $num_geographic_scopes_for_this_date + - parent_entity.StudyProtocolDocumentVersion + - parent_id.StudyProtocolDocumentVersion + - parent_rel.StudyProtocolDocumentVersion + - id.StudyProtocolDocumentVersion + - protocolVersion + - type.code.GovernanceDate + - type.decode.GovernanceDate + - dateValue + - type.code + - type.decode + - $num_dates_of_this_type + - $num_geographic_scopes_for_this_date Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - "GeographicScope" Sensitivity: Record diff --git a/Published/CORE-000802/rule.yml b/Published/CORE-000802/rule.yml index dfe017721..cba493bdc 100644 --- a/Published/CORE-000802/rule.yml +++ b/Published/CORE-000802/rule.yml @@ -1,72 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the duration of an administration will vary, a quantity is not expected for - the administration duration and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00003' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If the duration of an administration will vary, a quantity is not expected for + the administration duration and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00003" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'AdministrationDuration' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: durationWillVary - operator: equal_to - value: true - - not: - any: - - name: quantity - operator: not_exists - - name: quantity - operator: equal_to - value: false - - all: - - name: durationWillVary - operator: equal_to - value: false - - any: - - name: quantity - operator: not_exists - - name: quantity - operator: equal_to - value: false + - name: instanceType + operator: equal_to + value: "AdministrationDuration" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: durationWillVary + operator: equal_to + value: true + - not: + any: + - name: quantity + operator: not_exists + - name: quantity + operator: equal_to + value: false + - all: + - name: durationWillVary + operator: equal_to + value: false + - any: + - name: quantity + operator: not_exists + - name: quantity + operator: equal_to + value: false Core: - Id: 'CORE-000802' + Id: "CORE-000802" Status: Published - Version: '1' -Description: 'If the duration of an administration will vary, a quantity is not expected for the administration - duration and vice versa.' + Version: "1" +Description: + "If the duration of an administration will vary, a quantity is not expected for the administration + duration and vice versa." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A duration quantity has been specified when the duration will vary, or a duration quantity - has not been specified when the duration will not vary.' + Message: + "A duration quantity has been specified when the duration will vary, or a duration quantity + has not been specified when the duration will not vary." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - durationWillVary - - quantity - - quantity.id - - quantity.value - - quantity.unit.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - description + - durationWillVary + - quantity + - quantity.id + - quantity.value + - quantity.unit.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - AdministrationDuration + - AdministrationDuration Sensitivity: Record diff --git a/Published/CORE-000803/rule.yml b/Published/CORE-000803/rule.yml index 5f7b3a92b..f8112570c 100644 --- a/Published/CORE-000803/rule.yml +++ b/Published/CORE-000803/rule.yml @@ -1,59 +1,61 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a synonym is specified then it is not expected to be equal to the name of - the biomedical concept (case insensitive).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00079' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a synonym is specified then it is not expected to be equal to the name of + the biomedical concept (case insensitive)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00079" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConcept' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel.string - operator: equal_to - value: 'synonyms' - value_is_literal: true - - name: value - operator: equal_to_case_insensitive - value: name + - name: instanceType + operator: equal_to + value: "BiomedicalConcept" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_rel.string + operator: equal_to + value: "synonyms" + value_is_literal: true + - name: value + operator: equal_to_case_insensitive + value: name Core: - Id: 'CORE-000803' + Id: "CORE-000803" Status: Published - Version: '1' -Description: 'If a synonym is specified then it is not expected to be equal to the name of the biomedical - concept (case insensitive).' + Version: "1" +Description: + "If a synonym is specified then it is not expected to be equal to the name of the biomedical + concept (case insensitive)." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - Left: id - Right: parent_id - - rel_type - Name: string + - Keys: + - Left: id + Right: parent_id + - rel_type + Name: string Outcome: - Message: 'The biomedical concept synonym value is the same as the biomedical concept name (case insensitive).' + Message: "The biomedical concept synonym value is the same as the biomedical concept name (case insensitive)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_rel.string - - value + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_rel.string + - value Rule Type: Record Data Scope: Entities: Include: - - 'BiomedicalConcept' + - "BiomedicalConcept" Sensitivity: Record diff --git a/Published/CORE-000804/rule.yml b/Published/CORE-000804/rule.yml index 9fbfdc88d..692c5d589 100644 --- a/Published/CORE-000804/rule.yml +++ b/Published/CORE-000804/rule.yml @@ -1,95 +1,99 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing must only be specified as being relative to/from a scheduled activity/decision - instance that is defined within the same timeline as the timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00046' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing must only be specified as being relative to/from a scheduled activity/decision - instance that is defined within the same timeline as the timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00046' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00046" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00046" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - any: - - name: instanceType + - any: + - name: instanceType + operator: equal_to + value: "ScheduledActivityInstance" + - name: instanceType + operator: equal_to + value: "ScheduledDecisionInstance" + - name: rel_type operator: equal_to - value: 'ScheduledActivityInstance' - - name: instanceType + value: "reference" + - any: + - name: parent_rel + operator: equal_to + value: "relativeToScheduledInstanceId" + value_is_literal: true + - name: parent_rel + operator: equal_to + value: "relativeFromScheduledInstanceId" + value_is_literal: true + - name: rel_type.Timing operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'reference' - - any: - - name: parent_rel - operator: equal_to - value: 'relativeToScheduledInstanceId' - value_is_literal: true - - name: parent_rel - operator: equal_to - value: 'relativeFromScheduledInstanceId' - value_is_literal: true - - name: rel_type.Timing - operator: equal_to - value: 'definition' - - name: parent_id.Timing - operator: is_not_contained_by - value: $parent_of_scheduled_instance + value: "definition" + - name: parent_id.Timing + operator: is_not_contained_by + value: $parent_of_scheduled_instance Core: - Id: 'CORE-000804' + Id: "CORE-000804" Status: Published - Version: '1' -Description: 'A timing must only be specified as being relative to/from a scheduled activity/decision - instance that is defined within the same timeline as the timing.' + Version: "1" +Description: + "A timing must only be specified as being relative to/from a scheduled activity/decision + instance that is defined within the same timeline as the timing." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - Name: Timing + - Keys: + - Left: parent_id + Right: id + Name: Timing Operations: -- group: - - id - - rel_type - group_aliases: - - id - - rel_type.Timing - id: $parent_of_scheduled_instance - name: parent_id - operator: distinct + - group: + - id + - rel_type + group_aliases: + - id + - rel_type.Timing + id: $parent_of_scheduled_instance + name: parent_id + operator: distinct Outcome: - Message: 'The relative to/from scheduled instance of a timing was not defined within the same timeline + Message: + "The relative to/from scheduled instance of a timing was not defined within the same timeline as the timing: the parent_id of the scheduled instance ($parent_of_scheduled_instance) is not the - same as parent_id of the timing (parent_id.Timing).' + same as parent_id of the timing (parent_id.Timing)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.Timing - - $parent_of_scheduled_instance + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.Timing + - $parent_of_scheduled_instance Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' + - "ScheduledActivityInstance" + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-000805/rule.yml b/Published/CORE-000805/rule.yml index 79faa51dc..487ff36e8 100644 --- a/Published/CORE-000805/rule.yml +++ b/Published/CORE-000805/rule.yml @@ -1,60 +1,60 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The range specified for a planned age is not expected to be approximate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00042' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The range specified for a planned age is not expected to be approximate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00042' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The range specified for a planned age is not expected to be approximate." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00042" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "The range specified for a planned age is not expected to be approximate." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00042" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Range' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'plannedAge' - - name: isApproximate - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: "Range" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_rel + operator: equal_to + value: "plannedAge" + - name: isApproximate + operator: equal_to + value: true Core: - Id: 'CORE-000805' + Id: "CORE-000805" Status: Published - Version: '1' -Description: 'The range specified for a planned age is not expected to be approximate.' + Version: "1" +Description: "The range specified for a planned age is not expected to be approximate." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The planned age range is marked as approximate, which is not expected.' + Message: "The planned age range is marked as approximate, which is not expected." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - isApproximate + - parent_entity + - parent_id + - parent_rel + - id + - name + - isApproximate Rule Type: Record Data Scope: Entities: Include: - - Range + - Range Sensitivity: Record diff --git a/Published/CORE-000806/rule.yml b/Published/CORE-000806/rule.yml index 457fd0477..6b4fdca42 100644 --- a/Published/CORE-000806/rule.yml +++ b/Published/CORE-000806/rule.yml @@ -1,85 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. - the unit must be empty or %).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00017' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. - the unit must be empty or %).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00017' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within subject enrollment, the quantity must be a number or a percentage (i.e. + the unit must be empty or %)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00017" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within subject enrollment, the quantity must be a number or a percentage (i.e. + the unit must be empty or %)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00017" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Quantity' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_entity - operator: equal_to - value: 'SubjectEnrollment' - - name: parent_rel - operator: equal_to - value: 'quantity' - - not: - any: - - name: unit - operator: equal_to - value: false - - name: unit - operator: not_exists - - name: unit - operator: empty - - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.code - operator: equal_to - value: 'C25613' - - name: unit.standardCode.decode - operator: equal_to - value: '%' + - name: instanceType + operator: equal_to + value: "Quantity" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_entity + operator: equal_to + value: "SubjectEnrollment" + - name: parent_rel + operator: equal_to + value: "quantity" + - not: + any: + - name: unit + operator: equal_to + value: false + - name: unit + operator: not_exists + - name: unit + operator: empty + - all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: unit.standardCode.code + operator: equal_to + value: "C25613" + - name: unit.standardCode.decode + operator: equal_to + value: "%" Core: - Id: 'CORE-000806' + Id: "CORE-000806" Status: Published - Version: '1' -Description: 'Within subject enrollment, the quantity must be a number or a percentage (i.e. the unit - must be empty or %).' + Version: "1" +Description: + "Within subject enrollment, the quantity must be a number or a percentage (i.e. the unit + must be empty or %)." Executability: Fully Executable Outcome: - Message: 'The unit for a subject enrollement quantity is not empty or coded as % (codeSystem = http://www.cdisc.org, - code = C25613 and decode = %).' + Message: + "The unit for a subject enrollement quantity is not empty or coded as % (codeSystem = http://www.cdisc.org, + code = C25613 and decode = %)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - unit.standardCode.codeSystem - - unit.standardCode.code - - unit.standardCode.decode + - parent_entity + - parent_id + - parent_rel + - id + - value + - unit.standardCode.codeSystem + - unit.standardCode.code + - unit.standardCode.decode Rule Type: Record Data Scope: Entities: Include: - - Quantity + - Quantity Sensitivity: Record diff --git a/Published/CORE-000807/rule.yml b/Published/CORE-000807/rule.yml index 2712cfd5e..974e9f596 100644 --- a/Published/CORE-000807/rule.yml +++ b/Published/CORE-000807/rule.yml @@ -1,67 +1,70 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one scheduled activity instance within a timeline must point to a timeline - exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00037' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one scheduled activity instance within a timeline must point to a timeline - exit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: USDM Conformance Rules - Rule Identifier: - Id: 'DDF00037' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "At least one scheduled activity instance within a timeline must point to a timeline + exit." + Document: "USDM_CORE_Rules.xlsx" + Origin: USDM Conformance Rules + Rule Identifier: + Id: "DDF00037" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "At least one scheduled activity instance within a timeline must point to a timeline + exit." + Document: "USDM_CORE_Rules.xlsx" + Origin: USDM Conformance Rules + Rule Identifier: + Id: "DDF00037" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $timeline_exits - operator: empty + - name: instanceType + operator: equal_to + value: "ScheduleTimeline" + - name: rel_type + operator: equal_to + value: "definition" + - name: $timeline_exits + operator: empty Core: Id: CORE-000807 Status: Published - Version: '1' -Description: 'At least one scheduled activity instance within a timeline must point to a timeline exit.' + Version: "1" +Description: "At least one scheduled activity instance within a timeline must point to a timeline exit." Executability: Fully Executable Operations: -- domain: ScheduledActivityInstance - group: - - parent_id - group_aliases: - - id - id: $timeline_exits - name: timelineExitId - operator: distinct + - domain: ScheduledActivityInstance + group: + - parent_id + group_aliases: + - id + id: $timeline_exits + name: timelineExitId + operator: distinct Outcome: - Message: 'The schedule timeline does not have a defined exit: none of its scheduled activity instances - has a timeline exit.' + Message: + "The schedule timeline does not have a defined exit: none of its scheduled activity instances + has a timeline exit." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - ScheduleTimeline + - ScheduleTimeline Sensitivity: Record diff --git a/Published/CORE-000808/rule.yml b/Published/CORE-000808/rule.yml index ec3c111b7..c808b2dc2 100644 --- a/Published/CORE-000808/rule.yml +++ b/Published/CORE-000808/rule.yml @@ -1,77 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Only one version of any code system is expected to be used within a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00073' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Only one version of any code system is expected to be used within a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00073' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Only one version of any code system is expected to be used within a study version." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00073" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Only one version of any code system is expected to be used within a study version." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00073" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $min_codeSystemVersion - operator: not_equal_to - value: $max_codeSystemVersion - - name: id - operator: equal_to - value: $min_id_for_codeSystemVersion + - name: rel_type + operator: equal_to + value: "definition" + - name: $min_codeSystemVersion + operator: not_equal_to + value: $max_codeSystemVersion + - name: id + operator: equal_to + value: $min_id_for_codeSystemVersion Core: - Id: 'CORE-000808' + Id: "CORE-000808" Status: Published - Version: '1' -Description: 'Only one version of any code system is expected to be used within a study version.' + Version: "1" +Description: "Only one version of any code system is expected to be used within a study version." Executability: Partially Executable - Possible Overreporting Operations: -- group: - - codeSystem - id: $min_codeSystemVersion - name: codeSystemVersion - operator: min -- group: - - codeSystem - id: $max_codeSystemVersion - name: codeSystemVersion - operator: max -- group: - - codeSystem - - codeSystemVersion - id: $min_id_for_codeSystemVersion - name: id - operator: min -- group: - - codeSystem - - codeSystemVersion - id: $record_count - name: codeSystemVersion - operator: record_count + - group: + - codeSystem + id: $min_codeSystemVersion + name: codeSystemVersion + operator: min + - group: + - codeSystem + id: $max_codeSystemVersion + name: codeSystemVersion + operator: max + - group: + - codeSystem + - codeSystemVersion + id: $min_id_for_codeSystemVersion + name: id + operator: min + - group: + - codeSystem + - codeSystemVersion + id: $record_count + name: codeSystemVersion + operator: record_count Outcome: - Message: 'More than one code system version is used for the code system.' + Message: "More than one code system version is used for the code system." Output Variables: - - codeSystem - - codeSystemVersion - - $record_count + - codeSystem + - codeSystemVersion + - $record_count Rule Type: Record Data Scope: Entities: Include: - - 'Code' + - "Code" Sensitivity: Record diff --git a/Published/CORE-000809/rule.yml b/Published/CORE-000809/rule.yml index 64c28e888..8106edd95 100644 --- a/Published/CORE-000809/rule.yml +++ b/Published/CORE-000809/rule.yml @@ -1,85 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference elements that are defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00047' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference elements that are defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00047' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference elements that are defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00047" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference elements that are defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00047" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyElement' - - name: rel_type - operator: equal_to - value: 'reference' - - name: parent_rel - operator: equal_to - value: 'elementIds' - value_is_literal: true - - name: rel_type.StudyCell - operator: equal_to - value: 'definition' - - name: parent_id.StudyCell - operator: is_not_contained_by - value: $parent_of_study_element + - name: instanceType + operator: equal_to + value: "StudyElement" + - name: rel_type + operator: equal_to + value: "reference" + - name: parent_rel + operator: equal_to + value: "elementIds" + value_is_literal: true + - name: rel_type.StudyCell + operator: equal_to + value: "definition" + - name: parent_id.StudyCell + operator: is_not_contained_by + value: $parent_of_study_element Core: - Id: 'CORE-000809' + Id: "CORE-000809" Status: Published - Version: '1' -Description: 'A study cell must only reference elements that are defined within the same study design - as the study cell.' + Version: "1" +Description: + "A study cell must only reference elements that are defined within the same study design + as the study cell." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - Name: StudyCell + - Keys: + - Left: parent_id + Right: id + Name: StudyCell Operations: -- group: - - id - - rel_type - group_aliases: - - id - - rel_type.StudyCell - id: $parent_of_study_element - name: parent_id - operator: distinct + - group: + - id + - rel_type + group_aliases: + - id + - rel_type.StudyCell + id: $parent_of_study_element + name: parent_id + operator: distinct Outcome: - Message: 'The study element is referenced by a study cell but was not defined within the same study + Message: + "The study element is referenced by a study cell but was not defined within the same study design as the study cell: the parent_id of the study element ($parent_of_study_element) is not the - same as parent_id of the study cell (parent_id.StudyCell).' + same as parent_id of the study cell (parent_id.StudyCell)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - parent_id.StudyCell - - $parent_of_study_element + - parent_entity + - parent_id + - parent_rel + - id + - name + - parent_id.StudyCell + - $parent_of_study_element Rule Type: Record Data Scope: Entities: Include: - - StudyElement + - StudyElement Sensitivity: Record diff --git a/Published/CORE-000810/rule.yml b/Published/CORE-000810/rule.yml index e21c21ee6..0e6ce0597 100644 --- a/Published/CORE-000810/rule.yml +++ b/Published/CORE-000810/rule.yml @@ -1,81 +1,84 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity is expected to refer to at least one procedure, biomedical concept, - biomedical concept category or biomedical concept surrogate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00075' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity is expected to refer to at least one procedure, biomedical concept, + biomedical concept category or biomedical concept surrogate." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00075" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Activity' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: definedProcedures - operator: not_exists - - name: definedProcedures - operator: empty - - name: definedProcedures + - name: instanceType operator: equal_to - value: false - - any: - - name: biomedicalConceptIds - operator: not_exists - - name: biomedicalConceptIds - operator: empty - - name: biomedicalConceptIds + value: "Activity" + - name: rel_type operator: equal_to - value: false - - any: - - name: bcCategoryIds - operator: not_exists - - name: bcCategoryIds - operator: empty - - name: bcCategoryIds - operator: equal_to - value: false - - any: - - name: bcSurrogateIds - operator: not_exists - - name: bcSurrogateIds - operator: empty - - name: bcSurrogateIds - operator: equal_to - value: false + value: "definition" + - any: + - name: definedProcedures + operator: not_exists + - name: definedProcedures + operator: empty + - name: definedProcedures + operator: equal_to + value: false + - any: + - name: biomedicalConceptIds + operator: not_exists + - name: biomedicalConceptIds + operator: empty + - name: biomedicalConceptIds + operator: equal_to + value: false + - any: + - name: bcCategoryIds + operator: not_exists + - name: bcCategoryIds + operator: empty + - name: bcCategoryIds + operator: equal_to + value: false + - any: + - name: bcSurrogateIds + operator: not_exists + - name: bcSurrogateIds + operator: empty + - name: bcSurrogateIds + operator: equal_to + value: false Core: - Id: 'CORE-000810' + Id: "CORE-000810" Status: Published - Version: '1' -Description: 'An activity is expected to refer to at least one procedure, biomedical concept, biomedical - concept category or biomedical concept surrogate.' + Version: "1" +Description: + "An activity is expected to refer to at least one procedure, biomedical concept, biomedical + concept category or biomedical concept surrogate." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity does not refer to any procedure, biomedical concept, biomedical concept category - or biomedical concept surrogate.' + Message: + "The activity does not refer to any procedure, biomedical concept, biomedical concept category + or biomedical concept surrogate." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - definedProcedures - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - definedProcedures + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-000811/rule.yml b/Published/CORE-000811/rule.yml index 1df2b7492..9c9fcddb8 100644 --- a/Published/CORE-000811/rule.yml +++ b/Published/CORE-000811/rule.yml @@ -1,81 +1,84 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same Biomedical Concept Category must not be referenced more than once from - the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00090' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same Biomedical Concept Category must not be referenced more than once from - the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00090' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The same Biomedical Concept Category must not be referenced more than once from + the same activity." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00090" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The same Biomedical Concept Category must not be referenced more than once from + the same activity." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00090" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptCategory' - - name: rel_type - operator: equal_to - value: 'reference' - - name: rel_type.Activity - operator: equal_to - value: 'definition' - - name: parent_entity - operator: equal_to - value: 'Activity' - - name: parent_rel - operator: equal_to - value: 'bcCategoryIds' - value_is_literal: true - - name: id - operator: is_not_unique_set - value: - - parent_entity - - parent_id - - parent_rel - - rel_type.Activity + - name: instanceType + operator: equal_to + value: "BiomedicalConceptCategory" + - name: rel_type + operator: equal_to + value: "reference" + - name: rel_type.Activity + operator: equal_to + value: "definition" + - name: parent_entity + operator: equal_to + value: "Activity" + - name: parent_rel + operator: equal_to + value: "bcCategoryIds" + value_is_literal: true + - name: id + operator: is_not_unique_set + value: + - parent_entity + - parent_id + - parent_rel + - rel_type.Activity Core: - Id: 'CORE-000811' + Id: "CORE-000811" Status: Published - Version: '1' -Description: 'The same Biomedical Concept Category must not be referenced more than once from the same - activity.' + Version: "1" +Description: + "The same Biomedical Concept Category must not be referenced more than once from the same + activity." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - Left: parent_entity - Right: instanceType - Name: Activity + - Keys: + - Left: parent_id + Right: id + - Left: parent_entity + Right: instanceType + Name: Activity Outcome: - Message: 'The biomedical concept category is referenced more than once from the same activity.' + Message: "The biomedical concept category is referenced more than once from the same activity." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - name.Activity + - parent_entity + - parent_id + - parent_rel + - id + - name + - name.Activity Rule Type: Record Data Scope: Entities: Include: - - 'BiomedicalConceptCategory' + - "BiomedicalConceptCategory" Sensitivity: Record diff --git a/Published/CORE-000812/rule.yml b/Published/CORE-000812/rule.yml index fea3f77fb..2c5624a63 100644 --- a/Published/CORE-000812/rule.yml +++ b/Published/CORE-000812/rule.yml @@ -1,75 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A biomedical concept category is expected to have at least a member or a child.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00014' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A biomedical concept category is expected to have at least a member or a child.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00014' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A biomedical concept category is expected to have at least a member or a child." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00014" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "A biomedical concept category is expected to have at least a member or a child." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00014" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'BiomedicalConceptCategory' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: memberIds - operator: not_exists - - name: childIds - operator: not_exists - - not: - any: + - name: instanceType + operator: equal_to + value: "BiomedicalConceptCategory" + - name: rel_type + operator: equal_to + value: "definition" + - any: - all: - - name: memberIds - operator: exists - - name: memberIds - operator: equal_to - value: true - - all: - - name: childIds - operator: exists - - name: childIds - operator: equal_to - value: true + - name: memberIds + operator: not_exists + - name: childIds + operator: not_exists + - not: + any: + - all: + - name: memberIds + operator: exists + - name: memberIds + operator: equal_to + value: true + - all: + - name: childIds + operator: exists + - name: childIds + operator: equal_to + value: true Core: - Id: 'CORE-000812' + Id: "CORE-000812" Status: Published - Version: '1' -Description: 'A biomedical concept category is expected to have at least a member or a child.' + Version: "1" +Description: "A biomedical concept category is expected to have at least a member or a child." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The biomedical concept category does not have any members or children.' + Message: "The biomedical concept category does not have any members or children." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - memberIds - - childIds + - parent_entity + - parent_id + - parent_rel + - id + - name + - memberIds + - childIds Rule Type: Record Data Scope: Entities: Include: - - BiomedicalConceptCategory + - BiomedicalConceptCategory Sensitivity: Record diff --git a/Published/CORE-000813/rule.yml b/Published/CORE-000813/rule.yml index 549935b22..1f54ba9af 100644 --- a/Published/CORE-000813/rule.yml +++ b/Published/CORE-000813/rule.yml @@ -1,80 +1,83 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All standard code aliases referenced by an instance of the alias code class must - be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00052' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All standard code aliases referenced by an instance of the alias code class must - be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00052' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "All standard code aliases referenced by an instance of the alias code class must + be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00052" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "All standard code aliases referenced by an instance of the alias code class must + be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00052" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'AliasCode' - - name: parent_rel - operator: equal_to - value: 'standardCodeAliases' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "AliasCode" + - name: parent_rel + operator: equal_to + value: "standardCodeAliases" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000813" Status: Published - Version: '1' -Description: 'All standard code aliases referenced by an instance of the alias code class must be unique.' + Version: "1" +Description: "All standard code aliases referenced by an instance of the alias code class must be unique." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - Name: AliasCode + - Keys: + - Left: parent_id + Right: id + Name: AliasCode Outcome: - Message: 'The standard code aliases of the alias code are not unique - the same code is used more than - once with the same codeSystem and codeSystemVersion.' + Message: + "The standard code aliases of the alias code are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion." Output Variables: - - parent_entity.AliasCode - - parent_id.AliasCode - - parent_rel.AliasCode - - id.AliasCode - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity.AliasCode + - parent_id.AliasCode + - parent_rel.AliasCode + - id.AliasCode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000814/rule.yml b/Published/CORE-000814/rule.yml index 57a0c8d46..6c700015a 100644 --- a/Published/CORE-000814/rule.yml +++ b/Published/CORE-000814/rule.yml @@ -1,103 +1,107 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if a date of a specific type exists with a global geographic - scope then no other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00094' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, if a date of a specific type exists with a global geographic - scope then no other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00094' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study version, if a date of a specific type exists with a global geographic + scope then no other dates are expected with the same type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00094" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study version, if a date of a specific type exists with a global geographic + scope then no other dates are expected with the same type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00094" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'GeographicScope' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code + - name: instanceType operator: equal_to - value: 'C68846' - - name: type.decode - operator: equal_to_case_insensitive - value: 'Global' - - any: - - name: $num_geographic_scopes_for_this_date - operator: greater_than - value: 1 - - name: $num_dates_of_this_type - operator: greater_than - value: 1 + value: "GeographicScope" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: type.code + operator: equal_to + value: "C68846" + - name: type.decode + operator: equal_to_case_insensitive + value: "Global" + - any: + - name: $num_geographic_scopes_for_this_date + operator: greater_than + value: 1 + - name: $num_dates_of_this_type + operator: greater_than + value: 1 Core: - Id: 'CORE-000814' + Id: "CORE-000814" Status: Published - Version: '1' -Description: 'Within a study version, if a date of a specific type exists with a global geographic scope - then no other dates are expected with the same type.' + Version: "1" +Description: + "Within a study version, if a date of a specific type exists with a global geographic scope + then no other dates are expected with the same type." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: GovernanceDate -- Keys: - - Left: parent_id.GovernanceDate - Right: id - - rel_type - Name: StudyVersion + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: GovernanceDate + - Keys: + - Left: parent_id.GovernanceDate + Right: id + - rel_type + Name: StudyVersion Operations: -- group: - - parent_id - id: $num_geographic_scopes_for_this_date - operator: record_count -- domain: GovernanceDate - group: - - parent_id - - type.code - group_aliases: - - id.StudyVersion - - type.code.GovernanceDate - id: $num_dates_of_this_type - operator: record_count + - group: + - parent_id + id: $num_geographic_scopes_for_this_date + operator: record_count + - domain: GovernanceDate + group: + - parent_id + - type.code + group_aliases: + - id.StudyVersion + - type.code.GovernanceDate + id: $num_dates_of_this_type + operator: record_count Outcome: - Message: 'The study version has a type of governance date with a global geographic scope and either - another date of the same type or additional geographic scope(s) defined for the date.' + Message: + "The study version has a type of governance date with a global geographic scope and either + another date of the same type or additional geographic scope(s) defined for the date." Output Variables: - - parent_entity.StudyVersion - - parent_id.StudyVersion - - parent_rel.StudyVersion - - id.StudyVersion - - versionIdentifier - - type.code.GovernanceDate - - type.decode.GovernanceDate - - dateValue - - type.code - - type.decode - - $num_dates_of_this_type - - $num_geographic_scopes_for_this_date + - parent_entity.StudyVersion + - parent_id.StudyVersion + - parent_rel.StudyVersion + - id.StudyVersion + - versionIdentifier + - type.code.GovernanceDate + - type.decode.GovernanceDate + - dateValue + - type.code + - type.decode + - $num_dates_of_this_type + - $num_geographic_scopes_for_this_date Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - "GeographicScope" Sensitivity: Record diff --git a/Published/CORE-000815/rule.yml b/Published/CORE-000815/rule.yml index 017d56d3b..9ac995fdc 100644 --- a/Published/CORE-000815/rule.yml +++ b/Published/CORE-000815/rule.yml @@ -1,101 +1,105 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned age range must be specified either in the - study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00097' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned age range must be specified either in the - study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00097' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, the planned age range must be specified either in the + study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00097" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, the planned age range must be specified either in the + study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00097" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - any: - - name: plannedAge - operator: not_exists - - name: plannedAge - operator: empty - - name: plannedAge - operator: equal_to - value: false - - any: - - name: plannedAge.StudyCohort - operator: not_exists - - name: plannedAge.StudyCohort - operator: empty - - name: plannedAge.StudyCohort - operator: equal_to - value: false - - all: - - name: plannedAge - operator: equal_to - value: true - - name: plannedAge.StudyCohort - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: "StudyDesignPopulation" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - any: + - name: plannedAge + operator: not_exists + - name: plannedAge + operator: empty + - name: plannedAge + operator: equal_to + value: false + - any: + - name: plannedAge.StudyCohort + operator: not_exists + - name: plannedAge.StudyCohort + operator: empty + - name: plannedAge.StudyCohort + operator: equal_to + value: false + - all: + - name: plannedAge + operator: equal_to + value: true + - name: plannedAge.StudyCohort + operator: equal_to + value: true Core: - Id: 'CORE-000815' + Id: "CORE-000815" Status: Published - Version: '1' -Description: 'Within a study design, the planned age range must be specified either in the study population - or in all cohorts.' + Version: "1" +Description: + "Within a study design, the planned age range must be specified either in the study population + or in all cohorts." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - - rel_type - Name: StudyCohort + - Join Type: left + Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + - rel_type + Name: StudyCohort Outcome: - Message: 'Planned age has not been specified for either the study population or the cohort, or it has - been specified for both.' + Message: + "Planned age has not been specified for either the study population or the cohort, or it has + been specified for both." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - plannedAge - - plannedAge.minValue - - plannedAge.maxValue - - plannedAge.unit.decode - - id.StudyCohort - - name.StudyCohort - - plannedAge.StudyCohort - - plannedAge.minValue.StudyCohort - - plannedAge.maxValue.StudyCohort - - plannedAge.unit.decode.StudyCohort + - parent_entity + - parent_id + - parent_rel + - id + - name + - plannedAge + - plannedAge.minValue + - plannedAge.maxValue + - plannedAge.unit.decode + - id.StudyCohort + - name.StudyCohort + - plannedAge.StudyCohort + - plannedAge.minValue.StudyCohort + - plannedAge.maxValue.StudyCohort + - plannedAge.unit.decode.StudyCohort Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000816/rule.yml b/Published/CORE-000816/rule.yml index a3d28024d..7ef074b66 100644 --- a/Published/CORE-000816/rule.yml +++ b/Published/CORE-000816/rule.yml @@ -1,65 +1,65 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All epochs are expected to be referred to from a scheduled Activity Instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00099' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All epochs are expected to be referred to from a scheduled Activity Instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00099' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "All epochs are expected to be referred to from a scheduled Activity Instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00099" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "All epochs are expected to be referred to from a scheduled Activity Instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00099" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyEpoch' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: epochId - operator: not_exists - - name: epochId - operator: empty + - name: instanceType + operator: equal_to + value: "StudyEpoch" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: epochId + operator: not_exists + - name: epochId + operator: empty Core: - Id: 'CORE-000816' + Id: "CORE-000816" Status: Published - Version: '1' -Description: 'All epochs are expected to be referred to from a scheduled Activity Instance.' + Version: "1" +Description: "All epochs are expected to be referred to from a scheduled Activity Instance." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Join Type: left - Keys: - - Left: id - Right: epochId - - rel_type - Name: ScheduledActivityInstance + - Join Type: left + Keys: + - Left: id + Right: epochId + - rel_type + Name: ScheduledActivityInstance Outcome: - Message: 'The epoch is not referenced by any scheduled activity instances.' + Message: "The epoch is not referenced by any scheduled activity instances." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - 'StudyEpoch' + - "StudyEpoch" Sensitivity: Record diff --git a/Published/CORE-000817/rule.yml b/Published/CORE-000817/rule.yml index 8939c7089..4f3370a52 100644 --- a/Published/CORE-000817/rule.yml +++ b/Published/CORE-000817/rule.yml @@ -1,64 +1,64 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, there must be no more than one title of each type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00100' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, there must be no more than one title of each type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00100' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study version, there must be no more than one title of each type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00100" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study version, there must be no more than one title of each type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00100" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyTitle' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: type.code - operator: is_not_unique_set - value: - - parent_id - - name: type.decode - operator: is_not_unique_set - value: - - parent_id + - name: instanceType + operator: equal_to + value: "StudyTitle" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: type.code + operator: is_not_unique_set + value: + - parent_id + - name: type.decode + operator: is_not_unique_set + value: + - parent_id Core: - Id: 'CORE-000817' + Id: "CORE-000817" Status: Published - Version: '1' -Description: 'Within a study version, there must be no more than one title of each type.' + Version: "1" +Description: "Within a study version, there must be no more than one title of each type." Executability: Fully Executable Outcome: - Message: 'There is more than one title of the same type code or decode.' + Message: "There is more than one title of the same type code or decode." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - type.code - - type.decode + - parent_entity + - parent_id + - parent_rel + - id + - text + - type.code + - type.decode Rule Type: Record Data Scope: Entities: Include: - - StudyTitle + - StudyTitle Sensitivity: Record diff --git a/Published/CORE-000818/rule.yml b/Published/CORE-000818/rule.yml index aad1163ee..310047067 100644 --- a/Published/CORE-000818/rule.yml +++ b/Published/CORE-000818/rule.yml @@ -1,63 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must not point (via the "timeline" relationship) - to the timeline in which it is specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00026' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must not point (via the "timeline" relationship) - to the timeline in which it is specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00026' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'A scheduled activity instance must not point (via the "timeline" relationship) + to the timeline in which it is specified.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00026" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'A scheduled activity instance must not point (via the "timeline" relationship) + to the timeline in which it is specified.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00026" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_rel - operator: equal_to - value: 'instances' - - name: timelineId - operator: equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: "ScheduledActivityInstance" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_rel + operator: equal_to + value: "instances" + - name: timelineId + operator: equal_to + value: parent_id Core: Id: CORE-000818 Status: Published - Version: '1' -Description: 'A scheduled activity instance must not point (via the "timeline" relationship) to the timeline + Version: "1" +Description: + 'A scheduled activity instance must not point (via the "timeline" relationship) to the timeline in which it is specified.' Executability: Fully Executable Outcome: - Message: 'The scheduled activity instance is referencing its parent timeline as its sub-timeline.' + Message: "The scheduled activity instance is referencing its parent timeline as its sub-timeline." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance + - ScheduledActivityInstance Sensitivity: Record diff --git a/Published/CORE-000819/rule.yml b/Published/CORE-000819/rule.yml index 4a2ade78b..5ea199b1f 100644 --- a/Published/CORE-000819/rule.yml +++ b/Published/CORE-000819/rule.yml @@ -1,70 +1,74 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference a timeline exit that is defined - within the same schedule timeline as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00102' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference a timeline exit that is defined - within the same schedule timeline as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00102' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only reference a timeline exit that is defined + within the same schedule timeline as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00102" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only reference a timeline exit that is defined + within the same schedule timeline as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00102" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineExitId - operator: non_empty - - name: parent_id.ScheduleTimelineExit - operator: not_equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: "ScheduledActivityInstance" + - name: rel_type + operator: equal_to + value: "definition" + - name: timelineExitId + operator: non_empty + - name: parent_id.ScheduleTimelineExit + operator: not_equal_to + value: parent_id Core: - Id: 'CORE-000819' + Id: "CORE-000819" Status: Published - Version: '1' -Description: 'A scheduled activity instance must only reference a timeline exit that is defined within - the same schedule timeline as the scheduled activity instance.' + Version: "1" +Description: + "A scheduled activity instance must only reference a timeline exit that is defined within + the same schedule timeline as the scheduled activity instance." Executability: Fully Executable Match Datasets: -- Keys: - - Left: timelineExitId - Right: id - - rel_type - Name: ScheduleTimelineExit + - Keys: + - Left: timelineExitId + Right: id + - rel_type + Name: ScheduleTimelineExit Outcome: - Message: 'The scheduled activity instance references a timeline exit that is not defined within the - same schedule timeline as the scheduled activity instance.' + Message: + "The scheduled activity instance references a timeline exit that is not defined within the + same schedule timeline as the scheduled activity instance." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineExitId - - parent_id.ScheduleTimelineExit + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineExitId + - parent_id.ScheduleTimelineExit Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - "ScheduledActivityInstance" Sensitivity: Record diff --git a/Published/CORE-000820/rule.yml b/Published/CORE-000820/rule.yml index c78c2e7c3..7c2b1643c 100644 --- a/Published/CORE-000820/rule.yml +++ b/Published/CORE-000820/rule.yml @@ -1,64 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The value for each timing must be a non-negative duration specified in ISO 8601 - format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00060' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The value for each timing must be a non-negative duration specified in ISO 8601 - format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00060' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The value for each timing must be a non-negative duration specified in ISO 8601 + format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00060" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The value for each timing must be a non-negative duration specified in ISO 8601 + format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00060" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: value - operator: exists - - name: value - operator: non_empty - - name: value - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: "Timing" + - name: rel_type + operator: equal_to + value: "definition" + - name: value + operator: exists + - name: value + operator: non_empty + - name: value + negative: false + operator: invalid_duration Core: - Id: 'CORE-000820' + Id: "CORE-000820" Status: Published - Version: '1' -Description: 'The value for each timing must be a non-negative duration specified in ISO 8601 format.' + Version: "1" +Description: "The value for each timing must be a non-negative duration specified in ISO 8601 format." Executability: Fully Executable Outcome: - Message: 'The value attribute of the timing is not a non-negative duration in ISO 8601 format.' + Message: "The value attribute of the timing is not a non-negative duration in ISO 8601 format." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - value - - valueLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - value + - valueLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000821/rule.yml b/Published/CORE-000821/rule.yml index 14d13d315..e94283faa 100644 --- a/Published/CORE-000821/rule.yml +++ b/Published/CORE-000821/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The target for a condition must not be equal to its parent.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00044' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The target for a condition must not be equal to its parent.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00044' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The target for a condition must not be equal to its parent." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00044" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "The target for a condition must not be equal to its parent." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00044" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ConditionAssignment' - - name: 'rel_type' - operator: equal_to - value: 'definition' - - name: conditionTargetId - operator: equal_to - value: parent_id + - name: instanceType + operator: equal_to + value: "ConditionAssignment" + - name: "rel_type" + operator: equal_to + value: "definition" + - name: conditionTargetId + operator: equal_to + value: parent_id Core: - Id: 'CORE-000821' + Id: "CORE-000821" Status: Published - Version: '1' -Description: 'The target for a condition must not be equal to its parent.' + Version: "1" +Description: "The target for a condition must not be equal to its parent." Executability: Fully Executable Outcome: Message: "The condition assignment's target is the same as its parent." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - conditionTargetId + - parent_entity + - parent_id + - parent_rel + - id + - conditionTargetId Rule Type: Record Data Scope: Entities: Include: - - ConditionAssignment + - ConditionAssignment Sensitivity: Record diff --git a/Published/CORE-000822/rule.yml b/Published/CORE-000822/rule.yml index d045465a6..cfc88235d 100644 --- a/Published/CORE-000822/rule.yml +++ b/Published/CORE-000822/rule.yml @@ -1,65 +1,68 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "There must be at least one exit defined for each timeline (i.e., at least one - instance of StudyTimelineExit linked via the 'exits' relationship)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00108' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "There must be at least one exit defined for each timeline (i.e., at least one - instance of StudyTimelineExit linked via the 'exits' relationship)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00108' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "There must be at least one exit defined for each timeline (i.e., at least one + instance of StudyTimelineExit linked via the 'exits' relationship)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00108" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "There must be at least one exit defined for each timeline (i.e., at least one + instance of StudyTimelineExit linked via the 'exits' relationship)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00108" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: exits - operator: not_exists - - name: exits - operator: empty - - name: exits + - name: instanceType operator: equal_to - value: false + value: "ScheduleTimeline" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: exits + operator: not_exists + - name: exits + operator: empty + - name: exits + operator: equal_to + value: false Core: - Id: 'CORE-000822' + Id: "CORE-000822" Status: Published - Version: '1' -Description: "There must be at least one exit defined for each timeline (i.e., at least one instance of + Version: "1" +Description: + "There must be at least one exit defined for each timeline (i.e., at least one instance of StudyTimelineExit linked via the 'exits' relationship)." Executability: Fully Executable Outcome: - Message: 'There is no exit defined for the timeline.' + Message: "There is no exit defined for the timeline." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - exits + - parent_entity + - parent_id + - parent_rel + - id + - name + - exits Rule Type: Record Data Scope: Entities: Include: - - 'ScheduleTimeline' + - "ScheduleTimeline" Sensitivity: Record diff --git a/Published/CORE-000823/rule.yml b/Published/CORE-000823/rule.yml index 8afa3c39b..422fe19f6 100644 --- a/Published/CORE-000823/rule.yml +++ b/Published/CORE-000823/rule.yml @@ -1,85 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00115' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00115' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00115" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: 'Every study version must have a title of type "Official Study Title".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00115" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $study_title_type_codes - operator: does_not_contain_case_insensitive - value: 'C207616' - - name: $study_title_type_decodes - operator: does_not_contain_case_insensitive - value: 'Official Study Title' + - name: instanceType + operator: equal_to + value: "StudyVersion" + - name: rel_type + operator: equal_to + value: "definition" + - name: $study_title_type_codes + operator: does_not_contain_case_insensitive + value: "C207616" + - name: $study_title_type_decodes + operator: does_not_contain_case_insensitive + value: "Official Study Title" Core: - Id: 'CORE-000823' + Id: "CORE-000823" Status: Published - Version: '1' + Version: "1" Description: 'Every study version must have a title of type "Official Study Title".' Executability: Fully Executable Operations: -- domain: StudyTitle - group: - - parent_entity - - parent_id - - rel_type - group_aliases: - - instanceType - - id - id: $study_title_type_codes - name: type.code - operator: distinct -- domain: StudyTitle - group: - - parent_entity - - parent_id - - rel_type - group_aliases: - - instanceType - - id - id: $study_title_type_decodes - name: type.decode - operator: distinct + - domain: StudyTitle + group: + - parent_entity + - parent_id + - rel_type + group_aliases: + - instanceType + - id + id: $study_title_type_codes + name: type.code + operator: distinct + - domain: StudyTitle + group: + - parent_entity + - parent_id + - rel_type + group_aliases: + - instanceType + - id + id: $study_title_type_decodes + name: type.decode + operator: distinct Outcome: - Message: 'The study version does not have a title of type "Official Study Title" (type.code = C207616 + Message: + 'The study version does not have a title of type "Official Study Title" (type.code = C207616 or type.decode = "Official Study Title", both case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $study_title_type_codes - - $study_title_type_decodes + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $study_title_type_codes + - $study_title_type_decodes Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-000824/rule.yml b/Published/CORE-000824/rule.yml index 7ba72c6d3..60cf4758f 100644 --- a/Published/CORE-000824/rule.yml +++ b/Published/CORE-000824/rule.yml @@ -1,62 +1,64 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself as its default - condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00019' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must not refer to itself as its default - condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00019' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity/decision instance must not refer to itself as its default + condition." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00019" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity/decision instance must not refer to itself as its default + condition." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00019" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: is_contained_by - value: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: defaultConditionId - operator: equal_to - value: id + - name: instanceType + operator: is_contained_by + value: + - "ScheduledActivityInstance" + - "ScheduledDecisionInstance" + - name: rel_type + operator: equal_to + value: "definition" + - name: defaultConditionId + operator: equal_to + value: id Core: Id: CORE-000824 Status: Published - Version: '1' -Description: 'A scheduled activity/decision instance must not refer to itself as its default condition.' + Version: "1" +Description: "A scheduled activity/decision instance must not refer to itself as its default condition." Executability: Fully Executable Outcome: - Message: 'A scheduled activity/decision instance is referencing itself as its default condition.' + Message: "A scheduled activity/decision instance is referencing itself as its default condition." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - ScheduledActivityInstance - - ScheduledDecisionInstance + - ScheduledActivityInstance + - ScheduledDecisionInstance Sensitivity: Record diff --git a/Published/CORE-000825/rule.yml b/Published/CORE-000825/rule.yml index ad8da097f..4705c9228 100644 --- a/Published/CORE-000825/rule.yml +++ b/Published/CORE-000825/rule.yml @@ -1,66 +1,70 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the lower limit of a timing window must be a non-negative duration - in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00061' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the lower limit of a timing window must be a non-negative duration - in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00061' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When specified, the lower limit of a timing window must be a non-negative duration + in ISO 8601 format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00061" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When specified, the lower limit of a timing window must be a non-negative duration + in ISO 8601 format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00061" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: windowLower - operator: exists - - name: windowLower - operator: non_empty - - name: windowLower - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: "Timing" + - name: rel_type + operator: equal_to + value: "definition" + - name: windowLower + operator: exists + - name: windowLower + operator: non_empty + - name: windowLower + negative: false + operator: invalid_duration Core: - Id: 'CORE-000825' + Id: "CORE-000825" Status: Published - Version: '1' -Description: 'When specified, the lower limit of a timing window must be a non-negative duration in ISO - 8601 format.' + Version: "1" +Description: + "When specified, the lower limit of a timing window must be a non-negative duration in ISO + 8601 format." Executability: Fully Executable Outcome: - Message: 'The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601 - format.' + Message: + "The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601 + format." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - windowLower - - windowLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - windowLower + - windowLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000826/rule.yml b/Published/CORE-000826/rule.yml index a857a65df..bce610738 100644 --- a/Published/CORE-000826/rule.yml +++ b/Published/CORE-000826/rule.yml @@ -1,66 +1,70 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the upper limit of a timing window must be a non-negative duration - in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00062' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When specified, the upper limit of a timing window must be a non-negative duration - in ISO 8601 format.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00062' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When specified, the upper limit of a timing window must be a non-negative duration + in ISO 8601 format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00062" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When specified, the upper limit of a timing window must be a non-negative duration + in ISO 8601 format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00062" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Timing' - - name: rel_type - operator: equal_to - value: 'definition' - - name: windowUpper - operator: exists - - name: windowUpper - operator: non_empty - - name: windowUpper - negative: false - operator: invalid_duration + - name: instanceType + operator: equal_to + value: "Timing" + - name: rel_type + operator: equal_to + value: "definition" + - name: windowUpper + operator: exists + - name: windowUpper + operator: non_empty + - name: windowUpper + negative: false + operator: invalid_duration Core: - Id: 'CORE-000826' + Id: "CORE-000826" Status: Published - Version: '1' -Description: 'When specified, the upper limit of a timing window must be a non-negative duration in ISO - 8601 format.' + Version: "1" +Description: + "When specified, the upper limit of a timing window must be a non-negative duration in ISO + 8601 format." Executability: Fully Executable Outcome: - Message: 'The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601 - format.' + Message: + "The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601 + format." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - windowUpper - - windowLabel + - parent_entity + - parent_id + - parent_rel + - id + - name + - windowUpper + - windowLabel Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000827/rule.yml b/Published/CORE-000827/rule.yml index c00de5861..09ce90642 100644 --- a/Published/CORE-000827/rule.yml +++ b/Published/CORE-000827/rule.yml @@ -1,79 +1,83 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined within the same - study design as the encounter.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00127' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only be scheduled at a timing that is defined within the same - study design as the encounter.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00127' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter must only be scheduled at a timing that is defined within the same + study design as the encounter." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00127" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter must only be scheduled at a timing that is defined within the same + study design as the encounter." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00127" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Encounter' - - name: rel_type - operator: equal_to - value: 'definition' - - name: scheduledAtId - operator: non_empty - - name: parent_id - operator: not_equal_to - value: parent_id.ScheduleTimeline + - name: instanceType + operator: equal_to + value: "Encounter" + - name: rel_type + operator: equal_to + value: "definition" + - name: scheduledAtId + operator: non_empty + - name: parent_id + operator: not_equal_to + value: parent_id.ScheduleTimeline Core: - Id: 'CORE-000827' + Id: "CORE-000827" Status: Published - Version: '1' -Description: 'An encounter must only be scheduled at a timing that is defined within the same study design - as the encounter.' + Version: "1" +Description: + "An encounter must only be scheduled at a timing that is defined within the same study design + as the encounter." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: scheduledAtId - Right: id - - rel_type - Name: Timing -- Join Type: left - Keys: - - Left: parent_id.Timing - Right: id - - rel_type - Name: ScheduleTimeline + - Join Type: left + Keys: + - Left: scheduledAtId + Right: id + - rel_type + Name: Timing + - Join Type: left + Keys: + - Left: parent_id.Timing + Right: id + - rel_type + Name: ScheduleTimeline Outcome: - Message: 'The encounter is scheduled at a timing that either is not defined in the same study design - (the parent_id of the timing''s parent schedule timeline does not match the parent_id of the encounter) - or is invalid (schedulateAtId does not match the id of any timing).' + Message: + "The encounter is scheduled at a timing that either is not defined in the same study design + (the parent_id of the timing's parent schedule timeline does not match the parent_id of the encounter) + or is invalid (schedulateAtId does not match the id of any timing)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - scheduledAtId - - name.Timing - - parent_id.ScheduleTimeline + - parent_entity + - parent_id + - parent_rel + - id + - name + - scheduledAtId + - name.Timing + - parent_id.ScheduleTimeline Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000828/rule.yml b/Published/CORE-000828/rule.yml index f3f766a25..68c8c21e5 100644 --- a/Published/CORE-000828/rule.yml +++ b/Published/CORE-000828/rule.yml @@ -1,86 +1,90 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A standard code alias is not expected to be equal to the standard code (e.g. - no equal code or decode for the same coding system version is expected).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00063' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A standard code alias is not expected to be equal to the standard code (e.g. - no equal code or decode for the same coding system version is expected).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00063' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A standard code alias is not expected to be equal to the standard code (e.g. + no equal code or decode for the same coding system version is expected)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00063" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A standard code alias is not expected to be equal to the standard code (e.g. + no equal code or decode for the same coding system version is expected)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00063" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'AliasCode' - - name: parent_rel.Code - operator: equal_to - value: 'standardCodeAliases' - value_is_literal: true - - name: standardCode.codeSystem - operator: equal_to_case_insensitive - value: codeSystem - - name: standardCode.codeSystemVersion - operator: equal_to_case_insensitive - value: codeSystemVersion - - any: - - name: standardCode.code + - name: instanceType + operator: equal_to + value: "AliasCode" + - name: parent_rel.Code + operator: equal_to + value: "standardCodeAliases" + value_is_literal: true + - name: standardCode.codeSystem operator: equal_to_case_insensitive - value: code - - name: standardCode.decode + value: codeSystem + - name: standardCode.codeSystemVersion operator: equal_to_case_insensitive - value: decode + value: codeSystemVersion + - any: + - name: standardCode.code + operator: equal_to_case_insensitive + value: code + - name: standardCode.decode + operator: equal_to_case_insensitive + value: decode Core: - Id: 'CORE-000828' + Id: "CORE-000828" Status: Published - Version: '1' -Description: 'A standard code alias is not expected to be equal to the standard code (e.g. no equal code - or decode for the same coding system version is expected).' + Version: "1" +Description: + "A standard code alias is not expected to be equal to the standard code (e.g. no equal code + or decode for the same coding system version is expected)." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - Name: Code + - Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + Name: Code Outcome: - Message: 'The standard code alias is the same as the standard code - the same combination of code system, + Message: + "The standard code alias is the same as the standard code - the same combination of code system, code system version and either code or decode is used for both the standard code and the standard - code alias (case insensitive).' + code alias (case insensitive)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - standardCode.codeSystem - - standardCode.codeSystemVersion - - standardCode.code - - standardCode.decode - - codeSystem - - codeSystemVersion - - code - - decode + - parent_entity + - parent_id + - parent_rel + - id + - standardCode.codeSystem + - standardCode.codeSystemVersion + - standardCode.code + - standardCode.decode + - codeSystem + - codeSystemVersion + - code + - decode Rule Type: Record Data Scope: Entities: Include: - - 'AliasCode' + - "AliasCode" Sensitivity: Record diff --git a/Published/CORE-000829/rule.yml b/Published/CORE-000829/rule.yml index 5916afb77..1c1830622 100644 --- a/Published/CORE-000829/rule.yml +++ b/Published/CORE-000829/rule.yml @@ -1,76 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00054' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter there must be no duplicate contact modes.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00054' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within an encounter there must be no duplicate contact modes." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00054" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within an encounter there must be no duplicate contact modes." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00054" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'contactModes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "Encounter" + - name: parent_rel + operator: equal_to + value: "contactModes" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000829" Status: Published - Version: '1' -Description: 'Within an encounter there must be no duplicate contact modes.' + Version: "1" +Description: "Within an encounter there must be no duplicate contact modes." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The contact modes of the encounter are not unique - the same code is used more than once with - the same codeSystem and codeSystemVersion.' + Message: + "The contact modes of the encounter are not unique - the same code is used more than once with + the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000830/rule.yml b/Published/CORE-000830/rule.yml index bae7574d0..8eaf8440b 100644 --- a/Published/CORE-000830/rule.yml +++ b/Published/CORE-000830/rule.yml @@ -1,77 +1,81 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled - activity instance via a relativeFromScheduledInstance relationship.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00011' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled - activity instance via a relativeFromScheduledInstance relationship.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00011' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled + activity instance via a relativeFromScheduledInstance relationship.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00011" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled + activity instance via a relativeFromScheduledInstance relationship.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00011" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type.code - operator: equal_to - value: 'C201358' - - any: - - name: relativeFromScheduledInstanceId - operator: empty - - name: id.ScheduledActivityInstance - operator: not_exists - - name: id.ScheduledActivityInstance - operator: empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type.code + operator: equal_to + value: "C201358" + - any: + - name: relativeFromScheduledInstanceId + operator: empty + - name: id.ScheduledActivityInstance + operator: not_exists + - name: id.ScheduledActivityInstance + operator: empty Core: - Id: 'CORE-000830' + Id: "CORE-000830" Status: Published - Version: '1' -Description: 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled activity + Version: "1" +Description: + 'Anchor timings (e.g. type is "Fixed Reference") must be related to a scheduled activity instance via a relativeFromScheduledInstance relationship.' Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: relativeFromScheduledInstanceId - Right: id - - Left: instanceType - Right: parent_entity - Name: ScheduledActivityInstance + - Join Type: left + Keys: + - Left: relativeFromScheduledInstanceId + Right: id + - Left: instanceType + Right: parent_entity + Name: ScheduledActivityInstance Outcome: - Message: 'The timing has a type of "Fixed Reference" (type.code=C201358) but it is not related to a + Message: + 'The timing has a type of "Fixed Reference" (type.code=C201358) but it is not related to a scheduled activity instance via a relativeFromScheduledInstance relationship - the value of relativeFromScheduledInstanceId is missing or it does not match the id value of a ScheduledActivityInstance.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - type.code - - type.decode - - relativeFromScheduledInstanceId - - id.ScheduledActivityInstance + - parent_entity + - parent_id + - parent_rel + - id + - name + - type.code + - type.decode + - relativeFromScheduledInstanceId + - id.ScheduledActivityInstance Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000831/rule.yml b/Published/CORE-000831/rule.yml index 91fdef463..48630013d 100644 --- a/Published/CORE-000831/rule.yml +++ b/Published/CORE-000831/rule.yml @@ -1,76 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an indication, if more indication codes are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00058' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an indication, if more indication codes are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00058' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within an indication, if more indication codes are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00058" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within an indication, if more indication codes are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00058" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Indication' - - name: parent_rel - operator: equal_to - value: 'codes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "Indication" + - name: parent_rel + operator: equal_to + value: "codes" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000831" Status: Published - Version: '1' -Description: 'Within an indication, if more indication codes are defined, they must be distinct.' + Version: "1" +Description: "Within an indication, if more indication codes are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: Indication + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: Indication Outcome: - Message: 'The codes of the indication are not unique - the same code is used more than once with the - same codeSystem and codeSystemVersion.' + Message: + "The codes of the indication are not unique - the same code is used more than once with the + same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000832/rule.yml b/Published/CORE-000832/rule.yml index 0b8d9d895..5da31ed58 100644 --- a/Published/CORE-000832/rule.yml +++ b/Published/CORE-000832/rule.yml @@ -1,78 +1,81 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study intervention, if more intervention codes are defined, they must - be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00059' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study intervention, if more intervention codes are defined, they must - be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00059' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study intervention, if more intervention codes are defined, they must + be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00059" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study intervention, if more intervention codes are defined, they must + be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00059" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'StudyIntervention' - - name: parent_rel - operator: equal_to - value: 'codes' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "StudyIntervention" + - name: parent_rel + operator: equal_to + value: "codes" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: Id: "CORE-000832" Status: Published - Version: '1' -Description: 'Within a study intervention, if more intervention codes are defined, they must be distinct.' + Version: "1" +Description: "Within a study intervention, if more intervention codes are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyIntervention + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyIntervention Outcome: - Message: 'The codes of the study intervention are not unique - the same code is used more than once - with the same codeSystem and codeSystemVersion.' + Message: + "The codes of the study intervention are not unique - the same code is used more than once + with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000833/rule.yml b/Published/CORE-000833/rule.yml index 1d5501b66..151b96284 100644 --- a/Published/CORE-000833/rule.yml +++ b/Published/CORE-000833/rule.yml @@ -1,62 +1,62 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: >- - References must be a fixed value or a reference to items - stored elsewhere in the data model which must be specified in - the correct format. They must start with '' or '>', and must contain - 'klass="klassName"', 'id="idValue"', and - 'attribute="attributeName"/>' in any order (where "klassName" - and "attributeName" contain only letters in upper or lower - case). - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00137' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: >- - References must be a fixed value or a reference to items - stored elsewhere in the data model which must be specified in - the correct format. They must start with '' or '>', and must contain - 'klass="klassName"', 'id="idValue"', and - 'attribute="attributeName"/>' in any order (where "klassName" - and "attributeName" contain only letters in upper or lower - case). - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00137' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: >- + References must be a fixed value or a reference to items + stored elsewhere in the data model which must be specified in + the correct format. They must start with '' or '>', and must contain + 'klass="klassName"', 'id="idValue"', and + 'attribute="attributeName"/>' in any order (where "klassName" + and "attributeName" contain only letters in upper or lower + case). + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00137" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: >- + References must be a fixed value or a reference to items + stored elsewhere in the data model which must be specified in + the correct format. They must start with '' or '>', and must contain + 'klass="klassName"', 'id="idValue"', and + 'attribute="attributeName"/>' in any order (where "klassName" + and "attributeName" contain only letters in upper or lower + case). + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00137" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ParameterMap' - - name: rel_type - operator: equal_to - value: definition - - name: reference - operator: contains - value: 'usdm:ref' - - name: reference - operator: not_matches_regex - value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]* id=\"([^\"]+)\")(?=[^>]* attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$' + - name: instanceType + operator: equal_to + value: "ParameterMap" + - name: rel_type + operator: equal_to + value: definition + - name: reference + operator: contains + value: "usdm:ref" + - name: reference + operator: not_matches_regex + value: '^]* klass=\"[a-zA-Z]+\")(?=[^>]* id=\"([^\"]+)\")(?=[^>]* attribute=\"[a-zA-Z]+\")[^>]*)(\/>|><\/usdm:ref>)$' Core: - Id: 'CORE-000833' + Id: "CORE-000833" Status: Published - Version: '1' + Version: "1" Description: >- References must be a fixed value or a reference to items stored elsewhere in the data model which must be specified in the correct format. They must start @@ -66,18 +66,19 @@ Description: >- lower case). Executability: Fully Executable Outcome: - Message: 'The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the + Message: + 'The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the correct format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - tag - - reference + - parent_entity + - parent_id + - parent_rel + - id + - tag + - reference Rule Type: Record Data Scope: Entities: Include: - - 'ParameterMap' + - "ParameterMap" Sensitivity: Record diff --git a/Published/CORE-000834/rule.yml b/Published/CORE-000834/rule.yml index 50b277ca2..86294d549 100644 --- a/Published/CORE-000834/rule.yml +++ b/Published/CORE-000834/rule.yml @@ -1,97 +1,100 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then there must be only one geographic scope - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00151' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If geographic scope type is global then there must be only one geographic scope - specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00151' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If geographic scope type is global then there must be only one geographic scope + specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00151" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If geographic scope type is global then there must be only one geographic scope + specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00151" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'GovernanceDate' - - name: rel_type - operator: equal_to - value: 'definition' - - name: $num_of_geographic_scopes - operator: greater_than - value: 1 - - any: - - name: $geographic_scope_type_codes - operator: contains_case_insensitive - value: 'C68846' - - name: $geographic_scope_type_decodes - operator: contains_case_insensitive - value: 'Global' + - name: instanceType + operator: equal_to + value: "GovernanceDate" + - name: rel_type + operator: equal_to + value: "definition" + - name: $num_of_geographic_scopes + operator: greater_than + value: 1 + - any: + - name: $geographic_scope_type_codes + operator: contains_case_insensitive + value: "C68846" + - name: $geographic_scope_type_decodes + operator: contains_case_insensitive + value: "Global" Core: - Id: 'CORE-000834' + Id: "CORE-000834" Status: Published - Version: '1' -Description: 'If geographic scope type is global then there must be only one geographic scope specified.' + Version: "1" +Description: "If geographic scope type is global then there must be only one geographic scope specified." Executability: Fully Executable Operations: -- domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $num_of_geographic_scopes - operator: record_count -- domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $geographic_scope_type_codes - name: type.code - operator: distinct -- domain: GeographicScope - group: - - parent_id - - rel_type - group_aliases: - - id - id: $geographic_scope_type_decodes - name: type.decode - operator: distinct + - domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $num_of_geographic_scopes + operator: record_count + - domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $geographic_scope_type_codes + name: type.code + operator: distinct + - domain: GeographicScope + group: + - parent_id + - rel_type + group_aliases: + - id + id: $geographic_scope_type_decodes + name: type.decode + operator: distinct Outcome: - Message: 'The governance date has more than one geographic scope defined, at least one of which has + Message: + 'The governance date has more than one geographic scope defined, at least one of which has type of "Global" (type.code = C68846 or type.decode = "Global", both case insensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - dateValue - - $num_of_geographic_scopes - - $geographic_scope_type_codes - - $geographic_scope_type_decodes + - parent_entity + - parent_id + - parent_rel + - id + - name + - dateValue + - $num_of_geographic_scopes + - $geographic_scope_type_codes + - $geographic_scope_type_decodes Rule Type: Record Data Scope: Entities: Include: - - 'GovernanceDate' + - "GovernanceDate" Sensitivity: Record diff --git a/Published/CORE-000835/rule.yml b/Published/CORE-000835/rule.yml index 2f299d327..ab3a04af0 100644 --- a/Published/CORE-000835/rule.yml +++ b/Published/CORE-000835/rule.yml @@ -1,71 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an arm that is defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00071' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an arm that is defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00071' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference an arm that is defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00071" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference an arm that is defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00071" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyCell' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_id - operator: not_equal_to - value: parent_id.StudyArm + - name: instanceType + operator: equal_to + value: "StudyCell" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_id + operator: not_equal_to + value: parent_id.StudyArm Core: - Id: 'CORE-000835' + Id: "CORE-000835" Status: Published - Version: '1' -Description: 'A study cell must only reference an arm that is defined within the same study design as - the study cell.' + Version: "1" +Description: + "A study cell must only reference an arm that is defined within the same study design as + the study cell." Executability: Fully Executable Match Datasets: -- Keys: - - Left: armId - Right: id - - parent_entity - - rel_type - Name: StudyArm + - Keys: + - Left: armId + Right: id + - parent_entity + - rel_type + Name: StudyArm Outcome: - Message: 'The study cell references an arm that is not defined within the same study design as the study - cell.' + Message: + "The study cell references an arm that is not defined within the same study design as the study + cell." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - armId - - parent_id.StudyArm + - parent_entity + - parent_id + - parent_rel + - id + - armId + - parent_id.StudyArm Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - "StudyCell" Sensitivity: Record diff --git a/Published/CORE-000836/rule.yml b/Published/CORE-000836/rule.yml index 5cbe526ad..431b458ff 100644 --- a/Published/CORE-000836/rule.yml +++ b/Published/CORE-000836/rule.yml @@ -1,71 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an epoch that is defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00072' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cell must only reference an epoch that is defined within the same study - design as the study cell.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00072' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference an epoch that is defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00072" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cell must only reference an epoch that is defined within the same study + design as the study cell." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00072" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyCell' - - name: parent_entity - operator: equal_to - value: 'StudyDesign' - - name: rel_type - operator: equal_to - value: 'definition' - - name: parent_id - operator: not_equal_to - value: parent_id.StudyEpoch + - name: instanceType + operator: equal_to + value: "StudyCell" + - name: parent_entity + operator: equal_to + value: "StudyDesign" + - name: rel_type + operator: equal_to + value: "definition" + - name: parent_id + operator: not_equal_to + value: parent_id.StudyEpoch Core: - Id: 'CORE-000836' + Id: "CORE-000836" Status: Published - Version: '1' -Description: 'A study cell must only reference an epoch that is defined within the same study design as - the study cell.' + Version: "1" +Description: + "A study cell must only reference an epoch that is defined within the same study design as + the study cell." Executability: Fully Executable Match Datasets: -- Keys: - - Left: epochId - Right: id - - parent_entity - - rel_type - Name: StudyEpoch + - Keys: + - Left: epochId + Right: id + - parent_entity + - rel_type + Name: StudyEpoch Outcome: - Message: 'The study cell references an epoch that is not defined within the same study design as the - study cell.' + Message: + "The study cell references an epoch that is not defined within the same study design as the + study cell." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - epochId - - parent_id.StudyEpoch + - parent_entity + - parent_id + - parent_rel + - id + - epochId + - parent_id.StudyEpoch Rule Type: Record Data Scope: Entities: Include: - - 'StudyCell' + - "StudyCell" Sensitivity: Record diff --git a/Published/CORE-000837/rule.yml b/Published/CORE-000837/rule.yml index 1f27b1e96..6357e38ce 100644 --- a/Published/CORE-000837/rule.yml +++ b/Published/CORE-000837/rule.yml @@ -1,83 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference activities that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00028' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference activities that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00028' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity must only reference activities that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00028" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity must only reference activities that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00028" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Activity' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $activity_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $activity_ids_for_study_design + - name: instanceType + operator: equal_to + value: "Activity" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $activity_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $activity_ids_for_study_design Core: - Id: 'CORE-000837' + Id: "CORE-000837" Status: Published - Version: '1' -Description: 'An activity must only reference activities that are specified within the same study design.' + Version: "1" +Description: "An activity must only reference activities that are specified within the same study design." Executability: Fully Executable Operations: -- group: - - parent_id - - rel_type - id: $activity_ids_for_study_design - name: id - operator: distinct + - group: + - parent_id + - rel_type + id: $activity_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The activity references a previous or next activity that is not specified within the same - study design.' + Message: + "The activity references a previous or next activity that is not specified within the same + study design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $activity_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $activity_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-000838/rule.yml b/Published/CORE-000838/rule.yml index da0c95a5b..33a647fef 100644 --- a/Published/CORE-000838/rule.yml +++ b/Published/CORE-000838/rule.yml @@ -1,83 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only reference encounters that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00029' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An encounter must only reference encounters that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00029' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter must only reference encounters that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00029" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter must only reference encounters that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00029" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Encounter' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $encounter_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $encounter_ids_for_study_design + - name: instanceType + operator: equal_to + value: "Encounter" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $encounter_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $encounter_ids_for_study_design Core: - Id: 'CORE-000838' + Id: "CORE-000838" Status: Published - Version: '1' -Description: 'An encounter must only reference encounters that are specified within the same study design.' + Version: "1" +Description: "An encounter must only reference encounters that are specified within the same study design." Executability: Fully Executable Operations: -- group: - - parent_id - - rel_type - id: $encounter_ids_for_study_design - name: id - operator: distinct + - group: + - parent_id + - rel_type + id: $encounter_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The encounter references a previous or next encounter that is not specified within the same - study design.' + Message: + "The encounter references a previous or next encounter that is not specified within the same + study design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $encounter_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $encounter_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000839/rule.yml b/Published/CORE-000839/rule.yml index cdd078416..776ae4127 100644 --- a/Published/CORE-000839/rule.yml +++ b/Published/CORE-000839/rule.yml @@ -1,83 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An epoch must only reference epochs that are specified within the same study - design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00024' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An epoch must only reference epochs that are specified within the same study - design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00024' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An epoch must only reference epochs that are specified within the same study + design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00024" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An epoch must only reference epochs that are specified within the same study + design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00024" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyEpoch' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: previousId - operator: exists - - name: previousId - operator: non_empty - - name: previousId - operator: is_not_contained_by - value: $epoch_ids_for_study_design - - all: - - name: nextId - operator: exists - - name: nextId - operator: non_empty - - name: nextId - operator: is_not_contained_by - value: $epoch_ids_for_study_design + - name: instanceType + operator: equal_to + value: "StudyEpoch" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: previousId + operator: exists + - name: previousId + operator: non_empty + - name: previousId + operator: is_not_contained_by + value: $epoch_ids_for_study_design + - all: + - name: nextId + operator: exists + - name: nextId + operator: non_empty + - name: nextId + operator: is_not_contained_by + value: $epoch_ids_for_study_design Core: - Id: 'CORE-000839' + Id: "CORE-000839" Status: Published - Version: '1' -Description: 'An epoch must only reference epochs that are specified within the same study design.' + Version: "1" +Description: "An epoch must only reference epochs that are specified within the same study design." Executability: Fully Executable Operations: -- group: - - parent_id - - rel_type - id: $epoch_ids_for_study_design - name: id - operator: distinct + - group: + - parent_id + - rel_type + id: $epoch_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The epoch references a previous or next epoch that is not specified within the same study - design.' + Message: + "The epoch references a previous or next epoch that is not specified within the same study + design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - previousId - - nextId - - $epoch_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - previousId + - nextId + - $epoch_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'StudyEpoch' + - "StudyEpoch" Sensitivity: Record diff --git a/Published/CORE-000840/rule.yml b/Published/CORE-000840/rule.yml index 82cf491cb..21c300a98 100644 --- a/Published/CORE-000840/rule.yml +++ b/Published/CORE-000840/rule.yml @@ -1,72 +1,74 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference timelines that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00152' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference timelines that are specified within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00152' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity must only reference timelines that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00152" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity must only reference timelines that are specified within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00152" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Activity' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineId - operator: exists - - name: timelineId - operator: non_empty - - name: timelineId - operator: is_not_contained_by - value: $timeline_ids_for_study_design + - name: instanceType + operator: equal_to + value: "Activity" + - name: rel_type + operator: equal_to + value: "definition" + - name: timelineId + operator: exists + - name: timelineId + operator: non_empty + - name: timelineId + operator: is_not_contained_by + value: $timeline_ids_for_study_design Core: - Id: 'CORE-000840' + Id: "CORE-000840" Status: Published - Version: '1' -Description: 'An activity must only reference timelines that are specified within the same study design.' + Version: "1" +Description: "An activity must only reference timelines that are specified within the same study design." Executability: Fully Executable Operations: -- domain: ScheduleTimeline - group: - - parent_id - - rel_type - id: $timeline_ids_for_study_design - name: id - operator: distinct + - domain: ScheduleTimeline + group: + - parent_id + - rel_type + id: $timeline_ids_for_study_design + name: id + operator: distinct Outcome: - Message: 'The activity references a timeline that is not specified within the same study design.' + Message: "The activity references a timeline that is not specified within the same study design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId - - $timeline_ids_for_study_design + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId + - $timeline_ids_for_study_design Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-000847/rule.yml b/Published/CORE-000847/rule.yml index a0c2fce17..5e5b671b8 100644 --- a/Published/CORE-000847/rule.yml +++ b/Published/CORE-000847/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5121 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5121 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SCAN' - operator: exists + - name: "--SCAN" + operator: exists Core: Id: CORE-000847 Status: Published - Version: '1' -Description: '--SCAN must not be present in SEND dataset' + Version: "1" +Description: "--SCAN must not be present in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SCAN must not be present in SEND dataset' + Message: "--SCAN must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000848/rule.yml b/Published/CORE-000848/rule.yml index b8ed63f9e..a60279dd3 100644 --- a/Published/CORE-000848/rule.yml +++ b/Published/CORE-000848/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5122 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5122 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '--SCONG' - operator: exists + - name: "--SCONG" + operator: exists Core: Id: CORE-000848 Status: Published - Version: '1' -Description: '--SCONG (Congenital Anomaly or Birth Defect) must not be in SEND dataset' + Version: "1" +Description: "--SCONG (Congenital Anomaly or Birth Defect) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: '--SCONG must not be present in SEND dataset' + Message: "--SCONG must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000849/rule.yml b/Published/CORE-000849/rule.yml index df520d2d4..7e4b85366 100644 --- a/Published/CORE-000849/rule.yml +++ b/Published/CORE-000849/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its next instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00022' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not refer to itself as its next instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00022' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not refer to itself as its next instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00022" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not refer to itself as its next instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00022" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: nextId - operator: exists - - name: nextId - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: "definition" + - name: nextId + operator: exists + - name: nextId + operator: equal_to + value: id Core: Id: CORE-000849 Status: Published - Version: '1' -Description: 'An instance of a class must not refer to itself as its next instance.' + Version: "1" +Description: "An instance of a class must not refer to itself as its next instance." Executability: Fully Executable Outcome: - Message: 'An instance of a class is referencing itself as its next instance.' + Message: "An instance of a class is referencing itself as its next instance." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - nextId + - parent_entity + - parent_id + - parent_rel + - id + - name + - nextId Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000850/rule.yml b/Published/CORE-000850/rule.yml index 40548bd8a..aacb4baa5 100644 --- a/Published/CORE-000850/rule.yml +++ b/Published/CORE-000850/rule.yml @@ -1,84 +1,84 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a transition start rule is defined then an end rule is expected and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00078' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a transition start rule is defined then an end rule is expected and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00078" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: is_contained_by - value: - - 'Encounter' - - 'StudyElement' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: transitionStartRule - operator: exists - - name: transitionStartRule - operator: non_empty - - name: transitionStartRule - operator: equal_to - value: true - - any: - - name: transitionEndRule - operator: not_exists - - name: transitionEndRule - operator: empty - - name: transitionEndRule - operator: equal_to - value: false - - all: - - name: transitionEndRule - operator: exists - - name: transitionEndRule - operator: non_empty - - name: transitionEndRule - operator: equal_to - value: true - - any: - - name: transitionStartRule - operator: not_exists - - name: transitionStartRule - operator: empty - - name: transitionStartRule - operator: equal_to - value: false + - name: instanceType + operator: is_contained_by + value: + - "Encounter" + - "StudyElement" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: transitionStartRule + operator: exists + - name: transitionStartRule + operator: non_empty + - name: transitionStartRule + operator: equal_to + value: true + - any: + - name: transitionEndRule + operator: not_exists + - name: transitionEndRule + operator: empty + - name: transitionEndRule + operator: equal_to + value: false + - all: + - name: transitionEndRule + operator: exists + - name: transitionEndRule + operator: non_empty + - name: transitionEndRule + operator: equal_to + value: true + - any: + - name: transitionStartRule + operator: not_exists + - name: transitionStartRule + operator: empty + - name: transitionStartRule + operator: equal_to + value: false Core: - Id: 'CORE-000850' + Id: "CORE-000850" Status: Published - Version: '1' -Description: 'If a transition start rule is defined then an end rule is expected and vice versa.' + Version: "1" +Description: "If a transition start rule is defined then an end rule is expected and vice versa." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A transition start rule is defined but an end rule is missing, or vice versa.' + Message: "A transition start rule is defined but an end rule is missing, or vice versa." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - transitionStartRule - - transitionStartRule.id - - transitionStartRule.name - - transitionEndRule - - transitionEndRule.id - - transitionEndRule.name + - parent_entity + - parent_id + - parent_rel + - id + - name + - transitionStartRule + - transitionStartRule.id + - transitionStartRule.name + - transitionEndRule + - transitionEndRule.id + - transitionEndRule.name Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' - - 'StudyElement' + - "Encounter" + - "StudyElement" Sensitivity: Record diff --git a/Published/CORE-000851/rule.yml b/Published/CORE-000851/rule.yml index 4384ef1d4..51e28fb13 100644 --- a/Published/CORE-000851/rule.yml +++ b/Published/CORE-000851/rule.yml @@ -1,59 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not reference itself as one of its own children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00018' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An instance of a class must not reference itself as one of its own children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00018' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not reference itself as one of its own children." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00018" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "An instance of a class must not reference itself as one of its own children." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00018" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'reference' - - name: childIds - operator: exists - - name: parent_rel - operator: equal_to - value: 'childIds' - value_is_literal: true - - name: parent_id - operator: equal_to - value: id + - name: rel_type + operator: equal_to + value: "reference" + - name: childIds + operator: exists + - name: parent_rel + operator: equal_to + value: "childIds" + value_is_literal: true + - name: parent_id + operator: equal_to + value: id Core: Id: CORE-000851 Status: Published - Version: '1' -Description: 'An instance of a class must not reference itself as one of its own children.' + Version: "1" +Description: "An instance of a class must not reference itself as one of its own children." Executability: Fully Executable Outcome: - Message: 'An instance of a class is being referenced as one of its own children.' + Message: "An instance of a class is being referenced as one of its own children." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000852/rule.yml b/Published/CORE-000852/rule.yml index e818ca96f..a8915b2c7 100644 --- a/Published/CORE-000852/rule.yml +++ b/Published/CORE-000852/rule.yml @@ -1,206 +1,216 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variables are ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables are ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.3.1, 2.2.4, and 2.2.5 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Variables for the three general observation classes must be ordered with Identifiers - first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must - be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5' - Document: IG v3.2 - Section: 4.1.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0330 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Variables for the three general observation classes must be ordered with Identifiers - first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must - be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5' - Document: IG v3.3 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0330 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Variables for the 3 general observation classes must be ordered with - Identifiers variables first, followed by Topic, Qualifier, and Timing variables. Within - each role, variables must be ordered as shown in SDTM Sections 3.1.1, The Interventions - Observation Class; 3.1.2, The Events Observation Class; 3.1.3, The Findings Observation - Class; 3.1.3.1, Findings About Events or Interventions; 3.1.4, Identifiers for All - Classes; and 3.1.5, Timing Variables for All Classes. - Document: IG v3.4 - Section: 4.1.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0664 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: TIG - References: - - Citations: - - Cited Guidance: Dataset variables will be ordered per guidance in the SDTM Model v1.2. - Variable order in TIG Domain Specifications aligns with variable order in the SDTM. - Document: TIG 1.0 - Item: Tabulation Datasets Num 3 - Section: '2.6' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0698 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.0 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The order of variables in the data definition file should reflect the order - of variables in the dataset. The order of variables in the SDTM domain models has been - chosen to facilitate the review of the models and application of the models. Variables for - the three general observation classes should be ordered with Identifiers first, followed - by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as - shown in Tables 2.2.1-2.2.5 of the SDTM. - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND48 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Variables for the three general observation classes must be ordered with Identifiers + first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must + be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5" + Document: IG v3.2 + Section: 4.1.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0330 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Variables for the three general observation classes must be ordered with Identifiers + first; followed by the Topic; Qualifier; and Timing variables. Within each role; variables must + be ordered as shown in SDTM: Tables 2.2.1; 2.2.2; 2.2.3; 2.2.3.1; 2.2.4; and 2.2.5" + Document: IG v3.3 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0330 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Variables for the 3 general observation classes must be ordered with + Identifiers variables first, followed by Topic, Qualifier, and Timing variables. Within + each role, variables must be ordered as shown in SDTM Sections 3.1.1, The Interventions + Observation Class; 3.1.2, The Events Observation Class; 3.1.3, The Findings Observation + Class; 3.1.3.1, Findings About Events or Interventions; 3.1.4, Identifiers for All + Classes; and 3.1.5, Timing Variables for All Classes. + Document: IG v3.4 + Section: 4.1.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0664 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Dataset variables will be ordered per guidance in the SDTM Model v1.2. + Variable order in TIG Domain Specifications aligns with variable order in the SDTM. + Document: TIG 1.0 + Item: Tabulation Datasets Num 3 + Section: "2.6" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0698 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.0 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The order of variables in the data definition file should reflect the order + of variables in the dataset. The order of variables in the SDTM domain models has been + chosen to facilitate the review of the models and application of the models. Variables for + the three general observation classes should be ordered with Identifiers first, followed + by the Topic Qualifier, and Timing variables. Within each role, variables are ordered as + shown in Tables 2.2.1-2.2.5 of the SDTM. + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND48 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: $column_order_from_dataset - operator: is_not_ordered_subset_of - value: $column_order_from_library + - name: $column_order_from_dataset + operator: is_not_ordered_subset_of + value: $column_order_from_library Core: Id: CORE-000852 Status: Published - Version: '1' -Description: 'Raise an error when variables are not in the specified order' + Version: "1" +Description: "Raise an error when variables are not in the specified order" Executability: Fully Executable Operations: # variable order in CDISC-Library -- id: $column_order_from_library - operator: get_column_order_from_library - # variable order in dataset -- id: $column_order_from_dataset - operator: get_column_order_from_dataset + - id: $column_order_from_library + operator: get_column_order_from_library + # variable order in dataset + - id: $column_order_from_dataset + operator: get_column_order_from_dataset Outcome: Message: Variables are not in the correct order as shown in SDTM for the observation class. Output Variables: - - $column_order_from_dataset - - $column_order_from_library + - $column_order_from_dataset + - $column_order_from_library Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000853/rule.yml b/Published/CORE-000853/rule.yml index 145a0077f..e1f47364f 100644 --- a/Published/CORE-000853/rule.yml +++ b/Published/CORE-000853/rule.yml @@ -1,168 +1,180 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Collection study day should be populated when date/time of collection is - available. - Document: FDA - Section: FDAB016 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1602 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Collection study day should be populated when date/time of collection is + available. + Document: FDA + Section: FDAB016 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1602 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DTC - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: non_empty - - name: RFSTDTC - operator: is_complete_date - - name: --DY - operator: empty + - name: --DTC + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: non_empty + - name: RFSTDTC + operator: is_complete_date + - name: --DY + operator: empty Core: Id: "CORE-000853" Status: Published - Version: '1' -Description: Collection study day (--DY) should be populated when date/time of collection (--DTC) is + Version: "1" +Description: + Collection study day (--DY) should be populated when date/time of collection (--DTC) is populated Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: - Message: Collection study day (--DY) is not populated when date/time of collection (--DTC) is + Message: + Collection study day (--DY) is not populated when date/time of collection (--DTC) is populated. Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000854/rule.yml b/Published/CORE-000854/rule.yml index 6ec5a2bb1..416debeed 100644 --- a/Published/CORE-000854/rule.yml +++ b/Published/CORE-000854/rule.yml @@ -1,157 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion''s category must be specified using the Category of - Inclusion/Exclusion (C66797) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00110' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion''s category must be specified using the Category of - Inclusion/Exclusion (C66797) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00110' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An eligibility criterion's category must be specified using the Category of + Inclusion/Exclusion (C66797) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00110" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An eligibility criterion's category must be specified using the Category of + Inclusion/Exclusion (C66797) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00110" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: category - operator: equal_to - value: true - - not: - all: - - name: category.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: category.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: category.code - operator: equal_to - value: $code_for_decode_pref_term - - name: category.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: category.decode - operator: equal_to - value: $pref_term_for_code - - name: category.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: category + operator: equal_to + value: true + - not: + all: + - name: category.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: category.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: category.code + operator: equal_to + value: $code_for_decode_pref_term + - name: category.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: category.decode + operator: equal_to + value: $pref_term_for_code + - name: category.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000854' + Id: "CORE-000854" Status: Published - Version: '1' -Description: 'An eligibility criterion''s category must be specified using the Category of Inclusion/Exclusion - (C66797) SDTM codelist.' + Version: "1" +Description: + "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion + (C66797) SDTM codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66797 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: category.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: category.code - version: category.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: category.code - version: category.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: category.decode - version: category.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: category.decode - version: category.codeSystemVersion + - id: $codelist_code + map: + - output: C66797 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: category.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: category.code + version: category.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: category.code + version: category.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: category.decode + version: category.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: category.decode + version: category.codeSystemVersion Outcome: - Message: 'The eligibility criterion''s category is not specified using the Category of Inclusion/Exclusion + Message: + 'The eligibility criterion''s category is not specified using the Category of Inclusion/Exclusion (C66797) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - category.code - - $code_for_decode_value - - $code_for_decode_pref_term - - category.codeSystem - - category.codeSystemVersion - - category.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - category.code + - $code_for_decode_value + - $code_for_decode_pref_term + - category.codeSystem + - category.codeSystemVersion + - category.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'EligibilityCriterion' + - "EligibilityCriterion" Sensitivity: Record diff --git a/Published/CORE-000855/rule.yml b/Published/CORE-000855/rule.yml index 3e33b4d89..2793f9126 100644 --- a/Published/CORE-000855/rule.yml +++ b/Published/CORE-000855/rule.yml @@ -1,157 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s type must be specified using the Intervention Type Response - (C99078) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00128' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s type must be specified using the Intervention Type Response - (C99078) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00128' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study intervention's type must be specified using the Intervention Type Response + (C99078) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00128" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study intervention's type must be specified using the Intervention Type Response + (C99078) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00128" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000855' + Id: "CORE-000855" Status: Published - Version: '1' -Description: 'A study intervention''s type must be specified using the Intervention Type Response (C99078) - SDTM codelist.' + Version: "1" +Description: + "A study intervention's type must be specified using the Intervention Type Response (C99078) + SDTM codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C99078 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C99078 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study intervention''s type is not specified using the Intervention Type Response (C99078) + Message: + 'The study intervention''s type is not specified using the Intervention Type Response (C99078) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - "StudyIntervention" Sensitivity: Record diff --git a/Published/CORE-000856/rule.yml b/Published/CORE-000856/rule.yml index 3ae5efa1a..ac99305d1 100644 --- a/Published/CORE-000856/rule.yml +++ b/Published/CORE-000856/rule.yml @@ -1,175 +1,179 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's contact modes must be specified according to the extensible Mode - of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00136' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's contact modes must be specified according to the extensible Mode - of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the - codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00136' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter's contact modes must be specified according to the extensible Mode + of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the + codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00136" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter's contact modes must be specified according to the extensible Mode + of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the + codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00136" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: contactModes - operator: exists - - name: contactModes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'contactModes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: contactModes + operator: exists + - name: contactModes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "contactModes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000856' + Id: "CORE-000856" Status: Published - Version: '1' -Description: "An encounter's contact modes must be specified according to the extensible Mode of Subject + Version: "1" +Description: + "An encounter's contact modes must be specified according to the extensible Mode of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C171445 - parent_rel.Code: 'contactModes' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C171445 + parent_rel.Code: "contactModes" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s contact mode is not specified according to the extensible Mode of Subject + Message: + 'The encounter''s contact mode is not specified according to the extensible Mode of Subject Contact (C171445) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000857/rule.yml b/Published/CORE-000857/rule.yml index 7e81856fe..0be98184b 100644 --- a/Published/CORE-000857/rule.yml +++ b/Published/CORE-000857/rule.yml @@ -1,168 +1,169 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00141' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00141' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00141" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00141" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: plannedSex - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'plannedSex' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: plannedSex + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "plannedSex" + value_is_literal: true + - not: + all: + - name: codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000857' + Id: "CORE-000857" Status: Published - Version: '1' -Description: 'A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist.' + Version: "1" +Description: "A planned sex must be specified using the Sex of Participants (C66732) SDTM codelist." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C66732 - parent_rel.Code: 'plannedSex' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C66732 + parent_rel.Code: "plannedSex" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The planned sex is not specified using the Sex of Participants (C66732) SDTM codelist - codeSystem + Message: + 'The planned sex is not specified using the Sex of Participants (C66732) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' - - 'StudyCohort' + - "StudyDesignPopulation" + - "StudyCohort" Sensitivity: Record diff --git a/Published/CORE-000858/rule.yml b/Published/CORE-000858/rule.yml index 079915503..5c6c78f35 100644 --- a/Published/CORE-000858/rule.yml +++ b/Published/CORE-000858/rule.yml @@ -1,161 +1,164 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's environmental settings must be specified according to the extensible - Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00157' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter's environmental settings must be specified according to the extensible + Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00157" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: environmentalSettings - operator: exists - - name: environmentalSettings - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'environmentalSettings' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: environmentalSettings + operator: exists + - name: environmentalSettings + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "environmentalSettings" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000858' + Id: "CORE-000858" Status: Published - Version: '1' -Description: "An encounter's environmental settings must be specified according to the extensible Environmental + Version: "1" +Description: + "An encounter's environmental settings must be specified according to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C127262 - parent_rel.Code: 'environmentalSettings' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C127262 + parent_rel.Code: "environmentalSettings" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s environmental setting is not specified according to the extensible Environmental + Message: + 'The encounter''s environmental setting is not specified according to the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000859/rule.yml b/Published/CORE-000859/rule.yml index 86d7709cb..d05e086a3 100644 --- a/Published/CORE-000859/rule.yml +++ b/Published/CORE-000859/rule.yml @@ -1,148 +1,151 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administration's frequency must be specified according to the extensible Frequency - (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00175' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administration's frequency must be specified according to the extensible Frequency + (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00175" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: frequency.standardCode - operator: exists - - name: frequency.standardCode - operator: equal_to - value: true - - not: - all: - - name: frequency.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: frequency.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: frequency.standardCode + operator: exists + - name: frequency.standardCode + operator: equal_to + value: true + - not: + all: + - name: frequency.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: frequency.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: frequency.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: frequency.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: frequency.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: frequency.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000859' + Id: "CORE-000859" Status: Published - Version: '1' -Description: "An administration's frequency must be specified according to the extensible Frequency (C71113) + Version: "1" +Description: + "An administration's frequency must be specified according to the extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C71113 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C71113 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion Outcome: - Message: 'The administration''s frequency is not specified according to the extensible Frequency (C71113) + Message: + 'The administration''s frequency is not specified according to the extensible Frequency (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - frequency.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - frequency.standardCode.codeSystem - - frequency.standardCode.codeSystemVersion - - frequency.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - frequency.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - frequency.standardCode.codeSystem + - frequency.standardCode.codeSystemVersion + - frequency.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000860/rule.yml b/Published/CORE-000860/rule.yml index 8a2913d40..df7174a34 100644 --- a/Published/CORE-000860/rule.yml +++ b/Published/CORE-000860/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administration's route must be specified according to the extensible Route - of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00176' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administration's route must be specified according to the extensible Route + of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00176" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: route.standardCode - operator: exists - - name: route.standardCode - operator: equal_to - value: true - - not: - all: - - name: route.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: route.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: route.standardCode + operator: exists + - name: route.standardCode + operator: equal_to + value: true + - not: + all: + - name: route.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: route.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: route.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: route.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: route.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: route.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000860' + Id: "CORE-000860" Status: Published - Version: '1' -Description: "An administration's route must be specified according to the extensible Route of Administration + Version: "1" +Description: + "An administration's route must be specified according to the extensible Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66729 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: route.standardCode.decode - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: route.standardCode.decode - version: route.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66729 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: route.standardCode.decode + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: route.standardCode.decode + version: route.standardCode.codeSystemVersion Outcome: - Message: 'The administration''s route is not specified according to the extensible Route of Administration + Message: + 'The administration''s route is not specified according to the extensible Route of Administration Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - route.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - route.standardCode.codeSystem - - route.standardCode.codeSystemVersion - - route.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - route.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - route.standardCode.codeSystem + - route.standardCode.codeSystemVersion + - route.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000861/rule.yml b/Published/CORE-000861/rule.yml index 4c08f10ac..c2dca3df8 100644 --- a/Published/CORE-000861/rule.yml +++ b/Published/CORE-000861/rule.yml @@ -1,150 +1,153 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable dose form must be specified according to the extensible Pharmaceutical - Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00179' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administrable dose form must be specified according to the extensible Pharmaceutical + Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00179" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: administrableDoseForm.standardCode - operator: exists - - name: administrableDoseForm.standardCode - operator: equal_to - value: true - - not: - all: - - name: administrableDoseForm.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: administrableDoseForm.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: administrableDoseForm.standardCode + operator: exists + - name: administrableDoseForm.standardCode + operator: equal_to + value: true + - not: + all: + - name: administrableDoseForm.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: administrableDoseForm.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: administrableDoseForm.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: administrableDoseForm.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: administrableDoseForm.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: administrableDoseForm.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: administrableDoseForm.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: administrableDoseForm.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: administrableDoseForm.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: administrableDoseForm.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000861' + Id: "CORE-000861" Status: Published - Version: '1' -Description: "An administrable dose form must be specified according to the extensible Pharmaceutical + Version: "1" +Description: + "An administrable dose form must be specified according to the extensible Pharmaceutical Dosage Form (C66726) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66726 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: administrableDoseForm.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: administrableDoseForm.standardCode.code - version: administrableDoseForm.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: administrableDoseForm.standardCode.code - version: administrableDoseForm.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: administrableDoseForm.standardCode.decode - version: administrableDoseForm.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: administrableDoseForm.standardCode.decode - version: administrableDoseForm.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66726 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: administrableDoseForm.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: administrableDoseForm.standardCode.code + version: administrableDoseForm.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: administrableDoseForm.standardCode.code + version: administrableDoseForm.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: administrableDoseForm.standardCode.decode + version: administrableDoseForm.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: administrableDoseForm.standardCode.decode + version: administrableDoseForm.standardCode.codeSystemVersion Outcome: - Message: 'The administrable dose form is not specified according to the extensible Pharmaceutical Dosage + Message: + 'The administrable dose form is not specified according to the extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - administrableDoseForm.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - administrableDoseForm.standardCode.codeSystem - - administrableDoseForm.standardCode.codeSystemVersion - - administrableDoseForm.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - administrableDoseForm.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - administrableDoseForm.standardCode.codeSystem + - administrableDoseForm.standardCode.codeSystemVersion + - administrableDoseForm.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - "AdministrableProduct" Sensitivity: Record diff --git a/Published/CORE-000862/rule.yml b/Published/CORE-000862/rule.yml index d4a0920d8..f494b2eba 100644 --- a/Published/CORE-000862/rule.yml +++ b/Published/CORE-000862/rule.yml @@ -1,162 +1,174 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3205 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3205 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STDY - operator: exists - - name: --STDTC - operator: not_exists + - name: --STDY + operator: exists + - name: --STDTC + operator: not_exists Core: Id: CORE-000862 Status: Published - Version: '1' -Description: When Study Day of Start of Observation (--STDY) is present in the dataset, then the + Version: "1" +Description: + When Study Day of Start of Observation (--STDY) is present in the dataset, then the Start Date/Time of Observation (--STDTC) is also present in the dataset. Executability: Fully Executable Outcome: - Message: Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of + Message: + Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of Observation (--STDY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000863/rule.yml b/Published/CORE-000863/rule.yml index bcf106784..354f44aa3 100644 --- a/Published/CORE-000863/rule.yml +++ b/Published/CORE-000863/rule.yml @@ -1,152 +1,152 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Standardized Result in Numeric Format should be populated whenever it is applicable.' - Document: 'FDA' - Section: 'FDAB031' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3101' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Standardized Result in Numeric Format should be populated whenever it is applicable." + Document: "FDA" + Section: "FDAB031" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3101" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRESC - operator: non_empty - - name: --STRESC - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --STRESN - operator: empty + - name: --STRESC + operator: non_empty + - name: --STRESC + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --STRESN + operator: empty Core: Id: CORE-000863 Status: Published - Version: '1' + Version: "1" Description: When --STRESC is populated with a numeric value, --STRESN should be populated. Executability: Fully Executable Outcome: Message: --STRESC is populated with a numeric value, but --STRESN is not populated. Output Variables: - - --STRESC - - --STRESN + - --STRESC + - --STRESN Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000864/rule.yml b/Published/CORE-000864/rule.yml index b1824bbaf..436190794 100644 --- a/Published/CORE-000864/rule.yml +++ b/Published/CORE-000864/rule.yml @@ -1,162 +1,174 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: 3.1.1 - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3206 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: 3.1.1 + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3206 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --ENDY - operator: exists - - name: --ENDTC - operator: not_exists + - name: --ENDY + operator: exists + - name: --ENDTC + operator: not_exists Core: Id: CORE-000864 Status: Published - Version: '1' -Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End + Version: "1" +Description: + When Study Day of End of Observation (--ENDY) is present in the dataset, then the End Date/Time of Observation (--ENDTC) is also present in the dataset Executability: Fully Executable Outcome: - Message: End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of + Message: + End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of Observation (--ENDY) is present. Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000865/rule.yml b/Published/CORE-000865/rule.yml index a90580dc6..9bfb3f2b8 100644 --- a/Published/CORE-000865/rule.yml +++ b/Published/CORE-000865/rule.yml @@ -1,159 +1,170 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Applicable to SDTMIG versions 3.2, 3.3, 3.4 - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When timing info is provided as a reference to a particular timepoint, the timepoint - should be also populated.' - Document: 'FDA' - Section: 'FDAB044' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4405' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When timing info is provided as a reference to a particular timepoint, the timepoint + should be also populated." + Document: "FDA" + Section: "FDAB044" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4405" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # REMARK: --TPTNUM and --ELTM both are usually "permissible" all: - - name: '--TPTREF' - operator: exists - - name: '--ELTM' - operator: exists - #- name: '--TPTREF' - # operator: 'non_empty' - #- name: '--ELTM' - # operator: 'empty' - # Correction 2025-09-05 - - name: '--ELTM' - operator: 'non_empty' - - name: '--TPTREF' - operator: 'empty' + - name: "--TPTREF" + operator: exists + - name: "--ELTM" + operator: exists + #- name: '--TPTREF' + # operator: 'non_empty' + #- name: '--ELTM' + # operator: 'empty' + # Correction 2025-09-05 + - name: "--ELTM" + operator: "non_empty" + - name: "--TPTREF" + operator: "empty" Core: Id: CORE-000865 Status: Published - Version: '1' -Description: 'When Planned Elapsed Time from Time Point Ref (--ELTM) is populated, Time Point Reference - (--TPTREF) should also be populated.' + Version: "1" +Description: + "When Planned Elapsed Time from Time Point Ref (--ELTM) is populated, Time Point Reference + (--TPTREF) should also be populated." Executability: Fully Executable Outcome: Message: --ELTM is populated, but --TPTREF is missing. @@ -161,10 +172,10 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - EVENTS - - INTERVENTIONS + - FINDINGS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000866/rule.yml b/Published/CORE-000866/rule.yml index a49c66cf8..0f468d5fb 100644 --- a/Published/CORE-000866/rule.yml +++ b/Published/CORE-000866/rule.yml @@ -2,169 +2,180 @@ # Condition: --DTC ^= Null and --ENDTC ^= Null # Rule: --DTC <= --ENDTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3210 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3210 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --DTC - operator: exists - - name: --ENDTC - operator: exists - - name: --DTC - operator: non_empty - - name: --ENDTC - operator: non_empty - - name: --DTC - operator: date_greater_than_or_equal_to - value: --ENDTC + - name: --DTC + operator: exists + - name: --ENDTC + operator: exists + - name: --DTC + operator: non_empty + - name: --ENDTC + operator: non_empty + - name: --DTC + operator: date_greater_than_or_equal_to + value: --ENDTC Core: Id: CORE-000866 Status: Published - Version: '1' -Description: Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of + Version: "1" +Description: + Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of Observation (--ENDTC) Executability: Fully Executable Outcome: Message: --DTC falls after --ENDTC. Output Variables: - - --DTC - - --ENDTC + - --DTC + - --ENDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000867/rule.yml b/Published/CORE-000867/rule.yml index c00b58435..b0f4d2f0b 100644 --- a/Published/CORE-000867/rule.yml +++ b/Published/CORE-000867/rule.yml @@ -1,151 +1,151 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1501' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1501" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: matches_regex - value: ^\s # leading spaces + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: matches_regex + value: ^\s # leading spaces Core: Id: CORE-000867 Status: Published - Version: '1' + Version: "1" Description: Text variable in submitted dataset should not contain leading spaces ' '. Executability: Fully Executable Outcome: Message: Text variable contains leading spaces. Output Variables: - - variable_value - - variable_name + - variable_value + - variable_name Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000868/rule.yml b/Published/CORE-000868/rule.yml index f26910e4f..b5c72994d 100644 --- a/Published/CORE-000868/rule.yml +++ b/Published/CORE-000868/rule.yml @@ -1,89 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., - at least one scheduled activity instance that is referenced by a Fixed Reference timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00009' - Version: '1' - Version: '1.0' - Version: '3.0' -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., - at least one scheduled activity instance that is referenced by a Fixed Reference timing.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00009' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each schedule timeline must contain at least one anchor (fixed time) - i.e., + at least one scheduled activity instance that is referenced by a Fixed Reference timing." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00009" + Version: "1" + Version: "1.0" + Version: "3.0" + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each schedule timeline must contain at least one anchor (fixed time) - i.e., + at least one scheduled activity instance that is referenced by a Fixed Reference timing." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00009" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduleTimeline' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: $fixed_ref_sched_ins - operator: empty - - name: $instances - operator: empty - - name: $fixed_ref_sched_ins - operator: shares_no_elements_with - value: $instances + - name: instanceType + operator: equal_to + value: "ScheduleTimeline" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: $fixed_ref_sched_ins + operator: empty + - name: $instances + operator: empty + - name: $fixed_ref_sched_ins + operator: shares_no_elements_with + value: $instances Core: - Id: 'CORE-000868' + Id: "CORE-000868" Status: Published - Version: '1' -Description: 'Each schedule timeline must contain at least one anchor (fixed time) - i.e., at least one - scheduled activity instance that is referenced by a Fixed Reference timing.' + Version: "1" +Description: + "Each schedule timeline must contain at least one anchor (fixed time) - i.e., at least one + scheduled activity instance that is referenced by a Fixed Reference timing." Executability: Fully Executable Operations: -- domain: Timing - filter: - rel_type: 'definition' - type.code: 'C201358' - group: - - parent_id - group_aliases: - - id - id: $fixed_ref_sched_ins - name: relativeFromScheduledInstanceId - operator: distinct -- domain: ScheduledActivityInstance - filter: - rel_type: 'definition' - group: - - parent_id - group_aliases: - - id - id: $instances - name: id - operator: distinct + - domain: Timing + filter: + rel_type: "definition" + type.code: "C201358" + group: + - parent_id + group_aliases: + - id + id: $fixed_ref_sched_ins + name: relativeFromScheduledInstanceId + operator: distinct + - domain: ScheduledActivityInstance + filter: + rel_type: "definition" + group: + - parent_id + group_aliases: + - id + id: $instances + name: id + operator: distinct Outcome: - Message: 'The schedule timeline does not contain an anchor (i.e., a scheduled activity instance that - is referenced by a Fixed Reference timing).' + Message: + "The schedule timeline does not contain an anchor (i.e., a scheduled activity instance that + is referenced by a Fixed Reference timing)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Include: - - 'ScheduleTimeline' + - "ScheduleTimeline" Sensitivity: Record diff --git a/Published/CORE-000869/rule.yml b/Published/CORE-000869/rule.yml index a4fe8e5d6..b26f81425 100644 --- a/Published/CORE-000869/rule.yml +++ b/Published/CORE-000869/rule.yml @@ -1,62 +1,65 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute - reasonDurationWillVary) must be given and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00034' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If duration will vary (attribute durationWillVary is True) then a reason (attribute + reasonDurationWillVary) must be given and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00034" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Duration' - - any: - - name: durationWillVary - operator: not_equal_to - value: false - - all: - - name: reasonDurationWillVary - operator: exists - - name: reasonDurationWillVary - operator: non_empty - - any: - - name: durationWillVary - operator: not_equal_to - value: true - - name: reasonDurationWillVary - operator: not_exists - - name: reasonDurationWillVary - operator: empty + - name: instanceType + operator: equal_to + value: "Duration" + - any: + - name: durationWillVary + operator: not_equal_to + value: false + - all: + - name: reasonDurationWillVary + operator: exists + - name: reasonDurationWillVary + operator: non_empty + - any: + - name: durationWillVary + operator: not_equal_to + value: true + - name: reasonDurationWillVary + operator: not_exists + - name: reasonDurationWillVary + operator: empty Core: - Id: 'CORE-000869' + Id: "CORE-000869" Status: Published - Version: '1' -Description: 'If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) - must be given and vice versa.' + Version: "1" +Description: + "If duration will vary (attribute durationWillVary is True) then a reason (attribute reasonDurationWillVary) + must be given and vice versa." Executability: Fully Executable Outcome: - Message: The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is - populated), but it is not fully defined (durationWillVary is not 'true' or + Message: + The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is + populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing). Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - durationWillVary - - reasonDurationWillVary + - parent_entity + - parent_id + - parent_rel + - id + - text + - durationWillVary + - reasonDurationWillVary Rule Type: Record Data Scope: Entities: Include: - - Duration + - Duration Sensitivity: Record diff --git a/Published/CORE-000870/rule.yml b/Published/CORE-000870/rule.yml index 4c748568b..d4dc73a87 100644 --- a/Published/CORE-000870/rule.yml +++ b/Published/CORE-000870/rule.yml @@ -1,70 +1,72 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All scheduled activity instances in the main timeline are expected to refer to - an epoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00080' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All scheduled activity instances in the main timeline are expected to refer to - an epoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00080' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "All scheduled activity instances in the main timeline are expected to refer to + an epoch." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00080" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "All scheduled activity instances in the main timeline are expected to refer to + an epoch." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00080" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: mainTimeline - operator: equal_to - value: true - - any: - - name: epochId - operator: not_exists - - name: epochId - operator: empty + - name: rel_type + operator: equal_to + value: "definition" + - name: mainTimeline + operator: equal_to + value: true + - any: + - name: epochId + operator: not_exists + - name: epochId + operator: empty Core: - Id: 'CORE-000870' + Id: "CORE-000870" Status: Published - Version: '1' -Description: 'All scheduled activity instances in the main timeline are expected to refer to an epoch.' + Version: "1" +Description: "All scheduled activity instances in the main timeline are expected to refer to an epoch." Executability: Partially Executable - Possible Overreporting Match Datasets: -- Keys: - - Left: parent_entity - Right: instanceType - - Left: parent_id - Right: id - - rel_type - Name: ScheduleTimeline + - Keys: + - Left: parent_entity + Right: instanceType + - Left: parent_id + Right: id + - rel_type + Name: ScheduleTimeline Outcome: - Message: 'The scheduled activity instance is in the main timeline but does not refer to an epoch.' + Message: "The scheduled activity instance is in the main timeline but does not refer to an epoch." Output Variables: - - parent_entity - - parent_id - - parent_rel - - mainTimeline - - id - - name - - epochId + - parent_entity + - parent_id + - parent_rel + - mainTimeline + - id + - name + - epochId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - "ScheduledActivityInstance" Sensitivity: Record diff --git a/Published/CORE-000871/rule.yml b/Published/CORE-000871/rule.yml index 340f98a6b..4d9f0f593 100644 --- a/Published/CORE-000871/rule.yml +++ b/Published/CORE-000871/rule.yml @@ -1,88 +1,91 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design there is expected to be exactly one objective with level - 'Primary Objective'." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00084' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design there is expected to be exactly one objective with level - 'Primary Objective'." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00084' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design there is expected to be exactly one objective with level + 'Primary Objective'." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00084" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design there is expected to be exactly one objective with level + 'Primary Objective'." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00084" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - not: - all: - - name: $num_primary_obj - operator: non_empty - - name: $num_primary_obj - operator: equal_to - value: 1 + - name: rel_type + operator: equal_to + value: "definition" + - not: + all: + - name: $num_primary_obj + operator: non_empty + - name: $num_primary_obj + operator: equal_to + value: 1 Core: - Id: 'CORE-000871' + Id: "CORE-000871" Status: Published - Version: '1' -Description: "Within a study design there is expected to be exactly one objective with level 'Primary + Version: "1" +Description: + "Within a study design there is expected to be exactly one objective with level 'Primary Objective'." Executability: Partially Executable - Possible Overreporting Operations: -- domain: Objective - filter: - level.code: 'C85826' - rel_type: 'definition' - group: - - parent_id - - rel_type - group_aliases: - - id - id: $num_primary_obj - operator: record_count -- domain: Objective - filter: - level.code: 'C85826' - rel_type: 'definition' - group: - - parent_id - - rel_type - group_aliases: - - id - id: $primary_objectives - name: text - operator: distinct + - domain: Objective + filter: + level.code: "C85826" + rel_type: "definition" + group: + - parent_id + - rel_type + group_aliases: + - id + id: $num_primary_obj + operator: record_count + - domain: Objective + filter: + level.code: "C85826" + rel_type: "definition" + group: + - parent_id + - rel_type + group_aliases: + - id + id: $primary_objectives + name: text + operator: distinct Outcome: Message: "There is not exactly one objective with a level of 'Primary Objective' within the study design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $num_primary_obj - - $primary_objectives + - parent_entity + - parent_id + - parent_rel + - id + - name + - $num_primary_obj + - $primary_objectives Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000872/rule.yml b/Published/CORE-000872/rule.yml index fdf0c2db1..9bfefba5d 100644 --- a/Published/CORE-000872/rule.yml +++ b/Published/CORE-000872/rule.yml @@ -1,83 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study protocol document version must be unique regarding - the combination of type and geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00092' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Date values associated to a study protocol document version must be unique regarding + the combination of type and geographic scopes of the date." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00092" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyProtocolDocumentVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: "StudyProtocolDocumentVersion" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: - Id: 'CORE-000872' + Id: "CORE-000872" Status: Published - Version: '1' -Description: 'Date values associated to a study protocol document version must be unique regarding the - combination of type and geographic scopes of the date.' + Version: "1" +Description: + "Date values associated to a study protocol document version must be unique regarding the + combination of type and geographic scopes of the date." Executability: Fully Executable Match Datasets: -- Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate -- Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope + - Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate + - Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study protocol document version has more than one governance date with the same type and - geographic scope.' + Message: + "The study protocol document version has more than one governance date with the same type and + geographic scope." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - protocolVersion - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - protocolVersion + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyProtocolDocumentVersion' + - "StudyProtocolDocumentVersion" Sensitivity: Record diff --git a/Published/CORE-000873/rule.yml b/Published/CORE-000873/rule.yml index 886f9d24b..e0a3535c4 100644 --- a/Published/CORE-000873/rule.yml +++ b/Published/CORE-000873/rule.yml @@ -1,94 +1,97 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study version must be unique regarding the combination - of type and geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00093' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study version must be unique regarding the combination - of type and geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00093' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Date values associated to a study version must be unique regarding the combination + of type and geographic scopes of the date." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00093" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Date values associated to a study version must be unique regarding the combination + of type and geographic scopes of the date." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00093" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: "StudyVersion" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: - Id: 'CORE-000873' + Id: "CORE-000873" Status: Published - Version: '1' -Description: 'Date values associated to a study version must be unique regarding the combination of type - and geographic scopes of the date.' + Version: "1" +Description: + "Date values associated to a study version must be unique regarding the combination of type + and geographic scopes of the date." Executability: Fully Executable Match Datasets: -- Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate -- Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope + - Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate + - Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study version has more than one governance date with the same type and geographic scope.' + Message: "The study version has more than one governance date with the same type and geographic scope." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-000874/rule.yml b/Published/CORE-000874/rule.yml index cdcecf94c..e9cc4b016 100644 --- a/Published/CORE-000874/rule.yml +++ b/Published/CORE-000874/rule.yml @@ -1,69 +1,70 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All primary endpoints must be referenced by a primary objective.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00096' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All primary endpoints must be referenced by a primary objective.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00096' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "All primary endpoints must be referenced by a primary objective." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00096" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "All primary endpoints must be referenced by a primary objective." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00096" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level.code - operator: equal_to - value: 'C94496' - - name: level.code.Objective - operator: not_equal_to - value: 'C85826' + - name: rel_type + operator: equal_to + value: "definition" + - name: level.code + operator: equal_to + value: "C94496" + - name: level.code.Objective + operator: not_equal_to + value: "C85826" Core: - Id: 'CORE-000874' + Id: "CORE-000874" Status: Published - Version: '1' -Description: 'All primary endpoints must be referenced by a primary objective.' + Version: "1" +Description: "All primary endpoints must be referenced by a primary objective." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: parent_id - Right: id - - rel_type - Name: Objective + - Join Type: left + Keys: + - Left: parent_id + Right: id + - rel_type + Name: Objective Outcome: - Message: 'The primary endpoint (level.code = C94496) is not referenced by a primary objective (level.code.Objective - = C85826).' + Message: + "The primary endpoint (level.code = C94496) is not referenced by a primary objective (level.code.Objective + = C85826)." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - level.code - - level.decode - - name.Objective - - level.code.Objective - - level.decode.Objective + - parent_entity + - parent_id + - parent_rel + - id + - name + - level.code + - level.decode + - name.Objective + - level.code.Objective + - level.decode.Objective Rule Type: Record Data Scope: Entities: Include: - - 'Endpoint' + - "Endpoint" Sensitivity: Record diff --git a/Published/CORE-000875/rule.yml b/Published/CORE-000875/rule.yml index 99fc8be24..14bb95105 100644 --- a/Published/CORE-000875/rule.yml +++ b/Published/CORE-000875/rule.yml @@ -1,97 +1,101 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned sex must be specified either in the study - population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00098' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, the planned sex must be specified either in the study - population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00098' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, the planned sex must be specified either in the study + population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00098" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, the planned sex must be specified either in the study + population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00098" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDesignPopulation' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - any: - - name: plannedSex - operator: not_exists - - name: plannedSex - operator: empty - - name: plannedSex - operator: equal_to - value: false - - any: - - name: plannedSex.StudyCohort - operator: not_exists - - name: plannedSex.StudyCohort - operator: empty - - name: plannedSex.StudyCohort - operator: equal_to - value: false - - all: - - name: plannedSex - operator: equal_to - value: true - - name: plannedSex.StudyCohort - operator: equal_to - value: true + - name: instanceType + operator: equal_to + value: "StudyDesignPopulation" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - any: + - name: plannedSex + operator: not_exists + - name: plannedSex + operator: empty + - name: plannedSex + operator: equal_to + value: false + - any: + - name: plannedSex.StudyCohort + operator: not_exists + - name: plannedSex.StudyCohort + operator: empty + - name: plannedSex.StudyCohort + operator: equal_to + value: false + - all: + - name: plannedSex + operator: equal_to + value: true + - name: plannedSex.StudyCohort + operator: equal_to + value: true Core: - Id: 'CORE-000875' + Id: "CORE-000875" Status: Published - Version: '1' -Description: 'Within a study design, the planned sex must be specified either in the study population - or in all cohorts.' + Version: "1" +Description: + "Within a study design, the planned sex must be specified either in the study population + or in all cohorts." Executability: Fully Executable Match Datasets: -- Join Type: left - Keys: - - Left: id - Right: parent_id - - Left: instanceType - Right: parent_entity - - rel_type - Name: StudyCohort + - Join Type: left + Keys: + - Left: id + Right: parent_id + - Left: instanceType + Right: parent_entity + - rel_type + Name: StudyCohort Outcome: - Message: 'Planned sex has not been specified for either the study population or the cohort, or it has - been specified for both.' + Message: + "Planned sex has not been specified for either the study population or the cohort, or it has + been specified for both." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - plannedSex - - plannedSex.decode - - id.StudyCohort - - name.StudyCohort - - plannedSex.StudyCohort - - plannedSex.decode.StudyCohort + - parent_entity + - parent_id + - parent_rel + - id + - name + - plannedSex + - plannedSex.decode + - id.StudyCohort + - name.StudyCohort + - plannedSex.StudyCohort + - plannedSex.decode.StudyCohort Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000876/rule.yml b/Published/CORE-000876/rule.yml index ad9e77efc..524eb9d2f 100644 --- a/Published/CORE-000876/rule.yml +++ b/Published/CORE-000876/rule.yml @@ -1,64 +1,65 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a document version, the specified section numbers for narrative content - must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00103' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a document version, the specified section numbers for narrative content + must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00103" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: instanceType - operator: equal_to - value: 'NarrativeContent' - - name: rel_type - operator: equal_to - value: 'definition' - - name: sectionNumber - operator: non_empty - - name: sectionNumber - operator: is_not_unique_set - value: - - parent_entity - - parent_id + - name: instanceType + operator: equal_to + value: "NarrativeContent" + - name: rel_type + operator: equal_to + value: "definition" + - name: sectionNumber + operator: non_empty + - name: sectionNumber + operator: is_not_unique_set + value: + - parent_entity + - parent_id Core: - Id: 'CORE-000876' + Id: "CORE-000876" Status: Published - Version: '1' -Description: 'Within a document version, the specified section numbers for narrative content must be unique.' + Version: "1" +Description: "Within a document version, the specified section numbers for narrative content must be unique." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: StudyProtocolDocumentVersion -- Keys: - - Left: parent_id.StudyProtocolDocumentVersion - Right: id - - rel_type - Name: StudyProtocolDocument + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: StudyProtocolDocumentVersion + - Keys: + - Left: parent_id.StudyProtocolDocumentVersion + Right: id + - rel_type + Name: StudyProtocolDocument Outcome: - Message: 'The section number is not unique within the document version.' + Message: "The section number is not unique within the document version." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - sectionNumber - - name.StudyProtocolDocument - - protocolVersion + - parent_entity + - parent_id + - parent_rel + - id + - name + - sectionNumber + - name.StudyProtocolDocument + - protocolVersion Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-000877/rule.yml b/Published/CORE-000877/rule.yml index 006fe924f..597c84047 100644 --- a/Published/CORE-000877/rule.yml +++ b/Published/CORE-000877/rule.yml @@ -1,84 +1,88 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline that is defined within - the same study design as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00107' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only have a sub-timeline that is defined within - the same study design as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00107' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only have a sub-timeline that is defined within + the same study design as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00107" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only have a sub-timeline that is defined within + the same study design as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00107" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledActivityInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - name: timelineId - operator: non_empty - - name: $study_design_id_for_subtimeline - operator: not_equal_to - value: $study_design_id_for_scheduled_instance + - name: instanceType + operator: equal_to + value: "ScheduledActivityInstance" + - name: rel_type + operator: equal_to + value: "definition" + - name: timelineId + operator: non_empty + - name: $study_design_id_for_subtimeline + operator: not_equal_to + value: $study_design_id_for_scheduled_instance Core: - Id: 'CORE-000877' + Id: "CORE-000877" Status: Published - Version: '1' -Description: 'A scheduled activity instance must only have a sub-timeline that is defined within the same - study design as the scheduled activity instance.' + Version: "1" +Description: + "A scheduled activity instance must only have a sub-timeline that is defined within the same + study design as the scheduled activity instance." Executability: Fully Executable Operations: -- domain: ScheduleTimeline - group: - - id - - rel_type - group_aliases: - - parent_id - id: $study_design_id_for_scheduled_instance - name: parent_id - operator: distinct -- domain: ScheduleTimeline - group: - - id - - rel_type - group_aliases: - - timelineId - id: $study_design_id_for_subtimeline - name: parent_id - operator: distinct + - domain: ScheduleTimeline + group: + - id + - rel_type + group_aliases: + - parent_id + id: $study_design_id_for_scheduled_instance + name: parent_id + operator: distinct + - domain: ScheduleTimeline + group: + - id + - rel_type + group_aliases: + - timelineId + id: $study_design_id_for_subtimeline + name: parent_id + operator: distinct Outcome: - Message: 'The scheduled activity instance has a sub-timeline that is not defined within the same study - design.' + Message: + "The scheduled activity instance has a sub-timeline that is not defined within the same study + design." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - timelineId - - $study_design_id_for_scheduled_instance - - $study_design_id_for_subtimeline + - parent_entity + - parent_id + - parent_rel + - id + - name + - timelineId + - $study_design_id_for_scheduled_instance + - $study_design_id_for_subtimeline Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledActivityInstance' + - "ScheduledActivityInstance" Sensitivity: Record diff --git a/Published/CORE-000878/rule.yml b/Published/CORE-000878/rule.yml index 0e39ba907..a8a85909a 100644 --- a/Published/CORE-000878/rule.yml +++ b/Published/CORE-000878/rule.yml @@ -1,150 +1,154 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If specified, the context of a condition must point to a valid instance in the - activity or scheduled activity instance class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00114' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If specified, the context of a condition must point to a valid instance in the - activity or scheduled activity instance class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00114' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If specified, the context of a condition must point to a valid instance in the + activity or scheduled activity instance class." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00114" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If specified, the context of a condition must point to a valid instance in the + activity or scheduled activity instance class." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00114" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: parent_rel - operator: equal_to - value: 'contextIds' - value_is_literal: true - - name: $condition_count - operator: non_empty + - name: parent_rel + operator: equal_to + value: "contextIds" + value_is_literal: true + - name: $condition_count + operator: non_empty Core: - Id: 'CORE-000878' + Id: "CORE-000878" Status: Published - Version: '1' -Description: 'If specified, the context of a condition must point to a valid instance in the activity - or scheduled activity instance class.' + Version: "1" +Description: + "If specified, the context of a condition must point to a valid instance in the activity + or scheduled activity instance class." Executability: Fully Executable Operations: -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_count - operator: record_count -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_entity - name: parent_entity - operator: distinct -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_id - name: parent_id - operator: distinct -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_parent_rel - name: parent_rel - operator: distinct -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_rel_type - name: rel_type - operator: distinct -- domain: Condition - filter: - rel_type: definition - group: - - id - - instanceType - group_aliases: - - parent_id - - parent_entity - id: $condition_name - name: name - operator: distinct -- id: $error_type - map: - - output: The id value references an invalid instance type. - parent_entity: Condition - rel_type: reference - - output: The referenced id value is not valid. - parent_entity: Condition - rel_type: definition - operator: map + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_count + operator: record_count + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_entity + name: parent_entity + operator: distinct + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_id + name: parent_id + operator: distinct + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_parent_rel + name: parent_rel + operator: distinct + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_rel_type + name: rel_type + operator: distinct + - domain: Condition + filter: + rel_type: definition + group: + - id + - instanceType + group_aliases: + - parent_id + - parent_entity + id: $condition_name + name: name + operator: distinct + - id: $error_type + map: + - output: The id value references an invalid instance type. + parent_entity: Condition + rel_type: reference + - output: The referenced id value is not valid. + parent_entity: Condition + rel_type: definition + operator: map Outcome: - Message: 'The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance - class (the value of the condition''s contextIds attribute either matches the id of an instance that - is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance).' + Message: + "The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance + class (the value of the condition's contextIds attribute either matches the id of an instance that + is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance)." Output Variables: - - $condition_parent_entity - - $condition_parent_id - - $condition_parent_rel - - $condition_rel_type - - $condition_name - - id - - name - - parent_id - - parent_rel - - rel_type - - instanceType - - value - - $error_type + - $condition_parent_entity + - $condition_parent_id + - $condition_parent_rel + - $condition_rel_type + - $condition_name + - id + - name + - parent_id + - parent_rel + - rel_type + - instanceType + - value + - $error_type Rule Type: Record Data Scope: Entities: Exclude: - - 'Activity' - - 'ScheduledActivityInstance' + - "Activity" + - "ScheduledActivityInstance" Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000879/rule.yml b/Published/CORE-000879/rule.yml index 6de746ff2..a92e4b05c 100644 --- a/Published/CORE-000879/rule.yml +++ b/Published/CORE-000879/rule.yml @@ -1,67 +1,71 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), - the code system version must be a valid CDISC terminology release date in ISO 8601 date format." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00155' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), - the code system version must be a valid CDISC terminology release date in ISO 8601 date format." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00155' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), + the code system version must be a valid CDISC terminology release date in ISO 8601 date format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00155" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), + the code system version must be a valid CDISC terminology release date in ISO 8601 date format." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00155" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_not_contained_by - value: $valid_versions + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_not_contained_by + value: $valid_versions Core: - Id: 'CORE-000879' + Id: "CORE-000879" Status: Published - Version: '1' -Description: "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), the code + Version: "1" +Description: + "For CDISC codelist references (where the code system is 'http://www.cdisc.org'), the code system version must be a valid CDISC terminology release date in ISO 8601 date format." Executability: Fully Executable Operations: -- ct_package_types: - - DDF - - SDTM - - PROTOCOL - id: $valid_versions - operator: valid_codelist_dates + - ct_package_types: + - DDF + - SDTM + - PROTOCOL + id: $valid_versions + operator: valid_codelist_dates Outcome: - Message: 'The code system is "http://www.cdisc.org" but the code system version is not a valid CDISC + Message: + 'The code system is "http://www.cdisc.org" but the code system version is not a valid CDISC terminology release date in ISO 8601 date format.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - 'Code' + - "Code" Sensitivity: Record diff --git a/Published/CORE-000881/rule.yml b/Published/CORE-000881/rule.yml index f14cad614..27a3d95b9 100644 --- a/Published/CORE-000881/rule.yml +++ b/Published/CORE-000881/rule.yml @@ -1,53 +1,56 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable to SENDIG version 3.1 and 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on which group summaries - (group means and incidences) are calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on which group summaries - (group means and incidences) are calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4701 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data." + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4701 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data." + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4701 + Version: "1" + Version: "1.5" + Version: "3.1.1" Check: all: # - name: DSTERM - - name: DSDECOD - operator: is_contained_by - value: - - "INTERIM SACRIFICE" - - "RECOVERY SACRIFICE" - - "REMOVED FROM STUDY ALIVE" - - "TERMINAL SACRIFICE" - - name: VISITDY - operator: 'empty' - - name: DSNOMDY - operator: 'empty' + - name: DSDECOD + operator: is_contained_by + value: + - "INTERIM SACRIFICE" + - "RECOVERY SACRIFICE" + - "REMOVED FROM STUDY ALIVE" + - "TERMINAL SACRIFICE" + - name: VISITDY + operator: "empty" + - name: DSNOMDY + operator: "empty" Core: Id: CORE-000881 Status: Published - Version: '1' -Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as - these are required timing variables for identification of the day on which group summaries (Group + Version: "1" +Description: + VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as + these are required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for post mortem data. Executability: Fully Executable Outcome: @@ -56,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000882/rule.yml b/Published/CORE-000882/rule.yml index 3ea0c13e6..9369b5672 100644 --- a/Published/CORE-000882/rule.yml +++ b/Published/CORE-000882/rule.yml @@ -1,43 +1,45 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable to SENDIG version 3.0, not to SENDIG 3.1 and 3.1.1 # Very similar to FB4701, but without DSNOMDY, only with VISITDY - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on which group summaries - (group means and incidences) are calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4703 - Version: '1' - Version: '1.5' - Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data." + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4703 + Version: "1" + Version: "1.5" + Version: "3.0" Check: all: # - name: DSTERM - # "DSTERM" changed in "DSDECOD" - see comment Keith Moseley + # "DSTERM" changed in "DSDECOD" - see comment Keith Moseley # https://jira.cdisc.org/browse/CORERULES-9244 - - name: DSDECOD - operator: is_contained_by - value: - - "INTERIM SACRIFICE" - - "RECOVERY SACRIFICE" - - "REMOVED FROM STUDY ALIVE" - - "TERMINAL SACRIFICE" - - name: VISITDY - operator: 'empty' + - name: DSDECOD + operator: is_contained_by + value: + - "INTERIM SACRIFICE" + - "RECOVERY SACRIFICE" + - "REMOVED FROM STUDY ALIVE" + - "TERMINAL SACRIFICE" + - name: VISITDY + operator: "empty" Core: Id: CORE-000882 Status: Published - Version: '1' -Description: VISITDY should be populated in the DS dataset for disposition records where DSTERM has - been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY SACRIFICE', 'REMOVED FROM STUDY ALIVE', or - 'TERMINAL SACRIFICE', as these are required timing variables for identification of the day on + Version: "1" +Description: + VISITDY should be populated in the DS dataset for disposition records where DSTERM has + been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY SACRIFICE', 'REMOVED FROM STUDY ALIVE', or + 'TERMINAL SACRIFICE', as these are required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for post mortem data. Executability: Fully Executable Outcome: @@ -46,8 +48,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Published/CORE-000883/rule.yml b/Published/CORE-000883/rule.yml index 23cd01601..4bf19f569 100644 --- a/Published/CORE-000883/rule.yml +++ b/Published/CORE-000883/rule.yml @@ -1,117 +1,118 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # PART 1 for DM, as in TS, AGE, AGETXT and AGEU are parameters - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: # For DM: AGE, AGETXT and AGEU are variables - - all: + - all: #- name: DOMAIN # operator: equal_to # value: DM - - name: AGEU - operator: empty - - any: - - name: AGETXT - operator: non_empty - - name: AGE - operator: non_empty + - name: AGEU + operator: empty + - any: + - name: AGETXT + operator: non_empty + - name: AGE + operator: non_empty Core: Id: CORE-000883 Status: Published - Version: '1' -Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is - populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as + Version: "1" +Description: + AGEU is the unit associated with AGE or AGETXT. If either of those variables is + populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as parameters) Executability: Fully Executable Outcome: Message: AGE or AGETXT is populated, but AGEU is not populated Output Variables: - - USUBJID - - AGETXT - - AGE - - AGEU + - USUBJID + - AGETXT + - AGE + - AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-000884/rule.yml b/Published/CORE-000884/rule.yml index 82471d9f6..c1b7170d1 100644 --- a/Published/CORE-000884/rule.yml +++ b/Published/CORE-000884/rule.yml @@ -1,141 +1,143 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. - Document: IG v3.1.1 - Section: 3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND104.2 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: AGEU - Units associated with either AGE or AGETXT. + Document: IG v3.1.1 + Section: 3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND104.2 + Version: "1" + Version: "5.0" + Version: "1.0" Check: any: # For DM: AGE, AGETXT and AGEU are variables - - all: - - name: DOMAIN - operator: equal_to - value: DM - - name: AGEU - operator: empty - - any: - - name: AGETXT - operator: non_empty - - name: AGE - operator: non_empty - # for TS, they are parameters (values in TSPARMCD) - - all: - - name: DOMAIN - operator: equal_to - value: TS - - name: $ageu_count - operator: equal_to - value: 0 + - all: + - name: DOMAIN + operator: equal_to + value: DM + - name: AGEU + operator: empty + - any: + - name: AGETXT + operator: non_empty + - name: AGE + operator: non_empty + # for TS, they are parameters (values in TSPARMCD) + - all: + - name: DOMAIN + operator: equal_to + value: TS + - name: $ageu_count + operator: equal_to + value: 0 Core: Id: CORE-000884 Status: Published - Version: '1' -Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is - populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as + Version: "1" +Description: + AGEU is the unit associated with AGE or AGETXT. If either of those variables is + populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as parameters) Executability: Fully Executable Operations: -- domain: TS - # only keep the records with TSPARMCD=AGEU - filter: - TSPARMCD: AGEU - # group the records by value of TXSETCD - #group: - # - SETCD - # within the filtered and grouped records, count the number of TXVAL records - id: $ageu_count - name: TSVAL - operator: record_count + - domain: + TS + # only keep the records with TSPARMCD=AGEU + filter: + TSPARMCD: AGEU + # group the records by value of TXSETCD + #group: + # - SETCD + # within the filtered and grouped records, count the number of TXVAL records + id: $ageu_count + name: TSVAL + operator: record_count Outcome: Message: AGE or AGETXT is populated, but AGEU is not populated Output Variables: - - DOMAIN - - $ageu_count - #- USUBJID - #- AGETXT - #- AGE - #- AGEU + - DOMAIN + - $ageu_count + #- USUBJID + #- AGETXT + #- AGE + #- AGEU Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - TRIAL DESIGN + - SPECIAL PURPOSE + - TRIAL DESIGN Domains: Include: - - DM - - TS + - DM + - TS Sensitivity: Record diff --git a/Published/CORE-000888/rule.yml b/Published/CORE-000888/rule.yml index c108ba78b..7d7714d57 100644 --- a/Published/CORE-000888/rule.yml +++ b/Published/CORE-000888/rule.yml @@ -1,125 +1,126 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4608' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4608" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'PLANFSUB' + - name: "$txparmcd" + operator: "does_not_contain" + value: "PLANFSUB" Core: Id: CORE-000888 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female Subjects (PLANFSUB) record should be included. Executability: Fully Executable Grouping_Variables: -- SETCD + - SETCD # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'PLANFSUB' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule # Sensitivity: Record diff --git a/Published/CORE-000889/rule.yml b/Published/CORE-000889/rule.yml index a07f82e6f..2fbd4f68b 100644 --- a/Published/CORE-000889/rule.yml +++ b/Published/CORE-000889/rule.yml @@ -1,170 +1,181 @@ Authorities: -- Organization: FDA - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Upper limit of reference range should be greater than lower limit, whenever - both are submitted. - Document: 'FDA' - Section: 'FDAB039' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3902' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Upper limit of reference range should be greater than lower limit, whenever + both are submitted. + Document: "FDA" + Section: "FDAB039" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3902" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --ORNRLO - operator: non_empty - - name: --ORNRLO - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --ORNRHI - operator: non_empty - - name: --ORNRHI - operator: matches_regex - value: ^-?(0|[1-9]\d*)(\.\d+)?$ - - name: --ORNRHI - operator: less_than_or_equal_to - value: --ORNRLO + - name: --ORNRLO + operator: non_empty + - name: --ORNRLO + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --ORNRHI + operator: non_empty + - name: --ORNRHI + operator: matches_regex + value: ^-?(0|[1-9]\d*)(\.\d+)?$ + - name: --ORNRHI + operator: less_than_or_equal_to + value: --ORNRLO Core: Id: CORE-000889 Status: Published - Version: '1' -Description: 'Normal Range Upper Limit-Original Units (--ORNRHI) is greater than the Normal Range Lower - Limit-Original Units (--ORNRLO).' + Version: "1" +Description: + "Normal Range Upper Limit-Original Units (--ORNRHI) is greater than the Normal Range Lower + Limit-Original Units (--ORNRLO)." Executability: Partially Executable - Possible Underreporting Outcome: Message: --ORNRHI is less than or equal to --ORNRLO. Output Variables: - - --TESTCD - - --ORNRHI - - --ORNRLO + - --TESTCD + - --ORNRHI + - --ORNRLO Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000890/rule.yml b/Published/CORE-000890/rule.yml index 991f17e27..0bd12ce77 100644 --- a/Published/CORE-000890/rule.yml +++ b/Published/CORE-000890/rule.yml @@ -1,154 +1,154 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Character values should not have leading spaces or only have a period character.' - Document: 'FDA' - Section: 'FDAB015' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB1502' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Character values should not have leading spaces or only have a period character." + Document: "FDA" + Section: "FDAB015" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB1502" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: non_empty - - name: variable_value - operator: equal_to - value: '.' - value_is_literal: true + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: non_empty + - name: variable_value + operator: equal_to + value: "." + value_is_literal: true Core: Id: CORE-000890 Status: Published - Version: '1' + Version: "1" Description: Text variable in submitted dataset should not contain '.' as an entire value. Executability: Fully Executable Outcome: Message: Text variable contains '.' as an entire value. Output Variables: - - variable_value - - variable_name + - variable_value + - variable_name Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000891/rule.yml b/Published/CORE-000891/rule.yml index 2f1d545c1..a9ef82850 100644 --- a/Published/CORE-000891/rule.yml +++ b/Published/CORE-000891/rule.yml @@ -1,122 +1,123 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4603' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4603" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'ARMCD' + - name: "$txparmcd" + operator: "does_not_contain" + value: "ARMCD" Core: Id: CORE-000891 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include a TXPARMCD = 'ARMCD' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000892/rule.yml b/Published/CORE-000892/rule.yml index 33465df58..4e5c64899 100644 --- a/Published/CORE-000892/rule.yml +++ b/Published/CORE-000892/rule.yml @@ -1,233 +1,253 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'When end timepoint is provided, then a related start timepoint should also be - provided.' - Document: 'FDA' - Section: 'FDAB041' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB4301' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "When end timepoint is provided, then a related start timepoint should also be + provided." + Document: "FDA" + Section: "FDAB041" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB4301" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # TODO: FAILS when e.g. --ENRF and --STDTC columns are absent all: - - any: + - any: # Case ENDTC populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENDTC - operator: non_empty - # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty - # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty - # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty - # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENRF - operator: non_empty - # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty - # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty - # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty + - all: + - name: --ENDTC + operator: + non_empty + # we need to take into account that the column --STDTC may be absent + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: + empty + # we need to take into account that the column --STRF may be absent + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: + empty + # we need to take into account that the column --STRTPT may be absent + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty + # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated + - all: + - name: --ENRF + operator: + non_empty + # we need to take into account that the column --STDTC may be absent + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: + empty + # we need to take into account that the column --STRF may be absent + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: + empty + # we need to take into account that the column --STRTPT may be absent + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty - # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated - - all: - - name: --ENRTPT - operator: non_empty - # we need to take into account that the column --STDTC may be absent - - any: - - name: --STDTC - operator: not_exists - - name: --STDTC - operator: empty - # we need to take into account that the column --STRF may be absent - - any: - - name: --STRF - operator: not_exists - - name: --STRF - operator: empty - # we need to take into account that the column --STRTPT may be absent - - any: - - name: --STRTPT - operator: not_exists - - name: --STRTPT - operator: empty + # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated + - all: + - name: --ENRTPT + operator: + non_empty + # we need to take into account that the column --STDTC may be absent + - any: + - name: --STDTC + operator: not_exists + - name: --STDTC + operator: + empty + # we need to take into account that the column --STRF may be absent + - any: + - name: --STRF + operator: not_exists + - name: --STRF + operator: + empty + # we need to take into account that the column --STRTPT may be absent + - any: + - name: --STRTPT + operator: not_exists + - name: --STRTPT + operator: empty Core: Id: CORE-000892 Status: Published - Version: '1' -Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint + Version: "1" +Description: + When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint (--STDTC, --STRF or --STRTPT should also be populated. Executability: Fully Executable Outcome: Message: End timepoint is populated but start timepoint is missing. Output Variables: - - --STDTC - - --STRF - - --STRTPT - - --ENDTC - - --ENRF - - --ENRTPT + - --STDTC + - --STRF + - --STRTPT + - --ENDTC + - --ENRF + - --ENRTPT Rule Type: Record Data Scope: Classes: # Only applicable to EVENTS and INTERVENTIONS and Findings Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Exclude: - - NONE + - NONE Sensitivity: Record diff --git a/Published/CORE-000893/rule.yml b/Published/CORE-000893/rule.yml index f4da1f5c4..14c1c28f4 100644 --- a/Published/CORE-000893/rule.yml +++ b/Published/CORE-000893/rule.yml @@ -1,120 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4604' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4604" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'GRPLBL' + - name: "$txparmcd" + operator: "does_not_contain" + value: "GRPLBL" Core: Id: CORE-000893 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = GRPLBL record per SETCD. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000894/rule.yml b/Published/CORE-000894/rule.yml index 4b2e75ae9..188c8014b 100644 --- a/Published/CORE-000894/rule.yml +++ b/Published/CORE-000894/rule.yml @@ -1,120 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4605' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4605" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'TRTDOS' + - name: "$txparmcd" + operator: "does_not_contain" + value: "TRTDOS" Core: Id: CORE-000894 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: - Message: 'TX dataset should include a TXPARMCD = TRTDOS record per SETCD.' + Message: "TX dataset should include a TXPARMCD = TRTDOS record per SETCD." Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000895/rule.yml b/Published/CORE-000895/rule.yml index ffe19e445..896fd1982 100644 --- a/Published/CORE-000895/rule.yml +++ b/Published/CORE-000895/rule.yml @@ -1,120 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4606' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4606" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'TRTDOSU' + - name: "$txparmcd" + operator: "does_not_contain" + value: "TRTDOSU" Core: Id: CORE-000895 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include a TXPARMCD = TRTDOSU record per SETCD. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule Sensitivity: Record diff --git a/Published/CORE-000896/rule.yml b/Published/CORE-000896/rule.yml index 5e6aa282d..9befa36bc 100644 --- a/Published/CORE-000896/rule.yml +++ b/Published/CORE-000896/rule.yml @@ -1,119 +1,119 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Pool ID should match pool definition for nonclinical data.' - Document: FDA - Section: FDAB054 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5401 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: "Pool ID should match pool definition for nonclinical data." + Document: FDA + Section: FDAB054 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5401 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: POOLID - operator: non_empty - - name: POOLID - operator: is_not_contained_by - value: $pooldef_poolid + - name: POOLID + operator: non_empty + - name: POOLID + operator: is_not_contained_by + value: $pooldef_poolid Core: Id: CORE-000896 Status: Published - Version: '1' -Description: 'POOLID value in the dataset should match one of the POOLID values in the POOLDEF dataset' + Version: "1" +Description: "POOLID value in the dataset should match one of the POOLID values in the POOLDEF dataset" Executability: Fully Executable Operations: -- domain: POOLDEF - id: $pooldef_poolid - name: POOLID - operator: distinct + - domain: POOLDEF + id: $pooldef_poolid + name: POOLID + operator: distinct Outcome: - Message: 'POOLID value does not match a POOLID value in the POOLDEF dataset.' + Message: "POOLID value does not match a POOLID value in the POOLDEF dataset." Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS - - RELATIONSHIP + - INTERVENTIONS + - FINDINGS + - RELATIONSHIP Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000897/rule.yml b/Published/CORE-000897/rule.yml index e7a7554bd..14f74d473 100644 --- a/Published/CORE-000897/rule.yml +++ b/Published/CORE-000897/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study version's study phase must be specified according to the extensible Trial - Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00015' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study version's study phase must be specified according to the extensible Trial + Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00015" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyPhase.standardCode - operator: exists - - name: studyPhase.standardCode - operator: equal_to - value: true - - not: - all: - - name: studyPhase.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyPhase.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: studyPhase.standardCode + operator: exists + - name: studyPhase.standardCode + operator: equal_to + value: true + - not: + all: + - name: studyPhase.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: studyPhase.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyPhase.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: studyPhase.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyPhase.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: studyPhase.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000897' + Id: "CORE-000897" Status: Published - Version: '1' -Description: "A study version's study phase must be specified according to the extensible Trial Phase + Version: "1" +Description: + "A study version's study phase must be specified according to the extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66737 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66737 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion Outcome: - Message: 'The study version''s study phase is not specified according to the extensible Trial Phase + Message: + 'The study version''s study phase is not specified according to the extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $codelist_code - - $codelist_extensible - - studyPhase.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyPhase.standardCode.codeSystem - - studyPhase.standardCode.codeSystemVersion - - studyPhase.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $codelist_code + - $codelist_extensible + - studyPhase.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyPhase.standardCode.codeSystem + - studyPhase.standardCode.codeSystemVersion + - studyPhase.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-000898/rule.yml b/Published/CORE-000898/rule.yml index 3e8bdc9fd..cbe011bee 100644 --- a/Published/CORE-000898/rule.yml +++ b/Published/CORE-000898/rule.yml @@ -1,43 +1,43 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per implantation site per fetus per subject. - Document: IG-DART v1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND355 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per implantation site per fetus per subject. - Document: IG-DART v1.2 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND355 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per implantation site per fetus per subject. + Document: IG-DART v1.1 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND355 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per implantation site per fetus per subject. + Document: IG-DART v1.2 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND355 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: ICIMPLBL - operator: is_not_unique_set - value: - - FETUSID - - USUBJID + - name: ICIMPLBL + operator: is_not_unique_set + value: + - FETUSID + - USUBJID Core: Id: CORE-000898 Status: Published - Version: '1' + Version: "1" Description: Raise an error when the combination of USUBJID, ICIMPLBL and FETUSID in not unique Executability: Fully Executable Outcome: @@ -46,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - IC + - IC Sensitivity: Record diff --git a/Published/CORE-000899/rule.yml b/Published/CORE-000899/rule.yml index a440e66ed..937a8d854 100644 --- a/Published/CORE-000899/rule.yml +++ b/Published/CORE-000899/rule.yml @@ -1,74 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each implantation - site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per - protocol, the artificial label, ALL, is used to represent missing results (see Example 5). - Document: DART-IG v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND363 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The ICIMPLBL must be populated for each result, i.e. for each implantation - site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per - protocol, the artificial label, ALL, is used to represent missing results (see Example 5). - Document: DART-IG v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND363 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ICIMPLBL must be populated for each result, i.e. for each implantation + site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per + protocol, the artificial label, ALL, is used to represent missing results (see Example 5). + Document: DART-IG v1.1 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND363 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The ICIMPLBL must be populated for each result, i.e. for each implantation + site. In the situation where the implantations were not evaluated (ICSTAT = NOT DONE) per + protocol, the artificial label, ALL, is used to represent missing results (see Example 5). + Document: DART-IG v1.2 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND363 + Version: "1" + Version: "5.0" + Version: "1.2" Check: - # Rule has 2 parts: + # Rule has 2 parts: # a) number of records for this subject = 1 - # b) when ICSTAT='NOT DONE', ICIMPLBL = "ALL" + # b) when ICSTAT='NOT DONE', ICIMPLBL = "ALL" all: - - name: $record_count_USUBJID - operator: equal_to - value: 1 - - name: ICSTAT - operator: equal_to - value: 'NOT DONE' - # Raise issue when ICIMPLBL is not "ALL" - - name: ICIMPLBL - operator: not_equal_to - value: ALL + - name: $record_count_USUBJID + operator: equal_to + value: 1 + - name: ICSTAT + operator: equal_to + value: "NOT DONE" + # Raise issue when ICIMPLBL is not "ALL" + - name: ICIMPLBL + operator: not_equal_to + value: ALL Core: Id: CORE-000899 Status: Published - Version: '1' -Description: "Raise an issue when there is only one record for this subject in IC, LBSTAT='NOT DONE', + Version: "1" +Description: + "Raise an issue when there is only one record for this subject in IC, LBSTAT='NOT DONE', and ICIMPLBL is not 'ALL'" Executability: Fully Executable Operations: # This counts the number of records for the current USUBJID -- group: - - USUBJID - id: $record_count_USUBJID - operator: record_count + - group: + - USUBJID + id: $record_count_USUBJID + operator: record_count Outcome: Message: "ICIMPLBL must be 'ALL' when there is only one record for the subject and ICSTAT is 'NOT DONE'" Output Variables: - - $record_count_USUBJID - - ICSTAT - - ICIMPLBL + - $record_count_USUBJID + - ICSTAT + - ICIMPLBL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - IC + - IC Sensitivity: Record diff --git a/Published/CORE-000900/rule.yml b/Published/CORE-000900/rule.yml index d76318370..7ee1ceb93 100644 --- a/Published/CORE-000900/rule.yml +++ b/Published/CORE-000900/rule.yml @@ -1,66 +1,68 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within an encounter, if more environmental settings are defined, they must be - distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00156' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within an encounter, if more environmental settings are defined, they must be + distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00156" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'Code' - - name: parent_entity - operator: equal_to - value: 'Encounter' - - name: parent_rel - operator: equal_to - value: 'environmentalSettings' - value_is_literal: true - - name: code - operator: is_not_unique_set - value: - - parent_entity - - parent_rel - - parent_id - - codeSystem - - codeSystemVersion + - name: instanceType + operator: equal_to + value: "Code" + - name: parent_entity + operator: equal_to + value: "Encounter" + - name: parent_rel + operator: equal_to + value: "environmentalSettings" + value_is_literal: true + - name: code + operator: is_not_unique_set + value: + - parent_entity + - parent_rel + - parent_id + - codeSystem + - codeSystemVersion Core: - Id: 'CORE-000900' + Id: "CORE-000900" Status: Published - Version: '1' -Description: 'Within an encounter, if more environmental settings are defined, they must be distinct.' + Version: "1" +Description: "Within an encounter, if more environmental settings are defined, they must be distinct." Executability: Fully Executable Match Datasets: -- Keys: - - Left: parent_id - Right: id - - rel_type - Name: Encounter + - Keys: + - Left: parent_id + Right: id + - rel_type + Name: Encounter Outcome: - Message: 'The environmental settings of the encounter are not unique - the same code is used more than - once with the same codeSystem and codeSystemVersion.' + Message: + "The environmental settings of the encounter are not unique - the same code is used more than + once with the same codeSystem and codeSystemVersion." Output Variables: - - name - - parent_entity - - parent_id - - parent_rel - - id - - code - - codeSystem - - codeSystemVersion - - decode + - name + - parent_entity + - parent_id + - parent_rel + - id + - code + - codeSystem + - codeSystemVersion + - decode Rule Type: Record Data Scope: Entities: Include: - - Code + - Code Sensitivity: Record diff --git a/Published/CORE-000901/rule.yml b/Published/CORE-000901/rule.yml index 46a7f9013..c65ce949f 100644 --- a/Published/CORE-000901/rule.yml +++ b/Published/CORE-000901/rule.yml @@ -1,171 +1,181 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Drugs and metabolite names in pharmacokinetic datasets should be consistent - with naming in other datasets across a submission. - Document: FDA - Section: FDAB069 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6901 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Drugs and metabolite names in pharmacokinetic datasets should be consistent + with naming in other datasets across a submission. + Document: FDA + Section: FDAB069 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6901 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: PPCAT - operator: non_empty - - name: RELREC.PCRFTDTC - operator: non_empty - - name: PPRFTDTC - operator: equal_to - value: RELREC.PCRFTDTC - - name: PPCAT - operator: not_equal_to - value: RELREC.PCTEST + - name: PPCAT + operator: non_empty + - name: RELREC.PCRFTDTC + operator: non_empty + - name: PPRFTDTC + operator: equal_to + value: RELREC.PCRFTDTC + - name: PPCAT + operator: not_equal_to + value: RELREC.PCTEST Core: Id: CORE-000901 Status: Published - Version: '1' -Description: 'The values of PPCAT and PCTEST do not match at the same reference timepoint' + Version: "1" +Description: "The values of PPCAT and PCTEST do not match at the same reference timepoint" Executability: Partially Executable Match Datasets: -- Name: RELREC - Wildcard: PC + - Name: RELREC + Wildcard: PC Outcome: - Message: 'The values of PPCAT and PCTEST do not match at the same reference timepoint' + Message: "The values of PPCAT and PCTEST do not match at the same reference timepoint" Output Variables: - - PPCAT - - PPRFTDTC - - PPCAT - - RELREC.PCRFTDTC - - RELREC.PCTEST + - PPCAT + - PPRFTDTC + - PPCAT + - RELREC.PCRFTDTC + - RELREC.PCTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000902/rule.yml b/Published/CORE-000902/rule.yml index fe30f56b8..79467ca0c 100644 --- a/Published/CORE-000902/rule.yml +++ b/Published/CORE-000902/rule.yml @@ -1,235 +1,248 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # This rule is for SEND268/268.1 as well as for SEND269/269.1 # Part 1: SEND268/268.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than that are from the same general observation class) - must not be added, and existing variables must not be renamed or modified for novel usage. - Document: IG v3.0 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (SDTM - (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or - Qualifier variables from the same general observation class (described in SDTM Tables - 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use - the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix - E for a list of SDTM variables that should never be used in SEND. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (SDTM - (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or - Qualifier variables from the same general observation class (described in SDTM Tables - 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use - the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix - E for a list of SDTM variables that should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (SDTM - (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or - Qualifier variables from the same general observation class (described in SDTM Tables - 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use - the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix - E for a list of SDTM variables that should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (SDTM - (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or - Qualifier variables from the same general observation class (described in SDTM Tables - 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use - the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix - E for a list of SDTM variables that should never be used in SEND. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (SDTM - (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or - Qualifier variables from the same general observation class (described in SDTM Tables - 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use - the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix - E for a list of SDTM variables that should never be used in SEND. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND268.1 - Version: '1' - Version: '5.0' - Version: '1.2' - # Part 2: SEND269/269.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.0 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: New variables (other than those that are from the same general observation - class) must not be added, and existing variables must not be renamed or modified for novel - usage. - Document: IG v3.1.1 - Item: Specification - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND269.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + New variables (other than that are from the same general observation class) + must not be added, and existing variables must not be renamed or modified for novel usage. + Document: IG v3.0 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (SDTM + (http://www.cdisc.org/sdtm) Table 2.2.4), Timing variables (SDTM Table 2.2.5), or + Qualifier variables from the same general observation class (described in SDTM Tables + 2.2.1-2.2.3). The addition of non-standard variables will compromise the ability to use + the datasets (e.g., to populate a data repository and/or use standard tools). See Appendix + E for a list of SDTM variables that should never be used in SEND. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND268.1 + Version: "1" + Version: "5.0" + Version: + "1.2" + # Part 2: SEND269/269.1 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.0 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + New variables (other than those that are from the same general observation + class) must not be added, and existing variables must not be renamed or modified for novel + usage. + Document: IG v3.1.1 + Item: Specification + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND269.1 + Version: "1" + Version: "5.0" + Version: "1.2" # The code is the same as for CG0013, but the scope is slightly different # (for SEND, the scope is limited to Interventions, Events and Findings) Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CORE-000902 Status: Published - Version: '1' -Description: 'Trigger error when variable is not an allowed variable for the underlying Observation Class' + Version: "1" +Description: "Trigger error when variable is not an allowed variable for the underlying Observation Class" Executability: Fully Executable Operations: -- id: $allowed_variables - operator: get_model_column_order + - id: $allowed_variables + operator: get_model_column_order Outcome: - Message: 'The variable is not an allowed variable for the underlying Observation Class' + Message: "The variable is not an allowed variable for the underlying Observation Class" Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000903/rule.yml b/Published/CORE-000903/rule.yml index 685c7d79e..2babf4f62 100644 --- a/Published/CORE-000903/rule.yml +++ b/Published/CORE-000903/rule.yml @@ -1,67 +1,73 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study - data that do not conform to one of the three general observation classes. These are described - in Section 5" - Document: SENDIG v3.1 - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND297 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study - data that do not conform to one of the three general observation classes. These are described - in Section 5" - Document: SENDIG v3.1 - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND297 - Version: '1' - Version: '5.0' - Version: '1.1' - # P.S. Not applicable to SENDIG-3.1.1, DART-1.2 and GENETOX + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study + data that do not conform to one of the three general observation classes. These are described + in Section 5" + Document: SENDIG v3.1 + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND297 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure; ..Demographics (DM), Comments (CO), and Subject Elements (SE) include study + data that do not conform to one of the three general observation classes. These are described + in Section 5" + Document: SENDIG v3.1 + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND297 + Version: "1" + Version: "5.0" + Version: + "1.1" + # P.S. Not applicable to SENDIG-3.1.1, DART-1.2 and GENETOX Check: all: # select variable (is present) in dataset - - name: variable_name - operator: exists - # check whether the variable is known in the CDISC Library - - name: variable_name - operator: not_equal_to - value: library_variable_name + - name: variable_name + operator: + exists + # check whether the variable is known in the CDISC Library + - name: variable_name + operator: not_equal_to + value: library_variable_name Core: Id: CORE-000903 Status: Published - Version: '1' -Description: "Additional variables not specified in the SENDIG description of the domain (including both + Version: "1" +Description: + "Additional variables not specified in the SENDIG description of the domain (including both the domain table and assumptions) may not be added to DM, CO, or SE" Executability: Fully Executable Outcome: - Message: The variable is not allowed in this domain as it is not specified in the SENDIG for the + Message: + The variable is not allowed in this domain as it is not specified in the SENDIG for the specific domain Output Variables: - - variable_name - # - library_variable_name + - variable_name + # - library_variable_name Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM - - SE - - CO + - DM + - SE + - CO Sensitivity: Dataset diff --git a/Published/CORE-000904/rule.yml b/Published/CORE-000904/rule.yml index 8a863fd50..8e6d84226 100644 --- a/Published/CORE-000904/rule.yml +++ b/Published/CORE-000904/rule.yml @@ -1,157 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value Set Terminology - (C201264) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00051' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s type must be specified using the Timing Type Value Set Terminology - (C201264) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00051' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing's type must be specified using the Timing Type Value Set Terminology + (C201264) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00051" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing's type must be specified using the Timing Type Value Set Terminology + (C201264) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00051" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000904' + Id: "CORE-000904" Status: Published - Version: '1' -Description: 'A timing''s type must be specified using the Timing Type Value Set Terminology (C201264) - DDF codelist.' + Version: "1" +Description: + "A timing's type must be specified using the Timing Type Value Set Terminology (C201264) + DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C201264 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C201264 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The timing''s type is not specified using the Timing Type Value Set Terminology (C201264) + Message: + 'The timing''s type is not specified using the Timing Type Value Set Terminology (C201264) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000905/rule.yml b/Published/CORE-000905/rule.yml index 403a9994f..311e1a854 100644 --- a/Published/CORE-000905/rule.yml +++ b/Published/CORE-000905/rule.yml @@ -1,157 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s relative to/from property must be specified using the Timing Relative - To From Value Set Terminology (C201265) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00104' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A timing''s relative to/from property must be specified using the Timing Relative - To From Value Set Terminology (C201265) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00104' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing's relative to/from property must be specified using the Timing Relative + To From Value Set Terminology (C201265) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00104" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A timing's relative to/from property must be specified using the Timing Relative + To From Value Set Terminology (C201265) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00104" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: relativeToFrom - operator: equal_to - value: true - - not: - all: - - name: relativeToFrom.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: relativeToFrom.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: relativeToFrom.code - operator: equal_to - value: $code_for_decode_pref_term - - name: relativeToFrom.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: relativeToFrom.decode - operator: equal_to - value: $pref_term_for_code - - name: relativeToFrom.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: relativeToFrom + operator: equal_to + value: true + - not: + all: + - name: relativeToFrom.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: relativeToFrom.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: relativeToFrom.code + operator: equal_to + value: $code_for_decode_pref_term + - name: relativeToFrom.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: relativeToFrom.decode + operator: equal_to + value: $pref_term_for_code + - name: relativeToFrom.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000905' + Id: "CORE-000905" Status: Published - Version: '1' -Description: 'A timing''s relative to/from property must be specified using the Timing Relative To From - Value Set Terminology (C201265) DDF codelist.' + Version: "1" +Description: + "A timing's relative to/from property must be specified using the Timing Relative To From + Value Set Terminology (C201265) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C201265 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: relativeToFrom.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: relativeToFrom.code - version: relativeToFrom.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: relativeToFrom.code - version: relativeToFrom.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: relativeToFrom.decode - version: relativeToFrom.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: relativeToFrom.decode - version: relativeToFrom.codeSystemVersion + - id: $codelist_code + map: + - output: C201265 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: relativeToFrom.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: relativeToFrom.code + version: relativeToFrom.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: relativeToFrom.code + version: relativeToFrom.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: relativeToFrom.decode + version: relativeToFrom.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: relativeToFrom.decode + version: relativeToFrom.codeSystemVersion Outcome: - Message: 'The timing''s relative to/from property is not specified using the Timing Relative To From + Message: + 'The timing''s relative to/from property is not specified using the Timing Relative To From Value Set Terminology (C201265) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - relativeToFrom.code - - $code_for_decode_value - - $code_for_decode_pref_term - - relativeToFrom.codeSystem - - relativeToFrom.codeSystemVersion - - relativeToFrom.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - relativeToFrom.code + - $code_for_decode_value + - $code_for_decode_pref_term + - relativeToFrom.codeSystem + - relativeToFrom.codeSystemVersion + - relativeToFrom.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Timing' + - "Timing" Sensitivity: Record diff --git a/Published/CORE-000906/rule.yml b/Published/CORE-000906/rule.yml index cdc01cba5..b85b35569 100644 --- a/Published/CORE-000906/rule.yml +++ b/Published/CORE-000906/rule.yml @@ -1,146 +1,149 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "The unit of a planned age is expected to be specified using terms from the Age - Unit (C66781) SDTM codelist." - Document: "USDM_CORE_Rules.xlsx" - Origin: "USDM Conformance Rules" - Rule Identifier: - Id: "DDF00111" - Version: "1" - Version: "1.0" - Version: "3.0" + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The unit of a planned age is expected to be specified using terms from the Age + Unit (C66781) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00111" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: "definition" - - name: plannedAge.unit - operator: equal_to - value: true - - not: - all: - - name: plannedAge.unit.codeSystem - operator: equal_to - value: "http://www.cdisc.org" - - name: plannedAge.unit.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: plannedAge.unit.code - operator: equal_to - value: $code_for_decode_pref_term - - name: plannedAge.unit.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: plannedAge.unit.decode - operator: equal_to - value: $pref_term_for_code - - name: plannedAge.unit.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: plannedAge.unit + operator: equal_to + value: true + - not: + all: + - name: plannedAge.unit.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: plannedAge.unit.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: plannedAge.unit.code + operator: equal_to + value: $code_for_decode_pref_term + - name: plannedAge.unit.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: plannedAge.unit.decode + operator: equal_to + value: $pref_term_for_code + - name: plannedAge.unit.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: Id: "CORE-000906" Status: Published Version: "1" -Description: "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) +Description: + "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) SDTM codelist." Executability: Partially Executable - Possible Overreporting Operations: -- id: $codelist_code - map: - - output: C66781 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: plannedAge.unit.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: plannedAge.unit.code - version: plannedAge.unit.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: plannedAge.unit.code - version: plannedAge.unit.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: plannedAge.unit.decode - version: plannedAge.unit.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: plannedAge.unit.decode - version: plannedAge.unit.codeSystemVersion + - id: $codelist_code + map: + - output: C66781 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: plannedAge.unit.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: plannedAge.unit.code + version: plannedAge.unit.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: plannedAge.unit.code + version: plannedAge.unit.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: plannedAge.unit.decode + version: plannedAge.unit.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: plannedAge.unit.decode + version: plannedAge.unit.codeSystemVersion Outcome: - Message: 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem + Message: + 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - plannedAge.unit.code - - $code_for_decode_value - - $code_for_decode_pref_term - - plannedAge.unit.codeSystem - - plannedAge.unit.codeSystemVersion - - plannedAge.unit.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - plannedAge.unit.code + - $code_for_decode_value + - $code_for_decode_pref_term + - plannedAge.unit.codeSystem + - plannedAge.unit.codeSystemVersion + - plannedAge.unit.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - "StudyDesignPopulation" - - "StudyCohort" + - "StudyDesignPopulation" + - "StudyCohort" Sensitivity: Record diff --git a/Published/CORE-000907/rule.yml b/Published/CORE-000907/rule.yml index 5e8424aa6..8850d9153 100644 --- a/Published/CORE-000907/rule.yml +++ b/Published/CORE-000907/rule.yml @@ -1,157 +1,161 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s role must be specified using the study intervention role - (C207417) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00112' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s role must be specified using the study intervention role - (C207417) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00112' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study intervention's role must be specified using the study intervention role + (C207417) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00112" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study intervention's role must be specified using the study intervention role + (C207417) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00112" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: role - operator: equal_to - value: true - - not: - all: - - name: role.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: role.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: role.code - operator: equal_to - value: $code_for_decode_pref_term - - name: role.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: role.decode - operator: equal_to - value: $pref_term_for_code - - name: role.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: role + operator: equal_to + value: true + - not: + all: + - name: role.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: role.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: role.code + operator: equal_to + value: $code_for_decode_pref_term + - name: role.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: role.decode + operator: equal_to + value: $pref_term_for_code + - name: role.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000907' + Id: "CORE-000907" Status: Published - Version: '1' -Description: 'A study intervention''s role must be specified using the study intervention role (C207417) - DDF codelist.' + Version: "1" +Description: + "A study intervention's role must be specified using the study intervention role (C207417) + DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207417 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: role.code - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: role.code - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: role.decode - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: role.decode - version: role.codeSystemVersion + - id: $codelist_code + map: + - output: C207417 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: role.code + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: role.code + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: role.decode + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: role.decode + version: role.codeSystemVersion Outcome: - Message: 'The study intervention''s role is not specified using the study intervention role (C207417) + Message: + 'The study intervention''s role is not specified using the study intervention role (C207417) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - role.code - - $code_for_decode_value - - $code_for_decode_pref_term - - role.codeSystem - - role.codeSystemVersion - - role.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - role.code + - $code_for_decode_value + - $code_for_decode_pref_term + - role.codeSystem + - role.codeSystemVersion + - role.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - "StudyIntervention" Sensitivity: Record diff --git a/Published/CORE-000908/rule.yml b/Published/CORE-000908/rule.yml index 46767dd23..94ce02362 100644 --- a/Published/CORE-000908/rule.yml +++ b/Published/CORE-000908/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An agent administration's frequency must be specified according to the extensible - Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00113' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An agent administration's frequency must be specified according to the extensible + Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00113" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: frequency.standardCode - operator: exists - - name: frequency.standardCode - operator: equal_to - value: true - - not: - all: - - name: frequency.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: frequency.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: frequency.standardCode + operator: exists + - name: frequency.standardCode + operator: equal_to + value: true + - not: + all: + - name: frequency.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: frequency.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: frequency.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: frequency.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: frequency.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: frequency.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: frequency.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: frequency.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000908' + Id: "CORE-000908" Status: Published - Version: '1' -Description: "An agent administration's frequency must be specified according to the extensible Frequency + Version: "1" +Description: + "An agent administration's frequency must be specified according to the extensible Frequency (C71113) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C71113 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: frequency.standardCode.code - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: frequency.standardCode.decode - version: frequency.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C71113 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: frequency.standardCode.code + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: frequency.standardCode.decode + version: frequency.standardCode.codeSystemVersion Outcome: - Message: 'The agent administration''s frequency is not specified according to the extensible Frequency + Message: + 'The agent administration''s frequency is not specified according to the extensible Frequency (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - frequency.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - frequency.standardCode.codeSystem - - frequency.standardCode.codeSystemVersion - - frequency.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - frequency.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - frequency.standardCode.codeSystem + - frequency.standardCode.codeSystemVersion + - frequency.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AgentAdministration' + - "AgentAdministration" Sensitivity: Record diff --git a/Published/CORE-000909/rule.yml b/Published/CORE-000909/rule.yml index c315cf1ed..1c6458f0b 100644 --- a/Published/CORE-000909/rule.yml +++ b/Published/CORE-000909/rule.yml @@ -1,145 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study version''s study type must be specified using the Study Type Response - (C99077) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00116' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study version's study type must be specified using the Study Type Response + (C99077) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00116" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyType - operator: equal_to - value: true - - not: - all: - - name: studyType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyType.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyType.decode - operator: equal_to - value: $pref_term_for_code - - name: studyType.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: studyType + operator: equal_to + value: true + - not: + all: + - name: studyType.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: studyType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyType.decode + operator: equal_to + value: $pref_term_for_code + - name: studyType.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000909' + Id: "CORE-000909" Status: Published - Version: '1' -Description: 'A study version''s study type must be specified using the Study Type Response (C99077) SDTM - codelist.' + Version: "1" +Description: + "A study version's study type must be specified using the Study Type Response (C99077) SDTM + codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C99077 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyType.code - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyType.code - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyType.decode - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyType.decode - version: studyType.codeSystemVersion + - id: $codelist_code + map: + - output: C99077 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyType.code + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyType.code + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyType.decode + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyType.decode + version: studyType.codeSystemVersion Outcome: - Message: 'The study version''s study type is not specified using the Study Type Response (C99077) SDTM + Message: + 'The study version''s study type is not specified using the Study Type Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - versionIdentifier - - $codelist_code - - $codelist_extensible - - studyType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyType.codeSystem - - studyType.codeSystemVersion - - studyType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - versionIdentifier + - $codelist_code + - $codelist_extensible + - studyType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyType.codeSystem + - studyType.codeSystemVersion + - studyType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-000910/rule.yml b/Published/CORE-000910/rule.yml index 97d6830fd..2ba6a1365 100644 --- a/Published/CORE-000910/rule.yml +++ b/Published/CORE-000910/rule.yml @@ -1,145 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study protocol document version''s protocol status must be specified using - the Protocol Status Value Set Terminology (C188723) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00117' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study protocol document version's protocol status must be specified using + the Protocol Status Value Set Terminology (C188723) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00117" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: protocolStatus - operator: equal_to - value: true - - not: - all: - - name: protocolStatus.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: protocolStatus.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: protocolStatus.code - operator: equal_to - value: $code_for_decode_pref_term - - name: protocolStatus.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: protocolStatus.decode - operator: equal_to - value: $pref_term_for_code - - name: protocolStatus.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: protocolStatus + operator: equal_to + value: true + - not: + all: + - name: protocolStatus.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: protocolStatus.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: protocolStatus.code + operator: equal_to + value: $code_for_decode_pref_term + - name: protocolStatus.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: protocolStatus.decode + operator: equal_to + value: $pref_term_for_code + - name: protocolStatus.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000910' + Id: "CORE-000910" Status: Published - Version: '1' -Description: 'A study protocol document version''s protocol status must be specified using the Protocol - Status Value Set Terminology (C188723) DDF codelist.' + Version: "1" +Description: + "A study protocol document version's protocol status must be specified using the Protocol + Status Value Set Terminology (C188723) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188723 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: protocolStatus.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: protocolStatus.code - version: protocolStatus.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: protocolStatus.code - version: protocolStatus.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: protocolStatus.decode - version: protocolStatus.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: protocolStatus.decode - version: protocolStatus.codeSystemVersion + - id: $codelist_code + map: + - output: C188723 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: protocolStatus.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: protocolStatus.code + version: protocolStatus.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: protocolStatus.code + version: protocolStatus.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: protocolStatus.decode + version: protocolStatus.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: protocolStatus.decode + version: protocolStatus.codeSystemVersion Outcome: - Message: 'The study protocol document version''s protocol status is not specified using the Protocol + Message: + 'The study protocol document version''s protocol status is not specified using the Protocol Status Value Set Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - protocolVersion - - $codelist_code - - $codelist_extensible - - protocolStatus.code - - $code_for_decode_value - - $code_for_decode_pref_term - - protocolStatus.codeSystem - - protocolStatus.codeSystemVersion - - protocolStatus.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - protocolVersion + - $codelist_code + - $codelist_extensible + - protocolStatus.code + - $code_for_decode_value + - $code_for_decode_pref_term + - protocolStatus.codeSystem + - protocolStatus.codeSystemVersion + - protocolStatus.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyProtocolDocumentVersion' + - "StudyProtocolDocumentVersion" Sensitivity: Record diff --git a/Published/CORE-000911/rule.yml b/Published/CORE-000911/rule.yml index 39b010b4e..544840dc0 100644 --- a/Published/CORE-000911/rule.yml +++ b/Published/CORE-000911/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's trial intent types must be specified according to the extensible - Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00118' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's trial intent types must be specified according to the extensible + Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00118" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: trialIntentTypes - operator: exists - - name: trialIntentTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'trialIntentTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: trialIntentTypes + operator: exists + - name: trialIntentTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "trialIntentTypes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000911' + Id: "CORE-000911" Status: Published - Version: '1' -Description: "A study design's trial intent types must be specified according to the extensible Trial + Version: "1" +Description: + "A study design's trial intent types must be specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C66736 - parent_rel.Code: 'trialIntentTypes' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C66736 + parent_rel.Code: "trialIntentTypes" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s trial intent type is not specified according to the extensible Trial Intent + Message: + 'The study design''s trial intent type is not specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-000912/rule.yml b/Published/CORE-000912/rule.yml index 88a9caf5c..9243104e9 100644 --- a/Published/CORE-000912/rule.yml +++ b/Published/CORE-000912/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's trial types must be specified according to the extensible Trial - Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00119' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's trial types must be specified according to the extensible Trial + Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00119" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: trialTypes - operator: exists - - name: trialTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'trialTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: trialTypes + operator: exists + - name: trialTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "trialTypes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000912' + Id: "CORE-000912" Status: Published - Version: '1' -Description: "A study design's trial types must be specified according to the extensible Trial Type Response + Version: "1" +Description: + "A study design's trial types must be specified according to the extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C66739 - parent_rel.Code: 'trialTypes' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C66739 + parent_rel.Code: "trialTypes" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s trial type is not specified according to the extensible Trial Type Response + Message: + 'The study design''s trial type is not specified according to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-000914/rule.yml b/Published/CORE-000914/rule.yml index 90037047b..27014b10b 100644 --- a/Published/CORE-000914/rule.yml +++ b/Published/CORE-000914/rule.yml @@ -2,177 +2,188 @@ # Condition: --BLFL="Y" and '--STRESC ^= Null # Rule: 'Only one --BLFL per record having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: Records with a baseline flag should have a corresponding standard result - with a standardized unit where available. - Document: 'FDA' - Section: 'FDAB026' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB2603' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + Records with a baseline flag should have a corresponding standard result + with a standardized unit where available. + Document: "FDA" + Section: "FDAB026" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB2603" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STRESC - operator: non_empty - - name: --BLFL - operator: equal_to - value: 'Y' - value_is_literal: true - - name: --BLFL - operator: is_not_unique_set - value: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - USUBJID + - name: --STRESC + operator: non_empty + - name: --BLFL + operator: equal_to + value: "Y" + value_is_literal: true + - name: --BLFL + operator: is_not_unique_set + value: + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - USUBJID Core: Id: CORE-000914 Status: Published - Version: '1' -Description: There should be only one record with a baseline flag and non missing character standard + Version: "1" +Description: + There should be only one record with a baseline flag and non missing character standard result value having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values. Executability: Fully Executable Outcome: Message: There are multiple records per assigned baseline flag (--BLFL). Output Variables: - - --TESTCD - - --CAT - - --SCAT - - --SPEC - - --METHOD - - --BLFL + - --TESTCD + - --CAT + - --SCAT + - --SPEC + - --METHOD + - --BLFL Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000916/rule.yml b/Published/CORE-000916/rule.yml index 872b2d890..2ca87d419 100644 --- a/Published/CORE-000916/rule.yml +++ b/Published/CORE-000916/rule.yml @@ -2,124 +2,134 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000916 Status: Published - Version: '1' -Description: Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable + Version: "1" +Description: + Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: RELREC + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: RELREC Operations: -- domain: RELREC - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true + - domain: RELREC + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in RELREC does not represent a variable present in the dataset referenced + Message: + Value for IDVAR in RELREC does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000917/rule.yml b/Published/CORE-000917/rule.yml index 0629b762b..debb9779a 100644 --- a/Published/CORE-000917/rule.yml +++ b/Published/CORE-000917/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's intervention model must be specified according to the extensible - Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00120' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's intervention model must be specified according to the extensible + Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00120" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: interventionModel - operator: exists - - name: interventionModel - operator: equal_to - value: true - - not: - all: - - name: interventionModel.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: interventionModel.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: interventionModel + operator: exists + - name: interventionModel + operator: equal_to + value: true + - not: + all: + - name: interventionModel.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: interventionModel.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: interventionModel.code - operator: equal_to - value: $code_for_decode_pref_term - - name: interventionModel.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: interventionModel.decode - operator: equal_to - value: $pref_term_for_code - - name: interventionModel.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: interventionModel.code + operator: equal_to + value: $code_for_decode_pref_term + - name: interventionModel.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: interventionModel.decode + operator: equal_to + value: $pref_term_for_code + - name: interventionModel.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000917' + Id: "CORE-000917" Status: Published - Version: '1' -Description: "A study design's intervention model must be specified according to the extensible Intervention + Version: "1" +Description: + "A study design's intervention model must be specified according to the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C99076 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: interventionModel.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: interventionModel.code - version: interventionModel.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: interventionModel.code - version: interventionModel.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: interventionModel.decode - version: interventionModel.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: interventionModel.decode - version: interventionModel.codeSystemVersion + - id: $codelist_code + map: + - output: C99076 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: interventionModel.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: interventionModel.code + version: interventionModel.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: interventionModel.code + version: interventionModel.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: interventionModel.decode + version: interventionModel.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: interventionModel.decode + version: interventionModel.codeSystemVersion Outcome: - Message: 'The study design''s intervention model is not specified according to the extensible Intervention + Message: + 'The study design''s intervention model is not specified according to the extensible Intervention Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - interventionModel.code - - $code_for_decode_value - - $code_for_decode_pref_term - - interventionModel.codeSystem - - interventionModel.codeSystemVersion - - interventionModel.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - interventionModel.code + - $code_for_decode_value + - $code_for_decode_pref_term + - interventionModel.codeSystem + - interventionModel.codeSystemVersion + - interventionModel.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-000918/rule.yml b/Published/CORE-000918/rule.yml index 650e25ea9..f39b44ab7 100644 --- a/Published/CORE-000918/rule.yml +++ b/Published/CORE-000918/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's blinding schema must be specified according to the extensible - Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00121' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's blinding schema must be specified according to the extensible + Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00121" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: blindingSchema - operator: exists - - name: blindingSchema - operator: equal_to - value: true - - not: - all: - - name: blindingSchema.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: blindingSchema.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: blindingSchema + operator: exists + - name: blindingSchema + operator: equal_to + value: true + - not: + all: + - name: blindingSchema.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: blindingSchema.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: blindingSchema.code - operator: equal_to - value: $code_for_decode_pref_term - - name: blindingSchema.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: blindingSchema.decode - operator: equal_to - value: $pref_term_for_code - - name: blindingSchema.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: blindingSchema.code + operator: equal_to + value: $code_for_decode_pref_term + - name: blindingSchema.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: blindingSchema.decode + operator: equal_to + value: $pref_term_for_code + - name: blindingSchema.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000918' + Id: "CORE-000918" Status: Published - Version: '1' -Description: "A study design's blinding schema must be specified according to the extensible Trial Blinding + Version: "1" +Description: + "A study design's blinding schema must be specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66735 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: blindingSchema.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: blindingSchema.code - version: blindingSchema.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: blindingSchema.code - version: blindingSchema.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: blindingSchema.decode - version: blindingSchema.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: blindingSchema.decode - version: blindingSchema.codeSystemVersion + - id: $codelist_code + map: + - output: C66735 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: blindingSchema.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: blindingSchema.code + version: blindingSchema.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: blindingSchema.code + version: blindingSchema.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: blindingSchema.decode + version: blindingSchema.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: blindingSchema.decode + version: blindingSchema.codeSystemVersion Outcome: - Message: 'The study design''s blinding schema is not specified according to the extensible Trial Blinding + Message: + 'The study design''s blinding schema is not specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - blindingSchema.code - - $code_for_decode_value - - $code_for_decode_pref_term - - blindingSchema.codeSystem - - blindingSchema.codeSystemVersion - - blindingSchema.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - blindingSchema.code + - $code_for_decode_value + - $code_for_decode_pref_term + - blindingSchema.codeSystem + - blindingSchema.codeSystemVersion + - blindingSchema.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-000919/rule.yml b/Published/CORE-000919/rule.yml index d22a449a5..7148f2038 100644 --- a/Published/CORE-000919/rule.yml +++ b/Published/CORE-000919/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's characteristics must be specified according to the extensible - Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with - a code or decode used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00122' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's characteristics must be specified according to the extensible + Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with + a code or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00122" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: characteristics - operator: exists - - name: characteristics - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'characteristics' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: characteristics + operator: exists + - name: characteristics + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "characteristics" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000919' + Id: "CORE-000919" Status: Published - Version: '1' -Description: "A study design's characteristics must be specified according to the extensible Study Design + Version: "1" +Description: + "A study design's characteristics must be specified according to the extensible Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C207416 - parent_rel.Code: 'characteristics' - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C207416 + parent_rel.Code: "characteristics" + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s characteristic is not specified according to the extensible Study Design + Message: + 'The study design''s characteristic is not specified according to the extensible Study Design Characteristics Value Set Terminology (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-000920/rule.yml b/Published/CORE-000920/rule.yml index d1d876b79..d4215edda 100644 --- a/Published/CORE-000920/rule.yml +++ b/Published/CORE-000920/rule.yml @@ -1,148 +1,151 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A masking role must be specified according to the extensible masking role (C207414) - DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent - with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00123' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A masking role must be specified according to the extensible masking role (C207414) + DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent + with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00123" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: role - operator: exists - - name: role - operator: equal_to - value: true - - not: - all: - - name: role.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: role.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: role + operator: exists + - name: role + operator: equal_to + value: true + - not: + all: + - name: role.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: role.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: role.code - operator: equal_to - value: $code_for_decode_pref_term - - name: role.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: role.decode - operator: equal_to - value: $pref_term_for_code - - name: role.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: role.code + operator: equal_to + value: $code_for_decode_pref_term + - name: role.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: role.decode + operator: equal_to + value: $pref_term_for_code + - name: role.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000920' + Id: "CORE-000920" Status: Published - Version: '1' -Description: "A masking role must be specified according to the extensible masking role (C207414) DDF + Version: "1" +Description: + "A masking role must be specified according to the extensible masking role (C207414) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207414 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: role.code - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: role.code - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: role.decode - version: role.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: role.decode - version: role.codeSystemVersion + - id: $codelist_code + map: + - output: C207414 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: role.code + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: role.code + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: role.decode + version: role.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: role.decode + version: role.codeSystemVersion Outcome: - Message: 'The masking role is not specified according to the extensible masking role (C207414) DDF codelist + Message: + 'The masking role is not specified according to the extensible masking role (C207414) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - role.code - - $code_for_decode_value - - $code_for_decode_pref_term - - role.codeSystem - - role.codeSystemVersion - - role.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - role.code + - $code_for_decode_value + - $code_for_decode_pref_term + - role.codeSystem + - role.codeSystemVersion + - role.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Masking' + - "Masking" Sensitivity: Record diff --git a/Published/CORE-000921/rule.yml b/Published/CORE-000921/rule.yml index 5577107ae..ba5b89233 100644 --- a/Published/CORE-000921/rule.yml +++ b/Published/CORE-000921/rule.yml @@ -1,145 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study intervention''s product designation must be specified using the product - designation (C207418) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00129' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study intervention's product designation must be specified using the product + designation (C207418) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00129" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: productDesignation - operator: equal_to - value: true - - not: - all: - - name: productDesignation.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: productDesignation.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_pref_term - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: productDesignation.decode - operator: equal_to - value: $pref_term_for_code - - name: productDesignation.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: productDesignation + operator: equal_to + value: true + - not: + all: + - name: productDesignation.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: productDesignation.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_pref_term + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: productDesignation.decode + operator: equal_to + value: $pref_term_for_code + - name: productDesignation.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000921' + Id: "CORE-000921" Status: Published - Version: '1' -Description: 'A study intervention''s product designation must be specified using the product designation - (C207418) DDF codelist.' + Version: "1" +Description: + "A study intervention's product designation must be specified using the product designation + (C207418) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207418 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: productDesignation.code - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: productDesignation.code - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: productDesignation.decode - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: productDesignation.decode - version: productDesignation.codeSystemVersion + - id: $codelist_code + map: + - output: C207418 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: productDesignation.code + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: productDesignation.code + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: productDesignation.decode + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: productDesignation.decode + version: productDesignation.codeSystemVersion Outcome: - Message: 'The study intervention''s product designation is not specified using the product designation + Message: + 'The study intervention''s product designation is not specified using the product designation (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - productDesignation.code - - $code_for_decode_value - - $code_for_decode_pref_term - - productDesignation.codeSystem - - productDesignation.codeSystemVersion - - productDesignation.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - productDesignation.code + - $code_for_decode_value + - $code_for_decode_pref_term + - productDesignation.codeSystem + - productDesignation.codeSystemVersion + - productDesignation.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyIntervention' + - "StudyIntervention" Sensitivity: Record diff --git a/Published/CORE-000922/rule.yml b/Published/CORE-000922/rule.yml index 2238cfcb5..33ab05593 100644 --- a/Published/CORE-000922/rule.yml +++ b/Published/CORE-000922/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An agent administration's route must be specified according to the extensible - Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00130' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An agent administration's route must be specified according to the extensible + Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode + used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00130" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: route.standardCode - operator: exists - - name: route.standardCode - operator: equal_to - value: true - - not: - all: - - name: route.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: route.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: route.standardCode + operator: exists + - name: route.standardCode + operator: equal_to + value: true + - not: + all: + - name: route.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: route.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: route.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: route.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: route.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: route.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: route.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: route.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000922' + Id: "CORE-000922" Status: Published - Version: '1' -Description: "An agent administration's route must be specified according to the extensible Route of Administration + Version: "1" +Description: + "An agent administration's route must be specified according to the extensible Route of Administration Response (C66729) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66729 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: route.standardCode.code - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: route.standardCode.decode - version: route.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: route.standardCode.decode - version: route.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66729 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: route.standardCode.code + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: route.standardCode.decode + version: route.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: route.standardCode.decode + version: route.standardCode.codeSystemVersion Outcome: - Message: 'The agent administration''s route is not specified according to the extensible Route of Administration + Message: + 'The agent administration''s route is not specified according to the extensible Route of Administration Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - route.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - route.standardCode.codeSystem - - route.standardCode.codeSystemVersion - - route.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - route.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - route.standardCode.codeSystem + - route.standardCode.codeSystemVersion + - route.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AgentAdministration' + - "AgentAdministration" Sensitivity: Record diff --git a/Published/CORE-000923/rule.yml b/Published/CORE-000923/rule.yml index e6ea2952d..4f054db4b 100644 --- a/Published/CORE-000923/rule.yml +++ b/Published/CORE-000923/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter's environmental setting must be specified according to the extensible - Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00135' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter's environmental setting must be specified according to the extensible + Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00135" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: environmentalSetting - operator: exists - - name: environmentalSetting - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'environmentalSetting' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: environmentalSetting + operator: exists + - name: environmentalSetting + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "environmentalSetting" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000923' + Id: "CORE-000923" Status: Published - Version: '1' -Description: "An encounter's environmental setting must be specified according to the extensible Environmental + Version: "1" +Description: + "An encounter's environmental setting must be specified according to the extensible Environmental Setting (C127262) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C127262 - parent_rel.Code: 'environmentalSetting' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C127262 + parent_rel.Code: "environmentalSetting" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The encounter''s environmental setting is not specified according to the extensible Environmental + Message: + 'The encounter''s environmental setting is not specified according to the extensible Environmental Setting (C127262) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000924/rule.yml b/Published/CORE-000924/rule.yml index 8d7d1cc16..9d351f199 100644 --- a/Published/CORE-000924/rule.yml +++ b/Published/CORE-000924/rule.yml @@ -1,174 +1,177 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An organization type must be specified according to the extensible organization - type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should - be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00140' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An organization type must be specified according to the extensible organization + type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00140" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: organizationType - operator: exists - - name: organizationType - operator: equal_to - value: true - - not: - all: - - name: organizationType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: organizationType.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: organizationType + operator: exists + - name: organizationType + operator: equal_to + value: true + - not: + all: + - name: organizationType.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: organizationType.codeSystemVersion + operator: is_contained_by + value: $valid_versions - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: "Y" - any: - - name: organizationType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: organizationType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: organizationType.decode - operator: equal_to - value: $pref_term_for_code - - name: organizationType.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: organizationType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: organizationType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: organizationType.decode + operator: equal_to + value: $pref_term_for_code + - name: organizationType.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000924' + Id: "CORE-000924" Status: Published - Version: '1' -Description: "An organization type must be specified according to the extensible organization type (C188724) + Version: "1" +Description: + "An organization type must be specified according to the extensible organization type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188724 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: organizationType.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: -- id: $codelist_extensible_override - map: - - organizationType.codeSystemVersion: '2022-09-30' - output: "Y" - - organizationType.codeSystemVersion: '2022-12-16' - output: "Y" - - organizationType.codeSystemVersion: '2023-03-31' - output: "Y" - - organizationType.codeSystemVersion: '2023-06-30' - output: "Y" - - organizationType.codeSystemVersion: '2023-09-29' - output: "Y" - - organizationType.codeSystemVersion: '2023-12-15' - output: "Y" - - organizationType.codeSystemVersion: '2024-03-29' - output: "Y" - operator: map -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: organizationType.code - version: organizationType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: organizationType.code - version: organizationType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: organizationType.decode - version: organizationType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: organizationType.decode - version: organizationType.codeSystemVersion + - id: $codelist_code + map: + - output: C188724 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: organizationType.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: + - id: $codelist_extensible_override + map: + - organizationType.codeSystemVersion: "2022-09-30" + output: "Y" + - organizationType.codeSystemVersion: "2022-12-16" + output: "Y" + - organizationType.codeSystemVersion: "2023-03-31" + output: "Y" + - organizationType.codeSystemVersion: "2023-06-30" + output: "Y" + - organizationType.codeSystemVersion: "2023-09-29" + output: "Y" + - organizationType.codeSystemVersion: "2023-12-15" + output: "Y" + - organizationType.codeSystemVersion: "2024-03-29" + output: "Y" + operator: map + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: organizationType.code + version: organizationType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: organizationType.code + version: organizationType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: organizationType.decode + version: organizationType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: organizationType.decode + version: organizationType.codeSystemVersion Outcome: - Message: 'The organization type is not specified according to the extensible organization type (C188724) + Message: + 'The organization type is not specified according to the extensible organization type (C188724) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - organizationType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - organizationType.codeSystem - - organizationType.codeSystemVersion - - organizationType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - organizationType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - organizationType.codeSystem + - organizationType.codeSystemVersion + - organizationType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Organization' - - 'ResearchOrganization' + - "Organization" + - "ResearchOrganization" Sensitivity: Record diff --git a/Published/CORE-000925/rule.yml b/Published/CORE-000925/rule.yml index 9b10ac61e..42bb22635 100644 --- a/Published/CORE-000925/rule.yml +++ b/Published/CORE-000925/rule.yml @@ -1,162 +1,166 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A governance date type must be specified according to the extensible governance - date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00142' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A governance date type must be specified according to the extensible governance - date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00142' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A governance date type must be specified according to the extensible governance + date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00142" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A governance date type must be specified according to the extensible governance + date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00142" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000925' + Id: "CORE-000925" Status: Published - Version: '1' -Description: "A governance date type must be specified according to the extensible governance date type + Version: "1" +Description: + "A governance date type must be specified according to the extensible governance date type (C207413) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207413 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C207413 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The governance date type is not specified according to the extensible governance date type + Message: + 'The governance date type is not specified according to the extensible governance date type (C207413) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'GovernanceDate' + - "GovernanceDate" Sensitivity: Record diff --git a/Published/CORE-000926/rule.yml b/Published/CORE-000926/rule.yml index 419b94167..2aad3c41a 100644 --- a/Published/CORE-000926/rule.yml +++ b/Published/CORE-000926/rule.yml @@ -1,33 +1,34 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In Vivo Micronucleus is represented at the subject level, not the slide - level. - Document: SENDIG-GENETOX - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND409 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + In Vivo Micronucleus is represented at the subject level, not the slide + level. + Document: SENDIG-GENETOX + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND409 + Version: "1" + Version: "5.0" + Version: "1.0" # In Vivo Micronucleus is represented at the subject level, not the slide level. # i.e. when GVCAT = 'IN VIVO MICRONUCLEUS' then USUBJID must be populated, not POOLID # REMARK: but USUBJID = "required" anyway Check: all: - - name: 'GVCAT' - operator: equal_to - value: 'IN VIVO MICRONUCLEUS' - - name: 'USUBJID' - operator: empty + - name: "GVCAT" + operator: equal_to + value: "IN VIVO MICRONUCLEUS" + - name: "USUBJID" + operator: empty Core: Id: CORE-000926 Status: Published - Version: '1' + Version: "1" Description: In Vivo Micronucleus is represented at the subject level, not the slide level. Executability: Fully Executable Outcome: @@ -36,8 +37,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Published/CORE-000929/rule.yml b/Published/CORE-000929/rule.yml index a35025617..dd335d2dc 100644 --- a/Published/CORE-000929/rule.yml +++ b/Published/CORE-000929/rule.yml @@ -1,203 +1,207 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Using SDTM-specified standard domain names and prefixes where applicable. - Document: SDTMIG v3.4 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C - Controlled - Terminology] for reserved two-character domain identifiers or abbreviations. If one has - not been assigned by CDISC, then the sponsor may select the unique two-character domain - code to be used consistently throughout the submission. - Document: IG v3.2 - Item: 3.d - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Determine the domain code, one that is not a domain code in the CDISC - Controlled Terminology codelist "SDTM Domain Abbreviations" available at - http://www.cancer.gov/research/resources/terminology/cdisc. If it desired to have this - domain code as part of CDISC controlled terminology, then submit a request to - https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The sponsor-selected, - two-character domain code should be used consistently throughout the submission. - Document: IG v3.3 - Item: 3.e - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0001 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A dataset is created using a domain specification in this guide when the - scientific nature or role of the data is within the scope of a domain. Domains are - extended or custom domain specifications are only used when data are different in nature - and are not in scope for domains in this guide. - Document: TIG 1.0 - Item: Table 2 Num 2 - Section: '2.5' - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0289 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.0 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1 - Item: Text - Section: 4.1.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: See SEND CT for a list of standard and reserved domain codes - Document: SENDIG v3.1.1 - Item: Text - Section: 4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND16 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: TIG - References: - - Citations: - - Cited Guidance: To support implementation of standards, controlled terminology will be used - to name domain datasets and variables in datasets when applicable. - Document: TIG v1.0 - Item: Standards for Tabulation - Section: 2.3. - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0090 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Using SDTM-specified standard domain names and prefixes where applicable. + Document: SDTMIG v3.4 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Check the CDISC Controlled Terminology [see Appendix C - Controlled + Terminology] for reserved two-character domain identifiers or abbreviations. If one has + not been assigned by CDISC, then the sponsor may select the unique two-character domain + code to be used consistently throughout the submission. + Document: IG v3.2 + Item: 3.d + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Determine the domain code, one that is not a domain code in the CDISC + Controlled Terminology codelist "SDTM Domain Abbreviations" available at + http://www.cancer.gov/research/resources/terminology/cdisc. If it desired to have this + domain code as part of CDISC controlled terminology, then submit a request to + https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The sponsor-selected, + two-character domain code should be used consistently throughout the submission. + Document: IG v3.3 + Item: 3.e + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0001 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + A dataset is created using a domain specification in this guide when the + scientific nature or role of the data is within the scope of a domain. Domains are + extended or custom domain specifications are only used when data are different in nature + and are not in scope for domains in this guide. + Document: TIG 1.0 + Item: Table 2 Num 2 + Section: "2.5" + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0289 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.0 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1 + Item: Text + Section: 4.1.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: See SEND CT for a list of standard and reserved domain codes + Document: SENDIG v3.1.1 + Item: Text + Section: 4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND16 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: TIG + References: + - Citations: + - Cited Guidance: + To support implementation of standards, controlled terminology will be used + to name domain datasets and variables in datasets when applicable. + Document: TIG v1.0 + Item: Standards for Tabulation + Section: 2.3. + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0090 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" # Variable: DOMAIN # Condition: Not custom domain # Rule: DOMAIN = valid Domain Code published by CDISC Check: all: - - name: $domain_is_custom - operator: equal_to - value: false - - name: define_variable_ccode - operator: equal_to - value: C66734 - - name: define_variable_codelist_coded_codes - operator: is_not_contained_by - value: $domain_lib_ccode + - name: $domain_is_custom + operator: equal_to + value: false + - name: define_variable_ccode + operator: equal_to + value: C66734 + - name: define_variable_codelist_coded_codes + operator: is_not_contained_by + value: $domain_lib_ccode Core: Id: CORE-000929 Status: Published - Version: '1' + Version: "1" Description: Raise and error when the DOMAIN Code is not a valid Domain Code published by CDISC. Executability: Fully Executable Operations: -- id: $domain_is_custom - operator: domain_is_custom -- codelists: - - DOMAIN - id: $domain_lib_ccode - level: term - operator: codelist_terms - returntype: code + - id: $domain_is_custom + operator: domain_is_custom + - codelists: + - DOMAIN + id: $domain_lib_ccode + level: term + operator: codelist_terms + returntype: code Outcome: Message: DOMAIN Code is not a published DOMAIN Code in CDISC Controlled Terminology. Output Variables: - - $domain_lib_ccode - - define_variable_codelist_coded_codes + - $domain_lib_ccode + - define_variable_codelist_coded_codes Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Use Case: INDH, PROD, NONCLIN Sensitivity: Record diff --git a/Published/CORE-000930/rule.yml b/Published/CORE-000930/rule.yml index 2622ddddc..70757de4c 100644 --- a/Published/CORE-000930/rule.yml +++ b/Published/CORE-000930/rule.yml @@ -1,157 +1,160 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment reason must be coded using the study amendment reason (C207415) - DDF codelist." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00143' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment reason must be coded using the study amendment reason (C207415) - DDF codelist." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00143' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study amendment reason must be coded using the study amendment reason (C207415) + DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00143" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study amendment reason must be coded using the study amendment reason (C207415) + DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00143" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - not: - all: - - name: code.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: code.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code.code - operator: equal_to - value: $code_for_decode_pref_term - - name: code.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: code.decode - operator: equal_to - value: $pref_term_for_code - - name: code.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - not: + all: + - name: code.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: code.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code.code + operator: equal_to + value: $code_for_decode_pref_term + - name: code.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: code.decode + operator: equal_to + value: $pref_term_for_code + - name: code.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000930' + Id: "CORE-000930" Status: Published - Version: '1' + Version: "1" Description: "A study amendment reason must be coded using the study amendment reason (C207415) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207415 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code.code - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code.code - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: code.decode - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: code.decode - version: code.codeSystemVersion + - id: $codelist_code + map: + - output: C207415 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code.code + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code.code + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: code.decode + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: code.decode + version: code.codeSystemVersion Outcome: - Message: 'The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist + Message: + 'The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - code.code - - $code_for_decode_value - - $code_for_decode_pref_term - - code.codeSystem - - code.codeSystemVersion - - code.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - code.code + - $code_for_decode_value + - $code_for_decode_pref_term + - code.codeSystem + - code.codeSystemVersion + - code.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyAmendmentReason' + - "StudyAmendmentReason" Sensitivity: Record diff --git a/Published/CORE-000931/rule.yml b/Published/CORE-000931/rule.yml index 3850d803a..6bbf26dde 100644 --- a/Published/CORE-000931/rule.yml +++ b/Published/CORE-000931/rule.yml @@ -1,156 +1,160 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study geographic scope type must be specified using the geographic scope type - (C207412) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00144' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study geographic scope type must be specified using the geographic scope type - (C207412) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00144' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study geographic scope type must be specified using the geographic scope type + (C207412) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00144" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study geographic scope type must be specified using the geographic scope type + (C207412) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00144" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000931' + Id: "CORE-000931" Status: Published - Version: '1' -Description: 'A study geographic scope type must be specified using the geographic scope type (C207412) - DDF codelist.' + Version: "1" +Description: + "A study geographic scope type must be specified using the geographic scope type (C207412) + DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207412 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C207412 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study geographic scope type is not specified using the geographic scope type (C207412) + Message: + 'The study geographic scope type is not specified using the geographic scope type (C207412) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'GeographicScope' + - "GeographicScope" Sensitivity: Record diff --git a/Published/CORE-000932/rule.yml b/Published/CORE-000932/rule.yml index 9a2ce63dc..6a4d211e1 100644 --- a/Published/CORE-000932/rule.yml +++ b/Published/CORE-000932/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A quantity's unit must be coded according to the extensible unit (C71620) SDTM - codelist (e.g. an entry with a code or decode used from the codelist should be consistent with - the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00145' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A quantity's unit must be coded according to the extensible unit (C71620) SDTM + codelist (e.g. an entry with a code or decode used from the codelist should be consistent with + the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00145" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: unit - operator: exists - - name: unit - operator: equal_to - value: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: unit + operator: exists + - name: unit + operator: equal_to + value: true + - not: + all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000932' + Id: "CORE-000932" Status: Published - Version: '1' -Description: "A quantity's unit must be coded according to the extensible unit (C71620) SDTM codelist + Version: "1" +Description: + "A quantity's unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C71620 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C71620 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion Outcome: - Message: 'The quantity''s unit is not specified according to the extensible unit (C71620) SDTM codelist + Message: + 'The quantity''s unit is not specified according to the extensible unit (C71620) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - value + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Quantity' + - "Quantity" Sensitivity: Record diff --git a/Published/CORE-000933/rule.yml b/Published/CORE-000933/rule.yml index ddfa216fb..58de78ff5 100644 --- a/Published/CORE-000933/rule.yml +++ b/Published/CORE-000933/rule.yml @@ -1,156 +1,159 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study title type must be specified using the study title type (C207419) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00146' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study title type must be specified using the study title type (C207419) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00146' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study title type must be specified using the study title type (C207419) DDF + codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00146" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study title type must be specified using the study title type (C207419) DDF + codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00146" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000933' + Id: "CORE-000933" Status: Published - Version: '1' -Description: 'A study title type must be specified using the study title type (C207419) DDF codelist.' + Version: "1" +Description: "A study title type must be specified using the study title type (C207419) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207419 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C207419 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study title type is not specified using the study title type (C207419) DDF codelist - + Message: + 'The study title type is not specified using the study title type (C207419) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyTitle' + - "StudyTitle" Sensitivity: Record diff --git a/Published/CORE-000934/rule.yml b/Published/CORE-000934/rule.yml index c5b1004ae..709323a5c 100644 --- a/Published/CORE-000934/rule.yml +++ b/Published/CORE-000934/rule.yml @@ -1,81 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, - URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how to populate." - Document: IG v3.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, - URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, - URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how to populate." - Document: IG v3.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, - URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, - URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine - clearance), then refer to Section 4.3.6.2 for guidance on how to populate." - Document: IG v3.1.1 - Item: PPSPEC CDISC Notes - Section: 6.3.12 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND282" - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Defines the type of specimen used for a measurement. Examples: SERUM, PLASMA, + URINE. If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine + clearance), then refer to Section 4.3.6.2 for guidance on how to populate." + Document: IG v3.1.1 + Item: PPSPEC CDISC Notes + Section: 6.3.12 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND282" + Version: "1" + Version: "5.0" + Version: "1.0" Check: # 2022-09-29: Currently it is only checked whether the semicolon is correctly used as the separator # TODO: values must be checked against [SPEC] codelist, which requires use of the CDISC-Library API @@ -89,51 +94,53 @@ Check: # value: ^[A-Za-z\s,]+(;[A-Za-z\s,]+)*$ # PPSPEC value contains a semicolon # TODO: check whether each "splitted part follows the CT for "SPEC" (codelist) - - name: PPSPEC - operator: contains - value: ';' - # 2025-11-19: part that iterates of the "splitted parts" and checks each of them - #- name: $ppspec_value - # operator: not_contains_all - # value: $ppspec_codelist - # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY - - name: $ppspec_codelist - operator: not_contains_all - value: $ppspec_value - # operator: not_equal_to - # value: 'TEST' + - name: PPSPEC + operator: contains + value: ";" + # 2025-11-19: part that iterates of the "splitted parts" and checks each of them + #- name: $ppspec_value + # operator: not_contains_all + # value: $ppspec_codelist + # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY + - name: $ppspec_codelist + operator: not_contains_all + value: + $ppspec_value + # operator: not_equal_to + # value: 'TEST' Core: Id: CORE-000934 Status: Published Version: "1" -Description: If multiple specimen types are used for a calculation (e.g., serum and urine for - creatinine clearance), then this field should be populated with values from the (SPEC) Controlled +Description: + If multiple specimen types are used for a calculation (e.g., serum and urine for + creatinine clearance), then this field should be populated with values from the (SPEC) Controlled Terminology codelist delimited by a semicolon. Executability: Fully Executable Operations: -- delimiter: ';' - id: $ppspec_value - name: PPSPEC - operator: split_by -- codelists: - - SPEC - ct_package_type: SEND - id: $ppspec_codelist - level: term - operator: codelist_terms - returntype: value + - delimiter: ";" + id: $ppspec_value + name: PPSPEC + operator: split_by + - codelists: + - SPEC + ct_package_type: SEND + id: $ppspec_codelist + level: term + operator: codelist_terms + returntype: value Outcome: Message: The multiple specimens are not correctly separated by a semicolon Output Variables: - - PPSPEC - - $ppspec_value - - $ppspec_codelist + - PPSPEC + - $ppspec_value + - $ppspec_codelist Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Published/CORE-000935/rule.yml b/Published/CORE-000935/rule.yml index 3c61a7919..2e7b8d4ba 100644 --- a/Published/CORE-000935/rule.yml +++ b/Published/CORE-000935/rule.yml @@ -1,50 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform with the USDM - schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00082' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Data types of attributes (string, number, boolean) must conform with the USDM - schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00082' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Data types of attributes (string, number, boolean) must conform with the USDM + schema based on the API specification." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00082" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Data types of attributes (string, number, boolean) must conform with the USDM + schema based on the API specification." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00082" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: validator - operator: equal_to - value: 'type' + - name: validator + operator: equal_to + value: "type" Core: - Id: 'CORE-000935' + Id: "CORE-000935" Status: Published - Version: '1' -Description: 'Data types of attributes (string, number, boolean) must conform with the USDM schema based - on the API specification.' + Version: "1" +Description: + "Data types of attributes (string, number, boolean) must conform with the USDM schema based + on the API specification." Executability: Fully Executable Outcome: - Message: 'The datatype of the attribute does not conform with the USDM schema.' + Message: "The datatype of the attribute does not conform with the USDM schema." Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Published/CORE-000936/rule.yml b/Published/CORE-000936/rule.yml index f86b274e8..4eb3b7917 100644 --- a/Published/CORE-000936/rule.yml +++ b/Published/CORE-000936/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00086' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Syntax template text is expected to be HTML formatted." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00086" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: $xhtml_errors + operator: non_empty Core: - Id: 'CORE-000936' + Id: "CORE-000936" Status: Published - Version: '1' -Description: 'Syntax template text is expected to be HTML formatted.' + Version: "1" +Description: "Syntax template text is expected to be HTML formatted." Executability: Partially Executable - Possible Overreporting Operations: -- id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors + - id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: - Message: 'The text attribute contains non-conformant XHTML.' + Message: "The text attribute contains non-conformant XHTML." Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'Characteristic' - - 'Condition' - - 'EligibilityCriterion' - - 'Endpoint' - - 'Objective' + - "Characteristic" + - "Condition" + - "EligibilityCriterion" + - "Endpoint" + - "Objective" Sensitivity: Record diff --git a/Published/CORE-000937/rule.yml b/Published/CORE-000937/rule.yml index 0ec12e495..38a9d6d2f 100644 --- a/Published/CORE-000937/rule.yml +++ b/Published/CORE-000937/rule.yml @@ -1,52 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Attributes must be included as defined in the USDM schema based on the API specification - (i.e., all required properties are present and no additional attributes are present).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00125' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Attributes must be included as defined in the USDM schema based on the API specification - (i.e., all required properties are present and no additional attributes are present).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00125' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00125" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00125" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: validator - operator: is_contained_by - value: - - 'required' - - 'additionalProperties' + - name: validator + operator: is_contained_by + value: + - "required" + - "additionalProperties" Core: - Id: 'CORE-000937' + Id: "CORE-000937" Status: Published - Version: '1' -Description: 'Attributes must be included as defined in the USDM schema based on the API specification - (i.e., all required properties are present and no additional attributes are present).' + Version: "1" +Description: + "Attributes must be included as defined in the USDM schema based on the API specification + (i.e., all required properties are present and no additional attributes are present)." Executability: Fully Executable Outcome: - Message: 'Attributes are not included as defined in the USDM schema - required properties are missing - or additional properties are present.' + Message: + "Attributes are not included as defined in the USDM schema - required properties are missing + or additional properties are present." Output Variables: - - message + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Published/CORE-000938/rule.yml b/Published/CORE-000938/rule.yml index b5d3c3c7e..61e987312 100644 --- a/Published/CORE-000938/rule.yml +++ b/Published/CORE-000938/rule.yml @@ -1,55 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on the API specification - (i.e., required properties have at least one value and single-value properties are not lists).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00126' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Cardinalities must be as defined in the USDM schema based on the API specification - (i.e., required properties have at least one value and single-value properties are not lists).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00126' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Cardinalities must be as defined in the USDM schema based on the API specification + (i.e., required properties have at least one value and single-value properties are not lists)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00126" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Cardinalities must be as defined in the USDM schema based on the API specification + (i.e., required properties have at least one value and single-value properties are not lists)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00126" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: validator - operator: is_contained_by - value: - - 'minLength' - - 'minItems' - - 'maxItems' + - name: validator + operator: is_contained_by + value: + - "minLength" + - "minItems" + - "maxItems" Core: - Id: 'CORE-000938' + Id: "CORE-000938" Status: Published - Version: '1' -Description: 'Cardinalities must be as defined in the USDM schema based on the API specification (i.e., - required properties have at least one value and single-value properties are not lists).' + Version: "1" +Description: + "Cardinalities must be as defined in the USDM schema based on the API specification (i.e., + required properties have at least one value and single-value properties are not lists)." Executability: Fully Executable Outcome: - Message: 'The cardinality of the attribute is not as defined in the USDM schema - the attribute is required + Message: + "The cardinality of the attribute is not as defined in the USDM schema - the attribute is required but does not have a value (the value is too short), or the attribute is a list and has either too - few entries (the list is too short) or too many entries (the list is too long).' + few entries (the list is too short) or too many entries (the list is too long)." Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Published/CORE-000939/rule.yml b/Published/CORE-000939/rule.yml index 5e085e867..abe034870 100644 --- a/Published/CORE-000939/rule.yml +++ b/Published/CORE-000939/rule.yml @@ -1,156 +1,159 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An objective level must be specified using the objective level (C188725) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00147' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An objective level must be specified using the objective level (C188725) DDF - codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00147' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An objective level must be specified using the objective level (C188725) DDF + codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00147" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An objective level must be specified using the objective level (C188725) DDF + codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00147" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level - operator: equal_to - value: true - - not: - all: - - name: level.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: level.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: level.code - operator: equal_to - value: $code_for_decode_pref_term - - name: level.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: level.decode - operator: equal_to - value: $pref_term_for_code - - name: level.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: level + operator: equal_to + value: true + - not: + all: + - name: level.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: level.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: level.code + operator: equal_to + value: $code_for_decode_pref_term + - name: level.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: level.decode + operator: equal_to + value: $pref_term_for_code + - name: level.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000939' + Id: "CORE-000939" Status: Published - Version: '1' -Description: 'An objective level must be specified using the objective level (C188725) DDF codelist.' + Version: "1" +Description: "An objective level must be specified using the objective level (C188725) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188725 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: level.code - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: level.code - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: level.decode - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: level.decode - version: level.codeSystemVersion + - id: $codelist_code + map: + - output: C188725 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: level.code + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: level.code + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: level.decode + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: level.decode + version: level.codeSystemVersion Outcome: - Message: 'The objective level is not specified using the objective level (C188725) DDF codelist - codeSystem + Message: + 'The objective level is not specified using the objective level (C188725) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - level.code - - $code_for_decode_value - - $code_for_decode_pref_term - - level.codeSystem - - level.codeSystemVersion - - level.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - level.code + - $code_for_decode_value + - $code_for_decode_pref_term + - level.codeSystem + - level.codeSystemVersion + - level.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Objective' + - "Objective" Sensitivity: Record diff --git a/Published/CORE-000940/rule.yml b/Published/CORE-000940/rule.yml index ab6e43ff0..3dcb88e29 100644 --- a/Published/CORE-000940/rule.yml +++ b/Published/CORE-000940/rule.yml @@ -1,154 +1,155 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00148' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00148' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00148" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00148" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: level - operator: equal_to - value: true - - not: - all: - - name: level.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: level.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: level.code - operator: equal_to - value: $code_for_decode_pref_term - - name: level.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: level.decode - operator: equal_to - value: $pref_term_for_code - - name: level.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: level + operator: equal_to + value: true + - not: + all: + - name: level.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: level.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: level.code + operator: equal_to + value: $code_for_decode_pref_term + - name: level.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: level.decode + operator: equal_to + value: $pref_term_for_code + - name: level.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000940' + Id: "CORE-000940" Status: Published - Version: '1' -Description: 'An endpoint level must be specified using the endpoint level (C188726) DDF codelist.' + Version: "1" +Description: "An endpoint level must be specified using the endpoint level (C188726) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188726 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: level.code - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: level.code - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: level.decode - version: level.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: level.decode - version: level.codeSystemVersion + - id: $codelist_code + map: + - output: C188726 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: level.code + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: level.code + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: level.decode + version: level.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: level.decode + version: level.codeSystemVersion Outcome: - Message: 'The endpoint level is not specified using the endpoint level (C188726) DDF codelist - codeSystem + Message: + 'The endpoint level is not specified using the endpoint level (C188726) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - level.code - - $code_for_decode_value - - $code_for_decode_pref_term - - level.codeSystem - - level.codeSystemVersion - - level.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - level.code + - $code_for_decode_value + - $code_for_decode_pref_term + - level.codeSystem + - level.codeSystemVersion + - level.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Endpoint' + - "Endpoint" Sensitivity: Record diff --git a/Published/CORE-000941/rule.yml b/Published/CORE-000941/rule.yml index 0b1288f5c..80ed96496 100644 --- a/Published/CORE-000941/rule.yml +++ b/Published/CORE-000941/rule.yml @@ -1,186 +1,190 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study arm data origin type must be specified according to the extensible data - origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00149' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study arm data origin type must be specified according to the extensible data - origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00149' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study arm data origin type must be specified according to the extensible data + origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00149" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study arm data origin type must be specified according to the extensible data + origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00149" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: dataOriginType - operator: exists - - name: dataOriginType - operator: equal_to - value: true - - not: - all: - - name: dataOriginType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: dataOriginType.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: dataOriginType + operator: exists + - name: dataOriginType + operator: equal_to + value: true + - not: + all: + - name: dataOriginType.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: dataOriginType.codeSystemVersion + operator: is_contained_by + value: $valid_versions - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: "Y" - any: - - name: dataOriginType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: dataOriginType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: dataOriginType.decode - operator: equal_to - value: $pref_term_for_code - - name: dataOriginType.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: dataOriginType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: dataOriginType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: dataOriginType.decode + operator: equal_to + value: $pref_term_for_code + - name: dataOriginType.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000941' + Id: "CORE-000941" Status: Published - Version: '1' -Description: "A study arm data origin type must be specified according to the extensible data origin type + Version: "1" +Description: + "A study arm data origin type must be specified according to the extensible data origin type (C188727) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188727 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: dataOriginType.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: -- id: $codelist_extensible_override - map: - - dataOriginType.codeSystemVersion: '2022-09-30' - output: "Y" - - dataOriginType.codeSystemVersion: '2022-12-16' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-03-31' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-06-30' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-09-29' - output: "Y" - - dataOriginType.codeSystemVersion: '2023-12-15' - output: "Y" - - dataOriginType.codeSystemVersion: '2024-03-29' - output: "Y" - operator: map -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: dataOriginType.code - version: dataOriginType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: dataOriginType.code - version: dataOriginType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: dataOriginType.decode - version: dataOriginType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: dataOriginType.decode - version: dataOriginType.codeSystemVersion + - id: $codelist_code + map: + - output: C188727 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: dataOriginType.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: + - id: $codelist_extensible_override + map: + - dataOriginType.codeSystemVersion: "2022-09-30" + output: "Y" + - dataOriginType.codeSystemVersion: "2022-12-16" + output: "Y" + - dataOriginType.codeSystemVersion: "2023-03-31" + output: "Y" + - dataOriginType.codeSystemVersion: "2023-06-30" + output: "Y" + - dataOriginType.codeSystemVersion: "2023-09-29" + output: "Y" + - dataOriginType.codeSystemVersion: "2023-12-15" + output: "Y" + - dataOriginType.codeSystemVersion: "2024-03-29" + output: "Y" + operator: map + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: dataOriginType.code + version: dataOriginType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: dataOriginType.code + version: dataOriginType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: dataOriginType.decode + version: dataOriginType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: dataOriginType.decode + version: dataOriginType.codeSystemVersion Outcome: - Message: 'The study arm data origin type is not specified according to the extensible data origin type + Message: + 'The study arm data origin type is not specified according to the extensible data origin type (C188727) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - dataOriginType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - dataOriginType.codeSystem - - dataOriginType.codeSystemVersion - - dataOriginType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - dataOriginType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - dataOriginType.codeSystem + - dataOriginType.codeSystemVersion + - dataOriginType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyArm' + - "StudyArm" Sensitivity: Record diff --git a/Published/CORE-000942/rule.yml b/Published/CORE-000942/rule.yml index ceb8223f4..363740b8b 100644 --- a/Published/CORE-000942/rule.yml +++ b/Published/CORE-000942/rule.yml @@ -1,186 +1,190 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter type must be specified according to the extensible encounter type - (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00150' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "An encounter type must be specified according to the extensible encounter type - (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00150' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter type must be specified according to the extensible encounter type + (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00150" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An encounter type must be specified according to the extensible encounter type + (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00150" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: "Y" - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000942' + Id: "CORE-000942" Status: Published - Version: '1' -Description: "An encounter type must be specified according to the extensible encounter type (C188728) + Version: "1" +Description: + "An encounter type must be specified according to the extensible encounter type (C188728) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188728 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: -- id: $codelist_extensible_override - map: - - output: "Y" - type.codeSystemVersion: '2022-09-30' - - output: "Y" - type.codeSystemVersion: '2022-12-16' - - output: "Y" - type.codeSystemVersion: '2023-03-31' - - output: "Y" - type.codeSystemVersion: '2023-06-30' - - output: "Y" - type.codeSystemVersion: '2023-09-29' - - output: "Y" - type.codeSystemVersion: '2023-12-15' - - output: "Y" - type.codeSystemVersion: '2024-03-29' - operator: map -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C188728 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: + - id: $codelist_extensible_override + map: + - output: "Y" + type.codeSystemVersion: "2022-09-30" + - output: "Y" + type.codeSystemVersion: "2022-12-16" + - output: "Y" + type.codeSystemVersion: "2023-03-31" + - output: "Y" + type.codeSystemVersion: "2023-06-30" + - output: "Y" + type.codeSystemVersion: "2023-09-29" + - output: "Y" + type.codeSystemVersion: "2023-12-15" + - output: "Y" + type.codeSystemVersion: "2024-03-29" + operator: map + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The encounter type is not specified according to the extensible encounter type (C188728) DDF + Message: + 'The encounter type is not specified according to the extensible encounter type (C188728) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Encounter' + - "Encounter" Sensitivity: Record diff --git a/Published/CORE-000943/rule.yml b/Published/CORE-000943/rule.yml index 204c3e19d..097feca60 100644 --- a/Published/CORE-000943/rule.yml +++ b/Published/CORE-000943/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study definition document type must be specified according to the extensible - study definition document type (C215477) DDF codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00166' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study definition document type must be specified according to the extensible + study definition document type (C215477) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00166" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000943' + Id: "CORE-000943" Status: Published - Version: '1' -Description: "A study definition document type must be specified according to the extensible study definition + Version: "1" +Description: + "A study definition document type must be specified according to the extensible study definition document type (C215477) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215477 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C215477 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study definition document type is not specified according to the extensible study definition + Message: + 'The study definition document type is not specified according to the extensible study definition document type (C215477) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocument' + - "StudyDefinitionDocument" Sensitivity: Record diff --git a/Published/CORE-000944/rule.yml b/Published/CORE-000944/rule.yml index 287eeb273..158385bc6 100644 --- a/Published/CORE-000944/rule.yml +++ b/Published/CORE-000944/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A piece of narrative content must only reference narrative content items that - have been defined within the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00168' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A piece of narrative content must only reference narrative content items that + have been defined within the study." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00168" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.study)@$s.$s.documentedBy@$sd. $sd.versions@$sv. @@ -40,26 +41,28 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000944' + Id: "CORE-000944" Status: Published - Version: '1' -Description: 'A piece of narrative content must only reference narrative content items that have been - defined within the study.' + Version: "1" +Description: + "A piece of narrative content must only reference narrative content items that have been + defined within the study." Executability: Fully Executable Outcome: - Message: 'The reference to the narrative content item is not targetting a narrative content item that - has been defined within the study.' + Message: + "The reference to the narrative content item is not targetting a narrative content item that + has been defined within the study." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - contentItemId - - sectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - contentItemId + - sectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-000945/rule.yml b/Published/CORE-000945/rule.yml index 34e8ec58a..2fcc63496 100644 --- a/Published/CORE-000945/rule.yml +++ b/Published/CORE-000945/rule.yml @@ -1,51 +1,51 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Syntax template text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00247' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Syntax template text is expected to be HTML formatted." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00247" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: $xhtml_errors + operator: non_empty Core: - Id: 'CORE-000945' + Id: "CORE-000945" Status: Published - Version: '1' -Description: 'Syntax template text is expected to be HTML formatted.' + Version: "1" +Description: "Syntax template text is expected to be HTML formatted." Executability: Partially Executable - Possible Overreporting Operations: -- id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors + - id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: - Message: 'The text attribute contains non-conformant XHTML.' + Message: "The text attribute contains non-conformant XHTML." Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'Characteristic' - - 'Condition' - - 'EligibilityCriterionItem' - - 'Endpoint' - - 'IntercurrentEvent' - - 'Objective' + - "Characteristic" + - "Condition" + - "EligibilityCriterionItem" + - "Endpoint" + - "IntercurrentEvent" + - "Objective" Sensitivity: Record diff --git a/Published/CORE-000946/rule.yml b/Published/CORE-000946/rule.yml index 7f78a10e2..2ae5943cf 100644 --- a/Published/CORE-000946/rule.yml +++ b/Published/CORE-000946/rule.yml @@ -1,74 +1,75 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used - Document: IG-DART v1.1 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND351 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used - Document: IG-DART v1.2 - Section: '4.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND351 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used + Document: IG-DART v1.1 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND351 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: RPHASE variable is required when any Repro Phase day variable is used + Document: IG-DART v1.2 + Section: "4.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND351 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # RPPLDY ^= null OR RPPLSTDY ^= null OR RPPLENDY ^= null OR --RPDY ^= null OR --RPSTDY ^= null OR --RPENDY ^= null - - any: - - all: - - name: RPPLDY - operator: exists - - name: RPPLDY - operator: non_empty - - all: - - name: RPPLSTDY - operator: exists - - name: RPPLSTDY - operator: non_empty - - all: - - name: RPPLENDY - operator: exists - - name: RPPLENDY - operator: non_empty - - all: - - name: --RPDY - operator: exists - - name: --RPDY - operator: non_empty - - all: - - name: --RPSTDY - operator: exists - - name: --RPSTDY - operator: non_empty - - all: - - name: --RPENDY - operator: exists - - name: --RPENDY - operator: non_empty - # when one of the above is populated, RPHASE may not be empty - - name: RPHASE - operator: empty + - any: + - all: + - name: RPPLDY + operator: exists + - name: RPPLDY + operator: non_empty + - all: + - name: RPPLSTDY + operator: exists + - name: RPPLSTDY + operator: non_empty + - all: + - name: RPPLENDY + operator: exists + - name: RPPLENDY + operator: non_empty + - all: + - name: --RPDY + operator: exists + - name: --RPDY + operator: non_empty + - all: + - name: --RPSTDY + operator: exists + - name: --RPSTDY + operator: non_empty + - all: + - name: --RPENDY + operator: exists + - name: --RPENDY + operator: non_empty + # when one of the above is populated, RPHASE may not be empty + - name: RPHASE + operator: empty Core: Id: CORE-000946 Status: Published - Version: '1' -Description: Raise an error when one of the timing variables is populated and RPHASE is not + Version: "1" +Description: + Raise an error when one of the timing variables is populated and RPHASE is not populated Executability: Fully Executable Outcome: @@ -77,10 +78,10 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-000947/rule.yml b/Published/CORE-000947/rule.yml index decc13b64..5415e4503 100644 --- a/Published/CORE-000947/rule.yml +++ b/Published/CORE-000947/rule.yml @@ -1,116 +1,123 @@ Authorities: # TODO in future? Possibly merge with CG0013, TIG0298 -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those that are from the same general observation class) - must not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.0 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general observation class) must - not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general observation class) must - not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general observation class) must - not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general observation class) must - not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'New variables (other than those from the same general observation class) must - not be added, and existing variables must not be renamed or modified for novel usage.' - Document: IG v3.1.1 - Section: '2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND270.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "New variables (other than those that are from the same general observation class) + must not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.0 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.1 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.1.1 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.1.1 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.1 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "New variables (other than those from the same general observation class) must + not be added, and existing variables must not be renamed or modified for novel usage." + Document: IG v3.1.1 + Section: "2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND270.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # TODO in future?: add to rule implementation of rules CG0013, TIG0298 # Difference is that the current SEND rule is limited to Interventions, Findings, Events # Whereas CG0013, TIG0298 is for all classes - - name: 'variable_name' - operator: 'is_not_contained_by' - value: $allowed_variables + - name: "variable_name" + operator: "is_not_contained_by" + value: $allowed_variables Core: Id: CORE-000947 Status: Published - Version: '1' -Description: 'Report a violation when the variable is not found in the underlying SDTM model for the same - observation class' + Version: "1" +Description: + "Report a violation when the variable is not found in the underlying SDTM model for the same + observation class" # Set to "partially executable" as the second part "and use is consistent with SDTM v1.5 definition" # cannot be implemented as machine-executable Executability: Partially Executable Operations: -- id: $allowed_variables - operator: get_model_column_order + - id: $allowed_variables + operator: get_model_column_order Outcome: - Message: 'The variable is not found in the underlying SDTM model for the same observation class' + Message: "The variable is not found in the underlying SDTM model for the same observation class" # Rule Type: Variable Metadata Check against Library Metadata Rule Type: Variable Metadata Check Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Published/CORE-000948/rule.yml b/Published/CORE-000948/rule.yml index 612dd4f45..b3e254527 100644 --- a/Published/CORE-000948/rule.yml +++ b/Published/CORE-000948/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each combination of arm and epoch must occur no more than once within a study - design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00069' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each combination of arm and epoch must occur no more than once within a study - design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00069' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each combination of arm and epoch must occur no more than once within a study + design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00069" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each combination of arm and epoch must occur no more than once within a study + design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00069" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.versions.studyDesigns@$sd. $filter($sd.studyCells,function($v,$i,$a) @@ -52,23 +54,23 @@ Check: |- } ) Core: - Id: 'CORE-000948' + Id: "CORE-000948" Status: Published - Version: '1' -Description: 'Each combination of arm and epoch must occur no more than once within a study design.' + Version: "1" +Description: "Each combination of arm and epoch must occur no more than once within a study design." Executability: Fully Executable Outcome: - Message: 'The combination of arm and epoch occurs more than once within the study design.' + Message: "The combination of arm and epoch occurs more than once within the study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - armId - - StudyArm.name - - epochId - - StudyEpoch.name + - StudyDesign.id + - StudyDesign.name + - armId + - StudyArm.name + - epochId + - StudyEpoch.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyCell' + - "StudyCell" Sensitivity: Record diff --git a/Published/CORE-000949/rule.yml b/Published/CORE-000949/rule.yml index 4639e5d42..a16e7a1b7 100644 --- a/Published/CORE-000949/rule.yml +++ b/Published/CORE-000949/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Class relationships must conform with the USDM schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00081' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Class relationships must conform with the USDM schema based on the API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00081' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Class relationships must conform with the USDM schema based on the API specification." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00081" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Class relationships must conform with the USDM schema based on the API specification." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00081" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: validator - operator: equal_to - value: 'const' - - name: error_attribute - operator: equal_to - value: 'instanceType' + - name: validator + operator: equal_to + value: "const" + - name: error_attribute + operator: equal_to + value: "instanceType" Core: - Id: 'CORE-000949' + Id: "CORE-000949" Status: Published - Version: '1' -Description: 'Class relationships must conform with the USDM schema based on the API specification.' + Version: "1" +Description: "Class relationships must conform with the USDM schema based on the API specification." Executability: Fully Executable Outcome: - Message: 'The class relationship does not conform with the USDM schema.' + Message: "The class relationship does not conform with the USDM schema." Output Variables: - - error_attribute - - message + - error_attribute + - message Rule Type: JSON Schema Check Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Published/CORE-000950/rule.yml b/Published/CORE-000950/rule.yml index 73e61ddb8..8250abbd8 100644 --- a/Published/CORE-000950/rule.yml +++ b/Published/CORE-000950/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must only reference an epoch that is defined - within the same study design as the scheduled activity/decision instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00105' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity/decision instance must only reference an epoch that is defined - within the same study design as the scheduled activity/decision instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00105' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity/decision instance must only reference an epoch that is defined + within the same study design as the scheduled activity/decision instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00105" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity/decision instance must only reference an epoch that is defined + within the same study design as the scheduled activity/decision instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00105" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $lkp:=$merge($.**.studyDesigns.epochs.{id:%.id}); @@ -45,25 +47,27 @@ Check: |- ] ) Core: - Id: 'CORE-000950' + Id: "CORE-000950" Status: Published - Version: '1' -Description: 'A scheduled activity/decision instance must only reference an epoch that is defined within - the same study design as the scheduled activity/decision instance.' + Version: "1" +Description: + "A scheduled activity/decision instance must only reference an epoch that is defined within + the same study design as the scheduled activity/decision instance." Executability: Fully Executable Outcome: - Message: 'The scheduled activity/decision instance references an epoch that is not defined within the - same study design.' + Message: + "The scheduled activity/decision instance references an epoch that is not defined within the + same study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - epochId - - "Referenced epoch's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - epochId + - "Referenced epoch's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'ScheduledActivityInstance' - - 'ScheduledDecisionInstance' + - "ScheduledActivityInstance" + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-000951/rule.yml b/Published/CORE-000951/rule.yml index c97d8e875..fe5747acc 100644 --- a/Published/CORE-000951/rule.yml +++ b/Published/CORE-000951/rule.yml @@ -1,145 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version''s status must be specified using the status - Value Set Terminology (C188723) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00169' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study definition document version's status must be specified using the status + Value Set Terminology (C188723) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00169" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: status - operator: equal_to - value: true - - not: - all: - - name: status.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: status.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: status.code - operator: equal_to - value: $code_for_decode_pref_term - - name: status.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: status.decode - operator: equal_to - value: $pref_term_for_code - - name: status.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: status + operator: equal_to + value: true + - not: + all: + - name: status.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: status.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: status.code + operator: equal_to + value: $code_for_decode_pref_term + - name: status.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: status.decode + operator: equal_to + value: $pref_term_for_code + - name: status.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000951' + Id: "CORE-000951" Status: Published - Version: '1' -Description: 'A study definition document version''s status must be specified using the status Value Set - Terminology (C188723) DDF codelist.' + Version: "1" +Description: + "A study definition document version's status must be specified using the status Value Set + Terminology (C188723) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188723 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: status.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: status.code - version: status.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: status.code - version: status.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: status.decode - version: status.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: status.decode - version: status.codeSystemVersion + - id: $codelist_code + map: + - output: C188723 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: status.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: status.code + version: status.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: status.code + version: status.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: status.decode + version: status.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: status.decode + version: status.codeSystemVersion Outcome: - Message: 'The study definition document version''s status is not specified using the status Value Set + Message: + 'The study definition document version''s status is not specified using the status Value Set Terminology (C188723) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - version - - $codelist_code - - $codelist_extensible - - status.code - - $code_for_decode_value - - $code_for_decode_pref_term - - status.codeSystem - - status.codeSystemVersion - - status.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - version + - $codelist_code + - $codelist_extensible + - status.code + - $code_for_decode_value + - $code_for_decode_pref_term + - status.codeSystem + - status.codeSystemVersion + - status.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - "StudyDefinitionDocumentVersion" Sensitivity: Record diff --git a/Published/CORE-000953/rule.yml b/Published/CORE-000953/rule.yml index 9ce7d1696..df3858503 100644 --- a/Published/CORE-000953/rule.yml +++ b/Published/CORE-000953/rule.yml @@ -2,124 +2,134 @@ # Condition: IDVAR ^= null # Rule: IDVAR is variable in domain = RDOMAIN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v2.0 - Item: IDVAR - Section: Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Supplemental Qualifiers - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: Model v2.0 - Item: IDVAR - Section: Related Records - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.4 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: Model v1.7 - Section: 2.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0370 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: Identifying variable in the parent dataset that identifies the record(s) to - which the comment applies. - Document: SDTM v2.1 - Item: IDVAR - Section: 3.2.2 Comments - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: 6.2 Supplemental Qualifiers Datasets - - Cited Guidance: Name of the identifying variable in the general-observation-class dataset - that identifies the related record(s). - Document: SDTM v2.1 - Item: IDVAR - Section: Section 6.1 Related Records Dataset - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0534 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v2.0 + Item: IDVAR + Section: Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Supplemental Qualifiers + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: Model v2.0 + Item: IDVAR + Section: Related Records + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.4 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: Model v1.7 + Section: 2.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0370 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + Identifying variable in the parent dataset that identifies the record(s) to + which the comment applies. + Document: SDTM v2.1 + Item: IDVAR + Section: 3.2.2 Comments + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: 6.2 Supplemental Qualifiers Datasets + - Cited Guidance: + Name of the identifying variable in the general-observation-class dataset + that identifies the related record(s). + Document: SDTM v2.1 + Item: IDVAR + Section: Section 6.1 Related Records Dataset + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0534 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: RDOMAIN - operator: exists - - name: IDVAR - operator: non_empty - - name: IDVAR - operator: is_not_contained_by - value: $rdomain_variables + - name: RDOMAIN + operator: exists + - name: IDVAR + operator: non_empty + - name: IDVAR + operator: is_not_contained_by + value: $rdomain_variables Core: Id: CORE-000953 Status: Published - Version: '1' -Description: Part C - Raise and error when IDVAR in CO is not populated with a valid variable from + Version: "1" +Description: + Part C - Raise and error when IDVAR in CO is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: -- Child: true - Keys: - - USUBJID - - IDVAR - - IDVARVAL - Name: CO + - Child: true + Keys: + - USUBJID + - IDVAR + - IDVARVAL + Name: CO Operations: -- domain: CO - id: $rdomain_variables - name: IDVAR - operator: distinct - value_is_reference: true + - domain: CO + id: $rdomain_variables + name: IDVAR + operator: distinct + value_is_reference: true Outcome: - Message: Value for IDVAR in CO does not represent a variable present in the dataset referenced in + Message: + Value for IDVAR in CO does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - - IDVAR + - IDVAR Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Use Case: INDH, PROD Sensitivity: Record diff --git a/Published/CORE-000954/rule.yml b/Published/CORE-000954/rule.yml index 548b2d4f0..8a4a6d965 100644 --- a/Published/CORE-000954/rule.yml +++ b/Published/CORE-000954/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity with children must not refer to a timeline, procedure, biomedical - concept, biomedical concept category or biomedical concept surrogate.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00160' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity with children must not refer to a timeline, procedure, biomedical + concept, biomedical concept category or biomedical concept surrogate." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00160" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.activities@$p. @@ -41,28 +42,30 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000954' + Id: "CORE-000954" Status: Published - Version: '1' -Description: 'An activity with children must not refer to a timeline, procedure, biomedical concept, biomedical - concept category or biomedical concept surrogate.' + Version: "1" +Description: + "An activity with children must not refer to a timeline, procedure, biomedical concept, biomedical + concept category or biomedical concept surrogate." Executability: Fully Executable Outcome: - Message: 'The activity has children but also refers to a timeline, procedure, biomedical concept, biomedical - concept category, or biomedical concept surrogate as well.' + Message: + "The activity has children but also refers to a timeline, procedure, biomedical concept, biomedical + concept category, or biomedical concept surrogate as well." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - childIds - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds - - timelineId - - definedProcedures.id + - StudyDesign.id + - StudyDesign.name + - name + - childIds + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds + - timelineId + - definedProcedures.id Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-000955/rule.yml b/Published/CORE-000955/rule.yml index 7ed2865a1..58e01e0d5 100644 --- a/Published/CORE-000955/rule.yml +++ b/Published/CORE-000955/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every identifier must be unique within the scope of an identified organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00173' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Every identifier must be unique within the scope of an identified organization." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00173" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ( @@ -34,24 +34,24 @@ Check: |- } ).* Core: - Id: 'CORE-000955' + Id: "CORE-000955" Status: Published - Version: '1' -Description: 'Every identifier must be unique within the scope of an identified organization.' + Version: "1" +Description: "Every identifier must be unique within the scope of an identified organization." Executability: Fully Executable Outcome: - Message: 'The identifier text is not unique within the scope of the identified organization.' + Message: "The identifier text is not unique within the scope of the identified organization." Output Variables: - - text - - scopeId - - Organization.name - - type.decode + - text + - scopeId + - Organization.name + - type.decode Rule Type: JSONata Scope: Entities: Include: - - 'StudyIdentifier' - - 'ReferenceIdentifier' - - 'AdministrableProductIdentifier' - - 'MedicalDeviceIdentifier' + - "StudyIdentifier" + - "ReferenceIdentifier" + - "AdministrableProductIdentifier" + - "MedicalDeviceIdentifier" Sensitivity: Record diff --git a/Published/CORE-000956/rule.yml b/Published/CORE-000956/rule.yml index 72188e383..5e2450a54 100644 --- a/Published/CORE-000956/rule.yml +++ b/Published/CORE-000956/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An identified organization is not expected to have more than 1 identifier for - the study.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00174' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An identified organization is not expected to have more than 1 identifier for + the study." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00174" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ( @@ -35,20 +36,20 @@ Check: |- } ).* Core: - Id: 'CORE-000956' + Id: "CORE-000956" Status: Published - Version: '1' -Description: 'An identified organization is not expected to have more than 1 identifier for the study.' + Version: "1" +Description: "An identified organization is not expected to have more than 1 identifier for the study." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'More than 1 study identifier is specified for the same organization.' + Message: "More than 1 study identifier is specified for the same organization." Output Variables: - - text - - scopeId - - Organization.name + - text + - scopeId + - Organization.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyIdentifier' + - "StudyIdentifier" Sensitivity: Record diff --git a/Published/CORE-000957/rule.yml b/Published/CORE-000957/rule.yml index 523c269a7..c25fb4cf6 100644 --- a/Published/CORE-000957/rule.yml +++ b/Published/CORE-000957/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable product property type must be specified according to the extensible - administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode - used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00180' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administrable product property type must be specified according to the extensible + administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode + used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00180" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000957' + Id: "CORE-000957" Status: Published - Version: '1' -Description: "An administrable product property type must be specified according to the extensible administrable + Version: "1" +Description: + "An administrable product property type must be specified according to the extensible administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215479 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C215479 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The administrable product property type is not specified according to the extensible administrable + Message: + 'The administrable product property type is not specified according to the extensible administrable product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProductProperty' + - "AdministrableProductProperty" Sensitivity: Record diff --git a/Published/CORE-000958/rule.yml b/Published/CORE-000958/rule.yml index 0b6c3e6ce..bc0934f9c 100644 --- a/Published/CORE-000958/rule.yml +++ b/Published/CORE-000958/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A reference identifier type must be specified according to the extensible reference - identifier type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00183' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A reference identifier type must be specified according to the extensible reference + identifier type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00183" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000958' + Id: "CORE-000958" Status: Published - Version: '1' -Description: "A reference identifier type must be specified according to the extensible reference identifier + Version: "1" +Description: + "A reference identifier type must be specified according to the extensible reference identifier type (C215478) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215478 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C215478 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The reference identifier type is not specified according to the extensible reference identifier + Message: + 'The reference identifier type is not specified according to the extensible reference identifier type (C215478) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ReferenceIdentifier' + - "ReferenceIdentifier" Sensitivity: Record diff --git a/Published/CORE-000959/rule.yml b/Published/CORE-000959/rule.yml index 34f7cd8c5..52e7e33be 100644 --- a/Published/CORE-000959/rule.yml +++ b/Published/CORE-000959/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study amendment impact type must be specified according to the extensible study - amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from - the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00199' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study amendment impact type must be specified according to the extensible study + amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from + the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00199" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000959' + Id: "CORE-000959" Status: Published - Version: '1' -Description: "A study amendment impact type must be specified according to the extensible study amendment + Version: "1" +Description: + "A study amendment impact type must be specified according to the extensible study amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215481 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C215481 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The study impact type is not specified according to the extensible study amendment impact + Message: + 'The study impact type is not specified according to the extensible study amendment impact type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyAmendmentImpact' + - "StudyAmendmentImpact" Sensitivity: Record diff --git a/Published/CORE-000960/rule.yml b/Published/CORE-000960/rule.yml index 4c6aad6b0..b30b55821 100644 --- a/Published/CORE-000960/rule.yml +++ b/Published/CORE-000960/rule.yml @@ -1,46 +1,46 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00085' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Narrative content text is expected to be HTML formatted." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00085" + Version: "1" + Version: "1.0" + Version: "3.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: $xhtml_errors + operator: non_empty Core: - Id: 'CORE-000960' + Id: "CORE-000960" Status: Published - Version: '1' -Description: 'Narrative content text is expected to be HTML formatted.' + Version: "1" +Description: "Narrative content text is expected to be HTML formatted." Executability: Partially Executable - Possible Overreporting Operations: -- id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors + - id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: - Message: 'The narrative content text contains non-conformant XHTML.' + Message: "The narrative content text contains non-conformant XHTML." Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-000961/rule.yml b/Published/CORE-000961/rule.yml index b4e4fdcfc..6dc9e7c10 100644 --- a/Published/CORE-000961/rule.yml +++ b/Published/CORE-000961/rule.yml @@ -1,32 +1,34 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Encounter ordering using previous and next attributes is expected to be consistent - with the order of corresponding scheduled activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00087' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Encounter ordering using previous and next attributes is expected to be consistent - with the order of corresponding scheduled activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00087' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Encounter ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00087" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Encounter ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00087" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd. @@ -51,28 +53,30 @@ Check: |- }[`Encounter order by previous/next` != `Encounter order by timeline refs`] ) Core: - Id: 'CORE-000961' + Id: "CORE-000961" Status: Published - Version: '1' -Description: 'Encounter ordering using previous and next attributes is expected to be consistent with - the order of corresponding scheduled activity instances according to their specified default conditions.' + Version: "1" +Description: + "Encounter ordering using previous and next attributes is expected to be consistent with + the order of corresponding scheduled activity instances according to their specified default conditions." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The order of the encounters in the study design (as defined by the next attribute) does not + Message: + "The order of the encounters in the study design (as defined by the next attribute) does not match the order of encounters as referenced from scheduled activity instances in the main timeline - that are ordered by default condition.' + that are ordered by default condition." Output Variables: - - name - - ScheduleTimeline.id - - ScheduleTimeline.name - - ScheduleTimeline.mainTimeline - - Encounter order by previous/next - - Encounter order by timeline refs + - name + - ScheduleTimeline.id + - ScheduleTimeline.name + - ScheduleTimeline.mainTimeline + - Encounter order by previous/next + - Encounter order by timeline refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000962/rule.yml b/Published/CORE-000962/rule.yml index 1c8973707..1770200c2 100644 --- a/Published/CORE-000962/rule.yml +++ b/Published/CORE-000962/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned completion number is defined, it must be - specified either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00132' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned completion number is defined, it must be - specified either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00132' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if a planned completion number is defined, it must be + specified either in the study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00132" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if a planned completion number is defined, it must be + specified either in the study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00132" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -65,27 +67,29 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000962' + Id: "CORE-000962" Status: Published - Version: '1' -Description: 'Within a study design, if a planned completion number is defined, it must be specified either - in the study population or in all cohorts.' + Version: "1" +Description: + "Within a study design, if a planned completion number is defined, it must be specified either + in the study population or in all cohorts." Executability: Fully Executable Outcome: - Message: 'A planned completion number has been specified for both the study population and one or more - cohorts, or it has been specified for only a subset of the cohorts.' + Message: + "A planned completion number has been specified for both the study population and one or more + cohorts, or it has been specified for only a subset of the cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedCompletionNumber.id - - plannedCompletionNumber(value/range) - - cohorts.name - - cohorts.plannedCompletionNumber.id - - cohorts.plannedCompletionNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedCompletionNumber.id + - plannedCompletionNumber(value/range) + - cohorts.name + - cohorts.plannedCompletionNumber.id + - cohorts.plannedCompletionNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000963/rule.yml b/Published/CORE-000963/rule.yml index 039d913f2..c5d5b7ccd 100644 --- a/Published/CORE-000963/rule.yml +++ b/Published/CORE-000963/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned enrollment number is defined, it must be - specified either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00133' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if a planned enrollment number is defined, it must be - specified either in the study population or in all cohorts.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00133' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if a planned enrollment number is defined, it must be + specified either in the study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00133" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if a planned enrollment number is defined, it must be + specified either in the study population or in all cohorts." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00133" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -65,27 +67,29 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000963' + Id: "CORE-000963" Status: Published - Version: '1' -Description: 'Within a study design, if a planned enrollment number is defined, it must be specified either - in the study population or in all cohorts.' + Version: "1" +Description: + "Within a study design, if a planned enrollment number is defined, it must be specified either + in the study population or in all cohorts." Executability: Fully Executable Outcome: - Message: 'A planned enrollment number has been specified for both the study population and the cohorts, - or it has been specified for only a subset of the cohorts.' + Message: + "A planned enrollment number has been specified for both the study population and the cohorts, + or it has been specified for only a subset of the cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedEnrollmentNumber.id - - plannedEnrollmentNumber(value/range) - - cohorts.name - - cohorts.plannedEnrollmentNumber.id - - cohorts.plannedEnrollmentNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedEnrollmentNumber.id + - plannedEnrollmentNumber(value/range) + - cohorts.name + - cohorts.plannedEnrollmentNumber.id + - cohorts.plannedEnrollmentNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000964/rule.yml b/Published/CORE-000964/rule.yml index f840d7e41..b3b8739fb 100644 --- a/Published/CORE-000964/rule.yml +++ b/Published/CORE-000964/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a section number is to be displayed then a number must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00164' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a section number is to be displayed then a number must be specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00164" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.documentedBy)@$db. $db.versions@$sv. @@ -41,24 +41,24 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000964' + Id: "CORE-000964" Status: Published - Version: '1' -Description: 'If a section number is to be displayed then a number must be specified.' + Version: "1" +Description: "If a section number is to be displayed then a number must be specified." Executability: Fully Executable Outcome: - Message: 'A section number is indicated to be displayed (displaySectionNumber=true) but not specified.' + Message: "A section number is indicated to be displayed (displaySectionNumber=true) but not specified." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - displaySectionNumber - - sectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - displaySectionNumber + - sectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-000965/rule.yml b/Published/CORE-000965/rule.yml index 299742683..6098c47e1 100644 --- a/Published/CORE-000965/rule.yml +++ b/Published/CORE-000965/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a section title is to be displayed then a title must be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00165' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a section title is to be displayed then a title must be specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00165" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.documentedBy)@$db. $db.versions@$sv. @@ -41,24 +41,24 @@ Check: |- ] [check=true] Core: - Id: 'CORE-000965' + Id: "CORE-000965" Status: Published - Version: '1' -Description: 'If a section title is to be displayed then a title must be specified.' + Version: "1" +Description: "If a section title is to be displayed then a title must be specified." Executability: Fully Executable Outcome: - Message: 'A section title is indicated to be displayed (displaySectionTitle=true) but not specified.' + Message: "A section title is indicated to be displayed (displaySectionTitle=true) but not specified." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - displaySectionTitle - - sectionTitle + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - displaySectionTitle + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-000966/rule.yml b/Published/CORE-000966/rule.yml index 93959b122..18ef38e71 100644 --- a/Published/CORE-000966/rule.yml +++ b/Published/CORE-000966/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If an administration''s dose is specified then a corresponding route is expected - and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00177' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If an administration's dose is specified then a corresponding route is expected + and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00177" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.studyInterventions)@$si. $si.administrations@$sa. @@ -44,25 +45,26 @@ Check: |- } )][check=true] Core: - Id: 'CORE-000966' + Id: "CORE-000966" Status: Published - Version: '1' -Description: 'If an administration''s dose is specified then a corresponding route is expected and vice - versa.' + Version: "1" +Description: + "If an administration's dose is specified then a corresponding route is expected and vice + versa." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The administration dose has been specified without a route or vice versa.' + Message: "The administration dose has been specified without a route or vice versa." Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value) - - route.id - - route + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value) + - route.id + - route Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000967/rule.yml b/Published/CORE-000967/rule.yml index bc9039e91..1052f8e2e 100644 --- a/Published/CORE-000967/rule.yml +++ b/Published/CORE-000967/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a dose is specified then a corresponding frequency must also be specified.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00178' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a dose is specified then a corresponding frequency must also be specified." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00178" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.studyInterventions)@$si. $si.administrations@$sa. @@ -44,26 +44,26 @@ Check: |- "frequency": ($sa.frequency ? ($sa.frequency.standardCode.decode & " (" & $sa.frequency.standardCode.code & ")")), "check": ($exists($sa.dose.id) and $exists($sa.frequency.id)=false) } - )][check=true] + )][check=true] Core: - Id: 'CORE-000967' + Id: "CORE-000967" Status: Published - Version: '1' -Description: 'If a dose is specified then a corresponding frequency must also be specified.' + Version: "1" +Description: "If a dose is specified then a corresponding frequency must also be specified." Executability: Fully Executable Outcome: - Message: 'The administration dose has been specified without a frequency.' + Message: "The administration dose has been specified without a frequency." Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value/range) - - frequency.id - - frequency + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value/range) + - frequency.id + - frequency Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000968/rule.yml b/Published/CORE-000968/rule.yml index 29c3dbb06..a8a29f552 100644 --- a/Published/CORE-000968/rule.yml +++ b/Published/CORE-000968/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study definition document version, if a date of a specific type exists - with a global geographic scope then no other dates are expected with the same type.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00182' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study definition document version, if a date of a specific type exists + with a global geographic scope then no other dates are expected with the same type." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00182" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study@$s. $s.documentedBy@$sdd. @@ -37,26 +38,28 @@ Check: |- } ).* ~> $distinct Core: - Id: 'CORE-000968' + Id: "CORE-000968" Status: Published - Version: '1' -Description: 'Within a study definition document version, if a date of a specific type exists with a global - geographic scope then no other dates are expected with the same type.' + Version: "1" +Description: + "Within a study definition document version, if a date of a specific type exists with a global + geographic scope then no other dates are expected with the same type." Executability: Partially Executable - Possible Overreporting Outcome: - Message: "There is more than one date of this type for the study definition document version, but at + Message: + "There is more than one date of this type for the study definition document version, but at least one of the dates has a global geographic scope." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - type - - dateValue - - geographicScopes.type + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - type + - dateValue + - geographicScopes.type Rule Type: JSONata Scope: Entities: Include: - - 'GovernanceDate' + - "GovernanceDate" Sensitivity: Record diff --git a/Published/CORE-000969/rule.yml b/Published/CORE-000969/rule.yml index f4fa42691..4c00a4db0 100644 --- a/Published/CORE-000969/rule.yml +++ b/Published/CORE-000969/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a dose is specified, then a corresponding administrable product must also - be specified either directly or embedded in the medical device and vice versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00185' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a dose is specified, then a corresponding administrable product must also + be specified either directly or embedded in the medical device and vice versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00185" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyInterventions@$si. @@ -52,29 +53,31 @@ Check: |- } )][check=true] Core: - Id: 'CORE-000969' + Id: "CORE-000969" Status: Published - Version: '1' -Description: 'If a dose is specified, then a corresponding administrable product must also be specified - either directly or embedded in the medical device and vice versa.' + Version: "1" +Description: + "If a dose is specified, then a corresponding administrable product must also be specified + either directly or embedded in the medical device and vice versa." Executability: Fully Executable Outcome: - Message: 'The administration dose has been specified without an administrable product (either as a direct - administrable product or as an embedded product via the related medical device) or vice versa.' + Message: + "The administration dose has been specified without an administrable product (either as a direct + administrable product or as an embedded product via the related medical device) or vice versa." Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - dose.id - - dose(value/range) - - administrableProductId - - medicalDeviceId - - MedicalDevice.name - - MedicalDevice.embeddedProductId - - AdministrableProduct.name + - StudyIntervention.id + - StudyIntervention.name + - name + - dose.id + - dose(value/range) + - administrableProductId + - medicalDeviceId + - MedicalDevice.name + - MedicalDevice.embeddedProductId + - AdministrableProduct.name Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000970/rule.yml b/Published/CORE-000970/rule.yml index 0bb9a137a..f10013f10 100644 --- a/Published/CORE-000970/rule.yml +++ b/Published/CORE-000970/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Every study role must apply to either a study version or at least one study design, - but not both.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00189' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Every study role must apply to either a study version or at least one study design, + but not both." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00189" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ($sv.roles @@ -37,25 +38,27 @@ Check: |- "StudyVersion.studyDesigns.id": $sv.studyDesigns.id } Core: - Id: 'CORE-000970' + Id: "CORE-000970" Status: Published - Version: '1' -Description: 'Every study role must apply to either a study version or at least one study design, but - not both.' + Version: "1" +Description: + "Every study role must apply to either a study version or at least one study design, but + not both." Executability: Fully Executable Outcome: - Message: 'The study role does not only apply to the study version or at least one study design - it + Message: + "The study role does not only apply to the study version or at least one study design - it does not apply to anything, it applies to both the study version and at least one study design, or - it applies to something that is not a study version or a study design.' + it applies to something that is not a study version or a study design." Output Variables: - - name - - code - - appliesToIds - - StudyVersion.id - - StudyVersion.studyDesigns.id + - name + - code + - appliesToIds + - StudyVersion.id + - StudyVersion.studyDesigns.id Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-000971/rule.yml b/Published/CORE-000971/rule.yml index 039d6d56c..85e78a7b1 100644 --- a/Published/CORE-000971/rule.yml +++ b/Published/CORE-000971/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least one attribute must be specified for an address.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00194' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "At least one attribute must be specified for an address." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00194" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.organizations@$o. $o.legalAddress[$not(text or lines or city or district or state or postalCode or country)]. @@ -33,26 +33,26 @@ Check: |- } ) Core: - Id: 'CORE-000971' + Id: "CORE-000971" Status: Published - Version: '1' -Description: 'At least one attribute must be specified for an address.' + Version: "1" +Description: "At least one attribute must be specified for an address." Executability: Fully Executable Outcome: - Message: 'All attributes of the address are blank.' + Message: "All attributes of the address are blank." Output Variables: - - Organization.id - - Organization.name - - text - - lines - - district - - city - - postalCode - - state - - country + - Organization.id + - Organization.name + - text + - lines + - district + - city + - postalCode + - state + - country Rule Type: JSONata Scope: Entities: Include: - - Address + - Address Sensitivity: Record diff --git a/Published/CORE-000972/rule.yml b/Published/CORE-000972/rule.yml index 47da24d1d..9a7c249a1 100644 --- a/Published/CORE-000972/rule.yml +++ b/Published/CORE-000972/rule.yml @@ -1,173 +1,176 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An organization type must be specified according to the extensible organization - type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should - be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00200' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An organization type must be specified according to the extensible organization + type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should + be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00200" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - name: $codelist_extensible - operator: equal_to - value: true - - name: $codelist_extensible_override - operator: equal_to - value: 'Y' - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty + - name: $codelist_extensible + operator: equal_to + value: true + - name: $codelist_extensible_override + operator: equal_to + value: "Y" - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000972' + Id: "CORE-000972" Status: Published - Version: '1' -Description: "An organization type must be specified according to the extensible organization type (C188724) + Version: "1" +Description: + "An organization type must be specified according to the extensible organization type (C188724) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C188724 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: -- id: $codelist_extensible_override - map: - - output: "Y" - type.codeSystemVersion: '2022-09-30' - - output: "Y" - type.codeSystemVersion: '2022-12-16' - - output: "Y" - type.codeSystemVersion: '2023-03-31' - - output: "Y" - type.codeSystemVersion: '2023-06-30' - - output: "Y" - type.codeSystemVersion: '2023-09-29' - - output: "Y" - type.codeSystemVersion: '2023-12-15' - - output: "Y" - type.codeSystemVersion: '2024-03-29' - operator: map -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C188724 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: + - id: $codelist_extensible_override + map: + - output: "Y" + type.codeSystemVersion: "2022-09-30" + - output: "Y" + type.codeSystemVersion: "2022-12-16" + - output: "Y" + type.codeSystemVersion: "2023-03-31" + - output: "Y" + type.codeSystemVersion: "2023-06-30" + - output: "Y" + type.codeSystemVersion: "2023-09-29" + - output: "Y" + type.codeSystemVersion: "2023-12-15" + - output: "Y" + type.codeSystemVersion: "2024-03-29" + operator: map + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The organization type is not specified according to the extensible organization type (C188724) + Message: + 'The organization type is not specified according to the extensible organization type (C188724) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - $codelist_extensible_override - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - $codelist_extensible_override + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Organization' + - "Organization" Sensitivity: Record diff --git a/Published/CORE-000973/rule.yml b/Published/CORE-000973/rule.yml index f44e9de05..123a29b86 100644 --- a/Published/CORE-000973/rule.yml +++ b/Published/CORE-000973/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be exactly one study role with a code of sponsor.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00201' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "There must be exactly one study role with a code of sponsor." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00201" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ( @@ -26,20 +26,20 @@ Check: |- } )[`# Sponsor Roles` != 1] Core: - Id: 'CORE-000973' + Id: "CORE-000973" Status: Published - Version: '1' -Description: 'There must be exactly one study role with a code of sponsor.' + Version: "1" +Description: "There must be exactly one study role with a code of sponsor." Executability: Fully Executable Outcome: - Message: 'There is not exactly one study role with a code of sponsor (where code.code is C70793).' + Message: "There is not exactly one study role with a code of sponsor (where code.code is C70793)." Output Variables: - - versionIdentifier - - '# Sponsor Roles' - - 'Sponsor Roles' + - versionIdentifier + - "# Sponsor Roles" + - "Sponsor Roles" Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-000974/rule.yml b/Published/CORE-000974/rule.yml index b40d4bdb9..69e200ca8 100644 --- a/Published/CORE-000974/rule.yml +++ b/Published/CORE-000974/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The sponsor study role must be applicable to a study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00203' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The sponsor study role must be applicable to a study version." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00203" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ($sv.roles[code.code = "C70793" and $not($sv.id in appliesToIds)])@$r. @@ -26,23 +26,24 @@ Check: |- "StudyVersion.id": $sv.id } Core: - Id: 'CORE-000974' + Id: "CORE-000974" Status: Published - Version: '1' -Description: 'The sponsor study role must be applicable to a study version.' + Version: "1" +Description: "The sponsor study role must be applicable to a study version." Executability: Fully Executable Outcome: - Message: "The study role is a sponsor role (code.code is C70793) but it is not applicable to the study + Message: + "The study role is a sponsor role (code.code is C70793) but it is not applicable to the study version (appliesToIds does not contain the id of the study version)." Output Variables: - - name - - code.code - - code.decode - - appliesToIds - - StudyVersion.id + - name + - code.code + - code.decode + - appliesToIds + - StudyVersion.id Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-000975/rule.yml b/Published/CORE-000975/rule.yml index d16659368..484a37a8a 100644 --- a/Published/CORE-000975/rule.yml +++ b/Published/CORE-000975/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A medical device identifier type must be specified according to the extensible - medical device identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00207' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A medical device identifier type must be specified according to the extensible + medical device identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00207" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: type - operator: exists - - name: type - operator: equal_to - value: true - - not: - all: - - name: type.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: type.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: type + operator: exists + - name: type + operator: equal_to + value: true + - not: + all: + - name: type.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: type.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: type.code - operator: equal_to - value: $code_for_decode_pref_term - - name: type.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: type.decode - operator: equal_to - value: $pref_term_for_code - - name: type.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: type.code + operator: equal_to + value: $code_for_decode_pref_term + - name: type.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: type.decode + operator: equal_to + value: $pref_term_for_code + - name: type.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000975' + Id: "CORE-000975" Status: Published - Version: '1' -Description: "A medical device identifier type must be specified according to the extensible medical device + Version: "1" +Description: + "A medical device identifier type must be specified according to the extensible medical device identifier type (C215484) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215484 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: type.code - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: type.decode - version: type.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: type.decode - version: type.codeSystemVersion + - id: $codelist_code + map: + - output: C215484 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: type.code + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: type.decode + version: type.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: type.decode + version: type.codeSystemVersion Outcome: - Message: 'The medical device identifier type is not specified according to the extensible medical device + Message: + 'The medical device identifier type is not specified according to the extensible medical device identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - text - - $codelist_code - - $codelist_extensible - - type.code - - $code_for_decode_value - - $code_for_decode_pref_term - - type.codeSystem - - type.codeSystemVersion - - type.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - text + - $codelist_code + - $codelist_extensible + - type.code + - $code_for_decode_value + - $code_for_decode_pref_term + - type.codeSystem + - type.codeSystemVersion + - type.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'MedicalDeviceIdentifier' + - "MedicalDeviceIdentifier" Sensitivity: Record diff --git a/Published/CORE-000976/rule.yml b/Published/CORE-000976/rule.yml index 8f10bd455..bb8e5c911 100644 --- a/Published/CORE-000976/rule.yml +++ b/Published/CORE-000976/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An administrable product sourcing must be specified using the extensible administrable - product sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00208' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administrable product sourcing must be specified using the extensible administrable + product sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00208" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: sourcing - operator: exists - - name: sourcing - operator: equal_to - value: true - - not: - all: - - name: sourcing.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: sourcing.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: sourcing + operator: exists + - name: sourcing + operator: equal_to + value: true + - not: + all: + - name: sourcing.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: sourcing.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: sourcing.code - operator: equal_to - value: $code_for_decode_pref_term - - name: sourcing.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: sourcing.decode - operator: equal_to - value: $pref_term_for_code - - name: sourcing.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: sourcing.code + operator: equal_to + value: $code_for_decode_pref_term + - name: sourcing.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: sourcing.decode + operator: equal_to + value: $pref_term_for_code + - name: sourcing.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000976' + Id: "CORE-000976" Status: Published - Version: '1' -Description: "An administrable product sourcing must be specified using the extensible administrable product + Version: "1" +Description: + "An administrable product sourcing must be specified using the extensible administrable product sourcing (C215483) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215483 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: sourcing.code - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: sourcing.code - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: sourcing.decode - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: sourcing.decode - version: sourcing.codeSystemVersion + - id: $codelist_code + map: + - output: C215483 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: sourcing.code + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: sourcing.code + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: sourcing.decode + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: sourcing.decode + version: sourcing.codeSystemVersion Outcome: - Message: 'The administrable product sourcing is not specified according to the extensible administrable + Message: + 'The administrable product sourcing is not specified according to the extensible administrable product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - sourcing.code - - $code_for_decode_value - - $code_for_decode_pref_term - - sourcing.codeSystem - - sourcing.codeSystemVersion - - sourcing.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - sourcing.code + - $code_for_decode_value + - $code_for_decode_pref_term + - sourcing.codeSystem + - sourcing.codeSystemVersion + - sourcing.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - "AdministrableProduct" Sensitivity: Record diff --git a/Published/CORE-000977/rule.yml b/Published/CORE-000977/rule.yml index f39a60f4a..500524906 100644 --- a/Published/CORE-000977/rule.yml +++ b/Published/CORE-000977/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A medical device sourcing must be specified using the extensible medical device - sourcing (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00209' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A medical device sourcing must be specified using the extensible medical device + sourcing (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00209" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: sourcing - operator: exists - - name: sourcing - operator: equal_to - value: true - - not: - all: - - name: sourcing.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: sourcing.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: sourcing + operator: exists + - name: sourcing + operator: equal_to + value: true + - not: + all: + - name: sourcing.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: sourcing.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: sourcing.code - operator: equal_to - value: $code_for_decode_pref_term - - name: sourcing.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: sourcing.decode - operator: equal_to - value: $pref_term_for_code - - name: sourcing.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: sourcing.code + operator: equal_to + value: $code_for_decode_pref_term + - name: sourcing.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: sourcing.decode + operator: equal_to + value: $pref_term_for_code + - name: sourcing.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000977' + Id: "CORE-000977" Status: Published - Version: '1' -Description: "A medical device sourcing must be specified using the extensible medical device sourcing + Version: "1" +Description: + "A medical device sourcing must be specified using the extensible medical device sourcing (C215482) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215482 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: sourcing.code - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: sourcing.code - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: sourcing.decode - version: sourcing.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: sourcing.decode - version: sourcing.codeSystemVersion + - id: $codelist_code + map: + - output: C215482 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: sourcing.code + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: sourcing.code + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: sourcing.decode + version: sourcing.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: sourcing.decode + version: sourcing.codeSystemVersion Outcome: - Message: 'The medical device sourcing is not specified according to the extensible medical device sourcing + Message: + 'The medical device sourcing is not specified according to the extensible medical device sourcing (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - sourcing.code - - $code_for_decode_value - - $code_for_decode_pref_term - - sourcing.codeSystem - - sourcing.codeSystemVersion - - sourcing.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - sourcing.code + - $code_for_decode_value + - $code_for_decode_pref_term + - sourcing.codeSystem + - sourcing.codeSystemVersion + - sourcing.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'MedicalDevice' + - "MedicalDevice" Sensitivity: Record diff --git a/Published/CORE-000978/rule.yml b/Published/CORE-000978/rule.yml index 99846500c..477373055 100644 --- a/Published/CORE-000978/rule.yml +++ b/Published/CORE-000978/rule.yml @@ -1,145 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An administrable product''s product designation must be specified using the product - designation (C207418) DDF codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00210' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administrable product's product designation must be specified using the product + designation (C207418) DDF codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00210" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: productDesignation - operator: equal_to - value: true - - not: - all: - - name: productDesignation.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: productDesignation.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_pref_term - - name: productDesignation.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: productDesignation.decode - operator: equal_to - value: $pref_term_for_code - - name: productDesignation.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: productDesignation + operator: equal_to + value: true + - not: + all: + - name: productDesignation.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: productDesignation.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_pref_term + - name: productDesignation.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: productDesignation.decode + operator: equal_to + value: $pref_term_for_code + - name: productDesignation.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-000978' + Id: "CORE-000978" Status: Published - Version: '1' -Description: 'An administrable product''s product designation must be specified using the product designation - (C207418) DDF codelist.' + Version: "1" +Description: + "An administrable product's product designation must be specified using the product designation + (C207418) DDF codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C207418 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: productDesignation.code - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: productDesignation.code - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: productDesignation.decode - version: productDesignation.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: productDesignation.decode - version: productDesignation.codeSystemVersion + - id: $codelist_code + map: + - output: C207418 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: productDesignation.code + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: productDesignation.code + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: productDesignation.decode + version: productDesignation.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: productDesignation.decode + version: productDesignation.codeSystemVersion Outcome: - Message: 'The administrable product''s product designation is not specified using the product designation + Message: + 'The administrable product''s product designation is not specified using the product designation (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - productDesignation.code - - $code_for_decode_value - - $code_for_decode_pref_term - - productDesignation.codeSystem - - productDesignation.codeSystemVersion - - productDesignation.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - productDesignation.code + - $code_for_decode_value + - $code_for_decode_pref_term + - productDesignation.codeSystem + - productDesignation.codeSystemVersion + - productDesignation.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'AdministrableProduct' + - "AdministrableProduct" Sensitivity: Record diff --git a/Published/CORE-000979/rule.yml b/Published/CORE-000979/rule.yml index 4e32e4815..9609d17f5 100644 --- a/Published/CORE-000979/rule.yml +++ b/Published/CORE-000979/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An interventional study design's intent types must be specified according to - the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00214' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An interventional study design's intent types must be specified according to + the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code + or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00214" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: intentTypes - operator: exists - - name: intentTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'intentTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: intentTypes + operator: exists + - name: intentTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "intentTypes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000979' + Id: "CORE-000979" Status: Published - Version: '1' -Description: "An interventional study design's intent types must be specified according to the extensible + Version: "1" +Description: + "An interventional study design's intent types must be specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C66736 - parent_rel.Code: 'intentTypes' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C66736 + parent_rel.Code: "intentTypes" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The interventional study design''s intent type is not specified according to the extensible + Message: + 'The interventional study design''s intent type is not specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000980/rule.yml b/Published/CORE-000980/rule.yml index 5928cea75..5266f8291 100644 --- a/Published/CORE-000980/rule.yml +++ b/Published/CORE-000980/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more characteristics are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00219' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more characteristics are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00219" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns. ( @@ -30,22 +30,22 @@ Check: |- } } ) - ) + ) Core: - Id: 'CORE-000980' + Id: "CORE-000980" Status: Published - Version: '1' -Description: 'Within a study design, if more characteristics are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more characteristics are defined, they must be distinct." Executability: Fully Executable Outcome: - Message: 'The same characteristics code is used more than once within the study design.' + Message: "The same characteristics code is used more than once within the study design." Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000981/rule.yml b/Published/CORE-000981/rule.yml index b50043ab3..db04d3cd6 100644 --- a/Published/CORE-000981/rule.yml +++ b/Published/CORE-000981/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned enrollment number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00234' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A unit must not be specified for a planned enrollment number." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00234" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -59,25 +59,25 @@ Check: |- ] [check = true] Core: - Id: 'CORE-000981' + Id: "CORE-000981" Status: Published - Version: '1' -Description: 'A unit must not be specified for a planned enrollment number.' + Version: "1" +Description: "A unit must not be specified for a planned enrollment number." Executability: Fully Executable Outcome: - Message: 'A unit has been specified for a planned enrollment number' + Message: "A unit has been specified for a planned enrollment number" Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedEnrollmentNumber.id - - plannedEnrollmentNumber(value/range) - - cohorts.name - - cohorts.plannedEnrollmentNumber.id - - cohorts.plannedEnrollmentNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedEnrollmentNumber.id + - plannedEnrollmentNumber(value/range) + - cohorts.name + - cohorts.plannedEnrollmentNumber.id + - cohorts.plannedEnrollmentNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000982/rule.yml b/Published/CORE-000982/rule.yml index d9f7561d9..930e17c0e 100644 --- a/Published/CORE-000982/rule.yml +++ b/Published/CORE-000982/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A unit must not be specified for a planned completion number.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00235' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A unit must not be specified for a planned completion number." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00235" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.population@$p. @@ -59,25 +59,25 @@ Check: |- ] [check = true] Core: - Id: 'CORE-000982' + Id: "CORE-000982" Status: Published - Version: '1' -Description: 'A unit must not be specified for a planned completion number.' + Version: "1" +Description: "A unit must not be specified for a planned completion number." Executability: Fully Executable Outcome: - Message: 'A unit has been specified for a planned completion number' + Message: "A unit has been specified for a planned completion number" Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - plannedCompletionNumber.id - - plannedCompletionNumber(value/range) - - cohorts.name - - cohorts.plannedCompletionNumber.id - - cohorts.plannedCompletionNumber(value/range) + - StudyDesign.id + - StudyDesign.name + - name + - plannedCompletionNumber.id + - plannedCompletionNumber(value/range) + - cohorts.name + - cohorts.plannedCompletionNumber.id + - cohorts.plannedCompletionNumber(value/range) Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesignPopulation' + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000983/rule.yml b/Published/CORE-000983/rule.yml index 56fa7d2ac..b025b9b41 100644 --- a/Published/CORE-000983/rule.yml +++ b/Published/CORE-000983/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A procedure must only reference a study intervention that is referenced by the - same study design as the activity within which the procedure is defined.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00240' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A procedure must only reference a study intervention that is referenced by the + same study design as the activity within which the procedure is defined." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00240" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -34,27 +35,29 @@ Check: |- "StudyIntervention.name": $sv.studyInterventions[id=$sp.studyInterventionId].name }] Core: - Id: 'CORE-000983' + Id: "CORE-000983" Status: Published - Version: '1' -Description: 'A procedure must only reference a study intervention that is referenced by the same study - design as the activity within which the procedure is defined.' + Version: "1" +Description: + "A procedure must only reference a study intervention that is referenced by the same study + design as the activity within which the procedure is defined." Executability: Fully Executable Outcome: - Message: 'The reference to the intervention is not targetting an intervention that has been referenced - by the study design as a study intervention.' + Message: + "The reference to the intervention is not targetting an intervention that has been referenced + by the study design as a study intervention." Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.studyInterventionIds - - Activity.id - - Activity.name - - name - - studyInterventionId - - StudyIntervention.name + - StudyDesign.id + - StudyDesign.name + - StudyDesign.studyInterventionIds + - Activity.id + - Activity.name + - name + - studyInterventionId + - StudyIntervention.name Rule Type: JSONata Scope: Entities: Include: - - 'Procedure' + - "Procedure" Sensitivity: Record diff --git a/Published/CORE-000984/rule.yml b/Published/CORE-000984/rule.yml index 12c86f61a..6ea990cf7 100644 --- a/Published/CORE-000984/rule.yml +++ b/Published/CORE-000984/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study enrollment must apply to either a geographic scope, a study site, - or a study cohort.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00195' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each study enrollment must apply to either a geographic scope, a study site, + or a study cohort." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00195" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. $sv.amendments@$a. @@ -59,26 +60,28 @@ Check: |- } )[check=true] Core: - Id: 'CORE-000984' + Id: "CORE-000984" Status: Published - Version: '1' -Description: 'Each study enrollment must apply to either a geographic scope, a study site, or a study - cohort.' + Version: "1" +Description: + "Each study enrollment must apply to either a geographic scope, a study site, or a study + cohort." Executability: Fully Executable Outcome: - Message: 'The study enrollment does not apply to either a geographic scope, a study site, or a study + Message: + "The study enrollment does not apply to either a geographic scope, a study site, or a study cohort - it does not apply to one and only one of these, or the value for forStudySiteId or forStudyCohortId - is invalid.' + is invalid." Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - name - - forGeographicScope - - forStudySiteId - - forStudyCohortId + - StudyAmendment.id + - StudyAmendment.name + - name + - forGeographicScope + - forStudySiteId + - forStudyCohortId Rule Type: JSONata Scope: Entities: Include: - - SubjectEnrollment + - SubjectEnrollment Sensitivity: Record diff --git a/Published/CORE-000985/rule.yml b/Published/CORE-000985/rule.yml index ce8bc2c91..969868dc6 100644 --- a/Published/CORE-000985/rule.yml +++ b/Published/CORE-000985/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be a one-to-one relationship between referenced section number and - title within any study definition document affected by a study amendment.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00196' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "There must be a one-to-one relationship between referenced section number and + title within any study definition document affected by a study amendment." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00196" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study@$s. $s.versions@$sv. @@ -53,26 +54,28 @@ Check: |- } ) Core: - Id: 'CORE-000985' + Id: "CORE-000985" Status: Published - Version: '1' -Description: 'There must be a one-to-one relationship between referenced section number and title within - any study definition document affected by a study amendment.' + Version: "1" +Description: + "There must be a one-to-one relationship between referenced section number and title within + any study definition document affected by a study amendment." Executability: Fully Executable Outcome: - Message: 'There is not a one-to-one relationship between the referenced section number and title within - the study definition document affected by the study amendment.' + Message: + "There is not a one-to-one relationship between the referenced section number and title within + the study definition document affected by the study amendment." Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - StudyChange.id - - StudyChange.name - - appliesToId - - sectionNumber - - sectionTitle + - StudyAmendment.id + - StudyAmendment.name + - StudyChange.id + - StudyChange.name + - appliesToId + - sectionNumber + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - DocumentContentReference + - DocumentContentReference Sensitivity: Record diff --git a/Published/CORE-000986/rule.yml b/Published/CORE-000986/rule.yml index cdc655eed..b887b507c 100644 --- a/Published/CORE-000986/rule.yml +++ b/Published/CORE-000986/rule.yml @@ -1,19 +1,20 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An administrable product must not be referenced as both the administrable product - for an administration and the embedded product of a medical device that is referenced by the - same administration.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00205' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An administrable product must not be referenced as both the administrable product + for an administration and the embedded product of a medical device that is referenced by the + same administration." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00205" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyInterventions@$si. @@ -34,26 +35,28 @@ Check: |- } )][check=true] Core: - Id: 'CORE-000986' + Id: "CORE-000986" Status: Published - Version: '1' -Description: 'An administrable product must not be referenced as both the administrable product for an - administration and the embedded product of a medical device that is referenced by the same administration.' + Version: "1" +Description: + "An administrable product must not be referenced as both the administrable product for an + administration and the embedded product of a medical device that is referenced by the same administration." Executability: Fully Executable Outcome: - Message: 'The administrable product is referenced both as the administrable product for an administration - and as the embedded product of a medical device that is referenced by the same administration.' + Message: + "The administrable product is referenced both as the administrable product for an administration + and as the embedded product of a medical device that is referenced by the same administration." Output Variables: - - StudyIntervention.id - - StudyIntervention.name - - name - - administrableProductId - - AdministrableProduct.name - - medicalDeviceId - - MedicalDevice.name + - StudyIntervention.id + - StudyIntervention.name + - name + - administrableProductId + - AdministrableProduct.name + - medicalDeviceId + - MedicalDevice.name Rule Type: JSONata Scope: Entities: Include: - - 'Administration' + - "Administration" Sensitivity: Record diff --git a/Published/CORE-000987/rule.yml b/Published/CORE-000987/rule.yml index 4c56f2dee..86d193ccc 100644 --- a/Published/CORE-000987/rule.yml +++ b/Published/CORE-000987/rule.yml @@ -1,163 +1,166 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An interventional study design's sub types must be specified according to the - extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00215' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An interventional study design's sub types must be specified according to the + extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00215" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: subTypes - operator: exists - - name: subTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'subTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: subTypes + operator: exists + - name: subTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "subTypes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000987' + Id: "CORE-000987" Status: Published - Version: '1' -Description: "An interventional study design's sub types must be specified according to the extensible + Version: "1" +Description: + "An interventional study design's sub types must be specified according to the extensible Trial Type Response (C66739) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C66739 - parent_rel.Code: 'subTypes' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C66739 + parent_rel.Code: "subTypes" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The interventional study design''s sub type is not specified according to the extensible Trial + Message: + 'The interventional study design''s sub type is not specified according to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000988/rule.yml b/Published/CORE-000988/rule.yml index 2d339b7a4..1fd8a22ef 100644 --- a/Published/CORE-000988/rule.yml +++ b/Published/CORE-000988/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's intervention model must be specified according to the extensible - Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00216' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's intervention model must be specified according to the extensible + Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00216" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: model - operator: exists - - name: model - operator: equal_to - value: true - - not: - all: - - name: model.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: model.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: model + operator: exists + - name: model + operator: equal_to + value: true + - not: + all: + - name: model.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: model.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: model.code - operator: equal_to - value: $code_for_decode_pref_term - - name: model.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: model.decode - operator: equal_to - value: $pref_term_for_code - - name: model.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: model.code + operator: equal_to + value: $code_for_decode_pref_term + - name: model.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: model.decode + operator: equal_to + value: $pref_term_for_code + - name: model.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000988' + Id: "CORE-000988" Status: Published - Version: '1' -Description: "A study design's intervention model must be specified according to the extensible Intervention + Version: "1" +Description: + "A study design's intervention model must be specified according to the extensible Intervention Model Response (C99076) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C99076 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: model.code - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: model.code - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: model.decode - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: model.decode - version: model.codeSystemVersion + - id: $codelist_code + map: + - output: C99076 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: model.code + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: model.code + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: model.decode + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: model.decode + version: model.codeSystemVersion Outcome: - Message: 'The study design''s intervention model is not specified according to the extensible Intervention + Message: + 'The study design''s intervention model is not specified according to the extensible Intervention Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - model.code - - $code_for_decode_value - - $code_for_decode_pref_term - - model.codeSystem - - model.codeSystemVersion - - model.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - model.code + - $code_for_decode_value + - $code_for_decode_pref_term + - model.codeSystem + - model.codeSystemVersion + - model.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000989/rule.yml b/Published/CORE-000989/rule.yml index d0461114e..001a72e83 100644 --- a/Published/CORE-000989/rule.yml +++ b/Published/CORE-000989/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's blinding schema must be specified according to the extensible - Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00217' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's blinding schema must be specified according to the extensible + Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00217" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: blindingSchema.standardCode - operator: exists - - name: blindingSchema.standardCode - operator: equal_to - value: true - - not: - all: - - name: blindingSchema.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: blindingSchema.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: blindingSchema.standardCode + operator: exists + - name: blindingSchema.standardCode + operator: equal_to + value: true + - not: + all: + - name: blindingSchema.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: blindingSchema.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: blindingSchema.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: blindingSchema.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: blindingSchema.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: blindingSchema.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: blindingSchema.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: blindingSchema.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: blindingSchema.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: blindingSchema.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000989' + Id: "CORE-000989" Status: Published - Version: '1' -Description: "A study design's blinding schema must be specified according to the extensible Trial Blinding + Version: "1" +Description: + "A study design's blinding schema must be specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66735 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: blindingSchema.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: blindingSchema.standardCode.code - version: blindingSchema.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: blindingSchema.standardCode.code - version: blindingSchema.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: blindingSchema.standardCode.decode - version: blindingSchema.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: blindingSchema.standardCode.decode - version: blindingSchema.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66735 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: blindingSchema.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: blindingSchema.standardCode.code + version: blindingSchema.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: blindingSchema.standardCode.code + version: blindingSchema.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: blindingSchema.standardCode.decode + version: blindingSchema.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: blindingSchema.standardCode.decode + version: blindingSchema.standardCode.codeSystemVersion Outcome: - Message: 'The study design''s blinding schema is not specified according to the extensible Trial Blinding + Message: + 'The study design''s blinding schema is not specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - blindingSchema.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - blindingSchema.standardCode.codeSystem - - blindingSchema.standardCode.codeSystemVersion - - blindingSchema.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - blindingSchema.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - blindingSchema.standardCode.codeSystem + - blindingSchema.standardCode.codeSystemVersion + - blindingSchema.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000990/rule.yml b/Published/CORE-000990/rule.yml index 7132d3ef1..e76c689f6 100644 --- a/Published/CORE-000990/rule.yml +++ b/Published/CORE-000990/rule.yml @@ -1,163 +1,166 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's characteristics must be specified according to the extensible - study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00218' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's characteristics must be specified according to the extensible + study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00218" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: characteristics - operator: exists - - name: characteristics - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'characteristics' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: characteristics + operator: exists + - name: characteristics + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "characteristics" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000990' + Id: "CORE-000990" Status: Published - Version: '1' -Description: "A study design's characteristics must be specified according to the extensible study design + Version: "1" +Description: + "A study design's characteristics must be specified according to the extensible study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C207416 - parent_rel.Code: 'characteristics' - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C207416 + parent_rel.Code: "characteristics" + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The study design''s characteristic is not specified according to the extensible study design + Message: + 'The study design''s characteristic is not specified according to the extensible study design characteristics (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000991/rule.yml b/Published/CORE-000991/rule.yml index 0ea8520ac..3dfa0022b 100644 --- a/Published/CORE-000991/rule.yml +++ b/Published/CORE-000991/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's observational model must be specified according to the extensible - Observational Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used - from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00223' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's observational model must be specified according to the extensible + Observational Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used + from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00223" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: model - operator: exists - - name: model - operator: equal_to - value: true - - not: - all: - - name: model.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: model.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: model + operator: exists + - name: model + operator: equal_to + value: true + - not: + all: + - name: model.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: model.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: model.code - operator: equal_to - value: $code_for_decode_pref_term - - name: model.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: model.decode - operator: equal_to - value: $pref_term_for_code - - name: model.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: model.code + operator: equal_to + value: $code_for_decode_pref_term + - name: model.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: model.decode + operator: equal_to + value: $pref_term_for_code + - name: model.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000991' + Id: "CORE-000991" Status: Published - Version: '1' -Description: "A study design's observational model must be specified according to the extensible Observational + Version: "1" +Description: + "A study design's observational model must be specified according to the extensible Observational Study Model (C127259) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C127259 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: model.code - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: model.code - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: model.decode - version: model.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: model.decode - version: model.codeSystemVersion + - id: $codelist_code + map: + - output: C127259 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: model.code + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: model.code + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: model.decode + version: model.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: model.decode + version: model.codeSystemVersion Outcome: - Message: 'The study design''s observational model is not specified according to the extensible Observational + Message: + 'The study design''s observational model is not specified according to the extensible Observational Study Model (C127259) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - model.code - - $code_for_decode_value - - $code_for_decode_pref_term - - model.codeSystem - - model.codeSystemVersion - - model.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - model.code + - $code_for_decode_value + - $code_for_decode_pref_term + - model.codeSystem + - model.codeSystemVersion + - model.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000992/rule.yml b/Published/CORE-000992/rule.yml index 736e2a731..daa9ea6a6 100644 --- a/Published/CORE-000992/rule.yml +++ b/Published/CORE-000992/rule.yml @@ -1,150 +1,153 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's time perspective must be specified according - to the extensible Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry - with a code or decode used from the codelist should be consistent with the full entry in the - codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00224' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An observational study design's time perspective must be specified according + to the extensible Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry + with a code or decode used from the codelist should be consistent with the full entry in the + codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00224" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: timePerspective - operator: exists - - name: timePerspective - operator: equal_to - value: true - - not: - all: - - name: timePerspective.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: timePerspective.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: timePerspective + operator: exists + - name: timePerspective + operator: equal_to + value: true + - not: + all: + - name: timePerspective.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: timePerspective.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: timePerspective.code - operator: equal_to - value: $code_for_decode_pref_term - - name: timePerspective.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: timePerspective.decode - operator: equal_to - value: $pref_term_for_code - - name: timePerspective.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: timePerspective.code + operator: equal_to + value: $code_for_decode_pref_term + - name: timePerspective.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: timePerspective.decode + operator: equal_to + value: $pref_term_for_code + - name: timePerspective.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-000992' + Id: "CORE-000992" Status: Published - Version: '1' -Description: "An observational study design's time perspective must be specified according to the extensible + Version: "1" +Description: + "An observational study design's time perspective must be specified according to the extensible Observational Study Time Perspective (C127261) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C127261 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: timePerspective.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: timePerspective.code - version: timePerspective.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: timePerspective.code - version: timePerspective.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: timePerspective.decode - version: timePerspective.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: timePerspective.decode - version: timePerspective.codeSystemVersion + - id: $codelist_code + map: + - output: C127261 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: timePerspective.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: timePerspective.code + version: timePerspective.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: timePerspective.code + version: timePerspective.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: timePerspective.decode + version: timePerspective.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: timePerspective.decode + version: timePerspective.codeSystemVersion Outcome: - Message: 'The observational study design''s time perspective is not specified according to the extensible + Message: + 'The observational study design''s time perspective is not specified according to the extensible Observational Study Time Perspective (C127261) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - timePerspective.code - - $code_for_decode_value - - $code_for_decode_pref_term - - timePerspective.codeSystem - - timePerspective.codeSystemVersion - - timePerspective.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - timePerspective.code + - $code_for_decode_value + - $code_for_decode_pref_term + - timePerspective.codeSystem + - timePerspective.codeSystemVersion + - timePerspective.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000993/rule.yml b/Published/CORE-000993/rule.yml index c145fd9c0..c5b22883e 100644 --- a/Published/CORE-000993/rule.yml +++ b/Published/CORE-000993/rule.yml @@ -1,125 +1,126 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All nonclinical studies should include Trial Sets (tx.xpt) dataset.' - Document: 'FDA' - Section: 'FDAB046' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB4607' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "All nonclinical studies should include Trial Sets (tx.xpt) dataset." + Document: "FDA" + Section: "FDAB046" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB4607" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: '$txparmcd' - operator: 'does_not_contain' - value: 'PLANMSUB' + - name: "$txparmcd" + operator: "does_not_contain" + value: "PLANMSUB" Core: Id: CORE-000993 Status: Published - Version: '1' -Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male + Version: "1" +Description: + For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male Subjects (PLANMSUB) record should be included. Executability: Fully Executable Grouping_Variables: -- SETCD + - SETCD # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: -- domain: TX - group: - - SETCD - id: $txparmcd - name: TXPARMCD - operator: distinct + - domain: TX + group: + - SETCD + id: $txparmcd + name: TXPARMCD + operator: distinct Outcome: Message: TX dataset should include exactly one TXPARMCD = 'PLANMSUB' record per SETCD. Output Variables: - - SETCD - - $txparmcd + - SETCD + - $txparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX # When "Dataset" is taken for "Sensitivity", only the first violation is reported # When "Record" is taken for "Sensitivity", a violation is reported for each row in the group that violates the rule # Sensitivity: Record diff --git a/Published/CORE-000994/rule.yml b/Published/CORE-000994/rule.yml index 8d36ca802..4393070d4 100644 --- a/Published/CORE-000994/rule.yml +++ b/Published/CORE-000994/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least the text or the quantity must be specified for a duration.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00033' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "At least the text or the quantity must be specified for a duration." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00033" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**[instanceType="Duration"])@$d. $d.[{ @@ -23,19 +23,19 @@ Check: |- "check": $not(text or quantity) }][check=true] Core: - Id: 'CORE-000994' + Id: "CORE-000994" Status: Published - Version: '1' -Description: 'At least the text or the quantity must be specified for a duration.' + Version: "1" +Description: "At least the text or the quantity must be specified for a duration." Executability: Fully Executable Outcome: - Message: 'The quantity and text are both missing for the specified duration.' + Message: "The quantity and text are both missing for the specified duration." Output Variables: - - text - - quantity + - text + - quantity Rule Type: JSONata Scope: Entities: Include: - - 'Duration' + - "Duration" Sensitivity: Record diff --git a/Published/CORE-000995/rule.yml b/Published/CORE-000995/rule.yml index 8c783cee9..9bbe1b15a 100644 --- a/Published/CORE-000995/rule.yml +++ b/Published/CORE-000995/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the duration will vary, a quantity is not expected for the duration and vice - versa.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00039' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If the duration will vary, a quantity is not expected for the duration and vice + versa." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00039" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**[instanceType="Duration"])@$d. $d.[( @@ -39,19 +40,19 @@ Check: |- "check": (durationWillVary and quantity) or (durationWillVary=false and ($not(quantity) or $exists(quantity)=false)) })][check=true] Core: - Id: 'CORE-000995' + Id: "CORE-000995" Status: Published - Version: '1' -Description: 'If the duration will vary, a quantity is not expected for the duration and vice versa.' + Version: "1" +Description: "If the duration will vary, a quantity is not expected for the duration and vice versa." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The duration quantity is specified while the duration is indicated to vary or vice versa.' + Message: "The duration quantity is specified while the duration is indicated to vary or vice versa." Output Variables: - - quantity(value/range) - - durationWillVary + - quantity(value/range) + - durationWillVary Rule Type: JSONata Scope: Entities: Include: - - 'Duration' + - "Duration" Sensitivity: Record diff --git a/Published/CORE-000996/rule.yml b/Published/CORE-000996/rule.yml index 2242345f0..3e2a80707 100644 --- a/Published/CORE-000996/rule.yml +++ b/Published/CORE-000996/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned sex must either include a single entry of male or female or both female - and male as entries.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00188' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A planned sex must either include a single entry of male or female or both female + and male as entries." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00188" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**[plannedSex])@$p. $p.[{ @@ -24,22 +25,24 @@ Check: |- "check": ($count(plannedSex.id) != $count($distinct(plannedSex.code))) or false in $map(plannedSex.code,function($v){$v in ["C16576","C20197"]}) }][check=true] Core: - Id: 'CORE-000996' + Id: "CORE-000996" Status: Published - Version: '1' -Description: 'A planned sex must either include a single entry of male or female or both female and male - as entries.' + Version: "1" +Description: + "A planned sex must either include a single entry of male or female or both female and male + as entries." Executability: Fully Executable Outcome: - Message: 'The planned sex includes more than a single entry of male and/or female either by duplications - or unexpected codes.' + Message: + "The planned sex includes more than a single entry of male and/or female either by duplications + or unexpected codes." Output Variables: - - name - - plannedSex + - name + - plannedSex Rule Type: JSONata Scope: Entities: Include: - - 'StudyCohort' - - 'StudyDesignPopulation' + - "StudyCohort" + - "StudyDesignPopulation" Sensitivity: Record diff --git a/Published/CORE-000997/rule.yml b/Published/CORE-000997/rule.yml index eca6323ff..a42b878a6 100644 --- a/Published/CORE-000997/rule.yml +++ b/Published/CORE-000997/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study role must not reference both assigned persons and organizations.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00190' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A study role must not reference both assigned persons and organizations." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00190" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ($sv.roles[assignedPersons and organizationIds])@$r. @@ -25,21 +25,21 @@ Check: |- "organizationIds": "["&$join($r.organizationIds.($oid:=$;$oid&": "&($o:=$sv.organizations[id=$oid];$o?$o.name:"Invalid organizationId")),"; ")&"]" } Core: - Id: 'CORE-000997' + Id: "CORE-000997" Status: Published - Version: '1' -Description: 'A study role must not reference both assigned persons and organizations.' + Version: "1" +Description: "A study role must not reference both assigned persons and organizations." Executability: Fully Executable Outcome: - Message: 'The study role references both at least one assigned person and at least one organization.' + Message: "The study role references both at least one assigned person and at least one organization." Output Variables: - - name - - code - - assignedPersons - - organizationIds + - name + - code + - assignedPersons + - organizationIds Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-000998/rule.yml b/Published/CORE-000998/rule.yml index 4d4b8f660..8d397b244 100644 --- a/Published/CORE-000998/rule.yml +++ b/Published/CORE-000998/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version must not be referenced more than once by - the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00197' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study definition document version must not be referenced more than once by + the same study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00197" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns. { @@ -24,22 +25,24 @@ Check: |- $filter(documentVersionIds,function($v,$i,$a){$count($a[$=$v])>1}) ~> $sort }[`Duplicate documentVersionIds`] Core: - Id: 'CORE-000998' + Id: "CORE-000998" Status: Published - Version: '1' -Description: 'A study definition document version must not be referenced more than once by the same study - design.' + Version: "1" +Description: + "A study definition document version must not be referenced more than once by the same study + design." Executability: Fully Executable Outcome: - Message: "The study design references the same study definition document version more than once (there + Message: + "The study design references the same study definition document version more than once (there are duplicate id values in documentVersionIds)." Output Variables: - - name - - "Duplicate documentVersionIds" + - name + - "Duplicate documentVersionIds" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-000999/rule.yml b/Published/CORE-000999/rule.yml index b6b0b7247..a3cc04d8a 100644 --- a/Published/CORE-000999/rule.yml +++ b/Published/CORE-000999/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each study definition document version is expected to be referenced by either - a study version or a study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00198' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each study definition document version is expected to be referenced by either + a study version or a study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00198" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study@$s. $s.documentedBy@$sdd. @@ -26,22 +27,24 @@ Check: |- "version": version } Core: - Id: 'CORE-000999' + Id: "CORE-000999" Status: Published - Version: '1' -Description: 'Each study definition document version is expected to be referenced by either a study version - or a study design.' + Version: "1" +Description: + "Each study definition document version is expected to be referenced by either a study version + or a study design." Executability: Partially Executable - Possible Overreporting Outcome: - Message: "The study definition document version is not referenced by either a study version or a study + Message: + "The study definition document version is not referenced by either a study version or a study design." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - version + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - version Rule Type: JSONata Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - "StudyDefinitionDocumentVersion" Sensitivity: Record diff --git a/Published/CORE-001000/rule.yml b/Published/CORE-001000/rule.yml index 4acce42ec..2f6effd26 100644 --- a/Published/CORE-001000/rule.yml +++ b/Published/CORE-001000/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The sponsor study role must point to exactly one organization.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00202' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The sponsor study role must point to exactly one organization." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00202" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ($sv.roles[code.code = "C70793"])@$r. @@ -27,23 +27,24 @@ Check: |- "# Valid Organizations": $count($sv.organizations[id in $r.organizationIds]) } Core: - Id: 'CORE-001000' + Id: "CORE-001000" Status: Published - Version: '1' -Description: 'The sponsor study role must point to exactly one organization.' + Version: "1" +Description: "The sponsor study role must point to exactly one organization." Executability: Fully Executable Outcome: - Message: 'The study role is a sponsor role (code.code is C70793) but it does not point to exactly one + Message: + "The study role is a sponsor role (code.code is C70793) but it does not point to exactly one organization - it does not have exactly one value for organizationIds that is a valid id value for - an organization.' + an organization." Output Variables: - - name - - code - - organizationIds - - '# Valid Organizations' + - name + - code + - organizationIds + - "# Valid Organizations" Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-001001/rule.yml b/Published/CORE-001001/rule.yml index 84e8e0fd4..4bb94b49a 100644 --- a/Published/CORE-001001/rule.yml +++ b/Published/CORE-001001/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Sourcing must not be defined for an administrable product which is only referenced - as an embedded product for a medical device.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00206' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Sourcing must not be defined for an administrable product which is only referenced + as an embedded product for a medical device." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00206" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -31,24 +32,26 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001001' + Id: "CORE-001001" Status: Published - Version: '1' -Description: 'Sourcing must not be defined for an administrable product which is only referenced as an - embedded product for a medical device.' + Version: "1" +Description: + "Sourcing must not be defined for an administrable product which is only referenced as an + embedded product for a medical device." Executability: Fully Executable Outcome: - Message: 'The sourcing is defined while the administrable product is only referenced to as an embedded - product for a medical device.' + Message: + "The sourcing is defined while the administrable product is only referenced to as an embedded + product for a medical device." Output Variables: - - name - - sourcing - - MedicalDevice.id - - MedicalDevice.name - - MedicalDevice.embeddedProductId + - name + - sourcing + - MedicalDevice.id + - MedicalDevice.name + - MedicalDevice.embeddedProductId Rule Type: JSONata Scope: Entities: Include: - - 'AdministrableProduct' + - "AdministrableProduct" Sensitivity: Record diff --git a/Published/CORE-001002/rule.yml b/Published/CORE-001002/rule.yml index a8fc57e2b..911fff6dd 100644 --- a/Published/CORE-001002/rule.yml +++ b/Published/CORE-001002/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more sub types are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00220' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more sub types are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00220" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns. ( @@ -30,22 +30,22 @@ Check: |- } } ) - ) + ) Core: - Id: 'CORE-001002' + Id: "CORE-001002" Status: Published - Version: '1' -Description: 'Within a study design, if more sub types are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more sub types are defined, they must be distinct." Executability: Fully Executable Outcome: - Message: 'The same sub types code is used more than once within the study design.' + Message: "The same sub types code is used more than once within the study design." Output Variables: - - name - - subTypes + - name + - subTypes Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001003/rule.yml b/Published/CORE-001003/rule.yml index cac1d22e0..45d8f0a13 100644 --- a/Published/CORE-001003/rule.yml +++ b/Published/CORE-001003/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00221' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more therapeutic areas are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00221" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns@$sd.( $sd.therapeuticAreas. @@ -41,23 +41,24 @@ Check: |- ) ) Core: - Id: 'CORE-001003' + Id: "CORE-001003" Status: Published - Version: '1' -Description: 'Within a study design, if more therapeutic areas are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more therapeutic areas are defined, they must be distinct." Executability: Fully Executable Outcome: - Message: 'The therapeutic areas of the study design are not unique - the same code is used more than - once within the same codeSystem and codeSystemVersion.' + Message: + "The therapeutic areas of the study design are not unique - the same code is used more than + once within the same codeSystem and codeSystemVersion." Output Variables: - - name - - therapeuticAreas.codeSystem - - therapeuticAreas.codeSystemVersion - - therapeuticAreas + - name + - therapeuticAreas.codeSystem + - therapeuticAreas.codeSystemVersion + - therapeuticAreas Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001004/rule.yml b/Published/CORE-001004/rule.yml index f68f251b2..0909ca30c 100644 --- a/Published/CORE-001004/rule.yml +++ b/Published/CORE-001004/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An observational study (including patient registries) must be specified using - the ObservationalStudyDesign class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00228' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An observational study (including patient registries) must be specified using + the ObservationalStudyDesign class." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00228" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -26,22 +27,24 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001004' + Id: "CORE-001004" Status: Published - Version: '1' -Description: 'An observational study (including patient registries) must be specified using the ObservationalStudyDesign - class.' + Version: "1" +Description: + "An observational study (including patient registries) must be specified using the ObservationalStudyDesign + class." Executability: Fully Executable Outcome: - Message: 'The study type is observational (including patient registries) but is not specified using - the ObservationalStudyDesign class.' + Message: + "The study type is observational (including patient registries) but is not specified using + the ObservationalStudyDesign class." Output Variables: - - name - - studyType + - name + - studyType Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001005/rule.yml b/Published/CORE-001005/rule.yml index da6c0c7dd..abd4e2c1f 100644 --- a/Published/CORE-001005/rule.yml +++ b/Published/CORE-001005/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a study phase is specified for an observational study (including patient registries) - it is expected to have a study phase value indicating "Not Applicable".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00232' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'If a study phase is specified for an observational study (including patient registries) + it is expected to have a study phase value indicating "Not Applicable".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00232" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -28,22 +29,24 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001005' + Id: "CORE-001005" Status: Published - Version: '1' -Description: 'If a study phase is specified for an observational study (including patient registries) + Version: "1" +Description: + 'If a study phase is specified for an observational study (including patient registries) it is expected to have a study phase value indicating "Not Applicable".' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study type is observational (including patient registries) as coded by either "C16084" + Message: + 'The study type is observational (including patient registries) as coded by either "C16084" or "C129000" but the study phase is indicating a phase which is not "Not Applicable".' Output Variables: - - name - - studyType - - studyPhase + - name + - studyType + - studyPhase Rule Type: JSONata Scope: Entities: Include: - - 'ObservationalStudyDesign' + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001006/rule.yml b/Published/CORE-001006/rule.yml index 9cb4cb520..c2016d379 100644 --- a/Published/CORE-001006/rule.yml +++ b/Published/CORE-001006/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a synonym is specified then it is not expected to be equal to the label of - the biomedical concept (case insensitive).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00236' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a synonym is specified then it is not expected to be equal to the label of + the biomedical concept (case insensitive)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00236" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.biomedicalConcepts)@$bc. $bc. @@ -27,21 +28,22 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001006' + Id: "CORE-001006" Status: Published - Version: '1' -Description: 'If a synonym is specified then it is not expected to be equal to the label of the biomedical - concept (case insensitive).' + Version: "1" +Description: + "If a synonym is specified then it is not expected to be equal to the label of the biomedical + concept (case insensitive)." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The synonym is equal to the label (case insensitive).' + Message: "The synonym is equal to the label (case insensitive)." Output Variables: - - name - - label/synonym - - synonyms + - name + - label/synonym + - synonyms Rule Type: JSONata Scope: Entities: Include: - - 'BiomedicalConcept' + - "BiomedicalConcept" Sensitivity: Record diff --git a/Published/CORE-001007/rule.yml b/Published/CORE-001007/rule.yml index 764ce3a02..fec8e82fd 100644 --- a/Published/CORE-001007/rule.yml +++ b/Published/CORE-001007/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength numerator quantity is specified, it must have a unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00238' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a strength numerator quantity is specified, it must have a unit." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00238" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -34,24 +34,24 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001007' + Id: "CORE-001007" Status: Published - Version: '1' -Description: 'If a strength numerator quantity is specified, it must have a unit.' + Version: "1" +Description: "If a strength numerator quantity is specified, it must have a unit." Executability: Fully Executable Outcome: - Message: 'The strength numerator quantity is specified but it has no unit.' + Message: "The strength numerator quantity is specified but it has no unit." Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Substance.id - - Substance.name - - name - - numerator.value + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Substance.id + - Substance.name + - name + - numerator.value Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - "Strength" Sensitivity: Record diff --git a/Published/CORE-001008/rule.yml b/Published/CORE-001008/rule.yml index b62829fc9..f01d2982f 100644 --- a/Published/CORE-001008/rule.yml +++ b/Published/CORE-001008/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength numerator range is specified, both the minValue and maxValue must - have a unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00239' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a strength numerator range is specified, both the minValue and maxValue must + have a unit." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00239" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.administrableProducts@$ap. @@ -36,26 +37,27 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001008' + Id: "CORE-001008" Status: Published - Version: '1' -Description: 'If a strength numerator range is specified, both the minValue and maxValue must have a unit.' + Version: "1" +Description: "If a strength numerator range is specified, both the minValue and maxValue must have a unit." Executability: Fully Executable Outcome: - Message: 'The strength numerator range is specified but the minValue and/or maxValue does not have a - unit.' + Message: + "The strength numerator range is specified but the minValue and/or maxValue does not have a + unit." Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Substance.id - - Substance.name - - name - - numerator.minValue - - numerator.maxValue + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Substance.id + - Substance.name + - name + - numerator.minValue + - numerator.maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - "Strength" Sensitivity: Record diff --git a/Published/CORE-001009/rule.yml b/Published/CORE-001009/rule.yml index 65b4de3e4..be8c126e1 100644 --- a/Published/CORE-001009/rule.yml +++ b/Published/CORE-001009/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the unit is the same (or missing) for both the minimum and maximum value, - then the minimum value must be less than the maximum value.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00241' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If the unit is the same (or missing) for both the minimum and maximum value, + then the minimum value must be less than the maximum value." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00241" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.**[instanceType="Range"])@$rg. $rg. @@ -29,21 +30,23 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001009' + Id: "CORE-001009" Status: Published - Version: '1' -Description: 'If the unit is the same (or missing) for both the minimum and maximum value, then the minimum - value must be less than the maximum value.' + Version: "1" +Description: + "If the unit is the same (or missing) for both the minimum and maximum value, then the minimum + value must be less than the maximum value." Executability: Fully Executable Outcome: - Message: 'The maximum value is less or equal to the minimum value while the unit is the same (or missing) - for both the minimum and maximum value.' + Message: + "The maximum value is less or equal to the minimum value while the unit is the same (or missing) + for both the minimum and maximum value." Output Variables: - - minValue - - maxValue + - minValue + - maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Range' + - "Range" Sensitivity: Record diff --git a/Published/CORE-001010/rule.yml b/Published/CORE-001010/rule.yml index 07ed34de9..cc9f5a849 100644 --- a/Published/CORE-001010/rule.yml +++ b/Published/CORE-001010/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A reference substance must not have a reference substance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00253' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A reference substance must not have a reference substance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00253" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.administrableProducts)@$ap. $ap.ingredients@$in. @@ -34,26 +34,27 @@ Check: |- } ][check=true] Core: - Id: 'CORE-001010' + Id: "CORE-001010" Status: Published - Version: '1' -Description: 'A reference substance must not have a reference substance.' + Version: "1" +Description: "A reference substance must not have a reference substance." Executability: Fully Executable Outcome: - Message: 'A reference substance is specified for the substance, but the substance is a reference substance - for another substance (the parent substance).' + Message: + "A reference substance is specified for the substance, but the substance is a reference substance + for another substance (the parent substance)." Output Variables: - - AdministrableProduct.id - - AdministrableProduct.name - - Ingredient.id - - Parent Substance.id - - Parent Substance.name - - name - - referenceSubstance.id - - referenceSubstance.name + - AdministrableProduct.id + - AdministrableProduct.name + - Ingredient.id + - Parent Substance.id + - Parent Substance.name + - name + - referenceSubstance.id + - referenceSubstance.name Rule Type: JSONata Scope: Entities: Include: - - 'Substance' + - "Substance" Sensitivity: Record diff --git a/Published/CORE-001011/rule.yml b/Published/CORE-001011/rule.yml index fe0153ff9..5492e4a27 100644 --- a/Published/CORE-001011/rule.yml +++ b/Published/CORE-001011/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A primary study amendment reason is not expected to be ''not applicable''.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00255' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A primary study amendment reason is not expected to be 'not applicable'." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00255" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.amendments)@$am. $am.primaryReason@$pr. @@ -28,20 +28,20 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001011' + Id: "CORE-001011" Status: Published - Version: '1' -Description: 'A primary study amendment reason is not expected to be ''not applicable''.' + Version: "1" +Description: "A primary study amendment reason is not expected to be 'not applicable'." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The primary study amendment reason is ''not applicable'' (code=C48660).' + Message: "The primary study amendment reason is 'not applicable' (code=C48660)." Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - code + - StudyAmendment.id + - StudyAmendment.name + - code Rule Type: JSONata Scope: Entities: Include: - - 'StudyAmendmentReason' + - "StudyAmendmentReason" Sensitivity: Record diff --git a/Published/CORE-001012/rule.yml b/Published/CORE-001012/rule.yml index 8f0b2b802..74f1e71b7 100644 --- a/Published/CORE-001012/rule.yml +++ b/Published/CORE-001012/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'For each range, a unit must be specified either for both the minimum and the - maximum value, or for neither of them.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00242' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "For each range, a unit must be specified either for both the minimum and the + maximum value, or for neither of them." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00242" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.**[instanceType="Range"])@$rg. $rg. @@ -27,20 +28,21 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001012' + Id: "CORE-001012" Status: Published - Version: '1' -Description: 'For each range, a unit must be specified either for both the minimum and the maximum value, - or for neither of them.' + Version: "1" +Description: + "For each range, a unit must be specified either for both the minimum and the maximum value, + or for neither of them." Executability: Fully Executable Outcome: - Message: 'The unit is specified either for the minimum or the maximum value but not for both.' + Message: "The unit is specified either for the minimum or the maximum value but not for both." Output Variables: - - minValue - - maxValue + - minValue + - maxValue Rule Type: JSONata Scope: Entities: Include: - - 'Range' + - "Range" Sensitivity: Record diff --git a/Published/CORE-001013/rule.yml b/Published/CORE-001013/rule.yml index 1895c5824..81f886d1e 100644 --- a/Published/CORE-001013/rule.yml +++ b/Published/CORE-001013/rule.yml @@ -1,28 +1,28 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The names of all instances of the same class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00010' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The names of all instances of the same class must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00010' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The names of all instances of the same class must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00010" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "The names of all instances of the same class must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00010" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- **.*[id and instanceType and name].$ { @@ -39,18 +39,18 @@ Check: |- }}) ~> $reduce($append) Core: - Id: 'CORE-001013' + Id: "CORE-001013" Status: Published - Version: '1' -Description: 'The names of all instances of the same class must be unique.' + Version: "1" +Description: "The names of all instances of the same class must be unique." Executability: Fully Executable Outcome: - Message: 'The same name has been used for more than one instance of the class.' + Message: "The same name has been used for more than one instance of the class." Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-001014/rule.yml b/Published/CORE-001014/rule.yml index 06a9fb482..3be8bfeb2 100644 --- a/Published/CORE-001014/rule.yml +++ b/Published/CORE-001014/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'At least the text or the family name must be specified for a person name.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00030' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "At least the text or the family name must be specified for a person name." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00030" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.**[instanceType="PersonName"])@$pn. $pn. @@ -25,19 +25,19 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001014' + Id: "CORE-001014" Status: Published - Version: '1' -Description: 'At least the text or the family name must be specified for a person name.' + Version: "1" +Description: "At least the text or the family name must be specified for a person name." Executability: Fully Executable Outcome: - Message: 'Both the text and familyName are missing.' + Message: "Both the text and familyName are missing." Output Variables: - - familyName - - text + - familyName + - text Rule Type: JSONata Scope: Entities: Include: - - 'PersonName' + - "PersonName" Sensitivity: Record diff --git a/Published/CORE-001015/rule.yml b/Published/CORE-001015/rule.yml index 88902ace1..1c0f5a0aa 100644 --- a/Published/CORE-001015/rule.yml +++ b/Published/CORE-001015/rule.yml @@ -1,28 +1,28 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, all id values must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00083' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study version, all id values must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00083' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study version, all id values must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00083" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study version, all id values must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00083" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( **.*[id and instanceType]. @@ -39,18 +39,18 @@ Check: |- ~> $sift(function($v){$count($v) > 1}) ).* Core: - Id: 'CORE-001015' + Id: "CORE-001015" Status: Published - Version: '1' -Description: 'Within a study version, all id values must be unique.' + Version: "1" +Description: "Within a study version, all id values must be unique." Executability: Fully Executable Outcome: - Message: 'The id value is not unique.' + Message: "The id value is not unique." Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Published/CORE-001016/rule.yml b/Published/CORE-001016/rule.yml index d2418e894..32eeafa59 100644 --- a/Published/CORE-001016/rule.yml +++ b/Published/CORE-001016/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A planned duration is expected for the main timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00153' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A planned duration is expected for the main timeline." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00153" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.studyDesigns)@$sd. $sd.scheduleTimelines@$st. @@ -26,19 +26,19 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001016' + Id: "CORE-001016" Status: Published - Version: '1' -Description: 'A planned duration is expected for the main timeline.' + Version: "1" +Description: "A planned duration is expected for the main timeline." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The planned duration is not specified for the main timeline.' + Message: "The planned duration is not specified for the main timeline." Output Variables: - - name - - mainTimeline + - name + - mainTimeline Rule Type: JSONata Scope: Entities: Include: - - 'ScheduleTimeline' + - "ScheduleTimeline" Sensitivity: Record diff --git a/Published/CORE-001017/rule.yml b/Published/CORE-001017/rule.yml index 41730a7a2..d8cde3894 100644 --- a/Published/CORE-001017/rule.yml +++ b/Published/CORE-001017/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00154' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00154" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns["C217004" in characteristics.code and "C217005" in characteristics.code]. { @@ -22,20 +22,20 @@ Check: |- "characteristics": "["&$join(characteristics[code in ["C217004","C217005"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]" } Core: - Id: 'CORE-001017' + Id: "CORE-001017" Status: Published - Version: '1' + Version: "1" Description: 'A study design must not be characterized as both "Single-Centre" and "Multicentre".' Executability: Fully Executable Outcome: Message: 'The study design is characterized as both "Single-Centre" and "Multicentre".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001018/rule.yml b/Published/CORE-001018/rule.yml index cd58c2631..5ffd0f8eb 100644 --- a/Published/CORE-001018/rule.yml +++ b/Published/CORE-001018/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Each defined eligibility criterion must be used by at least one study population - or cohort within the same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00158' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Each defined eligibility criterion must be used by at least one study population + or cohort within the same study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00158" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$s. $s.eligibilityCriteria@$ec @@ -30,24 +31,26 @@ Check: |- "identifier": $ec.identifier } Core: - Id: 'CORE-001018' + Id: "CORE-001018" Status: Published - Version: '1' -Description: 'Each defined eligibility criterion must be used by at least one study population or cohort - within the same study design.' + Version: "1" +Description: + "Each defined eligibility criterion must be used by at least one study population or cohort + within the same study design." Executability: Fully Executable Outcome: - Message: "The eligibility criterion is not referenced by the study design's population or any of its + Message: + "The eligibility criterion is not referenced by the study design's population or any of its cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - category - - identifier + - StudyDesign.id + - StudyDesign.name + - name + - category + - identifier Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - "EligibilityCriterion" Sensitivity: Record diff --git a/Published/CORE-001019/rule.yml b/Published/CORE-001019/rule.yml index 33c29b8ad..bff0d234d 100644 --- a/Published/CORE-001019/rule.yml +++ b/Published/CORE-001019/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion must not be referenced by both a study design population - and any of the cohorts of the same study design population.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00159' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An eligibility criterion must not be referenced by both a study design population + and any of the cohorts of the same study design population." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00159" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$s. $s.eligibilityCriteria@$ec @@ -32,25 +33,27 @@ Check: |- "Used in": $s.**[$ec.id in $.criterionIds].(id&(name?"["&name&"]")) } Core: - Id: 'CORE-001019' + Id: "CORE-001019" Status: Published - Version: '1' -Description: 'An eligibility criterion must not be referenced by both a study design population and any - of the cohorts of the same study design population.' + Version: "1" +Description: + "An eligibility criterion must not be referenced by both a study design population and any + of the cohorts of the same study design population." Executability: Fully Executable Outcome: - Message: "The eligibility criterion is referenced by both the study design's population and at least + Message: + "The eligibility criterion is referenced by both the study design's population and at least one of its cohorts." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - category - - identifier - - "Used in" + - StudyDesign.id + - StudyDesign.name + - name + - category + - identifier + - "Used in" Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - "EligibilityCriterion" Sensitivity: Record diff --git a/Published/CORE-001020/rule.yml b/Published/CORE-001020/rule.yml index c6f494696..a11b5ab17 100644 --- a/Published/CORE-001020/rule.yml +++ b/Published/CORE-001020/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a strength denominator is specified, it must have a unit.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00186' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "If a strength denominator is specified, it must have a unit." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00186" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.administrableProducts)@$ap. $ap.ingredients@$in. @@ -33,23 +33,23 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001020' + Id: "CORE-001020" Status: Published - Version: '1' -Description: 'If a strength denominator is specified, it must have a unit.' + Version: "1" +Description: "If a strength denominator is specified, it must have a unit." Executability: Fully Executable Outcome: - Message: 'The unit for the strength denominator is missing.' + Message: "The unit for the strength denominator is missing." Output Variables: - - Ingredient.id - - Substance.id - - Substance.name - - name - - denominator.id - - denominator.value + - Ingredient.id + - Substance.id + - Substance.name + - name + - denominator.id + - denominator.value Rule Type: JSONata Scope: Entities: Include: - - 'Strength' + - "Strength" Sensitivity: Record diff --git a/Published/CORE-001021/rule.yml b/Published/CORE-001021/rule.yml index 68b13ea65..98fa25220 100644 --- a/Published/CORE-001021/rule.yml +++ b/Published/CORE-001021/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A product organization role is expected to apply to at least one medical device - or administrable product.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00211' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A product organization role is expected to apply to at least one medical device + or administrable product." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00211" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.productOrganizationRoles@$pr. @@ -28,21 +29,23 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001021' + Id: "CORE-001021" Status: Published - Version: '1' -Description: 'A product organization role is expected to apply to at least one medical device or administrable - product.' + Version: "1" +Description: + "A product organization role is expected to apply to at least one medical device or administrable + product." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The product organization role does not apply to at least one medical device or administrable - product.' + Message: + "The product organization role does not apply to at least one medical device or administrable + product." Output Variables: - - name - - appliesToIds + - name + - appliesToIds Rule Type: JSONata Scope: Entities: Include: - - 'ProductOrganizationRole' + - "ProductOrganizationRole" Sensitivity: Record diff --git a/Published/CORE-001022/rule.yml b/Published/CORE-001022/rule.yml index ae2c70e6a..191c2b263 100644 --- a/Published/CORE-001022/rule.yml +++ b/Published/CORE-001022/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If ''appliesTo'' is specified for a product organization role, then the product - organization role must only apply to medical devices or administrable products.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00212' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If 'appliesTo' is specified for a product organization role, then the product + organization role must only apply to medical devices or administrable products." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00212" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.productOrganizationRoles@$pr. @@ -31,22 +32,24 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001022' + Id: "CORE-001022" Status: Published - Version: '1' -Description: 'If ''appliesTo'' is specified for a product organization role, then the product organization - role must only apply to medical devices or administrable products.' + Version: "1" +Description: + "If 'appliesTo' is specified for a product organization role, then the product organization + role must only apply to medical devices or administrable products." Executability: Fully Executable Outcome: - Message: 'At least one of the ''appliesTo'' specifications does not apply to medical devices or administrable - products.' + Message: + "At least one of the 'appliesTo' specifications does not apply to medical devices or administrable + products." Output Variables: - - name - - appliesToIds - - appliesTo name + - name + - appliesToIds + - appliesTo name Rule Type: JSONata Scope: Entities: Include: - - 'ProductOrganizationRole' + - "ProductOrganizationRole" Sensitivity: Record diff --git a/Published/CORE-001023/rule.yml b/Published/CORE-001023/rule.yml index edcaeee66..c0aae7336 100644 --- a/Published/CORE-001023/rule.yml +++ b/Published/CORE-001023/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if more intent types are defined, they must be distinct.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00222' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, if more intent types are defined, they must be distinct." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00222" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns. ( @@ -30,21 +30,21 @@ Check: |- } } ) - ) + ) Core: - Id: 'CORE-001023' + Id: "CORE-001023" Status: Published - Version: '1' -Description: 'Within a study design, if more intent types are defined, they must be distinct.' + Version: "1" +Description: "Within a study design, if more intent types are defined, they must be distinct." Executability: Fully Executable Outcome: - Message: 'The same intent types code is used more than once within the study design.' + Message: "The same intent types code is used more than once within the study design." Output Variables: - - name - - intentTypes + - name + - intentTypes Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001024/rule.yml b/Published/CORE-001024/rule.yml index e4a1581bc..d9bd05f86 100644 --- a/Published/CORE-001024/rule.yml +++ b/Published/CORE-001024/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An interventional study must be specified using the InterventionalStudyDesign - class.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00227' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An interventional study must be specified using the InterventionalStudyDesign + class." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00227" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -26,21 +27,22 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001024' + Id: "CORE-001024" Status: Published - Version: '1' -Description: 'An interventional study must be specified using the InterventionalStudyDesign class.' + Version: "1" +Description: "An interventional study must be specified using the InterventionalStudyDesign class." Executability: Fully Executable Outcome: - Message: 'The study type is interventional but is not specified using the InterventionalStudyDesign - class.' + Message: + "The study type is interventional but is not specified using the InterventionalStudyDesign + class." Output Variables: - - name - - studyType + - name + - studyType Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001025/rule.yml b/Published/CORE-001025/rule.yml index ef502ea63..1b093521c 100644 --- a/Published/CORE-001025/rule.yml +++ b/Published/CORE-001025/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biospecimen retention indicates that a type of biospecimen is retained, - then there must be an indication of whether the type of biospecimen includes DNA.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00231' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a biospecimen retention indicates that a type of biospecimen is retained, + then there must be an indication of whether the type of biospecimen includes DNA." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00231" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions)@$sv. $sv.studyDesigns@$sd. @@ -28,23 +29,25 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001025' + Id: "CORE-001025" Status: Published - Version: '1' -Description: 'If a biospecimen retention indicates that a type of biospecimen is retained, then there - must be an indication of whether the type of biospecimen includes DNA.' + Version: "1" +Description: + "If a biospecimen retention indicates that a type of biospecimen is retained, then there + must be an indication of whether the type of biospecimen includes DNA." Executability: Fully Executable Outcome: - Message: 'The biospecimen retention is indicated as retained (isRetained=true) but information whether - it includes DNA (includesDNA attribute) is missing.' + Message: + "The biospecimen retention is indicated as retained (isRetained=true) but information whether + it includes DNA (includesDNA attribute) is missing." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - isRetained + - StudyDesign.id + - StudyDesign.name + - name + - isRetained Rule Type: JSONata Scope: Entities: Include: - - 'BiospecimenRetention' + - "BiospecimenRetention" Sensitivity: Record diff --git a/Published/CORE-001026/rule.yml b/Published/CORE-001026/rule.yml index 507012337..64e1cb394 100644 --- a/Published/CORE-001026/rule.yml +++ b/Published/CORE-001026/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: Each StudyArm is expected to have one StudyCell for each StudyEpoch.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00243' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: Each StudyArm is expected to have one StudyCell for each StudyEpoch.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00243" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns@$sd. $sd.arms@$sa.{ @@ -29,23 +29,23 @@ Check: |- } }.*[`Missing Epoch Refs`!="[]"] Core: - Id: 'CORE-001026' + Id: "CORE-001026" Status: Published - Version: '1' -Description: 'Each StudyArm is expected to have one StudyCell for each StudyEpoch.' + Version: "1" +Description: "Each StudyArm is expected to have one StudyCell for each StudyEpoch." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The StudyArm does not have one StudyCell for each StudyEpoch.' + Message: "The StudyArm does not have one StudyCell for each StudyEpoch." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - StudyDesign.epochs - - Arm's StudyCell Epoch Refs - - Missing Epoch Refs + - StudyDesign.id + - StudyDesign.name + - name + - StudyDesign.epochs + - Arm's StudyCell Epoch Refs + - Missing Epoch Refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyArm' + - "StudyArm" Sensitivity: Record diff --git a/Published/CORE-001027/rule.yml b/Published/CORE-001027/rule.yml index 8413287ef..d4efb605c 100644 --- a/Published/CORE-001027/rule.yml +++ b/Published/CORE-001027/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion item must not be used more than once within a study - design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00248' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An eligibility criterion item must not be used more than once within a study + design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00248" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns@$sd. ( @@ -32,21 +33,21 @@ Check: |- }{group:$count(details)>1?details} ).* Core: - Id: 'CORE-001027' + Id: "CORE-001027" Status: Published - Version: '1' -Description: 'An eligibility criterion item must not be used more than once within a study design.' + Version: "1" +Description: "An eligibility criterion item must not be used more than once within a study design." Executability: Fully Executable Outcome: Message: "The eligibility criterion item is used more than once within the study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - criterionItemId + - StudyDesign.id + - StudyDesign.name + - name + - criterionItemId Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' + - "EligibilityCriterion" Sensitivity: Record diff --git a/Published/CORE-001028/rule.yml b/Published/CORE-001028/rule.yml index c01df1efc..b1f748840 100644 --- a/Published/CORE-001028/rule.yml +++ b/Published/CORE-001028/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An eligibility criterion item is expected to be used in at least one study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00249' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "An eligibility criterion item is expected to be used in at least one study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00249" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. $sv.eligibilityCriterionItems @@ -27,20 +27,20 @@ Check: |- "name": name } Core: - Id: 'CORE-001028' + Id: "CORE-001028" Status: Published - Version: '1' -Description: 'An eligibility criterion item is expected to be used in at least one study design.' + Version: "1" +Description: "An eligibility criterion item is expected to be used in at least one study design." Executability: Partially Executable - Possible Overreporting Outcome: Message: "The eligibility criterion item is not used in at least one study design." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - name + - StudyVersion.id + - StudyVersion.versionIdentifier + - name Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterionItem' + - "EligibilityCriterionItem" Sensitivity: Record diff --git a/Published/CORE-001029/rule.yml b/Published/CORE-001029/rule.yml index de68a1e68..28819175d 100644 --- a/Published/CORE-001029/rule.yml +++ b/Published/CORE-001029/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study cohort must only reference indications that are defined within the same - study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00251' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study cohort must only reference indications that are defined within the same + study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00251" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$sd. $sd.population@$sp. @@ -30,25 +31,26 @@ Check: |- "Invalid indicationIds": indicationIds[$not($ in $sd.indications.id)] } Core: - Id: 'CORE-001029' + Id: "CORE-001029" Status: Published - Version: '1' -Description: 'A study cohort must only reference indications that are defined within the same study design.' + Version: "1" +Description: "A study cohort must only reference indications that are defined within the same study design." Executability: Fully Executable Outcome: - Message: 'The reference to the indication is not targetting an indication that has been defined within - the same study design.' + Message: + "The reference to the indication is not targetting an indication that has been defined within + the same study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.indications.id - - StudyDesignPopulation.id - - StudyDesignPopulation.name - - name - - Invalid indicationIds + - StudyDesign.id + - StudyDesign.name + - StudyDesign.indications.id + - StudyDesignPopulation.id + - StudyDesignPopulation.name + - name + - Invalid indicationIds Rule Type: JSONata Scope: Entities: Include: - - 'StudyCohort' + - "StudyCohort" Sensitivity: Record diff --git a/Published/CORE-001030/rule.yml b/Published/CORE-001030/rule.yml index 8e816ab82..1ee323bce 100644 --- a/Published/CORE-001030/rule.yml +++ b/Published/CORE-001030/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study element must only reference study interventions that are referenced by - the same study design as the study element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00252' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study element must only reference study interventions that are referenced by + the same study design as the study element." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00252" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.versions)@$sv. $sv.studyDesigns@$sd. @@ -29,25 +30,27 @@ Check: |- "Invalid StudyIntervention.name": "["&$join(studyInterventionIds[$not ($ in $sd.studyInterventionIds)].($oid:=$;$oid&": "&($o:=$sv.studyInterventions[id=$oid];$o?$o.name:"Not defined")),"; ")&"]" } Core: - Id: 'CORE-001030' + Id: "CORE-001030" Status: Published - Version: '1' -Description: 'A study element must only reference study interventions that are referenced by the same - study design as the study element.' + Version: "1" +Description: + "A study element must only reference study interventions that are referenced by the same + study design as the study element." Executability: Fully Executable Outcome: - Message: 'The reference to the intervention is not targetting an intervention that has been referenced - by the study design as a study intervention.' + Message: + "The reference to the intervention is not targetting an intervention that has been referenced + by the study design as a study intervention." Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.studyInterventionIds - - name - - Invalid studyInterventionIds - - Invalid StudyIntervention.name + - StudyDesign.id + - StudyDesign.name + - StudyDesign.studyInterventionIds + - name + - Invalid studyInterventionIds + - Invalid StudyIntervention.name Rule Type: JSONata Scope: Entities: Include: - - 'StudyElement' + - "StudyElement" Sensitivity: Record diff --git a/Published/CORE-001031/rule.yml b/Published/CORE-001031/rule.yml index d1450ce0f..1f91b29ca 100644 --- a/Published/CORE-001031/rule.yml +++ b/Published/CORE-001031/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The same reason is not expected to be given as a primary and secondary reason.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00256' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "The same reason is not expected to be given as a primary and secondary reason." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00256" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (study.versions.amendments)@$am. $am.secondaryReasons@$sr. @@ -29,21 +29,21 @@ Check: |- } )][check=true] Core: - Id: 'CORE-001031' + Id: "CORE-001031" Status: Published - Version: '1' -Description: 'The same reason is not expected to be given as a primary and secondary reason.' + Version: "1" +Description: "The same reason is not expected to be given as a primary and secondary reason." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The secondary reason code is equal to the primary reason code.' + Message: "The secondary reason code is equal to the primary reason code." Output Variables: - - StudyAmendment.id - - StudyAmendment.name - - code - - primaryReason.code + - StudyAmendment.id + - StudyAmendment.name + - code + - primaryReason.code Rule Type: JSONata Scope: Entities: Include: - - 'StudyAmendmentReason' + - "StudyAmendmentReason" Sensitivity: Record diff --git a/Published/CORE-001032/rule.yml b/Published/CORE-001032/rule.yml index a28b98b51..cc19ded30 100644 --- a/Published/CORE-001032/rule.yml +++ b/Published/CORE-001032/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design must not be characterized as both "Single Country" and "Multiple - Countries".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00257' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'A study design must not be characterized as both "Single Country" and "Multiple + Countries".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00257" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns["C217006" in characteristics.code and "C217007" in characteristics.code]. { @@ -23,20 +24,20 @@ Check: |- "characteristics": "["&$join(characteristics[code in ["C217006","C217007"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]" } Core: - Id: 'CORE-001032' + Id: "CORE-001032" Status: Published - Version: '1' + Version: "1" Description: 'A study design must not be characterized as both "Single Country" and "Multiple Countries".' Executability: Fully Executable Outcome: Message: 'The study design is characterized as both "Single Country" and "Multiple Countries".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001033/rule.yml b/Published/CORE-001033/rule.yml index 884bb8bc8..5c7934886 100644 --- a/Published/CORE-001033/rule.yml +++ b/Published/CORE-001033/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design is not expected to have more than one of the following characteristics: - "Randomized", "Stratification", "Stratified Randomisation".' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00258' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + 'A study design is not expected to have more than one of the following characteristics: + "Randomized", "Stratification", "Stratified Randomisation".' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00258" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns[$count(characteristics[code in ["C46079","C25689","C147145"]])>1]. { @@ -23,22 +24,24 @@ Check: |- "characteristics": "["&$join(characteristics[code in ["C46079","C25689","C147145"]].$.(id&": "&decode&" ("&code&")"),"; ")&"]" } Core: - Id: 'CORE-001033' + Id: "CORE-001033" Status: Published - Version: '1' -Description: 'A study design is not expected to have more than one of the following characteristics: "Randomized", + Version: "1" +Description: + 'A study design is not expected to have more than one of the following characteristics: "Randomized", "Stratification", "Stratified Randomisation".' Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has more than one of the following characteristics: "Randomized", "Stratification", + Message: + 'The study design has more than one of the following characteristics: "Randomized", "Stratification", "Stratified Randomisation".' Output Variables: - - name - - characteristics + - name + - characteristics Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001034/rule.yml b/Published/CORE-001034/rule.yml index 1dd748608..ba20a4daa 100644 --- a/Published/CORE-001034/rule.yml +++ b/Published/CORE-001034/rule.yml @@ -2,106 +2,110 @@ # Condition: REPNUM is in the dataset, and the are multiple records for a subject for a test within the timeframe identified by the timing variables on the record # Rule: --REPNUM ^= null and unique per subject per test per the timing variables Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given timeframe for - the same test. The level of granularity can vary (e.g., within a time point or within a - visit). - Document: Model v2.0 - Item: --REPNUM - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0562 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given timeframe for - the same test. The level of granularity can vary (e.g., within a time point or within a - visit). For example, multiple measurements of blood pressure or multiple analyses of a - sample. - Document: Model v1.7 - Item: --REPNUM - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0562 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: The instance number of a test that is repeated within a given timeframe for - the same test. The level of granularity can vary (e.g., within a time point or within a - visit). - Document: SDTM v2.1 - Item: --REPNUM - Section: 3.1.3 The Findings Observation Class - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0648 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). + Document: Model v2.0 + Item: --REPNUM + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0562 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). For example, multiple measurements of blood pressure or multiple analyses of a + sample. + Document: Model v1.7 + Item: --REPNUM + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0562 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + The instance number of a test that is repeated within a given timeframe for + the same test. The level of granularity can vary (e.g., within a time point or within a + visit). + Document: SDTM v2.1 + Item: --REPNUM + Section: 3.1.3 The Findings Observation Class + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0648 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: - - name: --REPNUM - operator: exists - - name: $record_count_per_subject_test_timing - operator: greater_than - value: 1 - - any: - name: --REPNUM - operator: empty - - name: --REPNUM - operator: is_not_unique_set - regex: ^\d{4}-\d{2}-\d{2} - value: - - USUBJID - - --TESTCD - - $TIMING_VARIABLES + operator: exists + - name: $record_count_per_subject_test_timing + operator: greater_than + value: 1 + - any: + - name: --REPNUM + operator: empty + - name: --REPNUM + operator: is_not_unique_set + regex: ^\d{4}-\d{2}-\d{2} + value: + - USUBJID + - --TESTCD + - $TIMING_VARIABLES Core: Id: CORE-001034 Status: Published - Version: '1' -Description: Raise an error when REPNUM is in the dataset and there are multiple records for a - subject for a test within the timeframe identified by the timing variables on the record, and + Version: "1" +Description: + Raise an error when REPNUM is in the dataset and there are multiple records for a + subject for a test within the timeframe identified by the timing variables on the record, and --REPNUM is null or not unique per subject per test per timing variables. Executability: Fully Executable Operations: -- id: $TIMING_VARIABLES - key_name: role - key_value: Timing - operator: get_dataset_filtered_variables -- group: - - USUBJID - - --TESTCD - - $TIMING_VARIABLES - id: $record_count_per_subject_test_timing - operator: record_count - regex: ^\d{4}-\d{2}-\d{2} + - id: $TIMING_VARIABLES + key_name: role + key_value: Timing + operator: get_dataset_filtered_variables + - group: + - USUBJID + - --TESTCD + - $TIMING_VARIABLES + id: $record_count_per_subject_test_timing + operator: record_count + regex: ^\d{4}-\d{2}-\d{2} Outcome: Message: --REPNUM is null or is not unique per subject per test per timing variables. Output Variables: - - USUBJID - - --TESTCD - - --REPNUM - - $TIMING_VARIABLES + - USUBJID + - --TESTCD + - --REPNUM + - $TIMING_VARIABLES Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Use Case: INDH Sensitivity: Record diff --git a/Published/CORE-001035/rule.yml b/Published/CORE-001035/rule.yml index c7766f91d..9ca681e19 100644 --- a/Published/CORE-001035/rule.yml +++ b/Published/CORE-001035/rule.yml @@ -1,48 +1,48 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled decision instance must refer to a default condition.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00038' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "A scheduled decision instance must refer to a default condition." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00038" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'ScheduledDecisionInstance' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: defaultConditionId - operator: not_exists - - name: defaultConditionId - operator: empty + - name: instanceType + operator: equal_to + value: "ScheduledDecisionInstance" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - name: defaultConditionId + operator: not_exists + - name: defaultConditionId + operator: empty Core: - Id: 'CORE-001035' + Id: "CORE-001035" Status: Published - Version: '1' -Description: 'A scheduled decision instance must refer to a default condition.' + Version: "1" +Description: "A scheduled decision instance must refer to a default condition." Executability: Fully Executable Outcome: - Message: 'The scheduled decision instance does not refer to a default condition.' + Message: "The scheduled decision instance does not refer to a default condition." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - defaultConditionId + - parent_entity + - parent_id + - parent_rel + - id + - name + - defaultConditionId Rule Type: Record Data Scope: Entities: Include: - - 'ScheduledDecisionInstance' + - "ScheduledDecisionInstance" Sensitivity: Record diff --git a/Published/CORE-001036/rule.yml b/Published/CORE-001036/rule.yml index 2b8f951df..b4195d81c 100644 --- a/Published/CORE-001036/rule.yml +++ b/Published/CORE-001036/rule.yml @@ -1,28 +1,28 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00041' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00041' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00041" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Within a study design, there must be at least one endpoint with level primary." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00041" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.versions.studyDesigns. { @@ -33,21 +33,21 @@ Check: |- "# Primary endpoints": $count(objectives.endpoints[level.code="C94496"]) }[`# Primary endpoints` = 0][] Core: - Id: 'CORE-001036' + Id: "CORE-001036" Status: Published - Version: '1' + Version: "1" Description: "Within a study design, there must be at least one endpoint with level primary." Executability: Fully Executable Outcome: Message: "There is not at least one endpoint with a level of primary within the study design." Output Variables: - - name - - '# Primary endpoints' + - name + - "# Primary endpoints" Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001037/rule.yml b/Published/CORE-001037/rule.yml index 2df2aa80a..e8633be1d 100644 --- a/Published/CORE-001037/rule.yml +++ b/Published/CORE-001037/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Any parameter name referenced in a tag in the text should be specified in the - data dictionary parameter maps.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00089' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Any parameter name referenced in a tag in the text should be specified in the + data dictionary parameter maps." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00089" + Version: "1" + Version: "1.0" + Version: "3.0" Check: |- **.study.versions@$sv. ($sv.studyDesigns)@$sd.($sd.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st. @@ -45,30 +46,32 @@ Check: |- } ) Core: - Id: 'CORE-001037' + Id: "CORE-001037" Status: Published - Version: '1' -Description: 'Any parameter name referenced in a tag in the text should be specified in the data dictionary - parameter maps.' + Version: "1" +Description: + "Any parameter name referenced in a tag in the text should be specified in the data dictionary + parameter maps." Executability: Fully Executable Outcome: - Message: "The parameter name referenced in the text is not specified in the data dictionary parameter + Message: + "The parameter name referenced in the text is not specified in the data dictionary parameter map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of the dictionary's parameter maps." Output Variables: - - name - - Parameter reference - - Parameter name - - dictionaryId - - SyntaxTemplateDictionary.name - - Issue + - name + - Parameter reference + - Parameter name + - dictionaryId + - SyntaxTemplateDictionary.name + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterion' - - 'Characteristic' - - 'Condition' - - 'Objective' - - 'Endpoint' + - "EligibilityCriterion" + - "Characteristic" + - "Condition" + - "Objective" + - "Endpoint" Sensitivity: Record diff --git a/Published/CORE-001038/rule.yml b/Published/CORE-001038/rule.yml index 94c7d546a..aff3ff1f4 100644 --- a/Published/CORE-001038/rule.yml +++ b/Published/CORE-001038/rule.yml @@ -1,32 +1,34 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical concept, biomedical - concept category, or biomedical concept surrogate then an instance must be available in the - corresponding class with the specified id.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00091' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'When a condition applies to a procedure, activity, biomedical concept, biomedical - concept category, or biomedical concept surrogate then an instance must be available in the - corresponding class with the specified id.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00091' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When a condition applies to a procedure, activity, biomedical concept, biomedical + concept category, or biomedical concept surrogate then an instance must be available in the + corresponding class with the specified id." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00091" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "When a condition applies to a procedure, activity, biomedical concept, biomedical + concept category, or biomedical concept surrogate then an instance must be available in the + corresponding class with the specified id." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00091" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $idityp:=$.study.versions.**[id]{id:instanceType}; @@ -52,25 +54,27 @@ Check: |- ] ) Core: - Id: 'CORE-001038' + Id: "CORE-001038" Status: Published - Version: '1' -Description: 'When a condition applies to a procedure, activity, biomedical concept, biomedical concept + Version: "1" +Description: + "When a condition applies to a procedure, activity, biomedical concept, biomedical concept category, or biomedical concept surrogate then an instance must be available in the corresponding class - with the specified id.' + with the specified id." Executability: Fully Executable Outcome: - Message: 'The id value specified to indicate what the condition applies to does not reference a procedure, + Message: + "The id value specified to indicate what the condition applies to does not reference a procedure, activity, biomedical concept, biomedical concept category, or biomedical concept surrogate - either the specified id is not an id for anything (it is invalid), or the instance identified by the id is - not one of the expected classes.' + not one of the expected classes." Output Variables: - - name - - 'appliesTo id' - - 'appliesTo instanceType' + - name + - "appliesTo id" + - "appliesTo instanceType" Rule Type: JSONata Scope: Entities: Include: - - 'Condition' + - "Condition" Sensitivity: Record diff --git a/Published/CORE-001039/rule.yml b/Published/CORE-001039/rule.yml index 51cd58f08..5b8ab954c 100644 --- a/Published/CORE-001039/rule.yml +++ b/Published/CORE-001039/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference an encounter that is defined - within the same study design as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00106' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A scheduled activity instance must only reference an encounter that is defined - within the same study design as the scheduled activity instance.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00106' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only reference an encounter that is defined + within the same study design as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00106" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A scheduled activity instance must only reference an encounter that is defined + within the same study design as the scheduled activity instance." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00106" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $lkp:=$merge($.**.studyDesigns.encounters.{id:%.id}); @@ -49,24 +51,26 @@ Check: |- ] ) Core: - Id: 'CORE-001039' + Id: "CORE-001039" Status: Published - Version: '1' -Description: 'A scheduled activity instance must only reference an encounter that is defined within the - same study design as the scheduled activity instance.' + Version: "1" +Description: + "A scheduled activity instance must only reference an encounter that is defined within the + same study design as the scheduled activity instance." Executability: Fully Executable Outcome: - Message: 'The scheduled activity instance references an encounter that is not defined within the same - study design.' + Message: + "The scheduled activity instance references an encounter that is not defined within the same + study design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - encounterId - - "Referenced encounter's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - encounterId + - "Referenced encounter's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'ScheduledActivityInstance' + - "ScheduledActivityInstance" Sensitivity: Record diff --git a/Published/CORE-001040/rule.yml b/Published/CORE-001040/rule.yml index fde1583be..e44b3fb58 100644 --- a/Published/CORE-001040/rule.yml +++ b/Published/CORE-001040/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study element must only reference study interventions that are defined within - the same study design as the study element.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00109' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study element must only reference study interventions that are defined within + the same study design as the study element." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00109" + Version: "1" + Version: "1.0" + Version: "3.0" Check: |- ( $lkp:=$merge($.**.studyDesigns.studyInterventions.{id:%.id}); @@ -35,24 +36,26 @@ Check: |- ] ) Core: - Id: 'CORE-001040' + Id: "CORE-001040" Status: Published - Version: '1' -Description: 'A study element must only reference study interventions that are defined within the same - study design as the study element.' + Version: "1" +Description: + "A study element must only reference study interventions that are defined within the same + study design as the study element." Executability: Fully Executable Outcome: - Message: 'The study element references a study intervention that is not defined within the same study - design.' + Message: + "The study element references a study intervention that is not defined within the same study + design." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - "studyInterventionIds value" - - "Referenced intervention's parent StudyDesign.id" + - StudyDesign.id + - StudyDesign.name + - name + - "studyInterventionIds value" + - "Referenced intervention's parent StudyDesign.id" Rule Type: JSONata Scope: Entities: Include: - - 'StudyElement' + - "StudyElement" Sensitivity: Record diff --git a/Published/CORE-001041/rule.yml b/Published/CORE-001041/rule.yml index a9184248a..89d60a6ea 100644 --- a/Published/CORE-001041/rule.yml +++ b/Published/CORE-001041/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: Within a document version, the specified displayed section numbers for - narrative content must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00245' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + Within a document version, the specified displayed section numbers for + narrative content must be unique.' + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00245" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -36,25 +37,26 @@ Check: |- } {group: $count(details)>1?details} ).* Core: - Id: 'CORE-001041' + Id: "CORE-001041" Status: Published - Version: '1' -Description: 'Within a document version, the specified displayed section numbers for narrative content - must be unique.' + Version: "1" +Description: + "Within a document version, the specified displayed section numbers for narrative content + must be unique." Executability: Fully Executable Outcome: - Message: 'The displayed section number is not unique within the study definition document version.' + Message: "The displayed section number is not unique within the study definition document version." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - displaySectionNumber + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - displaySectionNumber Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-001042/rule.yml b/Published/CORE-001042/rule.yml index b9d09e5ce..244325109 100644 --- a/Published/CORE-001042/rule.yml +++ b/Published/CORE-001042/rule.yml @@ -1,19 +1,20 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a geographic scope type is global then no code is expected to specify the - specific area within scope while if it is not global then a code is expected to specify the - specific area within scope.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00261' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a geographic scope type is global then no code is expected to specify the + specific area within scope while if it is not global then a code is expected to specify the + specific area within scope." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00261" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- **[instanceType="GeographicScope" and (type.code="C68846")=($exists(code) and code)]. { @@ -26,24 +27,26 @@ Check: |- "code.standardCode.decode": code.standardCode.decode } Core: - Id: 'CORE-001042' + Id: "CORE-001042" Status: Published - Version: '1' -Description: 'If a geographic scope type is global then no code is expected to specify the specific area - within scope while if it is not global then a code is expected to specify the specific area within scope.' + Version: "1" +Description: + "If a geographic scope type is global then no code is expected to specify the specific area + within scope while if it is not global then a code is expected to specify the specific area within scope." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The geographic scope is global (type.code = C68846) and a code has been specified for the + Message: + "The geographic scope is global (type.code = C68846) and a code has been specified for the specific area or the geographic scope is not global (type.code is not C68846) and no code has been - specified for the specific area.' + specified for the specific area." Output Variables: - - type.code - - type.decode - - code.standardCode.code - - code.standardCode.decode + - type.code + - type.decode + - code.standardCode.code + - code.standardCode.decode Rule Type: JSONata Scope: Entities: Include: - - 'GeographicScope' + - "GeographicScope" Sensitivity: Record diff --git a/Published/CORE-001044/rule.yml b/Published/CORE-001044/rule.yml index 501a1afae..1e19e2bfb 100644 --- a/Published/CORE-001044/rule.yml +++ b/Published/CORE-001044/rule.yml @@ -1,128 +1,136 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6401 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6401 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: "RFSTDTC" - operator: "date_not_equal_to" - value: "$ex_exstdtc" + - name: "RFSTDTC" + operator: "date_not_equal_to" + value: "$ex_exstdtc" Core: Id: CORE-001044 Status: Published - Version: '1' -Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start + Version: "1" +Description: + Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start Date/Time of Treatment (EXSDTC). Executability: Fully Executable Operations: -- domain: "EX" - group: - - USUBJID - id: "$ex_exstdtc" - name: "EXSTDTC" - operator: "min_date" + - domain: "EX" + group: + - USUBJID + id: "$ex_exstdtc" + name: "EXSTDTC" + operator: "min_date" Outcome: Message: RFSTDTC is not equal to the first EXSTDTC. Output Variables: - - RFSTDTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - SPECIAL PURPOSE + - INTERVENTIONS + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Published/CORE-001045/rule.yml b/Published/CORE-001045/rule.yml index 6b053e6fa..3a5c98795 100644 --- a/Published/CORE-001045/rule.yml +++ b/Published/CORE-001045/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference study populations or cohorts that are defined - within the same study design as the study arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00050' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study arm must only reference study populations or cohorts that are defined - within the same study design as the study arm.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00050' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study arm must only reference study populations or cohorts that are defined + within the same study design as the study arm." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00050" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study arm must only reference study populations or cohorts that are defined + within the same study design as the study arm." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00050" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.**.studyDesigns)@$s. [ @@ -42,25 +44,27 @@ Check: |- } ] Core: - Id: 'CORE-001045' + Id: "CORE-001045" Status: Published - Version: '1' -Description: 'A study arm must only reference study populations or cohorts that are defined within the - same study design as the study arm.' + Version: "1" +Description: + "A study arm must only reference study populations or cohorts that are defined within the + same study design as the study arm." Executability: Fully Executable Outcome: - Message: 'The study arm references a populationId that does not match the id of any study population - or study cohort defined within the same study design as the study arm.' + Message: + "The study arm references a populationId that does not match the id of any study population + or study cohort defined within the same study design as the study arm." Output Variables: - - StudyDesign.id - - StudyDesign.name - - StudyDesign.population.id - - StudyDesign.population.cohorts.id - - name - - populationId + - StudyDesign.id + - StudyDesign.name + - StudyDesign.population.id + - StudyDesign.population.cohorts.id + - name + - populationId Rule Type: JSONata Scope: Entities: Include: - - StudyArm + - StudyArm Sensitivity: Record diff --git a/Published/CORE-001046/rule.yml b/Published/CORE-001046/rule.yml index ee1f60610..d8de9c52d 100644 --- a/Published/CORE-001046/rule.yml +++ b/Published/CORE-001046/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If the intervention model indicates a single group design then only one intervention - is expected. In all other cases more interventions are expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00074' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If the intervention model indicates a single group design then only one intervention + is expected. In all other cases more interventions are expected." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00074" + Version: "1" + Version: "1.0" + Version: "3.0" Check: |- ($.study.versions.studyDesigns)@$sd. { @@ -29,26 +30,28 @@ Check: |- (`interventionModel.code` != "C82640" and `# Study Interventions` <= 1) ] Core: - Id: 'CORE-001046' + Id: "CORE-001046" Status: Published - Version: '1' -Description: 'If the intervention model indicates a single group design then only one intervention is - expected. In all other cases more interventions are expected.' + Version: "1" +Description: + "If the intervention model indicates a single group design then only one intervention is + expected. In all other cases more interventions are expected." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The number of study interventions defined for the study design is not consistent with intervention + Message: + "The number of study interventions defined for the study design is not consistent with intervention model specified for the study design - either the model indicates a single group and there is not only one study intervention, or the model does not indicate a single group and there are not multiple - study interventions.' + study interventions." Output Variables: - - id - - name - - interventionModel.code - - interventionModel.decode - - '# Study Interventions' + - id + - name + - interventionModel.code + - interventionModel.decode + - "# Study Interventions" Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' + - "StudyDesign" Sensitivity: Record diff --git a/Published/CORE-001047/rule.yml b/Published/CORE-001047/rule.yml index d3728507f..db1076b96 100644 --- a/Published/CORE-001047/rule.yml +++ b/Published/CORE-001047/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept is referenced from an activity then it is not expected - to be referenced as well by a biomedical concept category that is referenced from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00076' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If a biomedical concept is referenced from an activity then it is not expected - to be referenced as well by a biomedical concept category that is referenced from the same activity.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00076' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a biomedical concept is referenced from an activity then it is not expected + to be referenced as well by a biomedical concept category that is referenced from the same activity." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00076" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If a biomedical concept is referenced from an activity then it is not expected + to be referenced as well by a biomedical concept category that is referenced from the same activity." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00076" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. [ @@ -72,24 +74,26 @@ Check: |- ) ] Core: - Id: 'CORE-001047' + Id: "CORE-001047" Status: Published - Version: '1' -Description: 'If a biomedical concept is referenced from an activity then it is not expected to be referenced - as well by a biomedical concept category that is referenced from the same activity.' + Version: "1" +Description: + "If a biomedical concept is referenced from an activity then it is not expected to be referenced + as well by a biomedical concept category that is referenced from the same activity." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity references both a biomedical concept category and a biomedical concept, but the - biomedical concept is a member of the referenced category or one of its subcategories.' + Message: + "The activity references both a biomedical concept category and a biomedical concept, but the + biomedical concept is a member of the referenced category or one of its subcategories." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - biomedicalConceptId - - bcCategoryId(s) containing BC + - StudyDesign.id + - StudyDesign.name + - name + - biomedicalConceptId + - bcCategoryId(s) containing BC Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-001048/rule.yml b/Published/CORE-001048/rule.yml index 25166dee7..5ec978e68 100644 --- a/Published/CORE-001048/rule.yml +++ b/Published/CORE-001048/rule.yml @@ -1,32 +1,34 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Epoch ordering using previous and next attributes is expected to be consistent - with the order of corresponding scheduled activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00088' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Epoch ordering using previous and next attributes is expected to be consistent - with the order of corresponding scheduled activity instances according to their specified default - conditions.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00088' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Epoch ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00088" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Epoch ordering using previous and next attributes is expected to be consistent + with the order of corresponding scheduled activity instances according to their specified default + conditions." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00088" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd. @@ -51,28 +53,30 @@ Check: |- }[`Epoch order by previous/next` != `Epoch order by timeline refs`] ) Core: - Id: 'CORE-001048' + Id: "CORE-001048" Status: Published - Version: '1' -Description: 'Epoch ordering using previous and next attributes is expected to be consistent with the - order of corresponding scheduled activity instances according to their specified default conditions.' + Version: "1" +Description: + "Epoch ordering using previous and next attributes is expected to be consistent with the + order of corresponding scheduled activity instances according to their specified default conditions." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The order of the epochs in the study design (as defined by the next attribute) does not match + Message: + "The order of the epochs in the study design (as defined by the next attribute) does not match the order of epochs as referenced from scheduled activity instances in the main timeline that are - ordered by default condition.' + ordered by default condition." Output Variables: - - name - - ScheduleTimeline.id - - ScheduleTimeline.name - - ScheduleTimeline.mainTimeline - - Epoch order by previous/next - - Epoch order by timeline refs + - name + - ScheduleTimeline.id + - ScheduleTimeline.name + - ScheduleTimeline.mainTimeline + - Epoch order by previous/next + - Epoch order by timeline refs Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001049/rule.yml b/Published/CORE-001049/rule.yml index cbf21dca8..abfd336f5 100644 --- a/Published/CORE-001049/rule.yml +++ b/Published/CORE-001049/rule.yml @@ -1,28 +1,28 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00124' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in a parameter map must be available elsewhere in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00124' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Referenced items in a parameter map must be available elsewhere in the data model." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00124" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "Referenced items in a parameter map must be available elsewhere in the data model." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00124" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -83,21 +83,21 @@ Check: |- ) ) Core: - Id: 'CORE-001049' + Id: "CORE-001049" Status: Published - Version: '1' -Description: 'Referenced items in a parameter map must be available elsewhere in the data model.' + Version: "1" +Description: "Referenced items in a parameter map must be available elsewhere in the data model." Executability: Fully Executable Outcome: - Message: 'The item referenced in the parameter map is not available elsewhere in the model.' + Message: "The item referenced in the parameter map is not available elsewhere in the model." Output Variables: - - SyntaxTemplateDictionary.id - - SyntaxTemplateDictionary.name - - tag - - reference + - SyntaxTemplateDictionary.id + - SyntaxTemplateDictionary.name + - tag + - reference Rule Type: JSONata Scope: Entities: Include: - - 'ParameterMap' + - "ParameterMap" Sensitivity: Record diff --git a/Published/CORE-001050/rule.yml b/Published/CORE-001050/rule.yml index a3a92cd1e..313fd1e69 100644 --- a/Published/CORE-001050/rule.yml +++ b/Published/CORE-001050/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in the narrative content must be available elsewhere in the - data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00131' - Version: '1' - Version: '1.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Referenced items in the narrative content must be available elsewhere in the + data model." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00131" + Version: "1" + Version: "1.0" + Version: "3.0" Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -66,25 +67,25 @@ Check: |- ) ) Core: - Id: 'CORE-001050' + Id: "CORE-001050" Status: Published - Version: '1' -Description: 'Referenced items in the narrative content must be available elsewhere in the data model.' + Version: "1" +Description: "Referenced items in the narrative content must be available elsewhere in the data model." Executability: Fully Executable Outcome: - Message: 'The item referenced in the narrative content text is not available elsewhere in the model.' + Message: "The item referenced in the narrative content text is not available elsewhere in the model." Output Variables: - - StudyProtocolDocument.id - - StudyProtocolDocument.name - - StudyProtocolDocumentVersion.id - - StudyProtocolDocumentVersion.protocolVersion - - name - - sectionNumber - - sectionTitle - - 'Invalid Reference' + - StudyProtocolDocument.id + - StudyProtocolDocument.name + - StudyProtocolDocumentVersion.id + - StudyProtocolDocumentVersion.protocolVersion + - name + - sectionNumber + - sectionTitle + - "Invalid Reference" Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-001051/rule.yml b/Published/CORE-001051/rule.yml index 6b86b54af..384a66852 100644 --- a/Published/CORE-001051/rule.yml +++ b/Published/CORE-001051/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content is expected to point to a child and/or to a content item text.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00163' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Narrative content is expected to point to a child and/or to a content item text." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00163" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -33,24 +33,24 @@ Check: |- "sectionTitle": $c.sectionTitle } Core: - Id: 'CORE-001051' + Id: "CORE-001051" Status: Published - Version: '1' -Description: 'Narrative content is expected to point to a child and/or to a content item text.' + Version: "1" +Description: "Narrative content is expected to point to a child and/or to a content item text." Executability: Partially Executable - Possible Overreporting Outcome: Message: "The narrative content does not contain either a child or a narrative content item." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - sectionTitle + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - sectionTitle Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-001052/rule.yml b/Published/CORE-001052/rule.yml index ee92ef85f..e8d538dc4 100644 --- a/Published/CORE-001052/rule.yml +++ b/Published/CORE-001052/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study definition document version must not be referenced more than once by - the same study version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00167' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study definition document version must not be referenced more than once by + the same study version." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00167" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions. { @@ -24,21 +25,23 @@ Check: |- $filter(documentVersionIds,function($v,$i,$a){$count($a[$=$v])>1}) ~> $sort }[`Duplicate documentVersionIds`] Core: - Id: 'CORE-001052' + Id: "CORE-001052" Status: Published - Version: '1' -Description: 'A study definition document version must not be referenced more than once by the same study - version.' + Version: "1" +Description: + "A study definition document version must not be referenced more than once by the same study + version." Executability: Fully Executable Outcome: - Message: "The study version references the same study definition document version more than once (there + Message: + "The study version references the same study definition document version more than once (there are duplicate id values in documentVersionIds)." Output Variables: - - versionIdentifier - - "Duplicate documentVersionIds" + - versionIdentifier + - "Duplicate documentVersionIds" Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-001053/rule.yml b/Published/CORE-001053/rule.yml index 22a6d23ff..5de0eb9fb 100644 --- a/Published/CORE-001053/rule.yml +++ b/Published/CORE-001053/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'All abbreviations defined for a study version must be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00170' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "All abbreviations defined for a study version must be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00170" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ( @@ -30,21 +30,21 @@ Check: |- "expandedText": expandedText } Core: - Id: 'CORE-001053' + Id: "CORE-001053" Status: Published - Version: '1' -Description: 'All abbreviations defined for a study version must be unique.' + Version: "1" +Description: "All abbreviations defined for a study version must be unique." Executability: Fully Executable Outcome: Message: "The abbreviation's abbreviated text is not unique within the study version." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - abbreviatedText - - expandedText + - StudyVersion.id + - StudyVersion.versionIdentifier + - abbreviatedText + - expandedText Rule Type: JSONata Scope: Entities: Include: - - 'Abbreviation' + - "Abbreviation" Sensitivity: Record diff --git a/Published/CORE-001054/rule.yml b/Published/CORE-001054/rule.yml index 920981b5c..f469113f2 100644 --- a/Published/CORE-001054/rule.yml +++ b/Published/CORE-001054/rule.yml @@ -1,19 +1,20 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'There must be exactly one sponsor study identifier (i.e., a study identifier - whose scope is an organization that is identified as the organization for the sponsor study - role).' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00172' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "There must be exactly one sponsor study identifier (i.e., a study identifier + whose scope is an organization that is identified as the organization for the sponsor study + role)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00172" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- [$.study.versions@$sv. ( @@ -33,21 +34,22 @@ Check: |- } )][`# Sponsor Identifiers` != 1] Core: - Id: 'CORE-001054' + Id: "CORE-001054" Status: Published - Version: '1' -Description: 'There must be exactly one sponsor study identifier (i.e., a study identifier whose scope - is an organization that is identified as the organization for the sponsor study role).' + Version: "1" +Description: + "There must be exactly one sponsor study identifier (i.e., a study identifier whose scope + is an organization that is identified as the organization for the sponsor study role)." Executability: Fully Executable Outcome: - Message: 'The study version does not have exactly one sponsor study identifier.' + Message: "The study version does not have exactly one sponsor study identifier." Output Variables: - - versionIdentifier - - '# Sponsor Identifiers' - - 'Sponsor Identifiers' + - versionIdentifier + - "# Sponsor Identifiers" + - "Sponsor Identifiers" Rule Type: JSONata Scope: Entities: Include: - - 'StudyVersion' + - "StudyVersion" Sensitivity: Record diff --git a/Published/CORE-001055/rule.yml b/Published/CORE-001055/rule.yml index 1c91f7cf3..702ed86bc 100644 --- a/Published/CORE-001055/rule.yml +++ b/Published/CORE-001055/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content must only reference narrative content that is specified within - the same study definition document version.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00204' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Narrative content must only reference narrative content that is specified within + the same study definition document version." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00204" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.documentedBy@$sdd. $sdd.versions@$sddv. @@ -52,28 +53,30 @@ Check: |- "Invalid childIds": $c.childIds[$not($ in $sddv.contents.id)] ~> $join("; ") } Core: - Id: 'CORE-001055' + Id: "CORE-001055" Status: Published - Version: '1' -Description: 'Narrative content must only reference narrative content that is specified within the same - study definition document version.' + Version: "1" +Description: + "Narrative content must only reference narrative content that is specified within the same + study definition document version." Executability: Fully Executable Outcome: - Message: 'The narrative content references a previous, next or child id value that does not match the - id of any narrative content defined within the same study definition document version.' + Message: + "The narrative content references a previous, next or child id value that does not match the + id of any narrative content defined within the same study definition document version." Output Variables: - - StudyDefinitionDocument.id - - StudyDefinitionDocument.name - - StudyDefinitionDocumentVersion.id - - StudyDefinitionDocumentVersion.version - - name - - sectionNumber - - Invalid previousId - - Invalid nextId - - Invalid childIds + - StudyDefinitionDocument.id + - StudyDefinitionDocument.name + - StudyDefinitionDocumentVersion.id + - StudyDefinitionDocumentVersion.version + - name + - sectionNumber + - Invalid previousId + - Invalid nextId + - Invalid childIds Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContent' + - "NarrativeContent" Sensitivity: Record diff --git a/Published/CORE-001056/rule.yml b/Published/CORE-001056/rule.yml index d7006b11d..79727fbc0 100644 --- a/Published/CORE-001056/rule.yml +++ b/Published/CORE-001056/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's sampling method must be specified according to - the extensible Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with - a code or decode used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00225' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An observational study design's sampling method must be specified according to + the extensible Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with + a code or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00225" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: samplingMethod - operator: exists - - name: samplingMethod - operator: equal_to - value: true - - not: - all: - - name: samplingMethod.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: samplingMethod.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: samplingMethod + operator: exists + - name: samplingMethod + operator: equal_to + value: true + - not: + all: + - name: samplingMethod.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: samplingMethod.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: samplingMethod.code - operator: equal_to - value: $code_for_decode_pref_term - - name: samplingMethod.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: samplingMethod.decode - operator: equal_to - value: $pref_term_for_code - - name: samplingMethod.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: samplingMethod.code + operator: equal_to + value: $code_for_decode_pref_term + - name: samplingMethod.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: samplingMethod.decode + operator: equal_to + value: $pref_term_for_code + - name: samplingMethod.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-001056' + Id: "CORE-001056" Status: Published - Version: '1' -Description: "An observational study design's sampling method must be specified according to the extensible + Version: "1" +Description: + "An observational study design's sampling method must be specified according to the extensible Observational Study Sampling Method (C127260) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C127260 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: samplingMethod.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: samplingMethod.code - version: samplingMethod.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: samplingMethod.code - version: samplingMethod.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: samplingMethod.decode - version: samplingMethod.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: samplingMethod.decode - version: samplingMethod.codeSystemVersion + - id: $codelist_code + map: + - output: C127260 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: samplingMethod.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: samplingMethod.code + version: samplingMethod.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: samplingMethod.code + version: samplingMethod.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: samplingMethod.decode + version: samplingMethod.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: samplingMethod.decode + version: samplingMethod.codeSystemVersion Outcome: - Message: 'The observational study design''s sampling method is not specified according to the extensible + Message: + 'The observational study design''s sampling method is not specified according to the extensible Observational Study Sampling Method (C127260) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - samplingMethod.code - - $code_for_decode_value - - $code_for_decode_pref_term - - samplingMethod.codeSystem - - samplingMethod.codeSystemVersion - - samplingMethod.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - samplingMethod.code + - $code_for_decode_value + - $code_for_decode_pref_term + - samplingMethod.codeSystem + - samplingMethod.codeSystemVersion + - samplingMethod.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001057/rule.yml b/Published/CORE-001057/rule.yml index f77ed9069..3e035da80 100644 --- a/Published/CORE-001057/rule.yml +++ b/Published/CORE-001057/rule.yml @@ -1,162 +1,165 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "An observational study design's sub types must be specified according to the - extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code - or decode used from the codelist should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00226' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An observational study design's sub types must be specified according to the + extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code + or decode used from the codelist should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00226" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: subTypes - operator: exists - - name: subTypes - operator: equal_to - value: true - - name: parent_rel.Code - operator: equal_to - value: 'subTypes' - value_is_literal: true - - not: - all: - - name: codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: subTypes + operator: exists + - name: subTypes + operator: equal_to + value: true + - name: parent_rel.Code + operator: equal_to + value: "subTypes" + value_is_literal: true + - not: + all: + - name: codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code - operator: equal_to - value: $code_for_decode_pref_term - - name: code - operator: equal_to - value: $code_for_decode_value - - any: - - name: decode - operator: equal_to - value: $pref_term_for_code - - name: decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code + operator: equal_to + value: $code_for_decode_pref_term + - name: code + operator: equal_to + value: $code_for_decode_value + - any: + - name: decode + operator: equal_to + value: $pref_term_for_code + - name: decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-001057' + Id: "CORE-001057" Status: Published - Version: '1' -Description: "An observational study design's sub types must be specified according to the extensible + Version: "1" +Description: + "An observational study design's sub types must be specified according to the extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Match Datasets: -- Keys: - - Left: instanceType - Right: parent_entity - - Left: id - Right: parent_id - - rel_type - Name: Code + - Keys: + - Left: instanceType + Right: parent_entity + - Left: id + Right: parent_id + - rel_type + Name: Code Operations: -- id: $codelist_code - map: - - output: C215486 - parent_rel.Code: 'subTypes' - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: decode - version: codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: decode - version: codeSystemVersion + - id: $codelist_code + map: + - output: C215486 + parent_rel.Code: "subTypes" + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: decode + version: codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: decode + version: codeSystemVersion Outcome: - Message: 'The observational study design''s sub type is not specified according to the extensible observational + Message: + 'The observational study design''s sub type is not specified according to the extensible observational study design subtype (C215486) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - code - - $code_for_decode_value - - $code_for_decode_pref_term - - codeSystem - - codeSystemVersion - - decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - code + - $code_for_decode_value + - $code_for_decode_pref_term + - codeSystem + - codeSystemVersion + - decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'ObservationalStudyDesign' + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001058/rule.yml b/Published/CORE-001058/rule.yml index 96f4d3474..99fa4b66d 100644 --- a/Published/CORE-001058/rule.yml +++ b/Published/CORE-001058/rule.yml @@ -1,150 +1,153 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study design's study phase must be specified according to the extensible Trial - Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist - should be consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00229' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's study phase must be specified according to the extensible Trial + Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist + should be consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00229" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyPhase.standardCode - operator: exists - - name: studyPhase.standardCode - operator: equal_to - value: true - - not: - all: - - name: studyPhase.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyPhase.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: studyPhase.standardCode + operator: exists + - name: studyPhase.standardCode + operator: equal_to + value: true + - not: + all: + - name: studyPhase.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: studyPhase.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyPhase.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyPhase.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: studyPhase.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyPhase.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyPhase.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: studyPhase.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-001058' + Id: "CORE-001058" Status: Published - Version: '1' -Description: "A study design's study phase must be specified according to the extensible Trial Phase Response + Version: "1" +Description: + "A study design's study phase must be specified according to the extensible Trial Phase Response (C66737) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C66737 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyPhase.standardCode.code - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyPhase.standardCode.decode - version: studyPhase.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C66737 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyPhase.standardCode.code + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyPhase.standardCode.decode + version: studyPhase.standardCode.codeSystemVersion Outcome: - Message: 'The study design''s study phase is not specified according to the extensible Trial Phase Response + Message: + 'The study design''s study phase is not specified according to the extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - studyPhase.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyPhase.standardCode.codeSystem - - studyPhase.standardCode.codeSystemVersion - - studyPhase.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - studyPhase.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyPhase.standardCode.codeSystem + - studyPhase.standardCode.codeSystemVersion + - studyPhase.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001059/rule.yml b/Published/CORE-001059/rule.yml index 764550b06..383cee9a7 100644 --- a/Published/CORE-001059/rule.yml +++ b/Published/CORE-001059/rule.yml @@ -1,146 +1,149 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A study design''s study type must be specified using the Study Type Response - (C99077) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00230' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study design's study type must be specified using the Study Type Response + (C99077) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00230" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: studyType - operator: equal_to - value: true - - not: - all: - - name: studyType.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: studyType.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: studyType.code - operator: equal_to - value: $code_for_decode_pref_term - - name: studyType.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: studyType.decode - operator: equal_to - value: $pref_term_for_code - - name: studyType.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: studyType + operator: equal_to + value: true + - not: + all: + - name: studyType.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: studyType.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: studyType.code + operator: equal_to + value: $code_for_decode_pref_term + - name: studyType.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: studyType.decode + operator: equal_to + value: $pref_term_for_code + - name: studyType.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-001059' + Id: "CORE-001059" Status: Published - Version: '1' -Description: 'A study design''s study type must be specified using the Study Type Response (C99077) SDTM - codelist.' + Version: "1" +Description: + "A study design's study type must be specified using the Study Type Response (C99077) SDTM + codelist." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C99077 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: studyType.code - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: studyType.code - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: studyType.decode - version: studyType.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: studyType.decode - version: studyType.codeSystemVersion + - id: $codelist_code + map: + - output: C99077 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: studyType.code + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: studyType.code + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: studyType.decode + version: studyType.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: studyType.decode + version: studyType.codeSystemVersion Outcome: - Message: 'The study design''s study type is not specified using the Study Type Response (C99077) SDTM + Message: + 'The study design''s study type is not specified using the Study Type Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $codelist_code - - $codelist_extensible - - studyType.code - - $code_for_decode_value - - $code_for_decode_pref_term - - studyType.codeSystem - - studyType.codeSystemVersion - - studyType.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $codelist_code + - $codelist_extensible + - studyType.code + - $code_for_decode_value + - $code_for_decode_pref_term + - studyType.codeSystem + - studyType.codeSystemVersion + - studyType.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'InterventionalStudyDesign' - - 'ObservationalStudyDesign' + - "InterventionalStudyDesign" + - "ObservationalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001060/rule.yml b/Published/CORE-001060/rule.yml index b9e71929a..7851ccbb8 100644 --- a/Published/CORE-001060/rule.yml +++ b/Published/CORE-001060/rule.yml @@ -1,147 +1,150 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A unit must be coded according to the extensible unit (C71620) SDTM codelist - (e.g. an entry with a code or decode used from the codelist should be consistent with the full - entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00233' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A unit must be coded according to the extensible unit (C71620) SDTM codelist + (e.g. an entry with a code or decode used from the codelist should be consistent with the full + entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00233" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: unit.standardCode - operator: exists - - name: unit.standardCode - operator: equal_to - value: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: unit.standardCode + operator: exists + - name: unit.standardCode + operator: equal_to + value: true + - not: + all: + - name: unit.standardCode.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-001060' + Id: "CORE-001060" Status: Published - Version: '1' -Description: "A unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry + Version: "1" +Description: + "A unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C71620 - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion + - id: $codelist_code + map: + - output: C71620 + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion Outcome: - Message: 'The unit is not coded according to the extensible unit (C71620) SDTM codelist - codeSystem + Message: + 'The unit is not coded according to the extensible unit (C71620) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - value - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - value + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'Quantity' + - "Quantity" Sensitivity: Record diff --git a/Published/CORE-001061/rule.yml b/Published/CORE-001061/rule.yml index 036e6289a..529fe8479 100644 --- a/Published/CORE-001061/rule.yml +++ b/Published/CORE-001061/rule.yml @@ -1,169 +1,172 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The unit of a planned age is expected to be specified using terms from the Age - Unit (C66781) SDTM codelist.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00237' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The unit of a planned age is expected to be specified using terms from the Age + Unit (C66781) SDTM codelist." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00237" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: plannedAge - operator: equal_to - value: true - - name: unit - operator: equal_to - value: true - value_is_literal: true - - not: - all: - - name: unit.standardCode.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: unit.standardCode.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - any: - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty - - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_pref_term - - name: unit.standardCode.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: unit.standardCode.decode - operator: equal_to - value: $pref_term_for_code - - name: unit.standardCode.decode - operator: equal_to - value: $value_for_code - - all: - - name: $codelist_extensible + - name: rel_type + operator: equal_to + value: "definition" + - name: plannedAge + operator: equal_to + value: true + - name: unit + operator: equal_to + value: true + value_is_literal: true + - not: + all: + - name: unit.standardCode.codeSystem operator: equal_to - value: true - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty + value: "http://www.cdisc.org" + - name: unit.standardCode.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - any: + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_pref_term + - name: unit.standardCode.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: unit.standardCode.decode + operator: equal_to + value: $pref_term_for_code + - name: unit.standardCode.decode + operator: equal_to + value: $value_for_code + - all: + - name: $codelist_extensible + operator: equal_to + value: true + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty Core: - Id: 'CORE-001061' + Id: "CORE-001061" Status: Published - Version: '1' -Description: 'The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) - SDTM codelist.' + Version: "1" +Description: + "The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) + SDTM codelist." Executability: Fully Executable Match Datasets: -- Keys: - - Left: plannedAge.instanceType - Right: parent_entity - - Left: plannedAge.id - Right: parent_id - - rel_type - Name: Quantity + - Keys: + - Left: plannedAge.instanceType + Right: parent_entity + - Left: plannedAge.id + Right: parent_id + - rel_type + Name: Quantity Operations: -- id: $codelist_code - map: - - output: C66781 - parent_rel.Quantity: 'minValue' - - output: C66781 - parent_rel.Quantity: 'maxValue' - operator: map -- ct_package_types: - - SDTM - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: unit.standardCode.code - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: unit.standardCode.decode - version: unit.standardCode.codeSystemVersion -- id: $variable_with_issue - map: - - output: 'plannedAge.minValue' - parent_rel.Quantity: 'minValue' - - output: 'plannedAge.maxValue' - parent_rel.Quantity: 'maxValue' - operator: map + - id: $codelist_code + map: + - output: C66781 + parent_rel.Quantity: "minValue" + - output: C66781 + parent_rel.Quantity: "maxValue" + operator: map + - ct_package_types: + - SDTM + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: unit.standardCode.code + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: unit.standardCode.decode + version: unit.standardCode.codeSystemVersion + - id: $variable_with_issue + map: + - output: "plannedAge.minValue" + parent_rel.Quantity: "minValue" + - output: "plannedAge.maxValue" + parent_rel.Quantity: "maxValue" + operator: map Outcome: - Message: 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem + Message: + 'The unit of the planned age is not specified using the Age Unit (C66781) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - $variable_with_issue - - $codelist_code - - $codelist_extensible - - unit.standardCode.code - - $code_for_decode_value - - $code_for_decode_pref_term - - unit.standardCode.codeSystem - - unit.standardCode.codeSystemVersion - - unit.standardCode.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - name + - $variable_with_issue + - $codelist_code + - $codelist_extensible + - unit.standardCode.code + - $code_for_decode_value + - $code_for_decode_pref_term + - unit.standardCode.codeSystem + - unit.standardCode.codeSystemVersion + - unit.standardCode.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyDesignPopulation' - - 'StudyCohort' + - "StudyDesignPopulation" + - "StudyCohort" Sensitivity: Record diff --git a/Published/CORE-001062/rule.yml b/Published/CORE-001062/rule.yml index bdd04f3fd..49fda0849 100644 --- a/Published/CORE-001062/rule.yml +++ b/Published/CORE-001062/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity must only reference child activities that are specified within the - same study design.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00254' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity must only reference child activities that are specified within the + same study design." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00254" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.**.studyDesigns@$s. [ @@ -28,23 +29,25 @@ Check: |- } ] Core: - Id: 'CORE-001062' + Id: "CORE-001062" Status: Published - Version: '1' -Description: 'An activity must only reference child activities that are specified within the same study - design.' + Version: "1" +Description: + "An activity must only reference child activities that are specified within the same study + design." Executability: Fully Executable Outcome: - Message: 'The activity references a childId that does not match the id of any activity defined within - the same study design as the activity.' + Message: + "The activity references a childId that does not match the id of any activity defined within + the same study design as the activity." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - childId + - StudyDesign.id + - StudyDesign.name + - name + - childId Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-001063/rule.yml b/Published/CORE-001063/rule.yml index 8112a2f6f..03078d0e8 100644 --- a/Published/CORE-001063/rule.yml +++ b/Published/CORE-001063/rule.yml @@ -1,149 +1,152 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: "A study role code must be specified according to the extensible study role code - (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be - consistent with the full entry in the codelist)." - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00259' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A study role code must be specified according to the extensible study role code + (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be + consistent with the full entry in the codelist)." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00259" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: code - operator: exists - - name: code - operator: equal_to - value: true - - not: - all: - - name: code.codeSystem - operator: equal_to - value: 'http://www.cdisc.org' - - name: code.codeSystemVersion - operator: is_contained_by - value: $valid_versions - - name: $codelist_extensible - operator: equal_to - value: true - - any: - - all: - - name: $code_for_decode_pref_term - operator: empty - - name: $code_for_decode_value - operator: empty - - name: $pref_term_for_code - operator: empty - - name: $value_for_code - operator: empty - - all: - - name: $pref_term_for_code - operator: non_empty - - name: $value_for_code - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: code + operator: exists + - name: code + operator: equal_to + value: true + - not: + all: + - name: code.codeSystem + operator: equal_to + value: "http://www.cdisc.org" + - name: code.codeSystemVersion + operator: is_contained_by + value: $valid_versions + - name: $codelist_extensible + operator: equal_to + value: true - any: - - name: $code_for_decode_pref_term - operator: non_empty - - name: $code_for_decode_value - operator: non_empty - - any: - - name: code.code - operator: equal_to - value: $code_for_decode_pref_term - - name: code.code - operator: equal_to - value: $code_for_decode_value - - any: - - name: code.decode - operator: equal_to - value: $pref_term_for_code - - name: code.decode - operator: equal_to - value: $value_for_code + - all: + - name: $code_for_decode_pref_term + operator: empty + - name: $code_for_decode_value + operator: empty + - name: $pref_term_for_code + operator: empty + - name: $value_for_code + operator: empty + - all: + - name: $pref_term_for_code + operator: non_empty + - name: $value_for_code + operator: non_empty + - any: + - name: $code_for_decode_pref_term + operator: non_empty + - name: $code_for_decode_value + operator: non_empty + - any: + - name: code.code + operator: equal_to + value: $code_for_decode_pref_term + - name: code.code + operator: equal_to + value: $code_for_decode_value + - any: + - name: code.decode + operator: equal_to + value: $pref_term_for_code + - name: code.decode + operator: equal_to + value: $value_for_code Core: - Id: 'CORE-001063' + Id: "CORE-001063" Status: Published - Version: '1' -Description: "A study role code must be specified according to the extensible study role code (C215480) + Version: "1" +Description: + "A study role code must be specified according to the extensible study role code (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist)." Executability: Fully Executable Operations: -- id: $codelist_code - map: - - output: C215480 - operator: map -- ct_package_types: - - DDF - id: $valid_versions - operator: valid_codelist_dates -- codelist_code: $codelist_code - ct_package_type: DDF - id: $codelist_extensible - operator: codelist_extensible - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $value_for_code - operator: codelist_terms - returntype: value - term_code: code.code - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $pref_term_for_code - operator: codelist_terms - returntype: pref_term - term_code: code.code - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_pref_term - operator: codelist_terms - returntype: code - term_pref_term: code.decode - version: code.codeSystemVersion -- codelist_code: $codelist_code - ct_package_type: DDF - id: $code_for_decode_value - operator: codelist_terms - returntype: code - term_value: code.decode - version: code.codeSystemVersion + - id: $codelist_code + map: + - output: C215480 + operator: map + - ct_package_types: + - DDF + id: $valid_versions + operator: valid_codelist_dates + - codelist_code: $codelist_code + ct_package_type: DDF + id: $codelist_extensible + operator: codelist_extensible + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $value_for_code + operator: codelist_terms + returntype: value + term_code: code.code + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $pref_term_for_code + operator: codelist_terms + returntype: pref_term + term_code: code.code + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_pref_term + operator: codelist_terms + returntype: code + term_pref_term: code.decode + version: code.codeSystemVersion + - codelist_code: $codelist_code + ct_package_type: DDF + id: $code_for_decode_value + operator: codelist_terms + returntype: code + term_value: code.decode + version: code.codeSystemVersion Outcome: - Message: 'The study role code is not specified using to the extensible study role code (C215480) DDF + Message: + 'The study role code is not specified using to the extensible study role code (C215480) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).' Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - description - - $codelist_code - - $codelist_extensible - - code.code - - $code_for_decode_value - - $code_for_decode_pref_term - - code.codeSystem - - code.codeSystemVersion - - code.decode - - $value_for_code - - $pref_term_for_code + - parent_entity + - parent_id + - parent_rel + - id + - description + - $codelist_code + - $codelist_extensible + - code.code + - $code_for_decode_value + - $code_for_decode_pref_term + - code.codeSystem + - code.codeSystemVersion + - code.decode + - $value_for_code + - $pref_term_for_code Rule Type: Record Data Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-001065/rule.yml b/Published/CORE-001065/rule.yml index a87211e53..baf28fb1a 100644 --- a/Published/CORE-001065/rule.yml +++ b/Published/CORE-001065/rule.yml @@ -1,30 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if study type is Interventional then at least one intervention - is expected to be referenced from a procedure.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00101' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Within a study design, if study type is Interventional then at least one intervention - is expected to be referenced from a procedure.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00101' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if study type is Interventional then at least one intervention + is expected to be referenced from a procedure." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00101" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Within a study design, if study type is Interventional then at least one intervention + is expected to be referenced from a procedure." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00101" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sv. ($sv.studyDesigns[$not("studyType" in $keys($)) or studyType.code = "C98388"])@$sd. @@ -44,24 +46,26 @@ Check: |- ) }[`# Referenced Study Interventions` < 1][] Core: - Id: 'CORE-001065' + Id: "CORE-001065" Status: Published - Version: '1' -Description: 'Within a study design, if study type is Interventional then at least one intervention is - expected to be referenced from a procedure.' + Version: "1" +Description: + "Within a study design, if study type is Interventional then at least one intervention is + expected to be referenced from a procedure." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study type is Interventional (code=C98388) but a study intervention is not referenced - from any procedure.' + Message: + "The study type is Interventional (code=C98388) but a study intervention is not referenced + from any procedure." Output Variables: - - name - - studyType.code - - studyType.decode - - '# Referenced Study Interventions' + - name + - studyType.code + - studyType.decode + - "# Referenced Study Interventions" Rule Type: JSONata Scope: Entities: Include: - - 'StudyDesign' - - 'InterventionalStudyDesign' + - "StudyDesign" + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001066/rule.yml b/Published/CORE-001066/rule.yml index 6b56838f5..6a896d930 100644 --- a/Published/CORE-001066/rule.yml +++ b/Published/CORE-001066/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The ordering of activities (using the previous and next attributes) must include - the parents (e.g. activities referring to children) preceding their children.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00161' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The ordering of activities (using the previous and next attributes) must include + the parents (e.g. activities referring to children) preceding their children." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00161" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions.studyDesigns@$sd. $sd.activities@$a. @@ -51,31 +52,33 @@ Check: |- } )[`Issue(s)`] Core: - Id: 'CORE-001066' + Id: "CORE-001066" Status: Published - Version: '1' -Description: 'The ordering of activities (using the previous and next attributes) must include the parents - (e.g. activities referring to children) preceding their children.' + Version: "1" +Description: + "The ordering of activities (using the previous and next attributes) must include the parents + (e.g. activities referring to children) preceding their children." Executability: Fully Executable Outcome: - Message: "The previous/next ordering of the activity with respect to child activities is incorrect - + Message: + "The previous/next ordering of the activity with respect to child activities is incorrect - the activity has children but its nextId is not one if its childIds, the activity is a child but its previousId is not its parent or another descendant of its parent, and/or the activity's previousId refers to an activity with children but the activity is not one of those children." Output Variables: - - StudyDesign.id - - StudyDesign.name - - name - - previousId - - "Previous Activity's childIds" - - nextId - - childIds - - "Parent Activity's id" - - "Parent Activity's other descendants' ids" - - "Issue(s)" + - StudyDesign.id + - StudyDesign.name + - name + - previousId + - "Previous Activity's childIds" + - nextId + - childIds + - "Parent Activity's id" + - "Parent Activity's other descendants' ids" + - "Issue(s)" Rule Type: JSONata Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-001067/rule.yml b/Published/CORE-001067/rule.yml index 74cc8e0e2..9ef2219f1 100644 --- a/Published/CORE-001067/rule.yml +++ b/Published/CORE-001067/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'The expanded text for all abbreviations defined for a study version are expected - to be unique.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00171' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "The expanded text for all abbreviations defined for a study version are expected + to be unique." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00171" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- study.versions@$sv. ( @@ -31,21 +32,21 @@ Check: |- "expandedText": expandedText } Core: - Id: 'CORE-001067' + Id: "CORE-001067" Status: Published - Version: '1' -Description: 'The expanded text for all abbreviations defined for a study version are expected to be unique.' + Version: "1" +Description: "The expanded text for all abbreviations defined for a study version are expected to be unique." Executability: Partially Executable - Possible Overreporting Outcome: Message: "The abbreviation's expanded text is not unique within the study version (case insensitive)." Output Variables: - - StudyVersion.id - - StudyVersion.versionIdentifier - - abbreviatedText - - expandedText + - StudyVersion.id + - StudyVersion.versionIdentifier + - abbreviatedText + - expandedText Rule Type: JSONata Scope: Entities: Include: - - 'Abbreviation' + - "Abbreviation" Sensitivity: Record diff --git a/Published/CORE-001068/rule.yml b/Published/CORE-001068/rule.yml index c85dbffa4..a40ab078a 100644 --- a/Published/CORE-001068/rule.yml +++ b/Published/CORE-001068/rule.yml @@ -1,83 +1,86 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Date values associated to a study definition document version must be unique - regarding the combination of type and geographic scopes of the date.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00181' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Date values associated to a study definition document version must be unique + regarding the combination of type and geographic scopes of the date." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00181" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: instanceType - operator: equal_to - value: 'StudyDefinitionDocumentVersion' - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - all: - - name: code.standardCode.code - operator: exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope - - code.standardCode.code - - all: - - name: code.standardCode.code - operator: not_exists - - name: id - operator: is_not_unique_set - value: - - type.code - - type.code.GeographicScope + - name: instanceType + operator: equal_to + value: "StudyDefinitionDocumentVersion" + - name: rel_type + operator: equal_to + value: "definition" + - any: + - all: + - name: code.standardCode.code + operator: exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope + - code.standardCode.code + - all: + - name: code.standardCode.code + operator: not_exists + - name: id + operator: is_not_unique_set + value: + - type.code + - type.code.GeographicScope Core: - Id: 'CORE-001068' + Id: "CORE-001068" Status: Published - Version: '1' -Description: 'Date values associated to a study definition document version must be unique regarding the - combination of type and geographic scopes of the date.' + Version: "1" +Description: + "Date values associated to a study definition document version must be unique regarding the + combination of type and geographic scopes of the date." Executability: Fully Executable Match Datasets: -- Keys: - - Left: id - Right: parent_id - - rel_type - Name: GovernanceDate -- Keys: - - Left: id.GovernanceDate - Right: parent_id - - rel_type - Name: GeographicScope + - Keys: + - Left: id + Right: parent_id + - rel_type + Name: GovernanceDate + - Keys: + - Left: id.GovernanceDate + Right: parent_id + - rel_type + Name: GeographicScope Outcome: - Message: 'The study definition document version has more than one governance date with the same type - and geographic scope.' + Message: + "The study definition document version has more than one governance date with the same type + and geographic scope." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - version - - id.GovernanceDate - - name - - type.code - - type.decode - - type.code.GeographicScope - - type.decode.GeographicScope - - code.standardCode.code - - code.standardCode.decode - - dateValue + - parent_entity + - parent_id + - parent_rel + - id + - version + - id.GovernanceDate + - name + - type.code + - type.decode + - type.code.GeographicScope + - type.decode.GeographicScope + - code.standardCode.code + - code.standardCode.decode + - dateValue Rule Type: Record Data Scope: Entities: Include: - - 'StudyDefinitionDocumentVersion' + - "StudyDefinitionDocumentVersion" Sensitivity: Record diff --git a/Published/CORE-001069/rule.yml b/Published/CORE-001069/rule.yml index 84eaedad9..d9b2a9ad5 100644 --- a/Published/CORE-001069/rule.yml +++ b/Published/CORE-001069/rule.yml @@ -1,46 +1,46 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Narrative content item text is expected to be HTML formatted.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00187' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Narrative content item text is expected to be HTML formatted." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00187" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - name: $xhtml_errors - operator: non_empty + - name: rel_type + operator: equal_to + value: "definition" + - name: $xhtml_errors + operator: non_empty Core: - Id: 'CORE-001069' + Id: "CORE-001069" Status: Published - Version: '1' -Description: 'Narrative content item text is expected to be HTML formatted.' + Version: "1" +Description: "Narrative content item text is expected to be HTML formatted." Executability: Partially Executable - Possible Overreporting Operations: -- id: $xhtml_errors - name: text - namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 - operator: get_xhtml_errors + - id: $xhtml_errors + name: text + namespace: http://www.cdisc.org/ns/usdm/xhtml/v1.0 + operator: get_xhtml_errors Outcome: - Message: 'The narrative content item text contains non-conformant XHTML.' + Message: "The narrative content item text contains non-conformant XHTML." Output Variables: - - parent_entity - - parent_id - - parent_rel - - name - - $xhtml_errors + - parent_entity + - parent_id + - parent_rel + - name + - $xhtml_errors Rule Type: Record Data Scope: Entities: Include: - - 'NarrativeContentItem' + - "NarrativeContentItem" Sensitivity: Record diff --git a/Published/CORE-001070/rule.yml b/Published/CORE-001070/rule.yml index 6506b690c..8fec97792 100644 --- a/Published/CORE-001070/rule.yml +++ b/Published/CORE-001070/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is not expected to be defined for any study role in a study design - with an open label blinding schema.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00191' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A masking is not expected to be defined for any study role in a study design + with an open label blinding schema." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00191" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- $.study.versions@$sv. [ @@ -39,26 +40,28 @@ Check: |- } ] Core: - Id: 'CORE-001070' + Id: "CORE-001070" Status: Published - Version: '1' -Description: 'A masking is not expected to be defined for any study role in a study design with an open - label blinding schema.' + Version: "1" +Description: + "A masking is not expected to be defined for any study role in a study design with an open + label blinding schema." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'A masking is defined for the study role, but the role applies to a study design with an open - label blinding schema.' + Message: + "A masking is defined for the study role, but the role applies to a study design with an open + label blinding schema." Output Variables: - - name - - code - - masking.text - - masking.isMasked - - appliesToIds - - StudyDesign.id - - StudyDesign.blindingSchema + - name + - code + - masking.text + - masking.isMasked + - appliesToIds + - StudyDesign.id + - StudyDesign.blindingSchema Rule Type: JSONata Scope: Entities: Include: - - 'StudyRole' + - "StudyRole" Sensitivity: Record diff --git a/Published/CORE-001071/rule.yml b/Published/CORE-001071/rule.yml index 4daabdb9e..8fd76f156 100644 --- a/Published/CORE-001071/rule.yml +++ b/Published/CORE-001071/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is expected to be defined for at least two study roles in a study design - with a double blind blinding schema.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00192' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A masking is expected to be defined for at least two study roles in a study design + with a double blind blinding schema." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00192" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd @@ -47,24 +48,26 @@ Check: |- ) ][`# Masked Roles` < 2] Core: - Id: 'CORE-001071' + Id: "CORE-001071" Status: Published - Version: '1' -Description: 'A masking is expected to be defined for at least two study roles in a study design with - a double blind blinding schema.' + Version: "1" +Description: + "A masking is expected to be defined for at least two study roles in a study design with + a double blind blinding schema." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has a double blind blinding schema (code=C15228) but there are not at least - two applicable study roles that are masked.' + Message: + "The study design has a double blind blinding schema (code=C15228) but there are not at least + two applicable study roles that are masked." Output Variables: - - name - - blindingSchema.code - - blindingSchema.decode - - "# Masked Roles" - - "Applicable Roles" + - name + - blindingSchema.code + - blindingSchema.decode + - "# Masked Roles" + - "Applicable Roles" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001072/rule.yml b/Published/CORE-001072/rule.yml index 6903ba3fd..23f6f1aad 100644 --- a/Published/CORE-001072/rule.yml +++ b/Published/CORE-001072/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'A masking is expected to be defined for at least one study role in a study design - with a blinding schema that is not open label or double blind.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00193' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "A masking is expected to be defined for at least one study role in a study design + with a blinding schema that is not open label or double blind." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00193" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. ($sv.studyDesigns)@$sd @@ -48,24 +49,26 @@ Check: |- ) ][`# Masked Roles` < 1] Core: - Id: 'CORE-001072' + Id: "CORE-001072" Status: Published - Version: '1' -Description: 'A masking is expected to be defined for at least one study role in a study design with a - blinding schema that is not open label or double blind.' + Version: "1" +Description: + "A masking is expected to be defined for at least one study role in a study design with a + blinding schema that is not open label or double blind." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The study design has a blinding schema that is not open label or double blind (code is not - C49659 or C15228) but there is no applicable study role that is masked.' + Message: + "The study design has a blinding schema that is not open label or double blind (code is not + C49659 or C15228) but there is no applicable study role that is masked." Output Variables: - - name - - blindingSchema.code - - blindingSchema.decode - - "# Masked Roles" - - "Applicable Roles" + - name + - blindingSchema.code + - blindingSchema.decode + - "# Masked Roles" + - "Applicable Roles" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Published/CORE-001073/rule.yml b/Published/CORE-001073/rule.yml index fba0dec44..277a48ce1 100644 --- a/Published/CORE-001073/rule.yml +++ b/Published/CORE-001073/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced items in the narrative content item texts must be available elsewhere - in the data model.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00244' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Referenced items in the narrative content item texts must be available elsewhere + in the data model." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00244" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $lkp:=**[id and instanceType].$each(function($v,$k){{$join([instanceType,id,$k],"|"):$v}})~>$merge; @@ -58,20 +59,21 @@ Check: |- ) ) Core: - Id: 'CORE-001073' + Id: "CORE-001073" Status: Published - Version: '1' -Description: 'Referenced items in the narrative content item texts must be available elsewhere in the - data model.' + Version: "1" +Description: + "Referenced items in the narrative content item texts must be available elsewhere in the + data model." Executability: Fully Executable Outcome: - Message: 'The item referenced in the narrative content item text is not available elsewhere in the model.' + Message: "The item referenced in the narrative content item text is not available elsewhere in the model." Output Variables: - - name - - 'Invalid Reference' + - name + - "Invalid Reference" Rule Type: JSONata Scope: Entities: Include: - - 'NarrativeContentItem' + - "NarrativeContentItem" Sensitivity: Record diff --git a/Published/CORE-001074/rule.yml b/Published/CORE-001074/rule.yml index 098ef4696..823b523b7 100644 --- a/Published/CORE-001074/rule.yml +++ b/Published/CORE-001074/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Any parameter name referenced in a tag in the text should be specified in the - data dictionary parameter maps.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00246' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Any parameter name referenced in a tag in the text should be specified in the + data dictionary parameter maps." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00246" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- **.study.versions@$sv. ($sv.**[$type(text)="string" and $contains(text,/usdm:tag/)])@$st. @@ -45,31 +46,33 @@ Check: |- } ) Core: - Id: 'CORE-001074' + Id: "CORE-001074" Status: Published - Version: '1' -Description: 'Any parameter name referenced in a tag in the text should be specified in the data dictionary - parameter maps.' + Version: "1" +Description: + "Any parameter name referenced in a tag in the text should be specified in the data dictionary + parameter maps." Executability: Fully Executable Outcome: - Message: "The parameter name referenced in the text is not specified in the data dictionary parameter + Message: + "The parameter name referenced in the text is not specified in the data dictionary parameter map - the dictionaryId is missing or invalid, or the parameter name does not match a tag in any of the dictionary's parameter maps." Output Variables: - - name - - Parameter reference - - Parameter name - - dictionaryId - - SyntaxTemplateDictionary.name - - Issue + - name + - Parameter reference + - Parameter name + - dictionaryId + - SyntaxTemplateDictionary.name + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'EligibilityCriterionItem' - - 'Characteristic' - - 'Condition' - - 'Objective' - - 'Endpoint' - - 'IntercurrentEvent' + - "EligibilityCriterionItem" + - "Characteristic" + - "Condition" + - "Objective" + - "Endpoint" + - "IntercurrentEvent" Sensitivity: Record diff --git a/Published/CORE-001075/rule.yml b/Published/CORE-001075/rule.yml index e19a44372..6d1716114 100644 --- a/Published/CORE-001075/rule.yml +++ b/Published/CORE-001075/rule.yml @@ -1,17 +1,17 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Id values are expected not to have spaces in their string values.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00260' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "Id values are expected not to have spaces in their string values." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00260" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- (**[$contains($string(id)," ")])@$i. { @@ -21,18 +21,18 @@ Check: |- "name": $i.name } Core: - Id: 'CORE-001075' + Id: "CORE-001075" Status: Published - Version: '1' -Description: 'Id values are expected not to have spaces in their string values.' + Version: "1" +Description: "Id values are expected not to have spaces in their string values." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The id value contains a space.' + Message: "The id value contains a space." Output Variables: - - name + - name Rule Type: JSONata Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Published/CORE-001076/rule.yml b/Published/CORE-001076/rule.yml index aead92921..713801a0d 100644 --- a/Published/CORE-001076/rule.yml +++ b/Published/CORE-001076/rule.yml @@ -1,93 +1,96 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'An activity is expected to refer to at least one procedure, biomedical concept, - biomedical concept category, biomedical concept surrogate, child activity, or timeline.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00263' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "An activity is expected to refer to at least one procedure, biomedical concept, + biomedical concept category, biomedical concept surrogate, child activity, or timeline." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00263" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - name: rel_type - operator: equal_to - value: 'definition' - - any: - - name: definedProcedures - operator: not_exists - - name: definedProcedures - operator: empty - - name: definedProcedures + - name: rel_type operator: equal_to - value: false - - any: - - name: biomedicalConceptIds - operator: not_exists - - name: biomedicalConceptIds - operator: empty - - name: biomedicalConceptIds - operator: equal_to - value: false - - any: - - name: bcCategoryIds - operator: not_exists - - name: bcCategoryIds - operator: empty - - name: bcCategoryIds - operator: equal_to - value: false - - any: - - name: bcSurrogateIds - operator: not_exists - - name: bcSurrogateIds - operator: empty - - name: bcSurrogateIds - operator: equal_to - value: false - - any: - - name: childIds - operator: not_exists - - name: childIds - operator: empty - - name: childIds - operator: equal_to - value: false - - any: - - name: timelineId - operator: not_exists - - name: timelineId - operator: empty + value: "definition" + - any: + - name: definedProcedures + operator: not_exists + - name: definedProcedures + operator: empty + - name: definedProcedures + operator: equal_to + value: false + - any: + - name: biomedicalConceptIds + operator: not_exists + - name: biomedicalConceptIds + operator: empty + - name: biomedicalConceptIds + operator: equal_to + value: false + - any: + - name: bcCategoryIds + operator: not_exists + - name: bcCategoryIds + operator: empty + - name: bcCategoryIds + operator: equal_to + value: false + - any: + - name: bcSurrogateIds + operator: not_exists + - name: bcSurrogateIds + operator: empty + - name: bcSurrogateIds + operator: equal_to + value: false + - any: + - name: childIds + operator: not_exists + - name: childIds + operator: empty + - name: childIds + operator: equal_to + value: false + - any: + - name: timelineId + operator: not_exists + - name: timelineId + operator: empty Core: - Id: 'CORE-001076' + Id: "CORE-001076" Status: Published - Version: '1' -Description: 'An activity is expected to refer to at least one procedure, biomedical concept, biomedical - concept category, biomedical concept surrogate, child activity, or timeline.' + Version: "1" +Description: + "An activity is expected to refer to at least one procedure, biomedical concept, biomedical + concept category, biomedical concept surrogate, child activity, or timeline." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The activity does not refer to any procedure, biomedical concept, biomedical concept category, - biomedical concept surrogate, child activity, or timeline.' + Message: + "The activity does not refer to any procedure, biomedical concept, biomedical concept category, + biomedical concept surrogate, child activity, or timeline." Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name - - definedProcedures - - biomedicalConceptIds - - bcCategoryIds - - bcSurrogateIds - - childIds - - timelineId + - parent_entity + - parent_id + - parent_rel + - id + - name + - definedProcedures + - biomedicalConceptIds + - bcCategoryIds + - bcSurrogateIds + - childIds + - timelineId Rule Type: Record Data Scope: Entities: Include: - - 'Activity' + - "Activity" Sensitivity: Record diff --git a/Published/CORE-001077/rule.yml b/Published/CORE-001077/rule.yml index 115a0facb..bf6663f76 100644 --- a/Published/CORE-001077/rule.yml +++ b/Published/CORE-001077/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'If an interventional model indicates a cross-over, parallel or factorial design - then more than 1 intervention is expected.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00213' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "If an interventional model indicates a cross-over, parallel or factorial design + then more than 1 intervention is expected." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00213" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ($.study.versions)@$sv. ($sv.studyDesigns[studyType.code = "C98388"])@$sd. @@ -31,27 +32,29 @@ Check: |- (`model.code` in ["C82637","C82639","C82638"] and `# Referenced Study Interventions` <= 1) ] Core: - Id: 'CORE-001077' + Id: "CORE-001077" Status: Published - Version: '1' -Description: 'If an interventional model indicates a cross-over, parallel or factorial design then more - than 1 intervention is expected.' + Version: "1" +Description: + "If an interventional model indicates a cross-over, parallel or factorial design then more + than 1 intervention is expected." Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'The number of study interventions referenced for the interventional study design is not consistent + Message: + "The number of study interventions referenced for the interventional study design is not consistent with intervention model specified for the study design - the model indicates a cross-over, parallel or factorial design (model.code is C82637, C82639, or C82638) and there are not references to multiple - study interventions.' + study interventions." Output Variables: - - name - - studyType.code - - studyType.decode - - model.code - - model.decode - - '# Referenced Study Interventions' + - name + - studyType.code + - studyType.decode + - model.code + - model.decode + - "# Referenced Study Interventions" Rule Type: JSONata Scope: Entities: Include: - - 'InterventionalStudyDesign' + - "InterventionalStudyDesign" Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0005/rule.yml b/Unpublished/ADAMIG/AD0005/rule.yml index 7f10a19e8..30f21b7ca 100644 --- a/Unpublished/ADAMIG/AD0005/rule.yml +++ b/Unpublished/ADAMIG/AD0005/rule.yml @@ -1,141 +1,141 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.3 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.2 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.3 + Item: "4" + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.3 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "5" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.2 + Item: "4" + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.2 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "5" + Version: "5.0" + Version: "1.2" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.1 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.1 + Item: "4" + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.1 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "5" + Version: "5.0" + Version: "1.1" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables':' N = - no (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: 3.1.4 - - Cited Guidance: >- - ' For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. ' - Document: ADaM IG v1.0 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '5' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables':' N = + no (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: "4" + Section: 3.1.4 + - Cited Guidance: >- + ' For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. ' + Document: ADaM IG v1.0 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "5" + Version: "5.0" + Version: "1.0" Check: all: #- name: variable_name # operator: ends_with # value: 'FL' # - name: #*FL like --FL - - operator: is_not_contained_by - value: - - Y - - N - - '' - #- name: CRIT1FL #*FL like --FL + - operator: is_not_contained_by + value: + - Y + - N + - "" + #- name: CRIT1FL #*FL like --FL # operator: non_empty Core: Id: CDISC.ADaMIG.AD0005 Status: Draft - Version: '1' + Version: "1" Description: A variable with a suffix of FL must have a value Y, N or null Executability: Fully Executable @@ -148,16 +148,16 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - ADAM OTHER - - BASIC DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - BASIC DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0006/rule.yml b/Unpublished/ADAMIG/AD0006/rule.yml index fa396af78..048205224 100644 --- a/Unpublished/ADAMIG/AD0006/rule.yml +++ b/Unpublished/ADAMIG/AD0006/rule.yml @@ -1,148 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.3 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.3 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.3 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "6" + Version: "5.0" + Version: "1.3" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.2 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.1 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables: 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.0 - Item: 5 (General Flag Variable Conventions) - Section: '3' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: 9 (General Flag Variable Conventions) - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '6' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.2 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.2 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "6" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.1 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.1 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "6" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables: 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.0 + Item: 5 (General Flag Variable Conventions) + Section: "3" + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: 9 (General Flag Variable Conventions) + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "6" + Version: "5.0" + Version: "1.0" Check: all: - - name: -- 'FN' - operator: exists - - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 - operator: exists - - name: --'FN' - operator: non_empty - - name: --'FN' - operator: does_not_contain - value: (0,1) + - name: -- 'FN' + operator: exists + - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 + operator: exists + - name: --'FN' + operator: non_empty + - name: --'FN' + operator: does_not_contain + value: (0,1) Core: Id: CDISC.ADaMIG.AD0006 Status: Draft - Version: '1' + Version: "1" Description: >- 'A variable with a suffix of FN must have a value that is not 0, 1 or null' Executability: Fully Executable Outcome: Message: Variable with a suffix of FN does must have the value Y, N or null Output Variables: - - --FL - - --FN + - --FL + - --FN Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0007/rule.yml b/Unpublished/ADAMIG/AD0007/rule.yml index 1f6bd016f..38f2c0818 100644 --- a/Unpublished/ADAMIG/AD0007/rule.yml +++ b/Unpublished/ADAMIG/AD0007/rule.yml @@ -1,148 +1,148 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.3 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.3 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.3 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.3 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "7" + Version: "5.0" + Version: "1.3" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.2 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.2 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables':'' 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.1 - Item: '5' - Section: 3.1.4 - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.1 - Item: '9' - Section: 3.1.4 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level numeric population flag variables: 0 = no - (not included), 1 = yes (included). Null values are not - allowed. - Document: ADaM IG v1.0 - Item: 5 (General Flag Variable Conventions) - Section: '3' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: 9 (General Flag Variable Conventions) - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '7' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.2 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.2 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "7" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables':'' 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.1 + Item: "5" + Section: 3.1.4 + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.1 + Item: "9" + Section: 3.1.4 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "7" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level numeric population flag variables: 0 = no + (not included), 1 = yes (included). Null values are not + allowed. + Document: ADaM IG v1.0 + Item: 5 (General Flag Variable Conventions) + Section: "3" + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: 9 (General Flag Variable Conventions) + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "7" + Version: "5.0" + Version: "1.0" Check: all: - - name: -- 'FN' - operator: exists - - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 - operator: exists - - name: --'FN' - operator: non_empty - - name: --'FN' - operator: does_not_contain - value: (0,1) + - name: -- 'FN' + operator: exists + - name: ROOT(N)||'FL' # where ROOT(--FN) is  N characters up to LENGTH(--FN)-2 + operator: exists + - name: --'FN' + operator: non_empty + - name: --'FN' + operator: does_not_contain + value: (0,1) Core: Id: CDISC.ADaMIG.AD0007 Status: Draft - Version: '1' + Version: "1" Description: >- 'A variable with a suffix of FN must have a value that is not 0, 1 or null' Executability: Fully Executable Outcome: Message: Variable with a suffix of FN does must have the value Y, N or null Output Variables: - - --FL - - --FN + - --FL + - --FN Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0010/rule.yml b/Unpublished/ADAMIG/AD0010/rule.yml index a6d9ca2f5..4dbfcfc3b 100644 --- a/Unpublished/ADAMIG/AD0010/rule.yml +++ b/Unpublished/ADAMIG/AD0010/rule.yml @@ -1,152 +1,153 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Tables 3.3.4.3.1 and - 3.3.8.1, some common character flags use the scheme Y/null. - The choice of Y/N/null vs Y/null is dependent on analysis - needs. Y/N/null should be used when N and null values need to - be analyzed differently. Y/null can be used when the need is - to analyze just the Y values. Corresponding 1/0/null and - 1/null schemes apply to numeric flags with variable names that - end in FN and which are not population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables: N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4' - Section: '3.1.4' - - Cited Guidance: >- - For character flags with variable names that end in FL and - that are not population flags, a scheme of Y/N/null, or Y/null - may be specified. As indicated in Table 3.3.4.2, and Table - 3.3.8.1, some common character flags use the scheme Y/null. - Corresponding 1/0/null and 1/null schemes apply to numeric - flags with variable names that end in FN and that are not - population indicators. - Document: ADaM IG v1.0 - Item: '9' - Section: '3.1.4' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - For subject-level character population flag variables:N = no - (not included in the population), Y = yes (included). Null - values are not allowed. - Document: ADaM IG v1.0 - Item: '4 (General Flag Variable Conventions):' - Section: '3' - - Cited Guidance: >- - For subject-level character For character flags that are not - population flags, a scheme of Y/N/null, or Y/null may be - specified. As indicated in Table 3.2.6.1, some common - character flags use the scheme Y/null. Corresponding 1/0/null - and 1/null schemes apply to numeric flags that are not - population indicators. - Document: ADaM IG v1.0 - Item: '9 (General Flag Variable Conventions):' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '10' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: "4" + Section: "3.1.4" + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.0 + Item: "9" + Section: "3.1.4" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "10" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: "4" + Section: "3.1.4" + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Tables 3.3.4.3.1 and + 3.3.8.1, some common character flags use the scheme Y/null. + The choice of Y/N/null vs Y/null is dependent on analysis + needs. Y/N/null should be used when N and null values need to + be analyzed differently. Y/null can be used when the need is + to analyze just the Y values. Corresponding 1/0/null and + 1/null schemes apply to numeric flags with variable names that + end in FN and which are not population indicators. + Document: ADaM IG v1.0 + Item: "9" + Section: "3.1.4" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "10" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables: N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: "4" + Section: "3.1.4" + - Cited Guidance: >- + For character flags with variable names that end in FL and + that are not population flags, a scheme of Y/N/null, or Y/null + may be specified. As indicated in Table 3.3.4.2, and Table + 3.3.8.1, some common character flags use the scheme Y/null. + Corresponding 1/0/null and 1/null schemes apply to numeric + flags with variable names that end in FN and that are not + population indicators. + Document: ADaM IG v1.0 + Item: "9" + Section: "3.1.4" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "10" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + For subject-level character population flag variables:N = no + (not included in the population), Y = yes (included). Null + values are not allowed. + Document: ADaM IG v1.0 + Item: "4 (General Flag Variable Conventions):" + Section: "3" + - Cited Guidance: >- + For subject-level character For character flags that are not + population flags, a scheme of Y/N/null, or Y/null may be + specified. As indicated in Table 3.2.6.1, some common + character flags use the scheme Y/null. Corresponding 1/0/null + and 1/null schemes apply to numeric flags that are not + population indicators. + Document: ADaM IG v1.0 + Item: "9 (General Flag Variable Conventions):" + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "10" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name - operator: ends_with - value: 'FL' - - name: vatiable_value - operator: equal_to - value: 'Y' - - any: - - all: - - name: Root(variable_name) - operator: ends_with - value: 'FN' - - name: root(variable_value) - operator: not_equal_to - value: '1' - # + - name: variable_name + operator: ends_with + value: "FL" + - name: vatiable_value + operator: equal_to + value: "Y" + - any: + - all: + - name: Root(variable_name) + operator: ends_with + value: "FN" + - name: root(variable_value) + operator: not_equal_to + value: "1" + # Core: Id: CDSIC.ADaMIG.AD0010 Status: Draft - Version: '1' + Version: "1" Description: >- 'A variable with a suffix of FL is equal to Y and a variable with the same root and a suffix of FN is not equal to 1' Executability: Fully Executable Outcome: - Message: A variable with a suffix of FL is equal to Y and a variable with the same root and a + Message: + A variable with a suffix of FL is equal to Y and a variable with the same root and a suffix of FN is not equal to 1 Output Variables: - - variable_name + - variable_name Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0013/rule.yml b/Unpublished/ADAMIG/AD0013/rule.yml index 5c99dd6fa..4dc1de43b 100644 --- a/Unpublished/ADAMIG/AD0013/rule.yml +++ b/Unpublished/ADAMIG/AD0013/rule.yml @@ -1,183 +1,191 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: "1" + Section: 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "13" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "13" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.2 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.2 + Item: "1" + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "13" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "13" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: "1" + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "13" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "13" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all - ADaM variable names must be no more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). - All ADaM variable labels must be no more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions) - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '13' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '13' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length. + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions) + Section: "3" + Criteria: + Logical Expression: + Condition: "" + Rule: "13" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "13" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name - operator: longer_than - value: 8 + - name: variable_name + operator: longer_than + value: 8 Core: Id: CDISC.ADaMIG.AD0013 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: Variable name must be less than 8 charatcters Output Variables: - - variable_name #log a ticket to get schema updated - already logged for ID 16 - - variable_label + - variable_name #log a ticket to get schema updated - already logged for ID 16 + - variable_label Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0014/rule.yml b/Unpublished/ADAMIG/AD0014/rule.yml index 1eaa957b3..1f34418de 100644 --- a/Unpublished/ADAMIG/AD0014/rule.yml +++ b/Unpublished/ADAMIG/AD0014/rule.yml @@ -1,268 +1,276 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as the need to conform to the SAS - Transport format requirements (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), - and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. - All ADaM character variables must be no more than 200 characters in length. - Document: ADaMIG v1.3 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "Model v2.1" + References: + - Citations: + - Cited Guidance: + <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.3 + Item: "1" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" -- Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as the need to conform to the SAS - Transport format requirements (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), - and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. - All ADaM character variables must be no more than 200 characters in length. - Document: ADaMIG v1.2 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: "Model v2.1" + References: + - Citations: + - Cited Guidance: + <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.2 + Item: "1" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" -- Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as the need to conform to the SAS - Transport format requirements (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), - and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. - All ADaM character variables must be no more than 200 characters in length. - Document: ADaMIG v1.1 - Item: '1' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: "Model v2.1" + References: + - Citations: + - Cited Guidance: + <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be comprised only of letters (A-Z), underscore (_), + and numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. + All ADaM character variables must be no more than 200 characters in length. + Document: ADaMIG v1.1 + Item: "1" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" -- Organization: CDISC - Standards: - - Name: 'Model v2.1' - References: - - Citations: - - Cited Guidance: <- In developing naming conventions, sponsors should consider the - requirements noted in the eCTD guidance document as well as the need to conform to the SAS - Transport format requirements (e.g., the total length of the name cannot exceed 8 - characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all - ADaM variable names must be no more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). - All ADaM variable labels must be no more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length.8 characters). - Document: ADaMIG v1.0 - Item: '5 (General Variable Naming Conventions)' - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '14' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '14' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: "Model v2.1" + References: + - Citations: + - Cited Guidance: + <- In developing naming conventions, sponsors should consider the + requirements noted in the eCTD guidance document as well as the need to conform to the SAS + Transport format requirements (e.g., the total length of the name cannot exceed 8 + characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length.8 characters). + Document: ADaMIG v1.0 + Item: "5 (General Variable Naming Conventions)" + Section: "3" + Criteria: + Logical Expression: + Condition: "" + Rule: "14" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "14" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name - operator: not_prefix_matches_regex - prefix: 0 - value: '[A-Z]' + - name: variable_name + operator: not_prefix_matches_regex + prefix: 0 + value: "[A-Z]" Core: Id: CDISC.ADaMIG.AD0014 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: A variable name does not start with a letter (A-Z) Output Variables: - - variable_name - - variable_label + - variable_name + - variable_label Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0016/rule.yml b/Unpublished/ADAMIG/AD0016/rule.yml index fa4413f10..d52e831cf 100644 --- a/Unpublished/ADAMIG/AD0016/rule.yml +++ b/Unpublished/ADAMIG/AD0016/rule.yml @@ -1,182 +1,190 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: "1" + Section: 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "16" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "16" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.2 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.2 + Item: "1" + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "16" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "16" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: Section 3.1.1 - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: "1" + Section: Section 3.1.1 + Criteria: + Logical Expression: + Condition: "" + Rule: "16" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "16" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all - ADaM variable names must be no more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). - All ADaM variable labels must be no more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length. - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions) - Section: '3' - Criteria: - Logical Expression: - Condition: '' - Rule: '16' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Related Rules: - - Id: '' - Relationship: Related - Release Notes: '' - Rule Identifier: - Id: '16' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length. + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions) + Section: "3" + Criteria: + Logical Expression: + Condition: "" + Rule: "16" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Related Rules: + - Id: "" + Relationship: Related + Release Notes: "" + Rule Identifier: + Id: "16" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_label - operator: longer_than - value: 40 + - name: variable_label + operator: longer_than + value: 40 Core: Id: CDISC.ADaMIG.AD0016 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: Label must be less than 40 charatcters Output Variables: - - variable_label #log a ticket to get schema updated - - variable_name + - variable_label #log a ticket to get schema updated + - variable_name Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0017/rule.yml b/Unpublished/ADAMIG/AD0017/rule.yml index 9059798b0..aec12f34a 100644 --- a/Unpublished/ADAMIG/AD0017/rule.yml +++ b/Unpublished/ADAMIG/AD0017/rule.yml @@ -1,141 +1,150 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.3 - Item: '1' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "1" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.3 + Item: "1" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "17" + Version: "1" + Version: "5.0" + Version: "1.3" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length.'' - Document: ADaM IG v1.2 - Item: '1' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "1" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length.'' + Document: ADaM IG v1.2 + Item: "1" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "17" + Version: "1" + Version: "5.0" + Version: "1.2" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format and Oracle - constraints, all ADaM variable names must be no more than 8 characters in length, start - with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and - numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All - ADaM character variables must be no more than 200 characters in length. - Document: ADaM IG v1.1 - Item: '1' - Section: 3.1.1 - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "1" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle + constraints, all ADaM variable names must be no more than 8 characters in length, start + with a letter (not underscore), and be composed only of letters (A-Z), underscore (_), and + numerals (0-9). All ADaM variable labels must be no more than 40 characters in length. All + ADaM character variables must be no more than 200 characters in length. + Document: ADaM IG v1.1 + Item: "1" + Section: 3.1.1 + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "1" + Section: 4.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "17" + Version: "1" + Version: "5.0" + Version: "1.1" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: In developing naming conventions, sponsors should consider the requirements - noted in the eCTD guidance document as well as the need to conform to the SAS Transport - format requirements (e.g., the total length of the name cannot exceed 8 characters). - Document: Model v2.1 - Item: '1' - Section: 4.1.2 - - Cited Guidance: To ensure compliance with SAS Transport file and Oracle constraints, all - ADaM variable names must be no more than 8 characters in length, start with a letter (not - underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). - All ADaM variable labels must be no more than 40 characters in length. All ADaM character - variables must be no more than 200 characters in length - Document: ADaM IG v1.0 - Item: 5 (General Variable Naming Conventions)':' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '17' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + In developing naming conventions, sponsors should consider the requirements + noted in the eCTD guidance document as well as the need to conform to the SAS Transport + format requirements (e.g., the total length of the name cannot exceed 8 characters). + Document: Model v2.1 + Item: "1" + Section: 4.1.2 + - Cited Guidance: + To ensure compliance with SAS Transport file and Oracle constraints, all + ADaM variable names must be no more than 8 characters in length, start with a letter (not + underscore), and be comprised only of letters (A-Z), underscore (_), and numerals (0-9). + All ADaM variable labels must be no more than 40 characters in length. All ADaM character + variables must be no more than 200 characters in length + Document: ADaM IG v1.0 + Item: 5 (General Variable Naming Conventions)':' + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "17" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895 - operator: equal_to - value: char - - name: variable_value - operator: longer_than - value: 200 + - name: variable_data_type # ariable_value to work with other rule types than value metadata check against the define-xml #895 + operator: equal_to + value: char + - name: variable_value + operator: longer_than + value: 200 Core: Id: CDISC.ADaMIG.AD0017 Status: Draft - Version: '1' + Version: "1" Description: Variable Value must not be greather than 200 characters long Executability: Fully Executable Outcome: Message: Variable value is greather than 200 characters long Output Variables: - - variable_name + - variable_name Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Datasets: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL include_split_datasets: true Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0019/rule.yml b/Unpublished/ADAMIG/AD0019/rule.yml index 9f7073823..56ea16041 100644 --- a/Unpublished/ADAMIG/AD0019/rule.yml +++ b/Unpublished/ADAMIG/AD0019/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Population Indicator(s) have a Codelist / Controlled Term value - of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '19' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "19" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "19" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "19" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Population Indicator(s) have a Codelist / Controlled Term value + of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "19" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: COMPLFL - operator: exists - - name: COMPLFL - operator: is_not_contained_by - value: - - Y - - N + - name: COMPLFL + operator: exists + - name: COMPLFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0019 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when COMPLFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of COMPLFL are not following the "Y, N" codelist Output Variables: - - COMPLFL + - COMPLFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0020/rule.yml b/Unpublished/ADAMIG/AD0020/rule.yml index 886c36fe4..e3054806b 100644 --- a/Unpublished/ADAMIG/AD0020/rule.yml +++ b/Unpublished/ADAMIG/AD0020/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '20' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "20" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "20" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "20" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "20" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: FASFL - operator: exists - - name: FASFL - operator: is_not_contained_by - value: - - Y - - N + - name: FASFL + operator: exists + - name: FASFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0020 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when FASFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of FASFL are not following the "Y, N" codelist Output Variables: - - FASFL + - FASFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0021/rule.yml b/Unpublished/ADAMIG/AD0021/rule.yml index b584ffcbe..585c76566 100644 --- a/Unpublished/ADAMIG/AD0021/rule.yml +++ b/Unpublished/ADAMIG/AD0021/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '21' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "21" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "21" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "21" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "21" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: ITTFL - operator: exists - - name: ITTFL - operator: is_not_contained_by - value: - - Y - - N + - name: ITTFL + operator: exists + - name: ITTFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0021 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when ITTFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of ITTFL are not following the "Y, N" codelist Output Variables: - - ITTFL + - ITTFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0022/rule.yml b/Unpublished/ADAMIG/AD0022/rule.yml index 7d4ac9fd1..4a84003a4 100644 --- a/Unpublished/ADAMIG/AD0022/rule.yml +++ b/Unpublished/ADAMIG/AD0022/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '22' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "22" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "22" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "22" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "22" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: PPROTFL - operator: exists - - name: PPROTFL - operator: is_not_contained_by - value: - - Y - - N + - name: PPROTFL + operator: exists + - name: PPROTFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0022 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when PPROTFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of PPROTFL are not following the "Y, N" codelist Output Variables: - - PPROTFL + - PPROTFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0023/rule.yml b/Unpublished/ADAMIG/AD0023/rule.yml index 8cd9c7873..11580d524 100644 --- a/Unpublished/ADAMIG/AD0023/rule.yml +++ b/Unpublished/ADAMIG/AD0023/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '23' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "23" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "23" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "23" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "23" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: SAFFL - operator: exists - - name: SAFFL - operator: is_not_contained_by - value: - - Y - - N + - name: SAFFL + operator: exists + - name: SAFFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0023 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when SAFFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of SAFFL are not following the "Y, N" codelist Output Variables: - - SAFFL + - SAFFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0024/rule.yml b/Unpublished/ADAMIG/AD0024/rule.yml index 731ba266b..2d401eb5c 100644 --- a/Unpublished/ADAMIG/AD0024/rule.yml +++ b/Unpublished/ADAMIG/AD0024/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '24' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "24" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "24" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "24" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "24" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: RANDFL - operator: exists - - name: RANDFL - operator: is_not_contained_by - value: - - Y - - N + - name: RANDFL + operator: exists + - name: RANDFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0024 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when RANDFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of RANDFL are not following the "Y, N" codelist Output Variables: - - RANDFL + - RANDFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0025/rule.yml b/Unpublished/ADAMIG/AD0025/rule.yml index 031a716d2..6c95bd226 100644 --- a/Unpublished/ADAMIG/AD0025/rule.yml +++ b/Unpublished/ADAMIG/AD0025/rule.yml @@ -1,89 +1,89 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) - have a Codelist / Controlled Term value of "Y, N". - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '25' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "25" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.2, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "25" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.1, Section 3.2, Table 3.2.3: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "25" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + ADaM IG v1.0, Section 3.1, Table 3.1.1: Population Indicator(s) + have a Codelist / Controlled Term value of "Y, N". + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "25" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: ENRLFL - operator: exists - - name: ENRLFL - operator: is_not_contained_by - value: - - Y - - N + - name: ENRLFL + operator: exists + - name: ENRLFL + operator: is_not_contained_by + value: + - Y + - N Core: Id: CDISC.ADAMIG.AD0025 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when ENRLFL is present and has a value that is not Y or N Executability: Fully Executable Outcome: Message: The values of ENRLFL are not following the "Y, N" codelist Output Variables: - - ENRLFL + - ENRLFL Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0026/rule.yml b/Unpublished/ADAMIG/AD0026/rule.yml index 5e34dcf3d..fe1a260b8 100644 --- a/Unpublished/ADAMIG/AD0026/rule.yml +++ b/Unpublished/ADAMIG/AD0026/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '26' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "26" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "26" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "26" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "26" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: COMPLFN - operator: exists - - name: COMPLFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: COMPLFN + operator: exists + - name: COMPLFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0026 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when COMPLFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of COMPLFN are not equal to 1 or 0 Output Variables: - - COMPLFN + - COMPLFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0027/rule.yml b/Unpublished/ADAMIG/AD0027/rule.yml index ab3b7fe6e..0ed3a31c4 100644 --- a/Unpublished/ADAMIG/AD0027/rule.yml +++ b/Unpublished/ADAMIG/AD0027/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '27' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "27" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "27" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "27" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "27" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: FASFN - operator: exists - - name: FASFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: FASFN + operator: exists + - name: FASFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0027 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when FASFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of FASFN are not equal to 1 or 0 Output Variables: - - FASFN + - FASFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0028/rule.yml b/Unpublished/ADAMIG/AD0028/rule.yml index adc9803b1..cf50eecb5 100644 --- a/Unpublished/ADAMIG/AD0028/rule.yml +++ b/Unpublished/ADAMIG/AD0028/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '28' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "28" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "28" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "28" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "28" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: ITTFN - operator: exists - - name: ITTFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: ITTFN + operator: exists + - name: ITTFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0028 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when ITTFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of ITTFN are not equal to 1 or 0 Output Variables: - - ITTFN + - ITTFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0029/rule.yml b/Unpublished/ADAMIG/AD0029/rule.yml index fa63986cb..3b8e3a7ff 100644 --- a/Unpublished/ADAMIG/AD0029/rule.yml +++ b/Unpublished/ADAMIG/AD0029/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '29' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "29" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "29" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "29" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "29" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: PPROTFN - operator: exists - - name: PPROTFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: PPROTFN + operator: exists + - name: PPROTFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0029 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when PPROTFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of PPROTFN are not equal to 1 or 0 Output Variables: - - PPROTFN + - PPROTFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0030/rule.yml b/Unpublished/ADAMIG/AD0030/rule.yml index fb46a4c73..adc78b77d 100644 --- a/Unpublished/ADAMIG/AD0030/rule.yml +++ b/Unpublished/ADAMIG/AD0030/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '30' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "30" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "30" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "30" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "30" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: SAFFN - operator: exists - - name: SAFFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: SAFFN + operator: exists + - name: SAFFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0030 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when SAFFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of SAFFN are not equal to 1 or 0 Output Variables: - - SAFFN + - SAFFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0031/rule.yml b/Unpublished/ADAMIG/AD0031/rule.yml index 762e547d6..1aaeb7c90 100644 --- a/Unpublished/ADAMIG/AD0031/rule.yml +++ b/Unpublished/ADAMIG/AD0031/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '31' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "31" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "31" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "31" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "31" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: RANDFN - operator: exists - - name: RANDFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: RANDFN + operator: exists + - name: RANDFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0031 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when RANDFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of RANDFN are not equal to 1 or 0 Output Variables: - - RANDFN + - RANDFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0032/rule.yml b/Unpublished/ADAMIG/AD0032/rule.yml index 919a3fc46..43f6447e3 100644 --- a/Unpublished/ADAMIG/AD0032/rule.yml +++ b/Unpublished/ADAMIG/AD0032/rule.yml @@ -1,93 +1,93 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.3 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.2 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN, where 0=No - and 1=Yes) of the population flag can also be included. - Document: ADaM IG v1.1 - Item: Table 3.2.3 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The values of subject-level population flags cannot be blank. If - a flag is used, the corresponding numeric version (*FN) can also - be included. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '32' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.3 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "32" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.2 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "32" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN, where 0=No + and 1=Yes) of the population flag can also be included. + Document: ADaM IG v1.1 + Item: Table 3.2.3 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "32" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The values of subject-level population flags cannot be blank. If + a flag is used, the corresponding numeric version (*FN) can also + be included. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "32" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: ENRLFN - operator: exists - - name: ENRLFN - operator: is_not_contained_by - value: - - 1 - - 0 + - name: ENRLFN + operator: exists + - name: ENRLFN + operator: is_not_contained_by + value: + - 1 + - 0 Core: Id: CDISC.ADAMIG.AD0032 Status: Draft - Version: '1' + Version: "1" Description: >- Raise an error when ENRLFN is present and has a value that is not 1 or 0 Executability: Fully Executable Outcome: Message: Some values of ENRLFN are not equal to 1 or 0 Output Variables: - - ENRLFN + - ENRLFN Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0039/rule.yml b/Unpublished/ADAMIG/AD0039/rule.yml index b42dcf72e..3a29e0c9a 100644 --- a/Unpublished/ADAMIG/AD0039/rule.yml +++ b/Unpublished/ADAMIG/AD0039/rule.yml @@ -1,63 +1,64 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADAMIG - References: - # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.1.3, Item 1: As described in Table 3.1.5.1, - variables whose names end in DTF are date imputation flags. *DTF - variables represent the - highest level of imputation of the *DT variable based on the source - SDTM dataset DTC variable. *DTF = Y if the year is - imputed. *DTF = M if year is present and month is imputed. *DTF - = D if only day is imputed. *DTF = null if *DT equals the - SDTM dataset DTC variable date part equivalent. If a date was imputed, - *DTF must be populated and is required. Both *DTF and - *TMF may be needed to describe the level of imputation in *DTM if - imputation was done. Note that the list of examples in - Table 3.1.3.1 is not exhaustive. - Document: IG v1.3 - Item: '1' - Section: 3.1.3 - Origin: ADaM and ADaMIG Conformance Rules - Rule Identifier: - Id: AD0039 - Version: '1' - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADAMIG + References: + # Origin for ADaM/ADaMIG should be defined in yaml validation schema + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.1.3, Item 1: As described in Table 3.1.5.1, + variables whose names end in DTF are date imputation flags. *DTF + variables represent the + highest level of imputation of the *DT variable based on the source + SDTM dataset DTC variable. *DTF = Y if the year is + imputed. *DTF = M if year is present and month is imputed. *DTF + = D if only day is imputed. *DTF = null if *DT equals the + SDTM dataset DTC variable date part equivalent. If a date was imputed, + *DTF must be populated and is required. Both *DTF and + *TMF may be needed to describe the level of imputation in *DTM if + imputation was done. Note that the list of examples in + Table 3.1.3.1 is not exhaustive. + Document: IG v1.3 + Item: "1" + Section: 3.1.3 + Origin: ADaM and ADaMIG Conformance Rules + Rule Identifier: + Id: AD0039 + Version: "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: "4.0" + Version: "1.3" Check: all: -# - name: "variable_name" -# operator: matches_regex -# value: ^[A-Z][A-Z0-9]{0,4}DTF$ -# - name: "variable_name" -# operator: non_empty - - name: ADTF - operator: does_not_use_valid_codelist_terms - value: DATEFL + # - name: "variable_name" + # operator: matches_regex + # value: ^[A-Z][A-Z0-9]{0,4}DTF$ + # - name: "variable_name" + # operator: non_empty + - name: ADTF + operator: does_not_use_valid_codelist_terms + value: DATEFL Core: # Need to make yaml validation accept ADAMIG - # Will we need to prepend ADaM rules with "AD0..."? + # Will we need to prepend ADaM rules with "AD0..."? # (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") ) Id: CDISC.ADAMIG.AD0039 Status: Draft - Version: '1' -Description: Raise an error when a variable ends with DTF and values are not according to the DATEFL + Version: "1" +Description: + Raise an error when a variable ends with DTF and values are not according to the DATEFL controlled terminology codelist Outcome: Message: The values of ADTF are not following the DATEFL codelist Output Variables: - - ADTF + - ADTF Rule Type: Record Data Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ALL + - ALL Domains: Include: - - ADLB + - ADLB Sensitivity: Variable diff --git a/Unpublished/ADAMIG/AD0041/rule.yml b/Unpublished/ADAMIG/AD0041/rule.yml index b2dc17743..0e81acde4 100644 --- a/Unpublished/ADAMIG/AD0041/rule.yml +++ b/Unpublished/ADAMIG/AD0041/rule.yml @@ -1,53 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Numeric date, time, and datetime variables should be - formatted, so as to be human-readable with no loss of - precision. - Document: IG v1.3 - Item: '1' - Section: 3.1.2 - - Cited Guidance: >- - Variables whose names end in DT are numeric dates. - Document: IG v1.3 - Item: '2' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '41' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Numeric date, time, and datetime variables should be + formatted, so as to be human-readable with no loss of + precision. + Document: IG v1.3 + Item: "1" + Section: 3.1.2 + - Cited Guidance: >- + Variables whose names end in DT are numeric dates. + Document: IG v1.3 + Item: "2" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "41" + Version: "5.0" + Version: "1.3" Check: #1. check variable type is numeric 2. has suffix DT 3. has date format (look up list?) all: - - name: variable_type #1 - operator: is_numeric #type should be avialble from metadata variable_type - - name: variable_name #2 - operator: ends_with - value: DT - - name: variable_name #3 - operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column + - name: variable_type #1 + operator: is_numeric #type should be avialble from metadata variable_type + - name: variable_name #2 + operator: ends_with + value: DT + - name: variable_name #3 + operator: does_not_use_valid_format_terms #need to be able to extract metadata from xpt and read format from unit test data: add row call format under each column Core: Id: CDISC.ADAMIG.AD0041 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when a variable ends with DT and does not have a date format #list of all valid date format available? Outcome: Message: Value of --DT do not have a date format #human readable as per guidance then could define a list of acceptable formats? #Output Variables: - # - --DT + # - --DT #wildcard bing used Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ADLB + - ADLB Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0046/rule.yml b/Unpublished/ADAMIG/AD0046/rule.yml index c40138ed2..d04db26a9 100644 --- a/Unpublished/ADAMIG/AD0046/rule.yml +++ b/Unpublished/ADAMIG/AD0046/rule.yml @@ -1,81 +1,81 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. - Document: ADAM IG v1.3 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.3' - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Item 8: Variables whose names end in DY are relative day - variables. In ADaM as in the SDTM, there is no day 0. If there - is a need to create a relative day variable that includes day - 0, then its name must not end in DY. - Document: ADAM IG v1.2 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. + Document: ADAM IG v1.3 + Item: "8" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "46" + Version: "5.0" + Version: "1.3" + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Item 8: Variables whose names end in DY are relative day + variables. In ADaM as in the SDTM, there is no day 0. If there + is a need to create a relative day variable that includes day + 0, then its name must not end in DY. + Document: ADAM IG v1.2 + Item: "8" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "46" + Version: "5.0" + Version: "1.2" - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. - Document: ADAM IG v1.1 - Item: '8' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.1' + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. + Document: ADAM IG v1.1 + Item: "8" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "46" + Version: "5.0" + Version: "1.1" - - Name: ADAMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DY are relative day variables. In - ADaM as in the SDTM, there is no day 0. If there is a need to - create a relative day variable that includes day 0, then its - name must not end in DY. ADaM relative day variables need not - be anchored by SDTM RFSTDTC. When SDTM.RFSTDTC is not the - anchor date then the anchor date used must be stored in an - ADaM dataset. - Document: ADAM IG v1.0 - Item: '8 (General Timing Variable Conventions)' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '46' - Version: '5.0' - Version: '1.0' + - Name: ADAMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DY are relative day variables. In + ADaM as in the SDTM, there is no day 0. If there is a need to + create a relative day variable that includes day 0, then its + name must not end in DY. ADaM relative day variables need not + be anchored by SDTM RFSTDTC. When SDTM.RFSTDTC is not the + anchor date then the anchor date used must be stored in an + ADaM dataset. + Document: ADAM IG v1.0 + Item: "8 (General Timing Variable Conventions)" + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "46" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name - operator: ends_with - value: 'DY' + - name: variable_name + operator: ends_with + value: "DY" # - name: variable_name # operator: equal_to # value: 0 @@ -83,7 +83,7 @@ Check: Core: Id: CDISC.ADAMIG.AD0046 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when a variable ends with DY and has value equl to 0 Outcome: Message: Value of 0 is not permitted with variable ending with suffix DY @@ -91,8 +91,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0047/rule.yml b/Unpublished/ADAMIG/AD0047/rule.yml index 059f8f5ec..f9ccce22a 100644 --- a/Unpublished/ADAMIG/AD0047/rule.yml +++ b/Unpublished/ADAMIG/AD0047/rule.yml @@ -1,66 +1,66 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.3 - Item: Table 3.2.1 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '47' - Version: '1' - Version: '4.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.2 - Item: Table 3.2.1 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '47' - Version: '1' - Version: '4.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.1 - Item: Table 3.2.1 - Section: '3.2' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '47' - Version: '1' - Version: '4.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SITEID has Core=Req. - Document: ADaM IG v1.0 - Item: Table 3.1.1 - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '47' - Version: '1' - Version: '4.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.3 + Item: Table 3.2.1 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "47" + Version: "1" + Version: "4.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.2 + Item: Table 3.2.1 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "47" + Version: "1" + Version: "4.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.1 + Item: Table 3.2.1 + Section: "3.2" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "47" + Version: "1" + Version: "4.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SITEID has Core=Req. + Document: ADaM IG v1.0 + Item: Table 3.1.1 + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "47" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - - name: SITEID - operator: not_exists + - name: SITEID + operator: not_exists Core: Id: CDISC.ADAMIG.AD0047 Status: Draft - Version: '1' + Version: "1" Description: Variable SITEID should be present in dataset ADSL Executability: Fully Executable Outcome: @@ -69,8 +69,8 @@ Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Include: - - ADSL + - ADSL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0049/rule.yml b/Unpublished/ADAMIG/AD0049/rule.yml index 717a3c0ff..51d9a5c12 100644 --- a/Unpublished/ADAMIG/AD0049/rule.yml +++ b/Unpublished/ADAMIG/AD0049/rule.yml @@ -1,99 +1,99 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.1.1 - Section: '3.1' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGE has Core=Req - Document: ADaMIG - Item: Table 3.2.2 - Section: '3.2' - Criteria: - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '49' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.1.1 + Section: "3.1" + Criteria: + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "49" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: "3.2" + Criteria: + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "49" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: "3.2" + Criteria: + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "49" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGE has Core=Req + Document: ADaMIG + Item: Table 3.2.2 + Section: "3.2" + Criteria: + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "49" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: AGE - operator: not_exists + - name: AGE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0049 Status: Draft - Version: '1' + Version: "1" Description: Variable AGE must be present in dataset ADSL Executability: Fully Executable Outcome: Message: Variable AGE is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Include: - - ADSL + - ADSL Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0050/rule.yml b/Unpublished/ADAMIG/AD0050/rule.yml index 6ae22f60f..fa390f57b 100644 --- a/Unpublished/ADAMIG/AD0050/rule.yml +++ b/Unpublished/ADAMIG/AD0050/rule.yml @@ -1,109 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: AGEU has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '50' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: "Table 3.1.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "50" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "50" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "50" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: AGEU has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "50" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: AGEU - operator: not_exists + - name: AGEU + operator: not_exists Core: Id: CDISC.ADaMIG.AD050 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AGEU is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0051/rule.yml b/Unpublished/ADAMIG/AD0051/rule.yml index 948374eee..390bc1568 100644 --- a/Unpublished/ADAMIG/AD0051/rule.yml +++ b/Unpublished/ADAMIG/AD0051/rule.yml @@ -1,109 +1,109 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SEX has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '51' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: "Table 3.1.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "51" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "51" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "51" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SEX has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "51" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEX - operator: not_exists + - name: SEX + operator: not_exists Core: Id: CDISC.ADaMIG.AD051 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SEX is not present in ADSL Output Variables: - - USUBJID - - AGE + - USUBJID + - AGE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0052/rule.yml b/Unpublished/ADAMIG/AD0052/rule.yml index 4b1459660..91d1db3e2 100644 --- a/Unpublished/ADAMIG/AD0052/rule.yml +++ b/Unpublished/ADAMIG/AD0052/rule.yml @@ -1,110 +1,110 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: RACE has Core=Req - Document: ADaMIG - Item: 'Table 3.2.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '52' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: "Table 3.1.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "52" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "52" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "52" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: RACE has Core=Req + Document: ADaMIG + Item: "Table 3.2.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "52" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACE - operator: not_exists + - name: RACE + operator: not_exists Core: Id: CDISC.ADaMIG.AD052 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: RACE is not present in ADSL Output Variables: - - USUBJID - - AGE - - RACE + - USUBJID + - AGE + - RACE Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0053/rule.yml b/Unpublished/ADAMIG/AD0053/rule.yml index 2c51c4d71..b8a55196b 100644 --- a/Unpublished/ADAMIG/AD0053/rule.yml +++ b/Unpublished/ADAMIG/AD0053/rule.yml @@ -1,62 +1,62 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.1.1, Item 3: Any variable in an ADaM dataset - whose name is the same as an SDTM variable must be a copy of the - SDTM variable, - and its label, meaning, and values must not be modified. ADaM adheres - to a principle of harmonization known as "same name, same meaning, - same values." - Document: IG v1.3 - Item: '3' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '53' - Version: '1' - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + # Origin for ADaM/ADaMIG should be defined in yaml validation schema + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.1.1, Item 3: Any variable in an ADaM dataset + whose name is the same as an SDTM variable must be a copy of the + SDTM variable, + and its label, meaning, and values must not be modified. ADaM adheres + to a principle of harmonization known as "same name, same meaning, + same values." + Document: IG v1.3 + Item: "3" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "53" + Version: "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: "4.0" + Version: "1.3" Check: all: - - name: USUBJID - operator: is_not_contained_by - value: $dm_usubjid + - name: USUBJID + operator: is_not_contained_by + value: $dm_usubjid Core: # Need to make yaml validation accept ADAMIG - # Will we need to prepend ADaM rules with "AD0..."? + # Will we need to prepend ADaM rules with "AD0..."? # (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") ) Id: CDISC.ADAMIG.AD0053 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when the values of USUBJID are not present in SDTM.DM Executability: Fully Executable Operations: -- domain: DM - id: $dm_usubjid - name: USUBJID - operator: distinct + - domain: DM + id: $dm_usubjid + name: USUBJID + operator: distinct Outcome: Message: The values of USUBJID are not present in SDTM.DM Output Variables: - - USUBJID + - USUBJID Rule Type: Record Data Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ALL + - ALL Data Structures: Include: - - ADAM OTHER - - ALL + - ADAM OTHER + - ALL Domains: Include: - - ADSL - - DM + - ADSL + - DM Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0070/rule.yml b/Unpublished/ADAMIG/AD0070/rule.yml index ef0009e31..919119563 100644 --- a/Unpublished/ADAMIG/AD0070/rule.yml +++ b/Unpublished/ADAMIG/AD0070/rule.yml @@ -1,94 +1,95 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - the secondary variable of the variable pair cannot be present - in the dataset unless the primary variable is also present - Document: ADaM IG v1.3 - Item: '7' - Section: 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - One-to-one map to TRxxAGy - Document: ADaM IG v1.0 - Item: '' - Section: 3.1, Table 3.1.1 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '70' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: "7" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "70" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: "7" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "70" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + the secondary variable of the variable pair cannot be present + in the dataset unless the primary variable is also present + Document: ADaM IG v1.3 + Item: "7" + Section: 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "70" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + One-to-one map to TRxxAGy + Document: ADaM IG v1.0 + Item: "" + Section: 3.1, Table 3.1.1 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "70" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name #in dataset - operator: starts_with - value: TR - - name: variable_name #in dataset - operator: contains - value: AG - - name: variable_name #in dataset - operator: ends_with - value: N - #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails - # operator: not_exists + - name: variable_name #in dataset + operator: starts_with + value: TR + - name: variable_name #in dataset + operator: contains + value: AG + - name: variable_name #in dataset + operator: ends_with + value: N + #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails + # operator: not_exists Core: Id: CDSIC.ADaMIG.AD0070 Status: Draft - Version: '1' + Version: "1" Description: >- 'A variable with a prefix of TR, containing AG with a suffix of N is present and a variable with the same root without a suffix of N is not present' Executability: Fully Executable Outcome: - Message: A variable with a prefix of TR, containing AG with a suffix of N is present and a + Message: + A variable with a prefix of TR, containing AG with a suffix of N is present and a variable with the same root without a suffix of N is not present Output Variables: - - variable_name - - TTR01AG1N - - TTR02AG1N - - SUBJID + - variable_name + - TTR01AG1N + - TTR02AG1N + - SUBJID Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0111/rule.yml b/Unpublished/ADAMIG/AD0111/rule.yml index a0a9efc88..a371346a5 100644 --- a/Unpublished/ADAMIG/AD0111/rule.yml +++ b/Unpublished/ADAMIG/AD0111/rule.yml @@ -1,143 +1,148 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included - in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.2.3.1' - Section: '3.2.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included - in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included - in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'When ARELTM is present, the anchor time variable and ARELTMU must also be included - in the dataset, and the anchor time variable must be identified in the metadata for ARELTM' - Document: 'ADaMIG' - Item: 'Table 3.3.3.1' - Section: '3.3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: 'The MDBDS supports analysis needs by adding SPDEVID as a required key variable - and USUBJID as a conditionally required variable. See the BDS class for further details.' - Document: 'ADaMIG-MD' - Item: 'Table 3.3.3.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: 'Failure' - Origin: 'ADaM Conformance Rules' - Release Notes: '' - Rule Identifier: - Id: '111' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: "CDISC" + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + "When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM" + Document: "ADaMIG" + Item: "Table 3.2.3.1" + Section: "3.2.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "Failure" + Origin: "ADaM Conformance Rules" + Release Notes: "" + Rule Identifier: + Id: "111" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + "When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM" + Document: "ADaMIG" + Item: "Table 3.3.3.1" + Section: "3.3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "Failure" + Origin: "ADaM Conformance Rules" + Release Notes: "" + Rule Identifier: + Id: "111" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + "When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM" + Document: "ADaMIG" + Item: "Table 3.3.3.1" + Section: "3.3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "Failure" + Origin: "ADaM Conformance Rules" + Release Notes: "" + Rule Identifier: + Id: "111" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + "When ARELTM is present, the anchor time variable and ARELTMU must also be included + in the dataset, and the anchor time variable must be identified in the metadata for ARELTM" + Document: "ADaMIG" + Item: "Table 3.3.3.1" + Section: "3.3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "Failure" + Origin: "ADaM Conformance Rules" + Release Notes: "" + Rule Identifier: + Id: "111" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + "The MDBDS supports analysis needs by adding SPDEVID as a required key variable + and USUBJID as a conditionally required variable. See the BDS class for further details." + Document: "ADaMIG-MD" + Item: "Table 3.3.3.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "Failure" + Origin: "ADaM Conformance Rules" + Release Notes: "" + Rule Identifier: + Id: "111" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ARELTM - operator: exists - - name: ARELTMU - operator: not_exists + - name: ARELTM + operator: exists + - name: ARELTMU + operator: not_exists Core: Id: CDISC.ADAMIG.111 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'When ARELTM is present, ARELTMU must also be present' + Message: "When ARELTM is present, ARELTMU must also be present" Output Variables: - - USUBJID - - SUBJID - - ARELTM - - AVISIT + - USUBJID + - SUBJID + - ARELTM + - AVISIT Rule Type: Record Data #'more SDTM : Analysis DS variable Presence Check?' Scope: Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Datasets: Include: - - 'ALL' + - "ALL" Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0112/rule.yml b/Unpublished/ADAMIG/AD0112/rule.yml index ec6027895..64b62ed47 100644 --- a/Unpublished/ADAMIG/AD0112/rule.yml +++ b/Unpublished/ADAMIG/AD0112/rule.yml @@ -1,110 +1,110 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.3 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present - References: - - Citations: - - Cited Guidance: >- - v1.0, Section 3.1: The MDBDS supports analysis needs by adding - SPDEVID as a required key variable and USUBJID as a - conditionally required variable. See the BDS class for further - details.. - Document: ADaM MD v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.0' #or '1.3' against rule set 1.3 in excel sheet? - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.2 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.1 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - When ARELTM is present, the anchor time variable and ARELTMU - must also be included in the dataset, and the anchor time - variable must be identified in the metadata for ARELTM. - Document: ADaM IG v1.0 - Item: '' - Section: '3.2.3, Table 3.2.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '112' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.3 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "112" + Version: "5.0" + - Name: "ADaMIG-MD" # schema error : onlt accepts ADaMIG at present + References: + - Citations: + - Cited Guidance: >- + v1.0, Section 3.1: The MDBDS supports analysis needs by adding + SPDEVID as a required key variable and USUBJID as a + conditionally required variable. See the BDS class for further + details.. + Document: ADaM MD v1.0 + Item: "" + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "112" + Version: "5.0" + Version: "1.0" #or '1.3' against rule set 1.3 in excel sheet? + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.2 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "112" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.1 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "112" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + When ARELTM is present, the anchor time variable and ARELTMU + must also be included in the dataset, and the anchor time + variable must be identified in the metadata for ARELTM. + Document: ADaM IG v1.0 + Item: "" + Section: "3.2.3, Table 3.2.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "112" + Version: "5.0" + Version: "1.0" Check: all: - - name: ARELTM - operator: non_empty - value: '' - - name: ARELTMU - operator: empty + - name: ARELTM + operator: non_empty + value: "" + - name: ARELTMU + operator: empty Core: Id: CDSIC.ADaMIG.AD0112 Status: Draft - Version: '1' + Version: "1" Description: >- 'ARELTM is populated and ARELTMU is not populated' Executability: Fully Executable Outcome: Message: ARELTM is populated and ARELTMU is not populated Output Variables: - - SUBJID - - USUBJID - - ARELTM - - ARELTMU + - SUBJID + - USUBJID + - ARELTM + - ARELTMU Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0113/rule.yml b/Unpublished/ADAMIG/AD0113/rule.yml index cedcbd848..7cde57486 100644 --- a/Unpublished/ADAMIG/AD0113/rule.yml +++ b/Unpublished/ADAMIG/AD0113/rule.yml @@ -1,106 +1,106 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.3 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - - Name: 'ADaMIG-MD' # schema error : onlt accepts ADaMIG at present - References: - - Citations: - - Cited Guidance: >- - The MDBDS supports analysis needs by adding SPDEVID as a - required key variable and USUBJID as a conditionally required - variable. See the BDS class for further details. - Document: ADaM v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '2.0' #? where to set rule id version - Version: '5.0' - Version: '1.0' #or '1.3' against overall Conformance rule set 1.3 in excel sheet? - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.2 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.1 - Item: '' - Section: '3.3.3, Table 3.3.3.1' - Origin: ADaM Conformance Rules + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.3 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "113" + Version: "5.0" + - Name: "ADaMIG-MD" # schema error : onlt accepts ADaMIG at present + References: + - Citations: + - Cited Guidance: >- + The MDBDS supports analysis needs by adding SPDEVID as a + required key variable and USUBJID as a conditionally required + variable. See the BDS class for further details. + Document: ADaM v1.0 + Item: "" + Section: "3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "113" + Version: "2.0" #? where to set rule id version + Version: "5.0" + Version: "1.0" #or '1.3' against overall Conformance rule set 1.3 in excel sheet? + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.2 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "113" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.1 + Item: "" + Section: "3.3.3, Table 3.3.3.1" + Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU - is required if ARELTM is present. - Document: ADaM IG v1.0 - Item: '' - Section: '3.2.3, Table 3.2.3.1' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '113' - Version: '5.0' - Version: '1.0' + Rule Identifier: + Id: "113" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + The units of ARELTM. For example, "HOURS" or "MINUTES" ARELTMU + is required if ARELTM is present. + Document: ADaM IG v1.0 + Item: "" + Section: "3.2.3, Table 3.2.3.1" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "113" + Version: "5.0" + Version: "1.0" Check: all: - - name: ARELTMU - operator: exists - - name: ARELTM - operator: not_exists + - name: ARELTMU + operator: exists + - name: ARELTM + operator: not_exists Core: Id: CDSIC.ADaMIG.AD0113 Status: Draft - Version: '1' + Version: "1" Description: >- 'ARELTMU is present and ARELTM is not present' Executability: Fully Executable Outcome: Message: ARELTMU is present and ARELTM is not present Output Variables: - - SUBJID - - USUBJID - - VISIT - - ARELTMU + - SUBJID + - USUBJID + - VISIT + - ARELTMU Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Data Structures: Include: - - BASIC DATA STRUCTURE - - MEDICAL DEVICE BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE + - MEDICAL DEVICE BASIC DATA STRUCTURE Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0252/rule.yml b/Unpublished/ADAMIG/AD0252/rule.yml index a3698e8f8..69cc13e5b 100644 --- a/Unpublished/ADAMIG/AD0252/rule.yml +++ b/Unpublished/ADAMIG/AD0252/rule.yml @@ -1,46 +1,46 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: '' - Origin: '' - Release Notes: '' - Rule Identifier: - Id: '252' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: "" + Document: "" + Item: "" + Section: "" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "" + Origin: "" + Release Notes: "" + Rule Identifier: + Id: "252" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: '' - operator: '' - value: '' + - name: "" + operator: "" + value: "" Core: Id: CDISC.ADAMIG.252 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0869/rule.yml b/Unpublished/ADAMIG/AD0869/rule.yml index f2f9f408f..01e3f2006 100644 --- a/Unpublished/ADAMIG/AD0869/rule.yml +++ b/Unpublished/ADAMIG/AD0869/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '869' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "869" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACEN - operator: exists - - name: RACE - operator: not_exists + - name: RACEN + operator: exists + - name: RACE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0869 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: RACEN is present, but RACE is not present Output Variables: - - RACEN - - USUBJID - - SUBJID + - RACEN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0870/rule.yml b/Unpublished/ADAMIG/AD0870/rule.yml index e92aec895..61497408c 100644 --- a/Unpublished/ADAMIG/AD0870/rule.yml +++ b/Unpublished/ADAMIG/AD0870/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. - Example values can be as follows ':' 1=Male, 2=Male - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '870' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows ':' 1=Male, 2=Male + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "870" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEX - operator: non_empty - - name: SEXN - operator: empty + - name: SEX + operator: non_empty + - name: SEXN + operator: empty Core: Id: CDISC.ADaMIG.AD0870 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'SEX is populated, but SEXN is not populated' + Message: "SEX is populated, but SEXN is not populated" Output Variables: - - SEX - - SEXN - - USUBJID + - SEX + - SEXN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0871/rule.yml b/Unpublished/ADAMIG/AD0871/rule.yml index 7147e2143..fe12e5b41 100644 --- a/Unpublished/ADAMIG/AD0871/rule.yml +++ b/Unpublished/ADAMIG/AD0871/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. - Example values can be as follows':' 1=Male, 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '871' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "871" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: empty + - name: SEXN + operator: non_empty + - name: SEX + operator: empty Core: Id: CDISC.ADaMIG.AD0871 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'SEXN is populated, but SEX is not populated' + Message: "SEXN is populated, but SEX is not populated" Output Variables: - - SEX - - SEXN - - USUBJID + - SEX + - SEXN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0878/rule.yml b/Unpublished/ADAMIG/AD0878/rule.yml index 196c8f57e..a9cecd928 100644 --- a/Unpublished/ADAMIG/AD0878/rule.yml +++ b/Unpublished/ADAMIG/AD0878/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '878' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "878" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRY - operator: is_inconsistent_across_dataset - value: COUNTRYN + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRY + operator: is_inconsistent_across_dataset + value: COUNTRYN Core: Id: CDISC.ADaMIG.AD0878 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRY is not unique for a given value of COUNTRYN Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYN + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0879/rule.yml b/Unpublished/ADAMIG/AD0879/rule.yml index b6c21734e..ee324337e 100644 --- a/Unpublished/ADAMIG/AD0879/rule.yml +++ b/Unpublished/ADAMIG/AD0879/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '879' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "879" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYN - operator: exists - - name: COUNTRY - operator: not_exists + - name: COUNTRYN + operator: exists + - name: COUNTRY + operator: not_exists Core: Id: CDISC.ADaMIG.AD0879 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRYN is present, but COUNTRY is not present Output Variables: - - COUNTRYN - - USUBJID - - SUBJID + - COUNTRYN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0880/rule.yml b/Unpublished/ADAMIG/AD0880/rule.yml index f67498c67..a12fd5ac2 100644 --- a/Unpublished/ADAMIG/AD0880/rule.yml +++ b/Unpublished/ADAMIG/AD0880/rule.yml @@ -1,53 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '880' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "880" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRY - operator: non_empty - - name: COUNTRYL - operator: empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYL + operator: empty Core: Id: CDISC.ADaMIG.AD0880 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COUNTRY is populated, but COUNTRYL is not populated' + Message: "COUNTRY is populated, but COUNTRYL is not populated" Output Variables: - - COUNTRY - - COUNTRYL - - USUBJID + - COUNTRY + - COUNTRYL + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0881/rule.yml b/Unpublished/ADAMIG/AD0881/rule.yml index c88d5e228..0d3aec68a 100644 --- a/Unpublished/ADAMIG/AD0881/rule.yml +++ b/Unpublished/ADAMIG/AD0881/rule.yml @@ -1,53 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '881' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "881" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: empty + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: empty Core: Id: CDISC.ADaMIG.AD0881 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COUNTRYL is populated, but COUNTRY is not populated' + Message: "COUNTRYL is populated, but COUNTRY is not populated" Output Variables: - - COUNTRY - - COUNTRYL - - USUBJID + - COUNTRY + - COUNTRYL + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0882/rule.yml b/Unpublished/ADAMIG/AD0882/rule.yml index b84838094..93582e15b 100644 --- a/Unpublished/ADAMIG/AD0882/rule.yml +++ b/Unpublished/ADAMIG/AD0882/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '882' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY. + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "882" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRYL - operator: is_inconsistent_across_dataset - value: COUNTRY + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYL + operator: is_inconsistent_across_dataset + value: COUNTRY Core: Id: CDISC.ADaMIG.AD0882 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRYL is not unique for a given value of COUNTRY Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYL + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYL Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0883/rule.yml b/Unpublished/ADAMIG/AD0883/rule.yml index 24dee0827..1dfd0c182 100644 --- a/Unpublished/ADAMIG/AD0883/rule.yml +++ b/Unpublished/ADAMIG/AD0883/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '883' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "883" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYL - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRY - operator: is_inconsistent_across_dataset - value: COUNTRYL + - name: COUNTRYL + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRY + operator: is_inconsistent_across_dataset + value: COUNTRYL Core: Id: CDISC.ADaMIG.AD0883 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRY is not unique for a given value of COUNTRYL Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYL + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYL Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0884/rule.yml b/Unpublished/ADAMIG/AD0884/rule.yml index 8c1ebe724..b124cee9e 100644 --- a/Unpublished/ADAMIG/AD0884/rule.yml +++ b/Unpublished/ADAMIG/AD0884/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '884' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "884" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYL - operator: exists - - name: COUNTRY - operator: not_exists + - name: COUNTRYL + operator: exists + - name: COUNTRY + operator: not_exists Core: Id: CDISC.ADaMIG.AD0884 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRYL is present, but COUNTRY is not present Output Variables: - - COUNTRYL - - USUBJID - - SUBJID + - COUNTRYL + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0885/rule.yml b/Unpublished/ADAMIG/AD0885/rule.yml index d10165272..9e44a57e4 100644 --- a/Unpublished/ADAMIG/AD0885/rule.yml +++ b/Unpublished/ADAMIG/AD0885/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '885' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "885" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: USUBJIDN - operator: not_exists + - name: USUBJIDN + operator: not_exists Core: Id: CDISC.ADaMIG.AD0885 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: USUBJIDN is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0886/rule.yml b/Unpublished/ADAMIG/AD0886/rule.yml index 980daa4fa..1b86c00e1 100644 --- a/Unpublished/ADAMIG/AD0886/rule.yml +++ b/Unpublished/ADAMIG/AD0886/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '886' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "886" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: AFRLT - operator: not_exists + - name: AFRLT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0886 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AFRLT is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0887/rule.yml b/Unpublished/ADAMIG/AD0887/rule.yml index 2b924724e..918063c92 100644 --- a/Unpublished/ADAMIG/AD0887/rule.yml +++ b/Unpublished/ADAMIG/AD0887/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '887' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "887" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: EVID - operator: not_exists + - name: EVID + operator: not_exists Core: Id: CDISC.ADaMIG.AD0887 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: EVID is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0888/rule.yml b/Unpublished/ADAMIG/AD0888/rule.yml index de0810d77..17629395a 100644 --- a/Unpublished/ADAMIG/AD0888/rule.yml +++ b/Unpublished/ADAMIG/AD0888/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '888' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "888" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: DV - operator: not_exists + - name: DV + operator: not_exists Core: Id: CDISC.ADaMIG.AD0888 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: DV is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0889/rule.yml b/Unpublished/ADAMIG/AD0889/rule.yml index 868adaa88..c66310d26 100644 --- a/Unpublished/ADAMIG/AD0889/rule.yml +++ b/Unpublished/ADAMIG/AD0889/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '889' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "889" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: MDV - operator: not_exists + - name: MDV + operator: not_exists Core: Id: CDISC.ADaMIG.AD0889 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: MDV is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0890/rule.yml b/Unpublished/ADAMIG/AD0890/rule.yml index dc6cbc642..7602707fe 100644 --- a/Unpublished/ADAMIG/AD0890/rule.yml +++ b/Unpublished/ADAMIG/AD0890/rule.yml @@ -1,50 +1,50 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-Core Value is required. - Document: ADaM v1.3 - Item: 'TABLE 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '890' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <-Core Value is required. + Document: ADaM v1.3 + Item: "TABLE 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "890" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: AMT - operator: not_exists + - name: AMT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0890 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AMT is not present Output Variables: - - USUBJID - - SUBJID + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/AD0891/rule.yml b/Unpublished/ADAMIG/AD0891/rule.yml index bb91f85e1..cde22d7d1 100644 --- a/Unpublished/ADAMIG/AD0891/rule.yml +++ b/Unpublished/ADAMIG/AD0891/rule.yml @@ -1,126 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '891' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "891" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "891" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "891" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "891" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: COHORTN - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORTN - operator: is_inconsistent_across_dataset - value: COHORT + - name: COHORTN + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORTN + operator: is_inconsistent_across_dataset + value: COHORT Core: Id: CDISC.ADaMIG.AD0891 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COHORTN is not unique for a given value of COHORT Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTN + - USUBJID + - USUBJIDN + - COHORT + - COHORTN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE #Subclasses: #Include: # - NON-COMPARTMENTAL ANALYSIS diff --git a/Unpublished/ADAMIG/AD0892/rule.yml b/Unpublished/ADAMIG/AD0892/rule.yml index 5ffe9c416..c567813d1 100644 --- a/Unpublished/ADAMIG/AD0892/rule.yml +++ b/Unpublished/ADAMIG/AD0892/rule.yml @@ -1,127 +1,131 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between COHORT and COHORTN. When - COHORT and COHORTN are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '892' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "892" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "892" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "892" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between COHORT and COHORTN. When + COHORT and COHORTN are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "892" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: COHORTN - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORT - operator: is_inconsistent_across_dataset - value: COHORTN + - name: COHORTN + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORT + operator: is_inconsistent_across_dataset + value: COHORTN Core: Id: CDISC.ADaMIG.AD0892 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COHORT is not unique for a given value of COHORTN Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTN + - USUBJID + - USUBJIDN + - COHORT + - COHORTN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0893/rule.yml b/Unpublished/ADAMIG/AD0893/rule.yml index e54cb0e88..ebe04c728 100644 --- a/Unpublished/ADAMIG/AD0893/rule.yml +++ b/Unpublished/ADAMIG/AD0893/rule.yml @@ -1,127 +1,131 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '893' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "893" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "893" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "893" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "893" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: is_inconsistent_across_dataset - value: ACYCLE + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: is_inconsistent_across_dataset + value: ACYCLE Core: Id: CDISC.ADaMIG.AD0893 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ACYCLEC is not unique for a given value of ACYCLE Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0894/rule.yml b/Unpublished/ADAMIG/AD0894/rule.yml index e07107ff7..660a7d53a 100644 --- a/Unpublished/ADAMIG/AD0894/rule.yml +++ b/Unpublished/ADAMIG/AD0894/rule.yml @@ -1,127 +1,131 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When - ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or - both must be null. - Document: ADNCAIG v1.0 - Item: 'Table 4.2.1' - Section: '4.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '894' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "894" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "894" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "894" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- There must be a one-to-one mapping between ACYCLE and ACYCLEC. When + ACYCLE and ACYCLEC are present, then on a given record, either both must be populated or + both must be null. + Document: ADNCAIG v1.0 + Item: "Table 4.2.1" + Section: "4.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "894" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLE - operator: is_inconsistent_across_dataset - value: ACYCLEC + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLE + operator: is_inconsistent_across_dataset + value: ACYCLEC Core: Id: CDISC.ADaMIG.AD0894 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ACYCLE is not unique for a given value of ACYCLEC Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - NON-COMPARTMENTAL ANALYSIS + - NON-COMPARTMENTAL ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/AD0895/rule.yml b/Unpublished/ADAMIG/AD0895/rule.yml index e444eca93..bac9d18d3 100644 --- a/Unpublished/ADAMIG/AD0895/rule.yml +++ b/Unpublished/ADAMIG/AD0895/rule.yml @@ -1,69 +1,69 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.3' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: ANLzzFL has label= Analysis Flag zz. - Document: ADaM IG v1.1 - Item: Table 3.3.8.1 - Section: 3.2.3 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '895' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "895" + Version: "1" + Version: "5.0" + Version: "1.3" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "895" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "895" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: ANLzzFL has label= Analysis Flag zz. + Document: ADaM IG v1.1 + Item: Table 3.3.8.1 + Section: 3.2.3 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "895" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: ANL02FL - operator: exists - - name: variable_label - operator: does_not_contain - value: '02' + - name: ANL02FL + operator: exists + - name: variable_label + operator: does_not_contain + value: "02" Core: Id: Status: Draft - Version: '1' + Version: "1" Description: For analysis flag ANLzzFL, the label should contain the number zz. Executability: Fully Executable Outcome: @@ -72,8 +72,8 @@ Rule Type: Variable Metadata Check Scope: Classes: Exclude: - - ADSL + - ADSL Domains: Exclude: - - ADSL + - ADSL Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml index d722b38af..7448f6a52 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml @@ -1,49 +1,49 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADAMIG - References: - # Origin for ADaM/ADaMIG should be defined in yaml validation schema - - Citations: - - Cited Guidance: >- - ADaM IG v1.3, Section 3.2, Table 3.2.6: TRTSDT and/or TRTSDTM are - required if there is an investigational product. - Document: IG v1.3 - Section: 3.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: AD0061 - Version: '1' - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema - Version: '4.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADAMIG + References: + # Origin for ADaM/ADaMIG should be defined in yaml validation schema + - Citations: + - Cited Guidance: >- + ADaM IG v1.3, Section 3.2, Table 3.2.6: TRTSDT and/or TRTSDTM are + required if there is an investigational product. + Document: IG v1.3 + Section: 3.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: AD0061 + Version: "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: "4.0" + Version: "1.3" Check: all: - - name: $TRTSDT_EXISTS - operator: equal_to - value: false - - name: $TRTSDTM_EXISTS - operator: equal_to - value: false - - name: EX - operator: exists + - name: $TRTSDT_EXISTS + operator: equal_to + value: false + - name: $TRTSDTM_EXISTS + operator: equal_to + value: false + - name: EX + operator: exists Core: # Need to make yaml validation accept ADAMIG - # Will we need to prepend ADaM rules with "AD0..."? + # Will we need to prepend ADaM rules with "AD0..."? # (column "Check Number" in ADaM_Conformance_Rules_v4.0 is 1-3 digits only, some with a ",1" (e.g. "37,01") ) Id: CDISC.ADAMIG.AD0061 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when TRTSDT and/or TRTSDTM are not present, though data exist in SDTM.EX Operations: -- domain: ADSL - id: $TRTSDT_EXISTS - name: TRTSDT - operator: variable_exists -- domain: ADSL - id: $TRTSDTM_EXISTS - name: TRTSDTM - operator: variable_exists + - domain: ADSL + id: $TRTSDT_EXISTS + name: TRTSDT + operator: variable_exists + - domain: ADSL + id: $TRTSDTM_EXISTS + name: TRTSDTM + operator: variable_exists Outcome: Message: SDTM.EX is present and neither TRTSDT or TRTSDTM are present @@ -53,9 +53,9 @@ Scope: Classes: Include: # What ADaM classes will be defined? ADSL, BDS, OCCDS, OTHER? - - ADSL + - ADSL Domains: Include: - - ADSL - - EX + - ADSL + - EX Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml index 30a2c3073..e7d892745 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0088/CDISC.ADAMIG.AD0088.yml @@ -2,71 +2,71 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '88' - Version: '1' - Version: '4.0' + Id: "88" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.3 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: STUDYID has Core=Req. - Document: ADaM IG v1.3 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: STUDYID has Core=Req. - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '88' - Version: '1' - Version: '4.0' + Id: "88" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.2 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: STUDYID has Core=Req. - Document: ADaM IG v1.2 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: STUDYID has Core=Req. - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '88' - Version: '1' - Version: '4.0' + Id: "88" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.1 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: STUDYID has Core=Req. - Document: ADaM IG v1.1 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: STUDYID has Core=Req. - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '88' - Version: '1' - Version: '4.0' + Id: "88" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.0 - Section: '3.1' + Section: "3.1" Item: Table 3.1.1 Cited Guidance: STUDYID has Core=Req. - Document: ADaM IG v1.0 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1.1 Cited Guidance: STUDYID has Core=Req. Check: @@ -76,7 +76,7 @@ Check: Core: Id: CDISC.ADAMIG.AD0088 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when STUDYID is not present Executability: Fully Executable Outcome: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml index b9f136f45..399468229 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0089/CDISC.ADAMIG.AD0089.yml @@ -2,71 +2,71 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '89' - Version: '1' - Version: '4.0' + Id: "89" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.3 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: USUBJID has Core=Req. - Document: ADaM IG v1.3 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: USUBJID has Core=Req. - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '89' - Version: '1' - Version: '4.0' + Id: "89" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.2 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: USUBJID has Core=Req. - Document: ADaM IG v1.2 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: USUBJID has Core=Req. - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '89' - Version: '1' - Version: '4.0' + Id: "89" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.1 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1 Cited Guidance: USUBJID has Core=Req. - Document: ADaM IG v1.1 - Section: '3.3' + Section: "3.3" Item: Table 3.3.1.1 Cited Guidance: USUBJID has Core=Req. - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules Rule Identifier: - Id: '89' - Version: '1' - Version: '4.0' + Id: "89" + Version: "1" + Version: "4.0" Citations: - Document: ADaM IG v1.0 - Section: '3.1' + Section: "3.1" Item: Table 3.1.1 Cited Guidance: USUBJID has Core=Req. - Document: ADaM IG v1.0 - Section: '3.2' + Section: "3.2" Item: Table 3.2.1.1 Cited Guidance: USUBJID has Core=Req. Check: @@ -76,7 +76,7 @@ Check: Core: Id: CDISC.ADAMIG.AD0089 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when USUBJID is not present Executability: Fully Executable Outcome: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml index 1790a2c36..15cf0d25c 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0261/CDISC.ADAMIG.AD0261.yml @@ -4,79 +4,87 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for + - Cited Guidance: + --DECOD has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Item: Table 3.2.3.1 Section: 3.2.3 - - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC + - Cited Guidance: + --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Item: Table 3.2.3.1 Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '261' - Version: '1' - Version: '4.0' - Version: '1.3' + Id: "261" + Version: "1" + Version: "4.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for + - Cited Guidance: + --DECOD has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Item: Table 3.2.3.1 Section: 3.2.3 - - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC + - Cited Guidance: + --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Item: Table 3.2.3.1 Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '261' - Version: '1' - Version: '4.0' - Version: '1.2' + Id: "261" + Version: "1" + Version: "4.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for + - Cited Guidance: + --DECOD has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Item: Table 3.2.3.1 Section: 3.2.3 - - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC + - Cited Guidance: + --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Item: Table 3.2.3.1 Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '261' - Version: '1' - Version: '4.0' - Version: '1.1' + Id: "261" + Version: "1" + Version: "4.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: --DECOD has Core=Cond and the CDISC Notes state "Required for + - Cited Guidance: + --DECOD has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Item: Table 3.2.3.1 Section: 3.2.3 - - Cited Guidance: --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC + - Cited Guidance: + --DECOD has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Item: Table 3.2.3.1 Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '261' - Version: '1' - Version: '4.0' - Version: '1.0' + Id: "261" + Version: "1" + Version: "4.0" + Version: "1.0" Check: all: - name: AEDECOD @@ -84,12 +92,12 @@ Check: Core: Id: CDISC.ADAMIG.AD0261 Status: Draft - Version: '1' + Version: "1" Description: Variable AEDECOD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEDECOD is not present in ADVERSE EVENT dataset #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEDECOD is not present in ADVERSE EVENT dataset #Can we output actual dataset name in message, eg ADAE3M? #Output Variables: # - AEDECOD Rule Type: Record Data diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml index e5ae396be..5ecfda056 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0262/CDISC.ADAMIG.AD0262.yml @@ -2,77 +2,85 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '262' - Version: '1' + Id: "262" + Version: "1" Citations: - - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required + - Cited Guidance: + --BODSYS has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Section: 3.2.3 Item: Table 3.2.3.1 - - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and + - Cited Guidance: + --BODSYS has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '262' - Version: '1' + Id: "262" + Version: "1" Citations: - - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required + - Cited Guidance: + --BODSYS has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Section: 3.2.3 Item: Table 3.2.3.1 - - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and + - Cited Guidance: + --BODSYS has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '262' - Version: '1' + Id: "262" + Version: "1" Citations: - - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required + - Cited Guidance: + --BODSYS has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Section: 3.2.3 Item: Table 3.2.3.1 - - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and + - Cited Guidance: + --BODSYS has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '262' - Version: '1' + Id: "262" + Version: "1" Citations: - - Cited Guidance: --BODSYS has Core=Cond and the CDISC Notes state "Required + - Cited Guidance: + --BODSYS has Core=Cond and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.0 Section: 3.2.3 Item: Table 3.2.3.1 - - Cited Guidance: --BODSYS has Core=Req for SubClass=ADVERSE EVENT and + - Cited Guidance: + --BODSYS has Core=Req for SubClass=ADVERSE EVENT and the CDISC Notes state "Required for Adverse Event data". Document: OCCDS IG v1.1 Section: 3.2.3 @@ -84,12 +92,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0262 Status: Draft - Version: '1' -Description: Variable AEBODSYS should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEBODSYS should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEBODSYS is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEBODSYS is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml index 1d25683de..a5f6a6dad 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0278/CDISC.ADAMIG.AD0278.yml @@ -2,13 +2,13 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '278' - Version: '1' + Id: "278" + Version: "1" Citations: - Cited Guidance: AESER has Core=Req. Document: OCCDS IG v1.0 @@ -19,13 +19,13 @@ Authorities: Section: 3.2.8 Item: Table 3.2.8.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '278' - Version: '1' + Id: "278" + Version: "1" Citations: - Cited Guidance: AESER has Core=Req. Document: OCCDS IG v1.0 @@ -36,13 +36,13 @@ Authorities: Section: 3.2.8 Item: Table 3.2.8.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '278' - Version: '1' + Id: "278" + Version: "1" Citations: - Cited Guidance: AESER has Core=Req. Document: OCCDS IG v1.0 @@ -53,13 +53,13 @@ Authorities: Section: 3.2.8 Item: Table 3.2.8.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '278' - Version: '1' + Id: "278" + Version: "1" Citations: - Cited Guidance: AESER has Core=Req. Document: OCCDS IG v1.0 @@ -76,12 +76,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0278 Status: Draft - Version: '1' -Description: Variable AESER should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AESER should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AESER is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AESER is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml index c50c9aa76..55d4398ae 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0620/CDISC.ADAMIG.AD0620.yml @@ -10,10 +10,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '620' - Version: '1' - Version: '5.0' - Version: '1.3' + Id: "620" + Version: "1" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: @@ -23,10 +23,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '620' - Version: '1' - Version: '5.0' - Version: '1.2' + Id: "620" + Version: "1" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: @@ -36,10 +36,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '620' - Version: '1' - Version: '5.0' - Version: '1.1' + Id: "620" + Version: "1" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: @@ -49,10 +49,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '620' - Version: '1' - Version: '5.0' - Version: '1.0' + Id: "620" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - name: AETERM @@ -60,12 +60,12 @@ Check: Core: Id: CDISC.ADAMIG.AD0620 Status: Draft - Version: '1' + Version: "1" Description: Variable AETERM should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AETERM is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AETERM is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml index 5df66f6c8..9d6f8cd93 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0621/CDISC.ADAMIG.AD0621.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '621' - Version: '1' + Id: "621" + Version: "1" Citations: - Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.5 Item: Table 3.2.5.3 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '621' - Version: '1' + Id: "621" + Version: "1" Citations: - Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.5 Item: Table 3.2.5.3 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '621' - Version: '1' + Id: "621" + Version: "1" Citations: - Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.5 Item: Table 3.2.5.3 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '621' - Version: '1' + Id: "621" + Version: "1" Citations: - Cited Guidance: TRTEMFL has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0621 Status: Draft - Version: '1' -Description: Variable TRTEMFL should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable TRTEMFL should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable TRTEMFL is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable TRTEMFL is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml index 5f09e0e50..83d2aada9 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0623/CDISC.ADAMIG.AD0623.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '623' - Version: '1' + Id: "623" + Version: "1" Citations: - Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.2 Item: Table 3.2.2.2 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '623' - Version: '1' + Id: "623" + Version: "1" Citations: - Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.2 Item: Table 3.2.2.2 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '623' - Version: '1' + Id: "623" + Version: "1" Citations: - Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.2 Item: Table 3.2.2.2 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '623' - Version: '1' + Id: "623" + Version: "1" Citations: - Cited Guidance: --SEQ has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0623 Status: Draft - Version: '1' -Description: Variable AESEQ should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AESEQ should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AESEQ is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AESEQ is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml index bd129b649..e0b93ca11 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0624/CDISC.ADAMIG.AD0624.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '624' - Version: '1' + Id: "624" + Version: "1" Citations: - Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '624' - Version: '1' + Id: "624" + Version: "1" Citations: - Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '624' - Version: '1' + Id: "624" + Version: "1" Citations: - Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '624' - Version: '1' + Id: "624" + Version: "1" Citations: - Cited Guidance: --LLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0624 Status: Draft - Version: '1' -Description: Variable AELLT should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AELLT should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AELLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AELLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml index af98f8055..214e7ef8f 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0625/CDISC.ADAMIG.AD0625.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '625' - Version: '1' + Id: "625" + Version: "1" Citations: - Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '625' - Version: '1' + Id: "625" + Version: "1" Citations: - Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '625' - Version: '1' + Id: "625" + Version: "1" Citations: - Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '625' - Version: '1' + Id: "625" + Version: "1" Citations: - Cited Guidance: --BDSYCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0625 Status: Draft - Version: '1' -Description: Variable AEBDSYCD should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEBDSYCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEBDSYCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEBDSYCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml index 30aa1a976..f78ef2d1c 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0626/CDISC.ADAMIG.AD0626.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '626' - Version: '1' + Id: "626" + Version: "1" Citations: - Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '626' - Version: '1' + Id: "626" + Version: "1" Citations: - Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '626' - Version: '1' + Id: "626" + Version: "1" Citations: - Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '626' - Version: '1' + Id: "626" + Version: "1" Citations: - Cited Guidance: --LLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0626 Status: Draft - Version: '1' -Description: Variable AELLTCD should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AELLTCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AELLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AELLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml index ee9dad601..5833cfd68 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0627/CDISC.ADAMIG.AD0627.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '627' - Version: '1' + Id: "627" + Version: "1" Citations: - Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '627' - Version: '1' + Id: "627" + Version: "1" Citations: - Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '627' - Version: '1' + Id: "627" + Version: "1" Citations: - Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '627' - Version: '1' + Id: "627" + Version: "1" Citations: - Cited Guidance: --HLT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0627 Status: Draft - Version: '1' -Description: Variable AEHLT should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEHLT should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEHLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEHLT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml index d444c0e3b..fb49c3349 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0628/CDISC.ADAMIG.AD0628.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '628' - Version: '1' + Id: "628" + Version: "1" Citations: - Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '628' - Version: '1' + Id: "628" + Version: "1" Citations: - Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '628' - Version: '1' + Id: "628" + Version: "1" Citations: - Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '628' - Version: '1' + Id: "628" + Version: "1" Citations: - Cited Guidance: --HLTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0628 Status: Draft - Version: '1' -Description: Variable AEHLTCD should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEHLTCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEHLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEHLTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml index 11f7fe69b..96b7aac36 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0629/CDISC.ADAMIG.AD0629.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '629' - Version: '1' + Id: "629" + Version: "1" Citations: - Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '629' - Version: '1' + Id: "629" + Version: "1" Citations: - Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '629' - Version: '1' + Id: "629" + Version: "1" Citations: - Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '629' - Version: '1' + Id: "629" + Version: "1" Citations: - Cited Guidance: --HLGT has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0629 Status: Draft - Version: '1' -Description: Variable AEHLGT should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEHLGT should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEHLGT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEHLGT is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml index a29256b47..724c41e43 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0630/CDISC.ADAMIG.AD0630.yml @@ -10,10 +10,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '630' - Version: '1' - Version: '5.0' - Version: '1.3' + Id: "630" + Version: "1" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: @@ -23,10 +23,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '630' - Version: '1' - Version: '5.0' - Version: '1.2' + Id: "630" + Version: "1" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: @@ -36,10 +36,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '630' - Version: '1' - Version: '5.0' - Version: '1.1' + Id: "630" + Version: "1" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: @@ -49,10 +49,10 @@ Authorities: Section: 3.2.3 Origin: ADaM Conformance Rules Rule Identifier: - Id: '630' - Version: '1' - Version: '5.0' - Version: '1.0' + Id: "630" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - name: AEHLGTCD @@ -60,12 +60,12 @@ Check: Core: Id: CDISC.ADAMIG.AD0630 Status: Draft - Version: '1' + Version: "1" Description: Variable AEHLGTCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEHLGTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEHLGTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml index b8854773d..46659f8e9 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0631/CDISC.ADAMIG.AD0631.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '631' - Version: '1' + Id: "631" + Version: "1" Citations: - Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '631' - Version: '1' + Id: "631" + Version: "1" Citations: - Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '631' - Version: '1' + Id: "631" + Version: "1" Citations: - Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '631' - Version: '1' + Id: "631" + Version: "1" Citations: - Cited Guidance: --PTCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0631 Status: Draft - Version: '1' -Description: Variable AEPTCD should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AEPTCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AEPTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AEPTCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml index 91494d96a..f9d13e09f 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0632/CDISC.ADAMIG.AD0632.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '632' - Version: '1' + Id: "632" + Version: "1" Citations: - Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '632' - Version: '1' + Id: "632" + Version: "1" Citations: - Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '632' - Version: '1' + Id: "632" + Version: "1" Citations: - Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '632' - Version: '1' + Id: "632" + Version: "1" Citations: - Cited Guidance: --SOC has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0632 Status: Draft - Version: '1' -Description: Variable AESOC should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AESOC should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AESOC is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AESOC is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml index b3ebdbb02..78a576d61 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0633/CDISC.ADAMIG.AD0633.yml @@ -2,52 +2,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '633' - Version: '1' + Id: "633" + Version: "1" Citations: - Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '633' - Version: '1' + Id: "633" + Version: "1" Citations: - Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '633' - Version: '1' + Id: "633" + Version: "1" Citations: - Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 Section: 3.2.3 Item: Table 3.2.3.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '633' - Version: '1' + Id: "633" + Version: "1" Citations: - Cited Guidance: --SOCCD has Core=Req for SubClass=ADVERSE EVENT. Document: OCCDS IG v1.1 @@ -60,12 +60,13 @@ Check: Core: Id: CDISC.ADAMIG.AD0633 Status: Draft - Version: '1' -Description: Variable AESOCCD should be present in analysis dataset for Adverse Event + Version: "1" +Description: + Variable AESOCCD should be present in analysis dataset for Adverse Event analysis Executability: Fully Executable Outcome: - Message: Variable AESOCCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? + Message: Variable AESOCCD is not present in dataset ADAE #Can we output actual dataset name in message, eg ADAE3M? Rule Type: Record Data Scope: Data Structures: diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml index 4e650de43..0e01ec2f0 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0054/rule.yml @@ -1,130 +1,138 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.3 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial - design.' - Document: ADaMIG v1.3 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical - trial design.' - Document: ADaM IG v1.3 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.3 + Item: "" + Section: "1.3" + - Cited Guidance: + "ADSL contains one record per subject, regardless of the type of clinical trial + design." + Document: ADaMIG v1.3 + Item: "" + Section: "2.3.1" + - Cited Guidance: + "The structure of ADSL is one record per subject, regardless of the type of clinical + trial design." + Document: ADaM IG v1.3 + Item: "" + Section: "3.2" + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "54" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.2 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial - design.' - Document: ADaM IG v1.2 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical - trial design.' - Document: ADaM IG v1.2 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.2 + Item: "" + Section: "1.3" + - Cited Guidance: + "ADSL contains one record per subject, regardless of the type of clinical trial + design." + Document: ADaM IG v1.2 + Item: "" + Section: "2.3.1" + - Cited Guidance: + "The structure of ADSL is one record per subject, regardless of the type of clinical + trial design." + Document: ADaM IG v1.2 + Item: "" + Section: "3.2" + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "54" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.1 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial - design.' - Document: ADaM IG v1.1 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical - trial design.' - Document: ADaM IG v1.1 - Item: '' - Section: '3.2' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.1 + Item: "" + Section: "1.3" + - Cited Guidance: + "ADSL contains one record per subject, regardless of the type of clinical trial + design." + Document: ADaM IG v1.1 + Item: "" + Section: "2.3.1" + - Cited Guidance: + "The structure of ADSL is one record per subject, regardless of the type of clinical + trial design." + Document: ADaM IG v1.1 + Item: "" + Section: "3.2" + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "54" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: The ADSL dataset contains one record per subject. - Document: ADaM IG v1.0 - Item: '' - Section: '1.3' - - Cited Guidance: 'ADSL contains one record per subject, regardless of the type of clinical trial - design.' - Document: ADaM IG v1.0 - Item: '' - Section: '2.3.1' - - Cited Guidance: 'The structure of ADSL is one record per subject, regardless of the type of clinical - trial design.' - Document: ADaM IG v1.0 - Item: '' - Section: '3.1' - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '54' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: The ADSL dataset contains one record per subject. + Document: ADaM IG v1.0 + Item: "" + Section: "1.3" + - Cited Guidance: + "ADSL contains one record per subject, regardless of the type of clinical trial + design." + Document: ADaM IG v1.0 + Item: "" + Section: "2.3.1" + - Cited Guidance: + "The structure of ADSL is one record per subject, regardless of the type of clinical + trial design." + Document: ADaM IG v1.0 + Item: "" + Section: "3.1" + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "54" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - - name: USUBJID - operator: is_not_unique_set - value: - - STUDYID + - name: USUBJID + operator: is_not_unique_set + value: + - STUDYID Core: Id: CDISC.ADaMIG.AD0054 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'Duplicate USUBJIDs: Only one record permitted per USUBJID' + Message: "Duplicate USUBJIDs: Only one record permitted per USUBJID" Output Variables: - - USUBJID - - STUDYID + - USUBJID + - STUDYID Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml index fc9f25228..2650b4761 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0060/rule.yml @@ -1,84 +1,84 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: "3" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "60" + Version: "5.0" + Version: "1.3" - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3' - Section: 3.1.2 - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: >- - Variables whose names end in DTM are numeric datetimes - Document: ADaM IG v1.3 - Item: '3 (General Timing Variable Conventions)' - Section: '3' - Origin: ADaM Conformance Rules - Rule Identifier: - Id: '60' - Version: '5.0' - Version: '1.0' + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: "3" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "60" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: "3" + Section: 3.1.2 + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "60" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: >- + Variables whose names end in DTM are numeric datetimes + Document: ADaM IG v1.3 + Item: "3 (General Timing Variable Conventions)" + Section: "3" + Origin: ADaM Conformance Rules + Rule Identifier: + Id: "60" + Version: "5.0" + Version: "1.0" Check: all: - - name: -- DTM - operator: is_not_numeric + - name: -- DTM + operator: is_not_numeric Core: Id: CDISC.ADaMIG.AD0060 Status: Draft - Version: '1' + Version: "1" Description: >- 'A variable with a suffix of DTM must be numeric' Executability: Fully Executable Outcome: Message: Variable with a suffix of DTM must be numeric Output Variables: - - SUBJID - - --DTM + - SUBJID + - --DTM Rule Type: Record Data Scope: Data Structures: Include: - - ALL + - ALL Subclasses: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml index 99007e2e2..4fc7034a4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0143/CDISC.ADaMIG.AD0143.yml @@ -4,34 +4,36 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '143' - Plain Language Expression: '' + Condition: "" + Rule: "143" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '143' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "143" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -40,38 +42,40 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.2 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.2 - Item: '1' + Item: "1" Section: 3.4.1, Table 3.3.4.1.1 Criteria: Logical Expression: - Condition: '' - Rule: '143' - Plain Language Expression: '' + Condition: "" + Rule: "143" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '143' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "143" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -80,38 +84,40 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.2 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.2 - Item: '1' + Item: "1" Section: 3.4.1, Table 3.3.4.1.1 Criteria: Logical Expression: - Condition: '' - Rule: '143' - Plain Language Expression: '' + Condition: "" + Rule: "143" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '143' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "143" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -120,38 +126,40 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.1 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.1 - Item: '1' + Item: "1" Section: 3.3.4, Table 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '143' - Plain Language Expression: '' + Condition: "" + Rule: "143" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '143' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "143" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming + - Cited Guidance: + Values of PARAMCD should follow SAS 5 variable naming conventions (8 characters or less; starts with a letter; contains only letters and digits). Document: ADaMIG v1.0 @@ -159,21 +167,21 @@ Authorities: Section: 3.2.4 Criteria: Logical Expression: - Condition: '' - Rule: '143' - Plain Language Expression: '' + Condition: "" + Rule: "143" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '143' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "143" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: @@ -184,8 +192,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0143 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: Variable name has more than 8 characters diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml index 817cac66f..9d6118aa1 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0144/CDISC.ADaMIG.AD0144.yml @@ -1,36 +1,38 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG-MD' + - Name: "ADaMIG-MD" References: - Citations: - - Cited Guidance: <-The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + <-The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "144" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -39,55 +41,57 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.1 - Item: '1' - Section: '3.1.1' + Item: "1" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "144" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaMIG v1.1 - Item: '' - Section: '3.3.4, Table 3.3.4.1' + Item: "" + Section: "3.3.4, Table 3.3.4.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "144" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -96,55 +100,57 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.1 - Item: '1' - Section: '3.1.1' + Item: "1" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "144" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaMIG v1.1 - Item: '' - Section: '3.3.4, Table 3.3.4.1' + Item: "" + Section: "3.3.4, Table 3.3.4.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "144" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -153,77 +159,79 @@ Authorities: character variables must be no more than 200 characters in length. Document: ADaMIG v1.1 - Item: '1' - Section: '3.1.1' + Item: "1" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "144" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaMIG v1.1 - Item: '' - Section: '3.3.4, Table 3.3.4.1' + Item: "" + Section: "3.3.4, Table 3.3.4.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "144" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming + - Cited Guidance: + Values of PARAMCD should follow SAS 5 variable naming conventions (8 characters or less; starts with a letter; contains only letters and digits). Document: ADaMIG v1.0 - Item: '' - Section: '3.2.4, table 3.2.4.1' + Item: "" + Section: "3.2.4, table 3.2.4.1" Criteria: Logical Expression: - Condition: '' - Rule: '144' - Plain Language Expression: '' + Condition: "" + Rule: "144" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '144' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "144" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: @@ -234,8 +242,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0144 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAMCD starts with a character other than a letter diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml index 602795926..9b1b1d611 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0145/CDISC.ADaMIG.AD0145.yml @@ -4,34 +4,36 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '145' - Plain Language Expression: '' + Condition: "" + Rule: "145" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '145' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "145" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -40,38 +42,40 @@ Authorities: character variables must be no more than 200 characters in length. characters). Document: ADaMIG v1.3 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.3 - Item: '1' + Item: "1" Section: 3.3.4.1, Table 3.3.4.1.1 Criteria: Logical Expression: - Condition: '' - Rule: '145' - Plain Language Expression: '' + Condition: "" + Rule: "145" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '145' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "145" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -80,38 +84,40 @@ Authorities: character variables must be no more than 200 characters in length. characters). Document: ADaMIG v1.2 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.2 - Item: '1' + Item: "1" Section: 3.3.4.1, Table 3.3.4.1.1 Criteria: Logical Expression: - Condition: '' - Rule: '145' - Plain Language Expression: '' + Condition: "" + Rule: "145" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '145' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "145" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: To ensure compliance with SAS Version 5 transport file format + - Cited Guidance: + To ensure compliance with SAS Version 5 transport file format and Oracle constraints, all ADaM variable names must be no more than 8 characters in length, start with a letter (not underscore), and be comprised only of letters (A-Z), @@ -120,38 +126,40 @@ Authorities: character variables must be no more than 200 characters in length. characters). Document: ADaMIG v1.1 - Item: '1' + Item: "1" Section: 3.1.1 - - Cited Guidance: Values of PARAMCD should follow the SAS Version 5 transport file + - Cited Guidance: + Values of PARAMCD should follow the SAS Version 5 transport file format and Oracle constraints as noted under General Variable Conventions in Section 3.1.1. Document: ADaM IG v1.1 - Item: '1' + Item: "1" Section: 3.3.4, Table 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '145' - Plain Language Expression: '' + Condition: "" + Rule: "145" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '145' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "145" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Organization: CDISC Standards: - Name: ADaMIG References: - Citations: - - Cited Guidance: Values of PARAMCD should follow SAS 5 variable naming + - Cited Guidance: + Values of PARAMCD should follow SAS 5 variable naming conventions (8 characters or less; starts with a letter; contains only letters and digits). Document: ADaMIG v1.0 @@ -159,21 +167,21 @@ Authorities: Section: 3.2.4 Criteria: Logical Expression: - Condition: '' - Rule: '145' - Plain Language Expression: '' + Condition: "" + Rule: "145" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '' + - Id: "" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '145' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "145" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: @@ -184,8 +192,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0145 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAMCD has characters that are not letters, digits, and underscores diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml index 8ba403b98..45e19f504 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0159/CDISC.ADaMIG.AD0159.yml @@ -10,18 +10,18 @@ Authorities: Section: 3.2.5 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: 'AWTARGET is not populated' + Condition: "" + Rule: "" + Plain Language Expression: "AWTARGET is not populated" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '159' - Version: '' - Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated' - Version: '5.0' - Version: '1.0' + Id: "159" + Version: "" + Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: @@ -32,18 +32,18 @@ Authorities: Section: 3.2.5 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: 'AWTARGET is not populated' + Condition: "" + Rule: "" + Plain Language Expression: "AWTARGET is not populated" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '159' - Version: '' - Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated' - Version: '5.0' - Version: '1.1' + Id: "159" + Version: "" + Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: @@ -54,18 +54,18 @@ Authorities: Section: 3.2.5 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: 'AWTARGET is not populated' + Condition: "" + Rule: "" + Plain Language Expression: "AWTARGET is not populated" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '159' - Version: '' - Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated' - Version: '5.0' - Version: '1.2' + Id: "159" + Version: "" + Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: @@ -76,42 +76,43 @@ Authorities: Section: 3.2.5 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: 'AWTARGET is not populated' + Condition: "" + Rule: "" + Plain Language Expression: "AWTARGET is not populated" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '159' - Version: '2' - Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated' - Version: '5.0' - Version: '1.3' + Id: "159" + Version: "2" + Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated" + Version: "5.0" + Version: "1.3" - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details.Absolute difference between ADY or ARELTM and AWTARGET. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: 'AWTARGET is not populated' + Condition: "" + Rule: "" + Plain Language Expression: "AWTARGET is not populated" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '159' - Version: '2' - Validator Rule Message: 'AWTDIFF is populated and AWTARGET is not populated' - Version: '5.0' - Version: '1.0' + Id: "159" + Version: "2" + Validator Rule Message: "AWTDIFF is populated and AWTARGET is not populated" + Version: "5.0" + Version: "1.0" Check: all: @@ -123,8 +124,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0159 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AWTARGET must be populated when AWTDIFF is populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml index 796c10114..d2516e792 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0160/CDISC.ADaMIG.AD0160.yml @@ -15,13 +15,13 @@ Authorities: Plain Language Expression: When AWU is present, AWLO and AWH must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '160' - Version: '' + Id: "160" + Version: "" Validator Rule Message: AWU is present but AWLO and AWHI are not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -37,15 +37,15 @@ Authorities: Type: Failure Origin: ADaM Conformance Rules Related Rules: - - Id: '896' + - Id: "896" Relationship: Related - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '160' - Version: '1.0' + Id: "160" + Version: "1.0" Validator Rule Message: AWU is present but AWLO and AWHI are not present - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" #check logic that both need to absent for tule to fire? @@ -67,8 +67,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0160 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AWU is present but AWLO and AWHI are not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml index c26585865..ce69b35f6 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0163/CDISC.ADaMIG.AD0163.yml @@ -15,13 +15,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ATOXGR must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '163' - Version: '' + Id: "163" + Version: "" Validator Rule Message: BTOXGR is present but ATOXGR is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -36,13 +36,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ATOXGR must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '163' - Version: '' + Id: "163" + Version: "" Validator Rule Message: BTOXGR is present but ATOXGR is not present - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: @@ -58,19 +58,19 @@ Authorities: Plain Language Expression: When BTOXGR is present, ATOXGR must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '163' - Version: '' + Id: "163" + Version: "" Validator Rule Message: BTOXGR is present but ATOXGR is not present - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - Cited Guidance: ATOXGR of the baseline record identified by ABLFL. Document: ADaMIG - Item: '' + Item: "" Section: 3.3.7, Table 3.3.7.1 Criteria: Logical Expression: @@ -79,22 +79,23 @@ Authorities: Plain Language Expression: When BTOXGR is present, ATOXGR must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '163' - Version: '2' + Id: "163" + Version: "2" Validator Rule Message: BTOXGR is present but ATOXGR is not present - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details." Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: Condition: BTOXGR is present and ATOXGR is not present @@ -102,13 +103,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ATOXGR must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '163' - Version: '2' + Id: "163" + Version: "2" Validator Rule Message: BTOXGR is present but ATOXGR is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" Check: all: @@ -120,8 +121,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0163 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BTOXGR is present but ATOXGR is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml index d1fe6949d..49174d2b2 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0164/CDISC.ADaMIG.AD0164.yml @@ -4,12 +4,13 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details." Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: Condition: BTOXGR is present and ABLFL is not present @@ -17,13 +18,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '164' - Version: '2' + Id: "164" + Version: "2" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -38,13 +39,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '164' - Version: '' + Id: "164" + Version: "" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: @@ -60,13 +61,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '164' - Version: '' + Id: "164" + Version: "" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: @@ -82,13 +83,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '164' - Version: '' + Id: "164" + Version: "" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: @@ -104,13 +105,13 @@ Authorities: Plain Language Expression: When BTOXGR is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '164' - Version: '' + Id: "164" + Version: "" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" Check: all: @@ -122,8 +123,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0164 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BTOXGR is present but ABLFL is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml index 7e31f9a16..7f05cec89 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0166/CDISC.ADaMIG.AD0166.yml @@ -4,12 +4,13 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details." Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: Condition: BNRIND is present and ANRIND is not present @@ -17,13 +18,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ANRIND must also Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '166' - Version: '2' + Id: "166" + Version: "2" Validator Rule Message: BTOXGR is present but ABLFL is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -38,13 +39,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ANRIND must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '166' - Version: '' + Id: "166" + Version: "" Validator Rule Message: BNRIND is present but ANRIND is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: @@ -60,13 +61,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ANRIND must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '166' - Version: '' + Id: "166" + Version: "" Validator Rule Message: BNRIND is present but ANRIND is not present - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: @@ -82,13 +83,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ANRIND must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '166' - Version: '' + Id: "166" + Version: "" Validator Rule Message: BNRIND is present but ANRIND is not present - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: @@ -104,13 +105,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ANRIND must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '166' - Version: '2' + Id: "166" + Version: "2" Validator Rule Message: BNRIND is present but ANRIND is not present - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" Check: all: @@ -122,8 +123,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0166 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BNRIND is present but ANRIND is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml index d754f9319..df83cb0bf 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0167/CDISC.ADaMIG.AD0167.yml @@ -4,12 +4,13 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details." Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: Condition: BNRIND is present and ABLFL is not present @@ -17,13 +18,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '167' - Version: '2' + Id: "167" + Version: "2" Validator Rule Message: BNRIND is present but ABLFL is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -38,13 +39,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '167' - Version: '1' + Id: "167" + Version: "1" Validator Rule Message: BNRIND is present but ABLFL is not present - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: @@ -60,13 +61,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '167' - Version: '1' + Id: "167" + Version: "1" Validator Rule Message: BNRIND is present but ABLFL is not present - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: @@ -82,13 +83,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '167' - Version: '1' + Id: "167" + Version: "1" Validator Rule Message: BNRIND is present but ABLFL is not present - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: @@ -104,13 +105,13 @@ Authorities: Plain Language Expression: When BNRIND is present, ABLFL must also be present Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '167' - Version: '2' + Id: "167" + Version: "2" Validator Rule Message: BNRIND is present but ABLFL is not present - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" Check: all: @@ -122,8 +123,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0167 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BNRIND is present but ABLFL is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml index c5afadb06..8ab073d8c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0169/CDISC.ADaMIG.AD0169.yml @@ -4,12 +4,13 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details." Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: Condition: Event indicator value is a positive integer greater or equal to zero @@ -17,16 +18,17 @@ Authorities: Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '169' - Version: '2' + Id: "169" + Version: "2" Validator Rule Message: CNSR value is not an integer >= 0 - Version: '5.0' + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: It is strongly recommended to use 0 as an event indicator and + - Cited Guidance: + It is strongly recommended to use 0 as an event indicator and positive integers as censoring indicators Document: ADaMIG Item: Table 3.2.5.3 @@ -38,17 +40,18 @@ Authorities: Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '169' - Version: '1' + Id: "169" + Version: "1" Validator Rule Message: CNSR value is not an integer >= 0 - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: It is strongly recommended to use 0 as an event indicator and + - Cited Guidance: + It is strongly recommended to use 0 as an event indicator and positive integers as censoring indicators Document: ADaMIG Item: Table 3.3.6.1 @@ -60,17 +63,18 @@ Authorities: Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '169' - Version: '1' + Id: "169" + Version: "1" Validator Rule Message: CNSR value is not an integer >= 0 - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: It is strongly recommended to use 0 as an event indicator and + - Cited Guidance: + It is strongly recommended to use 0 as an event indicator and positive integers as censoring indicators Document: ADaMIG Item: Table 3.3.6.1 @@ -82,17 +86,18 @@ Authorities: Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '169' - Version: '1' + Id: "169" + Version: "1" Validator Rule Message: CNSR value is not an integer >= 0 - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: It is strongly recommended to use 0 as an event indicator and + - Cited Guidance: + It is strongly recommended to use 0 as an event indicator and positive integers as censoring indicators Document: ADaMIG Item: Table 3.3.6.1 @@ -104,13 +109,13 @@ Authorities: Plain Language Expression: CNSR value must be whole numbers greater then/equal to zero Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '169' - Version: '2' + Id: "169" + Version: "2" Validator Rule Message: CNSR value is not an integer >= 0 - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" Check: all: @@ -121,8 +126,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0169 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: CNSR value is not an integer >= 0 diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml index 42150bbd7..d88757a0f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0176/CDISC.ADaMIG.AD0176.yml @@ -4,7 +4,7 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}' + - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}" Document: ADaMIG Item: Table 3.2.6.1 Section: 3.2.6 @@ -15,17 +15,17 @@ Authorities: Plain Language Expression: ABLFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '176' - Version: '' + Id: "176" + Version: "" Validator Rule Message: ABLFL must equal to Y or missing - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}' + - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}" Document: ADaMIG Item: Table 3.3.8.1 Section: 3.3.8 @@ -36,13 +36,13 @@ Authorities: Plain Language Expression: ABLFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '176' - Version: '' + Id: "176" + Version: "" Validator Rule Message: ABLFL must equal to Y or missing - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" Check: all: - name: ABLFL @@ -53,8 +53,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0176 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ABLFL is not equal to Y or missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml index 29c266df1..7b2a5a0b6 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0178/CDISC.ADaMIG.AD0178.yml @@ -4,28 +4,28 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}' + - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}" Document: ADaMIG Item: Table 3.2.6.1 Section: 3.2.6 Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: ANLzzzL is equal to Y or null Plain Language Expression: ANLzzFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '178' - Version: '' + Id: "178" + Version: "" Validator Rule Message: ANLzzFL must equal to Y or missing - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: 'Codelist/Controlled Terms: Y {Y, NULL}' + - Cited Guidance: "Codelist/Controlled Terms: Y {Y, NULL}" Document: ADaMIG Item: Table 3.3.8.1 Section: 3.3.8 @@ -36,22 +36,22 @@ Authorities: Plain Language Expression: ANLzzFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '178' - Version: '' + Id: "178" + Version: "" Validator Rule Message: ANLzzFL must equal to Y or missing - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" Check: all: - name: variable_name operator: matches_regex - value: 'AN/[0-9]/[0-9]/FL' - - name: &variable_name #how to refer to return variable from first check? + value: "AN/[0-9]/[0-9]/FL" + - name: &variable_name #how to refer to return variable from first check? operator: is_not_contained_by value: - - 'Y' + - "Y" #or # all: @@ -63,12 +63,11 @@ Check: # value: # - 'Y' - Core: Id: CDISC.ADaMIG.AD0178 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ANLzzFL is not equal to Y or missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml index 9c9cd31e6..7bfa0c490 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0194/CDISC.ADaMIG.AD0194.yml @@ -4,25 +4,26 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '194' - Version: '2' + Id: "194" + Version: "2" Validator Rule Message: PARAM must be present - Version: '5.0' + Version: "5.0" - Name: ADaMIG References: - Citations: @@ -32,18 +33,18 @@ Authorities: Section: 3.2.4 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '194' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "194" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -53,62 +54,64 @@ Authorities: Section: 3.3.4 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '194' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "194" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: PARAM has Core=Req and PARAM must be present and populated on + - Cited Guidance: + PARAM has Core=Req and PARAM must be present and populated on every record in a BDS dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '194' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "194" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: PARAM has Core=Req and PARAM must be present and populated on + - Cited Guidance: + PARAM has Core=Req and PARAM must be present and populated on every record in a BDS dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '194' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "194" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - name: PARAM @@ -116,8 +119,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0194 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAM is not present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml index e1513e920..8a31d6916 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0195/CDISC.ADaMIG.AD0195.yml @@ -4,25 +4,26 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '195' - Version: '2' + Id: "195" + Version: "2" Validator Rule Message: PARAMCD must be present - Version: '5.0' + Version: "5.0" - Name: ADaMIG References: - Citations: @@ -32,18 +33,18 @@ Authorities: Section: 3.2.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '195' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "195" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -53,62 +54,64 @@ Authorities: Section: 3.3.4 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '195' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "195" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: PARAMCD has Core=Req and PARAMCD must be present and populated + - Cited Guidance: + PARAMCD has Core=Req and PARAMCD must be present and populated on every record in a BDS dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '195' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "195" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: PARAMCD has Core=Req and PARAMCD must be present and populated + - Cited Guidance: + PARAMCD has Core=Req and PARAMCD must be present and populated on every record in a BDS dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '195' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "195" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - name: PARAMCD @@ -116,8 +119,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0195 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAMCD is not present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml index 01fbd6476..cf23727b3 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0196/CDISC.ADaMIG.AD0196.yml @@ -4,55 +4,58 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '196' - Version: '2' + Id: "196" + Version: "2" Validator Rule Message: PARAM must be present - Version: '5.0' + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'The ADaM document introduces the ADaM Basic Data Structure. + - Cited Guidance: + -< 'The ADaM document introduces the ADaM Basic Data Structure. A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is conditionally required, depending on the analysis. In situations where there is no analysis timepoint, the structure is one or more records per subject per analysis parameter.' Document: ADaMIG - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '196' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "196" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data + - Cited Guidance: + -< 'The ADaM model document introduces the ADaM Basic Data Structure. A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is conditionally required, depending on the @@ -60,66 +63,68 @@ Authorities: the structure is one or more records per subject per analysis parameter'' Document: ADaMIG - Item: '' - Section: '3.3' + Item: "" + Section: "3.3" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '196' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "196" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'PARAM has Core=Req and PARAM must be present and populated + - Cited Guidance: + -< 'PARAM has Core=Req and PARAM must be present and populated on every record in a BDS dataset.' Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '196' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "196" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'PARAM has Core=Req and PARAM must be present and populated + - Cited Guidance: + -< 'PARAM has Core=Req and PARAM must be present and populated on every record in a BDS dataset.' Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '196' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "196" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - name: PARAM @@ -127,8 +132,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0196 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAM must be populated for all records in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml index ce40afced..0e52289ee 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0197/CDISC.ADaMIG.AD0197.yml @@ -4,29 +4,31 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '197' - Version: '2' + Id: "197" + Version: "2" Validator Rule Message: PARAMCD must be populated - Version: '5.0' + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data + - Cited Guidance: + -< 'The ADaM model document introduces the ADaM Basic Data Structure. A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is conditionally required, depending on the @@ -34,26 +36,27 @@ Authorities: the structure is one or more records per subject per analysis parameter.' Document: ADaMIG - Item: '' - Section: '3.3' + Item: "" + Section: "3.3" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '197' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "197" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'The ADaM model document introduces the ADaM Basic Data + - Cited Guidance: + -< 'The ADaM model document introduces the ADaM Basic Data Structure. A BDS dataset contains one or more records per subject, per analysis parameter, per analysis timepoint. Analysis timepoint is conditionally required, depending on the @@ -61,66 +64,68 @@ Authorities: the structure is one or more records per subject per analysis parameter.' Document: ADaMIG - Item: '' - Section: '3.3' + Item: "" + Section: "3.3" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '197' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "197" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'PARAMCD has Core=Req and PARAMCD must be present and + - Cited Guidance: + -< 'PARAMCD has Core=Req and PARAMCD must be present and populated on every record in a BDS dataset.' Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '197' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "197" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< 'PARAMCD has Core=Req and PARAMCD must be present and + - Cited Guidance: + -< 'PARAMCD has Core=Req and PARAMCD must be present and populated on every record in a BDS dataset.' Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '197' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "197" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - name: PARAMCD @@ -128,8 +133,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0197 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAMCD must be populted for ecery record in the dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml index f512903b9..48203da1b 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0198/CDISC.ADaMIG.AD0198.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '198' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "198" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -33,18 +34,18 @@ Authorities: Section: 3.2.4 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '198' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "198" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: @@ -54,65 +55,67 @@ Authorities: Section: 3.3.4 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '198' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "198" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: AVALC is required if AVAL is not present, since either AVAL or + - Cited Guidance: + AVALC is required if AVAL is not present, since either AVAL or AVALC must be present in the dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules #Related Rules: # - Id: '' # Relationship: Predecessor | Related | Successor - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '198' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "198" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: AVALC is required if AVAL is not present, since either AVAL or + - Cited Guidance: + AVALC is required if AVAL is not present, since either AVAL or AVALC must be present in the dataset. Document: ADaMIG Item: Table 3.3.4.1.1 Section: 3.3.4.1 Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '198' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "198" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - name: AVALC @@ -122,8 +125,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0198 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AVAL or AVALC must be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml index 9fe69064c..c11e72e25 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0204/CDISC.ADaMIG.AD0204.yml @@ -4,91 +4,95 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: If the variable is not a copy of DM.AGE, then an additional + - Cited Guidance: + If the variable is not a copy of DM.AGE, then an additional differently named variable must be added. Document: ADaMIG Item: Table 3.1.1 - Section: '3.1' + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '204' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "204" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of + - Cited Guidance: + When the value of ADSL.USUBJID is equal to the value of DM.USUBJID, ADSL.AGE must equal to DM.AGE Document: ADaMIG - Item: 'Table 3.2.2: DM.AGE' - Section: '3.2' + Item: "Table 3.2.2: DM.AGE" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '204' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "204" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of + - Cited Guidance: + When the value of ADSL.USUBJID is equal to the value of DM.USUBJID, ADSL.AGE must equal to DM.AGE Document: ADaMIG - Item: 'Table 3.2.2: DM.AGE' - Section: '3.2' + Item: "Table 3.2.2: DM.AGE" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '204' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "204" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: When the value of ADSL.USUBJID is equal to the value of + - Cited Guidance: + When the value of ADSL.USUBJID is equal to the value of DM.USUBJID, ADSL.AGE must equal to DM.AGE Document: ADaMIG - Item: 'Table 3.2.2: DM.AGE' - Section: '3.2' + Item: "Table 3.2.2: DM.AGE" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '204' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "204" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: # - name: USUBJID @@ -100,8 +104,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0204 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Match Datasets: - Keys: diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml index 70f02599c..c5898552c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0211/CDISC.ADaMIG.AD0211.yml @@ -4,52 +4,52 @@ Authorities: - Organization: CDISC Standards: - Name: ADaMIG - Version: '1.3' + Version: "1.3" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '211' - Version: '1.0' + Id: "211" + Version: "1.0" Citations: - Cited Guidance: Codelist/Controlled Terms 1 {1,NULL} Document: ADaM IG v1.3 Section: 3.3.8 Item: Table 3.3.8.1 - Name: ADaMIG - Version: '1.2' + Version: "1.2" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '211' - Version: '1.0' + Id: "211" + Version: "1.0" Citations: - Cited Guidance: Codelist/Controlled Terms 1 {1,NULL} Document: ADaM IG v1.2 Section: 3.3.8 Item: Table 3.3.8.1 - Name: ADaMIG - Version: '1.1' + Version: "1.1" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '211' - Version: '1.0' + Id: "211" + Version: "1.0" Citations: - Cited Guidance: Codelist/Controlled Terms 1 {1,NULL} Document: ADaM IG v1.1 Section: 3.3.8 Item: Table 3.3.8.1 - Name: ADaMIG - Version: '1.0' + Version: "1.0" References: - Origin: ADaM Conformance Rules - Version: '4.0' + Version: "4.0" Rule Identifier: - Id: '211' - Version: '1.0' + Id: "211" + Version: "1.0" Citations: - Cited Guidance: Codelist/Controlled Terms 1 {1,NULL} Document: ADaM IG v1.0 @@ -65,7 +65,7 @@ Check: Core: Id: CDISC.ADaMIG.AD0211 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when ABLFN is not equal to 1 or null Executability: Fully Executable Outcome: diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml index 2c5aa6e1c..e9541e8e2 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0252b/CDISC.ADaMIG.AD0252b.yml @@ -4,209 +4,218 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Version: '1.3' + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '252' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "252" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: any: @@ -217,8 +226,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0252b Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AVAL or AVALC must not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml index a50e46537..b44046ae4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254/CDISC.ADaMIG.AD0254.yml @@ -4,193 +4,194 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.1 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <- There is no PARAM nor AVAL Document: OCCDS v1.0 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.1 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.0 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - Cited Guidance: <-TThere is no PARAM nor AVAL Document: OCCDS v1.1 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.0 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.1 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - Cited Guidance: <-There is no PARAM nor AVAL Document: OCCDS v1.0 - Item: '' - Section: '3.2' + Item: "" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "254" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: any: @@ -200,8 +201,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0254 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PARAM must not be present in Occurence dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml index 4ea1af004..aa09549d4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0254b/CDISC.ADaMIG.AD0254b.yml @@ -4,209 +4,218 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Version: '1.3' + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.1 - Item: '1' - Section: '1.1.2.1' + Item: "1" + Section: "1.1.2.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - - Cited Guidance: <-There is no need for AVAL or AVALC. Occurrences are counted in + - Cited Guidance: + <-There is no need for AVAL or AVALC. Occurrences are counted in analysis, and there are typically one or more records for each occurrence assessment. Document: OCCDS v1.0 - Item: '' - Section: '1.1' + Item: "" + Section: "1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '254' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "254" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: any: @@ -217,8 +226,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0254b Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AVAL or AVALC must not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml index deb91b1c6..fc32ad68f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0268/CDISC.ADaMIG.AD0268.yml @@ -4,203 +4,212 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID to be a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included" Document: OCCDS v1.1 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included and units are not included in the label of ADURN". Document: OCCDS v1.0 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included" Document: OCCDS v1.1 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included and units are not included in the label of ADURN". Document: OCCDS v1.0 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included" Document: OCCDS v1.1 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included and units are not included in the label of ADURN". Document: OCCDS v1.0 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included" Document: OCCDS v1.1 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <- CDISC Notes for ADURU state':'' "Conditional on whether + - Cited Guidance: + <- CDISC Notes for ADURU state':'' "Conditional on whether ADURN is included and units are not included in the label of ADURN". Document: OCCDS v1.0 - Item: 'Table 3.2.4.1' - Section: '3.2.4' + Item: "Table 3.2.4.1" + Section: "3.2.4" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '268' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "268" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: @@ -212,8 +221,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0268 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ADURN must be populated when ADURN is not missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml index c9e9e2f2b..e5f5ef3d2 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0269/CDISC.ADaMIG.AD0269.yml @@ -4,201 +4,202 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "269" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "269" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <- Code List / Controlled Terms have allowable values of':' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "269" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.3' - Section: '3.2.5' + Item: "Table 3.2.5.3" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '269' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "269" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - name: TRTEMFL operator: is_not_contained_by value: - - 'Y' - - '' + - "Y" + - "" # - name: TRTEMFL # operator: non_empty # - name: TRTEMFL @@ -207,8 +208,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0269 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: TRTEMFL is not equal to Y or null diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml index 2ac532db0..e38a3f166 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0270/CDISC.ADaMIG.AD0270.yml @@ -4,201 +4,202 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "270" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "270" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <- Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "270" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '270' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "270" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - name: PREFL operator: is_not_contained_by value: - - 'Y' - - '' + - "Y" + - "" # - name: TRTEMFL # operator: non_empty # - name: TRTEMFL @@ -207,8 +208,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0270 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: PREFL is not equal to Y or null diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml index 43f9e3b47..8c3a45c3e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0271/CDISC.ADaMIG.AD0271.yml @@ -4,201 +4,202 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "271" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "271" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <- Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "271" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.0 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.1' + Version: "1.1" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - Cited Guidance: <-Code List / Controlled Terms have allowable values of':'' "Y" Document: OCCDS v1.1 - Item: 'Table 3.2.5.5' - Section: '3.2.5' + Item: "Table 3.2.5.5" + Section: "3.2.5" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '271' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "271" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: - name: FUPFL operator: is_not_contained_by value: - - 'Y' - - '' + - "Y" + - "" # - name: FUPFL # operator: non_empty # - name: FUPFL @@ -207,8 +208,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0271 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FUPFL not equal to Y or null diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml index 9fbe78790..b714d009b 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0279/CDISC.ADaMIG.AD0279.yml @@ -1,11 +1,11 @@ Authorities: - Organization: CDISC Standards: - - Name: ADaMIG References: - Citations: - - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN), + - Cited Guidance: + -< In a pair of corresponding variables (e.g., TRTP and TRTPN), the primary or most commonly used variable does not have the suffix or extension (i.e., N for Numeric or C for Character). The relevant suffix is used only on the name of the secondary @@ -19,93 +19,97 @@ Authorities: one-to-one relationship between the values of the two variables, as described in Item 5 above. Document: ADaMIG-MD v1.0 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "279" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "279" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.1 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "279" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.0 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "279" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN), + - Cited Guidance: + -< In a pair of corresponding variables (e.g., TRTP and TRTPN), the primary or most commonly used variable does not have the suffix or extension (i.e., N for Numeric or C for Character). The relevant suffix is used only on the name of the secondary @@ -119,70 +123,73 @@ Authorities: one-to-one relationship between the values of the two variables, as described in Item 5 above. Document: ADaMIG-MD v1.0 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: OCCDS References: - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.1 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.0 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< In a pair of corresponding variables (e.g., TRTP and TRTPN), + - Cited Guidance: + -< In a pair of corresponding variables (e.g., TRTP and TRTPN), the primary or most commonly used variable does not have the suffix or extension (e.g., N for Numeric or C for Character). The relevant suffix is used only on the name of the @@ -197,70 +204,73 @@ Authorities: the values of the two variables, as described in ADaMIG v1.1, Section 3.1.1, Item 5. Document: ADaMIG-MD v1.0 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: OCCDS References: - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.1 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code + - Cited Guidance: + <-CDISC Notes for AESEVN state':' Code AE.AESEV to numeric, Code List / Controlled Terms have allowable values of ';' "1, 2, 3". Document: OCCDS v1.0 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: -< In general, if SDTM character variables are converted to + - Cited Guidance: + -< In general, if SDTM character variables are converted to numeric variables in ADaM datasets, then they should be named as they are in the SDTM with an "N" suffix added. For example, the numeric version of the DM SEX variable is SEXN in an ADaM @@ -272,61 +282,61 @@ Authorities: character variables. Note also that this convention does not apply to date/time variables. Document: ADaMIG-MD v1.0 - Item: '9 (General Variable Naming Conventions)' - Section: '3.1.1' + Item: "9 (General Variable Naming Conventions)" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: OCCDS References: - Citations: - Cited Guidance: <-CDISC Notes for AESEVN state':' "Code AE.AESEV to numeric". Document: OCCDS v1.1 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - Cited Guidance: <-CDISC Notes for AESEVN state':' "Code AE.AESEV to numeric". Document: OCCDS v1.0 - Item: 'Table 3.2.8.1' - Section: '3.2.8' + Item: "Table 3.2.8.1" + Section: "3.2.8" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '279' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "279" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" Check: all: @@ -348,8 +358,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0279 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AESEVN not equal to Y or null diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml index 06892e45f..93262ab8e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0363/CDISC.ADaMIG.AD0363.yml @@ -4,29 +4,31 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: Code List / Controlled Terms for ONTRTFL have allowable values + - Cited Guidance: + Code List / Controlled Terms for ONTRTFL have allowable values of':' "Y" Document: ADaMIG Item: Table 3.2.6.1 Section: 3.2.6 Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: ONTRTFL have allowable values of "Y" Plain Language Expression: ONTRTFL is equal to Y Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '363' - Version: '' + Id: "363" + Version: "" Validator Rule Message: ONTRTFL can only have values of "Y" - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: Code List / Controlled Terms for ONTRTFL have allowable values + - Cited Guidance: + Code List / Controlled Terms for ONTRTFL have allowable values of':' "Y" Document: ADaMIG Item: Table 3.3.8.1 @@ -38,13 +40,13 @@ Authorities: Plain Language Expression: ONTRTFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '363' - Version: '' + Id: "363" + Version: "" Validator Rule Message: ONTRTFL must equal to Y or missing - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" Check: all: - name: ONTRTFL @@ -52,13 +54,13 @@ Check: - name: ONTRTFL operator: is_not_contained_by value: - - 'Y' + - "Y" Core: Id: CDISC.ADaMIG.AD0363 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ONTRTFL is not equal to Y or missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml index dae206fea..fab819904 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0364/CDISC.ADaMIG.AD0364.yml @@ -4,152 +4,159 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and allowing USUBJID as a conditionally required variable. See the OCCDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether + - Cited Guidance: + <- CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.1 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON + - Cited Guidance: + <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.0 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.3' + Version: "1.3" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether + - Cited Guidance: + <- CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.1 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON + - Cited Guidance: + <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.0 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Version: '1.2' + Version: "1.2" - Name: OCCDS References: - Citations: - - Cited Guidance: <- CDISC Notes for DOSEU state":"" "Conditional on whether + - Cited Guidance: + <- CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.1 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" - Citations: - - Cited Guidance: <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON + - Cited Guidance: + <-CDISC Notes for DOSEU state":"" "Conditional on whether DOSEON and/or DOSCUMA are included." Document: OCCDS v1.0 - Item: 'Table 3.2.7.1' - Section: '3.2.7' + Item: "Table 3.2.7.1" + Section: "3.2.7" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '364' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "364" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: - name: DOSEU @@ -162,8 +169,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0364 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: DOSEU is not present but DOSEON or DOSCUMA are present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml index 07aacb88a..c06d7410e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0373/CDISC.ADaMIG.AD0373.yml @@ -4,95 +4,99 @@ Authorities: - Name: ADTTE References: - Citations: - - Cited Guidance: CNSR is a required variable for a time-to-event analysis + - Cited Guidance: + CNSR is a required variable for a time-to-event analysis dataset, though it is a conditionally required variable with respect to the ADaM BDS. Document: ADTTE Item: Table 4.2 - Section: '4' + Section: "4" Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: CNSR is a required variable for a time-to-event analysis dataset - Plain Language Expression: '' + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '373' - Version: '' + Id: "373" + Version: "" Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADTTE References: - Citations: - - Cited Guidance: CNSR is a required variable for a time-to-event analysis + - Cited Guidance: + CNSR is a required variable for a time-to-event analysis dataset, though it is a conditionally required variable with respect to the ADaM BDS. Document: ADTTE Item: Table 4.2 - Section: '4' + Section: "4" Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: CNSR is a required variable for a time-to-event analysis dataset - Plain Language Expression: '' + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '373' - Version: '' + Id: "373" + Version: "" Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" - Name: ADTTE References: - Citations: - - Cited Guidance: CNSR is a required variable for a time-to-event analysis + - Cited Guidance: + CNSR is a required variable for a time-to-event analysis dataset, though it is a conditionally required variable with respect to the ADaM BDS. Document: ADTTE Item: Table 4.2 - Section: '4' + Section: "4" Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: CNSR is a required variable for a time-to-event analysis dataset - Plain Language Expression: '' + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '373' - Version: '' + Id: "373" + Version: "" Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset - Version: '5.0' - Version: '1.2' + Version: "5.0" + Version: "1.2" - Name: ADTTE References: - Citations: - - Cited Guidance: CNSR is a required variable for a time-to-event analysis + - Cited Guidance: + CNSR is a required variable for a time-to-event analysis dataset, though it is a conditionally required variable with respect to the ADaM BDS. Document: ADTTE Item: Table 4.2 - Section: '4' + Section: "4" Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: CNSR is a required variable for a time-to-event analysis dataset - Plain Language Expression: '' + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '373' - Version: '' + Id: "373" + Version: "" Validator Rule Message: CNSR is a required variable for a time-to-event analysis dataset - Version: '5.0' - Version: '1.3' + Version: "5.0" + Version: "1.3" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0373 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: CNSR is required for TTE analysis diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml index bd6396dab..9c94dc696 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0522b/CDISC.ADaMIG.AD0522b.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '522' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "522" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '522' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "522" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '522' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "522" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '522' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "522" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0522b Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BTOXGRN present but BTOXGR is not present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml index 2088a5c19..028565389 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0523b/CDISC.ADaMIG.AD0523b.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '523' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "523" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '523' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "523" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '523' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "523" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '523' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "523" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0523b Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ATOXGRLN present but ATOXGRL not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml index 2bd8e8730..d051fbc55 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0524/CDISC.ADaMIG.AD0524.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '524' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "524" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '524' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "524" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '524' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "524" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '524' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "524" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0524 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ATOXGRHN present but ATOXGRH not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml index 496114256..0f9254642 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0525/CDISC.ADaMIG.AD0525.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '525' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "525" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '525' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "525" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '525' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "525" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '525' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "525" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0525 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ABLFN present but ABLFL not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml index 80f3b00c3..640b3fcf5 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0529/CDISC.ADaMIG.AD0529.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '529' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "529" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '529' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "529" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '529' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "529" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '529' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "529" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0529 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: AESEVN present but AESEV not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml index 3b6ba8694..3fe3f6d96 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0530/CDISC.ADaMIG.AD0530.yml @@ -4,94 +4,98 @@ Authorities: - Name: ADaMIG-MD References: - Citations: - - Cited Guidance: The MDBDS supports analysis needs by adding SPDEVID as a + - Cited Guidance: + The MDBDS supports analysis needs by adding SPDEVID as a required key variable and USUBJID as a conditionally required variable. See the BDS class for further details. Document: ADaMIG-MD v1.0 - Item: '' - Section: '3.1' + Item: "" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '530' - Version: '2' - Validator Rule Message: '' - Version: '5.0' + Id: "530" + Version: "2" + Validator Rule Message: "" + Version: "5.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '530' - Version: '2' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "530" + Version: "2" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.2 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '530' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "530" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: <- When a secondary variable is included in the dataset, then + - Cited Guidance: + <- When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.1 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '530' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "530" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: @@ -102,8 +106,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0530 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ASEVN present but ASEV not be present in dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml index 5e21943a0..48766d85e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD055/rule.yml @@ -1,100 +1,100 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: SUBJID has Core=Req - Document: ADaMIG - Item: 'Table 3.2.1' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '55' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: "Table 3.1.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "55" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: "Table 3.2.1" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "55" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: "Table 3.2.1" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "55" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: SUBJID has Core=Req + Document: ADaMIG + Item: "Table 3.2.1" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "55" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SUBJID - operator: not_exists + - name: SUBJID + operator: not_exists Core: Id: CDISC.ADaMIG.AD055 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJID is not present in ADSL @@ -105,5 +105,5 @@ Rule Type: Record Data Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml index 6bc8871d1..9d06d4e1b 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0619/CDISC.ADaMIG.AD0619.yml @@ -4,29 +4,31 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: Code List / Controlled Terms for LVOTFL have allowable values + - Cited Guidance: + Code List / Controlled Terms for LVOTFL have allowable values of':' "Y" Document: ADaMIG Item: Table 3.2.6.1 Section: 3.2.6 Criteria: Logical Expression: - Condition: '' + Condition: "" Rule: LVOTFL have allowable values of "Y" Plain Language Expression: LVOTFL is equal to Y Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '619' - Version: '' + Id: "619" + Version: "" Validator Rule Message: LVOTFL can only have values of "Y" - Version: '5.0' - Version: '1.0' + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: Code List / Controlled Terms for LVOTFL have allowable values + - Cited Guidance: + Code List / Controlled Terms for LVOTFL have allowable values of':' "Y" Document: ADaMIG Item: Table 3.3.8.1 @@ -38,13 +40,13 @@ Authorities: Plain Language Expression: LVOTFL is equal to Y or missing Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '619' - Version: '' + Id: "619" + Version: "" Validator Rule Message: LVOTFL must equal to Y or missing - Version: '5.0' - Version: '1.1' + Version: "5.0" + Version: "1.1" Check: all: - name: LVOTFL @@ -52,13 +54,13 @@ Check: - name: LVOTFL operator: is_not_contained_by value: - - 'Y' + - "Y" Core: Id: CDISC.ADaMIG.AD0619 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: LVOTFL is not equal to Y or missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml index 1e749916f..d2491cb82 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD064/rule.yml @@ -1,125 +1,129 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: One-to-one map to TRTxxA - Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: the secondary variable of the variable pair cannot be present in the dataset - unless the primary variable is also present - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: When a secondary variable is included in the dataset, then the primary - variable must also be included - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: When a secondary variable is included in the dataset, then the primary - variable must also be included - Document: ADaMIG - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '64' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: One-to-one map to TRTxxA + Document: ADaMIG + Item: "Table 3.1.1" + Section: "3.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "64" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + the secondary variable of the variable pair cannot be present in the dataset + unless the primary variable is also present + Document: ADaMIG + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "64" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + When a secondary variable is included in the dataset, then the primary + variable must also be included + Document: ADaMIG + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "64" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + When a secondary variable is included in the dataset, then the primary + variable must also be included + Document: ADaMIG + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "64" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: variable_name # TRT11AN - operator: matches_regex # test 1 exist clause - value: ^TRT[0-9]{2}AN*$ - - name: $generated_variable_name # TRT11A - operator: is_not_contained_by - value: variable_name # [TRT11AN, ABCDE, FGHIJ] + - name: variable_name # TRT11AN + operator: matches_regex # test 1 exist clause + value: ^TRT[0-9]{2}AN*$ + - name: $generated_variable_name # TRT11A + operator: is_not_contained_by + value: variable_name # [TRT11AN, ABCDE, FGHIJ] Core: Id: CDISC.ADaMIG.AD064 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- find: ^TRT([0-9]{2})AN*$ - id: $generated_variable_name - name: variable_name - operator: regex_find_replace - replace: TRT\1A - # generates TRTxxA - # TRT11AN -> TRT11A - # ABCDE -> TRTA or null? + - find: ^TRT([0-9]{2})AN*$ + id: $generated_variable_name + name: variable_name + operator: regex_find_replace + replace: + TRT\1A + # generates TRTxxA + # TRT11AN -> TRT11A + # ABCDE -> TRTA or null? Outcome: Message: TRTxxAN is present and TRTxxA is not present in ADSL Output Variables: - - USUBJID - - TRT01AN + - USUBJID + - TRT01AN Rule Type: Variable Metadata Check Scope: Data Structures: Include: - - SUBJECT LEVEL ANALYSIS DATASET + - SUBJECT LEVEL ANALYSIS DATASET Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml index 7f5eae74a..008187fa9 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD071/CDISC.ADaMIG.AD071.yml @@ -6,85 +6,85 @@ Authorities: - Citations: - Cited Guidance: ARM has Core=Req Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' + Item: "Table 3.1.1" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '71' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "71" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - Cited Guidance: ARM has Core=Req Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '71' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "71" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - Cited Guidance: ARM has Core=Req Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '71' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "71" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - Cited Guidance: ARM has Core=Req Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '71' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "71" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -93,8 +93,8 @@ Check: Core: Id: CDISC.ADaMIG.AD071 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ARM is not present in ADSL @@ -108,5 +108,5 @@ Scope: - SUBJECT LEVEL ANALYSIS DATASET Datasets: Include: - - 'ALL' + - "ALL" Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml index d9ce6784e..3adf75585 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD072/CDISC.ADaMIG.AD072.yml @@ -6,88 +6,91 @@ Authorities: - Citations: - Cited Guidance: At least TRT01P is required. Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' + Item: "Table 3.1.1" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '72' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "72" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - - Cited Guidance: the secondary variable of the variable pair cannot be present in + - Cited Guidance: + the secondary variable of the variable pair cannot be present in the dataset unless the primary variable is also present Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '72' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "72" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - - Cited Guidance: the secondary variable of the variable pair cannot be present in + - Cited Guidance: + the secondary variable of the variable pair cannot be present in the dataset unless the primary variable is also present Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '72' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "72" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - - Cited Guidance: the secondary variable of the variable pair cannot be present in + - Cited Guidance: + the secondary variable of the variable pair cannot be present in the dataset unless the primary variable is also present Document: ADaMIG - Item: 'Table 3.2.4' - Section: '3.2' + Item: "Table 3.2.4" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '72' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "72" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -96,8 +99,8 @@ Check: Core: Id: CDISC.ADaMIG.AD072 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: TRT01P is not present in ADSL diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml index cea70a2c5..987a763c4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD080/CDISC.ADaMIG.AD080.yml @@ -6,85 +6,85 @@ Authorities: - Citations: - Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' + Item: "Table 3.1.1" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '80' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.0' + Id: "80" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.0" - Name: ADaMIG References: - Citations: - Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.1' + Item: "Table 3.1.1" + Section: "3.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '80' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + Id: "80" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" - Name: ADaMIG References: - Citations: - Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.2' + Item: "Table 3.1.1" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '80' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.2' + Id: "80" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.2" - Name: ADaMIG References: - Citations: - Cited Guidance: CDISC Notes for TRTxxP state':'' At least TRT01P is required Document: ADaMIG - Item: 'Table 3.1.1' - Section: '3.2' + Item: "Table 3.1.1" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '80' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "80" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" #follwoing is temporary coding to run the data, until oeprator to catched paired TRTxxA/TRTxxAP created. Check: any: @@ -140,8 +140,8 @@ Check: Core: Id: CDISC.ADaMIG.AD080 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable #Operations: # - find: ^TRT([0-9]{2})AN*$ diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml index 04fba21b7..925a33e1f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0800/CDISC.ADaMIG.AD0800.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of STUDYID. The numeric + - Cited Guidance: + <- Unique numerical representation of STUDYID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: '' - Section: '3.2, Table 3.2' + Item: "" + Section: "3.2, Table 3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '800' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "800" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -34,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0800 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: STUDYID is populated, but STUDYIDN is not populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml index 3ea4bea06..d1de76c30 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0802/CDISC.ADaMIG.AD0802.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of STUDYID. The numeric + - Cited Guidance: + <- Unique numerical representation of STUDYID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: '' + Item: "" Section: Table 3.2' Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '802' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "802" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0802 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: STUDYIDN is not unique for a given value of STUDYID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml index d9d10ba56..f2e6c0652 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0804/CDISC.ADaMIG.AD0804.yml @@ -4,25 +4,26 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADPPKIG v1.0 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '804' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "804" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0804 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: STUDYIDN is present, but STUDYID is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml index 8d12e4b73..e4be60724 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0805/CDISC.ADaMIG.AD0805.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- 'Unique character representation of SUBJTYP. For + - Cited Guidance: + <- 'Unique character representation of SUBJTYP. For first-in-human studies, the value can be “Healthy volunteers' Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '805' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "805" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0805 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJTYP is populated, but SUBJTYPC is not populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml index 35c7dd958..f76863a7a 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0806/CDISC.ADaMIG.AD0806.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- 'Unique character representation of SUBJTYP. For + - Cited Guidance: + <- 'Unique character representation of SUBJTYP. For first-in-human studies, the value can be “Healthy volunteers"' Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '806' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "806" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0806 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJTYP is populated, but SUBJTYPC is not populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml index 69fb90a46..34a27913e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0807/CDISC.ADaMIG.AD0807.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique character representation of SUBJTYP. For + - Cited Guidance: + <- Unique character representation of SUBJTYP. For first-in-human studies, the value can be “Healthy volunteers. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '807' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "807" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -36,8 +37,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0807 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJTYPC is not unique for a given value of SUBJTYP diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml index bb41d3d5e..54954f685 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0809/CDISC.ADaMIG.AD0809.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '809' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "809" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0809 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJTYPC is present, but SUBJTYP is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml index c451b970c..4edd63d22 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0811/CDISC.ADaMIG.AD0811.yml @@ -1,27 +1,27 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - Cited Guidance: Unique numerical representation of USUBJID. Document: ADPPKIG v1.0, - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '811' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "811" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -32,8 +32,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0811 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: USUBJIDN is populated but USUBJID is missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml index ae8afd2db..5e19299e2 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0812/CDISC.ADaMIG.AD0812.yml @@ -6,22 +6,22 @@ Authorities: - Citations: - Cited Guidance: <-Unique numerical representation of USUBJID Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '812' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "812" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0812 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: USUBJIDN is not unique for a given value of USUBJID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml index ed0d49070..282cff698 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0813/CDISC.ADaMIG.AD0813.yml @@ -6,22 +6,22 @@ Authorities: - Citations: - Cited Guidance: <-Unique numerical representation of USUBJID Document: ADPPKIG v1.0 - Item: '' + Item: "" Section: Table 3.2' Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '813' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "813" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0813 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: USUBJID is not unique for a given value of USUBJIDN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml index d75c100a9..518cb9d72 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0814/CDISC.ADaMIG.AD0814.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '814' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "814" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0814 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: USUBJIDN is present, but USUBJID is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml index 46008d561..028c931ec 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0815/CDISC.ADaMIG.AD0815.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: Unique numerical representation of SUBJID. The numeric versions + - Cited Guidance: + Unique numerical representation of SUBJID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0, - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '815' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "815" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -34,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0815 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJID is populated but SUBJIDN is missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml index 1a38acb45..599bd5967 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0816/CDISC.ADaMIG.AD0816.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: Unique numerical representation of SUBJID. The numeric versions + - Cited Guidance: + Unique numerical representation of SUBJID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0, - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '816' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "816" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -34,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0816 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJIDN is populated but SUBJID is missing diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml index b63d28c31..89ca8d935 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0817/CDISC.ADaMIG.AD0817.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SUBJID. The numeric + - Cited Guidance: + <- Unique numerical representation of SUBJID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '817' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "817" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0817 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJIDN is not unique for a given value of SUBJID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml index 986b1a259..3084814ef 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0818/CDISC.ADaMIG.AD0818.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SUBJID. The numeric + - Cited Guidance: + <- Unique numerical representation of SUBJID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '818' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "818" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0818 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJID is not unique for a given value of SUBJIDN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml index d9d111ec8..515659f75 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0819/CDISC.ADaMIG.AD0819.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '819' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "819" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0819 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SUBJIDN is present, but SUBJID is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml index 74c082c59..2a6bf9f54 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0820/CDISC.ADaMIG.AD0820.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: Unique numerical representation of SITEID. The numeric versions + - Cited Guidance: + Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0, - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '820' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "820" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -34,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0820 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SITEID is populated but SITEIDN is not populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml index 2c80f9138..1b3ae1e61 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0821/CDISC.ADaMIG.AD0821.yml @@ -1,29 +1,30 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: Unique numerical representation of SITEID. The numeric versions + - Cited Guidance: + Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0, - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '821' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "821" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -34,8 +35,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0821 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SITEIDN is populated but SITEID is not populated diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml index b40afea2f..7aa7e69f3 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0822/CDISC.ADaMIG.AD0822.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '822' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "822" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0822 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SITEIDN is not unique for a given value of SITEID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml index 726cebf5d..57167f4c5 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0823/CDISC.ADaMIG.AD0823.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '823' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "823" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0823 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SITEIDN is not unique for a given value of SITEID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml index e0ae8af00..07a4066aa 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0824/CDISC.ADaMIG.AD0824.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '824' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "824" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0824 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SITEIDN is present, but SITEID is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml index 16633e410..4c8dce371 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0825/CDISC.ADaMIG.AD0825.yml @@ -1,31 +1,32 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-Captures primary reason for identifying the record for data + - Cited Guidance: + <-Captures primary reason for identifying the record for data issues, e.g., dose time imputation flags, etc. A sequential number starting with 1 and increments with each unique reason. Examples of reasons for identification of Data Issue can be found in Section 3.4. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '825' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "825" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -36,11 +37,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0825 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'FLGREASC is populated, but FLGREAS is not populated' + Message: "FLGREASC is populated, but FLGREAS is not populated" Output Variables: - FLGREASC - FLGREAS diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml index a331babd0..4b85dd624 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0826/CDISC.ADaMIG.AD0826.yml @@ -1,31 +1,32 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-Captures primary reason for identifying the record for data + - Cited Guidance: + <-Captures primary reason for identifying the record for data issues, e.g., dose time imputation flags, etc. A sequential number starting with 1 and increments with each unique reason. Examples of reasons for identification of Data Issue can be found in Section 3.4. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '826' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "826" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -36,11 +37,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0826 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'FLGREAS is populated, but FLGREASC is not populated' + Message: "FLGREAS is populated, but FLGREASC is not populated" Output Variables: - FLGREASC - FLGREAS diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml index dea7541cb..d20134c30 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0827/CDISC.ADaMIG.AD0827.yml @@ -4,28 +4,29 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Captures primary reason for identifying the record for data + - Cited Guidance: + <- Captures primary reason for identifying the record for data issues, e.g., dose time imputation flags, etc. A sequential number starting with 1 and increments with each unique reason. Examples of reasons for identification of Data Issue can be found in Section 3.4. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '827' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "827" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -39,8 +40,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0827 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FLGREASC is not unique for a given value of FLGREASC diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml index 7d81495b0..97dbf3dbc 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0828/CDISC.ADaMIG.AD0828.yml @@ -4,28 +4,29 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Captures primary reason for identifying the record for data + - Cited Guidance: + <- Captures primary reason for identifying the record for data issues, e.g., dose time imputation flags, etc. A sequential number starting with 1 and increments with each unique reason. Examples of reasons for identification of Data Issue can be found in Section 3.4. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '828' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "828" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -39,8 +40,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0828 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FLGREAS is not unique for a given value of FLGREAS diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml index 6599274f6..0f19b35d5 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0829/CDISC.ADaMIG.AD0829.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaMIG v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '829' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "829" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0829 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FLGREAS is present, but FLGREAS is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml index 777aaefb1..98addd435 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0830/CDISC.ADaMIG.AD0830.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '830' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "830" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0830 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'DVID is populated, but DVIDN is not populated' + Message: "DVID is populated, but DVIDN is not populated" Output Variables: - DDVID - DVIDN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml index 297a8d7a2..88a556c1c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0831/CDISC.ADaMIG.AD0831.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '831' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "831" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0831 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'DVIDN is populated, but DVID is not populated' + Message: "DVIDN is populated, but DVID is not populated" Output Variables: - DDVID - DVIDN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml index 35e3e4616..f046c5e7b 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0832/CDISC.ADaMIG.AD0832.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '832' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "832" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0832 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: DVIDN is not unique for a given value of DVID diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml index 215a34933..8e62a5540 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0833/CDISC.ADaMIG.AD0833.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '833' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "833" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0833 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: DVID is not unique for a given value of DVIDN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml index 18847bdf3..a9d163ca8 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0834/CDISC.ADaMIG.AD0834.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '834' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "834" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0834 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: DIVDN is present, but DIVD is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml index ac11bc7a9..0c58b3105 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0835/CDISC.ADaMIG.AD0835.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '835' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "835" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0835 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'BLQF is populated, but BLQFN is not populated' + Message: "BLQF is populated, but BLQFN is not populated" Output Variables: - BLQF - BLQFN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml index c303c1627..60b88718e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0836/CDISC.ADaMIG.AD0836.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '836' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "836" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0836 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'BLQF is populated, but BLQFN is not populated' + Message: "BLQF is populated, but BLQFN is not populated" Output Variables: - BLQF - BLQFN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml index a5a92dfde..295906305 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0837/CDISC.ADaMIG.AD0837.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '837' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "837" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0837 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BLQFN is not unique for a given value of BLQF diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml index a8c9e5c52..89b1c7550 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0838/CDISC.ADaMIG.AD0838.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '838' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "838" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0838 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BLQF is not unique for a given value of BLQFN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml index e9ab929cc..b47effe8b 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0839/CDISC.ADaMIG.AD0839.yml @@ -1,28 +1,29 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary variable must also be included. Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' + Item: "6" + Section: "3.1.1" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '839' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "839" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -33,8 +34,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0839 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: BLQFLN is present, but BLQFL is not present diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml index bc1caaa04..ccb4eafee 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0840/CDISC.ADaMIG.AD0840.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '840' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "840" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0840 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ALQFL is populated, but ALQFLN is not populated' + Message: "ALQFL is populated, but ALQFLN is not populated" Output Variables: - ALQFL - ALQFLN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml index f1a00454d..b54edca80 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0841/CDISC.ADaMIG.AD0841.yml @@ -1,30 +1,31 @@ Authorities: - Organization: CDISC Standards: - - Name: 'ADaMIG' + - Name: "ADaMIG" References: - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, 1=for the first observation of interest, etc. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '841' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "841" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -35,11 +36,11 @@ Check: Core: Id: CDISC.ADaMIG.AD0841 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ALQFLN is populated, but ALQFL is not populated' + Message: "ALQFLN is populated, but ALQFL is not populated" Output Variables: - ALQFL - ALQFLN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml index e9950f33c..7411921ad 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0842/CDISC.ADaMIG.AD0842.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '842' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "842" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0842 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ALQFLN is not unique for a given value of ALQFL diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml index 7ed51e72a..5f101045c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0843/CDISC.ADaMIG.AD0843.yml @@ -4,26 +4,27 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the primary/character variables can be assigned from its corresponding character pair variable. Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' + Item: "Table 3.2" + Section: "3.2" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' + Condition: "" + Rule: "" + Plain Language Expression: "" Type: Failure Origin: ADaM Conformance Rules - Release Notes: '' + Release Notes: "" Rule Identifier: - Id: '843' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + Id: "843" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: @@ -37,8 +38,8 @@ Check: Core: Id: CDISC.ADaMIG.AD0843 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ALQF is not unique for a given value of ALQFN diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml index 464324c25..dc919a148 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0844/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '844' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "844" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ALQFLN - operator: exists - - name: ALQFL - operator: not_exists + - name: ALQFLN + operator: exists + - name: ALQFL + operator: not_exists Core: Id: CDISC.ADaMIG.AD0844 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ALQFLN is present, but ALQFL is not present Output Variables: - - ALQFLN - - USUBJID - - SUBJID + - ALQFLN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml index 264a929da..92e63498f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0845/rule.yml @@ -1,56 +1,57 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is normally 0=dose, - 1=for the first observation of interest, etc. The numeric versions of the - primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '845' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, + 1=for the first observation of interest, etc. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADaMPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "845" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: FORM - operator: non_empty - - name: FORMN - operator: empty + - name: FORM + operator: non_empty + - name: FORMN + operator: empty Core: Id: CDISC.ADaMIG.AD0845 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'FORM is populated, but FORMN is not populated' + Message: "FORM is populated, but FORMN is not populated" Output Variables: - - FORM - - FORMN - - USUBJID + - FORM + - FORMN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml index 07e427aa3..bd63f9acc 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0846/rule.yml @@ -1,56 +1,57 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of DVID. Convention is normally 0=dose, - 1=for the first observation of interest, etc. The numeric versions of the - primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '846' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Unique numerical representation of DVID. Convention is normally 0=dose, + 1=for the first observation of interest, etc. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADaMPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "846" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: empty + - name: FORMN + operator: non_empty + - name: FORM + operator: empty Core: Id: CDISC.ADaMIG.AD0846 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'FORMN is populated, but FORM is not populated' + Message: "FORMN is populated, but FORM is not populated" Output Variables: - - FORM - - FORMN - - USUBJID + - FORM + - FORMN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml index 80f5b078e..8017676c9 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0847/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric versions of the - primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '847' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "847" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: non_empty - - name: FORMN - operator: is_inconsistent_across_dataset - value: FORM + - name: FORMN + operator: non_empty + - name: FORM + operator: non_empty + - name: FORMN + operator: is_inconsistent_across_dataset + value: FORM Core: Id: CDISC.ADaMIG.AD0847 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FORMN is not unique for a given value of FORM Output Variables: - - USUBJID - - USUBJIDN - - FORM - - FORMN + - USUBJID + - USUBJIDN + - FORM + - FORMN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml index 26d0dc4a9..049fedb6f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0848/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Unique numerical representation of SITEID. The numeric versions of the - primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '848' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Unique numerical representation of SITEID. The numeric versions of the + primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "848" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: FORMN - operator: non_empty - - name: FORM - operator: non_empty - - name: FORM - operator: is_inconsistent_across_dataset - value: FORMN + - name: FORMN + operator: non_empty + - name: FORM + operator: non_empty + - name: FORM + operator: is_inconsistent_across_dataset + value: FORMN Core: Id: CDISC.ADaMIG.AD0848 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FORM is not unique for a given value of FORMN Output Variables: - - USUBJID - - USUBJIDN - - FORM - - FORMN + - USUBJID + - USUBJIDN + - FORM + - FORMN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml index 324b77188..4ee8df846 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0849/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '849' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "849" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: FORMN - operator: exists - - name: FORM - operator: not_exists + - name: FORMN + operator: exists + - name: FORM + operator: not_exists Core: Id: CDISC.ADaMIG.AD0849 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: FORMN is present, but FORM is not present Output Variables: - - FORMN - - USUBJID - - SUBJID + - FORMN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml index ca6264a68..9790a9543 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0850/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character versions of the - primary/character variables can be assigned from its corresponding numeric pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '850' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + Derived from ROUTE as one-on-one unique match. The character versions of the + primary/character variables can be assigned from its corresponding numeric pair variable. + Document: ADaMPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "850" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ROUTE - operator: non_empty - - name: ROUTEN - operator: empty + - name: ROUTE + operator: non_empty + - name: ROUTEN + operator: empty Core: Id: CDISC.ADaMIG.AD0850 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ROUTE is populated, but ROUTEN is not populated' + Message: "ROUTE is populated, but ROUTEN is not populated" Output Variables: - - ROUTE - - ROUTEN - - USUBJID + - ROUTE + - ROUTEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml index ac2b79123..bc4a2fe0f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0851/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: Derived from ROUTE as one-on-one unique match. The character versions of the - primary/character variables can be assigned from its corresponding numeric pair variable. - Document: ADaMPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '851' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + Derived from ROUTE as one-on-one unique match. The character versions of the + primary/character variables can be assigned from its corresponding numeric pair variable. + Document: ADaMPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "851" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: empty + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: empty Core: Id: CDISC.ADaMIG.AD0851 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ROUTEN is populated, but ROUTE is not populated' + Message: "ROUTEN is populated, but ROUTE is not populated" Output Variables: - - ROUTE - - ROUTEN - - USUBJID + - ROUTE + - ROUTEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml index 1a162bbf1..4025468b7 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0852/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric versions of - the primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '852' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Derived from ROUTE as one-on-one unique match. The numeric versions of + the primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "852" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: non_empty - - name: ROUTEN - operator: is_inconsistent_across_dataset - value: ROUTE + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: non_empty + - name: ROUTEN + operator: is_inconsistent_across_dataset + value: ROUTE Core: Id: CDISC.ADaMIG.AD0852 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ROUTEN is not unique for a given value of ROUTE Output Variables: - - USUBJID - - USUBJIDN - - ROUTE - - ROUTEN + - USUBJID + - USUBJIDN + - ROUTE + - ROUTEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml index 012466e61..ed5c08569 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0853/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ROUTE as one-on-one unique match. The numeric versions of - the primary/character variables can be assigned from its corresponding character pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '853' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Derived from ROUTE as one-on-one unique match. The numeric versions of + the primary/character variables can be assigned from its corresponding character pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "853" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ROUTEN - operator: non_empty - - name: ROUTE - operator: non_empty - - name: ROUTE - operator: is_inconsistent_across_dataset - value: ROUTEN + - name: ROUTEN + operator: non_empty + - name: ROUTE + operator: non_empty + - name: ROUTE + operator: is_inconsistent_across_dataset + value: ROUTEN Core: Id: CDISC.ADaMIG.AD0853 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ROUTE is not unique for a given value of ROUTEN Output Variables: - - USUBJID - - USUBJIDN - - ROUTE - - ROUTEN + - USUBJID + - USUBJIDN + - ROUTE + - ROUTEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml index 122fa0275..a35d5ecb7 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0854/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '854' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "854" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ROUTEC - operator: exists - - name: ROUTE - operator: not_exists + - name: ROUTEC + operator: exists + - name: ROUTE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0854 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ROUTEC is present, but ROUTE is not present Output Variables: - - ROUTEC - - USUBJID - - SUBJID + - ROUTEC + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml index e084a16bb..1812c9ee2 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0855/rule.yml @@ -1,55 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions - of the primary/character variables can be assigned from its corresponding numeric pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '855' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "855" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: empty Core: Id: CDISC.ADaMIG.AD0855 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ACYCLE is populated, but ACYCLEC is not populated' + Message: "ACYCLE is populated, but ACYCLEC is not populated" Output Variables: - - ACYCLE - - ACYCLEC - - USUBJID + - ACYCLE + - ACYCLEC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml index 1e5663474..70c680831 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0856/rule.yml @@ -1,55 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions - of the primary/character variables can be assigned from its corresponding numeric pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '856' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "856" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: empty + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: empty Core: Id: CDISC.ADaMIG.AD0856 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'ACYCLEC is populated, but ACYCLE is not populated' + Message: "ACYCLEC is populated, but ACYCLE is not populated" Output Variables: - - ACYCLE - - ACYCLEC - - USUBJID + - ACYCLE + - ACYCLEC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml index 5cc421fbe..1be74b8c6 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0857/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions - of the primary/character variables can be assigned from its corresponding numeric pair - variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '857' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "857" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLEC - operator: is_inconsistent_across_dataset - value: ACYCLE + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLEC + operator: is_inconsistent_across_dataset + value: ACYCLE Core: Id: CDISC.ADaMIG.AD0857 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ACYCLEC is not unique for a given value of ACYCLE Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml index 7b04f0ffb..856a3f9d8 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0858/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Derived from ACYCLE as one-on-one unique match. The character versions - of the primary/character variables can be assigned from its corresponding numeric pair - variable.. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '858' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Derived from ACYCLE as one-on-one unique match. The character versions + of the primary/character variables can be assigned from its corresponding numeric pair + variable.. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "858" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ACYCLEC - operator: non_empty - - name: ACYCLE - operator: non_empty - - name: ACYCLE - operator: is_inconsistent_across_dataset - value: ACYCLEC + - name: ACYCLEC + operator: non_empty + - name: ACYCLE + operator: non_empty + - name: ACYCLE + operator: is_inconsistent_across_dataset + value: ACYCLEC Core: Id: CDISC.ADaMIG.AD0858 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ACYCLE is not unique for a given value of ACYCLEC Output Variables: - - USUBJID - - USUBJIDN - - ACYCLE - - ACYCLEC + - USUBJID + - USUBJIDN + - ACYCLE + - ACYCLEC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml index c326f77eb..2342b2079 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0859/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '859' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "859" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: ACYCLEC - operator: exists - - name: ACYCLE - operator: not_exists + - name: ACYCLEC + operator: exists + - name: ACYCLE + operator: not_exists Core: Id: CDISC.ADaMIG.AD0859 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: ACYCLEC is present, but ACYCLE is not present Output Variables: - - ACYCLEC - - USUBJID - - SUBJID + - ACYCLEC + - USUBJID + - SUBJID Rule Type: Variable Metadata Check against Library Metadata Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml index 37aea5790..41873a002 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml @@ -1,55 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must be a - one-to-one mapping to COHORT. The character versions of the primary/character variables - can be assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '860' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "860" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COHORT - operator: non_empty - - name: COHORTC - operator: empty + - name: COHORT + operator: non_empty + - name: COHORTC + operator: empty Core: Id: CDISC.ADaMIG.AD0860 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COHORT is populated, but COHORTC is not populated' + Message: "COHORT is populated, but COHORTC is not populated" Output Variables: - - COHORT - - COHORTC - - USUBJID + - COHORT + - COHORTC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml index a76b4d539..c0218d009 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml @@ -1,55 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must be a - one-to-one mapping to COHORT. The character versions of the primary/character variables - can be assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '861' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "861" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: empty + - name: COHORTC + operator: non_empty + - name: COHORT + operator: empty Core: Id: CDISC.ADaMIG.AD0861 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COHORTC is populated, but COHORT is not populated' + Message: "COHORTC is populated, but COHORT is not populated" Output Variables: - - COHORT - - COHORTC - - USUBJID + - COHORT + - COHORTC + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml index f7dafd27e..6b789b553 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must be a - one-to-one mapping to COHORT. The character versions of the primary/character variables - can be assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '862' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "862" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORTC - operator: is_inconsistent_across_dataset - value: COHORT + - name: COHORTC + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORTC + operator: is_inconsistent_across_dataset + value: COHORT Core: Id: CDISC.ADaMIG.AD0862 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COHORTC is not unique for a given value of COHORT Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTC + - USUBJID + - USUBJIDN + - COHORT + - COHORTC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml index 0df150914..cc84f3573 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml @@ -1,58 +1,59 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Character representation of the COHORT variable. There must be a - one-to-one mapping to COHORT. The character versions of the primary/character variables - can be assigned from its corresponding numeric pair variable. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '863' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Character representation of the COHORT variable. There must be a + one-to-one mapping to COHORT. The character versions of the primary/character variables + can be assigned from its corresponding numeric pair variable. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "863" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COHORTC - operator: non_empty - - name: COHORT - operator: non_empty - - name: COHORT - operator: is_inconsistent_across_dataset - value: COHORTC + - name: COHORTC + operator: non_empty + - name: COHORT + operator: non_empty + - name: COHORT + operator: is_inconsistent_across_dataset + value: COHORTC Core: Id: CDISC.ADaMIG.AD0863 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COHORT is not unique for a given value of COHORTC Output Variables: - - USUBJID - - USUBJIDN - - COHORT - - COHORTC + - USUBJID + - USUBJIDN + - COHORT + - COHORTC Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml index a4c90be06..7618ac2cf 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0864/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '864' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "864" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COHORTC - operator: exists - - name: COHORT - operator: not_exists + - name: COHORTC + operator: exists + - name: COHORT + operator: not_exists Core: Id: CDISC.ADaMIG.AD0864 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COHORTC is present, but COHORT is not present Output Variables: - - COHORTC - - USUBJID - - SUBJID + - COHORTC + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml index b6fbc5d21..e0704f62c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml @@ -1,56 +1,57 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. - 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian - OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use - variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '865' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "865" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACE - operator: non_empty - - name: RACEN - operator: empty + - name: RACE + operator: non_empty + - name: RACEN + operator: empty Core: Id: CDISC.ADaMIG.AD0865 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'RACE is populated, but RACEN is not populated' + Message: "RACE is populated, but RACEN is not populated" Output Variables: - - RACE - - RACEN - - USUBJID + - RACE + - RACEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml index fb533496a..714773d3e 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml @@ -1,56 +1,57 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. - 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian - OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use - variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '866' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "866" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: empty + - name: RACEN + operator: non_empty + - name: RACE + operator: empty Core: Id: CDISC.ADaMIG.AD0866 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'RACEN is populated, but RACE is not populated' + Message: "RACEN is populated, but RACE is not populated" Output Variables: - - RACE - - RACEN - - USUBJID + - RACE + - RACEN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml index c4a3c8b37..4727b2ce4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml @@ -1,59 +1,60 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. - 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian - OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use - variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '867' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "867" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: non_empty - - name: RACEN - operator: is_inconsistent_across_dataset - value: RACE + - name: RACEN + operator: non_empty + - name: RACE + operator: non_empty + - name: RACEN + operator: is_inconsistent_across_dataset + value: RACE Core: Id: CDISC.ADaMIG.AD0867 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: RACEN is not unique for a given value of RACE Output Variables: - - USUBJID - - USUBJIDN - - RACE - - RACEN + - USUBJID + - USUBJIDN + - RACE + - RACEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml index 44ea01ef4..2ddfc21ea 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml @@ -1,59 +1,60 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. - 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian - OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use - variables ARACE and ARACEN. - Document: ADPPKIG v1.0 - Item: 'Table 3.2' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '868' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Numeric version of RACE eg. Codes used as per the specification. + 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian + OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use + variables ARACE and ARACEN. + Document: ADPPKIG v1.0 + Item: "Table 3.2" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "868" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: RACEN - operator: non_empty - - name: RACE - operator: non_empty - - name: RACE - operator: is_inconsistent_across_dataset - value: RACEN + - name: RACEN + operator: non_empty + - name: RACE + operator: non_empty + - name: RACE + operator: is_inconsistent_across_dataset + value: RACEN Core: Id: CDISC.ADaMIG.AD0868 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: RACE is not unique for a given value of RACEN Output Variables: - - USUBJID - - USUBJIDN - - RACE - - RACEN + - USUBJID + - USUBJIDN + - RACE + - RACEN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml index 288e37771..ef673112f 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0872/rule.yml @@ -1,57 +1,58 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. - Example values can be as follows':' 1=Male, 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '872' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "872" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: non_empty - - name: SEXN - operator: is_inconsistent_across_dataset - value: SEX + - name: SEXN + operator: non_empty + - name: SEX + operator: non_empty + - name: SEXN + operator: is_inconsistent_across_dataset + value: SEX Core: Id: CDISC.ADaMIG.AD0872 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SEXN is not unique for a given value of SEX Output Variables: - - USUBJID - - USUBJIDN - - SEX - - SEXN + - USUBJID + - USUBJIDN + - SEX + - SEXN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml index 40c92e6ae..7c76e4de9 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0873/rule.yml @@ -1,57 +1,58 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. - Example values can be as follows':' 1=Male, 2=Female - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.3' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '873' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: + <- Numeric version of SEX. Can be extended to other values beyond 1 and 2. + Example values can be as follows':' 1=Male, 2=Female + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.3" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "873" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEXN - operator: non_empty - - name: SEX - operator: non_empty - - name: SEX - operator: is_inconsistent_across_dataset - value: SEXN + - name: SEXN + operator: non_empty + - name: SEX + operator: non_empty + - name: SEX + operator: is_inconsistent_across_dataset + value: SEXN Core: Id: CDISC.ADaMIG.AD0873 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SEX is not unique for a given value of SEXN Output Variables: - - USUBJID - - USUBJIDN - - SEX - - SEXN + - USUBJID + - USUBJIDN + - SEX + - SEXN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml index 555e2a007..5e58e12f4 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0874/rule.yml @@ -1,54 +1,55 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <-When a secondary variable is included in the dataset, then the primary - variable must also be included. - Document: ADaM v1.3 - Item: '6' - Section: '3.1.1' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '874' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: + <-When a secondary variable is included in the dataset, then the primary + variable must also be included. + Document: ADaM v1.3 + Item: "6" + Section: "3.1.1" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "874" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: SEXN - operator: exists - - name: SEX - operator: not_exists + - name: SEXN + operator: exists + - name: SEX + operator: not_exists Core: Id: CDISC.ADaMIG.AD0874 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: SEXN is present, but SEX is not present Output Variables: - - SEXN - - USUBJID - - SUBJID + - SEXN + - USUBJID + - SUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Dataset diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml index de51f1c17..51571f580 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0875/rule.yml @@ -1,53 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '875' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "875" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRY - operator: non_empty - - name: COUNTRYN - operator: empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYN + operator: empty Core: Id: CDISC.ADaMIG.AD0875 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COUNTRY is populated, but COUNTRYN is not populated' + Message: "COUNTRY is populated, but COUNTRYN is not populated" Output Variables: - - COUNTRY - - COUNTRYN - - USUBJID + - COUNTRY + - COUNTRYN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml index d3cf99aad..f8064ea2c 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0876/rule.yml @@ -1,53 +1,53 @@ Authorities: -- Organization: CDISC - Standards: - - Name: 'ADaMIG' - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '876' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: "ADaMIG" + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "876" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: empty + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: empty Core: Id: CDISC.ADaMIG.AD0876 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'COUNTRYN is populated, but COUNTRY is not populated' + Message: "COUNTRYN is populated, but COUNTRY is not populated" Output Variables: - - COUNTRY - - COUNTRYN - - USUBJID + - COUNTRY + - COUNTRYN + - USUBJID Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml index fece852a5..fbb7dc9cc 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0877/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: ADaMIG - References: - - Citations: - - Cited Guidance: <- Numeric version of COUNTRY. - Document: ADPPKIG v1.0 - Item: 'Table 3.3' - Section: '3.2' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Failure - Origin: ADaM Conformance Rules - Release Notes: '' - Rule Identifier: - Id: '877' - Version: '1' - Validator Rule Message: '' - Version: '5.0' - Version: '1.3' + - Organization: CDISC + Standards: + - Name: ADaMIG + References: + - Citations: + - Cited Guidance: <- Numeric version of COUNTRY. + Document: ADPPKIG v1.0 + Item: "Table 3.3" + Section: "3.2" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Failure + Origin: ADaM Conformance Rules + Release Notes: "" + Rule Identifier: + Id: "877" + Version: "1" + Validator Rule Message: "" + Version: "5.0" + Version: "1.3" Check: all: - - name: COUNTRYN - operator: non_empty - - name: COUNTRY - operator: non_empty - - name: COUNTRYN - operator: is_inconsistent_across_dataset - value: COUNTRY + - name: COUNTRYN + operator: non_empty + - name: COUNTRY + operator: non_empty + - name: COUNTRYN + operator: is_inconsistent_across_dataset + value: COUNTRY Core: Id: CDISC.ADaMIG.AD0877 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: COUNTRYN is not unique for a given value of COUNTRY Output Variables: - - USUBJID - - USUBJIDN - - COUNTRY - - COUNTRYN + - USUBJID + - USUBJIDN + - COUNTRY + - COUNTRYN Rule Type: Record Data Scope: Data Structures: Include: - - BASIC DATA STRUCTURE + - BASIC DATA STRUCTURE Subclasses: Include: - - POPULATION PHARMACOKINETIC ANALYSIS + - POPULATION PHARMACOKINETIC ANALYSIS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000734/rule.yml b/Unpublished/FDA Business Rules/CORE-000734/rule.yml index e6b6b8098..ba3a15faa 100644 --- a/Unpublished/FDA Business Rules/CORE-000734/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000734/rule.yml @@ -1,80 +1,85 @@ # Variable: TSPARMCD, TSVAL # TSPARMCD = 'FDATCHSP' Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: '"All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain."' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1104' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1104" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1104" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + '"All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG). Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain."' + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1104" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: TSPARMCD - operator: 'not_equal_to' - value: 'FDATCHSP' + - name: TSPARMCD + operator: "not_equal_to" + value: "FDATCHSP" Core: Id: CORE-000734 Status: Draft - Version: '1' -Description: 'TSVAL (Standard Name) matches corresponding name as listed on the study data standards resources - website for technical specification documents.' + Version: "1" +Description: + "TSVAL (Standard Name) matches corresponding name as listed on the study data standards resources + website for technical specification documents." Executability: Fully Executable Outcome: - Message: 'TSVAL (Standard Name) does not match corresponding name as listed in on the study data standards - resources website for technical specification documents.' + Message: + "TSVAL (Standard Name) does not match corresponding name as listed in on the study data standards + resources website for technical specification documents." Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000737/rule.yml b/Unpublished/FDA Business Rules/CORE-000737/rule.yml index d1332ef2c..a575a30c4 100644 --- a/Unpublished/FDA Business Rules/CORE-000737/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000737/rule.yml @@ -1,111 +1,116 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1102' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1102" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1102" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1102" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: TSPARMCD - operator: not_contains_all - value: - - 'ACTSUB' - - 'ADAPT' - - 'ADDON' - - 'AGEMAX' - - 'AGEMIN' - - 'COMPTRT' - - 'DCUTDESC' - - 'DCUTDTC' - - 'EXTTIND' - - 'FCNTRY' - - 'HLTSUBJI' - - 'LENGTH' - - 'NARMS' - - 'NCOHORT' - - 'OBJPRIM' - - 'OBJSEC' - - 'ONGOSIND' - - 'OUTMSPRI' - - 'PDPSTIND' - - 'PDSTIND' - - 'PIPIND' - - 'PLANSUB' - - 'RDIND' - - 'REGID' - - 'SENDTC' - - 'SEXPOP' - - 'SPONSOR' - - 'SDTMVER' - - 'SDTIGVER' - - 'STOPRULE' - - 'SSTDTC' - - 'STYPE' - - 'TBLIND' - - 'TCNTRL' - - 'THERAREA' - - 'TITLE' - - 'TPHASE' - - 'TTYPE' - - 'INDIC' - - 'RANDQT' - - name: 'TSVAL' - operator: non_empty + - name: TSPARMCD + operator: not_contains_all + value: + - "ACTSUB" + - "ADAPT" + - "ADDON" + - "AGEMAX" + - "AGEMIN" + - "COMPTRT" + - "DCUTDESC" + - "DCUTDTC" + - "EXTTIND" + - "FCNTRY" + - "HLTSUBJI" + - "LENGTH" + - "NARMS" + - "NCOHORT" + - "OBJPRIM" + - "OBJSEC" + - "ONGOSIND" + - "OUTMSPRI" + - "PDPSTIND" + - "PDSTIND" + - "PIPIND" + - "PLANSUB" + - "RDIND" + - "REGID" + - "SENDTC" + - "SEXPOP" + - "SPONSOR" + - "SDTMVER" + - "SDTIGVER" + - "STOPRULE" + - "SSTDTC" + - "STYPE" + - "TBLIND" + - "TCNTRL" + - "THERAREA" + - "TITLE" + - "TPHASE" + - "TTYPE" + - "INDIC" + - "RANDQT" + - name: "TSVAL" + operator: non_empty Core: Id: CORE-000737 Status: Draft - Version: '1' -Description: 'The set of parameters without conditions listed in the TCG, Appendix B, is not included - in the list of TSPARAMCD with TSVAL populated.' + Version: "1" +Description: + "The set of parameters without conditions listed in the TCG, Appendix B, is not included + in the list of TSPARAMCD with TSVAL populated." Executability: Fully Executable Outcome: - Message: 'The set of parameters without conditions listed in the TCG, Appendix B, is not included in - the list of TSPARAMCD with TSVAL populated.' + Message: + "The set of parameters without conditions listed in the TCG, Appendix B, is not included in + the list of TSPARAMCD with TSVAL populated." Output Variables: - - TSVAL - - TSPARMCD + - TSVAL + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000738/rule.yml b/Unpublished/FDA Business Rules/CORE-000738/rule.yml index 5c3b25c3d..6bd4f1b19 100644 --- a/Unpublished/FDA Business Rules/CORE-000738/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000738/rule.yml @@ -1,82 +1,82 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1106' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1106" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1106" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1106" + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - - name: $crmdur_count - operator: less_than - value: 1 - - all: - name: $crmdur_count - operator: 'greater_than_or_equal_to' + operator: less_than value: 1 - - name: TSPARMCD - operator: equal_to - value: 'CRMDUR' - - name: TSVAL - operator: empty + - all: + - name: $crmdur_count + operator: "greater_than_or_equal_to" + value: 1 + - name: TSPARMCD + operator: equal_to + value: "CRMDUR" + - name: TSVAL + operator: empty Core: Id: CORE-000738 Status: Draft - Version: '1' -Description: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.' + Version: "1" +Description: "No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null." Executability: Partially Executable Operations: -- domain: TS - filter: - TSPARMCD: CRMDUR - id: $crmdur_count - name: TSPARMCD - operator: record_count + - domain: TS + filter: + TSPARMCD: CRMDUR + id: $crmdur_count + name: TSPARMCD + operator: record_count Outcome: - Message: 'No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null.' + Message: "No occurrence of TSPARMCD=’CRMDUR’ is included in TS or TSVAL is null." Output Variables: - - TSPARMCD - - TSVAL - - $crmdur_count + - TSPARMCD + - TSVAL + - $crmdur_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/CORE-000748/rule.yml b/Unpublished/FDA Business Rules/CORE-000748/rule.yml index 3cfdb7eb9..f3b90fa54 100644 --- a/Unpublished/FDA Business Rules/CORE-000748/rule.yml +++ b/Unpublished/FDA Business Rules/CORE-000748/rule.yml @@ -2,65 +2,65 @@ # Condition: ARMNRS ^= ("SCREEN FAILURE", N"OT ASSIGNED", "ASSIGNED, NOT TREATED") # Rule: Value is present for subject in EX Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2504 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2504 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2504 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2504 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: ARMNRS - operator: is_not_contained_by_case_insensitive - value: - - "SCREEN FAILURE" - - "NOT ASSIGNED" - - "ASSIGNED, NOT TREATED" - - name: USUBJID - operator: is_not_contained_by - value: $usubjids_in_ex + - name: ARMNRS + operator: is_not_contained_by_case_insensitive + value: + - "SCREEN FAILURE" + - "NOT ASSIGNED" + - "ASSIGNED, NOT TREATED" + - name: USUBJID + operator: is_not_contained_by + value: $usubjids_in_ex Core: Id: CORE-000748 Status: Draft - Version: '1' + Version: "1" Description: If a subject is assigned to an arm code, the subject should have a record in EX. Executability: Partially Executable Operations: -- domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct + - domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: Message: Subject is assigned to an arm (randomized) but has no record in EX. Output Variables: - - ARMNRS + - ARMNRS Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - INTERVENTIONS + - SPECIAL PURPOSE + - INTERVENTIONS Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB0804/rule.yml b/Unpublished/FDA Business Rules/FB0804/rule.yml index a9f57af1d..8f991b842 100644 --- a/Unpublished/FDA Business Rules/FB0804/rule.yml +++ b/Unpublished/FDA Business Rules/FB0804/rule.yml @@ -1,97 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'All treatment exposure date/time should be between first and last study treatment - date/time.' - Document: 'FDA' - Section: 'FDAB008' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0804' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "All treatment exposure date/time should be between first and last study treatment + date/time." + Document: "FDA" + Section: "FDAB008" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0804" + Version: "1" + Version: "1.5" + Version: "1.0" # rule failure criteria: TSPARMCD.EXPSTDTC => EXENDTC or EXENDTC => TSPARMCD.EXPENDTC Check: any: @@ -103,42 +110,44 @@ Check: # operator: date_greater_than_or_equal_to # value: EXENDTC # EXENDTC => TSPARMCD.EXPENDTC - - name: --ENDTC - operator: date_greater_than_or_equal_to - value: $ts_expendtc_value - #value: '2001-01-01' + - name: --ENDTC + operator: date_greater_than_or_equal_to + value: + $ts_expendtc_value + #value: '2001-01-01' Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- domain: TS - filter: - TSPARMCD: EXPENDTC - id: $ts_expendtc_value - name: TSVAL - operator: distinct - value_is_reference: false -- domain: TS - filter: - TSPARMCD: EXPSTDTC - id: $ts_expstdtc_value - name: TSVAL - operator: distinct + - domain: TS + filter: + TSPARMCD: EXPENDTC + id: $ts_expendtc_value + name: TSVAL + operator: distinct + value_is_reference: false + - domain: TS + filter: + TSPARMCD: EXPSTDTC + id: $ts_expstdtc_value + name: TSVAL + operator: distinct Outcome: - Message: 'Treatment exposure end date/time (EXENDTC) falls outside the date/time experimental start - (EXPSTDTC) and end date (EXPENDTC) in the TS dataset.' + Message: + "Treatment exposure end date/time (EXENDTC) falls outside the date/time experimental start + (EXPSTDTC) and end date (EXPENDTC) in the TS dataset." Output Variables: - - EXENDTC - - $ts_expstdtc_value - - $ts_expendtc_value + - EXENDTC + - $ts_expstdtc_value + - $ts_expendtc_value Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB1113/rule.yml b/Unpublished/FDA Business Rules/FB1113/rule.yml index 04a75f5d6..09596f801 100644 --- a/Unpublished/FDA Business Rules/FB1113/rule.yml +++ b/Unpublished/FDA Business Rules/FB1113/rule.yml @@ -1,103 +1,105 @@ # Variable: TSPARMCD -# Condition: +# Condition: # Success Criteria: The count of occurrences of TSPARAMCD = not in the set (‘FCNTRY’, ‘OBJPRIM’, ‘OBJSEC’, ‘OUTMSPRI’, ‘OUTMSSEC’, 'RANDQT', ‘REGID’, ‘TITLE’, ‘TTYPE’) included in the list of TSPARAMCD with TSVAL populated is eq 1. Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1113' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1113" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1113" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1113" + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - name: $tsparmcd - operator: does_not_contain - value: 'CURTRT' - value_is_literal: true - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - name: TSPARMCD - operator: 'equal_to' - value: 'CURTRT' - value_is_literal: true - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: "equal_to" + value: "ADDON" + value_is_literal: true + - name: TSVAL + operator: "equal_to" + value: "Y" + value_is_literal: true + - name: $tsparmcd + operator: does_not_contain + value: "CURTRT" + value_is_literal: true + - all: + - name: TSPARMCD + operator: "equal_to" + value: "ADDON" + value_is_literal: true + - name: TSVAL + operator: "equal_to" + value: "Y" + value_is_literal: true + - name: TSPARMCD + operator: "equal_to" + value: "CURTRT" + value_is_literal: true + - name: TSVAL + operator: empty Core: Id: Status: Draft - Version: '1' -Description: The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', - 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of + Version: "1" +Description: + The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', + 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is eq 1. Executability: Fully Executable Operations: -- domain: TS - id: $tsparmcd - name: TSPARMCD - operator: distinct + - domain: TS + id: $tsparmcd + name: TSPARMCD + operator: distinct Outcome: - Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of - occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', - .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL + Message: + No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of + occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', + .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is gt 1. Output Variables: - - TSPARMCD - - TSVAL - - $tsparmcd + - TSPARMCD + - TSVAL + - $tsparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB1901/rule.yml b/Unpublished/FDA Business Rules/FB1901/rule.yml index fbdf0aa88..18cb9c680 100644 --- a/Unpublished/FDA Business Rules/FB1901/rule.yml +++ b/Unpublished/FDA Business Rules/FB1901/rule.yml @@ -1,167 +1,178 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: SUPPQUAL variable length should be no longer than the maximum length of the - actual data within the dataset. - Document: FDA - Section: FDAB019 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1901 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + SUPPQUAL variable length should be no longer than the maximum length of the + actual data within the dataset. + Document: FDA + Section: FDAB019 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1901 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: SUPPQUAL - operator: exists - - name: RELREC - operator: exists - - name: SUPPQUAL - operator: is_inconsistent_across_dataset - value: - - all_variables - - name: RELREC - operator: is_inconsistent_across_dataset - value: - - all_variables + - name: SUPPQUAL + operator: exists + - name: RELREC + operator: exists + - name: SUPPQUAL + operator: is_inconsistent_across_dataset + value: + - all_variables + - name: RELREC + operator: is_inconsistent_across_dataset + value: + - all_variables Core: Status: Draft - Version: '1' -Description: All variables in each of the SUPPQUAL and RELREC datasets have a length that is not + Version: "1" +Description: + All variables in each of the SUPPQUAL and RELREC datasets have a length that is not longer than the length of the longest value for that variable. Executability: Partially Executable Outcome: Message: The length of the variable is longer than the data within the variable Output Variables: - - SUPPQUAL - - RELREC + - SUPPQUAL + - RELREC Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FB6501/rule.yml b/Unpublished/FDA Business Rules/FB6501/rule.yml index 6b52aeb1e..001e44392 100644 --- a/Unpublished/FDA Business Rules/FB6501/rule.yml +++ b/Unpublished/FDA Business Rules/FB6501/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission # then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: DS - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: DS + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'DS dataset should be present in the submission when related data is collected' + Version: "1" +Description: "DS dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing DS dataset. Output Variables: - - DS - - define_dataset_has_no_data + - DS + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "DS" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6502/rule.yml b/Unpublished/FDA Business Rules/FB6502/rule.yml index 62a640ca2..ee50a2a63 100644 --- a/Unpublished/FDA Business Rules/FB6502/rule.yml +++ b/Unpublished/FDA Business Rules/FB6502/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission # then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: CL - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: CL + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'CL dataset should be present in the submission when related data is collected' + Version: "1" +Description: "CL dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing CL dataset. Output Variables: - - CL - - define_dataset_has_no_data + - CL + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "CL" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6503/rule.yml b/Unpublished/FDA Business Rules/FB6503/rule.yml index b1cb18be2..736bef370 100644 --- a/Unpublished/FDA Business Rules/FB6503/rule.yml +++ b/Unpublished/FDA Business Rules/FB6503/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission # then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: EG - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: EG + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'EG dataset should be present in the submission when related data is collected' + Version: "1" +Description: "EG dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing EG dataset. Output Variables: - - EG - - define_dataset_has_no_data + - EG + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "EG" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6504/rule.yml b/Unpublished/FDA Business Rules/FB6504/rule.yml index 757a64ae2..f8b6f2607 100644 --- a/Unpublished/FDA Business Rules/FB6504/rule.yml +++ b/Unpublished/FDA Business Rules/FB6504/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission # then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: EX - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: EX + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'EX dataset should be present in the submission when related data is collected' + Version: "1" +Description: "EX dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing EX dataset. Output Variables: - - EX - - define_dataset_has_no_data + - EX + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "EX" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6505/rule.yml b/Unpublished/FDA Business Rules/FB6505/rule.yml index c4454522a..cfe5fc490 100644 --- a/Unpublished/FDA Business Rules/FB6505/rule.yml +++ b/Unpublished/FDA Business Rules/FB6505/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission # then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: LB - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: LB + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'LB dataset should be present in the submission when related data is collected' + Version: "1" +Description: "LB dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing LB dataset. Output Variables: - - LB - - define_dataset_has_no_data + - LB + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "LB" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6506/rule.yml b/Unpublished/FDA Business Rules/FB6506/rule.yml index 67c50c44c..8f8d3cb3a 100644 --- a/Unpublished/FDA Business Rules/FB6506/rule.yml +++ b/Unpublished/FDA Business Rules/FB6506/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission # then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: MA - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: MA + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'MA dataset should be present in the submission when related data is collected' + Version: "1" +Description: "MA dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing MA dataset. Output Variables: - - MA - - define_dataset_has_no_data + - MA + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "MA" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6507/rule.yml b/Unpublished/FDA Business Rules/FB6507/rule.yml index 71cdb5490..871842585 100644 --- a/Unpublished/FDA Business Rules/FB6507/rule.yml +++ b/Unpublished/FDA Business Rules/FB6507/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission # then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: MI - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: MI + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'MI dataset should be present in the submission when related data is collected' + Version: "1" +Description: "MI dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing MI dataset. Output Variables: - - MI - - define_dataset_has_no_data + - MI + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "MI" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6508/rule.yml b/Unpublished/FDA Business Rules/FB6508/rule.yml index 2e53b0fe8..81ce13a28 100644 --- a/Unpublished/FDA Business Rules/FB6508/rule.yml +++ b/Unpublished/FDA Business Rules/FB6508/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6507: When PC domain is present in the define.xml, but no PC dataset is present in the submission # then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: PC - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: PC + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'PC dataset should be present in the submission when related data is collected' + Version: "1" +Description: "PC dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing PC dataset. Output Variables: - - PC - - define_dataset_has_no_data + - PC + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "PC" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6509/rule.yml b/Unpublished/FDA Business Rules/FB6509/rule.yml index 632af5a9a..935daeed4 100644 --- a/Unpublished/FDA Business Rules/FB6509/rule.yml +++ b/Unpublished/FDA Business Rules/FB6509/rule.yml @@ -1,121 +1,121 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6507: When PP domain is present in the define.xml, but no PP dataset is present in the submission # then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: PP - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: PP + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'PP dataset should be present in the submission when related data is collected' + Version: "1" +Description: "PP dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing PP dataset. Output Variables: - - PP - - define_dataset_has_no_data + - PP + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "PP" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6510/rule.yml b/Unpublished/FDA Business Rules/FB6510/rule.yml index a80a1dd64..33396bd35 100644 --- a/Unpublished/FDA Business Rules/FB6510/rule.yml +++ b/Unpublished/FDA Business Rules/FB6510/rule.yml @@ -1,123 +1,123 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6510' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6510" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6510: When VS domain is present in the define.xml, but no VS dataset is present in the submission -# then the define.xml must contain ItemGroupDef for VS with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for VS with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: VS - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: VS + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'VS dataset should be present in the submission when related data is collected' + Version: "1" +Description: "VS dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing VS dataset. Output Variables: - - VS - - define_dataset_has_no_data + - VS + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "VS" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6601/rule.yml b/Unpublished/FDA Business Rules/FB6601/rule.yml index ba6ee78a6..e4be22802 100644 --- a/Unpublished/FDA Business Rules/FB6601/rule.yml +++ b/Unpublished/FDA Business Rules/FB6601/rule.yml @@ -1,118 +1,124 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Not applicable to SEND 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV should be - submitted if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: In SEND 3.1 data elements that would be mapped to RE and CV should be - submitted if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + In SEND 3.1 data elements that would be mapped to RE and CV should be + submitted if collected and included in the study report.' + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + In SEND 3.1 data elements that would be mapped to RE and CV should be + submitted if collected and included in the study report.' + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6601: When CV domain is present in the define.xml, but no CV dataset is present in the submission -# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: CV - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: CV + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'CV dataset should be present in the submission when related data is collected' + Version: "1" +Description: "CV dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing CV dataset. Output Variables: - - CV - - define_dataset_has_no_data + - CV + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "CV" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FB6602/rule.yml b/Unpublished/FDA Business Rules/FB6602/rule.yml index 51ca2b6c7..ac5fba790 100644 --- a/Unpublished/FDA Business Rules/FB6602/rule.yml +++ b/Unpublished/FDA Business Rules/FB6602/rule.yml @@ -1,118 +1,124 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Not applicable to SEND 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report..' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report.." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6602: When RE domain is present in the define.xml, but no RE dataset is present in the submission -# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" Check: all: # Also SEE FB0405 - - name: define_dataset_name - operator: equal_to - value: RE - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty -# + - name: define_dataset_name + operator: equal_to + value: RE + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty +# Core: Status: Draft - Version: '1' -Description: 'RE dataset should be present in the submission when related data is collected' + Version: "1" +Description: "RE dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing RE dataset. Output Variables: - - RE - - define_dataset_has_no_data + - RE + - define_dataset_has_no_data Rule Type: Domain Presence Check against Define XML # Scope: Important here to have "ALL", not "RE" ... Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Dataset Sensitivity: Study diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml index 22ae3622d..8ac88b29d 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml @@ -1,47 +1,48 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Origin: FDA Business Rules - Rule Identifier: - Id: FDAB017 - Version: '1' - Version: '1.5' - Version: '3.2 ' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Origin: FDA Business Rules + Rule Identifier: + Id: FDAB017 + Version: "1" + Version: "1.5" + Version: "3.2 " Check: all: - - name: SSSTRESC - operator: does_not_use_valid_codelist_terms - value: DEAD - value_is_literal: true - - name: $ds_dsdecod - operator: does_not_contain - value: DEATH - value_is_literal: true + - name: SSSTRESC + operator: does_not_use_valid_codelist_terms + value: DEAD + value_is_literal: true + - name: $ds_dsdecod + operator: does_not_contain + value: DEATH + value_is_literal: true Core: Id: FDA.SDTMIG.CT2001 Status: Draft - Version: '1' -Description: Variable must be populated with terms from its CDISC controlled terminology codelist. + Version: "1" +Description: + Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. Operations: -- domain: DS - group: - - USUBJID - id: $ds_dsdecod - name: DSDECOD - operator: distinct + - domain: DS + group: + - USUBJID + id: $ds_dsdecod + name: DSDECOD + operator: distinct Outcome: Message: Variable value not found in non-extensible codelist. Output Variables: - - + - Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml index 7bad09220..7fea770ad 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0101/rule.yml @@ -1,74 +1,74 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A treatment-emergent flag should be submitted. - Document: FDA - Section: FDAB001 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0101 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A treatment-emergent flag should be submitted. + Document: FDA + Section: FDAB001 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0101 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: # Because the data we're checking involves a pivoted join, there are multiple rows per # (USUBJID, AESEQ) combination: one per value of QNAM. We want to raise only one error per # (USUBJID, AESEQ) combination, so choose the row with the minimum value of QNAM. - - name: AETERM - operator: non_empty - - name: QNAM - operator: is_not_contained_by - value: AETRTEM + - name: AETERM + operator: non_empty + - name: QNAM + operator: is_not_contained_by + value: AETRTEM Core: Id: FDA.SDTMIG.FB0101 Status: Draft - Version: '1' + Version: "1" Description: Treatment-emergent flag should be present in SUPPAE for each Adverse Event. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: SUPPAE + - Keys: + - USUBJID + Name: SUPPAE Outcome: Message: Missing treatment-emergent flag (AETRTEM) for Adverse Event. Output Variables: - - AETERM - - AESTDTC - - QNAM + - AETERM + - AESTDTC + - QNAM Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml index 48ffb2903..a55d05db4 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0405/rule.yml @@ -1,71 +1,74 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if - collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if - collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if - collected.' - Document: 'FDA' - Section: 'FDAB004' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB0405' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected." + Document: "FDA" + Section: "FDAB004" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0405" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected." + Document: "FDA" + Section: "FDAB004" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0405" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted if + collected." + Document: "FDA" + Section: "FDAB004" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB0405" + Version: "1.5" + Version: "3.4" Check: all: - - name: define_dataset_name - operator: equal_to - value: LB - - name: define_dataset_has_no_data - operator: equal_to - value: false - - name: filename - operator: empty + - name: define_dataset_name + operator: equal_to + value: LB + - name: define_dataset_has_no_data + operator: equal_to + value: false + - name: filename + operator: empty Core: Id: FDA.SDTMIG.FB0405 Status: Draft - Version: '1' + Version: "1" Description: LB dataset should be present in the submission when related data is collected. Executability: Fully Executable Outcome: Message: Missing LB dataset. Output Variables: - - define_dataset_name - - define_dataset_has_no_data - - filename - - domain + - define_dataset_name + - define_dataset_has_no_data + - filename + - domain Rule Type: Domain Presence Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml index 289cb15af..33c77a0ab 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0411/rule.yml @@ -1,72 +1,75 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted - if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted - if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted - if collected. - Document: FDA - Section: FDAB004 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0411 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + AE, CE, CM, DS, EG, EX, LB, MH, PC, PP, SE, SV, and VS should be submitted + if collected. + Document: FDA + Section: FDAB004 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0411 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: PC - operator: exists - - name: ItemGroupDef - operator: is_inconsistent_across_dataset - value: - - Domain: PC - - Attribute: def:HasNoData - - Value: 'Yes' + - name: PC + operator: exists + - name: ItemGroupDef + operator: is_inconsistent_across_dataset + value: + - Domain: PC + - Attribute: def:HasNoData + - Value: "Yes" Core: Id: FDA.SDTMIG.FB0411 Status: Draft - Version: '1' + Version: "1" Description: PC dataset is present in the submission Executability: Fully Executable Outcome: Message: Dataset PC is missing Output Variables: - - PC - - ItemGroupDef.def:HasNoData + - PC + - ItemGroupDef.def:HasNoData Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml index 2096eb4bd..9dd02953f 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml @@ -1,162 +1,173 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB080 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.4' - # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0801 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB080 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: + "3.4" + # Not applicable to SENDIG-3.0 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0801 + Version: "1" + Version: "1.5" + Version: "1.0" Check: any: # This part of the rule is solely about --STDTC, NOT about --ENDTC # Remark that date_less_than and date_greater_than compare the shortest common part of the two dates. - # For example, when 2025-11-03 is compared with 2025-11-02T15:26, + # For example, when 2025-11-03 is compared with 2025-11-02T15:26, # the comparison done is between 2025-11-03 and 2025-11-02. # Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45 # then the comparison done is between 2025-11-03T07 and 2025-11-03T07 - - name: --STDTC - operator: date_less_than - value: RFXSTDTC - - name: --STDTC - operator: date_greater_than - value: RFXENDTC + - name: --STDTC + operator: date_less_than + value: RFXSTDTC + - name: --STDTC + operator: date_greater_than + value: RFXENDTC Core: Id: FDA.SDTMIG.FB0801 Status: Draft - Version: '1' -Description: Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC) + Version: "1" +Description: + Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: --STDTC does not fall on or between RFXSTDTC and RFENDTC. Output Variables: - - RFXSTDTC - - --STDTC - - RFXENDTC + - RFXSTDTC + - --STDTC + - RFXENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml index 40e3873fa..55aff97fe 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml @@ -1,163 +1,174 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB080 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.4' - # Not applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0802 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB080 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: + "3.4" + # Not applicable to SENDIG-3.0 + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0802 + Version: "1" + Version: "1.5" + Version: "1.0" Check: any: # This part of the rule is solely about --ENDTC, NOT about --STDTC # Remark that date_less_than and date_greater_than compare the shortest common part of the two dates. - # For example, when 2025-11-03 is compared with 2025-11-02T15:26, + # For example, when 2025-11-03 is compared with 2025-11-02T15:26, # the comparison done is between 2025-11-03 and 2025-11-02. # Similarly, when the comparison is done between 2025-11-03T07 and 2025-11-03T07:45 # then the comparison done is between 2025-11-03T07 and 2025-11-03T07 - - name: RFXSTDTC - operator: date_greater_than - value: --ENDTC - - name: --ENDTC - operator: date_greater_than - value: RFXENDTC + - name: RFXSTDTC + operator: date_greater_than + value: --ENDTC + - name: --ENDTC + operator: date_greater_than + value: RFXENDTC Core: Id: FDA.SDTMIG.FB0802 Status: Draft - Version: '1' -Description: Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC) + Version: "1" +Description: + Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: --ENDTC does not fall on or between RFXSTDTC and RFENDTC. Output Variables: - - "USUBJID" - - "--ENDTC" - - "RFXSTDTC" - - "RFXENDTC" + - "USUBJID" + - "--ENDTC" + - "RFXSTDTC" + - "RFXENDTC" Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC - - EX + - EC + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml index d1bbbaddb..91b6da1a6 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml @@ -1,130 +1,138 @@ Authorities: -- Organization: 'FDA' - Standards: + - Organization: "FDA" + Standards: # Alsot applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: All treatment exposure date/time should be between first and last study - treatment date/time. - Document: FDA - Section: FDAB008 - Origin: FDA Business Rules - Rule Identifier: - Id: FB0803 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + All treatment exposure date/time should be between first and last study + treatment date/time. + Document: FDA + Section: FDAB008 + Origin: FDA Business Rules + Rule Identifier: + Id: FB0803 + Version: "1" + Version: "1.5" + Version: "1.0" # rule failure criteria: TSPARMCD.EXPSTDTC => EXSTDTC OR EXSTDTC => TSPARMCD.EXPENDTC Check: all: - - name: $ts_expstdtc_value - operator: date_greater_than_or_equal_to - value: --EXSTDTC + - name: $ts_expstdtc_value + operator: date_greater_than_or_equal_to + value: --EXSTDTC Core: Id: FDA.SDTMIG.FB0803 Status: Draft - Version: '1' -Description: Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time + Version: "1" +Description: + Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset. Executability: Fully Executable Operations: -- domain: TS - filter: - TSPARMCD: EXPSTDTC - id: $ts_expstdtc_value - name: TSVAL - operator: distinct + - domain: TS + filter: + TSPARMCD: EXPSTDTC + id: $ts_expstdtc_value + name: TSVAL + operator: distinct Outcome: Message: EXSTDTC does not fall on or between EXPENDTC and EXPENDTC in TS dataset. Output Variables: - - $ts_expstdtc_value - - --EXSTDTC + - $ts_expstdtc_value + - --EXSTDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX - - EC + - EX + - EC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml index c6417052c..5ee0c03d0 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml @@ -1,60 +1,64 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1101' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1101" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1101" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1101" + Version: "1" + Version: "1.5" + Version: "3.4" Check: any: - - name: TA - operator: not_exists - - name: TE - operator: not_exists - - name: TS - operator: not_exists - - name: TV - operator: not_exists + - name: TA + operator: not_exists + - name: TE + operator: not_exists + - name: TS + operator: not_exists + - name: TV + operator: not_exists Core: Id: FDA.SDTMIG.FB1101 Status: Draft - Version: '1' -Description: All trial design datasets as listed in the corresponding IG should be present in the + Version: "1" +Description: + All trial design datasets as listed in the corresponding IG should be present in the submission. Executability: Fully Executable Outcome: @@ -63,8 +67,8 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml index 3ae7430d6..5a0a5dcf9 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1103/rule.yml @@ -1,92 +1,97 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # ONLY applicable to SDTMIG, not to SEND - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in - the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) - or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table - below in the TS domain.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1103 - Version: '1' - Version: '1.5' - Version: '3.4' + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG) Page 13: In addition to the study parameters indicated in + the appendix section, if the study data submitted follows a Therapeutic Area User Guide (TAUG) + or an FDA Technical Specification,30 use the values for TSPARM/TSPARMCD and TSVAL from the table + below in the TS domain." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1103 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: TSPARMCD - operator: equal_to - value: 'CTAUG' - - name: TSVAL - operator: is_not_contained_by - value: $terms + - name: TSPARMCD + operator: equal_to + value: "CTAUG" + - name: TSVAL + operator: is_not_contained_by + value: $terms Core: Id: FDA.SDTMIG.FB1103 Status: Draft - Version: '1' -Description: 'Raise an issue when TSVAL (Standard Name) does not match corresponding name as listed in + Version: "1" +Description: + "Raise an issue when TSVAL (Standard Name) does not match corresponding name as listed in section 5.2 of the TCG for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC - Library.' + Library." Executability: Fully Executable # 2025-09-29: still throws an error when tested on an Excel file # See Github ticket 1338: https://github.com/cdisc-org/cdisc-rules-engine/issues/1338 Operations: -- codelists: - - CTAUGRS - id: $terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - CTAUGRS + id: $terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: 'TSVAL (Standard Name) does not match corresponding name as listed in section 5.2 of the TCG - for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC Library.' + Message: + "TSVAL (Standard Name) does not match corresponding name as listed in section 5.2 of the TCG + for TAUGs and is in the CTAUGRS codelist (C160925), as published in the CDISC Library." Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml index 28cf040d5..b1efc55a0 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1107/rule.yml @@ -2,89 +2,89 @@ # Condition: TSPARAMCD=’ADDON’ and TSVAL=’Y’ # Success Criteria: At least one occurrence of TSPARAMCD=’CURTRT’ is included in TS with TSVAL populated. Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1107' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1107" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1107" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1107" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - all: - - name: TSPARMCD - operator: 'equal_to' - value: 'ADDON' - value_is_literal: true - - name: TSVAL - operator: 'equal_to' - value: 'Y' - value_is_literal: true - - any: - - name: $tsparmcd - operator: does_not_contain - value: 'CURTRT' - value_is_literal: true - - name: TSPARMCD - operator: 'equal_to' - value: 'CURTRT' - value_is_literal: true - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: "equal_to" + value: "ADDON" + value_is_literal: true + - name: TSVAL + operator: "equal_to" + value: "Y" + value_is_literal: true + - any: + - name: $tsparmcd + operator: does_not_contain + value: "CURTRT" + value_is_literal: true + - name: TSPARMCD + operator: "equal_to" + value: "CURTRT" + value_is_literal: true + - name: TSVAL + operator: empty Core: Id: FDA.SDTMIG.FB1107 Status: Draft - Version: '1' + Version: "1" Description: At least one occurrence of TSPARAMCD='CURTRT' is included in TS with TSVAL populated. Executability: Fully Executable Operations: -- domain: TS - id: $tsparmcd - name: TSPARMCD - operator: distinct + - domain: TS + id: $tsparmcd + name: TSPARMCD + operator: distinct Outcome: Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null. Output Variables: - - TSPARMCD - - TSVAL - - $tsparmcd + - TSPARMCD + - TSVAL + - $tsparmcd Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml index 241103572..65367365d 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1108/rule.yml @@ -1,65 +1,65 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1108' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1108" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1108" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1108" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: 'TSPARMCD' - operator: equal_to - value: DCUTDESC + - name: "TSPARMCD" + operator: equal_to + value: DCUTDESC Core: Id: FDA.SDTMIG.FB1108 Status: Draft - Version: '1' -Description: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values.' + Version: "1" +Description: "TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values." Executability: Fully Executable Outcome: - Message: 'TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values.' + Message: "TSPARAMCD=DCUTDESC and TSPARAMCD=DCUTDTC do not share the same TSGRPID and TSVAL values." Output Variables: - - TSPARMCD - - TSVAL - - TSGRPID + - TSPARMCD + - TSVAL + - TSGRPID Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml index e48284d6e..d66079819 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1109/rule.yml @@ -1,169 +1,171 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1109' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1109" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1109" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1109" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: TSPARMCD - operator: equal_to - value: CTAUG - - name: TSVAL - operator: starts_with - value: QT - - any: - name: TSPARMCD - operator: not_contains_all - value: - - EGBLIND - - EGCTMON - - EGLEADPR - - EGLEADSM - - EGRDMETH - - EGREPLBL - - EGREPLTR - - EGTWVALG - - name: $blind_count operator: equal_to - value: 1 - - name: $ctmon_count - operator: equal_to - value: 1 - - name: $leadpr_count - operator: equal_to - value: 1 - - name: $leadsm_count - operator: equal_to - value: 1 - - name: $rdmeth_count - operator: equal_to - value: 1 - - name: $replbl_count - operator: equal_to - value: 1 - - name: $repltr_count - operator: equal_to - value: 1 - - name: $twvalg_count - operator: equal_to - value: 1 + value: CTAUG + - name: TSVAL + operator: starts_with + value: QT + - any: + - name: TSPARMCD + operator: not_contains_all + value: + - EGBLIND + - EGCTMON + - EGLEADPR + - EGLEADSM + - EGRDMETH + - EGREPLBL + - EGREPLTR + - EGTWVALG + - name: $blind_count + operator: equal_to + value: 1 + - name: $ctmon_count + operator: equal_to + value: 1 + - name: $leadpr_count + operator: equal_to + value: 1 + - name: $leadsm_count + operator: equal_to + value: 1 + - name: $rdmeth_count + operator: equal_to + value: 1 + - name: $replbl_count + operator: equal_to + value: 1 + - name: $repltr_count + operator: equal_to + value: 1 + - name: $twvalg_count + operator: equal_to + value: 1 Core: Id: FDA.SDTMIG.FB1109 Status: Draft - Version: '1' -Description: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is - included in the list of TSPARAMCD with TSVAL populated.' + Version: "1" +Description: + "The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is + included in the list of TSPARAMCD with TSVAL populated." Executability: Fully Executable Operations: -- domain: TS - filter: - TSPARMCD: EGBLIND - TSVAL: '' - id: $blind_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGCTMON - TSVAL: '' - id: $ctmon_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGLEADPR - TSVAL: '' - id: $leadpr_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGLEADSM - TSVAL: '' - id: $leadsm_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGRDMETH - TSVAL: '' - id: $rdmeth_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGREPLBL - TSVAL: '' - id: $replbl_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGREPLTR - TSVAL: '' - id: $repltr_count - name: TSPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: EGTWVALG - TSVAL: '' - id: $twvalg_count - name: TSPARMCD - operator: record_count + - domain: TS + filter: + TSPARMCD: EGBLIND + TSVAL: "" + id: $blind_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGCTMON + TSVAL: "" + id: $ctmon_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGLEADPR + TSVAL: "" + id: $leadpr_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGLEADSM + TSVAL: "" + id: $leadsm_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGRDMETH + TSVAL: "" + id: $rdmeth_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGREPLBL + TSVAL: "" + id: $replbl_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGREPLTR + TSVAL: "" + id: $repltr_count + name: TSPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: EGTWVALG + TSVAL: "" + id: $twvalg_count + name: TSPARMCD + operator: record_count Outcome: - Message: 'The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is - included in the list of TSPARAMCD with TSVAL populated.' + Message: + "The set (EGBLIND, EGCTMON, EGLEADPR, EGLEADSM, EGRDMETH, EGREPLBL, EGREPLTR, EGTWVALG) is + included in the list of TSPARAMCD with TSVAL populated." Output Variables: - - TSVAL - - $blind_count - - $ctmon_count - - $leadpr_count - - $leadsm_count - - $rdmeth_count - - $replbl_count - - $repltr_count - - $twvalg_count + - TSVAL + - $blind_count + - $ctmon_count + - $leadpr_count + - $leadsm_count + - $rdmeth_count + - $replbl_count + - $repltr_count + - $twvalg_count Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml index 4f90ea520..98cabcaa3 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1112/rule.yml @@ -1,84 +1,86 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'TCG, Appendix B' - Document: 'FDA' - Section: 'FDAB011' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB1112' - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1112" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1112" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "TCG, Appendix B" + Document: "FDA" + Section: "FDAB011" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB1112" + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: $PCLASS_COUNT - operator: greater_than - value: 1 - - name: $INTTYPE_EXISTS - operator: equal_to - value: 1 - - all: - - name: TSPARMCD + - name: $PCLASS_COUNT + operator: greater_than + value: 1 + - name: $INTTYPE_EXISTS operator: equal_to - value: PCLASS - - name: TSVAL - operator: non_empty + value: 1 + - all: + - name: TSPARMCD + operator: equal_to + value: PCLASS + - name: TSVAL + operator: non_empty Core: Id: FDA.SDTMIG.FB1112 Status: Draft - Version: '1' -Description: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated - is gt 1.' + Version: "1" +Description: + "The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated + is gt 1." Executability: Partially Executable Operations: -- filter: - TSPARMCD: PCLASS - id: $PCLASS_COUNT - operator: record_count -- filter: - TSPARMCD: INTTYPE - id: $INTTYPE_EXISTS - operator: record_count + - filter: + TSPARMCD: PCLASS + id: $PCLASS_COUNT + operator: record_count + - filter: + TSPARMCD: INTTYPE + id: $INTTYPE_EXISTS + operator: record_count Outcome: - Message: 'The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated - is gt 1.' + Message: + "The count of occurrences of TSPARAMCD = PCLASS is in the list of TSPARAMCD with TSVAL populated + is gt 1." Output Variables: - - TSPARMCD - - TSVAL + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml index ad6281bb5..7ff695eb4 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml @@ -1,146 +1,157 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A variable's length across a study should be no longer than the maximum - length of the actual data (except for SUPPQUAL). - Document: FDA - Section: FDAB018 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1801 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + A variable's length across a study should be no longer than the maximum + length of the actual data (except for SUPPQUAL). + Document: FDA + Section: FDAB018 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1801 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: variable_size - operator: less_than_or_equal_to - value: 10 + - name: variable_size + operator: less_than_or_equal_to + value: 10 Core: Id: FDA.SDTMIG.FB1801 Status: Draft - Version: '1' -Description: The length of each variable cannot be different between datasets and should not be + Version: "1" +Description: + The length of each variable cannot be different between datasets and should not be longer than the maximum length of the data contained by the variable Executability: Partially Executable # Operations: @@ -150,16 +161,16 @@ Executability: Partially Executable Outcome: Message: The length of the variable is longer than the data within the variable Output Variables: - - variable_size - - variable_value_length - - variable_name - # - $size + - variable_size + - variable_value_length + - variable_name + # - $size Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml index df186dec1..41f264178 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml @@ -2,68 +2,70 @@ # Condition: DM.USUBJID in EX.USUBJID AND TSVAL = "INTERVENTIONAL" when TSPARMCD = "STYPE" # Rule: DM.ACTARMCD not in ("SCRNFAIL", "NOTASSGN", "NOTTRT") Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For interventional studies all treated subjects should have exposure data. - Document: FDA - Section: FDAB023 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2303 - Version: '1' - Version: '1.5' - Version: '3.2' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: For interventional studies all treated subjects should have exposure data. + Document: FDA + Section: FDAB023 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2303 + Version: "1" + Version: "1.5" + Version: "3.2" Check: all: - - name: ACTARMCD - operator: is_contained_by_case_insensitive - value: - - SCRNFAIL - - NOTASSGN - - NOTTRT - - name: TSPARMCD - operator: equal_to - value: "STYPE" - value_is_literal: true - - name: TSVAL - operator: equal_to - value: "INTERVENTIONAL" - value_is_literal: true - - name: USUBJID - operator: is_contained_by - value: $usubjids_in_ex + - name: ACTARMCD + operator: is_contained_by_case_insensitive + value: + - SCRNFAIL + - NOTASSGN + - NOTTRT + - name: TSPARMCD + operator: equal_to + value: "STYPE" + value_is_literal: true + - name: TSVAL + operator: equal_to + value: "INTERVENTIONAL" + value_is_literal: true + - name: USUBJID + operator: is_contained_by + value: $usubjids_in_ex Core: Id: FDA.SDTMIG.FB2303 Status: Draft - Version: '1' -Description: All subjects in the Exposure domain who are participating in a study that includes an + Version: "1" +Description: + All subjects in the Exposure domain who are participating in a study that includes an interventional product must be assigned to a treatment. Executability: Fully Executable Match Datasets: -- Keys: - - STUDYID - Name: TS + - Keys: + - STUDYID + Name: TS Operations: -- domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct + - domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: - Message: A subject has a record in EX but is not assigned to a treatment while participating in an + Message: + A subject has a record in EX but is not assigned to a treatment while participating in an interventional study Output Variables: - - ACTARMCD - - TSPARMCD - - TSVAL + - ACTARMCD + - TSPARMCD + - TSVAL Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml index 626374560..2b4fb1c5b 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2503/rule.yml @@ -2,56 +2,56 @@ # Condition: ARMCD ^= (SCRNFAIL, NOTASSGN) DM.ARMCD ^= (SCRNFAIL, NOTASSGN) and DM.ACTARMCD ^= NOTTRT # Rule: DM.USUBJID in EX.USUBJID Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Randomized subjects are expected to receive a study treatment. - Document: FDA - Section: FDAB025 - Origin: FDA Business Rules - Rule Identifier: - Id: FB2503 - Version: '1' - Version: '1.5' - Version: '3.2' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Randomized subjects are expected to receive a study treatment. + Document: FDA + Section: FDAB025 + Origin: FDA Business Rules + Rule Identifier: + Id: FB2503 + Version: "1" + Version: "1.5" + Version: "3.2" Check: all: - - name: ARMCD - operator: is_not_contained_by_case_insensitive - value: - - SCRNFAIL - - NOTASSGN - - name: ACTARMCD - operator: is_not_contained_by_case_insensitive - value: - - NOTTRT - - name: USUBJID - operator: is_not_contained_by - value: $usubjids_in_ex + - name: ARMCD + operator: is_not_contained_by_case_insensitive + value: + - SCRNFAIL + - NOTASSGN + - name: ACTARMCD + operator: is_not_contained_by_case_insensitive + value: + - NOTTRT + - name: USUBJID + operator: is_not_contained_by + value: $usubjids_in_ex Core: Id: FDA.SDTMIG.FB2503 Status: Draft - Version: '1' + Version: "1" Description: If a subject is assigned to an arm, the subject should have a record in EX. Executability: Partially Executable Operations: -- domain: EX - id: $usubjids_in_ex - name: USUBJID - operator: distinct + - domain: EX + id: $usubjids_in_ex + name: USUBJID + operator: distinct Outcome: Message: Subject is assigned to an arm code (randomized) but has no record in EX. Output Variables: - - ARMCD - - ACTARMCD + - ARMCD + - ACTARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml index 67fe132c7..669f85bc9 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml @@ -2,166 +2,177 @@ # Condition: --STDTC ^= Null and --DTC ^= Null # Rule: --STDTC <= --DTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: Start date/time of observation (--DTC) should be submitted, if collected, - and study day of observation (--DY) should be submitted. - Document: FDA - Section: FDAB032 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3211 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + Start date/time of observation (--DTC) should be submitted, if collected, + and study day of observation (--DY) should be submitted. + Document: FDA + Section: FDAB032 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3211 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: --STDTC - operator: non_empty - - name: --DTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: --DTC + - name: --STDTC + operator: non_empty + - name: --DTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: --DTC Core: Id: FDA.SDTMIG.FB3211 Status: Draft - Version: '1' -Description: Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection + Version: "1" +Description: + Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection (--DTC) Executability: Fully Executable Outcome: Message: --STDTC falls after --DTC. Output Variables: - - --STDTC - - --DTC + - --STDTC + - --DTC Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Exclude: - - BE + - BE Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml index 60e9df886..9fd74ae4b 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3402/rule.yml @@ -1,157 +1,158 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3402' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3402" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # TODO: check/adapt for value with different granularity all: - - name: EXSTDTC - operator: date_greater_than - value: '$max_dsstdtc' + - name: EXSTDTC + operator: date_greater_than + value: "$max_dsstdtc" Core: Id: FDA.SDTMIG.FB3402 Status: Draft - Version: '1' -Description: 'Start Date/Time of Treatment (EXSTDTC) should be prior or equal to the Start Date/Time of - the latest Disposition Event (DSSTDTC).' + Version: "1" +Description: + "Start Date/Time of Treatment (EXSTDTC) should be prior or equal to the Start Date/Time of + the latest Disposition Event (DSSTDTC)." Executability: Fully Executable Operations: -- domain: DS - group: - - USUBJID - id: $max_dsstdtc - name: DSSTDTC - operator: max_date + - domain: DS + group: + - USUBJID + id: $max_dsstdtc + name: DSSTDTC + operator: max_date Outcome: - Message: 'EXSTDTC falls after the last DSSTDTC.' + Message: "EXSTDTC falls after the last DSSTDTC." Output Variables: - - EXSTDTC - - $max_dsstdtc + - EXSTDTC + - $max_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml index 42f9c0d22..70b7ebacf 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3403/rule.yml @@ -1,157 +1,158 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Study start and end date/time should include month, day, and year.' - Document: 'FDA' - Section: 'FDAB034' - Origin: FDA Business Rules - Rule Identifier: - Id: 'FB3403' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "Study start and end date/time should include month, day, and year." + Document: "FDA" + Section: "FDAB034" + Origin: FDA Business Rules + Rule Identifier: + Id: "FB3403" + Version: "1" + Version: "1.5" + Version: "1.0" Check: # TODO: check/adapt for value with different granularity all: - - name: EXENDTC - operator: date_greater_than - value: '$max_dsstdtc' + - name: EXENDTC + operator: date_greater_than + value: "$max_dsstdtc" Core: Id: FDA.SDTMIG.FB3403 Status: Draft - Version: '1' -Description: 'End Date/Time of Treatment (EXENDTC) should be prior or equal to the Start Date/Time of - the latest Disposition Event (DSSTDTC).' + Version: "1" +Description: + "End Date/Time of Treatment (EXENDTC) should be prior or equal to the Start Date/Time of + the latest Disposition Event (DSSTDTC)." Executability: Fully Executable Operations: -- domain: DS - group: - - USUBJID - id: $max_dsstdtc - name: DSSTDTC - operator: max_date + - domain: DS + group: + - USUBJID + id: $max_dsstdtc + name: DSSTDTC + operator: max_date Outcome: - Message: 'EXENDTC falls after the last DSSTDTC.' + Message: "EXENDTC falls after the last DSSTDTC." Output Variables: - - EXENDTC - - $max_dsstdtc + - EXENDTC + - $max_dsstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml index 95ec236c3..94d02a062 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml @@ -2,77 +2,78 @@ # Condition: --STDTC ^= Null and DM.RFPENDTC ^= Null # Rule: --STDTC <= DM.RFPENDTC Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Study start and end date/time should include month, day, and year. - Document: FDA - Section: FDAB034 - Origin: FDA Business Rules - Rule Identifier: - Id: FB3405 - Version: '1' - Version: '1.5' - Version: '3.4' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Study start and end date/time should include month, day, and year. + Document: FDA + Section: FDAB034 + Origin: FDA Business Rules + Rule Identifier: + Id: FB3405 + Version: "1" + Version: "1.5" + Version: "3.4" Check: all: - - name: --STDTC - operator: non_empty - - name: RFPENDTC - operator: non_empty - - name: --STDTC - operator: date_greater_than - value: RFPENDTC + - name: --STDTC + operator: non_empty + - name: RFPENDTC + operator: non_empty + - name: --STDTC + operator: date_greater_than + value: RFPENDTC Core: Id: FDA.SDTMIG.FB3405 Status: Draft - Version: '1' -Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of + Version: "1" +Description: + Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of Participation (RFPENDTC) Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Outcome: Message: --STDTC falls after RFPENDTC. Output Variables: - - --STDTC - - RFPENDTC + - --STDTC + - RFPENDTC Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - SPECIAL PURPOSE + - INTERVENTIONS + - EVENTS + - SPECIAL PURPOSE Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml index 839e2afb8..9bad1c13d 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3801/rule.yml @@ -1,170 +1,180 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'Timing information of interventions, findings and events should be submitted, - if collected.' - Document: 'FDA' - Section: 'FDAB038' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB3801' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "Timing information of interventions, findings and events should be submitted, + if collected." + Document: "FDA" + Section: "FDAB038" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB3801" + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: define_variable_is_collected - operator: equal_to - value: true - - name: $timing_variables - operator: shares_exactly_one_element_with - value: $dataset_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: $timing_variables + operator: shares_exactly_one_element_with + value: $dataset_variables Core: Id: FDA.SDTMIG.FB3801 Status: Draft - Version: '1' -Description: 'Timing information should be submitted when collected.''' + Version: "1" +Description: "Timing information should be submitted when collected.'" Executability: Partially Executable Operations: -- id: $dataset_variables - operator: get_column_order_from_dataset -- id: $timing_variables - key_name: role - key_value: Timing - operator: get_model_filtered_variables + - id: $dataset_variables + operator: get_column_order_from_dataset + - id: $timing_variables + key_name: role + key_value: Timing + operator: get_model_filtered_variables Outcome: - Message: 'Timing information is collected but not submitted.' + Message: "Timing information is collected but not submitted." Output Variables: - - $dataset_variables - - $timing_variables + - $dataset_variables + - $timing_variables Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - INTERVENTIONS - - EVENTS - - FINDINGS + - INTERVENTIONS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml index 1aceb00df..04990ab49 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB7101/rule.yml @@ -1,173 +1,184 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A specimen material type should be named consistently across pharmacokinetic - datasets within a submission. - Document: FDA - Section: FDAB071 - Origin: FDA Business Rules - Rule Identifier: - Id: FB7101 - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + A specimen material type should be named consistently across pharmacokinetic + datasets within a submission. + Document: FDA + Section: FDAB071 + Origin: FDA Business Rules + Rule Identifier: + Id: FB7101 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: PPCAT - operator: non_empty - - name: PPSPEC - operator: not_equal_to - value: RELREC.PCSPEC - - name: PPCAT - operator: equal_to - value: RELREC.PCTEST + - name: PPCAT + operator: non_empty + - name: PPSPEC + operator: not_equal_to + value: RELREC.PCSPEC + - name: PPCAT + operator: equal_to + value: RELREC.PCTEST Core: Id: FDA.SDTMIG.FB7101 Status: Draft - Version: '1' -Description: 'For the same drug or metabolite (PCTEST), specimen type (PCSPEC) should be consistent across - pharmacokinetic datasets within a submission.' + Version: "1" +Description: + "For the same drug or metabolite (PCTEST), specimen type (PCSPEC) should be consistent across + pharmacokinetic datasets within a submission." Executability: Partially Executable Match Datasets: -- Name: RELREC - Wildcard: PC + - Name: RELREC + Wildcard: PC Outcome: Message: PCSPEC is not equal to PPSPEC for the same drug or metabolite. Output Variables: - - PPCAT - - PPSPEC - - PPCAT - - RELREC.PCSPEC - - RELREC.PCTEST + - PPCAT + - PPSPEC + - PPCAT + - RELREC.PCSPEC + - RELREC.PCTEST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS - - RELATIONSHIP + - FINDINGS + - RELATIONSHIP Domains: Include: - - PP - - PC - - RELREC + - PP + - PC + - RELREC Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml index c35e70851..abd1d19e0 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB1115/rule.yml @@ -1,114 +1,118 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not - included in the list of TSPARAMCD with TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not - included in the list of TSPARAMCD with TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The set of parameters without conditions listed in the TCG, Appendix C, is not - included in the list of TSPARAMCD with TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1115 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The set of parameters without conditions listed in the TCG, Appendix C, is not + included in the list of TSPARAMCD with TSVAL populated." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1115 + Version: "1" + Version: "1.5" + Version: "3.1.1" # List of parameters for which there must be a record, i.e. TSPARMCD: # 'AGEU','DOSDUR','DOSENDTC','DOSSTDTC','EXPENDTC','EXPSTDTC','GLPFL','GLPTYP','PCLASS','PPTCNAM','PPTEGID','PPTEGSYM','PPTMDA','ROUTE','SDESIGN','SEXPOP','SNDCTVER','SNDIGVER','SPECIES','SPLANSUB','SPLRNAM','SPREFID','SSPONSOR','SSTYP','STCAT','STDIR','STITLE','STRAIN','STRPSTAT','STSTDTC','TFCNTRY','TRMSAC','TRT','TRTCAS','TRTUNII','TRTV','TSTFLOC','TSTFNAM' # Starting from the code for FB1102 (which is for SDTM, but here the list is for SEND) Check: all: - - name: TSPARMCD - operator: not_contains_all - value: - - AGEU - #- 'DOSDUR' - #- 'DOSENDTC' - #- 'DOSSTDTC' - #- 'EXPENDTC' - #- 'EXPSTDTC' - #- 'GLPFL' - #- 'GLPTYP' - #- 'PCLASS' - #- 'PPTCNAM' - #- 'PPTEGID' - #- 'PPTEGSYM' - #- 'PPTEGSYM' - #- 'PPTMDA' - #- 'ROUTE' - #- 'SDESIGN' - #- 'SEXPOP' - #- 'SNDCTVER' - #- 'SPECIES' - #- 'SPLANSUB' - #- 'SPLRNAM' - #- 'SPREFID' - #- 'SSPONSOR' - #- 'SSTYP' - #- 'STCAT' - #- 'STDIR' - #- 'STITLE' - #- 'STRAIN' - #- 'STRPSTAT' - #- 'STSTDTC' - #- 'TFCNTRY' - #- 'TRMSAC' - #- 'TRT' - #- 'TRTCAS' - #- 'TRTUNII' - #- 'TRTV' - #- 'TSTFLOC' - #- 'TSTFNAM' + - name: TSPARMCD + operator: not_contains_all + value: + - AGEU + #- 'DOSDUR' + #- 'DOSENDTC' + #- 'DOSSTDTC' + #- 'EXPENDTC' + #- 'EXPSTDTC' + #- 'GLPFL' + #- 'GLPTYP' + #- 'PCLASS' + #- 'PPTCNAM' + #- 'PPTEGID' + #- 'PPTEGSYM' + #- 'PPTEGSYM' + #- 'PPTMDA' + #- 'ROUTE' + #- 'SDESIGN' + #- 'SEXPOP' + #- 'SNDCTVER' + #- 'SPECIES' + #- 'SPLANSUB' + #- 'SPLRNAM' + #- 'SPREFID' + #- 'SSPONSOR' + #- 'SSTYP' + #- 'STCAT' + #- 'STDIR' + #- 'STITLE' + #- 'STRAIN' + #- 'STRPSTAT' + #- 'STSTDTC' + #- 'TFCNTRY' + #- 'TRMSAC' + #- 'TRT' + #- 'TRTCAS' + #- 'TRTUNII' + #- 'TRTV' + #- 'TSTFLOC' + #- 'TSTFNAM' - - name: 'TSVAL' - operator: non_empty + - name: "TSVAL" + operator: non_empty Core: Id: FDA.SENDIG.FB1115 Status: Draft - Version: '1' -Description: 'Check whether all values in the list are populated for TSPARMCD and TSVAL is populated' + Version: "1" +Description: "Check whether all values in the list are populated for TSPARMCD and TSVAL is populated" Executability: Fully Executable Outcome: - Message: 'The set of parameters without conditions listed in the TCG, Appendix C, is not included in - the list of TSPARAMCD with TSVAL populated.' + Message: + "The set of parameters without conditions listed in the TCG, Appendix C, is not included in + the list of TSPARAMCD with TSVAL populated." Output Variables: - - TSVAL - - TSPARMCD + - TSVAL + - TSPARMCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml index 4ea34a636..ccf262416 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml @@ -1,33 +1,35 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable to SENDIG version 3.1 and 3.1.1 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on which group summaries - (group means and incidences) are calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB047 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4702 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Required timing variables for identification of the day on which group summaries - (group means and incidences) are calculated should be populated for nonclinical data.' - Document: FDA - Section: FDAB042 - Origin: FDA Business Rules - Rule Identifier: - Id: FB4702 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data." + Document: FDA + Section: FDAB047 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4702 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Required timing variables for identification of the day on which group summaries + (group means and incidences) are calculated should be populated for nonclinical data." + Document: FDA + Section: FDAB042 + Origin: FDA Business Rules + Rule Identifier: + Id: FB4702 + Version: "1" + Version: "1.5" + Version: "3.1.1" Check: all: # Rule = At least one of VISITDY or --NOMDY is populated as these are required timing variables @@ -40,30 +42,31 @@ Check: # 2025-09-30: also when --USCHFL and VISITDY columns (both permissible) are ABSENT # Then --NOMDY must be populated # PRECONDITIONS: Rule does not apply when --USCHFL is populated - - any: + - any: # --USCHFL column is absent or --USCHFL is empty - - name: --USCHFL - operator: not_exists - - name: --USCHFL - operator: empty - - any: - # --VISITDY column is absent or --VISITDY is + - name: --USCHFL + operator: not_exists + - name: --USCHFL + operator: empty + - any: + # --VISITDY column is absent or --VISITDY is # P.S. VISITDY = PLANNED Study Day of Collection - - name: VISITDY - operator: not_exists - - name: VISITDY - operator: 'empty' - # TEST CONDITION. Remark that --MOMDY is "expected" - - name: --NOMDY - operator: 'empty' + - name: VISITDY + operator: not_exists + - name: VISITDY + operator: "empty" + # TEST CONDITION. Remark that --MOMDY is "expected" + - name: --NOMDY + operator: "empty" Core: Id: FDA.SENDIG.FB4702 Status: Draft - Version: '1' -# Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is + Version: "1" +# Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is # populated and --USCHFL is not populated' -Description: VISITDY or --NOMDY should be populated for scheduled records as these are required - timing variables for identification of the day on which group summaries (Group Means and +Description: + VISITDY or --NOMDY should be populated for scheduled records as these are required + timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. Executability: Fully Executable Outcome: @@ -75,17 +78,17 @@ Scope: Classes: Include: # we can set to "FINDINGS", as --ORRES is only possible in FINDINGS - - FINDINGS + - FINDINGS Domains: Include: - - BW - - CL - - CV - - EG - - LB - - PC - - PM - - PP - - RE - - VS + - BW + - CL + - CV + - EG + - LB + - PC + - PM + - PP + - RE + - VS Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml index 28bed55aa..4b996d040 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB5132/rule.yml @@ -1,116 +1,123 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Variables intended only for human studies should not be included in nonclinical - data.' - Document: FDA - Section: FDAB051 - Origin: FDA Business Rules - Rule Identifier: - Id: FB5132 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Variables intended only for human studies should not be included in nonclinical + data." + Document: FDA + Section: FDAB051 + Origin: FDA Business Rules + Rule Identifier: + Id: FB5132 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: 'TSVALCD' - operator: exists + - name: "TSVALCD" + operator: exists Core: Id: FDA.SENDIG.FB5132 Status: Draft - Version: '1' -Description: 'TSVALCD (Parameter Value Code) must not be in SEND dataset' + Version: "1" +Description: "TSVALCD (Parameter Value Code) must not be in SEND dataset" Executability: Fully Executable Outcome: - Message: 'TSVALCD must not be present in SEND dataset' + Message: "TSVALCD must not be present in SEND dataset" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml index 7247554da..b9b5c318a 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6403/rule.yml @@ -1,163 +1,172 @@ Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # Applicable only to SENDIG-3.0, 3.1, 3.1.1 ; SENDIG-GENETOX 1.0 ; SENDIG-DART-1.1, 1.2 & SENDIG-AR 1.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'When possible, RFSTDTC should be the first day of exposure to test compound rather - than challenge agents or other interventions.' - Document: FDA - Section: FDAB064 - Origin: FDA Business Rules - Rule Identifier: - Id: FB6403 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "When possible, RFSTDTC should be the first day of exposure to test compound rather + than challenge agents or other interventions." + Document: FDA + Section: FDAB064 + Origin: FDA Business Rules + Rule Identifier: + Id: FB6403 + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - all: - - name: "RFSTDTC" - operator: "date_not_equal_to" - value: "$ex_exstdtc" - - any: - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$pr_prstdtc" - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$cm_cmstdtc" - - name: "RFSTDTC" - operator: "date_equal_to" - value: "$ag_agstdtc" + - all: + - name: "RFSTDTC" + operator: "date_not_equal_to" + value: "$ex_exstdtc" + - any: + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$pr_prstdtc" + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$cm_cmstdtc" + - name: "RFSTDTC" + operator: "date_equal_to" + value: "$ag_agstdtc" Core: Id: FDA.SENDIG.FB6403 Status: Draft - Version: '1' -Description: 'RFSTDTC should be the first treatment exposure date/time from EX and not equal to start - dates from PR/CM/AG' + Version: "1" +Description: + "RFSTDTC should be the first treatment exposure date/time from EX and not equal to start + dates from PR/CM/AG" Executability: Fully Executable Operations: -- domain: "EX" - group: - - USUBJID - id: "$ex_exstdtc" - name: "EXSTDTC" - operator: "min_date" -- domain: "PR" - group: - - USUBJID - id: "$pr_prstdtc" - name: "PRSTDTC" - operator: "min_date" -- domain: "CM" - group: - - USUBJID - id: "$cm_cmstdtc" - name: "CMSTDTC" - operator: "min_date" -- domain: "AG" - group: - - USUBJID - id: "$ag_agstdtc" - name: "AGSTDTC" - operator: "min_date" + - domain: "EX" + group: + - USUBJID + id: "$ex_exstdtc" + name: "EXSTDTC" + operator: "min_date" + - domain: "PR" + group: + - USUBJID + id: "$pr_prstdtc" + name: "PRSTDTC" + operator: "min_date" + - domain: "CM" + group: + - USUBJID + id: "$cm_cmstdtc" + name: "CMSTDTC" + operator: "min_date" + - domain: "AG" + group: + - USUBJID + id: "$ag_agstdtc" + name: "AGSTDTC" + operator: "min_date" Outcome: - Message: 'RFSTDTC is not the first treatment exposure date/time from EX and equal to one of the start - dates from PR/CM/AG' + Message: + "RFSTDTC is not the first treatment exposure date/time from EX and equal to one of the start + dates from PR/CM/AG" Output Variables: - - RFSTDTC - - $ex_exstdtc + - RFSTDTC + - $ex_exstdtc Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - SPECIAL PURPOSE + - INTERVENTIONS + - SPECIAL PURPOSE Domains: Include: - - DM - - EX - - PR - - CM - - AG + - DM + - EX + - PR + - CM + - AG Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml index d2e221978..5a44374cc 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6501/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6501' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6501" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6501: When DS domain is present in the define.xml, but no DS dataset is present in the submission -# then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for DS with attribute def:HasNoData marked as "Yes" Check: all: - - name: DS - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: DS + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6501 Status: Draft - Version: '1' -Description: 'DS dataset should be present in the submission when related data is collected' + Version: "1" +Description: "DS dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing DS dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml index 980d01900..6bb229b33 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6502/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6502' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6502" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6502: When CL domain is present in the define.xml, but no CL dataset is present in the submission -# then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for CL with attribute def:HasNoData marked as "Yes" Check: all: - - name: CL - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: CL + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6502 Status: Draft - Version: '1' -Description: 'CL dataset should be present in the submission when related data is collected.' + Version: "1" +Description: "CL dataset should be present in the submission when related data is collected." Executability: Fully Executable Outcome: Message: Missing CL dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml index 18b56774a..c0a2551a3 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6503/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6503' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6503" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6503: When EG domain is present in the define.xml, but no EG dataset is present in the submission -# then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for EG with attribute def:HasNoData marked as "Yes" Check: all: - - name: EG - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: EG + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6503 Status: Draft - Version: '1' -Description: 'EG dataset should be present in the submission when related data is collected' + Version: "1" +Description: "EG dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing EG dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml index 540283f27..e156809f9 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6504/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6504' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6504" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6504: When EX domain is present in the define.xml, but no EX dataset is present in the submission -# then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for EX with attribute def:HasNoData marked as "Yes" Check: all: - - name: EX - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: EX + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6504 Status: Draft - Version: '1' -Description: 'EX dataset is present in the submission when related data is collected' + Version: "1" +Description: "EX dataset is present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing EX dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml index 8093835ee..ae908b6cc 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6505/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6505' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6505" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6505: When LB domain is present in the define.xml, but no LB dataset is present in the submission -# then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for LB with attribute def:HasNoData marked as "Yes" Check: all: - - name: LB - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: LB + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6505 Status: Draft - Version: '1' -Description: 'LB dataset should be present in the submission when related data is collected' + Version: "1" +Description: "LB dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing LB dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml index 581cc8ee0..690e50f20 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6506/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6506' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6506" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6506: When MA domain is present in the define.xml, but no MA dataset is present in the submission -# then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for MA with attribute def:HasNoData marked as "Yes" Check: all: - - name: MA - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: MA + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6506 Status: Draft - Version: '1' -Description: 'MA dataset should be present in the submission when related data is collected' + Version: "1" +Description: "MA dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing MA dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml index 6d3303f8a..80a26fe18 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6507/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6507' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6507" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6507: When MI domain is present in the define.xml, but no MI dataset is present in the submission -# then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for MI with attribute def:HasNoData marked as "Yes" Check: all: - - name: MI - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: MI + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6507 Status: Draft - Version: '1' -Description: 'MI dataset should be present in the submission when related data is collected' + Version: "1" +Description: "MI dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing MI dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml index 1a090f2c8..d7c850467 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6508/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6508' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6508" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule 6508: When PC domain is present in the define.xml, but no PC dataset is present in the submission -# then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for PC with attribute def:HasNoData marked as "Yes" Check: all: - - name: PC - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: PC + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6508 Status: Draft - Version: '1' -Description: 'PC dataset should be present in the submission when related data is collected' + Version: "1" +Description: "PC dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing PC dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml index b63e06498..deb0445dd 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6509/rule.yml @@ -1,104 +1,104 @@ Authorities: -- Organization: 'FDA' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected.' - Document: 'FDA' - Section: 'FDAB056' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6509' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: "FDA" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: "DS, CL, EG, EX, LB, MA, MI, PC, PP, and VS should be submitted if collected." + Document: "FDA" + Section: "FDAB056" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6509" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB6509: When PP domain is present in the define.xml, but no PP dataset is present in the submission -# then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for PP with attribute def:HasNoData marked as "Yes" Check: all: - - name: PP - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: PP + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6509 Status: Draft - Version: '1' -Description: 'PC dataset should be present in the submission when related data is collected' + Version: "1" +Description: "PC dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing PP dataset. @@ -106,8 +106,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml index 48ea71c22..0694bf37d 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6601/rule.yml @@ -1,99 +1,106 @@ Authorities: -- Organization: 'FDA' - # FB6601 is not applicable to SENDIG-3.0 - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6601' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: + "FDA" + # FB6601 is not applicable to SENDIG-3.0 + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6601" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB5610: When CV domain is present in the define.xml, but no CV dataset is present in the submission -# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for CV with attribute def:HasNoData marked as "Yes" Check: all: - - name: CV - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: CV + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6601 Status: Draft - Version: '1' -Description: 'CV dataset should be present in the submission when related data is collected' + Version: "1" +Description: "CV dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing CV dataset. @@ -101,8 +108,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml index 0bdab39e0..d98326766 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB6602/rule.yml @@ -1,100 +1,106 @@ Authorities: -- Organization: 'FDA' - # FB6602 is not applicable to SENDIG-3.0 - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: 'SENDIG-AR' - References: - - Citations: - - Cited Guidance: 'In SEND 3.1 data elements that would be mapped to RE and CV should be submitted - if collected and included in the study report.' - Document: 'FDA' - Section: 'FDAB066' - Origin: 'FDA Business Rules' - Rule Identifier: - Id: 'FB6602' - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: + "FDA" + # FB6602 is not applicable to SENDIG-3.0 + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: "SENDIG-AR" + References: + - Citations: + - Cited Guidance: + "In SEND 3.1 data elements that would be mapped to RE and CV should be submitted + if collected and included in the study report." + Document: "FDA" + Section: "FDAB066" + Origin: "FDA Business Rules" + Rule Identifier: + Id: "FB6602" + Version: "1" + Version: "1.5" + Version: "1.0" # Rule FB5610: When RE domain is present in the define.xml, but no RE dataset is present in the submission -# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" +# then the define.xml must contain ItemGroupDef for RE with attribute def:HasNoData marked as "Yes" Check: all: - - - name: RE - operator: not_exists - - name: define_dataset_has_no_data - operator: equal_to - value: false + - name: RE + operator: not_exists + - name: define_dataset_has_no_data + operator: equal_to + value: false Core: Id: FDA.SENDIG.FB6602 Status: Draft - Version: '1' -Description: 'RE dataset should be present in the submission when related data is collected' + Version: "1" +Description: "RE dataset should be present in the submission when related data is collected" Executability: Fully Executable Outcome: Message: Missing RE dataset. @@ -102,8 +108,8 @@ Rule Type: Domain Presence Check # Is this correct? Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml index b6771b1fc..510405c06 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml @@ -1,34 +1,36 @@ Authorities: -- Organization: FDA - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has - a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of - NOT DONE.' - Document: FDA - Section: FDAB082 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8202 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has - a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of - NOT DONE.' - Document: FDA - Section: FDAB082 - Origin: FDA Business Rules - Rule Identifier: - Id: FB8202 - Version: '1' - Version: '1.5' - Version: '3.1.1' + - Organization: FDA + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has + a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of + NOT DONE." + Document: FDA + Section: FDAB082 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8202 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For carcinogenicity studies, MIRESCAT should be populated unless MISTRESC has + a value of UNREMARKABLE (for SENDIGv3.1) or NORMAL (for SENDIGv3.0) or MISTAT has a value of + NOT DONE." + Document: FDA + Section: FDAB082 + Origin: FDA Business Rules + Rule Identifier: + Id: FB8202 + Version: "1" + Version: "1.5" + Version: "3.1.1" Check: all: # TODO: still causes an error as this is a check on the dataset level @@ -39,20 +41,21 @@ Check: # - name: TSVAL # operator: equal_to # value: CARCINOGENICITY - - all: - - name: MISTRESC - operator: not_equal_to - value: 'UNREMARKABLE' - - name: MISTAT - operator: not_equal_to - value: 'NOT DONE' - - name: MIRESCAT - operator: empty + - all: + - name: MISTRESC + operator: not_equal_to + value: "UNREMARKABLE" + - name: MISTAT + operator: not_equal_to + value: "NOT DONE" + - name: MIRESCAT + operator: empty Core: Id: FDA.SENDIG.FB8202 Status: Draft - Version: '1' -Description: For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not + Version: "1" +Description: + For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not have a value of UNREMARKABLE or MISTAT has a value of NOT DONE. Executability: Fully Executable Outcome: @@ -61,8 +64,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml index c6b87447b..102e91f3d 100644 --- a/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.TRC1734a/rule.yml @@ -1,154 +1,164 @@ Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734a - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734a + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TS - operator: not_exists + - name: TS + operator: not_exists Core: Id: FDA.TRC1734a Status: Draft - Version: '1' + Version: "1" Description: TS dataset is present in the submission. Executability: Fully Executable Outcome: @@ -157,8 +167,8 @@ Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml index 9c52fc649..8e7217fb0 100644 --- a/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.TRC1734b/rule.yml @@ -2,177 +2,187 @@ # Condition: TS is present # Rule: TSPARMCD SSTDTC is present Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: A dataset named ts.xpt with information on study start date must be present - for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections - 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 - Document: FDA - Section: TRC1734 - Origin: FDA Business Rules - Rule Identifier: - Id: TRC1734b - Version: '1' - Version: '1.5' - Version: '1.0' + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + A dataset named ts.xpt with information on study start date must be present + for each study in Module 4, sections 4.2.3.1, 4.2.3.2, 4.2.3.4, and in Module 5, sections + 5.3.1.1, 5.3.1.2, 5.3.3.1, 5.3.3.2, 5.3.3.3, 5.3.3.4, 5.3.4, 5.3.5.1, 5.3.5.2 + Document: FDA + Section: TRC1734 + Origin: FDA Business Rules + Rule Identifier: + Id: TRC1734b + Version: "1" + Version: "1.5" + Version: "1.0" Check: all: - - name: TS - operator: exists - - name: $ts_tsparmcd - operator: does_not_contain - value: SSTDTC - value_is_literal: true + - name: TS + operator: exists + - name: $ts_tsparmcd + operator: does_not_contain + value: SSTDTC + value_is_literal: true Core: Id: FDA.TRC1734b Status: Draft - Version: '1' + Version: "1" Description: FDA desired parameter Study Start Date (SSTDTC) should be present in the TS domain. Executability: Fully Executable Operations: -- domain: TS - group: - - STUDYID - id: $ts_tsparmcd - name: TSPARMCD - operator: distinct + - domain: TS + group: + - STUDYID + id: $ts_tsparmcd + name: TSPARMCD + operator: distinct Outcome: Message: Missing TSPARMCD = SSTDTC record in TS dataset. Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml index faa6db47f..f504a7770 100644 --- a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml +++ b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml @@ -1,124 +1,130 @@ # FDAB1119 is just one of the many parts of FDAB011. This is currently just a temporary solution, Core: # as the better solution is to have all the SEND-required PARMCD-s in the CDISC Library and iterate over them Authorities: -- Organization: FDA - Standards: + - Organization: FDA + Standards: # ONLY applicable to SENDIG, NOT to SDTMIG - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'All trial design data should be submitted as specified in the FDA Study Data - Technical Conformance Guide (TCG).' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'TSPARAMCD=RECSAC is included in TS with TSVAL populated.' - Document: FDA - Section: FDAB011 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1119 - Version: '1' - Version: '1.5' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "All trial design data should be submitted as specified in the FDA Study Data + Technical Conformance Guide (TCG)." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: "TSPARAMCD=RECSAC is included in TS with TSVAL populated." + Document: FDA + Section: FDAB011 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1119 + Version: "1" + Version: "1.5" + Version: "1.0" # FDAB1119 is just one of the many parts of FDAB011. This is currently just a temporary solution, Core: # as the better solution is to have all the SEND-required PARMCD-s in the CDISC Library and iterate over them Check: any: # No record with TSPARMCD=RECSAC # REMARK: test at the dataset level - - all: - - name: TSPARMCD - operator: does_not_contain - value: RECSAC - # TSVAL empty for TSPARMCD=RECSAC - # REMARK: test at the record level - # OR: should we use a "filter" here? - - all: - - name: TSPARMCD - operator: equal_to - value: RECSAC - - name: TSVAL - operator: empty + - all: + - name: TSPARMCD + operator: does_not_contain + value: RECSAC + # TSVAL empty for TSPARMCD=RECSAC + # REMARK: test at the record level + # OR: should we use a "filter" here? + - all: + - name: TSPARMCD + operator: equal_to + value: RECSAC + - name: TSVAL + operator: empty Core: Id: FFDA.SENDIG.FB1119 Status: Draft - Version: '1' -Description: 'Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or when its TSVAL is not populated' + Version: "1" +Description: "Raise an error when TSPARMCD=RECSAC is not in the TS dataset, or when its TSVAL is not populated" Executability: Fully Executable Outcome: Message: TSPARMCD=RECSAC is missing or it's TSVAL value is empty @@ -126,8 +132,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml index e1f714b6b..fc7fea2f8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0002/rule.yml @@ -2,81 +2,84 @@ # Condition: --DUR ^= null # Rule: --DUR collected and not derived Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used only if collected on the CRF and not derived. - Document: SDTM v2.0 - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Collected duration of an event, intervention, or finding represented in ISO - 8601 character format. Used only if collected on the CRF and not derived. - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Collected duration of an event, intervention, or finding. Used only if - collected on the CRF and not derived. Format=ISO8601 - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0002 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Used only if collected on the CRF and not derived. + Document: SDTM v2.0 + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Collected duration of an event, intervention, or finding represented in ISO + 8601 character format. Used only if collected on the CRF and not derived. + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Collected duration of an event, intervention, or finding. Used only if + collected on the CRF and not derived. Format=ISO8601 + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0002 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_variable_is_collected - operator: equal_to - value: false - - name: variable_name - operator: matches_regex - value: ^..DUR$ - - name: $dur_is_null - operator: equal_to - value: false + - name: define_variable_is_collected + operator: equal_to + value: false + - name: variable_name + operator: matches_regex + value: ^..DUR$ + - name: $dur_is_null + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0002 Status: Draft - Version: '1' + Version: "1" Description: Raise a message when --DUR exists in a dataset, confirm collected and not derived. Executability: Fully Executable Operations: -- id: $dur_is_null - name: --DUR - operator: variable_is_null - # Return true if at least one record is non null + - id: $dur_is_null + name: --DUR + operator: + variable_is_null + # Return true if at least one record is non null Outcome: Message: --DUR exists in a dataset, confirm collected and not derived. Output Variables: - - variable_name - - define_variable_is_collected - - row_number - - $dur_is_null + - variable_name + - define_variable_is_collected + - row_number + - $dur_is_null Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml index ed45f4dda..26210fa04 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml @@ -2,84 +2,88 @@ # Condition: Variable Core Status = Permissible and data is collected # Rule: Variable present in dataset and ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The sponsor does not have the discretion to exclude permissible variables - when they contain data. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The sponsor does not have the discretion to exclude permissible variables - when they contain data. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a Permissible - variable, then that variable must be included in the SDTM dataset, even if null. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0015 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The sponsor does not have the discretion to exclude permissible variables + when they contain data. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The sponsor does not have the discretion to exclude permissible variables + when they contain data. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0015 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: define_variable_name - operator: non_empty - - name: library_variable_core - operator: equal_to - value: Perm - - name: define_variable_has_no_data - operator: empty - - any: - - name: variable_name - operator: not_exists - - name: variable_is_empty + - name: define_variable_name + operator: non_empty + - name: library_variable_core operator: equal_to - value: 'Yes' + value: Perm + - name: define_variable_has_no_data + operator: empty + - any: + - name: variable_name + operator: not_exists + - name: variable_is_empty + operator: equal_to + value: "Yes" Core: Id: CDISC.SDTMIG.CG0015 Status: Draft - Version: '1' -Description: Raise an error when a variable is permissible, data is collected but variable has no + Version: "1" +Description: + Raise an error when a variable is permissible, data is collected but variable has no data. Executability: Fully Executable Outcome: - Message: 'Variable is permissible, data is collected but data is missing.' + Message: "Variable is permissible, data is collected but data is missing." Output Variables: - - library_variable_name - - library_variable_core - - define_variable_name - - define_variable_has_no_data - - variable_name - - variable_is_empty + - library_variable_name + - library_variable_core + - define_variable_name + - define_variable_has_no_data + - variable_name + - variable_is_empty Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml index 992d7f32f..238efdef1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml @@ -1,93 +1,100 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Each record is unique per sponsor defined key variables as documented in the define.xml Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Note that the key variables shown in this table are examples only. A - sponsor's actual key structure may be different. - Document: IG v3.4 - Section: Table 3.2.1 - - Cited Guidance: Since the purpose of this column is to aid reviewers in understanding the - structure of a dataset, sponsors should list all of the natural keys (see definition - below) for the dataset. These keys should define uniqueness for records within a dataset, - and may define a record sort order. The identified keys for each dataset should be - consistent with the description of the dataset structure as described in the Define-XML - document. - Document: IG v3.4 - Section: 3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are examples - only. A sponsor's actual key structure may be different.]|3.2.1.1[Since the purpose of - this column is to aid reviewers in understanding the structure of a dataset, sponsors - should list all of the natural keys (see definition below) for the dataset. These keys - should define uniqueness for records within a dataset, and may define a record sort - order.] - Document: IG v3.2 - Section: Table 3.2.1|3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Table 3.2.1[Note that the key variables shown in this table are examples - only. A sponsor's actual key structure may be different.]||3.2.1.1[Since the purpose of - this column is to aid reviewers in understanding the structure of a dataset, sponsors - should list all of the natural keys (see definition below) for the dataset. These keys - should define uniqueness for records within a dataset, and may define a record sort - order.] - Document: IG v3.3 - Section: Table 3.2.1|3.2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0019 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Note that the key variables shown in this table are examples only. A + sponsor's actual key structure may be different. + Document: IG v3.4 + Section: Table 3.2.1 + - Cited Guidance: + Since the purpose of this column is to aid reviewers in understanding the + structure of a dataset, sponsors should list all of the natural keys (see definition + below) for the dataset. These keys should define uniqueness for records within a dataset, + and may define a record sort order. The identified keys for each dataset should be + consistent with the description of the dataset structure as described in the Define-XML + document. + Document: IG v3.4 + Section: 3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Table 3.2.1[Note that the key variables shown in this table are examples + only. A sponsor's actual key structure may be different.]|3.2.1.1[Since the purpose of + this column is to aid reviewers in understanding the structure of a dataset, sponsors + should list all of the natural keys (see definition below) for the dataset. These keys + should define uniqueness for records within a dataset, and may define a record sort + order.] + Document: IG v3.2 + Section: Table 3.2.1|3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Table 3.2.1[Note that the key variables shown in this table are examples + only. A sponsor's actual key structure may be different.]||3.2.1.1[Since the purpose of + this column is to aid reviewers in understanding the structure of a dataset, sponsors + should list all of the natural keys (see definition below) for the dataset. These keys + should define uniqueness for records within a dataset, and may define a record sort + order.] + Document: IG v3.3 + Section: Table 3.2.1|3.2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0019 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_dataset_key_sequence - operator: is_not_unique_set - # the operator can be changed to the opposite to make sure we get output - #operator: is_unique_set + - name: define_dataset_key_sequence + operator: + is_not_unique_set + # the operator can be changed to the opposite to make sure we get output + #operator: is_unique_set Core: Id: CDISC.SDTMIG.CG0019 Status: Draft - Version: '1' -Description: Trigger error if records are not unique as per sponsor defined key variables as + Version: "1" +Description: + Trigger error if records are not unique as per sponsor defined key variables as documented in the define.xml Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: SUPP-- + - Keys: + - USUBJID + Name: SUPP-- Outcome: - Message: Records are not unique as per sponsor defined key variables as documented in the + Message: + Records are not unique as per sponsor defined key variables as documented in the define.xml Output Variables: - - define_dataset_key_sequence - - define_dataset_variable_order + - define_dataset_key_sequence + - define_dataset_variable_order Rule Type: Dataset Contents Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml index bd7172df7..9d0d0155d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096/rule.yml @@ -2,97 +2,101 @@ # Condition: CMTRT has a decode value in the dictionary # Rule: CMDECOD ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by the sponsor - from the coding dictionary. It is expected that the reported term (CMTRT) or the modified - term (CMMODIFY) will be coded using a standard dictionary - Document: IG v3.4 - Item: Assumption 2c - Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide - the dictionary name and version used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a decode value in the - dictionary then CMDECOD will be left blank. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy - term derived by the sponsor from the coding dictionary. It is expected that the reported - term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text - description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. - The sponsor is expected to provide the dictionary name and version used to map the terms - utilizing the define.xml external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be left blank.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy - term derived by the sponsor from the coding dictionary. It is expected that the reported - term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text - description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. - The sponsor is expected to provide the dictionary name and version used to map the terms - utilizing the define.xml external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be left blank.] - Document: IG v3.3 - Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] - Section: IG v3.3[6.1.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + CMDECOD is the standardized medication/therapy term derived by the sponsor + from the coding dictionary. It is expected that the reported term (CMTRT) or the modified + term (CMMODIFY) will be coded using a standard dictionary + Document: IG v3.4 + Item: Assumption 2c + Section: 6.1.2 + - Cited Guidance: + Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide + the dictionary name and version used to map the terms utilizing the define.xml external + codelist attributes. If an intervention term does not have a decode value in the + dictionary then CMDECOD will be left blank. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.3 + Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] + Section: IG v3.3[6.1.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: CMTRT - operator: non_empty - - name: CMDECOD - operator: empty + - name: CMTRT + operator: non_empty + - name: CMDECOD + operator: empty Core: Id: CDISC.SDTMIG.CG0096 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when CMTRT is populated, CMDECOD is empty Executability: Fully Executable Outcome: Message: CMDECOD must be populated when CMTRT is populated Output Variables: - - CMTRT - - CMDECOD + - CMTRT + - CMDECOD Rule Type: Record Data Scope: Classes: Include: - - ALL - #- INTERVENTIONS - #- STUDY REFERENCE + - ALL + #- INTERVENTIONS + #- STUDY REFERENCE Domains: Include: - - CM - - WHODD + - CM + - WHODD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml index 25fc09d4c..a94c13722 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0096b/rule.yml @@ -2,90 +2,94 @@ # Condition: CMTRT has a decode value in the dictionary # Rule: CMDECOD ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMDECOD is the standardized medication/therapy term derived by the sponsor - from the coding dictionary. It is expected that the reported term (CMTRT) or the modified - term (CMMODIFY) will be coded using a standard dictionary - Document: IG v3.4 - Item: Assumption 2c - Section: 6.1.2 - - Cited Guidance: Standardized or dictionary-derived text description of CMTRT or CMMODIFY. - Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide - the dictionary name and version used to map the terms utilizing the define.xml external - codelist attributes. If an intervention term does not have a decode value in the - dictionary then CMDECOD will be left blank. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy - term derived by the sponsor from the coding dictionary. It is expected that the reported - term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text - description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. - The sponsor is expected to provide the dictionary name and version used to map the terms - utilizing the define.xml external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be left blank.] - Document: IG v3.2 - Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] - Section: IG v3.2[6.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy - term derived by the sponsor from the coding dictionary. It is expected that the reported - term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard - dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text - description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. - The sponsor is expected to provide the dictionary name and version used to map the terms - utilizing the define.xml external codelist attributes. If an intervention term does not - have a decode value in the dictionary then CMDECOD will be left blank.] - Document: IG v3.3 - Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] - Section: IG v3.3[6.1.2] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0096b - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + CMDECOD is the standardized medication/therapy term derived by the sponsor + from the coding dictionary. It is expected that the reported term (CMTRT) or the modified + term (CMMODIFY) will be coded using a standard dictionary + Document: IG v3.4 + Item: Assumption 2c + Section: 6.1.2 + - Cited Guidance: + Standardized or dictionary-derived text description of CMTRT or CMMODIFY. + Equivalent to the generic medication name in WHO Drug. The sponsor is expected to provide + the dictionary name and version used to map the terms utilizing the define.xml external + codelist attributes. If an intervention term does not have a decode value in the + dictionary then CMDECOD will be left blank. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.2[6.1][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.2[6.1][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.2 + Item: IG v3.2[6.1][Assumption 2c]|IG v3.2[6.1][Specification] + Section: IG v3.2[6.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + IG v3.3[6.1.2][Assumption 2c][CMDECOD is the standardized medication/therapy + term derived by the sponsor from the coding dictionary. It is expected that the reported + term (CMTRT) or the modified term (CMMODIFY) will be coded using a standard + dictionary.]|IG v3.3[6.1.2][Specification][Standardized or dictionary-derived text + description of CMTRT or CMMODIFY. Equivalent to the generic medication name in WHO Drug. + The sponsor is expected to provide the dictionary name and version used to map the terms + utilizing the define.xml external codelist attributes. If an intervention term does not + have a decode value in the dictionary then CMDECOD will be left blank.] + Document: IG v3.3 + Item: IG v3.3[6.1.2][Assumption 2c]|IG v3.3[6.1.2][Specification] + Section: IG v3.3[6.1.2] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0096b + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: CMTRT - operator: is_contained_by_case_insensitive - value: $DNames # $whodrug_refs_valid - - name: CMDECOD - operator: empty + - name: CMTRT + operator: is_contained_by_case_insensitive + value: $DNames # $whodrug_refs_valid + - name: CMDECOD + operator: empty Core: Id: CDISC.SDTMIG.CG0096b Status: Draft - Version: '1' + Version: "1" Description: Raise an error when CMTRT is populated, CMDECOD is empty Executability: Fully Executable Operations: -- domain: WHODD #Custiom lookup - id: $DNames #$whodrug_refs_valid - name: DrugName - operator: distinct #valid_whodrug_references + - domain: WHODD #Custiom lookup + id: $DNames #$whodrug_refs_valid + name: DrugName + operator: distinct #valid_whodrug_references Outcome: Message: CMDECOD must be populated when CMTRT is populated @@ -96,12 +100,12 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL - #- INTERVENTIONS - #- STUDY REFERENCE + - ALL + #- INTERVENTIONS + #- STUDY REFERENCE Domains: Include: - - CM - - WHODD + - CM + - WHODD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml index c548e14a7..f16142132 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml @@ -1,65 +1,65 @@ # Variable: CMTRT -# Condition: +# Condition: # Rule: CMTRT = collected on CRF Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. - Document: IG v3.4 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. - Document: IG v3.3 - Item: Specification - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0097 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.4 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.2 + Item: Specification + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Verbatim medication name that is either pre-printed or collected on a CRF. + Document: IG v3.3 + Item: Specification + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0097 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: variable_name - operator: equal_to - value: CMTRT - # skipping cases when CMTRT is not provided (though this should never be the case) - #- name: CMTRT - # operator: non_empty - # Generate an issue when CMTRT is not declared as "collected" in the define.xml - - name: define_variable_is_collected - operator: equal_to - value: false + - name: variable_name + operator: equal_to + value: CMTRT + # skipping cases when CMTRT is not provided (though this should never be the case) + #- name: CMTRT + # operator: non_empty + # Generate an issue when CMTRT is not declared as "collected" in the define.xml + - name: define_variable_is_collected + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0097 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if CMTRT was not collected on CRF Executability: Fully Executable Outcome: @@ -68,9 +68,9 @@ Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM + - CM # Sensitivity: Record # will generate an issue for each record. Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml index cf0bd2662..35bcda3fe 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0103/rule.yml @@ -1,63 +1,66 @@ # Variable: EXDOSU -# Condition: +# Condition: # Rule: EXDOSU = protocol-specified unit Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified - values. - Document: IG v3.4 - Item: Specification - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified - values. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified - values. - Document: IG v3.3 - Item: Specification - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0103 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.4 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.2 + Item: Specification + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Units for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified + values. + Document: IG v3.3 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0103 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: EXDOSU - operator: not_equal_to - value: TS.TSVAL - - name: TS.TSPARMCD - operator: starts_with - value: DOSU + - name: EXDOSU + operator: not_equal_to + value: TS.TSVAL + - name: TS.TSPARMCD + operator: starts_with + value: DOSU Core: Id: CDISC.SDTMIG.CG0103 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if EXDOSU not expressed in protocol-specified units Executability: Fully Executable Outcome: @@ -66,8 +69,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Domain diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml index 0bc76f588..cb3fd4298 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0104/rule.yml @@ -1,63 +1,66 @@ # Variable: EXTRT -# Condition: +# Condition: # Rule: EXTRT = protocol-specified treatment Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given during the dosing - period for the observation. - Document: IG v3.4 - Item: Specification - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given during the dosing - period for the observation. - Document: IG v3.2 - Item: Specification - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Name of the protocol-specified study treatment given during the dosing - period for the observation. - Document: IG v3.3 - Item: Specification - Section: 6.1.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0104 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.4 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.2 + Item: Specification + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Name of the protocol-specified study treatment given during the dosing + period for the observation. + Document: IG v3.3 + Item: Specification + Section: 6.1.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0104 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: EXTRT - operator: not_equal_to - value: TS.TSVAL - - name: TS.TSPARMCD - operator: starts_with - value: TRT + - name: EXTRT + operator: not_equal_to + value: TS.TSVAL + - name: TS.TSPARMCD + operator: starts_with + value: TRT Core: Id: CDISC.SDTMIG.CG0104 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if EXTRT is not the protocol-specified treatment Executability: Fully Executable Outcome: @@ -66,8 +69,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml index b436e85d9..353c30ac9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml @@ -2,69 +2,72 @@ # Condition: AP Core Domain # Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to identify the data - as AP data to and distinguish them from study subject data.][Associated Persons domain codes - in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains - as AP domains and to distinguish them from study subject domains. AP domain codes are therefore - four characters long.]' - Document: AP Guide v1.0 - Section: '2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0155 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '[Associated Persons datasets are given a prefix of AP-- to identify the data - as AP data to and distinguish them from study subject data.][Associated Persons domain codes - in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains - as AP domains and to distinguish them from study subject domains. AP domain codes are therefore - four characters long.]' - Document: AP Guide v1.0 - Section: '2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0155 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data.][Associated Persons domain codes + in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains + as AP domains and to distinguish them from study subject domains. AP domain codes are therefore + four characters long.]" + Document: AP Guide v1.0 + Section: "2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0155 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "[Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data.][Associated Persons domain codes + in the DOMAIN column of every record are also given a prefix of AP-- to identify the domains + as AP domains and to distinguish them from study subject domains. AP domain codes are therefore + four characters long.]" + Document: AP Guide v1.0 + Section: "2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0155 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: DOMAIN - operator: starts_with - value: AP - - name: DOMAIN - operator: not_matches_regex - value: "[A-Z]{4}$" + - name: DOMAIN + operator: starts_with + value: AP + - name: DOMAIN + operator: not_matches_regex + value: "[A-Z]{4}$" Core: Id: CDISC.SDTMIG.CG0155 Status: Draft - Version: '1' -Description: Raise an error when DOMAIN value begins with AP and length of domain variable is not 4 + Version: "1" +Description: + Raise an error when DOMAIN value begins with AP and length of domain variable is not 4 or DOMAIN value doesn't end with a valid SDTM domain. Executability: Partially Executable - Possible Overreporting Outcome: Message: AP DOMAIN value should start with 'AP' and length should be equal to 4. Output Variables: - - DOMAIN + - DOMAIN Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Exclude: - - APRELSUB - - FA - - POOLDEF + - APRELSUB + - FA + - POOLDEF Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml index 63ea4376b..5f6af0ad5 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0156/rule.yml @@ -2,69 +2,72 @@ # Condition: APID identifies group of associated persons defined in POOLDEF # Rule: APID in POOLDEF.POOLID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier for a single associated person, a group of associated persons, or - a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for - each associated person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier for a single associated person, a group of associated persons, or - a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for - each associated person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Identifier for a single associated person, a group of associated persons, or - a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for - each associated person. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0156 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Identifier for a single associated person, a group of associated persons, or + a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for + each associated person. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0156 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0156 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - AP-- + - AP-- Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml index 927edffb6..bfc0f5602 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0157/rule.yml @@ -2,77 +2,79 @@ # Condition: Relationship described is to a study subject # Rule: RSUBJID in DM.USUBJID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Relationship described is to a study subject.RSUBJID is not in DM.USUBJID. - Document: APGuidev1.0 - Item: RSUBJID - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0157 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Relationship described is to a study subject.RSUBJID is not in DM.USUBJID. + Document: APGuidev1.0 + Item: RSUBJID + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0157 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: RSUBJID - operator: is_not_contained_by - value: $dm_rsubjid + - name: RSUBJID + operator: is_not_contained_by + value: $dm_rsubjid Core: Id: CDISC.SDTMIG.CG0157 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when RSUBJID in not in DM.USUBJID Executability: Fully Executable Operations: -- domain: DM - id: $dm_rsubjid - name: RSUBJID - operator: distinct + - domain: DM + id: $dm_rsubjid + name: RSUBJID + operator: distinct Outcome: Message: RSUBJID is not in DM.USUBJID. Output Variables: - - APDM.RSUBJID - - DM.USUBJID + - APDM.RSUBJID + - DM.USUBJID Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - AP - - DM + - AP + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml index d9e56d7f5..c27515198 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml @@ -2,62 +2,66 @@ # Condition: Relationship described is to a pool # Rule: RSUBJID in POOLDEF.POOLID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0158 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0158 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RSUBJID - operator: is_not_contained_by - value: POOLDEF.POOLID + - name: + operator: + - name: RSUBJID + operator: is_not_contained_by + value: POOLDEF.POOLID Core: Id: CDISC.SDTMIG.CG0158 Status: Draft - Version: '1' -Description: Trigger error if relationship described is to a pool and RSUBJID is not in + Version: "1" +Description: + Trigger error if relationship described is to a pool and RSUBJID is not in POOLDEF.POOLID Executability: Fully Executable Outcome: @@ -66,8 +70,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATE PERSONS + - ASSOCIATE PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml index a12009b20..17774396e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml @@ -2,72 +2,77 @@ # Condition: Relationship described is to a study but not to individual study subjects # Rule: RSUBJID = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: RSUBJID will be populated with the USUBJID of the related subject or the - POOLID of the related pool. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0159 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + RSUBJID will be populated with the USUBJID of the related subject or the + POOLID of the related pool. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0159 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RSUBJID - operator: non_empty + - name: + operator: + - name: RSUBJID + operator: non_empty Core: Id: CDISC.SDTMIG.CG0159 Status: Draft - Version: '1' -Description: Trigger error if relationship described is to a study (but not to individual study + Version: "1" +Description: + Trigger error if relationship described is to a study (but not to individual study subject) and RSUBJID is not null Executability: Fully Executable Outcome: - Message: Relationship described is to a study (but not to individua study subject) and RSUBJID is + Message: + Relationship described is to a study (but not to individua study subject) and RSUBJID is not null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml index 993699dca..4070316b1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml @@ -2,84 +2,89 @@ # Condition: RSUBJID ^= null # Rule: Describes relationship of associated person to study subject or pool Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0160 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0160 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: RSUBJID - operator: non_empty - - name: SREL - operator: + - name: RSUBJID + operator: non_empty + - name: SREL + operator: Core: Id: CDISC.SDTMIG.CG0160 Status: Draft - Version: '1' -Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship of + Version: "1" +Description: + Trigger error when RSUBJID ^= null and SREL does not describe the relationship of associated person to study subject or pool Executability: Fully Executable Outcome: - Message: SREL does not describe the relationship of associated person to study subject or pool + Message: + SREL does not describe the relationship of associated person to study subject or pool when RSUBJID is not null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml index 3603abe80..33fdc6253 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml @@ -2,84 +2,89 @@ # Condition: RDEVID ^= null # Rule: Describes relationship of associated person to device identified in RDEVID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0161 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0161 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: RDEVID - operator: non_empty - - name: SREL - operator: + - name: RDEVID + operator: non_empty + - name: SREL + operator: Core: Id: CDISC.SDTMIG.CG0161 Status: Draft - Version: '1' -Description: Trigger error when RDEVID ^= null and SREL does not describe relationship of associated + Version: "1" +Description: + Trigger error when RDEVID ^= null and SREL does not describe relationship of associated person to device identified in RDEVID Executability: Fully Executable Outcome: - Message: SREL does not describe relationship of associated person to device identified in RDEVID + Message: + SREL does not describe relationship of associated person to device identified in RDEVID when RDEVID ^= null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml index 1e982051a..f7a6255b2 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml @@ -2,79 +2,84 @@ # Condition: RSUBJID = null and RDEVID = null # Rule: Describes relationship of associated person to study identified in STUDYID Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID. - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If RSUBJID is populated, describes the relationship of the associated - person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is - populated, describes the relationship of the associated person(s) identified in APID to - the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the - relationship of the associated person(s) identified in APID to the study identified in - STUDYID - Document: AP Guide v1.0 - Item: Specification - Section: 2.1.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0162 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID. + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If RSUBJID is populated, describes the relationship of the associated + person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is + populated, describes the relationship of the associated person(s) identified in APID to + the device identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the + relationship of the associated person(s) identified in APID to the study identified in + STUDYID + Document: AP Guide v1.0 + Item: Specification + Section: 2.1.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0162 + Version: "1" + Version: "2.0" + Version: "3.3" Check: Core: Id: CDISC.SDTMIG.CG0162 Status: Draft - Version: '1' -Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the + Version: "1" +Description: + Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the relationship of associated person to study identified in STUDYID Executability: Not Executable Outcome: - Message: SREL does not describe the relationship of associated person to study identified in + Message: + SREL does not describe the relationship of associated person to study identified in STUDYID when RSUBJID = null and RDEVID = null Rule Type: Record Data Scope: Classes: Include: - - ASSOCIATED PERSONS + - ASSOCIATED PERSONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml index a4073e506..4667284b0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0167/rule.yml @@ -1,68 +1,71 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Comments are unsolicited, free-text and voluntary Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Comments special-purpose domain provides a solution for submitting - free-text comments related to data in one or more SDTM domains (as described in Section - 8.5, Relating Comments to a Parent Domain) or collected on a separate CRF page dedicated - to comments. Comments are generally not responses to specific questions; instead, comments - usually consist of voluntary, free-text or unsolicited observations. - Document: IG v3.4 - Item: Assumption 1 - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The Comments special-purpose domain provides a solution for submitting free-text - comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating - Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments - are generally not responses to specific questions; instead, comments usually consist of voluntary, - free-text or unsolicited observations.' - Document: IG v3.2 - Item: Specification - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The Comments special-purpose domain provides a solution for submitting free-text - comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating - Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments - are generally not responses to specific questions; instead, comments usually consist of voluntary, - free-text or unsolicited observations.' - Document: IG v3.3 - Item: Specification - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0167 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Comments special-purpose domain provides a solution for submitting + free-text comments related to data in one or more SDTM domains (as described in Section + 8.5, Relating Comments to a Parent Domain) or collected on a separate CRF page dedicated + to comments. Comments are generally not responses to specific questions; instead, comments + usually consist of voluntary, free-text or unsolicited observations. + Document: IG v3.4 + Item: Assumption 1 + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The Comments special-purpose domain provides a solution for submitting free-text + comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating + Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments + are generally not responses to specific questions; instead, comments usually consist of voluntary, + free-text or unsolicited observations." + Document: IG v3.2 + Item: Specification + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The Comments special-purpose domain provides a solution for submitting free-text + comments related to data in one or more SDTM domains (as described in Section 8: 8.5, Relating + Comments To A Parent Domain) or collected on a separate CRF page dedicated to comments. Comments + are generally not responses to specific questions; instead, comments usually consist of voluntary, + free-text or unsolicited observations." + Document: IG v3.3 + Item: Specification + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0167 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0167 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when comments are not unsolicited, free-text and voluntary Executability: Fully Executable Outcome: @@ -71,8 +74,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml index a63564e94..842e0602f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml @@ -2,64 +2,68 @@ # Condition: No comment > 200 characters # Rule: COVALn not present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When the comment text is longer than 200 characters, the first 200 characters - of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed - to COVALn. See example, Rows 3-4. ' - Document: IG v3.4 - Item: Assumption 3 - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the comment text is longer than 200 characters, the first 200 - characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text - stored as needed to COVALn. See example, Rows 3-4. - Document: IG v3.2 - Item: Assumption 3 - Section: '5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the comment text is longer than 200 characters, the first 200 - characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text - stored as needed to COVALn. See example, Rows 3-4. - Document: IG v3.3 - Item: Assumption 3 - Section: '5.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0169 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When the comment text is longer than 200 characters, the first 200 characters + of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed + to COVALn. See example, Rows 3-4. " + Document: IG v3.4 + Item: Assumption 3 + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the comment text is longer than 200 characters, the first 200 + characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text + stored as needed to COVALn. See example, Rows 3-4. + Document: IG v3.2 + Item: Assumption 3 + Section: "5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the comment text is longer than 200 characters, the first 200 + characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text + stored as needed to COVALn. See example, Rows 3-4. + Document: IG v3.3 + Item: Assumption 3 + Section: "5.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0169 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: COVAL1 - operator: exists - - name: COVAL1 - operator: empty + - name: COVAL1 + operator: exists + - name: COVAL1 + operator: empty Core: Id: CDISC.SDTMIG.CG0169 Status: Draft - Version: '1' -Description: Trigger error when there are no comments greater than 200 characters and COVALn is + Version: "1" +Description: + Trigger error when there are no comments greater than 200 characters and COVALn is present Executability: Fully Executable Outcome: @@ -68,8 +72,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml index 06804e91a..d9cc3bde4 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml @@ -2,81 +2,86 @@ # Condition: Collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, 2.2.2, or 2.2.3, and are represented in the Findings About domain # Rule: The name of the variable is used as the value of FATESTCD. Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 3.1.1, - 3.1.2, or 3.1.3, and are represented in the Findings About domain, then the name of the variable - should be used as the value of FATESTCD.' - Document: IG v3.4 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, - 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable - should be used as the value of FATESTCD.' - Document: IG v3.2 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, - 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable - should be used as the value of FATESTCD.' - Document: IG v3.3 - Section: 6.4.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0173 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When collected data fit a Qualifier variable listed in SDTM: Sections 3.1.1, + 3.1.2, or 3.1.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD." + Document: IG v3.4 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, + 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD." + Document: IG v3.2 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "When collected data fit a Qualifier variable listed in SDTM: Sections 2.2.1, + 2.2.2, or 2.2.3, and are represented in the Findings About domain, then the name of the variable + should be used as the value of FATESTCD." + Document: IG v3.3 + Section: 6.4.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0173 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: $label_referenced_variable_role - operator: is_contained_by - value: "Qualifier" - - name: FATESTCD - operator: is_contained_by - value: $label_referenced_variable_name + - name: $label_referenced_variable_role + operator: is_contained_by + value: "Qualifier" + - name: FATESTCD + operator: is_contained_by + value: $label_referenced_variable_name Core: Id: CDISC.SDTMIG.CG0173 Status: Draft - Version: '1' -Description: Trigger error when collected data fits a Qualifier variable listed in specified SDTM + Version: "1" +Description: + Trigger error when collected data fits a Qualifier variable listed in specified SDTM Sections and are represented in the Findings About domain, and the name of the variable is used as FATESTCD Executability: Partially Executable - Possible Underreporting Operations: -- id: $label_referenced_variable_name - name: FATESTCD - operator: label_referenced_variable_metadata + - id: $label_referenced_variable_name + name: FATESTCD + operator: label_referenced_variable_metadata Outcome: - Message: Collected data fits a Qualifier variable listed in specified SDTM Sections and are + Message: + Collected data fits a Qualifier variable listed in specified SDTM Sections and are represented in the Findings About domain, and the name of the variable is used as FATESTCD Output Variables: - - $label_referenced_variable_name + - $label_referenced_variable_name Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml index 175be863b..6aa9cfa2c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml @@ -2,66 +2,68 @@ # Condition: LBORRES = continuous measurement # Rule: LBSTNRC = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: >- - For normal range values that are character in ordinal scale or - if categorical ranges were supplied (e.g., "-1 to +1", - "NEGATIVE TO TRACE"). - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For normal range values that are character in ordinal scale or if - categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For normal range values that are character in ordinal scale or if - categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0184 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: >- + For normal range values that are character in ordinal scale or + if categorical ranges were supplied (e.g., "-1 to +1", + "NEGATIVE TO TRACE"). + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For normal range values that are character in ordinal scale or if + categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For normal range values that are character in ordinal scale or if + categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0184 + Version: "1" + Version: "2.0" + Version: "3.3" Check: # Changed by Marcelina Hungria on 2025-07-22 # Fixed the regex per Description. # Changed to Fully Executable. See Jira ticket: CORERULES-160 (CG0184) all: - - name: LBORRES - operator: matches_regex - value: -?(\d+(\.\d+)?$)|(\.\d+$) - - name: LBSTNRC - operator: non_empty + - name: LBORRES + operator: matches_regex + value: -?(\d+(\.\d+)?$)|(\.\d+$) + - name: LBSTNRC + operator: non_empty Core: Id: CDISC.SDTMIG.CG0184 Status: Draft - Version: '1' + Version: "1" Description: When LBORRES is a continuous measurement, LBSTNRC should be null Executability: Fully Executable Outcome: @@ -70,8 +72,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml index d174409ae..5234af168 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0186/rule.yml @@ -1,56 +1,56 @@ # Variable: LBORNRLO -# Condition: +# Condition: # Rule: LBORNRLO is expressed using the units in LBORRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurement in original units. - Document: SDTMIG v3.4 - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements in original units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0186 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurement in original units. + Document: SDTMIG v3.4 + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Lower end of reference range for continuous measurements in original units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0186 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: LBORNRLO - operator: equal_to - value: LBORRESU + - name: LBORNRLO + operator: equal_to + value: LBORRESU Core: Id: CDISC.SDTMIG.CG0186 Status: Draft - Version: '1' + Version: "1" Description: LBORNRLO is expressed using the units in LBORRESU Executability: Fully Executable Outcome: @@ -59,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml index 80395ba46..8c106ce09 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0187/rule.yml @@ -1,64 +1,64 @@ # Variable: LBORNRHI -# Condition: +# Condition: # Rule: LBORNRHI is expressed using the units in LBORRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in original units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurement in original units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0187 - Version: '2' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurements in original units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: "2" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Upper end of reference range for continuous measurement in original units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0187 + Version: "2" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0187 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml index 899b8fcf6..a53883f43 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml @@ -1,65 +1,68 @@ # Variable: LBSTNRLO -# Condition: +# Condition: # Rule: LBSTNRLO is expressed using the units in LBSTRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Lower end of reference range for continuous measurements for - LBSTRESC/LBSTRESN in standardized units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0188 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Lower end of reference range for continuous measurements for + LBSTRESC/LBSTRESN in standardized units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0188 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: LBSTRESU - operator: non_empty - - name: LBORRESU - operator: equal_to - value: LBSTRESU - - name: LBORNRLO - operator: not_equal_to - value: LBSTNRLO + - name: LBSTRESU + operator: non_empty + - name: LBORRESU + operator: equal_to + value: LBSTRESU + - name: LBORNRLO + operator: not_equal_to + value: LBSTNRLO Core: Id: CDISC.SDTMIG.CG0188 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if LBORNRLO is not expressed using the units in LBSTRESU Executability: Fully Executable Outcome: @@ -68,8 +71,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml index c0ea94066..b870cd59d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0189/rule.yml @@ -1,65 +1,68 @@ # Variable: LBSTNRHI -# Condition: +# Condition: # Rule: LBSTNRHI is expressed using the units in LBSTRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in standardized - units. - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in standardized - units. - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Upper end of reference range for continuous measurements in standardized - units. - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0189 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Upper end of reference range for continuous measurements in standardized + units. + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0189 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: LBSTRESU - operator: non_empty - - name: LBORRESU - operator: equal_to - value: LBSTRESU - - name: LBORNRHI - operator: not_equal_to - value: LBSTNRHI + - name: LBSTRESU + operator: non_empty + - name: LBORRESU + operator: equal_to + value: LBSTRESU + - name: LBORNRHI + operator: not_equal_to + value: LBSTNRHI Core: Id: CDISC.SDTMIG.CG0189 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if LBSTNRHI is not expressed using the units in LBSTRESU Executability: Fully Executable Outcome: @@ -68,8 +71,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml index a7ee5542b..f4e6456d6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml @@ -2,59 +2,60 @@ # Condition: LBSTRESU ^= null # Rule: LBSTNRC is expressed using the units in LBSTRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.4 - Item: Specification - Section: 6.3.5.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.2 - Item: Specification - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference Range for Char Rslt-Std Units - Document: IG v3.3 - Item: Specification - Section: 6.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0190 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.4 + Item: Specification + Section: 6.3.5.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.2 + Item: Specification + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Reference Range for Char Rslt-Std Units + Document: IG v3.3 + Item: Specification + Section: 6.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0190 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: LBSTRESU - operator: non_empty - - name: - operator: - value: + - name: LBSTRESU + operator: non_empty + - name: + operator: + value: Core: Id: CDISC.SDTMIG.CG0190 Status: Draft - Version: '1' -Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in + Version: "1" +Description: + Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in LBSTRESU Executability: Fully Executable Outcome: @@ -63,8 +64,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml index e468fb27c..529334cab 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0192/rule.yml @@ -2,37 +2,37 @@ # Condition: Organisms present in the specimen # Rule: MBTESTCD = 'ORGANISM' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen is 'ORGANISM'. - Document: IG v3.2 - Item: Assumption 3 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0192 - Version: '1' - Version: '2.0' - Version: '3.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: 3. MBTESTCD value for organisms present in a specimen is 'ORGANISM'. + Document: IG v3.2 + Item: Assumption 3 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0192 + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: [] Core: Id: CDISC.SDTMIG.CG0192 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml index d35283eb6..239d610f9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0196/rule.yml @@ -2,64 +2,67 @@ # Condition: PEORRES ^= null and no abnormal findings # Rule: PEORRES = 'NORMAL' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text description of any abnormal findings. If the examination was completed - and there were no abnormal findings, the value should be NORMAL. - Document: IG v3.2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Text description of any abnormal findings. If the examination was completed - and there were no abnormal findings, the value should be NORMAL. - Document: IG v3.3 - Section: 6.3.12 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the examination was completed and there were no abnormal findings, the - value should be "NORMAL". - Document: IG v3.4 - Item: Specification - Section: 6.3.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0196 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Text description of any abnormal findings. If the examination was completed + and there were no abnormal findings, the value should be NORMAL. + Document: IG v3.2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Text description of any abnormal findings. If the examination was completed + and there were no abnormal findings, the value should be NORMAL. + Document: IG v3.3 + Section: 6.3.12 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the examination was completed and there were no abnormal findings, the + value should be "NORMAL". + Document: IG v3.4 + Item: Specification + Section: 6.3.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0196 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0196 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PE + - PE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml index 1021ea678..db5d03bc7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml @@ -2,79 +2,83 @@ # Condition: PESTRESC ^= null # Rule: PESTRESC = PEORRES OR a dictionary coded preferred term Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If there are findings for a body system, then either the dictionary - preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not - encoded) should appear here. - Document: IG v3.4 - Item: Specification - Section: 6.3.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If there are findings for a body system, then either the dictionary - preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not - coded) should appear here. - Document: IG v3.2 - Section: '6.3' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If there are findings for a body system, then either the dictionary - preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not - coded) should appear here. - Document: IG v3.3 - Section: 6.3.12 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0197 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + encoded) should appear here. + Document: IG v3.4 + Item: Specification + Section: 6.3.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + coded) should appear here. + Document: IG v3.2 + Section: "6.3" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If there are findings for a body system, then either the dictionary + preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not + coded) should appear here. + Document: IG v3.3 + Section: 6.3.12 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0197 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PESTRESC - operator: non_empty - - any: - name: PESTRESC - operator: equal_to - value: PEORRES - - name: PESTRES - operator: is_contained_by - value: + operator: non_empty + - any: + - name: PESTRESC + operator: equal_to + value: PEORRES + - name: PESTRES + operator: is_contained_by + value: Core: Id: CDISC.SDTMIG.CG0197 Status: Draft - Version: '1' -Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary + Version: "1" +Description: + Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary coded preferred term Executability: Fully Executable Outcome: Message: PESTRESC does not equal PEORRES OR a dictionary coded preferred term Output Variables: - - PESTRESC + - PESTRESC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PE + - PE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml index 9a0c462cc..952de7fee 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0198/rule.yml @@ -1,61 +1,64 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Relationships represented in RELREC are collected relationships Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Relationships represented in RELREC are collected relationships, either by - explicit references or check boxes on the CRF, or by design of the CRF, such as vital - signs captured during an exercise stress test. - Document: IG v3.4 - Section: '8.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Relationships represented in RELREC are collected relationships, either by - explicit references or check boxes on the CRF, or by design of the CRF, such as vital - signs captured during an exercise stress test. - Document: IG v3.2 - Section: '8.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Relationships represented in RELREC are collected relationships, either by - explicit references or check boxes on the CRF, or by design of the CRF, such as vital - signs captured during an exercise stress test. - Document: IG v3.3 - Section: '8.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0198 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.4 + Section: "8.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.2 + Section: "8.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Relationships represented in RELREC are collected relationships, either by + explicit references or check boxes on the CRF, or by design of the CRF, such as vital + signs captured during an exercise stress test. + Document: IG v3.3 + Section: "8.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0198 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0198 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when relationship represented in RELREC is not a collected relationship Executability: Fully Executable Outcome: @@ -64,8 +67,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - RELREC + - RELREC Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml index c4f4b404c..d54100ae3 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml @@ -1,80 +1,85 @@ # Variable: --DTC -# Condition: +# Condition: # Rule: --DTC is date/time of specimen collection or observation, not date/time of recording/acquisition Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data was - recorded. in order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.4 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data was - recorded. in order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.2 - Section: 4.1.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data were - recorded. In order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.3 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0236 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.2 + Section: 4.1.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data were + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.3 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0236 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0236 Status: Draft - Version: '1' -Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time of + Version: "1" +Description: + Trigger error when --DTC is date/time of recording/acquisition, not date/time of specimen collection or observation Executability: Fully Executable Outcome: - Message: --DTC is date/time of recording/acquisition, not date/time of specimen collection or + Message: + --DTC is date/time of recording/acquisition, not date/time of specimen collection or observation Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml index be3c1cb11..1353ab701 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml @@ -2,82 +2,87 @@ # Condition: --DTC present in dataset # Rule: --DTC is date/time of recording/data acquisition Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data was - recorded. in order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.4 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data was - recorded. in order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.2 - Section: 4.1.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For any domain based on the Findings general observation class, such as lab - tests which are based on a specimen, the collection date is likely to be tied to when the - specimen or source of the finding was captured, not necessarily when the data were - recorded. In order to ensure that the critical timing information is always represented in - the same variable, the --DTC variable is used to represent the time of specimen - collection. - Document: IG v3.3 - Section: 4.4.8 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0237 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.4 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data was + recorded. in order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.2 + Section: 4.1.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For any domain based on the Findings general observation class, such as lab + tests which are based on a specimen, the collection date is likely to be tied to when the + specimen or source of the finding was captured, not necessarily when the data were + recorded. In order to ensure that the critical timing information is always represented in + the same variable, the --DTC variable is used to represent the time of specimen + collection. + Document: IG v3.3 + Section: 4.4.8 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0237 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --DTC - operator: exists - - name: - operator: + - name: --DTC + operator: exists + - name: + operator: Core: Id: CDISC.SDTMIG.CG0237 Status: Draft - Version: '1' -Description: Trigger error when --DTC is present and not populated with the date/time of + Version: "1" +Description: + Trigger error when --DTC is present and not populated with the date/time of recording/data acquisition Executability: Fully Executable Outcome: - Message: --DTC is present in dataset and is not populated with the date/time of recording/data + Message: + --DTC is present in dataset and is not populated with the date/time of recording/data acquisition Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - INTERVENTIONS + - EVENTS + - INTERVENTIONS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml index d12d203ff..084620540 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0238/rule.yml @@ -1,93 +1,96 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "\"Dates are generally used only as timing variables, ... but there may be occasions - when it may be preferable \n to model a date as a result (--ORRES) in a Findings dataset. ... - this situation may occasionally occur when \n a) a group of questions (each of which has a date - response) is asked and analyzed together; or b) the Event(s) \n and Intervention(s) in question - are not medically significant (often the case when included in questionnaires). \n Consider - the following cases - Calculated due date, Date of last day on the job, Date of high school - graduation. \n One approach to modeling these data would be to place the text of the question - in --TEST and the response to the \n question, a date represented in ISO 8601 format, in --ORRES - and --STRESC as long as these date results do not \n contain the dates of medically significant - events or interventions. Again, use extreme caution when storing dates \n as the results of - Findings. Remember, in most cases, these dates should be timing variables associated with a\ - \ \n record in an Intervention or Events dataset.\"" - Document: IG v3.4 - Section: 4.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dates are generally used only as timing variables, ... but there may be occasions - when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this - situation may occasionally occur when a) a group of questions (each of which has a date response) - is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically - significant (often the case when included in questionnaires). Consider the following cases: - Calculated due date; Date of last day on the job; Date of high school graduation. One approach - to modeling these data would be to place the text of the question in --TEST and the response - to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these - date results do not contain the dates of medically significant events or interventions. Again, - use extreme caution when storing dates as the results of Findings. Remember, in most cases, - these dates should be timing variables associated with a record in an Intervention or Events - dataset.' - Document: IG v3.2 - Section: 4.1.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Dates are generally used only as timing variables, ... but there may be occasions - when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this - situation may occasionally occur when a) a group of questions (each of which has a date response) - is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically - significant (often the case when included in questionnaires). Consider the following cases: - Calculated due date, Date of last day on the job, Date of high school graduation. One approach - to modeling these data would be to place the text of the question in --TEST and the response - to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these - date results do not contain the dates of medically significant events or interventions. Again, - use extreme caution when storing dates as the results of Findings. Remember, in most cases, - these dates should be timing variables associated with a record in an Intervention or Events - dataset.' - Document: IG v3.3 - Section: 4.4.9 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0238 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "\"Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable \n to model a date as a result (--ORRES) in a Findings dataset. ... + this situation may occasionally occur when \n a) a group of questions (each of which has a date + response) is asked and analyzed together; or b) the Event(s) \n and Intervention(s) in question + are not medically significant (often the case when included in questionnaires). \n Consider + the following cases - Calculated due date, Date of last day on the job, Date of high school + graduation. \n One approach to modeling these data would be to place the text of the question + in --TEST and the response to the \n question, a date represented in ISO 8601 format, in --ORRES + and --STRESC as long as these date results do not \n contain the dates of medically significant + events or interventions. Again, use extreme caution when storing dates \n as the results of + Findings. Remember, in most cases, these dates should be timing variables associated with a\ + \ \n record in an Intervention or Events dataset.\"" + Document: IG v3.4 + Section: 4.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this + situation may occasionally occur when a) a group of questions (each of which has a date response) + is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically + significant (often the case when included in questionnaires). Consider the following cases: + Calculated due date; Date of last day on the job; Date of high school graduation. One approach + to modeling these data would be to place the text of the question in --TEST and the response + to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these + date results do not contain the dates of medically significant events or interventions. Again, + use extreme caution when storing dates as the results of Findings. Remember, in most cases, + these dates should be timing variables associated with a record in an Intervention or Events + dataset." + Document: IG v3.2 + Section: 4.1.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Dates are generally used only as timing variables, ... but there may be occasions + when it may be preferable to model a date as a result (--ORRES) in a Findings dataset. ... this + situation may occasionally occur when a) a group of questions (each of which has a date response) + is asked and analyzed together; or b) the Event(s) and Intervention(s) in question are not medically + significant (often the case when included in questionnaires). Consider the following cases: + Calculated due date, Date of last day on the job, Date of high school graduation. One approach + to modeling these data would be to place the text of the question in --TEST and the response + to the question, a date represented in ISO 8601 format, in --ORRES and --STRESC as long as these + date results do not contain the dates of medically significant events or interventions. Again, + use extreme caution when storing dates as the results of Findings. Remember, in most cases, + these dates should be timing variables associated with a record in an Intervention or Events + dataset." + Document: IG v3.3 + Section: 4.4.9 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0238 + Version: "1" + Version: "2.0" + Version: "3.3" # Variable: --ORRES # Condition: Date Value # Rule: --ORRES in ISO 8601 date format Check: all: - - any: - - name: --TEST - operator: contains_case_insensitive - value: date - - name: --TEST - operator: contains_case_insensitive - value: time - - name: --ORRES - operator: invalid_date + - any: + - name: --TEST + operator: contains_case_insensitive + value: date + - name: --TEST + operator: contains_case_insensitive + value: time + - name: --ORRES + operator: invalid_date Core: Id: CDISC.SDTMIG.CG0238 Status: Draft - Version: '1' + Version: "1" Description: Where -ORRES is a date or time, it must be entered in an ISO 8601 format Executability: Partially Executable # this rule is actually not executable @@ -97,8 +100,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml index 8cd031b19..bed794844 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml @@ -2,72 +2,77 @@ # Condition: Element does not end with a decision that could lead to a shortened path within the Arm # Rule: TATRANS = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If an Element does not end with a decision that could lead to a shortened - path within the Arm, then TATRANS will be blank. - Document: IG v3.4 - Item: Assumption 7 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If an Element does not end with a decision that could lead to a shortened - path within the Arm, then TATRANS will be blank. - Document: IG v3.2 - Item: Assumption 7 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If an Element does not end with a decision that could lead to a shortened - path within the Arm, then TATRANS will be blank. - Document: IG v3.3 - Item: Assumption 7 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0249 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.4 + Item: Assumption 7 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.2 + Item: Assumption 7 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If an Element does not end with a decision that could lead to a shortened + path within the Arm, then TATRANS will be blank. + Document: IG v3.3 + Item: Assumption 7 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0249 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: TATRANS - operator: non_empty + - name: + operator: + - name: TATRANS + operator: non_empty Core: Id: CDISC.SDTMIG.CG0249 Status: Draft - Version: '1' -Description: Trigger error when element does not end with a decision that could lead to a shortened + Version: "1" +Description: + Trigger error when element does not end with a decision that could lead to a shortened path within the Arm and TATRANS is not null Executability: Fully Executable Outcome: - Message: TATRANS is populated when the element does not end with a decision that could lead to a + Message: + TATRANS is populated when the element does not end with a decision that could lead to a shortened path within the Arm Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml index 37923e421..f36ba4677 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml @@ -1,58 +1,60 @@ # Variable: EPOCH -# Condition: +# Condition: # Rule: Each value of EPOCH is not associated with more than one conceptual trial period Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'EPOCH may be used as a timing variable in other datasets, such as EX and DS, - and values of EPOCH must be different for different epochs. ' - Document: IG v3.4 - Item: Assumption 12 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '... values of EPOCH must be different for different epochs.' - Document: IG v3.2 - Item: Assumption 11 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '... values of EPOCH must be different for different epochs.' - Document: IG v3.3 - Item: Assumption 12 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0250 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "EPOCH may be used as a timing variable in other datasets, such as EX and DS, + and values of EPOCH must be different for different epochs. " + Document: IG v3.4 + Item: Assumption 12 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "... values of EPOCH must be different for different epochs." + Document: IG v3.2 + Item: Assumption 11 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "... values of EPOCH must be different for different epochs." + Document: IG v3.3 + Item: Assumption 12 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0250 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0250 Status: Draft - Version: '1' -Description: Trigger error when at least one EPOCH is associated with more than one conceptual trial + Version: "1" +Description: + Trigger error when at least one EPOCH is associated with more than one conceptual trial period Executability: Fully Executable Outcome: @@ -61,8 +63,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml index 0cdc28669..2c846e7ba 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0251/rule.yml @@ -2,60 +2,63 @@ # Condition: Trial design branches # Rule: TABRANCH ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial - design for subjects in the Arm. - Document: IG v3.4 - Item: Assumption 3 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial - design for subjects in the Arm - Document: IG v3.2 - Item: Assumption 3 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TABRANCH describes the outcome of a branch decision point in the trial - design for subjects in the Arm - Document: IG v3.3 - Item: Assumption 3 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0251 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm. + Document: IG v3.4 + Item: Assumption 3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm + Document: IG v3.2 + Item: Assumption 3 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TABRANCH describes the outcome of a branch decision point in the trial + design for subjects in the Arm + Document: IG v3.3 + Item: Assumption 3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0251 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: TABRANCH - operator: empty + - name: + operator: + - name: TABRANCH + operator: empty Core: Id: CDISC.SDTMIG.CG0251 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when trial design branches and TABRANCH is null Executability: Fully Executable Outcome: @@ -64,8 +67,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml index b8c7095bf..b2d51980c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml @@ -2,74 +2,79 @@ # Condition: Trial Design allows for a Subject to transition to an Element other than the next Element in sequence # Rule: TATRANS ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element other than - the next Element in sequence, then the conditions for transitioning to those other - Elements, and the alternative Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.4 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element other than - the next Element in sequence, then the conditions for transitioning to those other - Elements, and the alternative Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.2 - Item: Specification - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the trial design allows a subject to transition to an Element other than - the next Element in sequence, then the conditions for transitioning to those other - Elements, and the alternative Element sequences, are specified in this rule (e.g., - Responders go to washout). - Document: IG v3.3 - Item: Specification - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0252 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.4 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.2 + Item: Specification + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the trial design allows a subject to transition to an Element other than + the next Element in sequence, then the conditions for transitioning to those other + Elements, and the alternative Element sequences, are specified in this rule (e.g., + Responders go to washout). + Document: IG v3.3 + Item: Specification + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0252 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: Core: Id: CDISC.SDTMIG.CG0252 Status: Draft - Version: '1' -Description: Trigger error when trial Design allows for a Subject to transition to an Element other + Version: "1" +Description: + Trigger error when trial Design allows for a Subject to transition to an Element other than the next Element in sequence, and TATRANS is null Executability: Not Executable Outcome: - Message: TATRANS is null when trial Design allows for a Subject to transition to an Element other + Message: + TATRANS is null when trial Design allows for a Subject to transition to an Element other than the next Element in sequence Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml index 1a02113b0..0182b64ab 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml @@ -2,73 +2,77 @@ # Condition: Greater than one version of the IE criteria in study documentation # Rule: TIVERS ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each - complete set of criteria must be included in the TI domain. TIVERS is used to distinguish - between the versions. - Document: IG v3.4 - Item: Assumption 1 - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each - complete set of criteria must be included in the TI domain. TIVERS is used to distinguish - between the versions. - Document: IG v3.2 - Item: Assumption 1 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If inclusion/exclusion criteria were amended during the trial, then each - complete set of criteria must be included in the TI domain. TIVERS is used to distinguish - between the versions. - Document: IG v3.3 - Item: Assumption 1 - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0253 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.4 + Item: Assumption 1 + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.2 + Item: Assumption 1 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If inclusion/exclusion criteria were amended during the trial, then each + complete set of criteria must be included in the TI domain. TIVERS is used to distinguish + between the versions. + Document: IG v3.3 + Item: Assumption 1 + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0253 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - Core: Id: CDISC.SDTMIG.CG0253 Status: Draft - Version: '1' -Description: Trigger error when TIVERS is null and there is more than one version of the IE criteria + Version: "1" +Description: + Trigger error when TIVERS is null and there is more than one version of the IE criteria in study documentation Executability: Not Executable Outcome: - Message: TIVERS is null when there is more than one version of the IE criteria in study + Message: + TIVERS is null when there is more than one version of the IE criteria in study documentation Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml index bf0740435..b5027b9c0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml @@ -2,61 +2,65 @@ # Condition: Greater than one version of the IE criteria # Rule: TIVERS present in dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be - omitted if there is only one version. - Document: IG v3.4 - Item: Specification - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be - omitted if there is only one version. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The number of this version of the Inclusion/Exclusion criteria. May be - omitted if there is only one version. - Document: IG v3.3 - Item: Specification - Section: 7.4.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0254 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.4 + Item: Specification + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The number of this version of the Inclusion/Exclusion criteria. May be + omitted if there is only one version. + Document: IG v3.3 + Item: Specification + Section: 7.4.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0254 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: TIVERS - operator: exists + - name: + operator: + - name: TIVERS + operator: exists Core: Id: CDISC.SDTMIG.CG0254 Status: Draft - Version: '1' -Description: Trigger error when TIVERS is not present in the data and there is more than one version + Version: "1" +Description: + Trigger error when TIVERS is not present in the data and there is more than one version of the IE criteria Executability: Fully Executable Outcome: @@ -65,8 +69,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TI + - TI Sensitivity: Study diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml index 1884859bb..257ece748 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0267/rule.yml @@ -2,53 +2,53 @@ # Condition: Reference Terminology is versioned. # Rule: TSVCDVER ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.4 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.2 - Item: Specification - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The version number of the Reference Terminology, if applicable. - Document: IG v3.3 - Item: Specification - Section: 7.4.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0267 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.4 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.2 + Item: Specification + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The version number of the Reference Terminology, if applicable. + Document: IG v3.3 + Item: Specification + Section: 7.4.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0267 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: Core: Id: CDISC.SDTMIG.CG0267 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when Reference Terminology is versioned and TSVCDVER is null Executability: Not Executable Outcome: @@ -57,8 +57,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml index ea77af0b3..c4f24573a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml @@ -2,72 +2,77 @@ # Condition: The timing and number of Visits for a trial does not depend on which ARM a subject is in # Rule: ARMCD = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject - is in, then ARMCD should be null. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject - is in, then ARMCD should be null. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which ARM a subject - is in, then ARMCD should be null. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0295 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which ARM a subject + is in, then ARMCD should be null. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0295 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: ARMCD - operator: non_empty + - name: + operator: + - name: ARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0295 Status: Draft - Version: '1' -Description: Trigger error when ARMCD is populated and the timing and number of Visits for a trial + Version: "1" +Description: + Trigger error when ARMCD is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Executability: Fully Executable Outcome: - Message: ARMCD is populated and the timing and number of Visits for a trial does not depend on + Message: + ARMCD is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml index c69501466..a85c2f2e0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml @@ -2,71 +2,75 @@ # Condition: The timing and number of Visits for a trial does not depend on which ARM a subject is in # Rule: ARM = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject - is in, then Arm should be left blank. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject - is in, then Arm should be left blank. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the timing of Visits for a trial does not depend on which Arm a subject - is in, then Arm should be left blank. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0296 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the timing of Visits for a trial does not depend on which Arm a subject + is in, then Arm should be left blank. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0296 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: ARM - operator: non_empty + - name: + operator: + - name: ARM + operator: non_empty Core: Id: CDISC.SDTMIG.CG0296 Status: Draft - Version: '1' -Description: Trigger error when ARM is populated and the timing and number of Visits for a trial + Version: "1" +Description: + Trigger error when ARM is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml index 04c4db4b0..b523f0579 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0298/rule.yml @@ -1,56 +1,56 @@ # Variable: VISIT -# Condition: +# Condition: # Rule: VISIT is described in protocol Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.4 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.2 - Item: Specification - Section: '7' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Protocol-defined description of clinical encounter. - Document: IG v3.3 - Item: Specification - Section: 7.3.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0298 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.4 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.2 + Item: Specification + Section: "7" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Protocol-defined description of clinical encounter. + Document: IG v3.3 + Item: Specification + Section: 7.3.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0298 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0298 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when a visit is not described in the protocol Executability: Fully Executable Outcome: @@ -59,8 +59,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TV + - TV Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml index f300b38aa..094fe5cf9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0312/rule.yml @@ -2,200 +2,203 @@ # Condition: Custom domain present in study # Rule: DOMAIN not in reserved or modeled standard Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: "'A custom domain may only be created if the data are different in nature and - do not fit into an existing published domain.'" - Document: IG v3.4 - Item: NA - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The following standard domains, listed in alphabetical order by Domain Code, - with their respective domain codes have been defined or referenced by the CDISC SDS Team - in this document. Note that other domain models may be posted separately for comment after - this publication. See list in 2.5 - Document: IG v3.2 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A custom domain may only be created if the data are different in nature and - do not fit into an existing published domain. - Document: IG v3.3 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0312 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "'A custom domain may only be created if the data are different in nature and + do not fit into an existing published domain.'" + Document: IG v3.4 + Item: NA + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The following standard domains, listed in alphabetical order by Domain Code, + with their respective domain codes have been defined or referenced by the CDISC SDS Team + in this document. Note that other domain models may be posted separately for comment after + this publication. See list in 2.5 + Document: IG v3.2 + Section: "2.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A custom domain may only be created if the data are different in nature and + do not fit into an existing published domain. + Document: IG v3.3 + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0312 + Version: "1" + Version: "2.0" + Version: "3.3" Check: any: - - all: - - name: define_dataset_class - operator: equal_to - value: TRIAL DESIGN - - name: define_dataset_name - operator: is_contained_by - value: - - TA - - TD - - TE - - TI - - TM - - TS - - TV - - all: - - name: define_dataset_class - operator: equal_to - value: SPECIAL PURPOSE - - name: define_dataset_name - operator: is_contained_by - value: - - CO - - DM - - SE - - SM - - SV - - all: - - name: define_dataset_class - operator: equal_to - value: INTERVENTIONS - - name: define_dataset_name - operator: is_contained_by - value: - - AG - - CM - - EC - - EX - - ML - - PR - - SU - - all: - - name: define_dataset_class - operator: equal_to - value: EVENTS - - name: define_dataset_name - operator: is_contained_by - value: - - AE - - BE - - CE - - DS - - DV - - HO - - MH - - all: - - name: define_dataset_class - operator: equal_to - value: FINDINGS - - name: define_dataset_name - operator: is_contained_by - value: - - BS - - CP - - CV - - DA - - DD - - EG - - FT - - GF - - IE - - IS - - LB - - MB - - MI - - MK - - MS - - NV - - OE - - PC - - PE - - PP - - QS - - RE - - RP - - RS - - SC - - SS - - TR - - TU - - UR - - VS - - all: - - name: define_dataset_class - operator: equal_to - value: FINDINGS ABOUT - - name: define_dataset_name - operator: is_contained_by - value: - - FA - - SR - - all: - all: - - name: define_dataset_class - operator: equal_to - value: RELATIONSHIP - - any: - - name: define_dataset_name - operator: is_not_contained_by - value: - - RELREC - - RELSPEC - - RELSUB - - SUPPQUAL - - name: define_dataset_name - operator: starts_with - value: SUPP - - all: - - name: define_dataset_class - operator: equal_to - value: STUDY REFERENCE - - name: define_dataset_name - operator: is_not_contained_by - value: - - OI + - name: define_dataset_class + operator: equal_to + value: TRIAL DESIGN + - name: define_dataset_name + operator: is_contained_by + value: + - TA + - TD + - TE + - TI + - TM + - TS + - TV + - all: + - name: define_dataset_class + operator: equal_to + value: SPECIAL PURPOSE + - name: define_dataset_name + operator: is_contained_by + value: + - CO + - DM + - SE + - SM + - SV + - all: + - name: define_dataset_class + operator: equal_to + value: INTERVENTIONS + - name: define_dataset_name + operator: is_contained_by + value: + - AG + - CM + - EC + - EX + - ML + - PR + - SU + - all: + - name: define_dataset_class + operator: equal_to + value: EVENTS + - name: define_dataset_name + operator: is_contained_by + value: + - AE + - BE + - CE + - DS + - DV + - HO + - MH + - all: + - name: define_dataset_class + operator: equal_to + value: FINDINGS + - name: define_dataset_name + operator: is_contained_by + value: + - BS + - CP + - CV + - DA + - DD + - EG + - FT + - GF + - IE + - IS + - LB + - MB + - MI + - MK + - MS + - NV + - OE + - PC + - PE + - PP + - QS + - RE + - RP + - RS + - SC + - SS + - TR + - TU + - UR + - VS + - all: + - name: define_dataset_class + operator: equal_to + value: FINDINGS ABOUT + - name: define_dataset_name + operator: is_contained_by + value: + - FA + - SR + - all: + - all: + - name: define_dataset_class + operator: equal_to + value: RELATIONSHIP + - any: + - name: define_dataset_name + operator: is_not_contained_by + value: + - RELREC + - RELSPEC + - RELSUB + - SUPPQUAL + - name: define_dataset_name + operator: starts_with + value: SUPP + - all: + - name: define_dataset_class + operator: equal_to + value: STUDY REFERENCE + - name: define_dataset_name + operator: is_not_contained_by + value: + - OI Core: Id: CDISC.SDTMIG.CG0312 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when custom domains use the reserved or modelled standard names Executability: Fully Executable Operations: -- ct_attribute: Term CCODE - ct_packages: - - sdtmct-2020-03-27 - ct_version: TSVCDVER - id: $TERM_CCODES - name: DOMAIN - operator: get_codelist_attributes + - ct_attribute: Term CCODE + ct_packages: + - sdtmct-2020-03-27 + ct_version: TSVCDVER + id: $TERM_CCODES + name: DOMAIN + operator: get_codelist_attributes Outcome: Message: Custom domains use the reserved or modelled standard names. Output Variables: - - $TERM_CCODES + - $TERM_CCODES Rule Type: Define Item Group Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml index 095d1c357..04e3a3566 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0320/rule.yml @@ -2,92 +2,96 @@ # Condition: Custom domain present in study # Rule: --TESTCD present in custom findings dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the topic variable from the identified general observation class - (e.g., --TESTCD for Findings) in the SDTM. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: For a Findings domain, the topic variable, --TESTCD, should use Controlled - Terminology (e.g., "SYSBP" for Systolic Blood Pressure) - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) - Document: IG v3.2 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0320 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM. + Document: IG v3.4 + Item: Item 3.b. + Section: "2.6" + - Cited Guidance: + For a Findings domain, the topic variable, --TESTCD, should use Controlled + Terminology (e.g., "SYSBP" for Systolic Blood Pressure) + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Item: 3.b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.3 + Item: 3.b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0320 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "FINDINGS" - - name: --TESTCD - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "FINDINGS" + - name: --TESTCD + operator: not_exists Core: Id: CDISC.SDTMIG.CG0320 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when variable --TESTCD is missing for custom Findings domains Executability: Fully Executable Operations: -- id: $dataset_variables - operator: get_column_order_from_dataset -- id: $custom_domain - operator: domain_is_custom + - id: $dataset_variables + operator: get_column_order_from_dataset + - id: $custom_domain + operator: domain_is_custom Outcome: Message: "--TESTCD does not exist in custom Findings domain." Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class - - define_dataset_key_sequence + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class + - define_dataset_key_sequence Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml index de1d1bbe8..402ce8751 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml @@ -1,46 +1,49 @@ # Document Start Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom domain, - which must be based on one of the three SDTM general observation classes. - Document: IG v3.4 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom domain, - which must be based on one of the three SDTM general observation classes. - Document: IG v3.2 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: This section describes the overall process for creating a custom domain, - which must be based on one of the three SDTM general observation classes. - Document: IG v3.3 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0321 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.4 + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.2 + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + This section describes the overall process for creating a custom domain, + which must be based on one of the three SDTM general observation classes. + Document: IG v3.3 + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0321 + Version: "1" + Version: "2.0" + Version: "3.3" # Variable: GEN # Condition: Custom domain present in study # Rule: Custom domain is based on one of the observation classes @@ -50,62 +53,63 @@ Authorities: # or to get the list of variables (or subsets, i.e, model_variables, model_identifiers, ...) from the IG underlying model - library metadata? Check: all: - - name: $custom_domain - operator: equal_to - value: true - - not: - any: - - name: --TESTCD - operator: exists - - name: --TRT - operator: exists - - name: --TERM - operator: exists - - not: - any: - - name: USUBJID - operator: exists - - name: POOLID - operator: exists - - name: SPDEVID - operator: exists - - name: SPTOBID - operator: exists + - name: $custom_domain + operator: equal_to + value: true + - not: + any: + - name: --TESTCD + operator: exists + - name: --TRT + operator: exists + - name: --TERM + operator: exists + - not: + any: + - name: USUBJID + operator: exists + - name: POOLID + operator: exists + - name: SPDEVID + operator: exists + - name: SPTOBID + operator: exists # pending to add the rest of check conditions Core: Id: CDISC.SDTMIG.CG0321 Status: Draft - Version: '1' -Description: Trigger error when a custom domain is present and is not based on one of the + Version: "1" +Description: + Trigger error when a custom domain is present and is not based on one of the observation classes Executability: Fully Executable Operations: -- id: $custom_domain - operator: domain_is_custom -- id: $dataset_variables - operator: get_column_order_from_dataset - # - id: $model_filtered_variables` - # key_name: "role" - # key_value: "Identifier" - # operation: get_model_filtered_variables` + - id: $custom_domain + operator: domain_is_custom + - id: $dataset_variables + operator: get_column_order_from_dataset + # - id: $model_filtered_variables` + # key_name: "role" + # key_value: "Identifier" + # operation: get_model_filtered_variables` Outcome: Message: Custom domain is not based on one of the observation classes Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - # - define_dataset_name - # - define_dataset_is_non_standard - # - define_dataset_class + - dataset_name + - $dataset_variables + - $custom_domain + # - define_dataset_name + # - define_dataset_is_non_standard + # - define_dataset_class Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset # Document End diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml index f4fb7d580..2bc225182 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml @@ -2,77 +2,81 @@ # Condition: ELEMENT is associated with > 1 ARM # Rule: ELEMENT value does not refer to any specific ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears - in more than one Arm in the Trial Arms dataset, then the Element description (ELEMENT) - must not refer to any Arms - Document: IG v3.4 - Item: Assumption 8 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears - in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) - must not refer to any Arms. - Document: IG v3.2 - Item: Assumption 8 for TE - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Arm. If the Element appears - in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) - must not refer to any Arms. - Document: IG v3.3 - Item: Assumption 8 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0322 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset, then the Element description (ELEMENT) + must not refer to any Arms + Document: IG v3.4 + Item: Assumption 8 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) + must not refer to any Arms. + Document: IG v3.2 + Item: Assumption 8 for TE + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Arm. If the Element appears + in more than one Arm in the Trial Arms dataset; then the Element description (ELEMENT) + must not refer to any Arms. + Document: IG v3.3 + Item: Assumption 8 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0322 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: ELEMENT - operator: contains - value: ARM + - name: ELEMENT + operator: contains + value: ARM Core: Id: CDISC.SDTMIG.CG0322 Status: Draft - Version: '1' -Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a + Version: "1" +Description: + When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a specific ARM Executability: Fully Executable Match Datasets: -- Keys: - - ARM - Name: TA + - Keys: + - ARM + Name: TA Outcome: Message: ELEMENT value refers to a specific ARM when ELEMENT is associated with more than 1 arm Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml index 9f08ec35a..9640d884c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml @@ -2,86 +2,90 @@ # Condition: ELEMENT is associated with > 1 EPOCH # Rule: ELEMENT value does not refer to any specific EPOCH Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element - appears in more than one Epoch in the Trial Arms dataset, then the Element description - (ELEMENT) must not refer to any Epochs. - Document: IG v3.4 - Item: Assumption 9 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element - appears in more than one Epoch in the Trial Arms dataset; then the Element description - (ELEMENT) must not refer to any Epochs. - Document: IG v3.2 - Item: Assumption 9 for TE - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: TESTRL should be expressed without referring to Epoch. If the Element - appears in more than one Epoch in the Trial Arms dataset; then the Element description - (ELEMENT) must not refer to any Epochs. - Document: IG v3.3 - Item: Assumption 9 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0323 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset, then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.4 + Item: Assumption 9 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset; then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.2 + Item: Assumption 9 for TE + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + TESTRL should be expressed without referring to Epoch. If the Element + appears in more than one Epoch in the Trial Arms dataset; then the Element description + (ELEMENT) must not refer to any Epochs. + Document: IG v3.3 + Item: Assumption 9 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0323 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: $ta_element - operator: is_not_unique_relationship - value: $ta_epoch - - name: ELEMENT - operator: contains - value: $ta_epoch + - name: $ta_element + operator: is_not_unique_relationship + value: $ta_epoch + - name: ELEMENT + operator: contains + value: $ta_epoch Core: Id: CDISC.SDTMIG.CG0323 Status: Draft - Version: '1' -Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a + Version: "1" +Description: + When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a specific EPOCH. Executability: Fully Executable Operations: -- domain: TA - id: $ta_element - name: ELEMENT - operator: distinct -- domain: TA - id: $ta_epoch - name: EPOCH - operator: distinct + - domain: TA + id: $ta_element + name: ELEMENT + operator: distinct + - domain: TA + id: $ta_epoch + name: EPOCH + operator: distinct Outcome: Message: ELEMENT refers to a specific EPOCH when ELEMENT is associated with more than 1 EPOCH Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA - - TE + - TA + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml index 0187b9af1..1109c207f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml @@ -1,76 +1,80 @@ # Variable: TEENRL -# Condition: +# Condition: # Rule: TEENRL value does not refer to any specific ARM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Trial Arms dataset, not the Trial Elements dataset, describes where the - subject moves next, so TEENRL must be expressed without referring to Arm. - Document: IG v3.4 - Item: Assumption 13 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; describes where the - subject moves next; so TEENRL must be expressed without referring to Arm. - Document: IG v3.2 - Item: Assumption 13 for TE - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The Trial Arms dataset; not the Trial Elements dataset; describes where the - subject moves next; so TEENRL must be expressed without referring to Arm. - Document: IG v3.3 - Item: Assumption 13 - Section: 7.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0324 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Trial Arms dataset, not the Trial Elements dataset, describes where the + subject moves next, so TEENRL must be expressed without referring to Arm. + Document: IG v3.4 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Trial Arms dataset; not the Trial Elements dataset; describes where the + subject moves next; so TEENRL must be expressed without referring to Arm. + Document: IG v3.2 + Item: Assumption 13 for TE + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The Trial Arms dataset; not the Trial Elements dataset; describes where the + subject moves next; so TEENRL must be expressed without referring to Arm. + Document: IG v3.3 + Item: Assumption 13 + Section: 7.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0324 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: TEENRL - operator: contains - value: $ta_arm + - name: TEENRL + operator: contains + value: $ta_arm Core: Id: CDISC.SDTMIG.CG0324 Status: Draft - Version: '1' -Description: TEENRL should not reference a specific ARM. This rule has only been partially executed + Version: "1" +Description: + TEENRL should not reference a specific ARM. This rule has only been partially executed to identify explicit references to ARM. Executability: Fully Executable Operations: -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: TEENRL refers to a specific ARM Rule Type: Record Data Scope: Classes: Include: - - STUDY REFERENCE + - STUDY REFERENCE Domains: Include: - - TE + - TE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml index 4896445be..a364a9b56 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml @@ -2,80 +2,85 @@ # Condition: The use of 'MULTIPLE' reflects multiple values (as opposed to a valid response in the context of the finding (e.g., Questionnaire CT). # Rule: --ORRES ^ = 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings - class dataset, multiple records should be submitted for that --TESTCD. When a finding can - have multiple results, the key structure for the findings dataset must be adequate to - distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the - Metadata. - Document: IG v3.4 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Multiple Values for a Findings Result Variable. If multiple result values (--ORRES) - are reported for a test in a Findings class dataset; multiple records should be submitted for - that --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FIBRILLATION. - - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FLUTTER' - Document: IG v3.2 - Section: 4.1.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple result values (--ORRES) are reported for a test in a Findings - class dataset; multiple records should be submitted for that --TESTCD. When a finding can - have multiple results; the key structure for the findings dataset must be adequate to - distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the - Metadata. - Document: IG v3.3 - Section: 4.2.8.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0347 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple result values (--ORRES) are reported for a test in a Findings + class dataset, multiple records should be submitted for that --TESTCD. When a finding can + have multiple results, the key structure for the findings dataset must be adequate to + distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the + Metadata. + Document: IG v3.4 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Multiple Values for a Findings Result Variable. If multiple result values (--ORRES) + are reported for a test in a Findings class dataset; multiple records should be submitted for + that --TESTCD. Example: - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FIBRILLATION. + - EGTESTCD=RHYRATE; EGTEST=Rhythm and Rate; EGORRES=ATRIAL FLUTTER" + Document: IG v3.2 + Section: 4.1.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple result values (--ORRES) are reported for a test in a Findings + class dataset; multiple records should be submitted for that --TESTCD. When a finding can + have multiple results; the key structure for the findings dataset must be adequate to + distinguish between the multiple results. See Section 4.1.9 Assigning Natural Keys in the + Metadata. + Document: IG v3.3 + Section: 4.2.8.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0347 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --ORRES - operator: does_not_contain - value: - - Questionnaire CT - - name: --ORRES - operator: equal_to - value: MULTIPLE + - name: --ORRES + operator: does_not_contain + value: + - Questionnaire CT + - name: --ORRES + operator: equal_to + value: MULTIPLE Core: Id: CDISC.SDTMIG.CG0347 Status: Draft - Version: '1' -Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the + Version: "1" +Description: + Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the context of the finding (e.g., Questionnaire CT) Executability: Fully Executable Outcome: - Message: --ORRES is equal to MULTIPLE when it is not a valid response in the context of the + Message: + --ORRES is equal to MULTIPLE when it is not a valid response in the context of the finding (e.g., Questionnaire CT) Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml index d731257c6..4610deca8 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0375/rule.yml @@ -1,69 +1,72 @@ # Variable: TDANCVAR -# Condition: +# Condition: # Rule: TDANCVAR = date variable name in ADSL Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'A reference to the date variable name that provides the start point from which - the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL - dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name.' - Document: IG v3.4 - Item: Specification - Section: 7.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.2[7.3][A reference to the date variable name that provides the start point - from which the planned disease assessment schedule is measured. This must be referenced from - the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date - variable name.]|Model v1.4[3.5.1][A reference to the date variable name that provides the start - point from which the planned disease assessment schedule is measured. This must be referenced - from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference - date variable name.]' - Document: IG v3.2|Model v1.4 - Section: IG v3.2[7.3]|Model v1.4[3.5.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'IG v3.3[7.3.2][A reference to the date variable name that provides the start - point from which the planned disease assessment schedule is measured. This must be referenced - from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference - date variable name.]|Model v1.7[3.4.1][A reference to the date variable name that provides the - start point from which the planned disease assessment schedule is measured. This must be referenced - from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference - date variable name.]' - Document: IG v3.3|Model v1.7 - Section: IG v3.3[7.3.2]|Model v1.7[3.4.1] - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0375 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "A reference to the date variable name that provides the start point from which + the planned disease assessment schedule is measured. This must be referenced from the ADaM ADSL + dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date variable name." + Document: IG v3.4 + Item: Specification + Section: 7.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.2[7.3][A reference to the date variable name that provides the start point + from which the planned disease assessment schedule is measured. This must be referenced from + the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference date + variable name.]|Model v1.4[3.5.1][A reference to the date variable name that provides the start + point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset e.g. ANCH1DT. Note: TDANCVAR is to contain the name of a reference + date variable name.]" + Document: IG v3.2|Model v1.4 + Section: IG v3.2[7.3]|Model v1.4[3.5.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "IG v3.3[7.3.2][A reference to the date variable name that provides the start + point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference + date variable name.]|Model v1.7[3.4.1][A reference to the date variable name that provides the + start point from which the planned disease assessment schedule is measured. This must be referenced + from the ADaM ADSL dataset (e.g., ANCH1DT). Note: TDANCVAR is to contain the name of a reference + date variable name.]" + Document: IG v3.3|Model v1.7 + Section: IG v3.3[7.3.2]|Model v1.7[3.4.1] + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0375 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: TDANCVAR - operator: is_not_contained_by - value: '[date variable name in ADSL]' + - name: TDANCVAR + operator: is_not_contained_by + value: "[date variable name in ADSL]" Core: Id: CDISC.SDTMIG.CG0375 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when TDANCVAR is not a date variable name in ADSL Executability: Fully Executable Outcome: @@ -72,8 +75,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TD + - TD Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml index abfbd0c83..17ce75ffc 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0377/rule.yml @@ -1,76 +1,76 @@ # Variable: --LLT -# Condition: +# Condition: # Rule: --LLT = MedDRA lowest level TERM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The lowest-level term assigned to the event from MedDRA. - Document: Model v2.0 - Item: --LLT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Lowest Level Term. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Lowest Level Term. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0377 - Version: '1' - Version: '2.0' - Version: '3.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The lowest-level term assigned to the event from MedDRA. + Document: Model v2.0 + Item: --LLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Lowest Level Term. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Lowest Level Term. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0377 + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - - name: $is_valid_llt_value - operator: equal_to - value: false + - name: $is_valid_llt_value + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0377 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when --LLT is not a valid MedDRA lowest level TERM. Executability: Fully Executable Operations: -- case_sensitive: true - dictionary_term_type: LLT - external_dictionary_type: meddra - id: $is_valid_llt_value - name: --LLT - operator: valid_external_dictionary_value + - case_sensitive: true + dictionary_term_type: LLT + external_dictionary_type: meddra + id: $is_valid_llt_value + name: --LLT + operator: valid_external_dictionary_value Outcome: Message: --LLT is not a valid MedDRA lowest level TERM. Output Variables: - - --LLT + - --LLT Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml index 683d783c1..0cf0f020c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml @@ -2,79 +2,81 @@ # Condition: --DECOD ^= null # Rule: --DECOD = MedDRA preferred TERM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Equivalent to the Preferred Term (PT in MedDRA). - Document: Model v2.0 - Item: --DECOD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic - variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to - the Preferred Term (PT in MedDRA). - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic - variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to - the Preferred Term (PT in MedDRA). - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0379 - Version: '1' - Version: '2.0' - Version: '3.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Equivalent to the Preferred Term (PT in MedDRA). + Document: Model v2.0 + Item: --DECOD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Dictionary or sponsor-defined derived text description of the topic + variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Dictionary or sponsor-defined derived text description of the topic + variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to + the Preferred Term (PT in MedDRA). + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0379 + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - - name: --DECOD - operator: non_empty - - name: $is_valid_pt_code - operator: equal_to - value: false + - name: --DECOD + operator: non_empty + - name: $is_valid_pt_code + operator: equal_to + value: false Core: Id: CDISC.SDTMIG.CG0378 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when --DECOD is completed but is not a valid MedDRA preferred TERM. Executability: Fully Executable Operations: -- case_sensitive: true - dictionary_term_type: PT - external_dictionary_type: meddra - id: $is_valid_pt_code - name: --DECOD - operator: valid_external_dictionary_code + - case_sensitive: true + dictionary_term_type: PT + external_dictionary_type: meddra + id: $is_valid_pt_code + name: --DECOD + operator: valid_external_dictionary_code Outcome: Message: --DECOD is completed but value is not a valid MedDRA preferred TERM. Output Variables: - - --DECOD + - --DECOD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE + - AE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml index 97658b96b..133bae716 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0380/rule.yml @@ -1,56 +1,56 @@ # Variable: --PTCD -# Condition: +# Condition: # Rule: --PTCD = MedDRA preferred TERM code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The preferred term code assigned to the event from MedDRA. - Document: Model v2.0 - Item: --PTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA Preferred Term code. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0380 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The preferred term code assigned to the event from MedDRA. + Document: Model v2.0 + Item: --PTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA Preferred Term code. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0380 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --PTCD - operator: is_contained_by - value: - - MedDRA preferred term code + - name: --PTCD + operator: is_contained_by + value: + - MedDRA preferred term code Core: Id: CDISC.SDTMIG.CG0380 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --PTCD is not a valid MedDRA preferred term code Executability: Fully Executable Outcome: @@ -59,10 +59,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml index a45296608..42c734793 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0381/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLT -# Condition: +# Condition: # Rule: --HLT = MedDRA high level TERM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level term from the primary hierarchy assigned to the event from - MedDRA. - Document: Model v2.0 - Item: --HLT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0381 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level term from the primary hierarchy assigned to the event from + MedDRA. + Document: Model v2.0 + Item: --HLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0381 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --HLT - operator: is_contained_by - value: - - MedDRA high level TERM + - name: --HLT + operator: is_contained_by + value: + - MedDRA high level TERM Core: Id: CDISC.SDTMIG.CG0381 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLT is not a valid MedDRA high level TERM Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml index 97c5caac9..76a7e58b1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0382/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLTCD -# Condition: +# Condition: # Rule: --HLTCD = MedDRA high level TERM code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level term code from the primary hierarchy assigned to the event - from MedDRA. - Document: Model v2.0 - Item: --HLTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0382 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level term code from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0382 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --HLTCD - operator: is_contained_by - value: - - MedDRA high level TERM code + - name: --HLTCD + operator: is_contained_by + value: + - MedDRA high level TERM code Core: Id: CDISC.SDTMIG.CG0382 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLTCD is not a valid MedDRA high level TERM code Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml index 38a3839dd..2687b14ed 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0383/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLGT -# Condition: +# Condition: # Rule: --HLGT = MedDRA high level group TERM Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level group term from the primary hierarchy assigned to the event - from MedDRA. - Document: Model v2.0 - Item: --HLGT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Group Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Group Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0383 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level group term from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLGT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0383 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --HLGT - operator: is_contained_by - value: - - MedDRA high level group TERM + - name: --HLGT + operator: is_contained_by + value: + - MedDRA high level group TERM Core: Id: CDISC.SDTMIG.CG0383 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLGT is not a valid MedDRA high level group TERM Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml index 6b5f47746..87937e3bd 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0384/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLGTCD -# Condition: +# Condition: # Rule: --HLGTCD = MedDRA high level group TERM code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level group term code from the primary hierarchy assigned to the - event from MedDRA. - Document: Model v2.0 - Item: --HLGTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Group Term code from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Group Term code from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0384 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level group term code from the primary hierarchy assigned to the + event from MedDRA. + Document: Model v2.0 + Item: --HLGTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Group Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0384 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --HLGTCD - operator: is_contained_by - value: - - MedDRA high level group TERM code + - name: --HLGTCD + operator: is_contained_by + value: + - MedDRA high level group TERM code Core: Id: CDISC.SDTMIG.CG0384 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLGTCD is not a valid MedDRA high level group TERM code Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml index af9181a81..3f8b72220 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0385/rule.yml @@ -1,60 +1,63 @@ # Variable: --BODSYS -# Condition: +# Condition: # Rule: --BODSYS = MedDRA system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A standardized or dictionary derived name for the body system or organ - class. Body system or system organ class assigned for analysis from a standard hierarchy - (e.g., MedDRA) associated with an event. - Document: Model v2.0 - Item: --BODSYS - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Body system or system organ class assigned for analysis from a standard hierarchy - (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.' - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Body system or system organ class assigned for analysis from a standard hierarchy - (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS.' - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0385 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A standardized or dictionary derived name for the body system or organ + class. Body system or system organ class assigned for analysis from a standard hierarchy + (e.g., MedDRA) associated with an event. + Document: Model v2.0 + Item: --BODSYS + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Body system or system organ class assigned for analysis from a standard hierarchy + (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS." + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Body system or system organ class assigned for analysis from a standard hierarchy + (e.g. MedDRA) associated with an event. Example: GASTROINTESTINAL DISORDERS." + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0385 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --BODSYS - operator: is_contained_by - value: - - MedDRA system organ class + - name: --BODSYS + operator: is_contained_by + value: + - MedDRA system organ class Core: Id: CDISC.SDTMIG.CG0385 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --BODSYS is not a valid MedDRA system organ class Executability: Fully Executable Outcome: @@ -63,10 +66,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml index eabb12458..b2cf4e152 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml @@ -1,81 +1,84 @@ # Variable: --BDSYCD -# Condition: +# Condition: # Rule: --BDSYCD = MedDRA system organ class code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A standardized or dictionary derived short sequence of characters used to - represent the body system or organ class. MedDRA System Organ Class code corresponding to - --BODSYS assigned for analysis. - Document: Model v2.0 - Item: --BDSYCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for - analysis. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for - analysis. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0386 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A standardized or dictionary derived short sequence of characters used to + represent the body system or organ class. MedDRA System Organ Class code corresponding to + --BODSYS assigned for analysis. + Document: Model v2.0 + Item: --BDSYCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + MedDRA System Organ Class code corresponding to -BODSYS assigned for + analysis. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + MedDRA System Organ Class code corresponding to -BODSYS assigned for + analysis. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0386 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - metadata: $valid_codes - operator: equal_to - value: true - #- name: --BDSYCD - # operator: is_contained_by - # value: - # - MedDRA system organ class code + - metadata: $valid_codes + operator: equal_to + value: true + #- name: --BDSYCD + # operator: is_contained_by + # value: + # - MedDRA system organ class code Core: Id: CDISC.SDTMIG.CG0386 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --BDSYCD is not a valid MedDRA system organ class code Executability: Fully Executable Operations: -- id: $valid_codes - name: --BDSYCD - operator: valid_meddra_code_references + - id: $valid_codes + name: --BDSYCD + operator: valid_meddra_code_references Outcome: Message: --BDSYCD is not a valid MedDRA system organ class code Output Variables: - - $valid_codes + - $valid_codes Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml index a78f975e1..27e748909 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml @@ -1,71 +1,76 @@ # Variable: --LOINC -# Condition: +# Condition: # Rule: --LOINC = valid code in the version of the LOINC dictionary specified in define.xml Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A short sequence of characters used to represent laboratory and clinical - tests within the Logical Observation Identifiers Names and Codes (LOINC) database. - Document: Model v2.0 - Item: --LOINC - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) code for the topic - variable such as a lab test. - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Logical Observation Identifiers Names and Codes (LOINC) code for the topic - variable such as a lab test. - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0400 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A short sequence of characters used to represent laboratory and clinical + tests within the Logical Observation Identifiers Names and Codes (LOINC) database. + Document: Model v2.0 + Item: --LOINC + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Logical Observation Identifiers Names and Codes (LOINC) code for the topic + variable such as a lab test. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Logical Observation Identifiers Names and Codes (LOINC) code for the topic + variable such as a lab test. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0400 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --LOINC - operator: is_not_contained_by - value: - - LOINC codes contained in the version of the LOINC dictionary specified in define.xml + - name: --LOINC + operator: is_not_contained_by + value: + - LOINC codes contained in the version of the LOINC dictionary specified in define.xml Core: Id: CDISC.SDTMIG.CG0400 Status: Draft - Version: '1' -Description: Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary + Version: "1" +Description: + Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary specified in define.xml Executability: Fully Executable Outcome: - Message: --LOINC is not a valid code in the version of the LOINC dictionary specified in + Message: + --LOINC is not a valid code in the version of the LOINC dictionary specified in define.xml Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml index a5321fed0..19669ae2e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0418/rule.yml @@ -1,72 +1,75 @@ # Variable: TAETORD -# Condition: +# Condition: # Rule: TAETORD order of elements match order in TA within ARM of the Subject Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the planned order of the Element within the Arm (see Trial - Arms; Section 3.2.2 ). - Document: Model v1.4 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Number that gives the planned order of the Element within the Arm (see - Section 3.1.2; Trial Arms). - Document: Model v1.7 - Section: 2.2.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: An assigned numeric identifier that gives the planned order of the element - within the trial arm of the study. - Document: Model v2.0 - Item: TAETORD - Section: Timing - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0418 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Number that gives the planned order of the Element within the Arm (see Trial + Arms; Section 3.2.2 ). + Document: Model v1.4 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Number that gives the planned order of the Element within the Arm (see + Section 3.1.2; Trial Arms). + Document: Model v1.7 + Section: 2.2.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + An assigned numeric identifier that gives the planned order of the element + within the trial arm of the study. + Document: Model v2.0 + Item: TAETORD + Section: Timing + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0418 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: TAETORD - operator: exists - - name: TAETORD - operator: is_not_ordered_set - value: - - ARM - - ARMCD + - name: TAETORD + operator: exists + - name: TAETORD + operator: is_not_ordered_set + value: + - ARM + - ARMCD Core: Id: CDISC.SDTMIG.CG0418 Status: Draft - Version: '1' -Description: 'Trigger error when the order of TAETORD does not match the order of Trial Arms' + Version: "1" +Description: "Trigger error when the order of TAETORD does not match the order of Trial Arms" Executability: Fully Executable Outcome: - Message: 'TAETORD does not match the order of Trial Arms' + Message: "TAETORD does not match the order of Trial Arms" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml index b7a5ee82e..b92293dc2 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml @@ -2,54 +2,57 @@ # Condition: --STRESC ^= null and units are applicable for the result # Rule: --STRESU ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'The unit of measure for the standardized result of the measurement, test, or - examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC - and --STREFN and --LLOQ and --ULOQ.' - Document: Model v2.0 - Item: --STRESU - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU: Standardized units used for --STRESC and --STRESN.' - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: '--STRESU:Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. - Example: "mol/L".' - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0425 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "The unit of measure for the standardized result of the measurement, test, or + examination. Variable(s) Qualified: --STRESC and --STRESN and --STNRLO and --STNRHI and --STREFC + and --STREFN and --LLOQ and --ULOQ." + Document: Model v2.0 + Item: --STRESU + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: "--STRESU: Standardized units used for --STRESC and --STRESN." + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + '--STRESU:Standardized units used for --STRESC, --STRESN, --STREFC, and --STREFN. + Example: "mol/L".' + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0425 + Version: "1" + Version: "2.0" + Version: "3.3" Check: Core: Id: CDISC.SDTMIG.CG0425 Status: Draft - Version: '1' -Description: Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for + Version: "1" +Description: + Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for the result Executability: Not Executable Outcome: @@ -58,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml index beeabc02f..f5ac49041 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml @@ -2,84 +2,88 @@ # Condition: Variable Core Status = Expected and data collected # Rule: Variable value ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the study does not include the data item for an expected variable, - however, a null column must still be included in the dataset, and a comment must be - included in the Define-XML document to state that the study does not include the data - item. - Document: IG v3.4 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When no data has been collected for an expected variable; however; a null - column must still be included in the dataset; and a comment must be included in the - define.xml to state that data was not collected. - Document: IG v3.2 - Section: 4.1.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When the study does not include the data item for an expected variable; - however; a null column must still be included in the dataset; and a comment must be - included in the Define-XML document to state that the study does not include the data - item. - Document: IG v3.3 - Section: 4.1.5 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0431 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the study does not include the data item for an expected variable, + however, a null column must still be included in the dataset, and a comment must be + included in the Define-XML document to state that the study does not include the data + item. + Document: IG v3.4 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When no data has been collected for an expected variable; however; a null + column must still be included in the dataset; and a comment must be included in the + define.xml to state that data was not collected. + Document: IG v3.2 + Section: 4.1.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When the study does not include the data item for an expected variable; + however; a null column must still be included in the dataset; and a comment must be + included in the Define-XML document to state that the study does not include the data + item. + Document: IG v3.3 + Section: 4.1.5 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0431 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: variable_name - operator: is_contained_by - value: $expected_variables - - name: define_variable_is_collected - operator: equal_to - value: true - - name: variable_is_empty - operator: equal_to - value: true + - name: variable_name + operator: is_contained_by + value: $expected_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: variable_is_empty + operator: equal_to + value: true Core: Id: CDISC.SDTMIG.CG0431 Status: Draft - Version: '1' -Description: Raise an error when the variable Core Status = Expected, data is collected, but the + Version: "1" +Description: + Raise an error when the variable Core Status = Expected, data is collected, but the variable has no data. Executability: Fully Executable Operations: -- id: $expected_variables - operator: expected_variables + - id: $expected_variables + operator: expected_variables Outcome: Message: Variable is empty, where variable core status is expected and data is collected. Output Variables: - - variable_name - - variable_is_empty + - variable_name + - variable_is_empty Rule Type: Value Check with Dataset Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml index 99c544d15..e5889daea 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0436/rule.yml @@ -1,70 +1,70 @@ # Variable: --SOC -# Condition: +# Condition: # Rule: --SOC = MedDRA primary system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class associated with the event. - Document: Model v2.0 - Item: --SOC - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0436 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class associated with the event. + Document: Model v2.0 + Item: --SOC + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0436 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: --SOC - operator: is_contained_by - value: - - MedDRA primary system organ class + - name: --SOC + operator: is_contained_by + value: + - MedDRA primary system organ class Core: Id: CDISC.SDTMIG.CG0436 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --SOC is not a valid MedDRA primary system organ class Executability: Fully Executable Outcome: Message: --SOC is not a valid MedDRA primary system organ class Output Variables: - - --SOC + - --SOC Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml index ef0ecfbf8..61920f006 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0437/rule.yml @@ -1,71 +1,72 @@ # Variable: --SOCCD -# Condition: +# Condition: # Rule: --SOCCD = MedDRA primary system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class code. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA primary System Organ Class code. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The system organ class code from the primary hierarchy assigned in the - MedDRA dictionary. - Document: Model v2.0 - Item: --SOCCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0437 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class code. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA primary System Organ Class code. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The system organ class code from the primary hierarchy assigned in the + MedDRA dictionary. + Document: Model v2.0 + Item: --SOCCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0437 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: --SOCCD - operator: is_contained_by - value: - - MedDRA primary system organ class code + - name: --SOCCD + operator: is_contained_by + value: + - MedDRA primary system organ class code Core: Id: CDISC.SDTMIG.CG0437 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --SOCCD is not a valid MedDRA primary system organ class code Executability: Fully Executable Outcome: Message: --SOCCD is not a valid MedDRA primary system organ class code Output Variables: - - --SOCCD + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml index 0d12d3324..281f6d46a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0442/rule.yml @@ -1,56 +1,58 @@ # Variable: --SOCCD -# Condition: +# Condition: # Rule: --SOCCD = MedDRA primary system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0442 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Section: 7.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0442 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0442 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Section: 7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0442 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - value: + - name: + operator: + value: Core: Id: CDISC.SDTMIG.CG0442 Status: Draft - Version: '1' + Version: "1" Description: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Executability: Fully Executable Outcome: Message: TSVAL is not a valid preferred term from FDA Substance Registration System (SRS) Output Variables: - - --SOCCD + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml index 3f96b003a..adb5b3b7f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0443/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'CURTRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0443 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0443 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0443 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0443 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0443 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml index 9990daed5..b5a64df35 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0445/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'COMPTRT' # Rule: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0445 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0445 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0445 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0445 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0445 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml index 6492d3078..f27a348f1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0446/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'COMPTRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0446 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0446 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0446 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0446 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0446 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml index 3cac1bfed..4cc44f67d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0448/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD in ('INDIC', 'TDIGRP') # Rule: TSVAL is a valid term from SNOMED CT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0448 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0448 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0448 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0448 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0448 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml index b97125a83..a8c9fabf7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0449/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD in ('INDIC', 'TDIGRP') # Rule: TSVALCD is a valid concept identifier from SNOMED CT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0449 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0449 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0449 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0449 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0449 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml index e986cf89e..da142c27c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0450/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'TRT' # Rule: TSVAL is a valid preferred term from FDA Substance Registration System (SRS) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0450 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0450 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0450 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0450 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0450 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml index 126f4e8c4..c243e4fef 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0451/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'TRT' # Rule: TSVALCD is a valid unique ingredient identifier from FDA Substance Registration System (SRS) Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0451 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0451 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0451 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0451 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0451 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml index 8dc14ad58..4001f4743 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0453/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'PCLAS' # Rule: TSVAL is a valid term from NDF-RT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0453 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0453 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0453 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0453 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0453 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml index a557672f9..b02994e36 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0454/rule.yml @@ -2,52 +2,54 @@ # Condition: TSPARMCD = 'PCLAS' # Rule: TSVALCD is a valid code from NDF-RT Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.2 - Item: Assumption 3 - Section: 7.4|Appendix C1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0454 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Further information about the parameters is included below in Table 1. TSVAL - may have controlled terminology depending on the value of TSPARMCD - Document: IG v3.3 - Item: Assumption 3 - Section: '7.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0454 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.2 + Item: Assumption 3 + Section: 7.4|Appendix C1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0454 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Further information about the parameters is included below in Table 1. TSVAL + may have controlled terminology depending on the value of TSPARMCD + Document: IG v3.3 + Item: Assumption 3 + Section: "7.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0454 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: [] Core: Id: CDISC.SDTMIG.CG0454 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml index 4e192b4a0..2e382a4c2 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0460/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLT -# Condition: +# Condition: # Rule: --HLT on path to MedDRA primary system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level term from the primary hierarchy assigned to the event from - MedDRA. - Document: Model v2.0 - Item: --HLT - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0460 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level term from the primary hierarchy assigned to the event from + MedDRA. + Document: Model v2.0 + Item: --HLT + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0460 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0460 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLT is not on the path to MedDRA primary system organ class Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - MH - - CE + - AE + - MH + - CE Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml index 41617fb6d..b4946c40e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0461/rule.yml @@ -1,57 +1,58 @@ # Variable: --HLGT -# Condition: +# Condition: # Rule: --HLGT on path to MedDRA primary system organ class Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The high-level term code from the primary hierarchy assigned to the event - from MedDRA. - Document: Model v2.0 - Item: --HLTCD - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.4 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: MedDRA High Level Term code from the primary path. - Document: Model v1.7 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0461 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The high-level term code from the primary hierarchy assigned to the event + from MedDRA. + Document: Model v2.0 + Item: --HLTCD + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.4 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: MedDRA High Level Term code from the primary path. + Document: Model v1.7 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0461 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: - operator: + - name: + operator: + - name: + operator: Core: Id: CDISC.SDTMIG.CG0461 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --HLGT is not on the path to MedDRA primary system organ class Executability: Fully Executable Outcome: @@ -60,10 +61,10 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - AE - - CE - - MH + - AE + - CE + - MH Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml index c7821c66d..47a5825f1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0463/rule.yml @@ -2,85 +2,88 @@ # Condition: Custom domain present in study # Rule: --TRT present in custom interventions dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) in the SDTM - Document: IG v3.4 - Item: Assumption 3b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) - Document: IG v3.2 - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0463 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM + Document: IG v3.4 + Item: Assumption 3b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.3 + Item: 3.b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0463 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "INTERVENTIONS" - - name: "--TRT" - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "INTERVENTIONS" + - name: "--TRT" + operator: not_exists Core: Id: CDISC.SDTMIG.CG0463 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --TRT is not present in custom interventions dataset Executability: Fully Executable Operations: -- id: $dataset_variables - operator: get_column_order_from_dataset -- id: $custom_domain - operator: domain_is_custom + - id: $dataset_variables + operator: get_column_order_from_dataset + - id: $custom_domain + operator: domain_is_custom Outcome: Message: --TRT is not present in custom interventions dataset Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml index 6b954dcf8..95909e355 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0464/rule.yml @@ -2,87 +2,90 @@ # Condition: Custom domain present in study # Rule: --TERM present in custom events dataset Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) in the SDTM - Document: IG v3.4 - Item: Assumption 3b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the Topic variable from the identified general observation class - (e.g., --TESTCD for Findings) - Document: IG v3.2 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Include the topic variable from the identified general observation class - (e.g., --TESTCD for Findings) in the SDTM. - Document: IG v3.3 - Item: 3.b - Section: '2.6' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0464 - Version: '2' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM + Document: IG v3.4 + Item: Assumption 3b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: "2" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the Topic variable from the identified general observation class + (e.g., --TESTCD for Findings) + Document: IG v3.2 + Item: 3.b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: "2" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Include the topic variable from the identified general observation class + (e.g., --TESTCD for Findings) in the SDTM. + Document: IG v3.3 + Item: 3.b + Section: "2.6" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0464 + Version: "2" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_dataset_is_non_standard - operator: equal_to - value: "Yes" - - name: define_dataset_class - operator: equal_to - value: "EVENTS" - - name: "--TERM" - operator: not_exists + - name: define_dataset_is_non_standard + operator: equal_to + value: "Yes" + - name: define_dataset_class + operator: equal_to + value: "EVENTS" + - name: "--TERM" + operator: not_exists Core: Id: CDISC.SDTMIG.CG0464 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --TERM is not present in custom events dataset Executability: Fully Executable Operations: -- id: $dataset_variables - operator: get_column_order_from_dataset -- id: $custom_domain - operator: domain_is_custom + - id: $dataset_variables + operator: get_column_order_from_dataset + - id: $custom_domain + operator: domain_is_custom Outcome: Message: "--TERM is not present in custom events dataset" Output Variables: - - dataset_name - - $dataset_variables - - $custom_domain - - define_dataset_name - - define_dataset_is_non_standard - - define_dataset_class + - dataset_name + - $dataset_variables + - $custom_domain + - define_dataset_name + - define_dataset_is_non_standard + - define_dataset_class Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml index f2f2fc0aa..3e681e27d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0466/rule.yml @@ -2,57 +2,59 @@ # Condition: --LLOQ present in dataset # Rule: --LLOQ is expressed using the units in --STRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units will be those used for --STRESU. - Document: Model v2.0 - Item: --LLOQ - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the lower limit of quantitation for an assay. Units will be those - used for --STRESU. - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the lower limit of quantitation for an assay. Units will be those - used for --STRESU. - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0466 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units will be those used for --STRESU. + Document: Model v2.0 + Item: --LLOQ + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the lower limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the lower limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0466 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --LLOQ - operator: exists - - name: - operator: + - name: --LLOQ + operator: exists + - name: + operator: Core: Id: CDISC.SDTMIG.CG0466 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --LLOQ is not expressed using the units in --STRESU Executability: Fully Executable Outcome: @@ -61,8 +63,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml index e404c3f5d..49948afde 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0523/rule.yml @@ -2,46 +2,48 @@ # Condition: Subject not assigned to treatment # Rule: ARMCD = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to - treatment. The same reason will provide the reason that both are null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0523 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to - treatment - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0523 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment. The same reason will provide the reason that both are null. + Document: IG v3.4 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0523 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment + Document: IG v3.3 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0523 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: ARMCD - operator: non_empty + - name: + operator: + - name: ARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0523 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when ARMCD is populated for a subject who was not assigned to treatment Executability: Fully Executable Outcome: @@ -50,8 +52,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml index fe46bd52c..ebc862ceb 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml @@ -2,47 +2,50 @@ # Condition: Subject not assigned to treatment # Rule: ACTARMCD = null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to - treatment. The same reason will provide the reason that both are null. - Document: IG v3.4 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0524 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Both ARMCD and ACTARMCD will be null for subjects who were not assigned to - treatment - Document: IG v3.3 - Item: Assumption 4 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0524 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment. The same reason will provide the reason that both are null. + Document: IG v3.4 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0524 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Both ARMCD and ACTARMCD will be null for subjects who were not assigned to + treatment + Document: IG v3.3 + Item: Assumption 4 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0524 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: ACTARMCD - operator: non_empty + - name: + operator: + - name: ACTARMCD + operator: non_empty Core: Id: CDISC.SDTMIG.CG0524 Status: Draft - Version: '1' -Description: Trigger error when ACTARMCD is populated for a subject who was not assigned to + Version: "1" +Description: + Trigger error when ACTARMCD is populated for a subject who was not assigned to treatment Executability: Fully Executable Outcome: @@ -51,8 +54,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml index 2c0e43fe2..a577712ab 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml @@ -2,50 +2,53 @@ # Condition: Sponsor collects Other, specify and chooses to map the value to SUPPDM # Rule: RACE = 'OTHER' or RACE = 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the race was collected via an "Other, Specify" field and the sponsor - chooses not to map the value as described in the current FDA guidance (see CDISC Notes for - RACE in the domain specification), then the value of RACE should be “OTHER”. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0525 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the race was collected via an "Other; Specify" field and the sponsor - chooses not to map the value as described in the current FDA guidance (see CDISC Notes for - RACE in the domain specification) then the value of RACE should be 'OTHER'. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0525 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the race was collected via an "Other, Specify" field and the sponsor + chooses not to map the value as described in the current FDA guidance (see CDISC Notes for + RACE in the domain specification), then the value of RACE should be “OTHER”. + Document: IG v3.4 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0525 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the race was collected via an "Other; Specify" field and the sponsor + chooses not to map the value as described in the current FDA guidance (see CDISC Notes for + RACE in the domain specification) then the value of RACE should be 'OTHER'. + Document: IG v3.3 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0525 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: UNKNOWN + - name: + operator: + - name: RACE + operator: not_equal_to + value: UNKNOWN Core: Id: CDISC.SDTMIG.CG0525 Status: Draft - Version: '1' -Description: Trigger error when Sponsor collects Other, specify and chooses to map the value to + Version: "1" +Description: + Trigger error when Sponsor collects Other, specify and chooses to map the value to SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE' Executability: Fully Executable Outcome: @@ -54,8 +57,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml index 95b731945..74d920647 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0526/rule.yml @@ -2,47 +2,49 @@ # Condition: Subject does not specify race # Rule: RACE = 'UNKNOWN' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'If a subject refuses to provide or does not know their race information, the - value of RACE could be “UNKNOWN”. ' - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0526 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a subject refuses to provide race information; the value of RACE could be - 'UNKNOWN'. - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0526 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "If a subject refuses to provide or does not know their race information, the + value of RACE could be “UNKNOWN”. " + Document: IG v3.4 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0526 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If a subject refuses to provide race information; the value of RACE could be + 'UNKNOWN'. + Document: IG v3.3 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0526 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: UNKNOWN + - name: + operator: + - name: RACE + operator: not_equal_to + value: UNKNOWN Core: Id: CDISC.SDTMIG.CG0526 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when subject does not specify race and RACE is not equal to "UNKNOWN" Executability: Fully Executable Outcome: @@ -51,8 +53,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml index 35b4b6923..59543965b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml @@ -2,59 +2,63 @@ # Condition: Mulitple races collected and primary race not specified # Rule: RACE = 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races are collected, then the value of RACE should be “MULTIPLE” - and the additional information will be included in the Supplemental Qualifiers dataset. - Document: IG v3.4 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0527 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If multiple races were collected and one was designated as primary; RACE in - DM should be the primary race and additional races should be reported in SUPPDM - Document: IG v3.3 - Item: Assumption 6 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0527 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple races are collected, then the value of RACE should be “MULTIPLE” + and the additional information will be included in the Supplemental Qualifiers dataset. + Document: IG v3.4 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0527 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If multiple races were collected and one was designated as primary; RACE in + DM should be the primary race and additional races should be reported in SUPPDM + Document: IG v3.3 + Item: Assumption 6 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0527 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RACE - operator: not_equal_to - value: MULTIPLE + - name: + operator: + - name: RACE + operator: not_equal_to + value: MULTIPLE Core: Id: CDISC.SDTMIG.CG0527 Status: Draft - Version: '1' -Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and + Version: "1" +Description: + Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and primary race not specified Executability: Fully Executable Outcome: - Message: RACE does not equal "MULTIPLE" when multiple races collected and primary race not + Message: + RACE does not equal "MULTIPLE" when multiple races collected and primary race not specified Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml index ea903fd3a..10454071c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml @@ -2,79 +2,81 @@ # Condition: Milestone associated with RFSTDTC is start of treatment and ARMNRS =null # Rule: RFSTDTC ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 - character format. Usually equivalent to date/time when subject was first exposed to study - treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.]|Assumption - 9[As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to calculate - study day variables. RFSTDTC is usually defined as the date/time when a subject was first - exposed to study drug. This definition applies for most interventional studies, when the - start of treatment is the natural and preferred starting point for study day variables and - thus the logical value for RFSTDTC. In such studies, when data are submitted for subjects - who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), - subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or - subjects who were randomized but not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will - be null. For studies with designs that include a substantial portion of subjects who are - not expected to be treated, a different protocol milestone may be chosen as the starting - point for study day variables. Some examples include non-interventional or observational - studies, studies with a no-treatment arm, or studies where there is a delay between - randomization and treatment.] - Document: IG v3.3 - Item: Specification|Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0532 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 - character format. Usually equivalent to date/time when subject was first exposed to study - treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.| Assumption - 9 [RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the - date/time when a subject was first exposed to study drug. This definition applies for most - interventional studies, when the start of treatment is the natural and preferred starting - point for study day variables and thus the logical value for RFSTDTC. In such studies, - when data are submitted for subjects who are ineligible for treatment (e.g., screen - failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not assigned to - an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but not treated - (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs that - include a substantial portion of subjects who are not expected to be treated, a different - protocol milestone may be chosen as the starting point for study day variables. Some - examples include non-interventional or observational studies, studies with a no-treatment - Arm, or studies where there is a delay between randomization and treatment.] - Document: IG v3.4 - Item: Specification|Assumption 9 - Section: '5.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0532 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Reference Start Date/time for the subject in ISO 8601 + character format. Usually equivalent to date/time when subject was first exposed to study + treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.]|Assumption + 9[As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to calculate + study day variables. RFSTDTC is usually defined as the date/time when a subject was first + exposed to study drug. This definition applies for most interventional studies, when the + start of treatment is the natural and preferred starting point for study day variables and + thus the logical value for RFSTDTC. In such studies, when data are submitted for subjects + who are ineligible for treatment (e.g., screen failures with ARMNRS = "SCREEN FAILURE"), + subjects who were enrolled but not assigned to an arm (e.g., ARMNRS = "NOT ASSIGNED"), or + subjects who were randomized but not treated (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will + be null. For studies with designs that include a substantial portion of subjects who are + not expected to be treated, a different protocol milestone may be chosen as the starting + point for study day variables. Some examples include non-interventional or observational + studies, studies with a no-treatment arm, or studies where there is a delay between + randomization and treatment.] + Document: IG v3.3 + Item: Specification|Assumption 9 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0532 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Specification[Reference Start Date/time for the subject in ISO 8601 + character format. Usually equivalent to date/time when subject was first exposed to study + treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.| Assumption + 9 [RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the + date/time when a subject was first exposed to study drug. This definition applies for most + interventional studies, when the start of treatment is the natural and preferred starting + point for study day variables and thus the logical value for RFSTDTC. In such studies, + when data are submitted for subjects who are ineligible for treatment (e.g., screen + failures with ARMNRS = "SCREEN FAILURE"), subjects who were enrolled but not assigned to + an arm (e.g., ARMNRS = "NOT ASSIGNED"), or subjects who were randomized but not treated + (e.g., ARMNRS = "NOT TREATED"), RFSTDTC will be null. For studies with designs that + include a substantial portion of subjects who are not expected to be treated, a different + protocol milestone may be chosen as the starting point for study day variables. Some + examples include non-interventional or observational studies, studies with a no-treatment + Arm, or studies where there is a delay between randomization and treatment.] + Document: IG v3.4 + Item: Specification|Assumption 9 + Section: "5.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0532 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0532 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml index c73562759..78ba6d08d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml @@ -5,90 +5,94 @@ # Author: Marcelina Hungria # Progress Date: 2025-10-23 Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For types of Disease Milestones that can occur multiple times, MIDS will - usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. - Sequence numbers should start with one and indicate the chronological order of the - instances of this type of Disease Milestone. - Document: IG v3.4 - Item: Assumption 2.b - Section: '5.4' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0546 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For types of Disease Milestones that can occur multiple times, MIDS will - usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. - Sequence numbers should start with one and indicate the chronological order of the - instances of this type of Disease Milestone. - Document: IG v3.3 - Item: Assumption 2.b - Section: '5.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0546 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For types of Disease Milestones that can occur multiple times, MIDS will + usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. + Sequence numbers should start with one and indicate the chronological order of the + instances of this type of Disease Milestone. + Document: IG v3.4 + Item: Assumption 2.b + Section: "5.4" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0546 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For types of Disease Milestones that can occur multiple times, MIDS will + usually be an abbreviated version of MIDSTYPE and will always end with a sequence number. + Sequence numbers should start with one and indicate the chronological order of the + instances of this type of Disease Milestone. + Document: IG v3.3 + Item: Assumption 2.b + Section: "5.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0546 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: TMRPT - operator: equal_to - value: Y - - name: --STDTC - operator: not_equal_to - value: "" - - name: $records_per_usubjid_per_midstype - operator: greater_than - value: 1 - - name: MIDS - operator: target_is_sorted_by - value: - - name: SMSTDTC - null_position: first - sort_order: asc - within: - - USUBJID - - MIDSTYPE + - name: TMRPT + operator: equal_to + value: Y + - name: --STDTC + operator: not_equal_to + value: "" + - name: $records_per_usubjid_per_midstype + operator: greater_than + value: 1 + - name: MIDS + operator: target_is_sorted_by + value: + - name: SMSTDTC + null_position: first + sort_order: asc + within: + - USUBJID + - MIDSTYPE Core: Id: CDISC.SDTMIG.CG0546 Status: Draft - Version: '1' -Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a + Version: "1" +Description: + Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a sequence number in consistent chronological order Executability: Fully Executable Match Datasets: -- Keys: - - MIDSTYPE - Name: TM + - Keys: + - MIDSTYPE + Name: TM Operations: -- group: - - USUBJID - - MIDSTYPE - id: $records_per_usubjid_per_midstype - operator: record_count + - group: + - USUBJID + - MIDSTYPE + id: $records_per_usubjid_per_midstype + operator: record_count Outcome: - Message: MIDS is not suffixed with a sequence number in consistent chronological order with + Message: + MIDS is not suffixed with a sequence number in consistent chronological order with SMSTDTC. Output Variables: - - MIDSTYPE - - $records_per_usubjid_per_midstype + - MIDSTYPE + - $records_per_usubjid_per_midstype Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - SM + - SM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml index 1e0eb9e88..28b56d4ee 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0548/rule.yml @@ -1,43 +1,43 @@ # Variable: --ORREF -# Condition: +# Condition: # Rule: --ORREF in same units as --ORRES Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. - Document: Model v2.0 - Item: --ORREF - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0548 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. - Document: Model v1.7 - Item: --ORREF - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0548 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. + Document: Model v2.0 + Item: --ORREF + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0548 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: --ORREF uses the same units as --ORRES, if applicable. + Document: Model v1.7 + Item: --ORREF + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0548 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --ORREF - operator: + - name: --ORREF + operator: Core: Id: CDISC.SDTMIG.CG0548 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --ORREF is not in the same units as --ORRES Executability: Fully Executable Outcome: @@ -46,8 +46,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml index 4f6d3f5ae..d1d6075e0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0551/rule.yml @@ -1,45 +1,47 @@ # Variable: --STREFN -# Condition: +# Condition: # Rule: --STREFN in same units as --STRESN Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in standard - format or in standard units. --STREFN uses the same units as --STRESN, if applicable. - Document: Model v2.0 - Item: --STREFN - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0551 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Reference value for continuous or numeric results or findings in standard - format or in standard units. --STREFN uses the same units as --STRESN, if applicable. - Document: Model v1.7 - Item: --STREFN - Section: Table 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0551 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: Model v2.0 + Item: --STREFN + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0551 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Reference value for continuous or numeric results or findings in standard + format or in standard units. --STREFN uses the same units as --STRESN, if applicable. + Document: Model v1.7 + Item: --STREFN + Section: Table 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0551 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: --STREFN - operator: + - name: --STREFN + operator: Core: Id: CDISC.SDTMIG.CG0551 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --STREFN is not in the same units as --STRESN Executability: Fully Executable Outcome: @@ -48,8 +50,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml index 484b70daf..19c871280 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml @@ -3,86 +3,89 @@ # Rule: Terminology is for non-normalized parameter (Codelist "PKUNIT") # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0555 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0555 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0555 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0555 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: does_not_contain_case_insensitive - value: "norm" - - name: PPORRESU - operator: is_not_contained_by - value: pkunit_terms + - name: PPTEST + operator: does_not_contain_case_insensitive + value: "norm" + - name: PPORRESU + operator: is_not_contained_by + value: pkunit_terms Core: Id: CDISC.SDTMIG.CG0555 Status: Draft - Version: '1' -Description: Trigger error when parameter is non-normalized and value in PPORRESU is not for a + Version: "1" +Description: + Trigger error when parameter is non-normalized and value in PPORRESU is not for a non-normalized parameter. Executability: Fully Executable Operations: -- codelists: - - PKUNIT - id: pkunit_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUNIT + id: pkunit_terms + level: term + operator: codelist_terms + returntype: value Outcome: Message: Parameter is non-normalized, and the value in PPORRESU is not in codelist PKUNIT. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml index 0e90e1303..cdf3c6332 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml @@ -3,96 +3,100 @@ # Rule: Terminology is for parameter normalized by dose amount. # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0556 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0556 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0556 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0556 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by dose" - - name: PPORRESU - operator: is_not_contained_by - value: pkudmg_terms - - name: PPORRESU - operator: is_not_contained_by - value: pkudug_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by dose" + - name: PPORRESU + operator: is_not_contained_by + value: pkudmg_terms + - name: PPORRESU + operator: is_not_contained_by + value: pkudug_terms Core: Id: CDISC.SDTMIG.CG0556 Status: Draft - Version: '1' -Description: Trigger error when parameter is normalized by dose and value in PPORRESU is not for a + Version: "1" +Description: + Trigger error when parameter is normalized by dose and value in PPORRESU is not for a parameter normalized by dose. Executability: Fully Executable Operations: -- codelists: - - PKUDMG - id: pkudmg_terms - level: term - operator: codelist_terms - returntype: value -- codelists: - - PKUDUG - id: pkudug_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUDMG + id: pkudmg_terms + level: term + operator: codelist_terms + returntype: value + - codelists: + - PKUDUG + id: pkudug_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor + Message: + Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor in codelist PKUDUG. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml index 83a2ac023..110e3f657 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml @@ -3,96 +3,100 @@ # Rule: Terminology is for parameter normalized by weight # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0557 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0557 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0557 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0557 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by wt" - - name: PPORRESU - operator: is_not_contained_by - value: pkuwg_terms - - name: PPORRESU - operator: is_not_contained_by - value: pkuwkg_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by wt" + - name: PPORRESU + operator: is_not_contained_by + value: pkuwg_terms + - name: PPORRESU + operator: is_not_contained_by + value: pkuwkg_terms Core: Id: CDISC.SDTMIG.CG0557 Status: Draft - Version: '1' -Description: Trigger error when parameter is normalized by weight and value in PPORRESU is not for a + Version: "1" +Description: + Trigger error when parameter is normalized by weight and value in PPORRESU is not for a parameter normalized by weight. Executability: Fully Executable Operations: -- codelists: - - PKUWG - id: pkuwg_terms - level: term - operator: codelist_terms - returntype: value -- codelists: - - PKUWKG - id: pkuwkg_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUWG + id: pkuwg_terms + level: term + operator: codelist_terms + returntype: value + - codelists: + - PKUWKG + id: pkuwkg_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor + Message: + Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor in codelist PKUWKG. Output Variables: - - PPTESTCD - - PPTEST - - PPORRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPORRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml index ec6724ba8..6a79b4edc 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml @@ -3,86 +3,89 @@ # Rule: Terminology is for non-normalized parameter # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0558 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0558 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0558 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0558 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: does_not_contain_case_insensitive - value: "norm" - - name: PPSTRESU - operator: is_not_contained_by - value: pkunit_terms + - name: PPTEST + operator: does_not_contain_case_insensitive + value: "norm" + - name: PPSTRESU + operator: is_not_contained_by + value: pkunit_terms Core: Id: CDISC.SDTMIG.CG0558 Status: Draft - Version: '1' -Description: Trigger error when parameter is non-normalized and value in PPSTRESU is not for a + Version: "1" +Description: + Trigger error when parameter is non-normalized and value in PPSTRESU is not for a non-normalized parameter. Executability: Fully Executable Operations: -- codelists: - - PKUNIT - id: pkunit_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUNIT + id: pkunit_terms + level: term + operator: codelist_terms + returntype: value Outcome: Message: Parameter is non-normalized, and the value in PPSTRESU is not in codelist PKUNIT. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml index b7f3bfab9..4f0b64b95 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml @@ -3,96 +3,100 @@ # Rule: Terminology is for non-normalized parameter # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0559 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0559 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0559 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0559 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by dose" - - name: PPSTRESU - operator: is_not_contained_by - value: pkudmg_terms - - name: PPSTRESU - operator: is_not_contained_by - value: pkudug_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by dose" + - name: PPSTRESU + operator: is_not_contained_by + value: pkudmg_terms + - name: PPSTRESU + operator: is_not_contained_by + value: pkudug_terms Core: Id: CDISC.SDTMIG.CG0559 Status: Draft - Version: '1' -Description: Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a + Version: "1" +Description: + Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a parameter normalized by dose. Executability: Fully Executable Operations: -- codelists: - - PKUDMG - id: pkudmg_terms - level: term - operator: codelist_terms - returntype: value -- codelists: - - PKUDUG - id: pkudug_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUDMG + id: pkudmg_terms + level: term + operator: codelist_terms + returntype: value + - codelists: + - PKUDUG + id: pkudug_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor + Message: + Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor in codelist PKUDUG. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml index 53b538272..7effbeaa1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml @@ -3,96 +3,100 @@ # Rule: Terminology is for parameter normalized by weight # Notes by author, Marcelina Hungria: # - The rule as written by the Conformance Rules team is fully executable -# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. -# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future +# - Added PPSTAT to the output to help the user visualize a potential over-reporting for tests not done. Reported a SDS Jira ticket to consider adding normative text in the SDTM IG 4.0 so that the conformance rule be adjusted. +# - A potential rule enhancement, cross-checking against the e-protocol , can be implemented in the future Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes - Document: IG v3.4 - Item: Assumption 3 - Section: 6.3.5.9.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0560 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: There are separate codelists used for PPORRESU/PPSTRESU where the choice - depends on whether the value of the pharmacokinetic parameter is normalized. Codelist - PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when - parameters are normalized by dose amount in milligrams or micrograms respectively. - Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or - kilograms respectively. Multiple subset codelists were created for the unique unit - expressions of the same concept across codelists, this approach allows study-context - appropriate use of unit values for PK analysis subtypes. - Document: IG v3.3 - Item: Assumption 3 - Section: 6.3.11.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0560 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes + Document: IG v3.4 + Item: Assumption 3 + Section: 6.3.5.9.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0560 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + There are separate codelists used for PPORRESU/PPSTRESU where the choice + depends on whether the value of the pharmacokinetic parameter is normalized. Codelist + PKUNIT is used for non-normalized parameters. Codelists PKUDMG and PKUDUG are used when + parameters are normalized by dose amount in milligrams or micrograms respectively. + Codelists PKUWG and PKUWKG are used when parameters are normalized by weight in grams or + kilograms respectively. Multiple subset codelists were created for the unique unit + expressions of the same concept across codelists, this approach allows study-context + appropriate use of unit values for PK analysis subtypes. + Document: IG v3.3 + Item: Assumption 3 + Section: 6.3.11.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0560 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: PPTEST - operator: contains_case_insensitive - value: "norm by wt" - - name: PPSTRESU - operator: is_not_contained_by - value: pkuwg_terms - - name: PPSTRESU - operator: is_not_contained_by - value: pkuwkg_terms + - name: PPTEST + operator: contains_case_insensitive + value: "norm by wt" + - name: PPSTRESU + operator: is_not_contained_by + value: pkuwg_terms + - name: PPSTRESU + operator: is_not_contained_by + value: pkuwkg_terms Core: Id: CDISC.SDTMIG.CG0560 Status: Draft - Version: '1' -Description: Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a + Version: "1" +Description: + Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a parameter not normalized by weight. Executability: Fully Executable Operations: -- codelists: - - PKUWG - id: pkuwg_terms - level: term - operator: codelist_terms - returntype: value -- codelists: - - PKUWKG - id: pkuwkg_terms - level: term - operator: codelist_terms - returntype: value + - codelists: + - PKUWG + id: pkuwg_terms + level: term + operator: codelist_terms + returntype: value + - codelists: + - PKUWKG + id: pkuwkg_terms + level: term + operator: codelist_terms + returntype: value Outcome: - Message: Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor + Message: + Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor in codelist PKUWKG. Output Variables: - - PPTESTCD - - PPTEST - - PPSTRESU - - PPSTAT + - PPTESTCD + - PPTEST + - PPSTRESU + - PPSTAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PP + - PP Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml index c00f9b887..031484b30 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml @@ -2,53 +2,56 @@ # Condition: Record is derived in a data collection tool. # Rule: RSDRVFL = 'Y' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Used to indicate a derived record (e.g., a record that represents the - average of other records such as a computed baseline). Should be "Y" or null. - Document: SDTMIG v3.4 - Section: Section 6.3.9.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0563 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The RS domain is intended for collected data. This includes records derived - by the investigator or with a data collection tool, but not sponsor-derived records. - Sponsor-derived records and results should be provided in an analysis dataset. For - example, BEST Response assessment records must be included in the RS domain only when - provided by an assessor, not the sponsor. a. Totals and sub-totals in clinical - classification measures are considered collected data if recorded by an assessor. If these - totals are operationally derived through a data collection tool, such as an eCRF or ePRO - device, then RSDRVL should be "Y". - Document: IG v3.3 - Item: Assumption 4 - Section: 6.3.13.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0563 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Used to indicate a derived record (e.g., a record that represents the + average of other records such as a computed baseline). Should be "Y" or null. + Document: SDTMIG v3.4 + Section: Section 6.3.9.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0563 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The RS domain is intended for collected data. This includes records derived + by the investigator or with a data collection tool, but not sponsor-derived records. + Sponsor-derived records and results should be provided in an analysis dataset. For + example, BEST Response assessment records must be included in the RS domain only when + provided by an assessor, not the sponsor. a. Totals and sub-totals in clinical + classification measures are considered collected data if recorded by an assessor. If these + totals are operationally derived through a data collection tool, such as an eCRF or ePRO + device, then RSDRVL should be "Y". + Document: IG v3.3 + Item: Assumption 4 + Section: 6.3.13.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0563 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: - operator: - - name: RSDRVFL - operator: not_equal_to - value: Y + - name: + operator: + - name: RSDRVFL + operator: not_equal_to + value: Y Core: Id: CDISC.SDTMIG.CG0563 Status: Draft - Version: '1' -Description: Raise an error when record is derived in a data collection tool and RSDRVFL is not + Version: "1" +Description: + Raise an error when record is derived in a data collection tool and RSDRVFL is not equal to "Y" Executability: Fully Executable Outcome: @@ -57,8 +60,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - RS + - RS Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml index 4ff080e9e..4d1c2747d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0604/rule.yml @@ -2,40 +2,41 @@ # Condition: Parent record does not exist, and NO name of event or intervention is coded # Rule: --OBJ = verbatim value Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and the name of - the event or intervention is collected in an "Other, specify" CRF field, the value in - --OBJ variable depends on whether the FA record has a parent record and whether the - "Other, specify" value was coded. - Document: IG v3.4 - Section: 4.2.7.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0604 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: 4.2.7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0604 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0604 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - F - - A + - F + - A Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml index 1ca86efc7..194313eaa 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0605/rule.yml @@ -2,40 +2,41 @@ # Condition: Parent record does not exist, and name of event or intervention is coded # Rule: --OBJ = coded value Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When findings are collected about an event or intervention, and the name of - the event or intervention is collected in an "Other, specify" CRF field, the value in - --OBJ variable depends on whether the FA record has a parent record and whether the - "Other, specify" value was coded. - Document: IG v3.4 - Section: 4.2.7.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0605 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When findings are collected about an event or intervention, and the name of + the event or intervention is collected in an "Other, specify" CRF field, the value in + --OBJ variable depends on whether the FA record has a parent record and whether the + "Other, specify" value was coded. + Document: IG v3.4 + Section: 4.2.7.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0605 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0605 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS ABOUT + - FINDINGS ABOUT Domains: Include: - - F - - A + - F + - A Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml index 89c5be804..9b635fdbb 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml @@ -2,44 +2,47 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTEST = name of the organism or antigen Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen - for identification, MBTEST equals the name of the organism/antigen targeted by the - identification assay. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0607 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0607 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: MBTEST - operator: not_equal_to - value: + - name: MBTEST + operator: not_equal_to + value: Core: Id: CDISC.SDTMIG.CG0607 Status: Draft - Version: '1' -Description: Verify MBTEST equals the name of the organism/antigen targeted by the identification + Version: "1" +Description: + Verify MBTEST equals the name of the organism/antigen targeted by the identification assay. Executability: Fully Executable Outcome: - Message: Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of + Message: + Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of the organism/antigen. Rule Type: Range and limit Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml index a44161e6a..273102318 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml @@ -2,33 +2,35 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTSTDTL='DETECTION' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen - for identification, MBTEST equals the name of the organism/antigen targeted by the - identification assay, and MBTSTDTL should be “DETECTION”. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0608 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay, and MBTSTDTL should be “DETECTION”. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0608 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: MBTSTDTL - operator: not_equal_to - value: DETECTION + - name: MBTSTDTL + operator: not_equal_to + value: DETECTION Core: Id: CDISC.SDTMIG.CG0608 Status: Draft - Version: '1' -Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or + Version: "1" +Description: + Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or antigen. Executability: Fully Executable Outcome: @@ -37,8 +39,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml index 1c81f5c7b..851a601fe 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml @@ -2,34 +2,36 @@ # Condition: Test for non-targeted identification of an organism # Rule: MBTESTCD='MCORGIDN' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For non-targeted identification of organisms (i.e., tests that have the - ability to identify a range of organisms without specifically targeting any), the value - for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the - result should be the name of the organism or group of organisms found to be present. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0609 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For non-targeted identification of organisms (i.e., tests that have the + ability to identify a range of organisms without specifically targeting any), the value + for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the + result should be the name of the organism or group of organisms found to be present. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0609 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: MBTESTCD - operator: not_equal_to - value: MCORGIDN + - name: MBTESTCD + operator: not_equal_to + value: MCORGIDN Core: Id: CDISC.SDTMIG.CG0609 Status: Draft - Version: '1' -Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of + Version: "1" +Description: + Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of organisms. Executability: Fully Executable Outcome: @@ -38,8 +40,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml index 36623f2bd..a71f8cbd7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml @@ -2,44 +2,47 @@ # Condition: Test for culture characteristics # Rule: MBTEST = name of the organism or group of organisms Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Culture characteristics covers concepts such as growth/no growth, colony - quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should - be the name of the organism or group of organisms being characterized. - Document: SDTMIG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0610 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Culture characteristics covers concepts such as growth/no growth, colony + quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should + be the name of the organism or group of organisms being characterized. + Document: SDTMIG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0610 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: - - name: MBTEST - operator: not_equal_to - value: + - name: MBTEST + operator: not_equal_to + value: Core: Id: CDISC.SDTMIG.CG0610 Status: Draft - Version: '1' -Description: If the test is for culture characteristics, verify that MBTEST equals the name of the + Version: "1" +Description: + If the test is for culture characteristics, verify that MBTEST equals the name of the organism/antigen being characterized. Executability: Fully Executable Outcome: - Message: Test is for culture characteristics, but MBTEST is not the name of the organism or group + Message: + Test is for culture characteristics, but MBTEST is not the name of the organism or group of organisms. Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml index 595a09e62..ca1e3604e 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0614/rule.yml @@ -2,39 +2,40 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTEST = name of the organism or antigen Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen - for identification, MBTEST equals the name of the organism/antigen targeted by the - identification assay. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0614 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0614 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0614 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml index c09ed2aba..86f5a2e88 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0615/rule.yml @@ -2,39 +2,40 @@ # Condition: Test targets an organism, group of organisms, or antigen # Rule: MBTSTDTL = 'DETECTION' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: In cases of tests that target an organism, group of organisms, or antigen - for identification, MBTEST equals the name of the organism/antigen targeted by the - identification assay, and MBTSTDTL should be “DETECTION”. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0615 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + In cases of tests that target an organism, group of organisms, or antigen + for identification, MBTEST equals the name of the organism/antigen targeted by the + identification assay, and MBTSTDTL should be “DETECTION”. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0615 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0615 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml index 354bef1d3..c2d0c97ac 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0616/rule.yml @@ -2,40 +2,41 @@ # Condition: Test for non-targeted identification of an organism # Rule: MBTESTCD = 'MCORGIDN' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For non-targeted identification of organisms (i.e., tests that have the - ability to identify a range of organisms without specifically targeting any), the value - for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the - result should be the name of the organism or group of organisms found to be present. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0616 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For non-targeted identification of organisms (i.e., tests that have the + ability to identify a range of organisms without specifically targeting any), the value + for MBTESTCD/MBTEST should be "MCORGIDN"/"Microbial Organism Identification", and the + result should be the name of the organism or group of organisms found to be present. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0616 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0616 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml index 694978689..613822c74 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0617/rule.yml @@ -2,39 +2,40 @@ # Condition: Test for culture characteristics # Rule: MBTEST = name of the organism or group of organisms Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Culture characteristics covers concepts such as growth/no growth, colony - quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should - be the name of the organism or group of organisms being characterized. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.3.5.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0617 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Culture characteristics covers concepts such as growth/no growth, colony + quantification measures, colony color, colony morphology, etc.... MBTESTCD/MBTEST should + be the name of the organism or group of organisms being characterized. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.3.5.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0617 + Version: "1" + Version: "2.0" + Version: "3.4" Check: all: [] Core: Id: CDISC.SDTMIG.CG0617 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MB + - MB Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml index ce776647c..4c8eef5cc 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml @@ -2,75 +2,79 @@ # Condition: Variable Core Status = Permissible and data is planned to be collected # Rule: Variable present in dataset # Logically, this check tests: -# if a library variable exists in the define, +# if a library variable exists in the define, # it should exist in the datasets Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a Permissible - variable, then that variable must be included in the SDTM dataset, even if null. Indicate - no data were available for that variable in the Define-XML document." - Document: IG v3.4 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0651 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If a study includes a data item that would be represented in a Permissible - variable, then that variable must be included in the SDTM dataset, even if null. Indicate - no data were available for that variable in the Define-XML document. - Document: IG v3.3 - Section: '2.5' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0651 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. Indicate + no data were available for that variable in the Define-XML document." + Document: IG v3.4 + Section: "2.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0651 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If a study includes a data item that would be represented in a Permissible + variable, then that variable must be included in the SDTM dataset, even if null. Indicate + no data were available for that variable in the Define-XML document. + Document: IG v3.3 + Section: "2.5" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0651 + Version: "1" + Version: "2.0" + Version: "3.3" Check: all: - - name: define_variable_name - operator: is_contained_by - value: - - $permissible_variables - - name: define_variable_is_collected - operator: equal_to - value: true - - name: define_variable_name - operator: is_not_contained_by - value: $get_column_order_from_dataset + - name: define_variable_name + operator: is_contained_by + value: + - $permissible_variables + - name: define_variable_is_collected + operator: equal_to + value: true + - name: define_variable_name + operator: is_not_contained_by + value: $get_column_order_from_dataset Core: Id: CDISC.SDTMIG.CG0651 Status: Draft - Version: '1' -Description: Raise an error when variable Core Status = Permissible and data is planned to be + Version: "1" +Description: + Raise an error when variable Core Status = Permissible and data is planned to be collected, but variable is not present Executability: Partially Executable - Possible Underreporting Operations: -- id: $permissible_variables - operator: permissible_variables -- id: $get_column_order_from_dataset - operator: get_column_order_from_dataset + - id: $permissible_variables + operator: permissible_variables + - id: $get_column_order_from_dataset + operator: get_column_order_from_dataset Outcome: - Message: Variable is missing, where variable core status is permissible and data is planned to be + Message: + Variable is missing, where variable core status is permissible and data is planned to be collected. Output Variables: - - define_variable_name - - $get_column_order_from_dataset + - define_variable_name + - $get_column_order_from_dataset Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml index 0abc092b7..c718df262 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml @@ -1,75 +1,79 @@ # Variable: DOMAIN # Condition: AP Core Domain -# Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain +# Rule: Value length = 4 characters beginning with 'AP' and ending with 2 character SDTM domain Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Associated Persons datasets are given a prefix of AP-- to identify the data - as AP data to and distinguish them from study subject data. Associated Persons domain - codes in the DOMAIN column of every record are also given a prefix of AP-- to identify the - domains as AP domains and to distinguish them from study subject domains. AP domain codes - are therefore four characters long. - Document: AP Guide v1.0 - Section: Section 2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0663 - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Associated Persons datasets are given a prefix of AP-- to identify the data + as AP data to and distinguish them from study subject data. Associated Persons domain + codes in the DOMAIN column of every record are also given a prefix of AP-- to identify the + domains as AP domains and to distinguish them from study subject domains. AP domain codes + are therefore four characters long. + Document: AP Guide v1.0 + Section: Section 2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0663 + Version: "1" + Version: "2.0" + Version: "3.4" Check: any: # Fire query if domain name does not start with APFA and does not have the format "AP" followed by an alpha character, then an alphanum character - - all: + - all: + - name: DOMAIN + operator: not_prefix_matches_regex + prefix: 4 + value: ^APFA$ + - name: DOMAIN + operator: not_matches_regex + value: ^AP[A-Z][A-Z0-9]$ + # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character + - all: + - name: DOMAIN + operator: prefix_matches_regex + prefix: 4 + value: ^APFA$ + - name: DOMAIN + operator: not_suffix_matches_regex + suffix: 2 + value: + "[A-Z0-9][A-Z0-9]$" + # Fire query if characters 3/4 refers to invalid SDTM domain + - name: DOMAIN + operator: suffix_is_not_contained_by + suffix: 2 + value: $valid_domain_name + # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) - name: DOMAIN - operator: not_prefix_matches_regex - prefix: 4 - value: ^APFA$ - - name: DOMAIN - operator: not_matches_regex - value: ^AP[A-Z][A-Z0-9]$ - # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character - - all: - - name: DOMAIN - operator: prefix_matches_regex - prefix: 4 - value: ^APFA$ - - name: DOMAIN - operator: not_suffix_matches_regex - suffix: 2 - value: '[A-Z0-9][A-Z0-9]$' - # Fire query if characters 3/4 refers to invalid SDTM domain - - name: DOMAIN - operator: suffix_is_not_contained_by - suffix: 2 - value: $valid_domain_name - # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) - - name: DOMAIN - operator: matches_regex - value: ^APFA(AD|AX|AP|SQ|SA)$ + operator: matches_regex + value: ^APFA(AD|AX|AP|SQ|SA)$ Core: Id: CDISC.SDTMIG.CG0663 Status: Draft - Version: '1' -Description: Raise an error when an AP Core Domain does not have a value length of 4 characters + Version: "1" +Description: + Raise an error when an AP Core Domain does not have a value length of 4 characters beginning with 'AP' and ending with 2 character SDTM domain Executability: Fully Executable Operations: -- id: $valid_domain_name - name: domain_suffix - operator: extract_metadata + - id: $valid_domain_name + name: domain_suffix + operator: extract_metadata Outcome: - Message: AP Core Domain does not have a value length of 4 characters beginning with 'AP' and + Message: + AP Core Domain does not have a value length of 4 characters beginning with 'AP' and ending with 2 character SDTM domain Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - AP-- + - AP-- Sensitivity: Record diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml index bf18ad952..200526fa2 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0998/rule.yml @@ -1,60 +1,60 @@ # Variable: -- -# Condition: -# Rule: +# Condition: +# Rule: Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: xxx. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: yyyyyyy. - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0998 - Version: '2' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: xxx. + Document: IG v3.4 + Item: Item 3.b. + Section: "2.6" + - Cited Guidance: yyyyyyy. + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0998 + Version: "2" + Version: "2.0" + Version: "3.4" Check: any: - - name: TS - operator: not_exists - - name: TA - operator: not_exists - - name: TE - operator: not_exists + - name: TS + operator: not_exists + - name: TA + operator: not_exists + - name: TE + operator: not_exists Core: Id: CDISC.SDTMIG.CG0998 Status: Draft - Version: '1' + Version: "1" Description: All TDM dataset(s) for the corresponding IG should be included in every submission. Executability: Fully Executable Grouping_Variables: -- $study_domains + - $study_domains Operations: -- id: $study_domains - operator: study_domains -- id: $dataset_names - operator: dataset_names + - id: $study_domains + operator: study_domains + - id: $dataset_names + operator: dataset_names Outcome: Message: Missing one or more TDM dataset(s) Output Variables: - - $study_domains + - $study_domains # - dataset_name #Rule Type: Dataset Metadata Check Rule Type: Domain Presence Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml index 40720ee52..729c9e9c0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0999/rule.yml @@ -1,62 +1,62 @@ # Variable: -- -# Condition: -# Rule: +# Condition: +# Rule: Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: xxx. - Document: IG v3.4 - Item: Item 3.b. - Section: '2.6' - - Cited Guidance: yyyyyyy. - Document: IG v3.4 - Section: 4.3.6 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0999 - Version: '2' - Version: '2.0' - Version: '3.4' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: xxx. + Document: IG v3.4 + Item: Item 3.b. + Section: "2.6" + - Cited Guidance: yyyyyyy. + Document: IG v3.4 + Section: 4.3.6 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0999 + Version: "2" + Version: "2.0" + Version: "3.4" Check: all: - - name: variable_name - operator: equal_to - value: library_variable_name - - name: variable_name - operator: equal_to - value: define_variable_name - - name: library_variable_ccode - operator: non_empty - - name: library_variable_ccode - operator: not_equal_to - value: define_variable_ccode + - name: variable_name + operator: equal_to + value: library_variable_name + - name: variable_name + operator: equal_to + value: define_variable_name + - name: library_variable_ccode + operator: non_empty + - name: library_variable_ccode + operator: not_equal_to + value: define_variable_ccode Core: Id: CDISC.SDTMIG.CG0999 Status: Draft - Version: '1' + Version: "1" Description: Testing rule type Variables Metadata Check against Define XML and Library Metadata Executability: Fully Executable Outcome: Message: "Issue with codelist definition in the Define-XML document." Output Variables: - - variable_name - - library_variable_name - - library_variable_ccode - - library_variable_data_type - - define_variable_name - - define_variable_ccode + - variable_name + - library_variable_name + - library_variable_ccode + - library_variable_data_type + - define_variable_name + - define_variable_ccode Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011/rule.yml b/Unpublished/SDTMIG/CG0011/rule.yml index 13763c13a..b2cad8f7c 100644 --- a/Unpublished/SDTMIG/CG0011/rule.yml +++ b/Unpublished/SDTMIG/CG0011/rule.yml @@ -1,89 +1,93 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011' - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: "CDISC" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011" + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011" + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011" + Version: "1" + Version: "2.0" + Version: "3.4" Check: # REMARK: This rule is strongly related to rule SEND49 all: # variable has CT assigned - - name: define_variable_name - operator: is_not_contained_by - value: - - STUDYID - - DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN" - # check whether variable has assigned CT in the CDISC Library - - name: library_variable_ccode - operator: non_empty - # if yes, a "CodeListRef" must be available either on the "Variable-ItemDef" - # or on each of the corresponding ValueList ItemDefs - #- any: - # - name: define_variable_ccode - # operator: empty - #value: '1234' - #- name: variable_name - # operator: equal_to - # value: library_variable_name - #- name: library_variable_data_type - # operator: not_equal_to - # value: ISO8601 - #- name: variable_order_number - # operator: not_equal_to - # value: 1 + - name: define_variable_name + operator: is_not_contained_by + value: + - STUDYID + - DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN" + # check whether variable has assigned CT in the CDISC Library + - name: library_variable_ccode + operator: + non_empty + # if yes, a "CodeListRef" must be available either on the "Variable-ItemDef" + # or on each of the corresponding ValueList ItemDefs + #- any: + # - name: define_variable_ccode + # operator: empty + #value: '1234' + #- name: variable_name + # operator: equal_to + # value: library_variable_name + #- name: library_variable_data_type + # operator: not_equal_to + # value: ISO8601 + #- name: variable_order_number + # operator: not_equal_to + # value: 1 Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'Test message' + Message: "Test message" Output Variables: - - library_variable_ccode - - define_variable_ccode + - library_variable_ccode + - define_variable_ccode # Rule Type: Variable Metadata Check against Library Metadata Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - LB + - LB Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CG0011A1/rule.yml b/Unpublished/SDTMIG/CG0011A1/rule.yml index e62aa9608..a479344eb 100644 --- a/Unpublished/SDTMIG/CG0011A1/rule.yml +++ b/Unpublished/SDTMIG/CG0011A1/rule.yml @@ -1,68 +1,72 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A1' - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: "CDISC" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A1" + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A1" + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A1" + Version: "1" + Version: "2.0" + Version: "3.4" Check: # PART A1: --DUR must be in ISO-8601 "duration" format all: - - name: --DUR - operator: non_empty - - name: --DUR - # negative: true means: allow negative durations - negative: true - operator: invalid_duration - #- name: --DUR - # operator: not_matches_regex - # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - #- name: --DUR - # operator: not_matches_regex - # value: ^-?P([0-9]+W)$ + - name: --DUR + operator: non_empty + - name: + --DUR + # negative: true means: allow negative durations + negative: true + operator: invalid_duration + #- name: --DUR + # operator: not_matches_regex + # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + #- name: --DUR + # operator: not_matches_regex + # value: ^-?P([0-9]+W)$ Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'Variable value for --DUR does not comply with ISO-8601-duration format' + Message: "Variable value for --DUR does not comply with ISO-8601-duration format" #Output Variables: # - library_variable_ccode # - define_variable_ccode @@ -71,8 +75,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011A2/rule.yml b/Unpublished/SDTMIG/CG0011A2/rule.yml index 9f0762753..b1c3968e7 100644 --- a/Unpublished/SDTMIG/CG0011A2/rule.yml +++ b/Unpublished/SDTMIG/CG0011A2/rule.yml @@ -1,70 +1,74 @@ # CG0011A = --DUR variables Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011A2' - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: "CDISC" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A2" + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A2" + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011A2" + Version: "1" + Version: "2.0" + Version: "3.4" # Part A2: check whether --DUR is declared as "durationDatetime" Check: all: - - name: --DUR - negative: true - operator: invalid_duration - #operator: non_conformant_value_data_type - #value: 'durationDatetime' + - name: --DUR + negative: true + operator: + invalid_duration + #operator: non_conformant_value_data_type + #value: 'durationDatetime' Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Variable Metadata Check against Define XML # Rule Type: Variable Metadata Check against Library Metadata -# Alternative: +# Alternative: Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CG0011B1/rule.yml b/Unpublished/SDTMIG/CG0011B1/rule.yml index c4025f033..b75311763 100644 --- a/Unpublished/SDTMIG/CG0011B1/rule.yml +++ b/Unpublished/SDTMIG/CG0011B1/rule.yml @@ -1,124 +1,127 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011B1' - Version: '1' - Version: '2.0' - Version: '3.4' -# TODO?: when 2 violations in same row, this is reported as 1 violation + - Organization: "CDISC" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011B1" + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011B1" + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011B1" + Version: "1" + Version: "2.0" + Version: "3.4" +# TODO?: when 2 violations in same row, this is reported as 1 violation Check: any: - - all: - - name: --DTC - operator: non_empty - - name: --DTC + - all: + - name: --DTC + operator: non_empty + - name: --DTC + operator: invalid_date + - all: + - name: --STDTC + operator: non_empty + - name: --STDTC + operator: invalid_date + - all: + - name: --ENDTC + operator: non_empty + - name: --ENDTC + operator: invalid_date + # DM-specific date/time variables + - all: + - name: RFSTDTC + operator: non_empty + - name: RFSTDTC + operator: invalid_date + - all: + - name: RFENDTC + operator: non_empty + - name: RFENDTC + operator: invalid_date + - all: + - name: RFXSTDTC + operator: non_empty + - name: RFXSTDTC + operator: invalid_date + - all: + - name: RFXENDTC + operator: non_empty + - name: RFXENDTC + operator: invalid_date + - all: + - name: RFCSTDTC + operator: non_empty + - name: RFCSTDTC + operator: invalid_date + - all: + - name: RFCENDTC + operator: non_empty + - name: RFCENDTC + operator: invalid_date + - all: + - name: RFICDTC + operator: non_empty + - name: RFICDTC + operator: invalid_date + - all: + - name: RFPENDTC + operator: non_empty + - name: RFPENDTC + operator: invalid_date + - all: + - name: DTHDTC + operator: non_empty + - name: DTHDTC + operator: invalid_date + - name: BRTHDTC operator: invalid_date - - all: - - name: --STDTC - operator: non_empty - - name: --STDTC - operator: invalid_date - - all: - - name: --ENDTC - operator: non_empty - - name: --ENDTC - operator: invalid_date - # DM-specific date/time variables - - all: - - name: RFSTDTC - operator: non_empty - - name: RFSTDTC - operator: invalid_date - - all: - - name: RFENDTC - operator: non_empty - - name: RFENDTC - operator: invalid_date - - all: - - name: RFXSTDTC - operator: non_empty - - name: RFXSTDTC - operator: invalid_date - - all: - - name: RFXENDTC - operator: non_empty - - name: RFXENDTC - operator: invalid_date - - all: - - name: RFCSTDTC - operator: non_empty - - name: RFCSTDTC - operator: invalid_date - - all: - - name: RFCENDTC - operator: non_empty - - name: RFCENDTC - operator: invalid_date - - all: - - name: RFICDTC - operator: non_empty - - name: RFICDTC - operator: invalid_date - - all: - - name: RFPENDTC - operator: non_empty - - name: RFPENDTC - operator: invalid_date - - all: - - name: DTHDTC - operator: non_empty - - name: DTHDTC - operator: invalid_date - - name: BRTHDTC - operator: invalid_date Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: '' + Message: "" Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CG0011C2/rule.yml b/Unpublished/SDTMIG/CG0011C2/rule.yml index 8d6b27801..934ae6895 100644 --- a/Unpublished/SDTMIG/CG0011C2/rule.yml +++ b/Unpublished/SDTMIG/CG0011C2/rule.yml @@ -1,45 +1,48 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specified controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: 'SDTMIG' - References: - - Citations: - - Cited Guidance: 'Following SDTM-specifieda controlled terminology and format guidelines for variables, - when provided' - Document: 'SDTMIG' - Section: '3.2.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: 'CG0011C2' - Version: '1' - Version: '2.0' - Version: '3.4' + - Organization: "CDISC" + Standards: + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011C2" + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specified controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011C2" + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: "SDTMIG" + References: + - Citations: + - Cited Guidance: + "Following SDTM-specifieda controlled terminology and format guidelines for variables, + when provided" + Document: "SDTMIG" + Section: "3.2.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: "CG0011C2" + Version: "1" + Version: "2.0" + Version: "3.4" # CG0011C2: if the variable is under controlled terminology (according CDISC-Library) # then a CodeList must be referenced in the define.xml Check: @@ -63,30 +66,31 @@ Check: #- name: library_variable_ccode # operator: equal_to # value: true - - name: library_variable_ccode - operator: non_empty - - name: define_variable_has_codelist - operator: equal_to - value: false + - name: library_variable_ccode + operator: non_empty + - name: define_variable_has_codelist + operator: equal_to + value: false Core: Status: Draft - Version: '1' -Description: 'Variables that are under CT must have an associated codelist defined in the define.xml' + Version: "1" +Description: "Variables that are under CT must have an associated codelist defined in the define.xml" Executability: Fully Executable Outcome: - Message: 'The variable is under controlled terminology, but no codelist has been defined for it in the - define.xml' + Message: + "The variable is under controlled terminology, but no codelist has been defined for it in the + define.xml" Output Variables: - - library_variable_ccode + - library_variable_ccode +# Rule Type: Define Item Metadata Check against Library Metadata # Rule Type: Define Item Metadata Check against Library Metadata -# Rule Type: Define Item Metadata Check against Library Metadata Rule Type: Variable Metadata Check against Define XML and Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000205/rule.yml b/Unpublished/SDTMIG/CORE-000205/rule.yml index 1e6ecbb01..1f87ed8ea 100644 --- a/Unpublished/SDTMIG/CORE-000205/rule.yml +++ b/Unpublished/SDTMIG/CORE-000205/rule.yml @@ -2,51 +2,53 @@ # Condition: --ULOQ present in dataset # Rule: --ULOQ is expressed using the units in --STRESU Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Units will be those used for --STRESU. - Document: Model v2.0 - Item: --ULOQ - Section: Findings - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units will be those - used for --STRESU. - Document: Model v1.4 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Indicates the upper limit of quantitation for an assay. Units will be those - used for --STRESU. - Document: Model v1.7 - Section: 2.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0399 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: Units will be those used for --STRESU. + Document: Model v2.0 + Item: --ULOQ + Section: Findings + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the upper limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.4 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Indicates the upper limit of quantitation for an assay. Units will be those + used for --STRESU. + Document: Model v1.7 + Section: 2.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0399 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000205 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --ULOQ is not expressed using the units in --STRESU Executability: Not Executable Outcome: @@ -55,8 +57,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000343/rule.yml b/Unpublished/SDTMIG/CORE-000343/rule.yml index 2735e39c7..879063250 100644 --- a/Unpublished/SDTMIG/CORE-000343/rule.yml +++ b/Unpublished/SDTMIG/CORE-000343/rule.yml @@ -1,64 +1,69 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Variable Format = SDTM-specified controlled terminology and format guidelines for variables, when provided Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for - variables, when provided - Document: IG v3.4 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for - variables, when provided - Document: IG v3.2 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Following SDTM-specified controlled terminology and format guidelines for - variables, when provided - Document: IG v3.3 - Section: 3.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0011 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.4 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.2 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Following SDTM-specified controlled terminology and format guidelines for + variables, when provided + Document: IG v3.3 + Section: 3.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0011 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000343 Status: Draft - Version: '1' -Description: Trigger error when variable format does not match SDTM-specified controlled terminology + Version: "1" +Description: + Trigger error when variable format does not match SDTM-specified controlled terminology or format guidelines for variables (when provided) Executability: Not Executable Outcome: - Message: Variable format does not match SDTM-specified controlled terminology or format guidelines + Message: + Variable format does not match SDTM-specified controlled terminology or format guidelines for variables (when provided) Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SDTMIG/CORE-000344/rule.yml b/Unpublished/SDTMIG/CORE-000344/rule.yml index 57c4d606c..ebac9d39b 100644 --- a/Unpublished/SDTMIG/CORE-000344/rule.yml +++ b/Unpublished/SDTMIG/CORE-000344/rule.yml @@ -2,67 +2,72 @@ # Condition: Use of value 'MULTIPLE' is appropriate to the data being represented # Rule: Value in associated codelist or 'MULTIPLE' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided - Document: IG v3.4 - Section: 3.2.2 - - Cited Guidance: The SDTM permits one value for each Qualifier variable per record. If - multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then - the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to - store the individual responses. - Document: IG v3.4 - Section: 4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided]4.1.2.8.3[The SDTM permits one value for each Qualifier variable per record. If - multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then - the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to - store the individual responses.] - Document: IG v3.2 - Section: 3.2.2|4.1.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided]4.2.8.3[The SDTM permits one value for each Qualifier variable per record. If - multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then - the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to - store the individual responses.] - Document: IG v3.3 - Section: 3.2.2|4.2.8.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0020 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided + Document: IG v3.4 + Section: 3.2.2 + - Cited Guidance: + The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses. + Document: IG v3.4 + Section: 4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]4.1.2.8.3[The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses.] + Document: IG v3.2 + Section: 3.2.2|4.1.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]4.2.8.3[The SDTM permits one value for each Qualifier variable per record. If + multiple values exist (e.g., due to a "Check all that apply" instruction on a CRF), then + the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to + store the individual responses.] + Document: IG v3.3 + Section: 3.2.2|4.2.8.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0020 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000344 Status: Draft - Version: '1' -Description: Trigger error if the value of a variable, which is associated with an extensible + Version: "1" +Description: + Trigger error if the value of a variable, which is associated with an extensible codelist, is in the associated codelist or equal to 'MULTIPLE' Executability: Not Executable Outcome: @@ -71,8 +76,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000345/rule.yml b/Unpublished/SDTMIG/CORE-000345/rule.yml index e30c077e5..102e152e3 100644 --- a/Unpublished/SDTMIG/CORE-000345/rule.yml +++ b/Unpublished/SDTMIG/CORE-000345/rule.yml @@ -2,61 +2,66 @@ # Condition: Variable associated with extensible codelist and the use of value 'OTHER' is appropriate to the data being represented # Rule: Value in associated codelist or 'OTHER' Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided - Document: IG v3.4 - Section: 3.2.2 - - Cited Guidance: When the CRF includes a list of values for a qualifier field that includes - "Other" and the "Other" is supplemented with a "Specify" free text field - Document: IG v3.4 - Section: 4.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided]|4.1.2.7.1[When the CRF includes a list of values for a qualifier field that - includes "Other" and the "Other" is supplemented with a "Specify" free text field,] - Document: IG v3.2 - Section: 3.2.2|4.1.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by - following SDTM-specified controlled terminology and format guidelines for variables, when - provided]|4.2.7.1[When the CRF includes a list of values for a qualifier field that - includes "Other" and the "Other" is supplemented with a "Specify" free text field,] - Document: IG v3.3 - Section: 3.2.2|4.2.7.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0021 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided + Document: IG v3.4 + Section: 3.2.2 + - Cited Guidance: + When the CRF includes a list of values for a qualifier field that includes + "Other" and the "Other" is supplemented with a "Specify" free text field + Document: IG v3.4 + Section: 4.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]|4.1.2.7.1[When the CRF includes a list of values for a qualifier field that + includes "Other" and the "Other" is supplemented with a "Specify" free text field,] + Document: IG v3.2 + Section: 3.2.2|4.1.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + 3.2.2[Conformance with the SDTMIG Domain Models is minimally indicated by + following SDTM-specified controlled terminology and format guidelines for variables, when + provided]|4.2.7.1[When the CRF includes a list of values for a qualifier field that + includes "Other" and the "Other" is supplemented with a "Specify" free text field,] + Document: IG v3.3 + Section: 3.2.2|4.2.7.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0021 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000345 Status: Draft - Version: '1' -Description: Trigger error if the value of a variable, which is associated with an extensible + Version: "1" +Description: + Trigger error if the value of a variable, which is associated with an extensible codelist, is in the associated codelist or equal to 'OTHER' Executability: Not Executable Outcome: @@ -65,8 +70,8 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000346/rule.yml b/Unpublished/SDTMIG/CORE-000346/rule.yml index 9dda2b8e3..e36307550 100644 --- a/Unpublished/SDTMIG/CORE-000346/rule.yml +++ b/Unpublished/SDTMIG/CORE-000346/rule.yml @@ -2,54 +2,57 @@ # Condition: --TERM modified for coding # Rule: --MODIFY ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value which represents an alteration to a collected value for coding - purposes. Synonym Qualifier of --TERM. - Document: Model v2.0 - Item: --MODIFY - Section: Events - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TERM is modified for coding purposes, then the modified - text is placed here. - Document: Model v1.4 - Item: Table 2.2.2 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TERM is modified for coding purposes, then the modified - text is placed here. - Document: Model v1.7 - Item: Table 2.2.2.1 - Section: 2.2.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0047 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A value which represents an alteration to a collected value for coding + purposes. Synonym Qualifier of --TERM. + Document: Model v2.0 + Item: --MODIFY + Section: Events + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the value for --TERM is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.4 + Item: Table 2.2.2 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the value for --TERM is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.7 + Item: Table 2.2.2.1 + Section: 2.2.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0047 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000346 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when --TERM has been modified for coding and --MODIFY is null Executability: Not Executable Outcome: @@ -58,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000347/rule.yml b/Unpublished/SDTMIG/CORE-000347/rule.yml index 22bca925a..3fb62f845 100644 --- a/Unpublished/SDTMIG/CORE-000347/rule.yml +++ b/Unpublished/SDTMIG/CORE-000347/rule.yml @@ -2,85 +2,91 @@ # Condition: DSCAT = 'DISPOSITION EVENT' # Rule: DSTERM = 'COMPLETED' or the reason for discontinuation Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if - the subject did not complete, specific verbatim information about the reason for - non-completion - Document: IG v3.4 - Item: Assumption 3b - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT='DISPOSITION EVENT", DSTERM contains either "COMPLETED" or, if - the subject did not complete, specific verbatim information about the disposition event - Document: IG v3.2 - Item: Assumption 3a - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if - the subject did not complete, specific verbatim information about the reason for - non-completion - Document: IG v3.3 - Item: Assumption 3b - Section: 6.2.3 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0071 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if - the subject did not complete, specific verbatim information about the reason for - non-completion - Document: TIG v1.0 - Item: Assumption 3b - Section: 2.8.10.8 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0340 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: IG v3.4 + Item: Assumption 3b + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When DSCAT='DISPOSITION EVENT", DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the disposition event + Document: IG v3.2 + Item: Assumption 3a + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: IG v3.3 + Item: Assumption 3b + Section: 6.2.3 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0071 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: + When DSCAT = "DISPOSITION EVENT" DSTERM contains either "COMPLETED" or, if + the subject did not complete, specific verbatim information about the reason for + non-completion + Document: TIG v1.0 + Item: Assumption 3b + Section: 2.8.10.8 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0340 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Core: Id: CORE-000347 Status: Draft - Version: '1' -Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or + Version: "1" +Description: + Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or the reason for discontinuation Executability: Not Executable Outcome: - Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT = + Message: + DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT = 'DISPOSITION EVENT' Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Use Case: INDH Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000348/rule.yml b/Unpublished/SDTMIG/CORE-000348/rule.yml index a6d2505b7..8a436af28 100644 --- a/Unpublished/SDTMIG/CORE-000348/rule.yml +++ b/Unpublished/SDTMIG/CORE-000348/rule.yml @@ -1,56 +1,60 @@ # Variable: GEN -# Condition: +# Condition: # Rule: Event is not derived Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not - for derived protocol deviations that are more likely to be part of analysis. - Document: IG v3.4 - Item: Assumption 1 - Section: 6.2.7 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not - for derived protocol deviations that are more likely to be part of analysis - Document: IG v3.2 - Item: Assumption 1 - Section: '6.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The DV domain is an Events model for collected protocol deviations and not - for derived protocol deviations that are more likely to be part of analysis. - Document: IG v3.3 - Item: Assumption 1 - Section: 6.2.4 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0076 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis. + Document: IG v3.4 + Item: Assumption 1 + Section: 6.2.7 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis + Document: IG v3.2 + Item: Assumption 1 + Section: "6.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + The DV domain is an Events model for collected protocol deviations and not + for derived protocol deviations that are more likely to be part of analysis. + Document: IG v3.3 + Item: Assumption 1 + Section: 6.2.4 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0076 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000348 Status: Draft - Version: '1' -Description: Trigger error if deviation record is a derived variable, not a deviation that was + Version: "1" +Description: + Trigger error if deviation record is a derived variable, not a deviation that was collected Executability: Not Executable Outcome: @@ -59,8 +63,8 @@ Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DV + - DV Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000349/rule.yml b/Unpublished/SDTMIG/CORE-000349/rule.yml index 37a25028c..4931d9481 100644 --- a/Unpublished/SDTMIG/CORE-000349/rule.yml +++ b/Unpublished/SDTMIG/CORE-000349/rule.yml @@ -1,55 +1,58 @@ # Variable: CMTRT -# Condition: +# Condition: # Rule: CMTRT = collected medication name only Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should not include - dosage, formulation, or other qualifying information. - Document: IG v3.4 - Item: Assumption 2a - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should not include - dosage, formulation, or other qualifying information. - Document: IG v3.2 - Item: Assumption 2a - Section: '6.1' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: CMTRT should only include the medication/therapy name and should not include - dosage, formulation, or other qualifying information. - Document: IG v3.3 - Item: Assumption 2a - Section: 6.1.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0098 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.4 + Item: Assumption 2a + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.2 + Item: Assumption 2a + Section: "6.1" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + CMTRT should only include the medication/therapy name and should not include + dosage, formulation, or other qualifying information. + Document: IG v3.3 + Item: Assumption 2a + Section: 6.1.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0098 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000349 Status: Draft - Version: '1' + Version: "1" Description: Trigger error if CMTRT contains more than just the medication name Executability: Not Executable Outcome: @@ -58,8 +61,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM + - CM Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000350/rule.yml b/Unpublished/SDTMIG/CORE-000350/rule.yml index 2f6d8ab60..cbd157e38 100644 --- a/Unpublished/SDTMIG/CORE-000350/rule.yml +++ b/Unpublished/SDTMIG/CORE-000350/rule.yml @@ -2,53 +2,57 @@ # Condition: --TRT modified # Rule: --MODIFY ^= null Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A value which represents an alteration to a collected value for coding - purposes. Synonym Qualifier of --TRT. - Document: Model v2.0 - Item: --MODIFY - Section: Interventions - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TRT is modified for coding purposes, then the modified - text is placed here. - Document: Model v1.4 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: If the value for --TRT is modified for coding purposes, then the modified - text is placed here. - Document: Model v1.7 - Section: 2.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0099 - Version: '1' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + A value which represents an alteration to a collected value for coding + purposes. Synonym Qualifier of --TRT. + Document: Model v2.0 + Item: --MODIFY + Section: Interventions + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the value for --TRT is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.4 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + If the value for --TRT is modified for coding purposes, then the modified + text is placed here. + Document: Model v1.7 + Section: 2.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0099 + Version: "1" + Version: "2.0" + Version: "3.3" Core: Id: CORE-000350 Status: Draft - Version: '1' -Description: Trigger error if --TRT represents an alteration to the collected value for coding + Version: "1" +Description: + Trigger error if --TRT represents an alteration to the collected value for coding purposes and --MODIFY is null Executability: Not Executable Outcome: @@ -57,9 +61,9 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - CM - - SU + - CM + - SU Sensitivity: Record diff --git a/Unpublished/SDTMIG/CORE-000536/rule.yml b/Unpublished/SDTMIG/CORE-000536/rule.yml index cff437772..5e48d7a85 100644 --- a/Unpublished/SDTMIG/CORE-000536/rule.yml +++ b/Unpublished/SDTMIG/CORE-000536/rule.yml @@ -1,66 +1,66 @@ # Variable: ARMCD -# Condition: +# Condition: # Rule: ARMCD is a valid planned arm code Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the trial. - Document: IG 3.4 - Item: '' - Section: 7.2.1 TA - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: The trial arms table describes each planned arm in the trial. - Document: IG v3.2 - Section: '7.2' - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the trial. - Document: IG v3.3 - Section: 7.2.1 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: CG0415 - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: TIG - References: - - Citations: - - Cited Guidance: A trial design domain that contains each planned arm in the trial. - Document: TIG 1.0 - Item: '' - Section: 2.8.10.27 - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0570 - Version: '1' - Version: '1.0' - Substandard: SDTM - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: IG 3.4 + Item: "" + Section: 7.2.1 TA + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: The trial arms table describes each planned arm in the trial. + Document: IG v3.2 + Section: "7.2" + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: "1" + Version: "2.0" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: IG v3.3 + Section: 7.2.1 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: CG0415 + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: TIG + References: + - Citations: + - Cited Guidance: A trial design domain that contains each planned arm in the trial. + Document: TIG 1.0 + Item: "" + Section: 2.8.10.27 + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0570 + Version: "1" + Version: "1.0" + Substandard: SDTM + Version: "1.0" Check: all: Core: Id: CORE-000536 Status: Draft - Version: '1' + Version: "1" Description: Verify that ARMCD in TA domain is valid planned arm code Executability: Not Executable Outcome: @@ -69,9 +69,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Use Case: INDH Sensitivity: Record diff --git a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml index fbbb95503..f9b7e4110 100644 --- a/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml +++ b/Unpublished/SDTMIG/NICRULE.MEDDRA/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: NICRULE.MEDDRA - Version: '1' - Version: '2.0' - Version: '3.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: NICRULE.MEDDRA + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - - name: $valid_code_term_pairs - operator: not_equal_to - value: true + - name: $valid_code_term_pairs + operator: not_equal_to + value: true Core: - Id: '' + Id: "" Status: Draft - Version: '1' + Version: "1" Description: MEDDRA CODE TERM PAIRS are wrong for SOCCD Operations: -- id: $valid_code_term_pairs - name: --SOCCD - operator: valid_meddra_code_term_pairs + - id: $valid_code_term_pairs + name: --SOCCD + operator: valid_meddra_code_term_pairs Outcome: Message: Invalid whodrug code hierarcy Output Variables: - - USUBJID - - --SOC - - --SOCCD + - USUBJID + - --SOC + - --SOCCD Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SDTMIG/NicTest/rule.yml b/Unpublished/SDTMIG/NicTest/rule.yml index 5af88468a..6076fdb18 100644 --- a/Unpublished/SDTMIG/NicTest/rule.yml +++ b/Unpublished/SDTMIG/NicTest/rule.yml @@ -1,31 +1,32 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: For example, if 0 tablets are taken within a timeframe or 0 mL infused at a - visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, - not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to - zero (0) as an alternative method for indicating doses not taken, not given, or missed. - Document: SDTMIG v3.3 - Item: Assumption 4a - Section: 6.1.3.2 - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: Demo - Version: '1.0' - Version: '2.0' - Version: '3.3' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + For example, if 0 tablets are taken within a timeframe or 0 mL infused at a + visit, then ECOCCUR = 'N' is the standard representation of the collected doses not taken, + not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be set to + zero (0) as an alternative method for indicating doses not taken, not given, or missed. + Document: SDTMIG v3.3 + Item: Assumption 4a + Section: 6.1.3.2 + Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: Demo + Version: "1.0" + Version: "2.0" + Version: "3.3" Check: all: - - name: EXOCCUR - operator: not_equal_to - value: N + - name: EXOCCUR + operator: not_equal_to + value: N Core: Id: NicTest Status: Draft - Version: '1' + Version: "1" Description: Verify the value for ECDOSE is less than 0 Outcome: Message: ECDOSE is less than or equal to 0 @@ -33,8 +34,8 @@ Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EC + - EC Sensitivity: Record diff --git a/Unpublished/SDTMIG/WHODrug/rule.yml b/Unpublished/SDTMIG/WHODrug/rule.yml index 5eedcf743..259f1d750 100644 --- a/Unpublished/SDTMIG/WHODrug/rule.yml +++ b/Unpublished/SDTMIG/WHODrug/rule.yml @@ -1,56 +1,56 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.4' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.3' - - Name: SDTMIG - References: - - Origin: SDTM and SDTMIG Conformance Rules - Rule Identifier: - Id: WHODrug - Version: '1' - Version: '2.0' - Version: '3.2' + - Organization: CDISC + Standards: + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: "1" + Version: "2.0" + Version: "3.4" + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: "1" + Version: "2.0" + Version: "3.3" + - Name: SDTMIG + References: + - Origin: SDTM and SDTMIG Conformance Rules + Rule Identifier: + Id: WHODrug + Version: "1" + Version: "2.0" + Version: "3.2" Check: all: - - name: $valid_whodrug_codes - operator: not_equal_to - value: true + - name: $valid_whodrug_codes + operator: not_equal_to + value: true Core: Id: WHODrug Status: Draft - Version: '1' + Version: "1" Description: WHODRUG hierarchy is valid in provided whodrug dictionary version Executability: Fully Executable Operations: -- id: $valid_whodrug_codes - operator: whodrug_code_hierarchy + - id: $valid_whodrug_codes + operator: whodrug_code_hierarchy Outcome: Message: Invalid whodrug code hierarcy Output Variables: - - --DECOD - - --CLAS - - --CLASCD + - --DECOD + - --CLAS + - --CLASCD Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml index fcc8fff54..2eb350f4f 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml @@ -1,102 +1,110 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.0 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFENDTC in - the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND101 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.0 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFENDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND101 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: variable_name - operator: equal_to - value: RFENDTC - - any: - # TODO: change into define_variable_has_method (function requested https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) - - name: define_variable_has_comment + - name: variable_name operator: equal_to - value: false - #- name: define_variable_origin_type - # operator: equal_to - # value: Derived + value: RFENDTC + - any: + # TODO: change into define_variable_has_method (function requested https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) + - name: define_variable_has_comment + operator: equal_to + value: + false + #- name: define_variable_origin_type + # operator: equal_to + # value: Derived Core: Id: CDISC.SENDIG.101 Status: Draft - Version: '1' -Description: Raise a message when the define.xml does not explain how DM.RFENDTC was populated, + Version: "1" +Description: + Raise a message when the define.xml does not explain how DM.RFENDTC was populated, using either def:CommentOID (on ItemDef) or MethodOID (on ItemRef) Executability: Partially Executable - Possible Underreporting Outcome: @@ -106,8 +114,8 @@ Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml index 9f5177f35..ba9603167 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml @@ -1,101 +1,107 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.2 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.2 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND105 - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: "2" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.2 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.2 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND105 + Version: "2" + Version: "5.0" + Version: "1.0" Check: # Rule applies for the case that all of DM, TS, and TX are all present # which applies to >99% of the cases # When one of the above domains is not present, the rule may be skipped all: # DM: SPECIES variable does not exists - - name: SPECIES - operator: not_exists - # There is no TSPARMCD=SPECIES in TS - #- name: $distinct_tsparmcd - # operator: does_not_contain - # value: SPECIES - # value_is_literal: true - #- all: - # #- name: TX - # # operator: non_empty - # - name: $distinct_txparmcd - # operator: is_not_contained_by - # value: SPECIES - # #value_is_literal: true + - name: SPECIES + operator: not_exists + # There is no TSPARMCD=SPECIES in TS + #- name: $distinct_tsparmcd + # operator: does_not_contain + # value: SPECIES + # value_is_literal: true + #- all: + # #- name: TX + # # operator: non_empty + # - name: $distinct_txparmcd + # operator: is_not_contained_by + # value: SPECIES + # #value_is_literal: true Core: Id: CDISC.SENDIG.105 Status: Draft - Version: '1' -Description: Raise an error when the variable SPECIES is not present in DM, and there is no record + Version: "1" +Description: + Raise an error when the variable SPECIES is not present in DM, and there is no record TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX Executability: Fully Executable #Operations: @@ -114,7 +120,8 @@ Executability: Fully Executable # name: TXPARMCD # operator: distinct Outcome: - Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is + Message: + SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX #Output Variables: # - $distinct_tsparmcd @@ -124,12 +131,12 @@ Rule Type: Variable Metadata Check Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE # #- TRIAL DESIGN # - ALL Domains: Include: - - DM - # - ALL - # Sensitivity: Record + - DM + # - ALL + # Sensitivity: Record Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml index cf4bbfe3b..25841fe01 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml @@ -1,19 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the TA domain. - Document: IG v3.1 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND107 - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: DM.ARMCD; Should be populated when Arms have been defined in the TA domain. + Document: IG v3.1 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND107 + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: # TODO: operator "exists" must act on the set of datasets (i.e. the whole submission) @@ -22,7 +22,7 @@ Check: # check on value for DM.ARMCD #- name: ARMCD # operator: empty - # 2024-03-15: starting from Wiki under 'operations', + # 2024-03-15: starting from Wiki under 'operations', # Flag an error if MIDS is in the dataset currently being evaluated and the TM domain is not present in the study # check whether TA dataset is present (in combination with Rule Type: Domain Presence Check) #- name: TA @@ -31,40 +31,41 @@ Check: # operator: equal_to # value: true # Just trying an alternative 2024-06-04 - - name: ARMCD - operator: empty - #- name: $TA_exists - # operator: equal_to - # value: true - - name: $TA_present - operator: equal_to - value: true + - name: ARMCD + operator: empty + #- name: $TA_exists + # operator: equal_to + # value: true + - name: $TA_present + operator: equal_to + value: true Core: Id: CDISC.SENDIG.107 Status: Draft - Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must - be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not - present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Fully Executable Operations: -- domain: DM # necessary? - id: $DM_ARMCD_null - name: ARMCD - operator: variable_is_null - # Alternative approach 2024-06-04 - # BUT this fails when there is no TA dataset at all -- domain: TA - id: $TA_exists - name: ARMCD - operator: variable_exists - # 2024-06-04: does this check whether TA is present in the study? - # NO: it doesn't like that it works as I was thinking -- id: $TA_present - name: TA - operator: study_domains + - domain: DM # necessary? + id: $DM_ARMCD_null + name: ARMCD + operator: variable_is_null + # Alternative approach 2024-06-04 + # BUT this fails when there is no TA dataset at all + - domain: TA + id: $TA_exists + name: ARMCD + operator: variable_exists + # 2024-06-04: does this check whether TA is present in the study? + # NO: it doesn't like that it works as I was thinking + - id: $TA_present + name: TA + operator: study_domains Outcome: Message: Arms are defined in TA.ARMCD, but DM.ARMCD is empty # Rule Type: Record Data @@ -72,10 +73,10 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - # - ALL + - SPECIAL PURPOSE + # - ALL Domains: Include: - - DM - # - TA # ? + - DM + # - TA # ? Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml index b27c3f640..047511805 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.111/rule.yml @@ -1,90 +1,90 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.0 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Data in BRTHDTC should never be derived from another variable. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND111 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.0 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: Data in BRTHDTC should never be derived from another variable. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND111 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: variable_name - operator: equal_to - value: BRTHDTC - - name: define_variable_is_collected - operator: equal_to - value: false + - name: variable_name + operator: equal_to + value: BRTHDTC + - name: define_variable_is_collected + operator: equal_to + value: false Core: Id: CDISC.SENDIG.111 Status: Draft - Version: '1' + Version: "1" Description: Check 'BRTHDTC ORIGIN = collected in the Define-XML document' Executability: Fully Executable Outcome: @@ -94,8 +94,8 @@ Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml index f77eb70d1..937100c73 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml @@ -1,123 +1,131 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.0 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Sponsors may choose to derive AGE and AGEU using an algorithm involving - BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file - comments. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND112.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.0 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Sponsors may choose to derive AGE and AGEU using an algorithm involving + BRTHDTC and RFSTDTC. Sponsors should indicate how AGE was populated in the define file + comments. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND112.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: variable_name - operator: equal_to - value: AGE - # This may cause to be "overreporting", as there is no function define_variable_is_derived - # but essentially, AGE should not be "assigned" - - name: define_variable_is_collected - operator: equal_to - value: false - - name: define_variable_has_comment - operator: equal_to - value: false - # Commented out for the moment, as awaiting new function - #- name: define_variable_has_method - # operator: equal_to - # value: false + - name: variable_name + operator: equal_to + value: AGE + # This may cause to be "overreporting", as there is no function define_variable_is_derived + # but essentially, AGE should not be "assigned" + - name: define_variable_is_collected + operator: equal_to + value: false + - name: define_variable_has_comment + operator: equal_to + value: false + # Commented out for the moment, as awaiting new function + #- name: define_variable_has_method + # operator: equal_to + # value: false Core: Id: CDISC.SENDIG.112 Status: Draft - Version: '1' -Description: When AGE is described as "derived" in the define.xml, check whether either a Method or + Version: "1" +Description: + When AGE is described as "derived" in the define.xml, check whether either a Method or a Comment is assigned to the variable AGE in the define.xml Executability: Partially Executable - Possible Overreporting Outcome: - Message: 'When AGE is described as "derived" in the define.xml, either a Comment or a Method must be + Message: + 'When AGE is described as "derived" in the define.xml, either a Comment or a Method must be associated to the variable in the define.xml' Rule Type: Value Check against Define XML Variable Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml index 3c625caad..5d7acdb6b 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml @@ -1,33 +1,35 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Because there are no time gaps between Elements, the SEENDTC value for the - last Element is the date of subject disposition. - # ATTENTION: only applicable to SENDIG-3.0 - # REPLACED by rule 284 as of SENDIG-3-1 - Document: IG v3.0 - Item: Specification - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND127 - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Because there are no time gaps between Elements, the SEENDTC value for the + last Element is the date of subject disposition. + # ATTENTION: only applicable to SENDIG-3.0 + # REPLACED by rule 284 as of SENDIG-3-1 + Document: IG v3.0 + Item: Specification + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND127 + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: # TODO: operator "exists" must act on the set of datasets (i.e. the whole submission) - - name: SEENDTC - operator: not_equal_to - value: '2006-06-10' + - name: SEENDTC + operator: not_equal_to + value: "2006-06-10" Core: Id: CDISC.SENDIG.127 Status: Draft - Version: '1' -Description: Because there are no time gaps between Elements, the SEENDTC value for the last Element + Version: "1" +Description: + Because there are no time gaps between Elements, the SEENDTC value for the last Element is the date of subject disposition. Executability: Fully Executable Outcome: @@ -36,8 +38,8 @@ Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - SE + - SE Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml index e8b1aa14b..cf4fe560c 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml @@ -1,45 +1,48 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Define-XML document contains an explanation of EXDOSE values with - respect for intended or actual dose levels. - Document: IG v3.1 - Item: Assumption 4 - Section: 6.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND137 - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Define-XML document contains an explanation of EXDOSE values with + respect for intended or actual dose levels. + Document: IG v3.1 + Item: Assumption 4 + Section: 6.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND137 + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: - - name: variable_name - operator: equal_to - value: EXDOSE - - name: define_variable_has_comment - operator: equal_to - value: false + - name: variable_name + operator: equal_to + value: EXDOSE + - name: define_variable_has_comment + operator: equal_to + value: false Core: Id: CDISC.SENDIG.137 Status: Draft - Version: '1' -Description: Raise a message when the define.xml does not contain an explanation of EXDOSE values + Version: "1" +Description: + Raise a message when the define.xml does not contain an explanation of EXDOSE values with respect for intended or actual dose levels, using a reference to a def:CommentDef Executability: Partially Executable - Possible Underreporting Outcome: - Message: The define.xml does not contain an explanation of EXDOSE values with respect for intended + Message: + The define.xml does not contain an explanation of EXDOSE values with respect for intended or actual dose levels # Rule Type: Value Check against Define XML Variable Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - INTERVENTIONS + - INTERVENTIONS Domains: Include: - - EX + - EX Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml index 8c6f7ccab..791325559 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml @@ -1,70 +1,74 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a record of the - final disposition of subjects as they reach their final disposition, and this can be - recorded at any stage throughout the study. At study completion, one record must exist for - each subject used in the study. - Document: IG v3.0 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a record of the - final disposition of subjects as they reach their final disposition, and this can be - recorded at any stage throughout the study. At study completion, one record must exist for - each subject used in the study. - Document: IG v3.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a record of the - final disposition of subjects as they reach their final disposition, and this can be - recorded at any stage throughout the study. At study completion, one record must exist for - each subject used in the study. - Document: IG v3.1.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per subject. The disposition dataset provides a record of the - final disposition of subjects as they reach their final disposition, and this can be - recorded at any stage throughout the study. At study completion, one record must exist for - each subject used in the study. - Document: IG v3.1 - Item: Assumption 1.a - Section: 6.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND140 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.0 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + One record per subject. The disposition dataset provides a record of the + final disposition of subjects as they reach their final disposition, and this can be + recorded at any stage throughout the study. At study completion, one record must exist for + each subject used in the study. + Document: IG v3.1 + Item: Assumption 1.a + Section: 6.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND140 + Version: "1" + Version: "5.0" + Version: "1.1" Check: # Rule: DS has one record per USUBJID in DM any: @@ -76,18 +80,18 @@ Check: # operator: is_not_contained_by # value: $dm_usubjid # DM.USUBJID must be in DS.USUBJID - - all: - - name: USUBJID - operator: non_empty - - name: USUBJID - operator: is_not_contained_by - value: $ds_usubjid - # TODO: how do we express that for each record in DM, there must exactly be one record in DS? + - all: + - name: USUBJID + operator: non_empty + - name: USUBJID + operator: is_not_contained_by + value: $ds_usubjid + # TODO: how do we express that for each record in DM, there must exactly be one record in DS? Core: Id: CDISC.SENDIG.140 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when USUBJID is not present in DM in DM.USUBJID Executability: Fully Executable Operations: @@ -95,20 +99,20 @@ Operations: # id: $dm_usubjid # name: USUBJID # operator: distinct -- domain: DS - id: $ds_usubjid - name: USUBJID - operator: distinct + - domain: DS + id: $ds_usubjid + name: USUBJID + operator: distinct Outcome: Message: There is no record in DS or there is more than 1 record in DS for a record in DM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE - - EVENTS + - SPECIAL PURPOSE + - EVENTS Domains: Include: # - DS - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml index b71ab189b..b58706a44 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.153/rule.yml @@ -1,107 +1,113 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the - BGSTRESU should remain consistent throughout the course of the study. - Document: IG v3.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU for a subject may change over the course of the study, for - example, g to kg, but the BGSTRESU should remain consistent throughout the course of the - study. - Document: IG v3.0 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the - BGSTRESU should remain consistent throughout the course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the - BGSTRESU should remain consistent throughout the course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the - BGSTRESU should remain consistent throughout the course of the study. - Document: IG v3.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The BGORRESU may change over the course of the study, e.g., g to kg, but the - BGSTRESU should remain consistent throughout the course of the study. - Document: IG v3.1.1 - Section: 6.3.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND153 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The BGORRESU for a subject may change over the course of the study, for + example, g to kg, but the BGSTRESU should remain consistent throughout the course of the + study. + Document: IG v3.0 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The BGORRESU may change over the course of the study, e.g., g to kg, but the + BGSTRESU should remain consistent throughout the course of the study. + Document: IG v3.1.1 + Section: 6.3.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND153 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: BGSTRESU - operator: is_inconsistent_across_dataset - value: BGTESTCD + - name: BGSTRESU + operator: is_inconsistent_across_dataset + value: BGTESTCD Core: Id: CDISC.SENDIG.153 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when BGSTRESU is not consistent within BGTESTCD Executability: Fully Executable Outcome: Message: BGSTRESU is not consistent within BGTESTCD Output Variables: - - BGSTRESU - - BGTESTCD + - BGSTRESU + - BGTESTCD Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BG + - BG Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml index f4e8c8edd..400c9a4c4 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.161/rule.yml @@ -1,88 +1,92 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization of results and should - not be a duplication of CLTEST or CLSCAT which are considered categories at the time of - collection. - Document: IG v.3.0 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization of results and should - not be a duplication of CLTEST or CLSCAT which are considered categories at the time of - collection. - Document: IG v.3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization of results and should - not be a duplication of CLTEST or CLSCAT which are considered categories at the time of - collection. - Document: IG v.3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: CLRESCAT is used for post collection categorization of results and should - not be a duplication of CLTEST or CLSCAT which are considered categories at the time of - collection. - Document: IG v.3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND161 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.0 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + CLRESCAT is used for post collection categorization of results and should + not be a duplication of CLTEST or CLSCAT which are considered categories at the time of + collection. + Document: IG v.3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND161 + Version: "1" + Version: "5.0" + Version: "1.1" Check: any: - - name: CLRESCAT - operator: equal_to - value: CLTEST - - name: CLRESCAT - operator: equal_to - value: CLSCAT + - name: CLRESCAT + operator: equal_to + value: CLTEST + - name: CLRESCAT + operator: equal_to + value: CLSCAT Core: Id: CDISC.SENDIG.161 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when CLRESCAT is equal to CLTEST or when CLRESCAT is equal to CLSCAT Executability: Fully Executable Outcome: Message: CLRESCAT may not be equal to CLTEST and CLRESCAT may not be equal to CLSCAT Output Variables: - - CLRESCAT - - CLTEST - - CLSCAT + - CLRESCAT + - CLTEST + - CLSCAT Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL + - CL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml index a4e9045f8..cd7a1e757 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml @@ -1,98 +1,100 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.0 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per finding per specimen per subject - Document: SENDIG v3.1 - Section: 6.3.7.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND180 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.0 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per finding per specimen per subject + Document: SENDIG v3.1 + Section: 6.3.7.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND180 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: #- name: MIDTC # operator: non_empty #- name: MISPEC # operator: non_empty - - name: USUBJID - operator: is_not_unique_set - value: - - MISTESTCD - - MISPEC - - MISTRESC - - MILAT # Laterality: when present and populated - - MIDIR # Directionality: when present and populated - - MIANTREG # Anatomical region: when present and populated + - name: USUBJID + operator: is_not_unique_set + value: + - MISTESTCD + - MISPEC + - MISTRESC + - MILAT # Laterality: when present and populated + - MIDIR # Directionality: when present and populated + - MIANTREG # Anatomical region: when present and populated Core: Id: CDISC.SENDIG.180 Status: Draft - Version: '1' -Description: Raise an error when there is more than one record present for any particular - Microscopic Finding in the MI Domain, for a specific subject, test code, specimen, laterality, + Version: "1" +Description: + Raise an error when there is more than one record present for any particular + Microscopic Finding in the MI Domain, for a specific subject, test code, specimen, laterality, directionality, anatomical region and standardized resulz Executability: Fully Executable Outcome: - Message: The Microscopic Finding record is not unique for this subject, test code, specimen, - standardized result and laterality (when present and populated), directionality (when present + Message: + The Microscopic Finding record is not unique for this subject, test code, specimen, + standardized result and laterality (when present and populated), directionality (when present and populated) and anatomical region (when present and populated) Output Variables: - - USUBJID - - MITESTCD - - MISTRESC - - MISPEC - # The following variables and values should also appear in the output - # when the column is present. - # In case it is not, we get a "skip" - # - MILAT - # - MIDIR - # - MIANTREG + - USUBJID + - MITESTCD + - MISTRESC + - MISPEC + # The following variables and values should also appear in the output + # when the column is present. + # In case it is not, we get a "skip" + # - MILAT + # - MIDIR + # - MIANTREG Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml index 4e8d1273e..e87bba749 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml @@ -1,118 +1,124 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # ATTENTION: NOT APPLICABLE to SENDIG v.3.0! For SENDIG 3.0, only "%" is allowed. # This is part 2 of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=RATIO may not be mixed - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') - or percentages (unit = %). Ratios and percentages should not be mixed. - Document: IG v3.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') - or percentages (unit = %). Ratios and percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') - or percentages (unit = %). Ratios and percentages should not be mixed. - Document: IG v3.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') - or percentages (unit = %). Ratios and percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Organ weight measurement ratios should be presented as pure ratios ('RATIO') - or percentages (unit = %). Ratios and percentages should not be mixed. - Document: IG v3.1.1 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Organ weight measurement ratios should be presented as pure ratios ('RATIO') + or percentages (unit = %). Ratios and percentages should not be mixed. + Document: IG v3.1.1 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # Precondition SEND190.1: # Rule is for OMTESTCD=OWBR,OWBW,OWHT - - any: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMTESTCD - operator: equal_to - value: OWHT - # Part: Ratios and percentages should not be mixed. - - all: - - name: OMSTRESU - operator: is_inconsistent_across_dataset - value: - - OMTESTCD + - any: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMTESTCD + operator: equal_to + value: OWHT + # Part: Ratios and percentages should not be mixed. + - all: + - name: OMSTRESU + operator: is_inconsistent_across_dataset + value: + - OMTESTCD Core: Id: CDISC.SENDIG.190.1B Status: Draft - Version: '1' -Description: "Second part of the rule: trigger error when, for the given test, the value of OMSTRESU is + Version: "1" +Description: + "Second part of the rule: trigger error when, for the given test, the value of OMSTRESU is inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT" Executability: Fully Executable Outcome: Message: The organ weight standardized measurement unit must be consistent for the given OMTESTCD. Output Variables: - - OMTESTCD - - OMSTRESC - - OMSTRESN - - OMSTRESU + - OMTESTCD + - OMSTRESC + - OMSTRESN + - OMSTRESU Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml index 3d2e9d32a..bc61341bb 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml @@ -1,188 +1,194 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # ATTENTION: ONLY APPLICABLE to SENDIG v.3.0! For SENDIG 3.1, only "%" and "RATIO" is allowed. # This is part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Organ measurement ratios within a single study should either be pure ratios - with no units specified or percentages with unit shown as "%". It is strongly recommended - that pure ratios and percentages should not be mixed. - Document: IG v3.0 - Item: Assumption 3 - Section: 6.3.9.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND190 - Version: '1' - Version: '5.0' - Version: '3.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Organ measurement ratios within a single study should either be pure ratios + with no units specified or percentages with unit shown as "%". It is strongly recommended + that pure ratios and percentages should not be mixed. + Document: IG v3.0 + Item: Assumption 3 + Section: 6.3.9.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND190 + Version: "1" + Version: "5.0" + Version: "3.0" Check: any: # Part A: of the rule: only "%" and null are allowed - - all: - - name: OMTESTCD - operator: equal_to - value: OWHT - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMSTRESU - operator: not_equal_to - value: '' - - name: OMSTRESU - operator: not_equal_to - value: '%' - # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed - # 2026-03-03: we exclude OMSTAT='NOT DONE' - # "RATIO" is not considered here - # OMTESTCD=OWBR: Organ to Brain Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 - - all: - - name: OMTESTCD - operator: equal_to - value: OWBR - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owbr_percent - operator: greater_than - value: 0 - - name: $owbr_ratio_null_unit - operator: greater_than - value: 0 - # OMTESTCD=OWBW: Organ to BodyWeight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 - # 2026-03-03: we exclude OMSTAT='NOT DONE' - - all: - - name: OMTESTCD - operator: equal_to - value: OWBW - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owbw_percent - operator: greater_than - value: 0 - - name: $owbw_ratio_null_unit - operator: greater_than - value: 0 - # OMTESTCD=OWHT: Organ to Heart Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU='RATIO'' rcords > 0 - - all: - - name: OMTESTCD - operator: equal_to - value: OWHT - - name: OMSTAT # exclude "NOT DONE" records - operator: not_equal_to - value: 'NOT DONE' - - name: $owht_percent - operator: greater_than - value: 0 - - name: $owht_ratio_null_unit - operator: greater_than - value: 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWHT + - name: OMSTRESU + operator: not_equal_to + value: "" + - name: OMSTRESU + operator: not_equal_to + value: "%" + - all: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMSTRESU + operator: not_equal_to + value: "" + - name: OMSTRESU + operator: not_equal_to + value: "%" + - all: + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMSTRESU + operator: not_equal_to + value: "" + - name: OMSTRESU + operator: not_equal_to + value: "%" + # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed + # 2026-03-03: we exclude OMSTAT='NOT DONE' + # "RATIO" is not considered here + # OMTESTCD=OWBR: Organ to Brain Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWBR + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: "NOT DONE" + - name: $owbr_percent + operator: greater_than + value: 0 + - name: $owbr_ratio_null_unit + operator: greater_than + value: 0 + # OMTESTCD=OWBW: Organ to BodyWeight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 + # 2026-03-03: we exclude OMSTAT='NOT DONE' + - all: + - name: OMTESTCD + operator: equal_to + value: OWBW + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: "NOT DONE" + - name: $owbw_percent + operator: greater_than + value: 0 + - name: $owbw_ratio_null_unit + operator: greater_than + value: 0 + # OMTESTCD=OWHT: Organ to Heart Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU='RATIO'' rcords > 0 + - all: + - name: OMTESTCD + operator: equal_to + value: OWHT + - name: OMSTAT # exclude "NOT DONE" records + operator: not_equal_to + value: "NOT DONE" + - name: $owht_percent + operator: greater_than + value: 0 + - name: $owht_ratio_null_unit + operator: greater_than + value: 0 Core: Id: CDISC.SENDIG.190B Status: Draft - Version: '1' -Description: Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the + Version: "1" +Description: + Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT Executability: Fully Executable Operations: # OWBR: Organ to Brain Weight Ratio -- filter: - OMSTRESU: '%' - OMTESTCD: 'OWBR' - id: $owbr_percent - name: OMTESTCD # 2026-02-10 - operator: record_count -- filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWBR' - # OMSTRESU: empty # 2026-02-10 - id: $owbr_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count - # OWBW: Organ to BodyWeight Ratio -- filter: - OMSTRESU: '%' - OMTESTCD: 'OWBW' - id: $owbw_percent - name: OMTESTCD # 2026-02-10 - operator: record_count -- filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWBW' - # OMSTRESU: empty # 2026-02-10 - id: $owbw_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count - # OWHT: Organ to Heart Weight Ratio -- filter: - OMSTRESU: '%' - OMTESTCD: 'OWHT' - id: $owht_percent - name: OMTESTCD # 2026-02-10 - operator: record_count -- filter: - OMSTAT: '' # OMSTAT must be empty - OMSTRESU: '' - OMTESTCD: 'OWHT' - # OMSTRESU: empty # 2026-02-10 - id: $owht_ratio_null_unit - name: OMTESTCD # 2026-02-10 - operator: record_count - # NOT USED FOR THE MOMENT - # - domain: OM - # id: $om_stresu_distinct - # name: OMSTRESU - # operator: distinct + - filter: + OMSTRESU: "%" + OMTESTCD: "OWBR" + id: $owbr_percent + name: OMTESTCD # 2026-02-10 + operator: record_count + - filter: + OMSTAT: "" # OMSTAT must be empty + OMSTRESU: "" + OMTESTCD: + "OWBR" + # OMSTRESU: empty # 2026-02-10 + id: $owbr_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count + # OWBW: Organ to BodyWeight Ratio + - filter: + OMSTRESU: "%" + OMTESTCD: "OWBW" + id: $owbw_percent + name: OMTESTCD # 2026-02-10 + operator: record_count + - filter: + OMSTAT: "" # OMSTAT must be empty + OMSTRESU: "" + OMTESTCD: + "OWBW" + # OMSTRESU: empty # 2026-02-10 + id: $owbw_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count + # OWHT: Organ to Heart Weight Ratio + - filter: + OMSTRESU: "%" + OMTESTCD: "OWHT" + id: $owht_percent + name: OMTESTCD # 2026-02-10 + operator: record_count + - filter: + OMSTAT: "" # OMSTAT must be empty + OMSTRESU: "" + OMTESTCD: + "OWHT" + # OMSTRESU: empty # 2026-02-10 + id: $owht_ratio_null_unit + name: OMTESTCD # 2026-02-10 + operator: record_count + # NOT USED FOR THE MOMENT + # - domain: OM + # id: $om_stresu_distinct + # name: OMSTRESU + # operator: distinct Outcome: - Message: The organ weight standardized measurement unit must be consistent for the given + Message: + The organ weight standardized measurement unit must be consistent for the given OMTESTCD'. Output Variables: - - OMTESTCD - - OMSTRESC - - OMSTRESN - - OMSTRESU - - $owbr_percent - - $owbr_ratio_null_unit - - $owbw_percent - - $owbw_ratio_null_unit - - $owht_percent - - $owht_ratio_null_unit + - OMTESTCD + - OMSTRESC + - OMSTRESN + - OMSTRESU + - $owbr_percent + - $owbr_ratio_null_unit + - $owbw_percent + - $owbw_ratio_null_unit + - $owht_percent + - $owht_ratio_null_unit Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - OM + - OM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml index 0fd22dd03..c352c88a3 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.203/rule.yml @@ -1,141 +1,148 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 3.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based - off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC - - EXSTDTC) + 1.' - Document: 'SENDIG v3.0' - Item: 'Assumption 4.b' - Section: '6.3.14.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND203' - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 3.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "3.0" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 4.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 4.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "3.1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 4.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 4.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "TFDETECT: If the tumor was detected as a palpable mass, then TFDETECT is based + off the PM domain variable PMDTC (Start Date/Time of Observation). This is calculated as (PMDTC + - EXSTDTC) + 1." + Document: "SENDIG v3.0" + Item: "Assumption 4.b" + Section: "6.3.14.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND203" + Version: "2" + Version: "5.0" + Version: "1.0" Check: all: - - name: PMDTC - operator: is_complete_date - - name: EXSTDTC - operator: is_complete_date - - name: TFDETECT # checking failure criteria - operator: not_equal_to - value: 2 #$val_dy # this is created in the operations statement that follows + - name: PMDTC + operator: is_complete_date + - name: EXSTDTC + operator: is_complete_date + - name: TFDETECT # checking failure criteria + operator: not_equal_to + value: 2 #$val_dy # this is created in the operations statement that follows # Questions Jozef (Discussion with Christy Kubin): # I presume we must add that PMSPID = TFSPID - # Does this assume that all the records with a specific PMSPID all have the same + # Does this assume that all the records with a specific PMSPID all have the same # TFDTC (or at least the data part of it)? Core: Id: CDISC.SENDIG.203 Status: Draft - Version: '1' -Description: 'Raise an error when TFDETECT is not equal to the date portion of PMDTC - date portion of - EXSTDTC + 1.' + Version: "1" +Description: + "Raise an error when TFDETECT is not equal to the date portion of PMDTC - date portion of + EXSTDTC + 1." Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: PM -- Keys: - - USUBJID - Name: EX + - Keys: + - USUBJID + Name: PM + - Keys: + - USUBJID + Name: EX Operations: -- id: $val_dy - name: --DTC - operator: dy # does dy op take into acct +1? + - id: $val_dy + name: --DTC + operator: dy # does dy op take into acct +1? Outcome: - Message: 'TFDETECT is not equal to (PMDTC - EXSTDTC) + 1' + Message: "TFDETECT is not equal to (PMDTC - EXSTDTC) + 1" Output Variables: #- $val_dy - - TFDETECT - - PMDTC - - EXSTDTC + - TFDETECT + - PMDTC + - EXSTDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - TF + - TF Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml index 1eee935c5..97fa2c24e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.216/rule.yml @@ -1,160 +1,166 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.0 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Elements with different start and end rules are different Elements and must - be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same - treatment but different durations are different Elements). The same applies to - nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from - a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 - days if drug can be detected in a blood sample). Additional factors beyond treatment, - start rule, and either end rule or duration do not distinguish separate Elements. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND216 - Version: '2' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.0 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Elements with different start and end rules are different Elements and must + be represented as unique values in ELEMENT and ETCD (i.e., Elements involving the same + treatment but different durations are different Elements). The same applies to + nontreatment Elements (e.g., a washout with a fixed duration of 14 days is different from + a washout that ends after 7 days if drug cannot be detected in a blood sample or after 14 + days if drug can be detected in a blood sample). Additional factors beyond treatment, + start rule, and either end rule or duration do not distinguish separate Elements. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND216 + Version: "2" + Version: "5.0" + Version: "1.0" Check: any: - - all: + - all: + - name: ETCD + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEENRL + - name: TEDUR + operator: not_exists + - all: + - name: ETCD + operator: is_not_unique_set + value: + - ELEMENT + - TESTRL + - TEDUR + - name: TEENRL + operator: not_exists - name: ETCD operator: is_not_unique_set value: - - ELEMENT - - TESTRL - - TEENRL - - name: TEDUR - operator: not_exists - - all: - - name: ETCD - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEDUR - - name: TEENRL - operator: not_exists - - name: ETCD - operator: is_not_unique_set - value: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Core: Id: CDISC.SENDIG.216 Status: Draft - Version: '1' + Version: "1" Description: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR must be unique for each ETCD. Executability: Fully Executable Outcome: Message: The combination of ELEMENT, TESTRL, TEENRL, and TEDUR is not unique for each ETCD Output Variables: - - ELEMENT - - TESTRL - - TEENRL - - TEDUR + - ELEMENT + - TESTRL + - TEENRL + - TEDUR Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE + - TE Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml index 7b3487dbc..b33aff074 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.217/rule.yml @@ -1,122 +1,128 @@ # Variable: ALL -# Condition: +# Condition: # Rule: No gaps between elements Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.0 - Item: Assumption 5 | Assumption 4 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are no gaps between Elements. The instant one Element ends, the next - Element begins. A subject spends no time "between" Elements; The Elements in each Arm must - be consecutive in time; it is not correct to leave any gaps in time between Elements. - Document: IG v3.1.1 - Item: Assumption 6 | Assumption 5 - Section: 7.2.1.1 | 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND217 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.0 + Item: Assumption 5 | Assumption 4 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + There are no gaps between Elements. The instant one Element ends, the next + Element begins. A subject spends no time "between" Elements; The Elements in each Arm must + be consecutive in time; it is not correct to leave any gaps in time between Elements. + Document: IG v3.1.1 + Item: Assumption 6 | Assumption 5 + Section: 7.2.1.1 | 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND217 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - Core: Id: CDISC.SENDIG.217 Status: Draft - Version: '1' + Version: "1" Description: Executability: Fully Executable Outcome: @@ -125,9 +131,9 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA - - TE + - TA + - TE Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml index 48bef19eb..6f810ca0f 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml @@ -1,123 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.0 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '3.0' -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '3.1' -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: 3.1.1 -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.1' -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.2' -- Organization: CDISC - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The values of ETCD used in the Trial Arms dataset must match values for the - same Element in the Trial Elements dataset. - Document: IG v3.1.1 - Section: 7.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND222 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.0 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: "3.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: "3.1" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: "1.1" + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: "1.2" + - Organization: CDISC + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The values of ETCD used in the Trial Arms dataset must match values for the + same Element in the Trial Elements dataset. + Document: IG v3.1.1 + Section: 7.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND222 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # TA.ETCD non-empty. Required as otherwise the "blank" value is checked against TE - - name: ETCD - operator: non_empty - # TA.ETCD is not in the list of distinct values of ETCD in TE - - name: ETCD - operator: is_not_contained_by - value: $te_etcd + - name: ETCD + operator: non_empty + # TA.ETCD is not in the list of distinct values of ETCD in TE + - name: ETCD + operator: is_not_contained_by + value: $te_etcd Core: Id: CDISC.SENDIG.222 Status: Draft - Version: '1' -Description: The values of ETCD used in the Trial Arms dataset must match values for the same + Version: "1" +Description: + The values of ETCD used in the Trial Arms dataset must match values for the same Element in the Trial Elements dataset. Executability: Fully Executable Operations: -- domain: TE - id: $te_etcd - name: ETCD - operator: distinct + - domain: TE + id: $te_etcd + name: ETCD + operator: distinct Outcome: Message: TA.ETCD is not present in TE.ETCD Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TA + - TA Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml index 40b9f727f..e78fc4583 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml @@ -1,119 +1,126 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND223 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND223 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: ARMCD - operator: non_empty - - name: ARMCD - operator: is_not_contained_by - value: $ta_armcd + - name: ARMCD + operator: non_empty + - name: ARMCD + operator: is_not_contained_by + value: $ta_armcd Core: Id: CDISC.SENDIG.223 Status: Draft - Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must - be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not - present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Fully Executable Operations: -- domain: TA - id: $ta_armcd - name: ARMCD - operator: distinct + - domain: TA + id: $ta_armcd + name: ARMCD + operator: distinct Outcome: Message: ARMCD is not present in TA.ARMCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml index 102af0041..84e275af9 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml @@ -1,119 +1,126 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.0 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined - as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). - Document: IG v3.1.1 - Item: Specification - Section: 7.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND225 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.0 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + ARM and ARMCD values in DM and TA must coincide (ARM and ARMCD are defined + as the planned Trial Arms in TA, and the planned Arms are then applied to subjects in DM). + Document: IG v3.1.1 + Item: Specification + Section: 7.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND225 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: ARM - operator: non_empty - - name: ARM - operator: is_not_contained_by - value: $ta_arm + - name: ARM + operator: non_empty + - name: ARM + operator: is_not_contained_by + value: $ta_arm Core: Id: CDISC.SENDIG.225 Status: Draft - Version: '1' -Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must - be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not - present in TA.ARMCD and therefore acknowledges that false positives may be recorded when + Version: "1" +Description: + When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must + be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not + present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. Executability: Fully Executable Operations: -- domain: TA - id: $ta_arm - name: ARM - operator: distinct + - domain: TA + id: $ta_arm + name: ARM + operator: distinct Outcome: Message: ARM is not present in TA.ARM Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml index 15b606716..01b4875db 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml @@ -1,108 +1,114 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.0 - Item: Specification - Section: 7.6.1 | 7.6.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The parameters listed as "Yes" in the "Should Include" column should always - be included in the Trial Summary dataset, in order to provide proper study definition. - (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, - SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, - TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) - Document: IG v3.1.1 - Item: Specification - Section: 7.6.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND247.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.0 + Item: Specification + Section: 7.6.1 | 7.6.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The parameters listed as "Yes" in the "Should Include" column should always + be included in the Trial Summary dataset, in order to provide proper study definition. + (AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, + SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, + TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV) + Document: IG v3.1.1 + Item: Specification + Section: 7.6.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND247.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: @@ -119,128 +125,129 @@ Check: # TODO: the following works, but it does not allow to show which one is missing # but I also do not think we should split this rule in 26 parts do we? - - name: $distinct_tsparmcd - operator: does_not_contain - value: AGEU - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SDESIGN - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: DOSDUR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: EXPENDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: EXPSTDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: GLPFL - value_is_literal: true - ## GLPTYP is only mandatory in SENDIG-3.0 - ## SO TODO? split off SENDIG-3.0 in separate file/rule - ##- name: $distinct_tsparmcd - ## operator: does_not_contain - ## value: GLPTYP - ## value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: ROUTE - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDIGVER - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDCTVER - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPECIES - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPLRNAM - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SPREFID - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SSPONSOR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STCAT - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STDIR - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STSTDTC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: STITLE - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: SSTYP - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRT - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TFCNTRY - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TSTFLOC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TSTFNAM - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRMSAC - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRTCAS - value_is_literal: true - - name: $distinct_tsparmcd - operator: does_not_contain - value: TRTV - value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: AGEU + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SDESIGN + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: DOSDUR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: EXPENDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: EXPSTDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: GLPFL + value_is_literal: true + ## GLPTYP is only mandatory in SENDIG-3.0 + ## SO TODO? split off SENDIG-3.0 in separate file/rule + ##- name: $distinct_tsparmcd + ## operator: does_not_contain + ## value: GLPTYP + ## value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: ROUTE + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SNDIGVER + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SNDCTVER + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPECIES + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPLRNAM + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SPREFID + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SSPONSOR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STCAT + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STDIR + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STSTDTC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: STITLE + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: SSTYP + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRT + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TFCNTRY + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TSTFLOC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TSTFNAM + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRMSAC + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRTCAS + value_is_literal: true + - name: $distinct_tsparmcd + operator: does_not_contain + value: TRTV + value_is_literal: true Core: Id: CDISC.SENDIG.247 Status: Draft - Version: '1' -Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, - SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, + Version: "1" +Description: + For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, + SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV, a record must be present in TS Executability: Fully Executable Operations: -- id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct + - id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct Outcome: # TODO? Can we add soemthing here that shows which one is missing: # showing "A not in the list of B" @@ -249,8 +256,8 @@ Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml index 505db7fc3..450eb5d5b 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml @@ -1,73 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (from the SDTM model 1.5). - Document: IG v3.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (from the SDTM model 1.5). - Document: IG v3.1.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: 3.1.1 + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When preparing datasets based on the SENDIG domain models, sponsors must not - add any variables other than specified Identifier variables (from the SDTM model 1.5). - Document: IG v3.1 - Item: Specification - Section: 2.1 | 2.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND265.1 - Version: '1' - Version: '5.0' - Version: '1.1' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When preparing datasets based on the SENDIG domain models, sponsors must not + add any variables other than specified Identifier variables (from the SDTM model 1.5). + Document: IG v3.1 + Item: Specification + Section: 2.1 | 2.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND265.1 + Version: "1" + Version: "5.0" + Version: "1.1" # REMARK: this will ONLY validate the define.xml dataset definitions # for which a dataset is actually being provided Check: all: - - name: define_variable_role - operator: equal_to - value: 'Identifier' - #- name: define_variable_role - # operator: equal_to - # value: 'Identifier' - - name: define_variable_name - operator: is_not_contained_by - value: $model_variables + - name: define_variable_role + operator: equal_to + value: "Identifier" + #- name: define_variable_role + # operator: equal_to + # value: 'Identifier' + - name: define_variable_name + operator: is_not_contained_by + value: $model_variables Core: Id: CDISC.SENDIG.265.1 Status: Draft - Version: '1' -Description: Raise an error when variable role is 'Identifier', but the variable is not found in the + Version: "1" +Description: + Raise an error when variable role is 'Identifier', but the variable is not found in the SDTM model correspond to the role in the IG Executability: Fully Executable Operations: -- id: $model_variables - operator: get_column_order_from_library + - id: $model_variables + operator: get_column_order_from_library Outcome: Message: The Identfier variable in the define.xml is not found in the SDTM model #Output Variables: @@ -82,8 +86,8 @@ Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml index 0a268e954..4666df26a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.266/rule.yml @@ -1,101 +1,102 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.0 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: test - Document: IG v3.1.1 - Section: '2.1 | 2.3' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND266.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.0 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: test + Document: IG v3.1.1 + Section: "2.1 | 2.3" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND266.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Id: CDISC.SENDIG.266 Status: Draft - Version: '1' + Version: "1" Description: Trigger when variable cannot be found in the SDTM model (v.1.7 for SENDIG-3.1) Executability: Fully Executable Operations: -- id: $allowed_variables - # This works on the IG level, not on the Model level - operator: get_column_order_from_library + - id: + $allowed_variables + # This works on the IG level, not on the Model level + operator: get_column_order_from_library Outcome: Message: Variable is not an allowed variable for an Observation Class Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml index 5e8bd1cfd..0c23a793a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.277/rule.yml @@ -1,77 +1,77 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: SEND dataset file names are in lowercase - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND277 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.0 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: SEND dataset file names are in lowercase + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND277 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: dataset_location - operator: not_matches_regex - value: '^[a-z0-9\-\.]+$' + - name: dataset_location + operator: not_matches_regex + value: '^[a-z0-9\-\.]+$' Core: Id: CDISC.SENDIG.277 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when a file name has uppercase characters Executability: Fully Executable Outcome: Message: File name must be all lowercase characters Output Variables: - - dataset_name - - dataset_label - - dataset_location + - dataset_name + - dataset_label + - dataset_location Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml index 7cdc80bbe..143903199 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299A/rule.yml @@ -1,107 +1,112 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.1 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.1 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' + - name: "variable_name" + operator: not_equal_to + value: "STUDYID" + - name: "variable_name" + operator: not_equal_to + value: "USUBJID" + - name: "variable_name" + operator: not_equal_to + value: "POOLID" Core: Id: CDISC.SENDIG.299A Status: Draft - Version: '1' -Description: 'No other variables than STUDYID, USUBJID and POOLID may be present in the POOLDEF dataset' + Version: "1" +Description: "No other variables than STUDYID, USUBJID and POOLID may be present in the POOLDEF dataset" Executability: Fully Executable Outcome: - Message: 'No other variables than STUDYID, USUBJID and POOLID may be present in POOLDEF' + Message: "No other variables than STUDYID, USUBJID and POOLID may be present in POOLDEF" Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml index ad2340603..1405d589d 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299B/rule.yml @@ -1,133 +1,140 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.2 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.2 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'RDOMAIN' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVAR' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVARVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'QNAM' - - name: 'variable_name' - operator: not_equal_to - value: 'QLABEL' - - name: 'variable_name' - operator: not_equal_to - value: 'QVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'QORIG' - - name: 'variable_name' - operator: not_equal_to - value: 'QEVAL' + - name: "variable_name" + operator: not_equal_to + value: "STUDYID" + - name: "variable_name" + operator: not_equal_to + value: "RDOMAIN" + - name: "variable_name" + operator: not_equal_to + value: "USUBJID" + - name: "variable_name" + operator: not_equal_to + value: "POOLID" + - name: "variable_name" + operator: not_equal_to + value: "IDVAR" + - name: "variable_name" + operator: not_equal_to + value: "IDVARVAL" + - name: "variable_name" + operator: not_equal_to + value: "QNAM" + - name: "variable_name" + operator: not_equal_to + value: "QLABEL" + - name: "variable_name" + operator: not_equal_to + value: "QVAL" + - name: "variable_name" + operator: not_equal_to + value: "QORIG" + - name: "variable_name" + operator: not_equal_to + value: "QEVAL" Core: Id: CDISC.SENDIG.299B Status: Draft - Version: '1' -Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, - QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in the SUPP-- dataset' + Version: "1" +Description: + "No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, + QNAM, QLABEL, QVAL, QORIG, QEVAL may be present in the SUPP-- dataset" Executability: Fully Executable Outcome: - Message: 'SUPPxx may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, - IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL' + Message: + "SUPPxx may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, + IDVARVAL, QNAM, QLABEL, QVAL, QORIG, QEVAL" Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - SUPP-- + - SUPP-- Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml index cf260b85c..5fe6bd49e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.299C/rule.yml @@ -1,124 +1,131 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # SEND299 is not applicable to SENDIG-3.0 - see CORE rule SEND10 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described - in Section 8." - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND299.3 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ...RELREC, SUPP--, and POOLDEF are relationship datasets. These are described + in Section 8." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND299.3 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: 'variable_name' - operator: not_equal_to - value: 'STUDYID' - - name: 'variable_name' - operator: not_equal_to - value: 'RDOMAIN' - - name: 'variable_name' - operator: not_equal_to - value: 'USUBJID' - - name: 'variable_name' - operator: not_equal_to - value: 'POOLID' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVAR' - - name: 'variable_name' - operator: not_equal_to - value: 'IDVARVAL' - - name: 'variable_name' - operator: not_equal_to - value: 'RELTYPE' - - name: 'variable_name' - operator: not_equal_to - value: 'RELID' + - name: "variable_name" + operator: not_equal_to + value: "STUDYID" + - name: "variable_name" + operator: not_equal_to + value: "RDOMAIN" + - name: "variable_name" + operator: not_equal_to + value: "USUBJID" + - name: "variable_name" + operator: not_equal_to + value: "POOLID" + - name: "variable_name" + operator: not_equal_to + value: "IDVAR" + - name: "variable_name" + operator: not_equal_to + value: "IDVARVAL" + - name: "variable_name" + operator: not_equal_to + value: "RELTYPE" + - name: "variable_name" + operator: not_equal_to + value: "RELID" Core: Id: CDISC.SENDIG.299C Status: Draft - Version: '1' -Description: 'No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, - RELTYPE, RELID may be present in the RELREC dataset' + Version: "1" +Description: + "No other variables other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, IDVARVAL, + RELTYPE, RELID may be present in the RELREC dataset" Executability: Fully Executable Outcome: - Message: 'RELREC may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, - IDVARVAL, RELTYPE, RELID' + Message: + "RELREC may not contain any other variables than STUDYID, RDOMAIN, USUBJID, POOLID, IDVAR, + IDVARVAL, RELTYPE, RELID" Rule Type: Variable Metadata Check Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREC + - RELREC Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml index 4d90ae6c7..5bedcaab7 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml @@ -1,93 +1,98 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.0 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In the event that no records are present in a dataset, the empty dataset - should not be submitted and should not be described in the data definition file. - Document: SENDIG v3.1 - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.0 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In the event that no records are present in a dataset, the empty dataset + should not be submitted and should not be described in the data definition file. + Document: SENDIG v3.1 + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: $record_count - operator: equal_to - value: 0 - # check whether there is an entry for the dataset in the define.xml - #- name: define_dataset_name - # operator: exists - - name: define_dataset_name - operator: exists - #value: 'Not in dataset' - #operator: not_equal_to - #value: dataset_name + - name: $record_count + operator: equal_to + value: 0 + # check whether there is an entry for the dataset in the define.xml + #- name: define_dataset_name + # operator: exists + - name: define_dataset_name + operator: + exists + #value: 'Not in dataset' + #operator: not_equal_to + #value: dataset_name Core: Id: CDISC.SENDIG.300 Status: Draft - Version: '1' + Version: "1" Description: Trigger error when a dataset has no records Executability: Fully Executable Operations: -- id: $record_count - operator: record_count + - id: $record_count + operator: record_count Outcome: Message: Dataset may not be empty, it must contain records Output Variables: - - dataset_name - - dataset_label - - $record_count - - define_dataset_name + - dataset_name + - dataset_label + - $record_count + - define_dataset_name Rule Type: Dataset Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml index 21fffe236..e15f0a635 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.304/rule.yml @@ -1,33 +1,34 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When there are multiple terms that express the same base concept, SEND CT - provides the Preferred Term to include in a submission, and thus the term to which the - synonymous term(s) should be mapped. - Document: IG v3.1 - Section: '4.3.7' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND304 - Version: '' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When there are multiple terms that express the same base concept, SEND CT + provides the Preferred Term to include in a submission, and thus the term to which the + synonymous term(s) should be mapped. + Document: IG v3.1 + Section: "4.3.7" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND304 + Version: "" + Version: "5.0" + Version: "3.1" Check: all: - - name: LBTESTCD - operator: 'equal_to' - value: 'ALB' - - name: LBTEST - operator: not_equal_to - value: 'Albumin' + - name: LBTESTCD + operator: "equal_to" + value: "ALB" + - name: LBTEST + operator: not_equal_to + value: "Albumin" Core: Id: CDISC.SENDIG.304 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: #- codelists: @@ -36,23 +37,23 @@ Operations: # level: term # operator: codelist_terms # returntype: value -- codelist: LBTEST - id: $extensible - operator: codelist_extensible + - codelist: LBTEST + id: $extensible + operator: codelist_extensible Outcome: - Message: 'test message' + Message: "test message" Output Variables: - - LBTESTCD - - LBTEST - # - $codelist_terms - - $extensible - # - $synonyms + - LBTESTCD + - LBTEST + # - $codelist_terms + - $extensible + # - $synonyms Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - LB + - LB Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml index 97dd269b1..5e677bfc0 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml @@ -1,75 +1,79 @@ Authorities: -- Organization: CDISC - # REMARK: not applicable to SENDIG-3.0 - # 2023-10-22: CURRENT IMPLEMENTATION IS NOT CORRECT! - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are - different by set. DM records with different values for SPECIES cannot have the same SETCD - value. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are - different by set. DM records with different values for SPECIES cannot have the same SETCD - value. - Document: IG v3.1.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are - different by set. DM records with different values for SPECIES cannot have the same SETCD - value. - Document: IG v3.1 - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND309 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: + CDISC + # REMARK: not applicable to SENDIG-3.0 + # 2023-10-22: CURRENT IMPLEMENTATION IS NOT CORRECT! + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Trial Sets (TX) can have multiple species and/or strains if they are + different by set. DM records with different values for SPECIES cannot have the same SETCD + value. + Document: IG v3.1 + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND309 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: #- name: SETCD # operator: is_not_unique_set # value: SPECIES - - name: SPECIES - operator: is_not_unique_set - value: SETCD + - name: SPECIES + operator: is_not_unique_set + value: SETCD Core: Id: CDISC.SENDIG.309 Status: Draft - Version: '1' + Version: "1" Description: DM records with different values for SPECIES may not have the same SETCD value. Executability: Fully Executable Outcome: Message: The same SETCD is assigned to different SPECIES Output Variables: - - SPECIES - - SETCD + - SPECIES + - SETCD Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml index de50403a3..a27fb4b35 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.318/rule.yml @@ -1,68 +1,69 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: --NOMDY is an integer - Document: IG v3.1.1 - Section: 6.2.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND318 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: --NOMDY is an integer + Document: IG v3.1.1 + Section: 6.2.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND318 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: --NOMDY - operator: non_empty - - name: --NOMDY - operator: not_matches_regex - # value can be a negative or positive integer, but may not be 0. - # This is more restrictive, but approved by the SEND team - # than the original statement "--NOMDY must be an integer" - value: '^-?[1-9]{1}\d*$' + - name: --NOMDY + operator: non_empty + - name: --NOMDY + operator: + not_matches_regex + # value can be a negative or positive integer, but may not be 0. + # This is more restrictive, but approved by the SEND team + # than the original statement "--NOMDY must be an integer" + value: '^-?[1-9]{1}\d*$' Core: Id: CDISC.SENDIG.318 Status: Draft - Version: '1' -Description: 'The value of -NOMDY must be a positive or negative integer other than 0' + Version: "1" +Description: "The value of -NOMDY must be a positive or negative integer other than 0" Executability: Fully Executable Outcome: - Message: 'The value of -NOMDY must be a positive or negative integer other than 0' + Message: "The value of -NOMDY must be a positive or negative integer other than 0" Rule Type: Record Data Scope: Classes: Include: - - EVENTS - - FINDINGS + - EVENTS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml index eddb07aec..24920bb25 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.319/rule.yml @@ -1,94 +1,99 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is needed to - identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, - CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; - in those cases, CLNOMDY must be populated. - Document: IG v3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is needed to - identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, - CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; - in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is needed to - identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, - CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; - in those cases, CLNOMDY must be populated. - Document: IG v3.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is needed to - identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, - CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; - in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Information about the time of collection for any observation is needed to - identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, - CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; - in those cases, CLNOMDY must be populated. - Document: IG v3.1.1 - Section: 6.3.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND319' - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND319" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND319" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND319" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND319" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + Information about the time of collection for any observation is needed to + identify the record. CLDTC is Expected, and the data will, in most cases, contain CLDTC, + CLDY, or both. However, some studies (e.g., legacy studies) may not collect CLDTC or CLDY; + in those cases, CLNOMDY must be populated. + Document: IG v3.1.1 + Section: 6.3.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND319" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --DTC - operator: empty - - name: --DY - operator: empty - - name: --NOMDY - operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty + - name: --NOMDY + operator: empty Core: Id: CDISC.SENDIG.319 Status: Draft - Version: '1' + Version: "1" Description: If --DTC and --DY were not collected, --NOMDY must be populated. Executability: Fully Executable Outcome: @@ -97,9 +102,9 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - LB - - CL + - LB + - CL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml index 20db6bbd6..28b50faff 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.335/rule.yml @@ -1,76 +1,78 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. - Document: SENDIG v3.0 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. - Document: SENDIG v3.1.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: One record per test per palpable mass per observation time per subject - Document: SENDIG v3.1 - Section: 6.3.10 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND335 - Version: '1' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.0 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: PMSTRESC should contain the finding without the location specified in PMLOC. + Document: SENDIG v3.1.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: One record per test per palpable mass per observation time per subject + Document: SENDIG v3.1 + Section: 6.3.10 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND335 + Version: "1" + Version: "5.0" + Version: "1.1" Check: all: - - name: PMLOC - operator: non_empty - - name: PMSTRESC - operator: non_empty - - name: PMSTRESC - # operator: contains_case_insensitive - # EXAMPLE: PSLOC = LEFT HIND LIMB - # PSSTRESC = NON-ULCERATED LEFT HIND LIMB - # operator: equals_string_part - BUT we do not know at what position to start ... - operator: equals_string_part - regex: ".{*}(..).*" - value: PMLOC - #operator: matches_regex - # regex: "[a-zA-Z](..)[a-zA-Z]" - #regex: "*(..)*" - #value: PMLOC + - name: PMLOC + operator: non_empty + - name: PMSTRESC + operator: non_empty + - name: + PMSTRESC + # operator: contains_case_insensitive + # EXAMPLE: PSLOC = LEFT HIND LIMB + # PSSTRESC = NON-ULCERATED LEFT HIND LIMB + # operator: equals_string_part - BUT we do not know at what position to start ... + operator: equals_string_part + regex: ".{*}(..).*" + value: + PMLOC + #operator: matches_regex + # regex: "[a-zA-Z](..)[a-zA-Z]" + #regex: "*(..)*" + #value: PMLOC Core: Id: CDISC.SENDIG.335 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when PMSTRESC contains (case insensitive) the value of PMLOC Executability: Fully Executable # Operations: @@ -78,17 +80,17 @@ Executability: Fully Executable Outcome: Message: PMSTRESC may not contain the finding with the location specified in PMLOC. Output Variables: - - USUBJID - - PMTESTCD - - PMORRES - - PMSTRESC - - PMLOC + - USUBJID + - PMTESTCD + - PMORRES + - PMSTRESC + - PMLOC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PM + - PM Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml index a052fb110..bfc2e0ed7 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.356/rule.yml @@ -1,45 +1,45 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 # FETUSID is "expected" in IC and FM, "required in FX" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for the fetus identifier is unique per subject within a study. - Document: IG-DART v1.1 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND356 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The value for the fetus identifier is unique per subject within a study. - Document: IG-DART v1.2 - Section: '5.1.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND356 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for the fetus identifier is unique per subject within a study. + Document: IG-DART v1.1 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND356 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: The value for the fetus identifier is unique per subject within a study. + Document: IG-DART v1.2 + Section: "5.1.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND356 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: FETUSID - operator: non_empty - - name: FETUSID - operator: is_not_unique_set - value: - - USUBJID + - name: FETUSID + operator: non_empty + - name: FETUSID + operator: is_not_unique_set + value: + - USUBJID Core: Id: CDISC.SENDIG.356 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when the combination of USUBJID and FETUSID in not unique Executability: Fully Executable Outcome: @@ -48,10 +48,10 @@ Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - IC - - FM - - FX + - IC + - FM + - FX Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml index 68554e29e..61b1812d2 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml @@ -1,81 +1,81 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND359 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: All Study Day values are integers. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND359 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND359 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: All Study Day values are integers. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND359 + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: # REMARK that the rule does not say anything about a value being 0 # nor about negative integers - - name: RPPLDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: RPPLSTDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: RPPLENDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - - name: --RPDY - operator: not_matches_regex - value: ^[+-]?[0-9]+$ - #- name: --RPSTDY - # operator: not_matches_regex - # value: ^[+-]?[0-9]+$ - #- name: --RPENDY - # operator: not_matches_regex - # value: ^[+-]?[0-9]+$ + - name: RPPLDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: RPPLSTDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: RPPLENDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + - name: --RPDY + operator: not_matches_regex + value: ^[+-]?[0-9]+$ + #- name: --RPSTDY + # operator: not_matches_regex + # value: ^[+-]?[0-9]+$ + #- name: --RPENDY + # operator: not_matches_regex + # value: ^[+-]?[0-9]+$ Core: Id: CDISC.SENDIG.359 Status: Draft - Version: '1' -Description: 'When populated, values for all Repro Phase Day timing variables are integers' + Version: "1" +Description: "When populated, values for all Repro Phase Day timing variables are integers" Executability: Fully Executable Outcome: - Message: 'Repro Phase Day timing variable value must be an integer' + Message: "Repro Phase Day timing variable value must be an integer" Output Variables: - - RPPLDY - - RPPLSTDY - - RPPLENDY - - --RPDY - - --RPSTDY - - --RPENDY + - RPPLDY + - RPPLSTDY + - RPPLENDY + - --RPDY + - --RPSTDY + - --RPENDY Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - EX - - BW - - FW - - LB - - PC - - PP - - DS - - DD - - MA + - EX + - BW + - FW + - LB + - PC + - PP + - DS + - DD + - MA Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml index 57145d918..2d03f2076 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml @@ -1,67 +1,70 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # REMARK: Only applicable to SENDIG-DART 1.1 and 1.2 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value - in the PYFINDRS controlled terminology list. - Document: IG-DART v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value - in the PYFINDRS controlled terminology list. - Document: IG-DART v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value + in the PYFINDRS controlled terminology list. + Document: IG-DART v1.1 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + When the PYTESTCD is "PREGSTAT", PYSTRESC should be populated with a value + in the PYFINDRS controlled terminology list. + Document: IG-DART v1.2 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: PYTESTCD - operator: equal_to - value: PREGSTAT - # TODO: retrieve values from CDISC Library for codelist PYFINDRS - - name: PYSTRESC - operator: is_not_contained_by - value: - - ABORTED - - EARLY DELIVERY - - NOT PREGNANT - - PREGNANT - - RESORBED OR DEAD LITTER - - UNDETERMINED + - name: PYTESTCD + operator: equal_to + value: PREGSTAT + # TODO: retrieve values from CDISC Library for codelist PYFINDRS + - name: PYSTRESC + operator: is_not_contained_by + value: + - ABORTED + - EARLY DELIVERY + - NOT PREGNANT + - PREGNANT + - RESORBED OR DEAD LITTER + - UNDETERMINED Core: Id: CDISC.SENDIG.362 Status: Draft - Version: '1' -Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not + Version: "1" +Description: + Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not one of the codelist PYFINDRS Executability: Fully Executable Outcome: Message: The value of PYSTRESC is not one from the codelist PYFINDRS for PYTESTCD 'PREGSTAT' Output Variables: - - PYTESTCD - - PYSTRESC + - PYTESTCD + - PYSTRESC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - PY + - PY Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml index bda3290c4..352ebc37a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml @@ -1,84 +1,90 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...' - Document: IG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ..." + Document: IG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: #- name: variable_data_type @@ -86,7 +92,7 @@ Check: # value: 'Char' #- name: define_variable_data_type # operator: is_contained_by - # value: + # value: # - 'integer' # - 'float' # Looks as define_variable_type can only have the values "Char" and "Num" @@ -95,30 +101,31 @@ Check: # It would then also allow whether a -DTC variable has been declared as one of "date", "datetime", "partialdate" ... # # First part: check whether variable name is defined in the define.xml - - name: variable_name - operator: equal_to - value: define_variable_name - # Second part: check whether the data types match - - name: variable_data_type - operator: not_equal_to - value: define_variable_data_type + - name: variable_name + operator: equal_to + value: define_variable_name + # Second part: check whether the data types match + - name: variable_data_type + operator: not_equal_to + value: define_variable_data_type Core: Id: CDISC.SENDIG.4 Status: Draft - Version: '1' -Description: Raise an error when the data type in the define.xml does not correspond to the data + Version: "1" +Description: + Raise an error when the data type in the define.xml does not correspond to the data type in the dataset Executability: Fully Executable Outcome: Message: Variable datatype in the define.xml does not correspond to the data type in the dataset Output Variables: - - variable_name + - variable_name Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml index aa62ad983..fb14b7090 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.40/rule.yml @@ -1,45 +1,48 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Variables with controlled terminology should follow the case sensitivity of - the Controlled Terminology List - Document: IG v3.0 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables with controlled terminology should follow the case sensitivity of the - Controlled Terminology List ' - Document: IG v3.1 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Variables with controlled terminology should follow the case sensitivity of the - Controlled Terminology List ' - Document: IG v3.1.1 - Section: 4.2.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND40 - Version: '1' - Version: '5.0' - Version: 3.1.1 + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Variables with controlled terminology should follow the case sensitivity of + the Controlled Terminology List + Document: IG v3.0 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables with controlled terminology should follow the case sensitivity of the + Controlled Terminology List " + Document: IG v3.1 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Variables with controlled terminology should follow the case sensitivity of the + Controlled Terminology List " + Document: IG v3.1.1 + Section: 4.2.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND40 + Version: "1" + Version: "5.0" + Version: 3.1.1 Check: all: # TODO: replace "LBTESTCD" - by variable_name, variable_value ??? @@ -55,26 +58,27 @@ Check: #codelistcheck: value # can be "value" or "code" #codelistlevel: term # can be "term" or "codelist" - - name: LBTESTCD # name: variable_name - operator: does_not_use_valid_codelist_terms - # Next line must become a lookup in the IG - value: LBTESTCD # means terms of LBTESTCD codelist - TODO: replace by lookup for corresponding codelist + - name: LBTESTCD # name: variable_name + operator: + does_not_use_valid_codelist_terms + # Next line must become a lookup in the IG + value: LBTESTCD # means terms of LBTESTCD codelist - TODO: replace by lookup for corresponding codelist Core: Id: CDISC.SENDIG.40 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: Variable does not use valid codelist terms Output Variables: - - LBTESTCD + - LBTESTCD Rule Type: Variable Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml index d4e481620..33e10b823 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.407/rule.yml @@ -1,36 +1,36 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: One record per test per observation time per subject - Document: SENDIG-GENETOX - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND407 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: One record per test per observation time per subject + Document: SENDIG-GENETOX + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND407 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # TODO: also raise an error when GVSPEC/GVDTC (both "expected") absent - - name: GVSPEC - operator: non_empty - - name: GVDTC - operator: non_empty - - name: GVTESTCD - operator: is_not_unique_set - value: - - USUBJID - - GVSPEC - - GVDTC + - name: GVSPEC + operator: non_empty + - name: GVDTC + operator: non_empty + - name: GVTESTCD + operator: is_not_unique_set + value: + - USUBJID + - GVSPEC + - GVDTC Core: Id: CDISC.SENDIG.407 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: The combination of USUBJID, GVTESTCD, GVSPEC and GVDTC is not unique @@ -38,8 +38,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml index 6e39d3c58..3a779d533 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.408/rule.yml @@ -1,32 +1,32 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: Comet is represented at the subject level, not the gel level. - Document: SENDIG-GENETOX - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND408 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: Comet is represented at the subject level, not the gel level. + Document: SENDIG-GENETOX + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND408 + Version: "1" + Version: "5.0" + Version: "1.0" # Comet is represented at the subject level, not the gel level. # i.e. when GVCAT = 'IN VIVO COMET' then USUBJID must be populated, not POOLID # REMARK: but USUBJID = "required" anyway Check: all: - - name: 'GVCAT' - operator: equal_to - value: 'IN VIVO COMET' - - name: 'USUBJID' - operator: empty + - name: "GVCAT" + operator: equal_to + value: "IN VIVO COMET" + - name: "USUBJID" + operator: empty Core: Id: CDISC.SENDIG.408 Status: Draft - Version: '1' + Version: "1" Description: Comet is represented at the subject level, not the gel level. Executability: Fully Executable Outcome: @@ -35,8 +35,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml index c366a8907..5a63a5228 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.6A/rule.yml @@ -1,120 +1,128 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: + - Organization: CDISC + Standards: + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: # IMPORTANT TO PROVIDE THE RIGHT TYPE OF RULE CHECK HERE! - - Citations: - - Cited Guidance: Metadata in Define-XML document should match both the SENDIG label and the - label in the .xpt datasets - Document: SENDIG v3.1.1 - Section: 3.2.2 | 4.21 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND6 - Version: '1' - Version: '5.0' - Version: '1.0' + - Citations: + - Cited Guidance: + Metadata in Define-XML document should match both the SENDIG label and the + label in the .xpt datasets + Document: SENDIG v3.1.1 + Section: 3.2.2 | 4.21 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND6 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # Precondition: define variable name = library variable name - - name: define_variable_name - operator: equal_to - value: library_variable_name - - name: define_variable_label - operator: not_equal_to - # Look up in the CDISC-Library API - see https://github.com/cdisc-org/cdisc-rules-engine/issues/243 - value: library_variable_label + - name: define_variable_name + operator: equal_to + value: library_variable_name + - name: define_variable_label + operator: + not_equal_to + # Look up in the CDISC-Library API - see https://github.com/cdisc-org/cdisc-rules-engine/issues/243 + value: library_variable_label Core: Id: CDISC.SENDIG.6A Status: Draft - Version: '1' -Description: 'Raise an error when the variable label in the define.xml does not correspond to the variable + Version: "1" +Description: + "Raise an error when the variable label in the define.xml does not correspond to the variable label in the Implementation Guide. NOTE: This rule has been split in two parts: A. check define variable - label against IG label B. check define variable label against the label in the dataset ' + label against IG label B. check define variable label against the label in the dataset " Executability: Fully Executable Outcome: Message: The label of the variable is incorrect Output Variables: - - define_variable_name - - define_variable_label - - library_variable_label + - define_variable_name + - define_variable_label + - library_variable_label Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml index 76d1fe51e..969885480 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml @@ -1,123 +1,130 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.0 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the - relative day of the observation starting with the reference date as Day 1. - Document: IG v3.1.1 - Section: 4.4.4 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND71.1 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.0 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The Permissible Study Day variables (--DY, --STDY, and --ENDY) describe the + relative day of the observation starting with the reference date as Day 1. + Document: IG v3.1.1 + Section: 4.4.4 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND71.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --DY - operator: non_empty - - name: --DTC - operator: is_complete_date - - name: RFSTDTC - operator: is_complete_date - - name: --DY - operator: not_equal_to - value: $val_dy + - name: --DY + operator: non_empty + - name: --DTC + operator: is_complete_date + - name: RFSTDTC + operator: is_complete_date + - name: --DY + operator: not_equal_to + value: $val_dy Core: Id: CDISC.SENDIG.71 Status: Draft Version: "1" -Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after +Description: + --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC Executability: Fully Executable Match Datasets: -- Keys: - - USUBJID - Name: DM + - Keys: + - USUBJID + Name: DM Operations: -- id: $val_dy - name: --DTC - operator: dy + - id: $val_dy + name: --DTC + operator: dy Outcome: Message: --DY was calculated incorrectly. Output Variables: - - $val_dy - - --DY - - --DTC - - RFSTDTC + - $val_dy + - --DY + - --DTC + - RFSTDTC Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml index 883a1a8e0..5789768b4 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.80/rule.yml @@ -1,50 +1,51 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When using time points, at least one corresponding timing variable should be - provided (e.g., VISITDY, --DTC, --DY). - Document: IG v3.0 - Item: Specification - Section: 4.2.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND80 - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When using time points, at least one corresponding timing variable should be + provided (e.g., VISITDY, --DTC, --DY). + Document: IG v3.0 + Item: Specification + Section: 4.2.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND80 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: --TPT - operator: non_empty - - name: VISITDY - operator: empty - - name: --DTC - operator: empty - - name: --DY - operator: empty + - name: --TPT + operator: non_empty + - name: VISITDY + operator: empty + - name: --DTC + operator: empty + - name: --DY + operator: empty # REMARK: ONLY applicable to SENDIG-3.0! # REMARK: rule says "e.g., VISITDY, --DTC, --DY": is this "e.g." sufficient! Core: Id: CDISC.SENDIG.80 Status: Draft - Version: '1' + Version: "1" Description: When --TPT is populated, at least one of VISITDY, --DTC or --DY must be populated Executability: Fully Executable Outcome: Message: --TPT is populated, but none of of VISITDY, --DTC or --DY is populated Output Variables: - - --TPT + - --TPT Rule Type: Record Data Scope: Classes: Include: - - INTERVENTIONS - - FINDINGS + - INTERVENTIONS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml index 322c1ffcc..a8f378a26 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND1/rule.yml @@ -1,38 +1,38 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. - Document: SENDIG v3.1 - Section: 4.1.4 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND1' - Version: '1' - Version: '5' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: SDTM datasets are normally named to be consistent with the domain code. + Document: SENDIG v3.1 + Section: 4.1.4 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND1" + Version: "1" + Version: "5" + Version: "3.1" Check: all: - - name: dataset_name - operator: equal_to_case_insensitive - value: DOMAIN + - name: dataset_name + operator: equal_to_case_insensitive + value: DOMAIN Core: Id: CDISC.SENDIG.SEND1 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when the filename is not equal to the value of DOMAIN. Outcome: Message: The filename is not equal to the 2-character domain code. Output Variables: - - DOMAIN + - DOMAIN Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml index 0306b325f..7396369bd 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml @@ -1,104 +1,110 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - #need to determine what can be done with catalog version 5 if anything - - Citations: - - Cited Guidance: One record per test per observation time per subject, Tabulation. - #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: '3.0' - - Name: SENDIG - References: - #need to determine what can be done with catalog version 5 if anything - - Citations: - - Cited Guidance: One record per test per observation time per subject, Tabulation. - #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: '3.1' - - Name: SENDIG-DART - References: - #need to determine what can be done with catalog version 5 if anything - - Citations: - - Cited Guidance: One record per test per observation time per subject, Tabulation. - #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.1 - - Name: SENDIG-DART - References: - #need to determine what can be done with catalog version 5 if anything - - Citations: - - Cited Guidance: One record per test per observation time per subject, Tabulation. - #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.2 - - Name: SENDID-GENETOX - References: - #need to determine what can be done with catalog version 5 if anything - - Citations: - - Cited Guidance: One record per test per observation time per subject, Tabulation. - #SMEs do we want to keep "Tabulation" for any reason? - Document: SENDIG v3.1 - Section: 6.3.1 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND142' - Version: '1' - Version: '5' - Version: v1.0 #double check the last few + - Organization: CDISC + Standards: + - Name: SENDIG + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: + One record per test per observation time per subject, Tabulation. + #SMEs do we want to keep "Tabulation" for any reason? + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND142" + Version: "1" + Version: "5" + Version: "3.0" + - Name: SENDIG + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: + One record per test per observation time per subject, Tabulation. + #SMEs do we want to keep "Tabulation" for any reason? + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND142" + Version: "1" + Version: "5" + Version: "3.1" + - Name: SENDIG-DART + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: + One record per test per observation time per subject, Tabulation. + #SMEs do we want to keep "Tabulation" for any reason? + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND142" + Version: "1" + Version: "5" + Version: v1.1 + - Name: SENDIG-DART + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: + One record per test per observation time per subject, Tabulation. + #SMEs do we want to keep "Tabulation" for any reason? + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND142" + Version: "1" + Version: "5" + Version: v1.2 + - Name: SENDID-GENETOX + References: + #need to determine what can be done with catalog version 5 if anything + - Citations: + - Cited Guidance: + One record per test per observation time per subject, Tabulation. + #SMEs do we want to keep "Tabulation" for any reason? + Document: SENDIG v3.1 + Section: 6.3.1 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND142" + Version: "1" + Version: "5" + Version: v1.0 #double check the last few Check: all: - - name: BWDTC - operator: non_empty - - name: BWTESTCD - operator: is_not_unique_set - value: - - USUBJID - - BWDTC + - name: BWDTC + operator: non_empty + - name: BWTESTCD + operator: is_not_unique_set + value: + - USUBJID + - BWDTC Core: Id: CDISC.SENDIG.SEND142 Status: Draft - Version: '1' -Description: Raise an error when there is more than one record present for any particular Body + Version: "1" +Description: + Raise an error when there is more than one record present for any particular Body Weight test, in the BW Domain, for a subject on a particular date. #The check for this rule was revised to NOT check the records where BWDTC is null Outcome: Message: The Body Weight test is not unique for this subject and date/time. Output Variables: - - USUBJID - - BWTESTCD - - BWDTC + - USUBJID + - BWTESTCD + - BWDTC Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - BW + - BW Sensitivity: Domain diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml index f0812c6cb..ce11b77fb 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml @@ -1,137 +1,153 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: '3.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.2 - - Name: SENDID-GENETOX - References: - - Citations: - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.0 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1 - Section: 6.3.3 - - Cited Guidance: The mass identification should be unique within the subject, regardless of - mass location. - Document: SENDIG v3.1.1 - Section: 6.3.3 - Origin: SENDIG Conformance Rules - Rule Identifier: - Id: 'SEND157' - Version: '1' - Version: '5' - Version: v1.0 + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND157" + Version: "1" + Version: "5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND157" + Version: "1" + Version: "5" + Version: "3.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND157" + Version: "1" + Version: "5" + Version: v1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND157" + Version: "1" + Version: "5" + Version: v1.2 + - Name: SENDID-GENETOX + References: + - Citations: + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.0 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1 + Section: 6.3.3 + - Cited Guidance: + The mass identification should be unique within the subject, regardless of + mass location. + Document: SENDIG v3.1.1 + Section: 6.3.3 + Origin: SENDIG Conformance Rules + Rule Identifier: + Id: "SEND157" + Version: "1" + Version: "5" + Version: v1.0 Check: any: - - name: --SPID - operator: is_not_unique_set - value: -"USUBJID" + - name: --SPID + operator: is_not_unique_set + value: -"USUBJID" Core: Id: CDISC.SENDIG.SEND157 Status: Draft - Version: '1' -Description: Raise an error when the mass identification is not unique within the subject, + Version: "1" +Description: + Raise an error when the mass identification is not unique within the subject, regardless of the mass location. Outcome: Message: The mass identification is not unique within the subject regardless of the mass location. Output Variables: - - --SPID - - USUBJID + - --SPID + - USUBJID Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - CL - - PM - - MA - - MI - - TF + - CL + - PM + - MA + - MI + - TF Sensitivity: Variable diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml index 9d333fed3..39c93e2d5 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND293/rule.yml @@ -1,102 +1,107 @@ # REMARK: Not applicable to SENDIG-3.0 Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: For each unique planned time point (--TPT), there must be a one-to-one - relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is - determined by a combination of the domain, study day, and, if present, category and/or - subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be - needed in some cases to define uniqueness. When this occurs, clarification should be - provided as a comment to --TPTNUM in the define file. - Document: IG v3.1.1 - Section: 4.4.7.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND293' - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND293" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND293" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND293" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND293" + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + For each unique planned time point (--TPT), there must be a one-to-one + relationship between the values of --TPT and --TPTNUM. Uniqueness for these time points is + determined by a combination of the domain, study day, and, if present, category and/or + subcategory (--CAT/--SCAT). Other variables, such as --TESTCD and --METHOD, may also be + needed in some cases to define uniqueness. When this occurs, clarification should be + provided as a comment to --TPTNUM in the define file. + Document: IG v3.1.1 + Section: 4.4.7.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND293" + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: --TPT - operator: non_empty - - name: --TPTNUM - operator: empty + - name: --TPT + operator: non_empty + - name: --TPTNUM + operator: empty Core: Id: CDISC.SENDIG.SEND293 Status: Draft - Version: '1' + Version: "1" Description: Raise an error when --TPT is populated but --TPTNUM is not populated. Executability: Fully Executable Outcome: @@ -105,8 +110,8 @@ Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml index 20008335a..dfd2b47fc 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND411/rule.yml @@ -1,37 +1,37 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: GVSCAT is always populated with the analysis intention. - Document: SENDIG-DART - Section: 5.1.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND411 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: GVSCAT is always populated with the analysis intention. + Document: SENDIG-DART + Section: 5.1.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND411 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # GVSCAT must be populated with the analysis intention all: - - name: 'GVSCAT' - operator: empty + - name: "GVSCAT" + operator: empty Core: Id: CDISC.SENDIG.SEND411 Status: Draft - Version: '1' -Description: 'GVSCAT must be populated with the analysis intention' + Version: "1" +Description: "GVSCAT must be populated with the analysis intention" Executability: Partially Executable - Possible Underreporting Outcome: - Message: 'GVSCAT must be populated with the analysis intention' + Message: "GVSCAT must be populated with the analysis intention" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - GV + - GV Sensitivity: Record diff --git a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml index 6db5fa579..715f1bf3d 100644 --- a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml +++ b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml @@ -2,265 +2,277 @@ # Condition: Variable Core Status = Required # Rule: Variable present in dataset and ^= null Authorities: -- Organization: FDA - Standards: - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.2' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.3' - - Name: SDTMIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.4' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.2' - - Name: SENDIG-AR - References: - - Citations: - - Cited Guidance: 'Controlled terms should use the exact term (case, spelling, and punctuation) - used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology).' - Document: FDA - Section: FDAB017 - Origin: FDA Business Rules - Rule Identifier: - Id: FB1701 - Version: '1' - Version: '1.5' - Version: '1.0' -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. - Document: IG v3.0 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. - Document: IG v3.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. - Document: IG v3.1.1 - Section: 4.1.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND296 - Version: '1' - Version: '5.0' - Version: 3.1.1 -# Comment/Answer Christy Kubin: -# The intent of this rule is to check the values in the dataset against the CT in the CDISC library. + - Organization: FDA + Standards: + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.2" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.3" + - Name: SDTMIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.4" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "1.2" + - Name: SENDIG-AR + References: + - Citations: + - Cited Guidance: + "Controlled terms should use the exact term (case, spelling, and punctuation) + used by the terminology maintenance organizations (e.g., MedDRA, CDISC controlled terminology)." + Document: FDA + Section: FDAB017 + Origin: FDA Business Rules + Rule Identifier: + Id: FB1701 + Version: "1" + Version: "1.5" + Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.0 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: The SEND CT indicates whether a particular codelist is extensible or not. + Document: IG v3.1.1 + Section: 4.1.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND296 + Version: "1" + Version: "5.0" + Version: 3.1.1 +# Comment/Answer Christy Kubin: +# The intent of this rule is to check the values in the dataset against the CT in the CDISC library. # The define file should not be checked in this case. Check: all: - - name: LBTESTCD ## only for exploring - operator: not_equal_to - value: 'test variable' - # See DDF00110 (Richard Marshall) - - name: $codelist_extensible - operator: equal_to - value: false - #- codelistcheck: value - # codelistlevel: term - # name: --STAT - # operator: does_not_use_valid_codelist_terms - # value: true - #- name: $variable - # operator: empty - #- name: library_variable_has_codelist - # operator: equal_to - # value: true - #- codelist: 'LBTESTCD' - # name: $codelist_extensible - # operator: equal_to - # value: false - #- name: $column_order_from_dataset - # operator: is_not_ordered_by - # order: asc - # value: $column_order_from_library + - name: LBTESTCD ## only for exploring + operator: not_equal_to + value: "test variable" + # See DDF00110 (Richard Marshall) + - name: $codelist_extensible + operator: equal_to + value: + false + #- codelistcheck: value + # codelistlevel: term + # name: --STAT + # operator: does_not_use_valid_codelist_terms + # value: true + #- name: $variable + # operator: empty + #- name: library_variable_has_codelist + # operator: equal_to + # value: true + #- codelist: 'LBTESTCD' + # name: $codelist_extensible + # operator: equal_to + # value: false + #- name: $column_order_from_dataset + # operator: is_not_ordered_by + # order: asc + # value: $column_order_from_library Core: Id: FDA.SDTMIG.FB1901 Status: Draft - Version: '1' -Description: When CDISC published Controlled Terminology indicates that a codelist is non-extensible + Version: "1" +Description: + When CDISC published Controlled Terminology indicates that a codelist is non-extensible then only terms from the codelist should be used. Executability: Fully Executable Operations: # See DDF00110 (Richard Marshall) -- codelist_code: $codelist_code - ct_package_type: SDTM - id: $codelist_extensible - operator: codelist_extensible - version: category.codeSystemVersion - #- id: $column_order_from_library - # operator: get_column_order_from_library - # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist - # TODO: as we need to iterate over ALL variables that do have a codelist - # How do I pass the variable name and/or its codelist name as an argument to this? - # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked - # id: $codelist_extensible - # operator: codelist_extensible - # + - codelist_code: $codelist_code + ct_package_type: SDTM + id: $codelist_extensible + operator: codelist_extensible + version: category.codeSystemVersion + #- id: $column_order_from_library + # operator: get_column_order_from_library + # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist + # TODO: as we need to iterate over ALL variables that do have a codelist + # How do I pass the variable name and/or its codelist name as an argument to this? + # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked + # id: $codelist_extensible + # operator: codelist_extensible + # - # - id: $codelist_terms - # operator: codelist_terms - # ct_packages: - # - sdtmct-2020-03-27 - # ct_version: LBVERSION - # id: $CODELISTEXTENSIBLE - # name: LBTESTCD - # operator: get_codelist_attributes - #- id: $column_order_from_library - # operator: get_column_order_from_library + # - id: $codelist_terms + # operator: codelist_terms + # ct_packages: + # - sdtmct-2020-03-27 + # ct_version: LBVERSION + # id: $CODELISTEXTENSIBLE + # name: LBTESTCD + # operator: get_codelist_attributes + #- id: $column_order_from_library + # operator: get_column_order_from_library - # - ct_attribute: extensible - # ct_packages: - # - sdtmct-2020-03-27 - # ct_version: 'LBVERSION' - # id: $CODELISTEXTENSIBLE - # name: LBTESTCD - # operator: get_codelist_attributes + # - ct_attribute: extensible + # ct_packages: + # - sdtmct-2020-03-27 + # ct_version: 'LBVERSION' + # id: $CODELISTEXTENSIBLE + # name: LBTESTCD + # operator: get_codelist_attributes Outcome: Message: A new term has been added to a non-extensible code list. Output Variables: # - $column_order_from_library - - $codelist_extensible - - $codelist_code - # - variable_name - # - $var_codelist - # - $CODELISTEXTENSIBLE + - $codelist_extensible + - $codelist_code + # - variable_name + # - $var_codelist + # - $CODELISTEXTENSIBLE Rule Type: Record Data # Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND100/rule.yml b/Unpublished/SENDIG/SEND100/rule.yml index 3d92a7d17..78e5ac32a 100644 --- a/Unpublished/SENDIG/SEND100/rule.yml +++ b/Unpublished/SENDIG/SEND100/rule.yml @@ -1,110 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.0 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The sponsor must define what collected date is used to populate RFSTDTC in - the data define file. - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND100 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.0 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The sponsor must define what collected date is used to populate RFSTDTC in + the data define file. + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND100 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: RFSTDTC - operator: non_empty - # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) - - name: define_variable_has_comment - operator: equal_to - value: false + - name: RFSTDTC + operator: non_empty + # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) + - name: define_variable_has_comment + operator: equal_to + value: false Core: Id: SEND100 Status: Draft - Version: '1' -Description: Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to + Version: "1" +Description: + Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to the DM variable DM Executability: Fully Executable Outcome: Message: No 'method' (through @MethodOID/MethodDef) has been assigned to the variable RFSTDTC Output Variables: - - RFSTDTC - - RFENDTC + - RFSTDTC + - RFENDTC Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND106.1/rule.yml b/Unpublished/SENDIG/SEND106.1/rule.yml index 9cc09144b..70b6fdc51 100644 --- a/Unpublished/SENDIG/SEND106.1/rule.yml +++ b/Unpublished/SENDIG/SEND106.1/rule.yml @@ -1,142 +1,148 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Implementation of SEND106.1 like for SEND106, but for 3.1, 3.1.1, DART and Genetox - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: IG v3.1.1 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND106.1 - Version: '1' - Version: '5.0' - Version: '1.0' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: IG v3.1.1 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND106.1 + Version: "1" + Version: "5.0" + Version: "1.0" Check: # 2025-02-25: NOT TESTED AT ALL YET - first need to resolve issues for SEND106 all: # STRAIN is missing from DM or from a DM record - - any: - - name: STRAIN - operator: not_exists - - name: STRAIN - operator: empty - # Either TSPARMCD=STRAIN is missing from TS - # or TSVAL is null when TSPARMCD=STRAIN - # or TXVAL is null when TXPARMCD=STRAIN - - all: - any: - - name: $distinct_tsparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - all: - - name: TSPARMCD - operator: equal_to - value: STRAIN - value_is_literal: true - - name: TSVAL - operator: empty - - any: - - name: $distinct_txparmcd - operator: does_not_contain - value: STRAIN - value_is_literal: true - - all: - - name: TXPARMCD - operator: equal_to - value: STRAIN - value_is_literal: true - - name: TXVAL + - name: STRAIN + operator: not_exists + - name: STRAIN operator: empty + # Either TSPARMCD=STRAIN is missing from TS + # or TSVAL is null when TSPARMCD=STRAIN + # or TXVAL is null when TXPARMCD=STRAIN + - all: + - any: + - name: $distinct_tsparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - all: + - name: TSPARMCD + operator: equal_to + value: STRAIN + value_is_literal: true + - name: TSVAL + operator: empty + - any: + - name: $distinct_txparmcd + operator: does_not_contain + value: STRAIN + value_is_literal: true + - all: + - name: TXPARMCD + operator: equal_to + value: STRAIN + value_is_literal: true + - name: TXVAL + operator: empty Core: Id: SEND106.1 Status: Draft - Version: '1' -Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an + Version: "1" +Description: + When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an error Executability: Fully Executable # 2025-02-25: Jozef: what is this doing? Match Datasets: -- Keys: - - STUDYID - Name: TS + - Keys: + - STUDYID + Name: TS Operations: # gets the distinct values of TSPARMCD -- domain: TS - id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct - # gets the distinct values of TXPARMCD + - domain: TS + id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct + # gets the distinct values of TXPARMCD Outcome: Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is not present in DM Output Variables: - - TSPARMCD - - TSVAL - - TXPARMCD - - TXVAL - - STRAIN + - TSPARMCD + - TSVAL + - TXPARMCD + - TXVAL + - STRAIN Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND238/rule.yml b/Unpublished/SENDIG/SEND238/rule.yml index 8f31eb37d..00e507806 100644 --- a/Unpublished/SENDIG/SEND238/rule.yml +++ b/Unpublished/SENDIG/SEND238/rule.yml @@ -1,132 +1,139 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: In general, each Set should have a distinct combination of TXPARMCD, TXPARM, - and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have - the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain - nformation that distinguishes the two Trial Sets from each other. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND238 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + In general, each Set should have a distinct combination of TXPARMCD, TXPARM, + and TXVAL whenever possible. If two Trial Sets (identified by distinct SETCD values) have + the same set of TXPARMCD, TXPARM, and TXVAL entries, the SET variable must contain + nformation that distinguishes the two Trial Sets from each other. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND238 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # We only report a violation when the texts in SET are identical. # This is very probably underreporting - - name: 'SET' - operator: 'is_not_unique_set' - value: - - TXPARMCD - - TXPARM - - TXVAL + - name: "SET" + operator: "is_not_unique_set" + value: + - TXPARMCD + - TXPARM + - TXVAL Core: Status: Draft - Version: '1' -Description: 'Report a violation when the texts in SET are identical for the combination of SET, TXPARMCD, - TXPARM' + Version: "1" +Description: + "Report a violation when the texts in SET are identical for the combination of SET, TXPARMCD, + TXPARM" Executability: Fully Executable Outcome: - Message: 'The combination of SET, TXPARMCD, TXPARM and TXVAL must be unique' + Message: "The combination of SET, TXPARMCD, TXPARM and TXVAL must be unique" Output Variables: - - SETCD - - SET - - TXPARMCD - - TXPARM - - TXVAL + - SETCD + - SET + - TXPARMCD + - TXPARM + - TXVAL Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX + - TX Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND239/rule.yml b/Unpublished/SENDIG/SEND239/rule.yml index e67cf9920..3d2724ecd 100644 --- a/Unpublished/SENDIG/SEND239/rule.yml +++ b/Unpublished/SENDIG/SEND239/rule.yml @@ -1,102 +1,108 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.0 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The TXPARMCD values marked as "Yes" in the "Should Include" column in - Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD - values are expected to occur in almost all studies and may be necessary for clear - interpretation of the data package. - Document: IG v3.1.1 - Item: Specification - Section: 7.4.1.1 | 7.4.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND239 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.0 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The TXPARMCD values marked as "Yes" in the "Should Include" column in + Section 7.4.2 should be included in a well-formed TX domain submission. These TXPARMCD + values are expected to occur in almost all studies and may be necessary for clear + interpretation of the data package. + Document: IG v3.1.1 + Item: Specification + Section: 7.4.1.1 | 7.4.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND239 + Version: "1" + Version: "5.0" + Version: "1.2" Check: # all: # count the number of TRTDOC records within each group @@ -104,82 +110,83 @@ Check: # if there are issues with other sets, these are not reported # When Sensitivity=Record, a violation is reported for EACH row within the set that violates the rule any: - - name: $num_trtdos - operator: equal_to - value: 0 - - name: $num_trtdosu - operator: equal_to - value: 0 - - name: $num_armcd - operator: equal_to - value: 0 - - name: $num_spgrpcd - operator: equal_to - value: 0 - - name: $num_grplbl - operator: equal_to - value: 0 + - name: $num_trtdos + operator: equal_to + value: 0 + - name: $num_trtdosu + operator: equal_to + value: 0 + - name: $num_armcd + operator: equal_to + value: 0 + - name: $num_spgrpcd + operator: equal_to + value: 0 + - name: $num_grplbl + operator: equal_to + value: 0 Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable -# Within each SETCD group, we must have at least one record +# Within each SETCD group, we must have at least one record # with TXPARMCD = TRTDOS, TRTDOSU, ARMCD, SPGRPCD, and GRPLBL Operations: # count the number of records for TXPARMCD=TRTDOS within each SETCD group -- filter: - TXPARMCD: TRTDOS - group: - - SETCD - id: $num_trtdos - operator: record_count - # count the number of records for TXOARMCD=TRTDOSU within each SETCD group -- filter: - TXPARMCD: TRTDOSU - group: - - SETCD - id: $num_trtdosu - operator: record_count - # count the number of records for TXPARMCD=ARMCD within each SETCD group -- filter: - TXPARMCD: ARMCD - group: - - SETCD - id: $num_armcd - operator: record_count - # count the number of records for TXPARMCD=SPGRPCD within each SETCD group -- filter: - TXPARMCD: SPGRPCD - group: - - SETCD - id: $num_spgrpcd - operator: record_count - # count the number of records for TXPARMCD=GRPLBL within each SETCD group -- filter: - TXPARMCD: GRPLBL - group: - - SETCD - id: $num_grplbl - operator: record_count + - filter: + TXPARMCD: TRTDOS + group: + - SETCD + id: $num_trtdos + operator: record_count + # count the number of records for TXOARMCD=TRTDOSU within each SETCD group + - filter: + TXPARMCD: TRTDOSU + group: + - SETCD + id: $num_trtdosu + operator: record_count + # count the number of records for TXPARMCD=ARMCD within each SETCD group + - filter: + TXPARMCD: ARMCD + group: + - SETCD + id: $num_armcd + operator: record_count + # count the number of records for TXPARMCD=SPGRPCD within each SETCD group + - filter: + TXPARMCD: SPGRPCD + group: + - SETCD + id: $num_spgrpcd + operator: record_count + # count the number of records for TXPARMCD=GRPLBL within each SETCD group + - filter: + TXPARMCD: GRPLBL + group: + - SETCD + id: $num_grplbl + operator: record_count Outcome: - Message: 'For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD, TXPARMCD=GRPLBL, TXPARMCD=TRTDOC - and TXPARMCD=TRTDOSU must be provided' + Message: + "For each set, a record with TXPARMCD=ARMCD, TXPARMCD=SPGRPCD, TXPARMCD=GRPLBL, TXPARMCD=TRTDOC + and TXPARMCD=TRTDOSU must be provided" Output Variables: - - SETCD - - $num_trtdos - - $num_trtdosu - - $num_armcd - - $num_spgrpcd - - $num_grplbl + - SETCD + - $num_trtdos + - $num_trtdosu + - $num_armcd + - $num_spgrpcd + - $num_grplbl Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TX -# When set to "Dataset" only the first violation is + - TX +# When set to "Dataset" only the first violation is # When set to "Record", EVERY row within the set that violates the rule is reported Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND261/rule.yml b/Unpublished/SENDIG/SEND261/rule.yml index d9673a9b1..297776999 100644 --- a/Unpublished/SENDIG/SEND261/rule.yml +++ b/Unpublished/SENDIG/SEND261/rule.yml @@ -1,111 +1,117 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.0 - Section: '8.7' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: It is important to note that POOLID values are unique for a given set of - subjects. While the same value of POOLID may not be re-used to refer to different sets of - subjects, different POOLIDs may be used to refer to the same set of subjects. - Document: IG v3.1.1 - Section: '8.5' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND261 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.0 + Section: "8.7" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + It is important to note that POOLID values are unique for a given set of + subjects. While the same value of POOLID may not be re-used to refer to different sets of + subjects, different POOLIDs may be used to refer to the same set of subjects. + Document: IG v3.1.1 + Section: "8.5" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND261 + Version: "1" + Version: "5.0" + Version: "1.0" # IMPORTANT REMARK 2025-09-10: The code of this rule is identical to that of SEND262.1 # as we believe that both rules have essentially the same meaning. # TODO: discuss with the team whether 261 and 262.1 must be merged (216 is published ...) Check: all: - - name: POOLID - operator: is_not_unique_set - value: USUBJID + - name: POOLID + operator: is_not_unique_set + value: USUBJID Core: Status: Draft - Version: '1' -Description: 'A POOLID can only refer to one set of subjects' + Version: "1" +Description: "A POOLID can only refer to one set of subjects" Executability: Fully Executable Outcome: - Message: 'POOLID does not refer to one single set of subjects' + Message: "POOLID does not refer to one single set of subjects" Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - POOLDEF + - POOLDEF Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND283/rule.yml b/Unpublished/SENDIG/SEND283/rule.yml index 54d476140..ee72cf180 100644 --- a/Unpublished/SENDIG/SEND283/rule.yml +++ b/Unpublished/SENDIG/SEND283/rule.yml @@ -1,121 +1,127 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # NOT applicable to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the - value of SEENDTC for one Element will always be immediately before or the same as the - value of SESTDTC for the next Element. Each Element continues until the time at which the - next Element begins, and a subject must be in only one element at a time. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the - value of SEENDTC for one Element will always be immediately before or the same as the - value of SESTDTC for the next Element. Each Element continues until the time at which the - next Element begins, and a subject must be in only one element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the - value of SEENDTC for one Element will always be immediately before or the same as the - value of SESTDTC for the next Element. Each Element continues until the time at which the - next Element begins, and a subject must be in only one element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the - value of SEENDTC for one Element will always be immediately before or the same as the - value of SESTDTC for the next Element. Each Element continues until the time at which the - next Element begins, and a subject must be in only one element at a time. - Document: IG v3.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: There are, by definition, no time gaps between Elements; therefore, the - value of SEENDTC for one Element will always be immediately before or the same as the - value of SESTDTC for the next Element. Each Element continues until the time at which the - next Element begins, and a subject must be in only one element at a time. - Document: IG v3.1.1 - Item: Specification - Section: 5.3.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND283 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + There are, by definition, no time gaps between Elements; therefore, the + value of SEENDTC for one Element will always be immediately before or the same as the + value of SESTDTC for the next Element. Each Element continues until the time at which the + next Element begins, and a subject must be in only one element at a time. + Document: IG v3.1.1 + Item: Specification + Section: 5.3.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND283 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # 2025-05-06: IMPORTANT: The implementation CURRENTLY ONLY checks that DSSTDTC is LATER - # than the highest date value of SEENDTC for the subject. + # than the highest date value of SEENDTC for the subject. # As such, the rule is currently "partially executable". - - name: 'DSSTDTC' - operator: 'date_less_than' - value: '$max_seendtc' - # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction + - name: "DSSTDTC" + operator: "date_less_than" + value: "$max_seendtc" + # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction Core: Status: Draft - Version: '1' -Description: 'The value of SEENDTC for the last Element must immediately precede or be the same as the - date/time of disposition (DSSTDTC) for the subject.' + Version: "1" +Description: + "The value of SEENDTC for the last Element must immediately precede or be the same as the + date/time of disposition (DSSTDTC) for the subject." Executability: Partially Executable - Possible Underreporting Operations: -- domain: SE - group: - - USUBJID - id: $max_seendtc - name: SEENDTC - operator: max_date + - domain: SE + group: + - USUBJID + id: $max_seendtc + name: SEENDTC + operator: max_date Outcome: # TODO? Should we reverse this? - Message: 'Date/time of disposition event DSSTDTC is not equal to or immediately after last element date/time' + Message: "Date/time of disposition event DSSTDTC is not equal to or immediately after last element date/time" Output Variables: - - DSSTDTC - - $max_seendtc + - DSSTDTC + - $max_seendtc Rule Type: Record Data Scope: Classes: Include: - - EVENTS + - EVENTS Domains: Include: - - DS + - DS Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND298/rule.yml b/Unpublished/SENDIG/SEND298/rule.yml index 78675339f..1e642215a 100644 --- a/Unpublished/SENDIG/SEND298/rule.yml +++ b/Unpublished/SENDIG/SEND298/rule.yml @@ -1,114 +1,120 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Remark: does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial - Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design - but do not contain subject data. These are described in Section 7 ...' - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: rial Design Model datasets, consisting of Trial Elements (TE), Trial Arms - (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design but - do not contain subject data. These are described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial - Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design - but do not contain subject data. These are described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial - Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design - but do not contain subject data. These are described in Section 7 ...' - Document: IG v3.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The SDTM includes three types of special-purpose datasets, each of which has - a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial - Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design - but do not contain subject data. These are described in Section 7 ...' - Document: IG v3.1.1 - Item: Specification - Section: '2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND298 - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ..." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: rial Design Model datasets, consisting of Trial Elements (TE), Trial Arms + (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design but + do not contain subject data. These are described in Section 7 ..." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ..." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ..." + Document: IG v3.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The SDTM includes three types of special-purpose datasets, each of which has + a fixed structure: ... Trial Design Model datasets, consisting of Trial Elements (TE), Trial + Arms (TA), Trial Sets (TX), and Trial Summary (TS), contain information about the study design + but do not contain subject data. These are described in Section 7 ..." + Document: IG v3.1.1 + Item: Specification + Section: "2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND298 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: variable_name - operator: is_not_contained_by - value: $allowed_variables + - name: variable_name + operator: is_not_contained_by + value: $allowed_variables Core: Status: Draft - Version: '1' -Description: 'Trigger error when variable is not an allowed variable for the TE, TA, TX, or TS domain' + Version: "1" +Description: "Trigger error when variable is not an allowed variable for the TE, TA, TX, or TS domain" Executability: Fully Executable Operations: -- id: $allowed_variables - # operator: get_model_column_order - NO !!! - operator: get_column_order_from_library + - id: + $allowed_variables + # operator: get_model_column_order - NO !!! + operator: get_column_order_from_library Outcome: - Message: 'The variable is not an allowed variable for the domain' + Message: "The variable is not an allowed variable for the domain" Rule Type: Variable Metadata Check # Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TE - - TA - - TX - - TS + - TE + - TA + - TX + - TS # We use "Record" as when using "Dataset", only the first violation is reported Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND300/rule.yml b/Unpublished/SENDIG/SEND300/rule.yml index 1cab00849..ecb853ed8 100644 --- a/Unpublished/SENDIG/SEND300/rule.yml +++ b/Unpublished/SENDIG/SEND300/rule.yml @@ -1,50 +1,51 @@ Authorities: -- Organization: CDISC - Standards: + - Organization: CDISC + Standards: # Remark: does not apply to SENDIG-3.0 - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'In the event that no records are present in a dataset, the empty dataset should - not be submitted and should not be described in the data definition file.' - Document: IG v3.1 - Item: Specification - Section: '3.2.1' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND300 - Version: '1' - Version: '5.0' - Version: '3.1' + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "In the event that no records are present in a dataset, the empty dataset should + not be submitted and should not be described in the data definition file." + Document: IG v3.1 + Item: Specification + Section: "3.2.1" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND300 + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: - - name: $records_in_dataset - operator: equal_to - value: 0 - # check whether the dataset is described in the define.xml - - name: define_dataset_name - operator: not_equal_to - value: 'test' + - name: $records_in_dataset + operator: equal_to + value: 0 + # check whether the dataset is described in the define.xml + - name: define_dataset_name + operator: not_equal_to + value: "test" Core: Status: Draft - Version: '1' -Description: 'Empty datasets may not be described in the define.xml' + Version: "1" +Description: "Empty datasets may not be described in the define.xml" Executability: Fully Executable Operations: -- id: $records_in_dataset - operator: record_count + - id: $records_in_dataset + operator: record_count Outcome: - Message: 'Empty dataset may not be described in the define.xml' + Message: "Empty dataset may not be described in the define.xml" Output Variables: - - dataset_name - - define_dataset_name + - dataset_name + - define_dataset_name Rule Type: Dataset Contents Check against Define XML # Rule Type: Dataset Metadata Check Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND310/rule.yml b/Unpublished/SENDIG/SEND310/rule.yml index a4081c930..19ca707c0 100644 --- a/Unpublished/SENDIG/SEND310/rule.yml +++ b/Unpublished/SENDIG/SEND310/rule.yml @@ -1,95 +1,100 @@ Authorities: -- Organization: 'CDISC' - Standards: + - Organization: "CDISC" + Standards: # Not applicable to SENDIG 3.0 - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'Trial Sets (TX) can have multiple species and/or strains if they are different - by set.' - Document: 'IG v3.1.1' - Section: '5.1.1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND310' - Version: '1' - Version: '5.0' - Version: '1.2' + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND310" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND310" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND310" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND310" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "Trial Sets (TX) can have multiple species and/or strains if they are different + by set." + Document: "IG v3.1.1" + Section: "5.1.1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND310" + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: # First case: STRAIN - - all: + - all: # Only apply when STRAIN is present, as it is "permissible" - - name: 'STRAIN' - operator: exists - - name: STRAIN - operator: is_inconsistent_across_dataset - value: SETCD - # Second case: SPECIES - - all: + - name: "STRAIN" + operator: exists + - name: STRAIN + operator: is_inconsistent_across_dataset + value: SETCD + # Second case: SPECIES + - all: # only apply when SPECIES is present, as it is "permissible" - - name: SPECIES - operator: exists - - name: SPECIES - operator: is_inconsistent_across_dataset - value: SETCD + - name: SPECIES + operator: exists + - name: SPECIES + operator: is_inconsistent_across_dataset + value: SETCD Core: Status: Draft - Version: '1' -Description: 'DM records with different values for DM.STRAIN must have different values for DM.SETCD.' + Version: "1" +Description: "DM records with different values for DM.STRAIN must have different values for DM.SETCD." Executability: Fully Executable # Operations: # The following operations, only used for reporting purposes, @@ -109,18 +114,18 @@ Executability: Fully Executable # name: SPECIES # operator: distinct Outcome: - Message: 'Within each SETCD, only a single STRAIN and only a single SPECIES is allowed' + Message: "Within each SETCD, only a single STRAIN and only a single SPECIES is allowed" Output Variables: - - STRAIN - - SPECIES - #- $distinct_strain - #- $distinct_species + - STRAIN + - SPECIES + #- $distinct_strain + #- $distinct_species Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND313/rule.yml b/Unpublished/SENDIG/SEND313/rule.yml index 113d4b8ec..d0f9edf37 100644 --- a/Unpublished/SENDIG/SEND313/rule.yml +++ b/Unpublished/SENDIG/SEND313/rule.yml @@ -1,69 +1,71 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When using COVAL1-COVALn, the variable label should match the corresponding variable - name (e.g., Comment1, Comment2).' - Document: IG v3.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND313' - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: "CDISC" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "When using COVAL1-COVALn, the variable label should match the corresponding variable + name (e.g., Comment1, Comment2)." + Document: IG v3.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND313" + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: # The first two checks select COVALn variables, excluding "COVAL" itself - - name: variable_name - operator: starts_with - value: COVAL - - name: variable_name - operator: longer_than - value: 5 - # check whether 6th and 7th character represent a digit - - any: - # 6th character - name: variable_name - operator: matches_regex - value: ^.{5}\d{1} - # 6th and 7th character + operator: starts_with + value: COVAL + - name: variable_name + operator: longer_than + value: 5 + # check whether 6th and 7th character represent a digit + - any: + # 6th character + - name: variable_name + operator: matches_regex + value: + ^.{5}\d{1} + # 6th and 7th character + - name: variable_name + operator: matches_regex + value: ^.{5}\d{2} - name: variable_name - operator: matches_regex - value: ^.{5}\d{2} - - name: variable_name - operator: suffix_not_equal_to - suffix: 1 - value: '1' # this need to be replaced by the last 1 or 2 charaters of the label - # Proposal Els - #- name: variable_label - # operator: does_not_equal_string_part - # regex: (\d+)$ - # value: variable_name + operator: suffix_not_equal_to + suffix: 1 + value: "1" # this need to be replaced by the last 1 or 2 charaters of the label + # Proposal Els + #- name: variable_label + # operator: does_not_equal_string_part + # regex: (\d+)$ + # value: variable_name Core: Id: SEND313 Status: Draft - Version: '1' -Description: 'Variable Label for COVALn must end with n (as a number from COVALn)' + Version: "1" +Description: "Variable Label for COVALn must end with n (as a number from COVALn)" Executability: Fully Executable Operations: # we need something here to retrieve the last character of the label # but it looks as we cannot use "operator" in the same way as in "Check" -- id: $last_character - name: variable_label - operator: matches_regex - value: ".$" + - id: $last_character + name: variable_label + operator: matches_regex + value: ".$" Outcome: - Message: 'Variable Label must end with the number n in the variable name' + Message: "Variable Label must end with the number n in the variable name" Rule Type: Variable Metadata Check Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - CO + - CO Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND321/rule.yml b/Unpublished/SENDIG/SEND321/rule.yml index 97bf6e581..75fa09fb9 100644 --- a/Unpublished/SENDIG/SEND321/rule.yml +++ b/Unpublished/SENDIG/SEND321/rule.yml @@ -1,66 +1,71 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM controlled list. - Document: IG v3.1 - Section: 6.3.8 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND321' - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: Neoplastic findings must be populated using the NEOPLASM controlled list. + Document: IG v3.1 + Section: 6.3.8 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND321" + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: - - any: - - name: MIRESCAT - operator: equal_to - value: 'MALIGNANT' - - name: MIRESCAT - operator: equal_to - value: 'BENIGN' - - name: MISTRESC - operator: is_not_contained_by - # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!! - value: $NEOPASM_CODELIST - # The following does not seem to work => "invalid operator" - #- name: MISTRESC - # operator: does_not_use_valid_codelist_terms - # value: NEOPLASM + - any: + - name: MIRESCAT + operator: equal_to + value: "MALIGNANT" + - name: MIRESCAT + operator: equal_to + value: "BENIGN" + - name: MISTRESC + operator: + is_not_contained_by + # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!! + value: $NEOPASM_CODELIST + # The following does not seem to work => "invalid operator" + #- name: MISTRESC + # operator: does_not_use_valid_codelist_terms + # value: NEOPLASM Core: Status: Draft - Version: '1' -Description: 'Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and the value in MISTRESC is - not from the NEOPLASM codelist (NCI C88025)' + Version: "1" +Description: + "Report an issue when MIRESCAT is either MALIGNANT or BENIGN, and the value in MISTRESC is + not from the NEOPLASM codelist (NCI C88025)" Executability: Fully Executable Operations: # 2025-09-11: This still returns an EMPTY list! # or just - codelist: NEOPLASM -- codelists: - - NEOPLASM - ct_package_type: SEND - id: $NEOPASM_CODELIST - level: term - # level: codelist - operator: codelist_terms - returntype: value - # version: '2024-03-29' - #version: codeSystemVersion + - codelists: + - NEOPLASM + ct_package_type: SEND + id: $NEOPASM_CODELIST + level: + term + # level: codelist + operator: codelist_terms + returntype: + value + # version: '2024-03-29' + #version: codeSystemVersion Outcome: - Message: 'The term for the record is not present in the NEOPLASM codelist and may be a term added to - the extensible list' + Message: + "The term for the record is not present in the NEOPLASM codelist and may be a term added to + the extensible list" Output Variables: - - MISTRESC - - $NEOPASM_CODELIST + - MISTRESC + - $NEOPASM_CODELIST Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - MI + - MI Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND327/rule.yml b/Unpublished/SENDIG/SEND327/rule.yml index b399ebb5b..47bde5904 100644 --- a/Unpublished/SENDIG/SEND327/rule.yml +++ b/Unpublished/SENDIG/SEND327/rule.yml @@ -1,87 +1,92 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 -- Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM - must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM - must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'When a predose sample is collected as part of the profile analysis, then PCELTM - must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under - the curve.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND327' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND327" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND327" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + 'When a predose sample is collected as part of the profile analysis, then PCELTM + must be populated as "PT0H" because negative elapsed time would lead to an incorrect area under + the curve.' + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND327" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat - - name: PCELTM - operator: non_empty - # value of PCELTM may not start with a dash (minus-character) - - name: PCELTM - operator: starts_with - value: '-' - # Alternative test for first character being "-" - # - name: PCELTM - # operator: prefix_equal_to - # prefix: 1 - # value: '-' + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat + - name: PCELTM + operator: non_empty + # value of PCELTM may not start with a dash (minus-character) + - name: PCELTM + operator: starts_with + value: "-" + # Alternative test for first character being "-" + # - name: PCELTM + # operator: prefix_equal_to + # prefix: 1 + # value: '-' Core: Status: Draft - Version: '1' -Description: 'Duration in PCELTM may not be negative when record used in concentration profile in PP' + Version: "1" +Description: "Duration in PCELTM may not be negative when record used in concentration profile in PP" Executability: Fully Executable Operations: -- domain: PP - # TODO: ensure that we do NEED OR NOT NEED to use "group", as "distinct" is already on the subject level? - group: - - USUBJID - id: $pp_ppcat - name: PPCAT - operator: distinct + - domain: + PP + # TODO: ensure that we do NEED OR NOT NEED to use "group", as "distinct" is already on the subject level? + group: + - USUBJID + id: $pp_ppcat + name: PPCAT + operator: distinct Outcome: - Message: 'A negative value for PCELTM is not allowed as the record is used in a concentration profile - in PP' + Message: + "A negative value for PCELTM is not allowed as the record is used in a concentration profile + in PP" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND328-1/rule.yml b/Unpublished/SENDIG/SEND328-1/rule.yml index 10bc6bede..c7ee2c0ce 100644 --- a/Unpublished/SENDIG/SEND328-1/rule.yml +++ b/Unpublished/SENDIG/SEND328-1/rule.yml @@ -1,146 +1,154 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-1' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-1" + Version: "1" + Version: "5.0" + Version: "1.2" Check: # Part 1, USUBJID is present and populated, and PCSCAT is present all: - - name: USUBJID - operator: exists - - name: USUBJID - operator: non_empty - # case that PCSCAT is present - - name: PCSCAT - operator: exists - # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - - name: PCELTM - operator: equal_to - value: 'PT0H' - # 2025-07-09: PPCAT must correspond to PCTESTCD - # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) - # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' - #- name: PCTESTCD - # operator: is_contained_by - # value: $pp_cat - # reference of measurement in PC must be equal to reference of profile in PP - # TODO: This must be for the GIVEN SUBJECT! - - name: PCTPTREF - operator: is_contained_by - value: $pp_tptref - # reference time (time point) must be equal to reference time of profile in PP - - name: PCRFTDTC - operator: is_contained_by - value: $pp_rftdtc - # Report a violation when the number of records for PCELTM=PT0H is not 1 - - name: $pc_group - operator: not_equal_to - value: 1 + - name: USUBJID + operator: exists + - name: USUBJID + operator: non_empty + # case that PCSCAT is present + - name: PCSCAT + operator: exists + # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' + - name: PCELTM + operator: equal_to + value: "PT0H" + # 2025-07-09: PPCAT must correspond to PCTESTCD + # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) + # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' + #- name: PCTESTCD + # operator: is_contained_by + # value: $pp_cat + # reference of measurement in PC must be equal to reference of profile in PP + # TODO: This must be for the GIVEN SUBJECT! + - name: PCTPTREF + operator: is_contained_by + value: $pp_tptref + # reference time (time point) must be equal to reference time of profile in PP + - name: PCRFTDTC + operator: is_contained_by + value: $pp_rftdtc + # Report a violation when the number of records for PCELTM=PT0H is not 1 + - name: $pc_group + operator: not_equal_to + value: 1 Core: Id: SEND328-1 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- domain: PC - # we will count the number of records for which PCELTM = PT0H within each group - filter: - PCELTM: PT0H - # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF - group: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC # added 2025-07-09 - - PCTPTREF - id: $pc_group - operator: record_count - # 2025-07-09: PPCAT and PCTESTCD must correspond -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_cat - name: PPCAT - operator: distinct - # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_tptref - name: PPTPTREF - operator: distinct -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_rftdtc - name: PPRFTDTC - operator: distinct + - domain: + PC + # we will count the number of records for which PCELTM = PT0H within each group + filter: + PCELTM: PT0H + # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF + group: + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC # added 2025-07-09 + - PCTPTREF + id: $pc_group + operator: record_count + # 2025-07-09: PPCAT and PCTESTCD must correspond + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_cat + name: PPCAT + operator: distinct + # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_tptref + name: PPTPTREF + operator: distinct + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_rftdtc + name: PPRFTDTC + operator: distinct Outcome: - Message: 'specimen concentrations to calculate a time concentration profile may only have one record - with PCELTM=PT0H' + Message: + "specimen concentrations to calculate a time concentration profile may only have one record + with PCELTM=PT0H" Output Variables: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC - - PCTPTREF - - $pc_group - - $pp_cat - - $pp_tptref - - $pp_rftdtc + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC + - PCTPTREF + - $pc_group + - $pp_cat + - $pp_tptref + - $pp_rftdtc Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND328-2/rule.yml b/Unpublished/SENDIG/SEND328-2/rule.yml index dc733ab26..9ec411ccb 100644 --- a/Unpublished/SENDIG/SEND328-2/rule.yml +++ b/Unpublished/SENDIG/SEND328-2/rule.yml @@ -1,143 +1,151 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: 'SENDIG-GENETOX' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'In case of immediate postdose sampling, there should not be 2 PT0H records for - the same profile; instead, the immediate postdose sample should be separated from predose samples - with a different PCELTM value so that each is uniquely identifiable.' - Document: 'IG v3.1.1' - Section: '6.3.11.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND328-2' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-2" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: "SENDIG-GENETOX" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-2" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "In case of immediate postdose sampling, there should not be 2 PT0H records for + the same profile; instead, the immediate postdose sample should be separated from predose samples + with a different PCELTM value so that each is uniquely identifiable." + Document: "IG v3.1.1" + Section: "6.3.11.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND328-2" + Version: "1" + Version: "5.0" + Version: "1.2" Check: # Part 2, USUBJID is present and populated, and PCSCAT is absent all: - - name: USUBJID - operator: exists - - name: USUBJID - operator: non_empty - - name: PCSCAT - operator: not_exists - # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - - name: PCELTM - operator: equal_to - value: 'PT0H' - # 2025-07-09: PPCAT must correspond to PCTESTCD - # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) - # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' - #- name: PCTESTCD - # operator: is_contained_by - # value: $pp_cat - # reference of measurement in PC must be equal to reference of profile in PP - # P.S. This must be for the GIVEN SUBJECT! - - name: PCTPTREF - operator: is_contained_by - value: $pp_tptref - # reference time (time point) must be equal to reference time of profile in PP - - name: PCRFTDTC - operator: is_contained_by - value: $pp_rftdtc - # Report a violation when the number of records for PCELTM=PT0H is not 1 - - name: $pc_group_no_pcscat - operator: not_equal_to - value: 1 + - name: USUBJID + operator: exists + - name: USUBJID + operator: non_empty + - name: PCSCAT + operator: not_exists + # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' + - name: PCELTM + operator: equal_to + value: "PT0H" + # 2025-07-09: PPCAT must correspond to PCTESTCD + # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) + # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' + #- name: PCTESTCD + # operator: is_contained_by + # value: $pp_cat + # reference of measurement in PC must be equal to reference of profile in PP + # P.S. This must be for the GIVEN SUBJECT! + - name: PCTPTREF + operator: is_contained_by + value: $pp_tptref + # reference time (time point) must be equal to reference time of profile in PP + - name: PCRFTDTC + operator: is_contained_by + value: $pp_rftdtc + # Report a violation when the number of records for PCELTM=PT0H is not 1 + - name: $pc_group_no_pcscat + operator: not_equal_to + value: 1 Core: Id: SEND328-2 Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- domain: PC - # we will count the number of records for which PCELTM = PT0H within each group - filter: - PCELTM: PT0H - # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent - group: - - USUBJID - - PCTESTCD - - PCCAT - - PCSPEC # added 2025-07-09 - - PCTPTREF - id: $pc_group_no_pcscat - operator: record_count - # 2025-07-09: PPCAT and PCTESTCD must correspond -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_cat - name: PPCAT - operator: distinct - # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_tptref - name: PPTPTREF - operator: distinct -- domain: PP - # we only want it for the current subject - group: - - USUBJID - id: $pp_rftdtc - name: PPRFTDTC - operator: distinct + - domain: + PC + # we will count the number of records for which PCELTM = PT0H within each group + filter: + PCELTM: PT0H + # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent + group: + - USUBJID + - PCTESTCD + - PCCAT + - PCSPEC # added 2025-07-09 + - PCTPTREF + id: $pc_group_no_pcscat + operator: record_count + # 2025-07-09: PPCAT and PCTESTCD must correspond + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_cat + name: PPCAT + operator: distinct + # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_tptref + name: PPTPTREF + operator: distinct + - domain: + PP + # we only want it for the current subject + group: + - USUBJID + id: $pp_rftdtc + name: PPRFTDTC + operator: distinct Outcome: - Message: 'specimen concentrations to calculate a time concentration profile may only have one record - with PCELTM=PT0H' + Message: + "specimen concentrations to calculate a time concentration profile may only have one record + with PCELTM=PT0H" Output Variables: - - USUBJID - - PCTESTCD - - PCCAT - - PCSCAT - - PCSPEC - - PCTPTREF - - $pp_cat - - $pp_tptref - - $pp_rftdtc - - $pc_group_no_pcscat + - USUBJID + - PCTESTCD + - PCCAT + - PCSCAT + - PCSPEC + - PCTPTREF + - $pp_cat + - $pp_tptref + - $pp_rftdtc + - $pc_group_no_pcscat Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND333/rule.yml b/Unpublished/SENDIG/SEND333/rule.yml index afceb559c..be1505afd 100644 --- a/Unpublished/SENDIG/SEND333/rule.yml +++ b/Unpublished/SENDIG/SEND333/rule.yml @@ -1,109 +1,114 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 -- Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY - and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY - and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a single time concentration profile, the PCNOMDY - and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND333' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND333" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND333" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a single time concentration profile, the PCNOMDY + and PCTPTREF pair must be the same as the PPNOMDY and PPTPTREF pair for that same profile." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND333" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat - # TODO: count number of distinct values of PPCAT for this subject - #- name: $pp_cat - # operator: equal_to - # value: 'blabla' - # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF - - any: - - name: PCNOMDY # old - operator: empty - - name: PCTPTREF # old - operator: empty - - name: PCELTM # old - operator: empty + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat + # TODO: count number of distinct values of PPCAT for this subject + #- name: $pp_cat + # operator: equal_to + # value: 'blabla' + # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF + - any: + - name: PCNOMDY # old + operator: empty + - name: PCTPTREF # old + operator: empty + - name: PCELTM # old + operator: empty Core: Status: Draft - Version: '1' -Description: 'When PC record is used in only 1 concentration profile, ensure that PCNOMDY=PPNOMDY and - PPCTPTREF=PPTPTREF' + Version: "1" +Description: + "When PC record is used in only 1 concentration profile, ensure that PCNOMDY=PPNOMDY and + PPCTPTREF=PPTPTREF" Executability: Fully Executable Operations: # get the distinct values of PPCAT per subject in domain PP -- domain: PP + - domain: PP # We need to group per subject - group: - - USUBJID - id: $pp_ppcat - name: PPCAT - operator: distinct - #- id: $countppcat - # name: $pp_ppcat - # operator: record_count + group: + - USUBJID + id: $pp_ppcat + name: PPCAT + operator: distinct + #- id: $countppcat + # name: $pp_ppcat + # operator: record_count - # just trying something else - #- group: - # - PCTESTCD -- domain: PP - filter: - PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD - group: - - USUBJID - id: $profile_count - operator: record_count + # just trying something else + #- group: + # - PCTESTCD + - domain: PP + filter: + PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD + group: + - USUBJID + id: $profile_count + operator: record_count Outcome: - Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration - profile in PP' + Message: + "PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration + profile in PP" Output Variables: - - USUBJID - - PCNOMDY - - PCTPTREF - - PCELTM - - $pp_ppcat - - $profile_count - #- $countppcat + - USUBJID + - PCNOMDY + - PCTPTREF + - PCELTM + - $pp_ppcat + - $profile_count + #- $countppcat Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND340/rule.yml b/Unpublished/SENDIG/SEND340/rule.yml index 5b5f134cf..dbc5a0a77 100644 --- a/Unpublished/SENDIG/SEND340/rule.yml +++ b/Unpublished/SENDIG/SEND340/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If expected variables in a domain are all null, a comment should be included - in the Define-XML document to explain why all records are null. - Document: SENDIG - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND340 - Version: '1' - Version: '5.0' - Version: '3.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If expected variables in a domain are all null, a comment should be included + in the Define-XML document to explain why all records are null. + Document: SENDIG + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND340 + Version: "1" + Version: "5.0" + Version: "3.1" Check: all: #- name: variable_name @@ -21,51 +22,54 @@ Check: # value: # - $expected_variables # Get any "expected" columns that are empty - - all: + - all: # This checks on the individual record, not for an empty column - - metadata: $var_perm - operator: variable_metadata_not_equal_to - value: 'Exp' - #- operator: non_empty - #- name: USUBJID - # operator: not_equal_to - # value: BLABLA - #- name: $VARIABLE_NULL - # operator: equal_to - # value: TRUE - #- name: define_variable_has_comment - # operator: equal_to - # value: false + - metadata: $var_perm + operator: variable_metadata_not_equal_to + value: + "Exp" + #- operator: non_empty + #- name: USUBJID + # operator: not_equal_to + # value: BLABLA + #- name: $VARIABLE_NULL + # operator: equal_to + # value: TRUE + #- name: define_variable_has_comment + # operator: equal_to + # value: false Core: Id: SEND340 Status: Draft - Version: '1' -Description: If expected variables in a domain are all null, a comment should be included in the + Version: "1" +Description: + If expected variables in a domain are all null, a comment should be included in the Define-XML document to explain why all records are null. Executability: Fully Executable Operations: -- id: $var_perm - name: core - operator: variable_library_metadata - #- id: $expected_variables - # operator: expected_variables - #- id: $VARIABLE_NULL - # what do we need for "name" here? - #operator: variable_is_null + - id: $var_perm + name: core + operator: + variable_library_metadata + #- id: $expected_variables + # operator: expected_variables + #- id: $VARIABLE_NULL + # what do we need for "name" here? + #operator: variable_is_null Outcome: Message: Expected variable with missing value for all records Output Variables: - - $var_perm + - $var_perm # - $expected_variables # Rule Type: 'Variable Metadata Check against Library Metadata' Rule Type: Record Data Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record #Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND348/rule.yml b/Unpublished/SENDIG/SEND348/rule.yml index 9588d627e..c482dc562 100644 --- a/Unpublished/SENDIG/SEND348/rule.yml +++ b/Unpublished/SENDIG/SEND348/rule.yml @@ -1,117 +1,124 @@ Authorities: # Only applicable to SENDIG-3.1.1, SENDIG-GENETOX-1.0 and SENDIG-DART-1.2 -- Organization: 'CDISC' - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables - PCNOMDY, PCTPTREF, and PCELTM must all be populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables - PCNOMDY, PCTPTREF, and PCELTM must all be populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'For PC records contributing to a time concentration profile, the timing variables - PCNOMDY, PCTPTREF, and PCELTM must all be populated.' - Document: IG v3.1.1 - Section: 6.3.11.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND348' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND348" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND348" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "For PC records contributing to a time concentration profile, the timing variables + PCNOMDY, PCTPTREF, and PCELTM must all be populated." + Document: IG v3.1.1 + Section: 6.3.11.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND348" + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: # Case that USUBJID is populated - - all: - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat_usubjid + - all: + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat_usubjid - - any: - - name: PCNOMDY - operator: empty - - name: PCTPTREF - operator: empty - - name: PCELTM - operator: empty - # case that POOLID is populated. ATTENTION: POOLID is permissible! - - all: + - any: + - name: PCNOMDY + operator: empty + - name: PCTPTREF + operator: empty + - name: PCELTM + operator: empty + # case that POOLID is populated. ATTENTION: POOLID is permissible! + - all: # PC-POOLID column is present - - name: POOLID - operator: exists - # PC-POOLID is populated - - name: POOLID - operator: non_empty - - name: PCTESTCD - operator: is_contained_by - value: $pp_ppcat_poolid - - any: - - name: PCNOMDY - operator: empty - - name: PCTPTREF - operator: empty - - name: PCELTM - operator: empty + - name: POOLID + operator: + exists + # PC-POOLID is populated + - name: POOLID + operator: non_empty + - name: PCTESTCD + operator: is_contained_by + value: $pp_ppcat_poolid + - any: + - name: PCNOMDY + operator: empty + - name: PCTPTREF + operator: empty + - name: PCELTM + operator: empty Core: Status: Draft - Version: '1' -Description: 'When PCTESTCD = PPCAT, then PCNOMDY, PCTPTREF and PCELTM must be populated' + Version: "1" +Description: "When PCTESTCD = PPCAT, then PCNOMDY, PCTPTREF and PCELTM must be populated" Executability: Fully Executable Operations: -- domain: PP - # group by USUBJID - group: - - USUBJID - id: $pp_ppcat_usubjid - name: PPCAT - operator: distinct -- domain: PP - # group by POOLID - group: - - POOLID - id: $pp_ppcat_poolid - name: PPCAT - operator: distinct + - domain: + PP + # group by USUBJID + group: + - USUBJID + id: $pp_ppcat_usubjid + name: PPCAT + operator: distinct + - domain: + PP + # group by POOLID + group: + - POOLID + id: $pp_ppcat_poolid + name: PPCAT + operator: distinct Outcome: - Message: 'PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration - profile in PP' + Message: + "PCNOMDY, PCTPTREF and PCELTM must be populated as the record contributes to a concentration + profile in PP" Output Variables: - - USUBJID - - POOLID # can this lead to a "skip" when POOLID column absent? - - PCNOMDY - - PCTPTREF - - PCELTM - - $pp_ppcat_usubjid - - $pp_ppcat_poolid + - USUBJID + - POOLID # can this lead to a "skip" when POOLID column absent? + - PCNOMDY + - PCTPTREF + - PCELTM + - $pp_ppcat_usubjid + - $pp_ppcat_poolid Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - PC + - PC Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND362/rule.yml b/Unpublished/SENDIG/SEND362/rule.yml index 755e6b02f..15a9e4008 100644 --- a/Unpublished/SENDIG/SEND362/rule.yml +++ b/Unpublished/SENDIG/SEND362/rule.yml @@ -1,57 +1,62 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: FETUSID should be populated for implantations that have individual fetal - examinations or measurements that will be captured in other domains. The USUBJID / FETUSID - combination must be consistent across domains within a study. - Document: DART-IG v1.1 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: FETUSID should be populated for implantations that have individual fetal - examinations or measurements that will be captured in other domains. The USUBJID / FETUSID - combination must be consistent across domains within a study. - Document: DART-IG v1.2 - Section: '5.1.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND362 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + FETUSID should be populated for implantations that have individual fetal + examinations or measurements that will be captured in other domains. The USUBJID / FETUSID + combination must be consistent across domains within a study. + Document: DART-IG v1.1 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + FETUSID should be populated for implantations that have individual fetal + examinations or measurements that will be captured in other domains. The USUBJID / FETUSID + combination must be consistent across domains within a study. + Document: DART-IG v1.2 + Section: "5.1.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND362 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: - - any: - - name: USUBJID - operator: non_empty - #- name: FETUSID - # operator: empty + - any: + - name: USUBJID + operator: + non_empty + #- name: FETUSID + # operator: empty Core: Status: Draft - Version: '1' -Description: 'Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements) is not found in IC (Implantation - Classification)' + Version: "1" +Description: + "Report an issue when a USUBJID-FETUSID in FM (Fetus Measurements) is not found in IC (Implantation + Classification)" # Also see Christy's mail 2025-10-13 - issues the question of the difference between SEND262 and SEND263 Executability: Fully Executable Outcome: - Message: 'The combination of USUBJID and FETUSID in FM (Fetus Measurements) was not found in IC (Implantation - Classification)' + Message: + "The combination of USUBJID and FETUSID in FM (Fetus Measurements) was not found in IC (Implantation + Classification)" Rule Type: Record Data Scope: Classes: Include: - - FINDINGS + - FINDINGS Domains: Include: - - FM + - FM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND399/rule.yml b/Unpublished/SENDIG/SEND399/rule.yml index c799c3c52..a6afbdff5 100644 --- a/Unpublished/SENDIG/SEND399/rule.yml +++ b/Unpublished/SENDIG/SEND399/rule.yml @@ -1,74 +1,78 @@ Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards for the submission - of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred - to as the SENDIG-DART. This IG is based on and should be used in close concert with Version - 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version - 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/.' - Document: 'SENDIG DART' - Section: '1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND399' - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: 'SENDIG-DART' - References: - - Citations: - - Cited Guidance: 'This Implementation Guide (IG) defines recommended standards for the submission - of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred - to as the SENDIG-DART. This IG is based on and should be used in close concert with Version - 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version - 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/.' - Document: 'SENDIG DART' - Section: '1.1' - Origin: 'SEND Conformance Rules' - Rule Identifier: - Id: 'SEND399' - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: "CDISC" + Standards: + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "This Implementation Guide (IG) defines recommended standards for the submission + of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred + to as the SENDIG-DART. This IG is based on and should be used in close concert with Version + 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version + 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/." + Document: "SENDIG DART" + Section: "1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND399" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: "SENDIG-DART" + References: + - Citations: + - Cited Guidance: + "This Implementation Guide (IG) defines recommended standards for the submission + of data from nonclinical Developmental and Reproductive Toxicology (DART) studies, and is referred + to as the SENDIG-DART. This IG is based on and should be used in close concert with Version + 3.1 of the Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG) and Version + 1.6 of the CDISC Study Data Tabulation Model (SDTM), available at https://www.cdisc.org/standards/." + Document: "SENDIG DART" + Section: "1.1" + Origin: "SEND Conformance Rules" + Rule Identifier: + Id: "SEND399" + Version: "1" + Version: "5.0" + Version: "1.2" Check: any: # check on whether there is a record with TSPARMCD=SNDIGVER - - name: $distinct_tsparmcd - operator: does_not_contain - value: SNDIGVER - # when there is a record with TSPARMCD=SNDIGVER, - # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2 - - all: - - name: TSPARMCD - operator: equal_to + - name: $distinct_tsparmcd + operator: does_not_contain value: SNDIGVER - - name: TSVAL - operator: is_not_contained_by - value: - - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.1 - - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.2 + # when there is a record with TSPARMCD=SNDIGVER, + # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2 + - all: + - name: TSPARMCD + operator: equal_to + value: SNDIGVER + - name: TSVAL + operator: is_not_contained_by + value: + - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.1 + - SEND DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY IMPLEMENTATION GUIDE VERSION 1.2 Core: Status: Draft - Version: '1' -Description: 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL = Controlled Terminology term + Version: "1" +Description: + 'A record exists in TS where TSPARMCD = "SNDIGVER" and TSVAL = Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist' Executability: Fully Executable Operations: -- id: $distinct_tsparmcd - name: TSPARMCD - operator: distinct + - id: $distinct_tsparmcd + name: TSPARMCD + operator: distinct Outcome: - Message: 'A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL for SNDIGVER must be the - Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist.' + Message: + "A record with TSPARMCD=SNDIGVER must be present in TS and the TSVAL for SNDIGVER must be the + Controlled Terminology term for SENDIG-DART from the SNDIGVER codelist." Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND4/rule.yml b/Unpublished/SENDIG/SEND4/rule.yml index f0a04462d..cafb29fd4 100644 --- a/Unpublished/SENDIG/SEND4/rule.yml +++ b/Unpublished/SENDIG/SEND4/rule.yml @@ -1,130 +1,138 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ...The data Type.' - Document: SENDIG v3.0 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ... The data Type.' - Document: SENDIG v3.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ...The data Type.' - Document: SENDIG v3.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: 'The define.xml specification includes seven distinct attributes to describe variable-level - metadata; ...The data Type.' - Document: SENDIG v3.1.1 - Section: '3.2.2' - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND4 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type." + Document: SENDIG v3.0 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ... The data Type." + Document: SENDIG v3.1 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type." + Document: SENDIG v3.1.1 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type." + Document: SENDIG v3.1.1 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type." + Document: SENDIG v3.1 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata; ...The data Type." + Document: SENDIG v3.1.1 + Section: "3.2.2" + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND4 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: #- name: variable_data_type # operator: not_equal_to # # value: 'Char' # temporary (uppercase) # value: define_variable_data_type - - name: variable_name # JUST TRYING ... - operator: equal_to - value: define_variable_name - - name: variable_data_type - # ALTHOUGH equivalent: variable_data_type equal_to "Char" DOES NOT WORK !!! - #operator: equal_to - #value: "Char" - operator: not_equal_to # Character - value: "Num" - #- all: - # # ALTHOUGH mostly equivalent, define_variable_data_type equal_to "text" DOES NOT WORK !!! - # - name: define_variable_data_type - # operator: not_equal_to - # value: "integer" - #- any: - # - name: define_variable_data_type - # operator: equal_to - # value: 'integer' - # - name: define_variable_data_type - # operator: equal_to - # value: 'float' + - name: variable_name # JUST TRYING ... + operator: equal_to + value: define_variable_name + - name: + variable_data_type + # ALTHOUGH equivalent: variable_data_type equal_to "Char" DOES NOT WORK !!! + #operator: equal_to + #value: "Char" + operator: not_equal_to # Character + value: + "Num" + #- all: + # # ALTHOUGH mostly equivalent, define_variable_data_type equal_to "text" DOES NOT WORK !!! + # - name: define_variable_data_type + # operator: not_equal_to + # value: "integer" + #- any: + # - name: define_variable_data_type + # operator: equal_to + # value: 'integer' + # - name: define_variable_data_type + # operator: equal_to + # value: 'float' Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'variable data type mismatch' + Message: "variable data type mismatch" Output Variables: - - variable_name - - define_variable_name - - variable_data_type - - define_variable_data_type + - variable_name + - define_variable_name + - variable_data_type + - define_variable_data_type # Rule Type: Record Data Rule Type: Variable Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND41/rule.yml b/Unpublished/SENDIG/SEND41/rule.yml index 13d17f10d..524d4123b 100644 --- a/Unpublished/SENDIG/SEND41/rule.yml +++ b/Unpublished/SENDIG/SEND41/rule.yml @@ -1,38 +1,39 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: When extending a controlled terminology list, the case-sensitivity - convention of that list should be followed. - Document: IG v3.0 - Item: Specification - Section: 4.2.4 | 4.3.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: 'SEND41' - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + When extending a controlled terminology list, the case-sensitivity + convention of that list should be followed. + Document: IG v3.0 + Item: Specification + Section: 4.2.4 | 4.3.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND41" + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: SITEID - operator: 'equal_to' - value: '701' + - name: SITEID + operator: "equal_to" + value: "701" Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'Value may not be 701' + Message: "Value may not be 701" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND49/rule.yml b/Unpublished/SENDIG/SEND49/rule.yml index 598f0cdf9..74f083cf0 100644 --- a/Unpublished/SENDIG/SEND49/rule.yml +++ b/Unpublished/SENDIG/SEND49/rule.yml @@ -1,142 +1,151 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.0 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.0' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.1.0 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: If a controlled terminology codelist exists for a variable in a SEND domain, - the name of the codelist will be populated in the Controlled Terms, Codelist, or Format - column of the domain model to indicate that a distinct set of controlled values exist and - is expected to be used. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND49 - Version: '1' - Version: '5.0' - Version: '1.2' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.0 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.0 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + If a controlled terminology codelist exists for a variable in a SEND domain, + the name of the codelist will be populated in the Controlled Terms, Codelist, or Format + column of the domain model to indicate that a distinct set of controlled values exist and + is expected to be used. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND49 + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # This first condition (define_variable_name != 'STUDYID') seems to be necessary to select the variables - - name: define_variable_name - operator: not_equal_to - value: 'STUDYID' - # 2025-08-16: library_variable_code looks to work well - - name: 'library_variable_ccode' - operator: non_empty - - any: + - name: define_variable_name + operator: not_equal_to + value: + "STUDYID" + # 2025-08-16: library_variable_code looks to work well + - name: "library_variable_ccode" + operator: non_empty + - any: # - name: define_vlm_ccode # operator: not_equal_to # value: 'test' - - name: define_variable_ccode - operator: empty - - name: define_variable_ccode - operator: not_equal_to - value: library_variable_ccode + - name: define_variable_ccode + operator: empty + - name: define_variable_ccode + operator: not_equal_to + value: library_variable_ccode Core: Status: Draft - Version: '1' -Description: 'For a variable identified in the SENDIG as being subject to CDISC published Controlled Terminology, + Version: "1" +Description: + "For a variable identified in the SENDIG as being subject to CDISC published Controlled Terminology, the Codelist listed in the Define-XML document must properly reference the Controlled Terminology Codelist - used.' + used." Executability: Fully Executable Outcome: - Message: 'As a controlled terminology codelist exists for the variable in the SEND domain, the codelist - must be referenced for the variable in the define.xml' + Message: + "As a controlled terminology codelist exists for the variable in the SEND domain, the codelist + must be referenced for the variable in the define.xml" Output Variables: - - define_variable_name - - define_variable_ccode - - library_variable_ccode - - define_vlm_ccode + - define_variable_name + - define_variable_ccode + - library_variable_ccode + - define_vlm_ccode Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND5/rule.yml b/Unpublished/SENDIG/SEND5/rule.yml index 97bfd9ab6..f607217dc 100644 --- a/Unpublished/SENDIG/SEND5/rule.yml +++ b/Unpublished/SENDIG/SEND5/rule.yml @@ -1,117 +1,125 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.0 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport - format)" - Document: IG v3.1.1 - Item: Specification - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND5 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.0 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The Variable Name (limited to 8 characters for compatibility with the SAS v5 Transport + format)" + Document: IG v3.1.1 + Item: Specification + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND5 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: - - name: define_variable_name - operator: not_equal_to - # P.S.: library_variable_name points to the IG plus to the model. - value: library_variable_name + - name: define_variable_name + operator: + not_equal_to + # P.S.: library_variable_name points to the IG plus to the model. + value: library_variable_name Core: Status: Draft - Version: '1' -Description: 'Checks the variable name in the define.xml for its existence in the CDISC Library for the - provided SENDIG version' + Version: "1" +Description: + "Checks the variable name in the define.xml for its existence in the CDISC Library for the + provided SENDIG version" Executability: Fully Executable Outcome: - Message: 'The variable in the define.xml is not from the SENDIG' + Message: "The variable in the define.xml is not from the SENDIG" Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL # Sensitivity: Record Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND50.99/rule.yml b/Unpublished/SENDIG/SEND50.99/rule.yml index 5073747c1..e779a92de 100644 --- a/Unpublished/SENDIG/SEND50.99/rule.yml +++ b/Unpublished/SENDIG/SEND50.99/rule.yml @@ -1,42 +1,43 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. Transport format)" - Document: IG v3.0 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50.99 - Version: "1" - Version: "5.0" - Version: "3.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.0 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50.99 + Version: "1" + Version: "5.0" + Version: "3.0" Check: all: - - name: define_variable_name - operator: not_equal_to - value: STUDYID - - name: define_vlm_ccode - operator: 'not_equal_to' - value: '99999' + - name: define_variable_name + operator: not_equal_to + value: STUDYID + - name: define_vlm_ccode + operator: "not_equal_to" + value: "99999" Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'test message' + Message: "test message" Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND50/rule.yml b/Unpublished/SENDIG/SEND50/rule.yml index 56057aa4a..e2c4574d3 100644 --- a/Unpublished/SENDIG/SEND50/rule.yml +++ b/Unpublished/SENDIG/SEND50/rule.yml @@ -1,136 +1,144 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. Transport format)" - Document: IG v3.0 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "3.0" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. Transport format)" - Document: IG v3.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. - Document: IG v3.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.2" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: The controlled terminology or a link to the controlled terminology should be - included in the data definition file wherever applicable. See the define.xml specification - for details on including or referencing controlled terminology lists. - Document: IG v3.1.1 - Item: Specification - Section: 4.3.3 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND50 - Version: "1" - Version: "5.0" - Version: "1.0" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.0 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. Transport format)" + Document: IG v3.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + The controlled terminology or a link to the controlled terminology should be + included in the data definition file wherever applicable. See the define.xml specification + for details on including or referencing controlled terminology lists. + Document: IG v3.1.1 + Item: Specification + Section: 4.3.3 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND50 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: # The rule fails (false positive) when the codelist reference in the define.xml # is on the ValueList level, and NOT on the Variable level. # ALSO: the current implementation only reports the FIRST violation per dataset - - name: library_variable_ccode - operator: not_equal_to - value: '' - # 2025-11-08: TEMPORARY solution: - #- name: define_variable_has_codelist - # operator: equal_to - # value: true - # better would be to also have a "define_variable_has_valuelist" - # so that the rule can be implemented as: - # "do not check when there is no codelist referenced on the Variable level, - # but there is a ValueList referenced". - # Remark however this may lead to false negatives - - name: library_variable_ccode - operator: not_equal_to - value: define_variable_ccode + - name: library_variable_ccode + operator: not_equal_to + value: + "" + # 2025-11-08: TEMPORARY solution: + #- name: define_variable_has_codelist + # operator: equal_to + # value: true + # better would be to also have a "define_variable_has_valuelist" + # so that the rule can be implemented as: + # "do not check when there is no codelist referenced on the Variable level, + # but there is a ValueList referenced". + # Remark however this may lead to false negatives + - name: library_variable_ccode + operator: not_equal_to + value: define_variable_ccode Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: 'The associated codelist for this variable does not match the codelist provided in the define.xml - through the CDISC-NCI Code' + Message: + "The associated codelist for this variable does not match the codelist provided in the define.xml + through the CDISC-NCI Code" Output Variables: - - define_variable_name - - library_variable_ccode - - define_variable_ccode - - define_vlm_ccode + - define_variable_name + - library_variable_ccode + - define_variable_ccode + - define_vlm_ccode # Rule Type: Define Item Metadata Check against Library Metadata Rule Type: Value Level Metadata Check against Define XML Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND57.1/rule.yml b/Unpublished/SENDIG/SEND57.1/rule.yml index 153f8951c..03f60380c 100644 --- a/Unpublished/SENDIG/SEND57.1/rule.yml +++ b/Unpublished/SENDIG/SEND57.1/rule.yml @@ -1,142 +1,149 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1" - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "3.1.1" - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.0" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.1" - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "In some cases, a variable value may comprise multiple individual values. In these - cases, each contributing value is a separately collected or analyzed item...In these scenarios, - when controlled terminology applies to the corresponding variable, each contributing value must - be included as its controlled terminology submission value, and delimited from other terms by - a semicolon." - Document: IG v3.1.1 - Section: 4.3.6.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: "SEND57.1" - Version: "1" - Version: "5.0" - Version: "1.2" + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.0" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "In some cases, a variable value may comprise multiple individual values. In these + cases, each contributing value is a separately collected or analyzed item...In these scenarios, + when controlled terminology applies to the corresponding variable, each contributing value must + be included as its controlled terminology submission value, and delimited from other terms by + a semicolon." + Document: IG v3.1.1 + Section: 4.3.6.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: "SEND57.1" + Version: "1" + Version: "5.0" + Version: "1.2" Check: all: # selector to select all variables, except for STUDY #- name: variable_name # operator: not_equal_to # value: 'STUDYID' - - name: variable_data_type - operator: equal_to - value: Char - - name: variable_value - operator: non_empty - ## The following works for FB1502 test data - #- name: variable_value - # operator: equal_to - # value: '.' - # value_is_literal: true - ## The following DOES NOT work - #- name: variable_value - # operator: contains - # value: ';' - # value_is_literal: true - # Trying with a regex: does not return anything even when value has a semicolon - - name: variable_value - operator: matches_regex - value: ';' + - name: variable_data_type + operator: equal_to + value: Char + - name: variable_value + operator: non_empty + ## The following works for FB1502 test data + #- name: variable_value + # operator: equal_to + # value: '.' + # value_is_literal: true + ## The following DOES NOT work + #- name: variable_value + # operator: contains + # value: ';' + # value_is_literal: true + # Trying with a regex: does not return anything even when value has a semicolon + - name: variable_value + operator: matches_regex + value: ";" Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: - Message: "The variable value is a list of values separated by a semicolon, and the variable is under + Message: + "The variable value is a list of values separated by a semicolon, and the variable is under controlled terminology, but not all values after splitting are in the controlled terminology list" # Rule Type: Record Data Rule Type: Value Check with Variable Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND7/rule.yml b/Unpublished/SENDIG/SEND7/rule.yml index 0bf9c91ce..b35528c11 100644 --- a/Unpublished/SENDIG/SEND7/rule.yml +++ b/Unpublished/SENDIG/SEND7/rule.yml @@ -1,122 +1,128 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.0 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.0' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.1' - - Name: SENDIG - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '3.1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.1' - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.2' - - Name: SENDIG-GENETOX - References: - - Citations: - - Cited Guidance: "The define.xml specification includes seven distinct attributes to describe variable-level - metadata: ...The set of controlled terminology for the value or the presentation format of the - variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on - Controlled Terminology." - Document: SENDIG v3.1.1 - Section: 3.2.2 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND7 - Version: '1' - Version: '5.0' - Version: '1.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.0 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "3.0" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "3.1" + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "3.1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "1.1" + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "1.2" + - Name: SENDIG-GENETOX + References: + - Citations: + - Cited Guidance: + "The define.xml specification includes seven distinct attributes to describe variable-level + metadata: ...The set of controlled terminology for the value or the presentation format of the + variable (Controlled Term, Codelist or Format). Refer to Section 4.3 for more information on + Controlled Terminology." + Document: SENDIG v3.1.1 + Section: 3.2.2 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND7 + Version: "1" + Version: "5.0" + Version: "1.0" Check: all: #- name: library_variable_has_codelist # operator: equal_to # value: true - - name: define_variable_ccode - operator: not_equal_to - value: library_variable_ccode + - name: define_variable_ccode + operator: not_equal_to + value: library_variable_ccode Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Outcome: Message: Variable Codelist does not match with the one provided by the CDISC Library Output Variables: - - define_variable_name - - define_variable_ccode - # THE FOLLOWING causes "not in dataset" - # - library_variable_ccode + - define_variable_name + - define_variable_ccode + # THE FOLLOWING causes "not in dataset" + # - library_variable_ccode Rule Type: Define Item Metadata Check against Library Metadata Scope: Classes: Include: - - ALL + - ALL Domains: Include: - - ALL + - ALL Sensitivity: Record diff --git a/Unpublished/SENDIG/SEND98/rule.yml b/Unpublished/SENDIG/SEND98/rule.yml index d5f19a0ed..7aad7cb61 100644 --- a/Unpublished/SENDIG/SEND98/rule.yml +++ b/Unpublished/SENDIG/SEND98/rule.yml @@ -1,47 +1,49 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: Unique identifier for a study site within a submission. Use only if subjects - are housed at different sites. - Document: IG v3.0 - Section: 5.1.1 - Origin: SEND Conformance Rules - Rule Identifier: - Id: SEND98 - Version: '1' - Version: '5.0' - Version: '3.0' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: + Unique identifier for a study site within a submission. Use only if subjects + are housed at different sites. + Document: IG v3.0 + Section: 5.1.1 + Origin: SEND Conformance Rules + Rule Identifier: + Id: SEND98 + Version: "1" + Version: "5.0" + Version: "3.0" # SITEID should only be used if the in-life portion of the study is conducted at different sites # When in-life portion is conducted at a single site, SITEID must me null Check: all: # With thanks to Richard Marshall for the suggestion in cdisccore.slack - - name: SITEID - operator: non_empty - - name: SITEID - operator: has_same_values + - name: SITEID + operator: non_empty + - name: SITEID + operator: has_same_values Core: Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: -- domain: DM - id: $distinct_siteid - name: SITEID - operator: distinct + - domain: DM + id: $distinct_siteid + name: SITEID + operator: distinct Outcome: - Message: 'SITEID may only be populated when there is more than one site where the in-life portion of - the study was conducted' + Message: + "SITEID may only be populated when there is more than one site where the in-life portion of + the study was conducted" Rule Type: Record Data Scope: Classes: Include: - - SPECIAL PURPOSE + - SPECIAL PURPOSE Domains: Include: - - DM + - DM Sensitivity: Dataset diff --git a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml index 6141cbaa4..0d75b9a94 100644 --- a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml +++ b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml @@ -1,788 +1,790 @@ Authorities: -- Organization: CDISC - Standards: - - Name: SENDIG - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: This is where you describe the rule in human readable - sentence(s). - Type: Success - Origin: SEND Conformance Rules - Related Rules: - - Id: '' - Relationship: Predecessor | Related | Successor - Release Notes: '' - Rule Identifier: - Id: SEND_AUTHORING_TEMPLATE - Version: '0.1' - Validator Rule Message: This is where you enter the message that will be output when this rule - is triggered. - Version: '5.0' - Version: 3.0 | 3.1 | 3.1.1 - - Name: SENDIG-DART - References: - - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' - Criteria: - Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: Success - Origin: SEND Conformance Rules - Related Rules: - - Id: '' - Relationship: Predecessor | Related | Successor - Release Notes: '' - Rule Identifier: - Id: '' - Version: '' - Validator Rule Message: '' - Version: '5.0' - Version: '1.1' + - Organization: CDISC + Standards: + - Name: SENDIG + References: + - Citations: + - Cited Guidance: "" + Document: "" + Item: "" + Section: "" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: + This is where you describe the rule in human readable + sentence(s). + Type: Success + Origin: SEND Conformance Rules + Related Rules: + - Id: "" + Relationship: Predecessor | Related | Successor + Release Notes: "" + Rule Identifier: + Id: SEND_AUTHORING_TEMPLATE + Version: "0.1" + Validator Rule Message: + This is where you enter the message that will be output when this rule + is triggered. + Version: "5.0" + Version: 3.0 | 3.1 | 3.1.1 + - Name: SENDIG-DART + References: + - Citations: + - Cited Guidance: "" + Document: "" + Item: "" + Section: "" + Criteria: + Logical Expression: + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: Success + Origin: SEND Conformance Rules + Related Rules: + - Id: "" + Relationship: Predecessor | Related | Successor + Release Notes: "" + Rule Identifier: + Id: "" + Version: "" + Validator Rule Message: "" + Version: "5.0" + Version: "1.1" Check: all: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - "...": "" any: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - "...": "" not: operator: variable_metadata_not_equal_to Core: - Id: '' + Id: "" Status: Draft -Description: '' +Description: "" Executability: >- Fully Executable | Partially Executable | Partially Executable - Possible Overreporting | Partially Executable - Possible Underreporting Match Datasets: -- Is Relationship: true - Keys: - - '' - Name: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... + - Is Relationship: true + Keys: + - "" + Name: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... Operations: -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: define_variable_metadata -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: distinct -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: domain_is_custom -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: domain_label -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: dy -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: extract_metadata -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: expected_variables -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_codelist_attributes -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_column_order_from_dataset -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_column_order_from_library -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_model_column_order -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_model_filtered_variables -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: get_parent_model_column_order -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: label_referenced_variable_metadata -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: max -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: max_date -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: mean -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: min -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: min_date -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: name_referenced_variable_metadata -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: permissible_variables -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: record_count -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: required_variables -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: study_domains -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_codelist_dates -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_code_references -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_code_term_pairs -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_meddra_term_references -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: valid_whodrug_references -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_count -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_exists -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_is_null -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_library_metadata -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_names -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: variable_value_count -- attribute_name: variable_value_length - ct_attribute: '' - ct_packages: - - '' - ct_version: '' - domain: >- - ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | - ADAM OTHER | BASIC DATA STRUCTURE | ... - group: - - '' - id: '' - key_name: >- - definition | examples | label | name | notes | ordinal | role | - simpleDatatype | variableCcode - key_value: '' - name: '' - operator: whodrug_code_hierarchy + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: define_variable_metadata + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: distinct + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: domain_is_custom + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: domain_label + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: dy + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: extract_metadata + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: expected_variables + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_codelist_attributes + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_column_order_from_dataset + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_column_order_from_library + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_model_column_order + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_model_filtered_variables + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: get_parent_model_column_order + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: label_referenced_variable_metadata + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: max + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: max_date + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: mean + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: min + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: min_date + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: name_referenced_variable_metadata + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: permissible_variables + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: record_count + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: required_variables + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: study_domains + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: valid_codelist_dates + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: valid_meddra_code_references + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: valid_meddra_code_term_pairs + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: valid_meddra_term_references + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: valid_whodrug_references + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_count + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_exists + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_is_null + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_library_metadata + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_names + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: variable_value_count + - attribute_name: variable_value_length + ct_attribute: "" + ct_packages: + - "" + ct_version: "" + domain: >- + ALL | AP-- | APRELSUB | POOLDEF | RELREC | RELSPEC | RELSUB | SUPP-- | + ADAM OTHER | BASIC DATA STRUCTURE | ... + group: + - "" + id: "" + key_name: >- + definition | examples | label | name | notes | ordinal | role | + simpleDatatype | variableCcode + key_value: "" + name: "" + operator: whodrug_code_hierarchy Outcome: - Message: '' + Message: "" Output Variables: - - variable_value_length + - variable_value_length Rule Type: Variable Metadata Check against Library Metadata Scope: Classes: Exclude: - - ALL - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - INTERVENTIONS - - RELATIONSHIP - - SPECIAL PURPOSE - - STUDY REFERENCE - - TRIAL DESIGN + - ALL + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - INTERVENTIONS + - RELATIONSHIP + - SPECIAL PURPOSE + - STUDY REFERENCE + - TRIAL DESIGN Include: - - ALL - - EVENTS - - FINDINGS - - FINDINGS ABOUT - - INTERVENTIONS - - RELATIONSHIP - - SPECIAL PURPOSE - - STUDY REFERENCE - - TRIAL DESIGN + - ALL + - EVENTS + - FINDINGS + - FINDINGS ABOUT + - INTERVENTIONS + - RELATIONSHIP + - SPECIAL PURPOSE + - STUDY REFERENCE + - TRIAL DESIGN Data Structures: Exclude: - - ADAM OTHER - - ALL - - BASIC DATA STRUCTURE - - DEVICE LEVEL ANALYSIS DATASET - - MEDICAL DEVICE BASIC DATA STRUCTURE - - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - ALL + - BASIC DATA STRUCTURE + - DEVICE LEVEL ANALYSIS DATASET + - MEDICAL DEVICE BASIC DATA STRUCTURE + - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Include: - - ADAM OTHER - - ALL - - BASIC DATA STRUCTURE - - DEVICE LEVEL ANALYSIS DATASET - - MEDICAL DEVICE BASIC DATA STRUCTURE - - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE - - OCCURRENCE DATA STRUCTURE - - SUBJECT LEVEL ANALYSIS DATASET + - ADAM OTHER + - ALL + - BASIC DATA STRUCTURE + - DEVICE LEVEL ANALYSIS DATASET + - MEDICAL DEVICE BASIC DATA STRUCTURE + - MEDICAL DEVICE OCCURRENCE DATA STRUCTURE + - OCCURRENCE DATA STRUCTURE + - SUBJECT LEVEL ANALYSIS DATASET Datasets: Exclude: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Include: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Domains: Exclude: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- Include: - - ALL - - AP-- - - APRELSUB - - POOLDEF - - RELREC - - RELSPEC - - RELSUB - - SUPP-- + - ALL + - AP-- + - APRELSUB + - POOLDEF + - RELREC + - RELSPEC + - RELSUB + - SUPP-- include_split_datasets: true | false Subclasses: Exclude: - - ADVERSE EVENT - - ALL - - MEDICAL DEVICE TIME-TO-EVENT - - NON-COMPARTMENTAL ANALYSIS - - TIME-TO-EVENT + - ADVERSE EVENT + - ALL + - MEDICAL DEVICE TIME-TO-EVENT + - NON-COMPARTMENTAL ANALYSIS + - TIME-TO-EVENT Include: - - ADVERSE EVENT - - ALL - - MEDICAL DEVICE TIME-TO-EVENT - - NON-COMPARTMENTAL ANALYSIS - - TIME-TO-EVENT + - ADVERSE EVENT + - ALL + - MEDICAL DEVICE TIME-TO-EVENT + - NON-COMPARTMENTAL ANALYSIS + - TIME-TO-EVENT Sensitivity: Record diff --git a/Unpublished/TIG/TIG0031/rule.yml b/Unpublished/TIG/TIG0031/rule.yml index 1a06c5b84..dcc2b7de1 100644 --- a/Unpublished/TIG/TIG0031/rule.yml +++ b/Unpublished/TIG/TIG0031/rule.yml @@ -1,57 +1,60 @@ # Variable: LEVEL # Condition: Record has an associated PARENT record -# Rule: Value for LEVEL = value for PARENT LEVEL + 1 +# Rule: Value for LEVEL = value for PARENT LEVEL + 1 Authorities: -- Organization: 'CDISC' - Standards: - - Name: 'TIG' - References: - - Citations: - - Cited Guidance: If a record has a PARENT, LEVEL must be populated with a LEVEL that is - sequentially one greater than the PARENT record (e.g., value for LEVEL = value for PARENT - LEVEL + 1). - Document: 'TIG 1.0' - Item: 'assumption 6' - Section: '2.8.9.23' - Origin: TIG Conformance Rules - Rule Identifier: - Id: 'TIG0031' - Version: '1' - Version: '1.0' - Version: '1.0' + - Organization: "CDISC" + Standards: + - Name: "TIG" + References: + - Citations: + - Cited Guidance: + If a record has a PARENT, LEVEL must be populated with a LEVEL that is + sequentially one greater than the PARENT record (e.g., value for LEVEL = value for PARENT + LEVEL + 1). + Document: "TIG 1.0" + Item: "assumption 6" + Section: "2.8.9.23" + Origin: TIG Conformance Rules + Rule Identifier: + Id: "TIG0031" + Version: "1" + Version: "1.0" + Version: "1.0" Check: all: - - name: PARENT - operator: non_empty - - name: LEVEL - operator: equal_to - value: $LEVEL_join + 1 + - name: PARENT + operator: non_empty + - name: LEVEL + operator: equal_to + value: $LEVEL_join + 1 Core: Status: Draft - Version: '1' -Description: Raise an error when a record has a PARENT record but the value for LEVEL does not equal + Version: "1" +Description: + Raise an error when a record has a PARENT record but the value for LEVEL does not equal the level of the PARENT LEVEL + 1. Executability: Fully Executable Match Datasets: -- Keys: - - SETCD - - Left: PARENT - Right: REFID - Name: RELREF + - Keys: + - SETCD + - Left: PARENT + Right: REFID + Name: RELREF Outcome: - Message: Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT + Message: + Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT LEVEL + 1. Output Variables: - - LEVEL - - PARENT - - SETCD + - LEVEL + - PARENT + - SETCD Rule Type: Record Data Scope: Classes: Include: - - RELATIONSHIP + - RELATIONSHIP Domains: Include: - - RELREF + - RELREF Use Case: NONCLIN Sensitivity: Record diff --git a/Unpublished/TIG/TIG0044/rule.yml b/Unpublished/TIG/TIG0044/rule.yml index 78a6537a4..d112bcb1c 100644 --- a/Unpublished/TIG/TIG0044/rule.yml +++ b/Unpublished/TIG/TIG0044/rule.yml @@ -1,67 +1,70 @@ # Variable: STRAIN # Rule: Record with TSPARMCD = "STRAIN" is present in TS and TSVAL ^= null for that record OR Record with TXPARMCD = "STRAIN" is present in TX and TXVAL ^= null for that record Authorities: -- Organization: CDISC - Standards: - - Name: TIG - References: - - Citations: - - Cited Guidance: If this variable is excluded in the DM domain, the information must be - present at a higher level (either Trial Sets or Trial Summary). - Document: TIG 1.0 - Item: STRAIN CDISC Notes - Section: 2.8.9.6 SEND Demographics (DM) - Origin: TIG Conformance Rules - Rule Identifier: - Id: TIG0044 - Version: '1' - Version: '1.0' - Substandard: SEND - Version: '1.0' + - Organization: CDISC + Standards: + - Name: TIG + References: + - Citations: + - Cited Guidance: + If this variable is excluded in the DM domain, the information must be + present at a higher level (either Trial Sets or Trial Summary). + Document: TIG 1.0 + Item: STRAIN CDISC Notes + Section: 2.8.9.6 SEND Demographics (DM) + Origin: TIG Conformance Rules + Rule Identifier: + Id: TIG0044 + Version: "1" + Version: "1.0" + Substandard: SEND + Version: "1.0" Check: all: - - name: $tsparmcdstrain_count - operator: equal_to - value: 0 - - name: $txparmcdstrain_count - operator: equal_to - value: 0 + - name: $tsparmcdstrain_count + operator: equal_to + value: 0 + - name: $txparmcdstrain_count + operator: equal_to + value: 0 Core: Id: Status: Draft - Version: '1' -Description: Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS - or TSVAL is not completed and no record with TXPARMCD = "STRAIN" present in TX or TXVAL is not + Version: "1" +Description: + Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS + or TSVAL is not completed and no record with TXPARMCD = "STRAIN" present in TX or TXVAL is not completed. Executability: Fully Executable Operations: -- domain: TX - filter: - TXPARMCD: STRAIN - group: - - SETCD - id: $txparmcdstrain_count - name: TXPARMCD - operator: record_count -- domain: TS - filter: - TSPARMCD: STRAIN - id: $tsparmcdstrain_count - name: TSPARMCD - operator: record_count + - domain: TX + filter: + TXPARMCD: STRAIN + group: + - SETCD + id: $txparmcdstrain_count + name: TXPARMCD + operator: record_count + - domain: TS + filter: + TSPARMCD: STRAIN + id: $tsparmcdstrain_count + name: TSPARMCD + operator: record_count Outcome: - Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record + Message: + There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record in TX with TXPARMCD = "STRAIN" and completed TXVAL. Output Variables: - - $txparmcdstrain_count - - $tsparmcdstrain_count + - $txparmcdstrain_count + - $tsparmcdstrain_count Rule Type: Record Data Scope: Classes: Include: - - TRIAL DESIGN + - TRIAL DESIGN Domains: Include: - - TS + - TS Use Case: NONCLIN Sensitivity: Record diff --git a/Unpublished/USDM/DDF00262/rule.yml b/Unpublished/USDM/DDF00262/rule.yml index 5b35967f6..14276b746 100644 --- a/Unpublished/USDM/DDF00262/rule.yml +++ b/Unpublished/USDM/DDF00262/rule.yml @@ -1,18 +1,19 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: 'Referenced id values must be valid according to the USDM schema based on the - API specification.' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'DDF00262' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: + "Referenced id values must be valid according to the USDM schema based on the + API specification." + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "DDF00262" + Version: "1" + Version: "1.0" + Version: "4.0" Check: |- ( $idl := **[id and instanceType]{id:$distinct(instanceType)}; @@ -325,21 +326,22 @@ Check: |- ) ~> $reduce($append) ) Core: - Id: '' + Id: "" Status: Draft - Version: '1' -Description: 'Referenced id values must be valid according to the USDM schema based on the API specification.' + Version: "1" +Description: "Referenced id values must be valid according to the USDM schema based on the API specification." Executability: Fully Executable Outcome: - Message: 'The referenced id value is not valid - the id value doesn''t match any object or the id value - refers to an instance of an incorrect entity.' + Message: + "The referenced id value is not valid - the id value doesn't match any object or the id value + refers to an instance of an incorrect entity." Output Variables: - - 'Id Attribute' - - 'Id Value' - - Issue + - "Id Attribute" + - "Id Value" + - Issue Rule Type: JSONata Scope: Entities: Include: - - 'ALL' + - "ALL" Sensitivity: Record diff --git a/Unpublished/USDM/USDM_TEMPLATE/rule.yml b/Unpublished/USDM/USDM_TEMPLATE/rule.yml index 29763705f..6b4d61c57 100644 --- a/Unpublished/USDM/USDM_TEMPLATE/rule.yml +++ b/Unpublished/USDM/USDM_TEMPLATE/rule.yml @@ -1,42 +1,42 @@ Authorities: -- Organization: CDISC - Standards: - - Name: USDM - References: - - Citations: - - Cited Guidance: '' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'USDM_TEMPLATE' - Version: '1' - Version: '1.0' - Version: '3.0' - - Name: USDM - References: - - Citations: - - Cited Guidance: '' - Document: 'USDM_CORE_Rules.xlsx' - Origin: 'USDM Conformance Rules' - Rule Identifier: - Id: 'USDM_TEMPLATE' - Version: '1' - Version: '1.0' - Version: '4.0' + - Organization: CDISC + Standards: + - Name: USDM + References: + - Citations: + - Cited Guidance: "" + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "USDM_TEMPLATE" + Version: "1" + Version: "1.0" + Version: "3.0" + - Name: USDM + References: + - Citations: + - Cited Guidance: "" + Document: "USDM_CORE_Rules.xlsx" + Origin: "USDM Conformance Rules" + Rule Identifier: + Id: "USDM_TEMPLATE" + Version: "1" + Version: "1.0" + Version: "4.0" Check: all: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - "...": "" any: - - operator: variable_metadata_not_equal_to - - '...': '' + - operator: variable_metadata_not_equal_to + - "...": "" not: operator: variable_metadata_not_equal_to Core: - Id: '' + Id: "" Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: >- Fully Executable | Not Executable | Partially Executable | Partially Executable - Possible Overreporting | Partially Executable - Possible @@ -45,30 +45,30 @@ Executability: >- # - if needed, remove this comment # - if not needed, remove the Match Datasets section Match Datasets: -- Keys: - - '' - - Left: '' - Right: '' - Name: >- - ... + - Keys: + - "" + - Left: "" + Right: "" + Name: >- + ... # Operations is optional # - if needed, remove this comment # - if not needed, remove the Operations section Operations: -- '...': '' + - "...": "" Outcome: - Message: '' + Message: "" Output Variables: - - parent_entity - - parent_id - - parent_rel - - id - - name + - parent_entity + - parent_id + - parent_rel + - id + - name Rule Type: Record Data Scope: Entities: Exclude: - - '' + - "" Include: - - '' + - "" Sensitivity: Record diff --git a/scripts/sort_yaml.py b/scripts/sort_yaml.py index d929eeb9a..7591a5515 100644 --- a/scripts/sort_yaml.py +++ b/scripts/sort_yaml.py @@ -17,6 +17,7 @@ import sys import argparse +import subprocess from io import StringIO from pathlib import Path @@ -66,15 +67,40 @@ def sort_recursive(obj): return obj -def canonical(content: str) -> str: - """Return the canonical (sorted + formatted) representation of a YAML string.""" +def run_prettier(content: str, path: Path) -> str: + """Format a YAML string through Prettier. `path` is only used so Prettier + can infer the parser/config (via --stdin-filepath); the file itself is + not read or written here.""" + try: + result = subprocess.run( + ["npx", "--no-install", "prettier", "--stdin-filepath", str(path)], + input=content, + capture_output=True, + text=True, + check=True, + ) + except FileNotFoundError as exc: + raise RuntimeError( + "Prettier not found. Run `npm ci` (or `npm install`) in the repo root first." + ) from exc + except subprocess.CalledProcessError as exc: + raise RuntimeError(f"Prettier failed on {path}:\n{exc.stderr}") from exc + return result.stdout + + +def canonical(content: str, path: Path, format_with_prettier: bool = True) -> str: + """Return the canonical representation of a YAML string: keys sorted, and + (unless format_with_prettier is False) passed through Prettier.""" data = _yaml.load(content) if data is None: return content sorted_data = sort_recursive(data) stream = StringIO() _yaml.dump(sorted_data, stream) - return stream.getvalue() + result = stream.getvalue() + if format_with_prettier: + result = run_prettier(result, path) + return result def find_rule_files(root: Path) -> list[Path]: @@ -87,7 +113,7 @@ def find_rule_files(root: Path) -> list[Path]: return sorted(files) -def process_files(files: list[Path], check_mode: bool) -> int: +def process_files(files: list[Path], check_mode: bool, format_with_prettier: bool = True) -> int: """Format (or check) the given files. Returns exit code.""" changed = [] errors = [] @@ -95,7 +121,7 @@ def process_files(files: list[Path], check_mode: bool) -> int: for path in files: try: original = path.read_text(encoding="utf-8") - formatted = canonical(original) + formatted = canonical(original, path, format_with_prettier=format_with_prettier) except Exception as exc: errors.append(f" {path}: {exc}") continue @@ -145,6 +171,12 @@ def main(): action="store_true", help="Check mode: exit 1 if any file needs formatting, without modifying files.", ) + parser.add_argument( + "--no-format", + action="store_true", + help="Sort keys only; skip the Prettier formatting pass. Doesn't require Node — " + "intended for the pre-commit hook, where format-on-save already covers styling.", + ) parser.add_argument( "files", nargs="*", @@ -167,7 +199,7 @@ def main(): mode = "Checking" if args.check else "Formatting" print(f"{mode} {len(files)} rule.yml file(s)...") - sys.exit(process_files(files, check_mode=args.check)) + sys.exit(process_files(files, check_mode=args.check, format_with_prettier=not args.no_format)) if __name__ == "__main__": diff --git a/template/template-rule.yml b/template/template-rule.yml index 4e257135f..fc9874f34 100644 --- a/template/template-rule.yml +++ b/template/template-rule.yml @@ -1,46 +1,46 @@ Authorities: - - Organization: '' + - Organization: "" Standards: - - Name: '' + - Name: "" References: - Citations: - - Cited Guidance: '' - Document: '' - Item: '' - Section: '' + - Cited Guidance: "" + Document: "" + Item: "" + Section: "" Criteria: Logical Expression: - Condition: '' - Rule: '' - Plain Language Expression: '' - Type: '' - Origin: '' - Release Notes: '' + Condition: "" + Rule: "" + Plain Language Expression: "" + Type: "" + Origin: "" + Release Notes: "" Rule Identifier: - Id: '' - Version: '' - Validator Rule Message: '' - Version: '' - Version: '' + Id: "" + Version: "" + Validator Rule Message: "" + Version: "" + Version: "" Check: all: - - operator: '' - name: '' - value: '' + - operator: "" + name: "" + value: "" Core: - Id: '' + Id: "" Status: Draft - Version: '1' -Description: '' + Version: "1" +Description: "" Executability: Fully Executable Operations: - - id: '' - operator: '' + - id: "" + operator: "" Outcome: - Message: '' + Message: "" Output Variables: - - '' -Rule Type: '' + - "" +Rule Type: "" Scope: Classes: Include: @@ -48,4 +48,4 @@ Scope: Domains: Include: - ALL -Sensitivity: '' +Sensitivity: "" From 557dbb33ccb3323fdc618833f5a493d64d6724af Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 11:50:17 -0400 Subject: [PATCH 08/18] workflow reworks --- .github/workflows/auto-format-yaml.yml | 35 +++++++ .github/workflows/validate-yaml-format.yml | 113 +++++++++++---------- scripts/sort_yaml.py | 70 ++++--------- 3 files changed, 113 insertions(+), 105 deletions(-) create mode 100644 .github/workflows/auto-format-yaml.yml diff --git a/.github/workflows/auto-format-yaml.yml b/.github/workflows/auto-format-yaml.yml new file mode 100644 index 000000000..a52dd0e7b --- /dev/null +++ b/.github/workflows/auto-format-yaml.yml @@ -0,0 +1,35 @@ +name: Auto-format Rule YAML +on: + workflow_dispatch: {} +jobs: + format-yaml: + runs-on: ubuntu-latest + permissions: + contents: write + steps: + - uses: actions/checkout@v4 + with: + ref: ${{ github.head_ref || github.ref_name }} + fetch-depth: 0 + + - uses: actions/setup-python@v5 + with: + python-version: "3.12" + - run: pip install ruamel.yaml + + - name: Sort rule.yml files + run: python scripts/sort_yaml.py + + - uses: actions/setup-node@v4 + - name: Run Prettier to format rule.yml files + run: | + npm i prettier + npx prettier "Published/**/rule.yml" "Unpublished/**/rule.yml" --write + + - name: Commit and push formatting fixes + run: | + git config user.name github-actions + git config user.email github-actions@cdisc.org + git add Published Unpublished + git diff-index --quiet HEAD || git commit -m "chore: sort and format rule.yml files" + git push diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml index 705ddb333..c4fce4feb 100644 --- a/.github/workflows/validate-yaml-format.yml +++ b/.github/workflows/validate-yaml-format.yml @@ -1,4 +1,4 @@ -name: Sort and Format Rule YAML +name: Validate YAML Formatting on: pull_request: paths: @@ -7,32 +7,13 @@ on: types: [opened, synchronize, reopened] workflow_dispatch: {} jobs: - format-yaml: + check-yaml-format: runs-on: ubuntu-latest permissions: - contents: write + contents: read pull-requests: write steps: - - name: Determine PR origin - id: origin - run: | - if [ "${{ github.event_name }}" = "workflow_dispatch" ] || [ "${{ github.event.pull_request.head.repo.full_name }}" = "${{ github.repository }}" ]; then - echo "is_internal=true" >> $GITHUB_OUTPUT - else - echo "is_internal=false" >> $GITHUB_OUTPUT - fi - - # Same-repo branches: check out the actual head branch so we can push fixes to it. - - name: Checkout (same-repo branch) - if: steps.origin.outputs.is_internal == 'true' - uses: actions/checkout@v4 - with: - ref: ${{ github.head_ref || github.ref_name }} - fetch-depth: 0 - - # Fork PRs: check out the default merge ref. Read-only, never pushed to. - - name: Checkout (fork PR) - if: steps.origin.outputs.is_internal == 'false' + - name: Checkout uses: actions/checkout@v4 with: fetch-depth: 0 @@ -42,14 +23,13 @@ jobs: with: python-version: "3.12" - run: pip install ruamel.yaml - # Both paths check formatting (sort + Prettier), so both need Node. - # Only the internal path actually writes/pushes fixes. + - name: Set up Node.js uses: actions/setup-node@v4 with: node-version: "20" - name: Install Prettier - run: npm ci + run: npm install -g prettier@3.3.3 - name: Detect changed rule.yml files id: changed-files @@ -69,51 +49,68 @@ jobs: echo "$FILES" > /tmp/changed_rule_files.txt fi - # Same-repo: sort + format in place, then commit and push the fix. - - name: Sort and format (same-repo) - if: steps.origin.outputs.is_internal == 'true' && steps.changed-files.outputs.has_files == 'true' + - name: Check YAML sorting + id: sort-check + if: steps.changed-files.outputs.has_files == 'true' run: | FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ') - python scripts/sort_yaml.py $FILES + python scripts/sort_yaml.py --check $FILES 2> /tmp/sort_stderr.txt + continue-on-error: true - - name: Commit and push formatting fixes - id: commit - if: steps.origin.outputs.is_internal == 'true' && steps.changed-files.outputs.has_files == 'true' + - name: Check Prettier formatting + id: prettier-check + if: steps.changed-files.outputs.has_files == 'true' run: | - if [ -n "$(git status --porcelain)" ]; then - git config user.name "github-actions[bot]" - git config user.email "github-actions[bot]@users.noreply.github.com" - git add -A - git commit -m "chore: auto-sort and format rule.yml files" - git push origin HEAD:${{ github.head_ref || github.ref_name }} - echo "pushed=true" >> $GITHUB_OUTPUT + : > /tmp/prettier_unformatted.txt + while read -r f; do + [ -z "$f" ] && continue + if ! prettier --check "$f" > /dev/null 2>&1; then + echo " $f" >> /tmp/prettier_unformatted.txt + fi + done < /tmp/changed_rule_files.txt + if [ -s /tmp/prettier_unformatted.txt ]; then + echo "passed=false" >> $GITHUB_OUTPUT else - echo "pushed=false" >> $GITHUB_OUTPUT + echo "passed=true" >> $GITHUB_OUTPUT fi - # Fork PRs: full sort + format check (read-only, never writes or pushes). - # A failure here shows as a red X on the PR's checks list; the job log - # lists exactly which files and prints the fix command to run locally. - - name: Check sorting and formatting (fork PR) - if: steps.origin.outputs.is_internal == 'false' && steps.changed-files.outputs.has_files == 'true' - run: | - FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ') - python scripts/sort_yaml.py --check $FILES - - name: Post result to PR - if: always() && steps.origin.outputs.is_internal == 'true' && github.event_name == 'pull_request' && steps.changed-files.outputs.has_files == 'true' + if: always() && github.event_name == 'pull_request' && steps.changed-files.outputs.has_files == 'true' uses: actions/github-script@v7 with: github-token: ${{ secrets.GITHUB_TOKEN }} script: | - const pushed = '${{ steps.commit.outputs.pushed }}'; + const fs = require('fs'); + const sortOk = '${{ steps.sort-check.outcome }}' === 'success'; + const prettierOk = '${{ steps.prettier-check.outputs.passed }}' === 'true'; const marker = ''; let body = marker + '\n'; - if (pushed === 'true') { - body += '## \u270f\ufe0f YAML Auto-Formatted\n\nOne or more `rule.yml` files were not sorted/formatted correctly, so this workflow sorted and formatted them automatically and pushed a commit to this branch. Pull the latest changes before continuing.'; + + if (sortOk && prettierOk) { + body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files are correctly sorted and formatted.'; } else { - body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files were already correctly sorted and formatted.'; + body += '## \u274c YAML Format Check Failed\n\n'; + + if (!sortOk) { + let sortList = ''; + try { sortList = fs.readFileSync('/tmp/sort_stderr.txt', 'utf8'); } catch (e) {} + body += '**Sorting issue** — one or more `rule.yml` files are not sorted alphabetically by key.\n\n'; + body += 'Run the following command locally to fix them:\n\n```bash\npython scripts/sort_yaml.py\n```\n\n'; + if (sortList) { + body += '
Details\n\n```\n' + sortList + '\n```\n
\n\n'; + } + } + + if (!prettierOk) { + let prettierList = ''; + try { prettierList = fs.readFileSync('/tmp/prettier_unformatted.txt', 'utf8'); } catch (e) {} + body += '**Formatting issue** — the following files are not formatted with Prettier:\n\n'; + body += '```\n' + prettierList + '```\n\n'; + body += 'Install the [Prettier VS Code extension](https://marketplace.visualstudio.com/items?itemName=esbenp.prettier-vscode) (recommended in `.vscode/extensions.json`) and make sure "Format On Save" is enabled, then re-save these files and push.\n\n'; + body += 'Alternatively, trigger the **Auto-format Rule YAML** workflow to fix them automatically.'; + } } + const { data: comments } = await github.rest.issues.listComments({ owner: context.repo.owner, repo: context.repo.repo, issue_number: context.issue.number, @@ -130,3 +127,9 @@ jobs: issue_number: context.issue.number, body, }); } + + - name: Fail if any check failed + if: steps.sort-check.outcome == 'failure' || steps.prettier-check.outputs.passed == 'false' + run: | + echo "YAML sort and/or Prettier format check failed. See PR comment for details." + exit 1 diff --git a/scripts/sort_yaml.py b/scripts/sort_yaml.py index 7591a5515..987f679e1 100644 --- a/scripts/sort_yaml.py +++ b/scripts/sort_yaml.py @@ -1,23 +1,24 @@ #!/usr/bin/env python3 """ -Sort and format rule YAML files alphabetically and recursively by key name. +Sort rule YAML files alphabetically and recursively by key name, preserving comments. -This matches the auto-format/auto-sort behavior of the CDISC conformance rules editor. +This matches the auto-sort behavior of the CDISC conformance rules editor. +Prettier formatting is handled separately (via the VS Code extension locally, +or in CI) — this script only handles key sorting. Usage: - # Format files in-place (default: all rule.yml under Published/ and Unpublished/) + # Sort files in-place (default: all rule.yml under Published/ and Unpublished/) python scripts/sort_yaml.py - # Format specific files + # Sort specific files python scripts/sort_yaml.py path/to/rule.yml another/rule.yml - # Check mode: exit with code 1 if any file is not formatted correctly + # Check mode: exit with code 1 if any file is not sorted correctly python scripts/sort_yaml.py --check [files...] """ import sys import argparse -import subprocess from io import StringIO from pathlib import Path @@ -67,40 +68,15 @@ def sort_recursive(obj): return obj -def run_prettier(content: str, path: Path) -> str: - """Format a YAML string through Prettier. `path` is only used so Prettier - can infer the parser/config (via --stdin-filepath); the file itself is - not read or written here.""" - try: - result = subprocess.run( - ["npx", "--no-install", "prettier", "--stdin-filepath", str(path)], - input=content, - capture_output=True, - text=True, - check=True, - ) - except FileNotFoundError as exc: - raise RuntimeError( - "Prettier not found. Run `npm ci` (or `npm install`) in the repo root first." - ) from exc - except subprocess.CalledProcessError as exc: - raise RuntimeError(f"Prettier failed on {path}:\n{exc.stderr}") from exc - return result.stdout - - -def canonical(content: str, path: Path, format_with_prettier: bool = True) -> str: - """Return the canonical representation of a YAML string: keys sorted, and - (unless format_with_prettier is False) passed through Prettier.""" +def canonical(content: str) -> str: + """Return the canonical (sorted) representation of a YAML string.""" data = _yaml.load(content) if data is None: return content sorted_data = sort_recursive(data) stream = StringIO() _yaml.dump(sorted_data, stream) - result = stream.getvalue() - if format_with_prettier: - result = run_prettier(result, path) - return result + return stream.getvalue() def find_rule_files(root: Path) -> list[Path]: @@ -113,15 +89,15 @@ def find_rule_files(root: Path) -> list[Path]: return sorted(files) -def process_files(files: list[Path], check_mode: bool, format_with_prettier: bool = True) -> int: - """Format (or check) the given files. Returns exit code.""" +def process_files(files: list[Path], check_mode: bool) -> int: + """Sort (or check) the given files. Returns exit code.""" changed = [] errors = [] for path in files: try: original = path.read_text(encoding="utf-8") - formatted = canonical(original, path, format_with_prettier=format_with_prettier) + formatted = canonical(original) except Exception as exc: errors.append(f" {path}: {exc}") continue @@ -130,7 +106,7 @@ def process_files(files: list[Path], check_mode: bool, format_with_prettier: boo changed.append(path) if not check_mode: path.write_text(formatted, encoding="utf-8") - print(f" Formatted: {path}") + print(f" Sorted: {path}") if errors: print("\nERROR: Failed to process the following files:", file=sys.stderr) @@ -141,7 +117,7 @@ def process_files(files: list[Path], check_mode: bool, format_with_prettier: boo if check_mode: if changed: print( - "\nThe following rule.yml files are not correctly sorted/formatted:\n", + "\nThe following rule.yml files are not correctly sorted:\n", file=sys.stderr, ) for p in changed: @@ -152,10 +128,10 @@ def process_files(files: list[Path], check_mode: bool, format_with_prettier: boo ) return 1 else: - print("All rule.yml files are correctly sorted and formatted.") + print("All rule.yml files are correctly sorted.") else: if not changed: - print("All rule.yml files are already correctly sorted and formatted.") + print("All rule.yml files are already correctly sorted.") return 0 @@ -169,13 +145,7 @@ def main(): parser.add_argument( "--check", action="store_true", - help="Check mode: exit 1 if any file needs formatting, without modifying files.", - ) - parser.add_argument( - "--no-format", - action="store_true", - help="Sort keys only; skip the Prettier formatting pass. Doesn't require Node — " - "intended for the pre-commit hook, where format-on-save already covers styling.", + help="Check mode: exit 1 if any file needs sorting, without modifying files.", ) parser.add_argument( "files", @@ -196,10 +166,10 @@ def main(): print("No rule.yml files found.") return 0 - mode = "Checking" if args.check else "Formatting" + mode = "Checking" if args.check else "Sorting" print(f"{mode} {len(files)} rule.yml file(s)...") - sys.exit(process_files(files, check_mode=args.check, format_with_prettier=not args.no_format)) + sys.exit(process_files(files, check_mode=args.check)) if __name__ == "__main__": From 7724824d25aa253260c9563c033df25510d9084b Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 14:33:31 -0400 Subject: [PATCH 09/18] rules sort then format --- Published/CORE-000004/rule.yml | 6 +- Published/CORE-000007/rule.yml | 2 +- Published/CORE-000108/rule.yml | 2 +- Published/CORE-000252/rule.yml | 2 +- Published/CORE-000253/rule.yml | 2 +- Published/CORE-000254/rule.yml | 2 +- Published/CORE-000257/rule.yml | 2 +- Published/CORE-000265/rule.yml | 2 +- Published/CORE-000342/rule.yml | 2 +- Published/CORE-000353/rule.yml | 2 +- Published/CORE-000387/rule.yml | 21 +++---- Published/CORE-000398/rule.yml | 5 +- Published/CORE-000429/rule.yml | 7 ++- Published/CORE-000444/rule.yml | 5 +- Published/CORE-000459/rule.yml | 12 ++-- Published/CORE-000471/rule.yml | 4 +- Published/CORE-000493/rule.yml | 7 ++- Published/CORE-000503/rule.yml | 23 +++---- Published/CORE-000505/rule.yml | 5 +- Published/CORE-000509/rule.yml | 9 +-- Published/CORE-000526/rule.yml | 2 +- Published/CORE-000557/rule.yml | 2 +- Published/CORE-000561/rule.yml | 2 +- Published/CORE-000576/rule.yml | 10 ++-- Published/CORE-000578/rule.yml | 5 +- Published/CORE-000618/rule.yml | 2 +- Published/CORE-000620/rule.yml | 2 +- Published/CORE-000670/rule.yml | 9 +-- Published/CORE-000768/rule.yml | 5 +- Published/CORE-000770/rule.yml | 7 ++- Published/CORE-000775/rule.yml | 5 +- Published/CORE-000781/rule.yml | 5 +- Published/CORE-000782/rule.yml | 5 +- Published/CORE-000852/rule.yml | 5 +- Published/CORE-000854/rule.yml | 8 +-- Published/CORE-000865/rule.yml | 13 ++-- Published/CORE-000884/rule.yml | 13 ++-- Published/CORE-000892/rule.yml | 10 ++-- Published/CORE-000899/rule.yml | 5 +- Published/CORE-000910/rule.yml | 4 +- Published/CORE-000924/rule.yml | 7 ++- Published/CORE-000934/rule.yml | 13 ++-- Published/CORE-000941/rule.yml | 7 ++- Published/CORE-000942/rule.yml | 7 ++- Published/CORE-000946/rule.yml | 2 +- Published/CORE-000972/rule.yml | 7 ++- Published/CORE-001059/rule.yml | 4 +- Unpublished/ADAMIG/AD0039/rule.yml | 5 +- Unpublished/ADAMIG/AD0053/rule.yml | 5 +- Unpublished/ADAMIG/AD0070/rule.yml | 7 ++- .../ADAMIG/CDISC.ADAMIG.AD0061/rule.yml | 5 +- .../FDA.SENDIG.FB4702/rule.yml | 2 +- .../FFDA.SENDIG.FB1119/rule.yml | 6 +- .../SDTMIG/CDISC.SDTMIG.CG0097/rule.yml | 11 ++-- .../SDTMIG/CDISC.SDTMIG.CG0321/rule.yml | 11 ++-- .../SDTMIG/CDISC.SDTMIG.CG0386/rule.yml | 11 ++-- .../SDTMIG/CDISC.SDTMIG.CG0663/rule.yml | 7 ++- Unpublished/SDTMIG/CG0011/rule.yml | 2 +- Unpublished/SDTMIG/CG0011A1/rule.yml | 15 ++--- Unpublished/SDTMIG/CG0011B1/rule.yml | 2 +- Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml | 27 +++++---- Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml | 23 +++---- Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml | 18 +++--- Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml | 2 +- .../SENDIG/CDISC.SENDIG.190.1B/rule.yml | 2 +- Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml | 49 ++++++++------- Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml | 5 +- Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml | 15 ++--- .../SENDIG/CDISC.SENDIG.265.1/rule.yml | 9 +-- Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml | 9 +-- Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml | 15 ++--- Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml | 5 +- Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml | 5 +- Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml | 60 ++++++++++--------- Unpublished/SENDIG/SEND100/rule.yml | 5 +- Unpublished/SENDIG/SEND106.1/rule.yml | 11 ++-- Unpublished/SENDIG/SEND239/rule.yml | 20 ++++--- Unpublished/SENDIG/SEND283/rule.yml | 5 +- Unpublished/SENDIG/SEND300/rule.yml | 5 +- Unpublished/SENDIG/SEND310/rule.yml | 2 +- Unpublished/SENDIG/SEND313/rule.yml | 18 +++--- Unpublished/SENDIG/SEND321/rule.yml | 11 ++-- Unpublished/SENDIG/SEND327/rule.yml | 18 +++--- Unpublished/SENDIG/SEND328-1/rule.yml | 54 ++++++++++------- Unpublished/SENDIG/SEND328-2/rule.yml | 49 ++++++++------- Unpublished/SENDIG/SEND333/rule.yml | 28 +++++---- Unpublished/SENDIG/SEND348/rule.yml | 2 +- Unpublished/SENDIG/SEND399/rule.yml | 7 ++- Unpublished/SENDIG/SEND57.1/rule.yml | 25 ++++---- 89 files changed, 485 insertions(+), 396 deletions(-) diff --git a/Published/CORE-000004/rule.yml b/Published/CORE-000004/rule.yml index c7ae33e98..16c58af95 100644 --- a/Published/CORE-000004/rule.yml +++ b/Published/CORE-000004/rule.yml @@ -76,9 +76,9 @@ Authorities: - Citations: - Cited Guidance: "[Assumption 4a][For example, if 0 tablets are taken within a timeframe or 0 mL - is infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected - doses not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not - be set to zero (0) as an alternative method for indicating doses not taken, not given, or missed." + is infused at a visit, then ECOCCUR = 'N' is the standard representation of the collected doses + not taken, not given, or missed. Dose amount variables (e.g., ECDOSE, ECDOSTXT) must not be + set to zero (0) as an alternative method for indicating doses not taken, not given, or missed." Document: TIG 1.0 Item: Assumption 4a Section: 2.8.10.11 diff --git a/Published/CORE-000007/rule.yml b/Published/CORE-000007/rule.yml index 42dce3221..63ac979cc 100644 --- a/Published/CORE-000007/rule.yml +++ b/Published/CORE-000007/rule.yml @@ -63,7 +63,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - #CG0435 is identical to rule FB0606. Added metadata for FB0606. + #CG0435 is identical to rule FB0606. Added metadata for FB0606. - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000108/rule.yml b/Published/CORE-000108/rule.yml index 12ecbc188..b509ac700 100644 --- a/Published/CORE-000108/rule.yml +++ b/Published/CORE-000108/rule.yml @@ -72,7 +72,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - #CG0133 is identical to rule FB0602. Added metadata for FB0602. + #CG0133 is identical to rule FB0602. Added metadata for FB0602. - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000252/rule.yml b/Published/CORE-000252/rule.yml index abcad815a..fa1f32d4d 100644 --- a/Published/CORE-000252/rule.yml +++ b/Published/CORE-000252/rule.yml @@ -65,7 +65,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 + #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000253/rule.yml b/Published/CORE-000253/rule.yml index a469c57d2..3eb20f7cc 100644 --- a/Published/CORE-000253/rule.yml +++ b/Published/CORE-000253/rule.yml @@ -65,7 +65,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 + #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000254/rule.yml b/Published/CORE-000254/rule.yml index 55a205f55..3cd50202d 100644 --- a/Published/CORE-000254/rule.yml +++ b/Published/CORE-000254/rule.yml @@ -65,7 +65,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 + #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000257/rule.yml b/Published/CORE-000257/rule.yml index 09c3548b8..d3796e959 100644 --- a/Published/CORE-000257/rule.yml +++ b/Published/CORE-000257/rule.yml @@ -69,7 +69,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - # FDA rule FB4401 is identical - added Jozef 2024-12-19 + # FDA rule FB4401 is identical - added Jozef 2024-12-19 - Organization: "FDA" Standards: - Name: "SDTMIG" diff --git a/Published/CORE-000265/rule.yml b/Published/CORE-000265/rule.yml index 395176951..e25f253a9 100644 --- a/Published/CORE-000265/rule.yml +++ b/Published/CORE-000265/rule.yml @@ -65,7 +65,7 @@ Authorities: Version: "1.0" Substandard: SDTM Version: "1.0" - # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 + # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 - Organization: "FDA" Standards: - Name: "SDTMIG" diff --git a/Published/CORE-000342/rule.yml b/Published/CORE-000342/rule.yml index deb605c82..21980ac61 100644 --- a/Published/CORE-000342/rule.yml +++ b/Published/CORE-000342/rule.yml @@ -107,7 +107,7 @@ Authorities: Version: "1.0" Substandard: SEND Version: "1.0" - # FDA BUsiness Rule metadata added as both have the same logic + # FDA BUsiness Rule metadata added as both have the same logic - Organization: FDA Standards: - Name: SENDIG diff --git a/Published/CORE-000353/rule.yml b/Published/CORE-000353/rule.yml index 139779895..3a23dc531 100644 --- a/Published/CORE-000353/rule.yml +++ b/Published/CORE-000353/rule.yml @@ -133,7 +133,7 @@ Check: value: STENDTC - name: TSVAL operator: invalid_date - # Duration parameter values - P.S. negative durations are allowed + # Duration parameter values - P.S. negative durations are allowed - all: - name: TSPARMCD operator: equal_to diff --git a/Published/CORE-000387/rule.yml b/Published/CORE-000387/rule.yml index 2f17022f0..0b0e70f77 100644 --- a/Published/CORE-000387/rule.yml +++ b/Published/CORE-000387/rule.yml @@ -84,16 +84,17 @@ Check: operator: non_empty - name: COSEQ operator: is_not_unique_set - value: USUBJID - # case that USUBJID is not populated - #- all: - # - name: USUBJID - # operator: empty - # - name: POOLID - # operator: non_empty - # - name: COSEQ - # operator: is_not_unique_set - # value: POOLID + value: + USUBJID + # case that USUBJID is not populated + #- all: + # - name: USUBJID + # operator: empty + # - name: POOLID + # operator: non_empty + # - name: COSEQ + # operator: is_not_unique_set + # value: POOLID Core: Id: CORE-000387 Status: Published diff --git a/Published/CORE-000398/rule.yml b/Published/CORE-000398/rule.yml index 62f3d230c..04f065b2d 100644 --- a/Published/CORE-000398/rule.yml +++ b/Published/CORE-000398/rule.yml @@ -106,8 +106,9 @@ Check: operator: equal_to value: library_variable_name - name: library_variable_label - operator: non_empty - # variable label must be equal to that in the CDISC-library + operator: + non_empty + # variable label must be equal to that in the CDISC-library - name: variable_label operator: not_equal_to value: library_variable_label diff --git a/Published/CORE-000429/rule.yml b/Published/CORE-000429/rule.yml index a73f6b0d1..bc352ad82 100644 --- a/Published/CORE-000429/rule.yml +++ b/Published/CORE-000429/rule.yml @@ -20,9 +20,10 @@ Check: all: - name: PCORRES operator: not_matches_regex - value: "[+-]?([0-9]*[.])?[0-9]+$" - # report an error when either PCORRES does not represent a number - all: - # and PCSTRESN is populated + value: + "[+-]?([0-9]*[.])?[0-9]+$" + # report an error when either PCORRES does not represent a number - all: + # and PCSTRESN is populated - name: PCSTRESN operator: non_empty Core: diff --git a/Published/CORE-000444/rule.yml b/Published/CORE-000444/rule.yml index bf6ab6085..7295d6459 100644 --- a/Published/CORE-000444/rule.yml +++ b/Published/CORE-000444/rule.yml @@ -48,8 +48,9 @@ Check: all: - name: PCORRES operator: not_matches_regex - value: "[+-]?([0-9]*[.])?[0-9]+$" - # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ" + value: + "[+-]?([0-9]*[.])?[0-9]+$" + # report an error when either PCORRES is not a number, and PCSTRESC is neither "BLQ" or "ALQ" - name: PCSTRESC operator: not_equal_to value: "BLQ" diff --git a/Published/CORE-000459/rule.yml b/Published/CORE-000459/rule.yml index 49947ac2c..b0b073156 100644 --- a/Published/CORE-000459/rule.yml +++ b/Published/CORE-000459/rule.yml @@ -95,12 +95,14 @@ Check: all: - name: TXPARMCD operator: equal_to - value: ENVTEMPU - # addition Jozef 2024-03-16 - # pre-condition is that TXVAL is not null + value: + ENVTEMPU + # addition Jozef 2024-03-16 + # pre-condition is that TXVAL is not null - name: TXVAL - operator: non_empty - # end of addition + operator: + non_empty + # end of addition - name: TXVAL operator: not_equal_to value: C diff --git a/Published/CORE-000471/rule.yml b/Published/CORE-000471/rule.yml index 11b1cf6a8..5a84ae8c9 100644 --- a/Published/CORE-000471/rule.yml +++ b/Published/CORE-000471/rule.yml @@ -87,8 +87,8 @@ Check: value: "MEASUREMENT" - name: EGEVAL operator: non_empty - # report an error when EGORRESU is not null and EGEVAL is populated - # the idea is that evaluations do not have a unit + # report an error when EGORRESU is not null and EGEVAL is populated + # the idea is that evaluations do not have a unit - all: - name: EGORRESU operator: non_empty diff --git a/Published/CORE-000493/rule.yml b/Published/CORE-000493/rule.yml index 366930512..485fabe28 100644 --- a/Published/CORE-000493/rule.yml +++ b/Published/CORE-000493/rule.yml @@ -60,9 +60,10 @@ Authorities: Id: SEND102 Version: "1" Version: "5.0" - Version: "1.1" - # FDA Business rule FB5301 is identical, so extending the scope here - # FB5301 as of SEND 3.1 + Version: + "1.1" + # FDA Business rule FB5301 is identical, so extending the scope here + # FB5301 as of SEND 3.1 - Organization: "FDA" Standards: - Name: "SENDIG" diff --git a/Published/CORE-000503/rule.yml b/Published/CORE-000503/rule.yml index 02905cf31..d22c6dc89 100644 --- a/Published/CORE-000503/rule.yml +++ b/Published/CORE-000503/rule.yml @@ -124,17 +124,18 @@ Check: value: OTHER - name: QORIG operator: not_equal_to - value: NOT AVAILABLE - # Simplification 2024-05-21 - # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation - # see e.g. CG0118 - # - name: QORIG - # operator: is_not_contained_by - # value: - # - COLLECTED - # - DERIVED - # - OTHER - # - NOT AVAILABLE + value: + NOT AVAILABLE + # Simplification 2024-05-21 + # NO: this is NOT how is_not_contained_by works, it requires a reference to a separate operation + # see e.g. CG0118 + # - name: QORIG + # operator: is_not_contained_by + # value: + # - COLLECTED + # - DERIVED + # - OTHER + # - NOT AVAILABLE Core: Id: CORE-000503 Status: Published diff --git a/Published/CORE-000505/rule.yml b/Published/CORE-000505/rule.yml index 8a83ca494..075cf18c2 100644 --- a/Published/CORE-000505/rule.yml +++ b/Published/CORE-000505/rule.yml @@ -34,8 +34,9 @@ Authorities: Id: CG0285 Version: "1" Version: "2.0" - Version: "3.3" - ##CGO285 is similar to TRC1734c. Added FDA Business rule. + Version: + "3.3" + ##CGO285 is similar to TRC1734c. Added FDA Business rule. - Organization: FDA Standards: - Name: SDTMIG diff --git a/Published/CORE-000509/rule.yml b/Published/CORE-000509/rule.yml index 4b7cd5857..4f3246ccf 100644 --- a/Published/CORE-000509/rule.yml +++ b/Published/CORE-000509/rule.yml @@ -85,8 +85,8 @@ Check: - name: $record_count_AGE operator: greater_than_or_equal_to value: 1 - # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present - # Both counts are 0 + # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present + # Both counts are 0 - all: - name: $record_count_AGETXT operator: equal_to @@ -108,8 +108,9 @@ Operations: - filter: TSPARMCD: AGE id: $record_count_AGE - operator: record_count - # Record count for TSPARMCD=AGETXT + operator: + record_count + # Record count for TSPARMCD=AGETXT - filter: TSPARMCD: AGETXT id: $record_count_AGETXT diff --git a/Published/CORE-000526/rule.yml b/Published/CORE-000526/rule.yml index cf08029db..9e136bd1e 100644 --- a/Published/CORE-000526/rule.yml +++ b/Published/CORE-000526/rule.yml @@ -98,7 +98,7 @@ Check: - PPCAT - PPSPEC - PPTPTREF - # Implementation with POOLID + # Implementation with POOLID - name: PPTESTCD operator: is_not_unique_set value: diff --git a/Published/CORE-000557/rule.yml b/Published/CORE-000557/rule.yml index ea98b22d2..820efa8b5 100644 --- a/Published/CORE-000557/rule.yml +++ b/Published/CORE-000557/rule.yml @@ -127,7 +127,7 @@ Check: - name: RELTYPE operator: not_equal_to value: MANY - # Case that the POOLID column is present + # Case that the POOLID column is present - all: - name: USUBJID operator: empty diff --git a/Published/CORE-000561/rule.yml b/Published/CORE-000561/rule.yml index 5c9539560..4a9c9aa2c 100644 --- a/Published/CORE-000561/rule.yml +++ b/Published/CORE-000561/rule.yml @@ -89,7 +89,7 @@ Check: - USUBJID - TFSPEC - TFANTREG - # case that TFANTREG is not present + # case that TFANTREG is not present - all: - name: TFANTREG operator: not_exists diff --git a/Published/CORE-000576/rule.yml b/Published/CORE-000576/rule.yml index 8d18eb7fe..226e2d054 100644 --- a/Published/CORE-000576/rule.yml +++ b/Published/CORE-000576/rule.yml @@ -107,12 +107,14 @@ Check: all: - name: TXPARMCD operator: equal_to - value: TRTDOS - # check whether value is a number + value: + TRTDOS + # check whether value is a number - name: TXVAL operator: not_matches_regex - value: "[+-]?([0-9]*[.])?[0-9]+$" - # check whether a comma-separated list of values + value: + "[+-]?([0-9]*[.])?[0-9]+$" + # check whether a comma-separated list of values - name: TXVAL operator: not_matches_regex diff --git a/Published/CORE-000578/rule.yml b/Published/CORE-000578/rule.yml index babac4242..af44be4bf 100644 --- a/Published/CORE-000578/rule.yml +++ b/Published/CORE-000578/rule.yml @@ -54,8 +54,9 @@ Check: all: - name: PCSTRESC operator: equal_to - value: "BLQ" - # report an error when either PCLLOQ is not populated or PCSTRESU is not populated + value: + "BLQ" + # report an error when either PCLLOQ is not populated or PCSTRESU is not populated - any: - name: PCLLOQ operator: empty diff --git a/Published/CORE-000618/rule.yml b/Published/CORE-000618/rule.yml index 2840ae4b1..62285be30 100644 --- a/Published/CORE-000618/rule.yml +++ b/Published/CORE-000618/rule.yml @@ -110,7 +110,7 @@ Check: - name: "MIRESCAT" operator: not_equal_to value: "BENIGN" - # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN + # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN - all: - name: "MISTRESC" operator: contains diff --git a/Published/CORE-000620/rule.yml b/Published/CORE-000620/rule.yml index b57485d33..17cc63b5b 100644 --- a/Published/CORE-000620/rule.yml +++ b/Published/CORE-000620/rule.yml @@ -53,7 +53,7 @@ Authorities: Version: "1" Version: "5.0" Version: "1.1" - # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here + # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here - Organization: FDA Standards: - Name: SENDIG diff --git a/Published/CORE-000670/rule.yml b/Published/CORE-000670/rule.yml index b2652d8a9..e3ef189ba 100644 --- a/Published/CORE-000670/rule.yml +++ b/Published/CORE-000670/rule.yml @@ -17,10 +17,11 @@ Authorities: Check: all: - name: "DDTESTCD" - operator: non_empty - # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD - # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE - # for "unscheduled" + operator: + non_empty + # For SENDIG-3.0, there is no DDUSCHFL, so a check is done on DSDECOD + # which has ACCIDENTAL DEATH, FOUND DEAD, MORIBUND SACRIFICE, NON-MORIBUND SACRIFICE + # for "unscheduled" - name: "DSDECOD" # "is_not_contained_by" gives an error "'list' object has no attribute 'startswith'" diff --git a/Published/CORE-000768/rule.yml b/Published/CORE-000768/rule.yml index f36cd76b2..599332d09 100644 --- a/Published/CORE-000768/rule.yml +++ b/Published/CORE-000768/rule.yml @@ -97,8 +97,9 @@ Operations: TX # only keep the records with TXPARMCD=ARMCD filter: - TXPARMCD: ARMCD - # group the records by value of TXSETCD + TXPARMCD: + ARMCD + # group the records by value of TXSETCD group: - SETCD # within the filtered and grouped records, count the number of TXVAL records diff --git a/Published/CORE-000770/rule.yml b/Published/CORE-000770/rule.yml index 39d78bfc9..eaf7e9954 100644 --- a/Published/CORE-000770/rule.yml +++ b/Published/CORE-000770/rule.yml @@ -99,7 +99,7 @@ Authorities: Version: "1.0" Substandard: SEND Version: "1.0" - # FDA rule FB4602 added (SEND-only) + # FDA rule FB4602 added (SEND-only) - Organization: FDA Standards: # Applicable to SENDIG as of version 3.1 @@ -181,8 +181,9 @@ Check: # See Github issue https://github.com/cdisc-org/cdisc-rules-engine/issues/831 - name: "$txgroupsbysetcd" operator: "does_not_contain" - value: "SPGRPCD" - # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule + value: + "SPGRPCD" + # TODO???: also check the TXVAL is populated for TXPARMCD=SPGRPCD, this however seems not to be part of the rule Core: Id: CORE-000770 Status: Published diff --git a/Published/CORE-000775/rule.yml b/Published/CORE-000775/rule.yml index 11e02abf9..605148f98 100644 --- a/Published/CORE-000775/rule.yml +++ b/Published/CORE-000775/rule.yml @@ -121,8 +121,9 @@ Operations: group: - SETCD id: $num_trtdos_see_protocol - operator: record_count - # counts the records with TRTDOSU='SEE PROTOCOL' within the group + operator: + record_count + # counts the records with TRTDOSU='SEE PROTOCOL' within the group - filter: TXPARMCD: TRTDOSU TXVAL: "SEE PROTOCOL" diff --git a/Published/CORE-000781/rule.yml b/Published/CORE-000781/rule.yml index ce18a896a..0ebd083a5 100644 --- a/Published/CORE-000781/rule.yml +++ b/Published/CORE-000781/rule.yml @@ -90,8 +90,9 @@ Operations: TX # only keep the records with TXPARMCD=SPECIES filter: - TXPARMCD: SPECIES - # group the records by value of TXSETCD + TXPARMCD: + SPECIES + # group the records by value of TXSETCD group: - SETCD # within the filtered and grouped records, count the number of records diff --git a/Published/CORE-000782/rule.yml b/Published/CORE-000782/rule.yml index 55bdbe5ba..dd19638b6 100644 --- a/Published/CORE-000782/rule.yml +++ b/Published/CORE-000782/rule.yml @@ -90,8 +90,9 @@ Operations: TX # only keep the records with TXPARMCD=STRAIN filter: - TXPARMCD: STRAIN - # group the records by value of TXSETCD + TXPARMCD: + STRAIN + # group the records by value of TXSETCD group: - SETCD # within the filtered and grouped records, count the number of records diff --git a/Published/CORE-000852/rule.yml b/Published/CORE-000852/rule.yml index a8915b2c7..1ee924b76 100644 --- a/Published/CORE-000852/rule.yml +++ b/Published/CORE-000852/rule.yml @@ -196,8 +196,9 @@ Executability: Fully Executable Operations: # variable order in CDISC-Library - id: $column_order_from_library - operator: get_column_order_from_library - # variable order in dataset + operator: + get_column_order_from_library + # variable order in dataset - id: $column_order_from_dataset operator: get_column_order_from_dataset Outcome: diff --git a/Published/CORE-000854/rule.yml b/Published/CORE-000854/rule.yml index 416debeed..4111edd65 100644 --- a/Published/CORE-000854/rule.yml +++ b/Published/CORE-000854/rule.yml @@ -5,8 +5,8 @@ Authorities: References: - Citations: - Cited Guidance: - "An eligibility criterion's category must be specified using the Category of - Inclusion/Exclusion (C66797) SDTM codelist." + "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion + (C66797) SDTM codelist." Document: "USDM_CORE_Rules.xlsx" Origin: "USDM Conformance Rules" Rule Identifier: @@ -18,8 +18,8 @@ Authorities: References: - Citations: - Cited Guidance: - "An eligibility criterion's category must be specified using the Category of - Inclusion/Exclusion (C66797) SDTM codelist." + "An eligibility criterion's category must be specified using the Category of Inclusion/Exclusion + (C66797) SDTM codelist." Document: "USDM_CORE_Rules.xlsx" Origin: "USDM Conformance Rules" Rule Identifier: diff --git a/Published/CORE-000865/rule.yml b/Published/CORE-000865/rule.yml index 9bfb3f2b8..f976bb838 100644 --- a/Published/CORE-000865/rule.yml +++ b/Published/CORE-000865/rule.yml @@ -148,12 +148,13 @@ Check: - name: "--TPTREF" operator: exists - name: "--ELTM" - operator: exists - #- name: '--TPTREF' - # operator: 'non_empty' - #- name: '--ELTM' - # operator: 'empty' - # Correction 2025-09-05 + operator: + exists + #- name: '--TPTREF' + # operator: 'non_empty' + #- name: '--ELTM' + # operator: 'empty' + # Correction 2025-09-05 - name: "--ELTM" operator: "non_empty" - name: "--TPTREF" diff --git a/Published/CORE-000884/rule.yml b/Published/CORE-000884/rule.yml index c1b7170d1..39e65bf03 100644 --- a/Published/CORE-000884/rule.yml +++ b/Published/CORE-000884/rule.yml @@ -90,7 +90,7 @@ Check: operator: non_empty - name: AGE operator: non_empty - # for TS, they are parameters (values in TSPARMCD) + # for TS, they are parameters (values in TSPARMCD) - all: - name: DOMAIN operator: equal_to @@ -113,11 +113,12 @@ Operations: TS # only keep the records with TSPARMCD=AGEU filter: - TSPARMCD: AGEU - # group the records by value of TXSETCD - #group: - # - SETCD - # within the filtered and grouped records, count the number of TXVAL records + TSPARMCD: + AGEU + # group the records by value of TXSETCD + #group: + # - SETCD + # within the filtered and grouped records, count the number of TXVAL records id: $ageu_count name: TSVAL operator: record_count diff --git a/Published/CORE-000892/rule.yml b/Published/CORE-000892/rule.yml index 4e5c64899..f70420983 100644 --- a/Published/CORE-000892/rule.yml +++ b/Published/CORE-000892/rule.yml @@ -169,8 +169,9 @@ Check: - name: --STRTPT operator: not_exists - name: --STRTPT - operator: empty - # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated + operator: + empty + # Case ENRF populated: check that one of --STDTC, --STRF or --STRTPT is populated - all: - name: --ENRF operator: @@ -194,9 +195,10 @@ Check: - name: --STRTPT operator: not_exists - name: --STRTPT - operator: empty + operator: + empty - # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated + # Case ENRTPT populated: check that one of --STDTC, --STRF or --STRTPT is populated - all: - name: --ENRTPT operator: diff --git a/Published/CORE-000899/rule.yml b/Published/CORE-000899/rule.yml index 937a8d854..567b4ea58 100644 --- a/Published/CORE-000899/rule.yml +++ b/Published/CORE-000899/rule.yml @@ -41,8 +41,9 @@ Check: value: 1 - name: ICSTAT operator: equal_to - value: "NOT DONE" - # Raise issue when ICIMPLBL is not "ALL" + value: + "NOT DONE" + # Raise issue when ICIMPLBL is not "ALL" - name: ICIMPLBL operator: not_equal_to value: ALL diff --git a/Published/CORE-000910/rule.yml b/Published/CORE-000910/rule.yml index 2ba6a1365..7d95f61aa 100644 --- a/Published/CORE-000910/rule.yml +++ b/Published/CORE-000910/rule.yml @@ -5,8 +5,8 @@ Authorities: References: - Citations: - Cited Guidance: - "A study protocol document version's protocol status must be specified using - the Protocol Status Value Set Terminology (C188723) DDF codelist." + "A study protocol document version's protocol status must be specified using the + Protocol Status Value Set Terminology (C188723) DDF codelist." Document: "USDM_CORE_Rules.xlsx" Origin: "USDM Conformance Rules" Rule Identifier: diff --git a/Published/CORE-000924/rule.yml b/Published/CORE-000924/rule.yml index 9d351f199..9b3c55dd9 100644 --- a/Published/CORE-000924/rule.yml +++ b/Published/CORE-000924/rule.yml @@ -96,9 +96,10 @@ Operations: ct_package_type: DDF id: $codelist_extensible operator: codelist_extensible - version: organizationType.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: + version: + organizationType.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: - id: $codelist_extensible_override map: - organizationType.codeSystemVersion: "2022-09-30" diff --git a/Published/CORE-000934/rule.yml b/Published/CORE-000934/rule.yml index 709323a5c..7e0c23065 100644 --- a/Published/CORE-000934/rule.yml +++ b/Published/CORE-000934/rule.yml @@ -96,12 +96,13 @@ Check: # TODO: check whether each "splitted part follows the CT for "SPEC" (codelist) - name: PPSPEC operator: contains - value: ";" - # 2025-11-19: part that iterates of the "splitted parts" and checks each of them - #- name: $ppspec_value - # operator: not_contains_all - # value: $ppspec_codelist - # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY + value: + ";" + # 2025-11-19: part that iterates of the "splitted parts" and checks each of them + #- name: $ppspec_value + # operator: not_contains_all + # value: $ppspec_codelist + # TRYING JUST THE OTHER WAY AROUND - THIS SEEMS TO BE THE RIGHT WAY - name: $ppspec_codelist operator: not_contains_all value: diff --git a/Published/CORE-000941/rule.yml b/Published/CORE-000941/rule.yml index 80ed96496..e9d60f51e 100644 --- a/Published/CORE-000941/rule.yml +++ b/Published/CORE-000941/rule.yml @@ -110,9 +110,10 @@ Operations: ct_package_type: DDF id: $codelist_extensible operator: codelist_extensible - version: dataOriginType.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: + version: + dataOriginType.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: - id: $codelist_extensible_override map: - dataOriginType.codeSystemVersion: "2022-09-30" diff --git a/Published/CORE-000942/rule.yml b/Published/CORE-000942/rule.yml index 363740b8b..88c6d5248 100644 --- a/Published/CORE-000942/rule.yml +++ b/Published/CORE-000942/rule.yml @@ -110,9 +110,10 @@ Operations: ct_package_type: DDF id: $codelist_extensible operator: codelist_extensible - version: type.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: + version: + type.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: - id: $codelist_extensible_override map: - output: "Y" diff --git a/Published/CORE-000946/rule.yml b/Published/CORE-000946/rule.yml index 2ae5943cf..8af856afb 100644 --- a/Published/CORE-000946/rule.yml +++ b/Published/CORE-000946/rule.yml @@ -60,7 +60,7 @@ Check: operator: exists - name: --RPENDY operator: non_empty - # when one of the above is populated, RPHASE may not be empty + # when one of the above is populated, RPHASE may not be empty - name: RPHASE operator: empty diff --git a/Published/CORE-000972/rule.yml b/Published/CORE-000972/rule.yml index 9a7c249a1..670a08e81 100644 --- a/Published/CORE-000972/rule.yml +++ b/Published/CORE-000972/rule.yml @@ -96,9 +96,10 @@ Operations: ct_package_type: DDF id: $codelist_extensible operator: codelist_extensible - version: type.codeSystemVersion - # DDF codelist extensibility was not defined in earlier CT packages and - # defaults to false, so assigning an override: + version: + type.codeSystemVersion + # DDF codelist extensibility was not defined in earlier CT packages and + # defaults to false, so assigning an override: - id: $codelist_extensible_override map: - output: "Y" diff --git a/Published/CORE-001059/rule.yml b/Published/CORE-001059/rule.yml index 383cee9a7..8a0bd8f50 100644 --- a/Published/CORE-001059/rule.yml +++ b/Published/CORE-001059/rule.yml @@ -5,8 +5,8 @@ Authorities: References: - Citations: - Cited Guidance: - "A study design's study type must be specified using the Study Type Response - (C99077) SDTM codelist." + "A study design's study type must be specified using the Study Type Response (C99077) + SDTM codelist." Document: "USDM_CORE_Rules.xlsx" Origin: "USDM Conformance Rules" Rule Identifier: diff --git a/Unpublished/ADAMIG/AD0039/rule.yml b/Unpublished/ADAMIG/AD0039/rule.yml index 3a29e0c9a..d4c21220e 100644 --- a/Unpublished/ADAMIG/AD0039/rule.yml +++ b/Unpublished/ADAMIG/AD0039/rule.yml @@ -24,8 +24,9 @@ Authorities: Origin: ADaM and ADaMIG Conformance Rules Rule Identifier: Id: AD0039 - Version: "1" - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: + "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema Version: "4.0" Version: "1.3" Check: diff --git a/Unpublished/ADAMIG/AD0053/rule.yml b/Unpublished/ADAMIG/AD0053/rule.yml index b8a55196b..a5f16aca7 100644 --- a/Unpublished/ADAMIG/AD0053/rule.yml +++ b/Unpublished/ADAMIG/AD0053/rule.yml @@ -18,8 +18,9 @@ Authorities: Origin: ADaM Conformance Rules Rule Identifier: Id: "53" - Version: "1" - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: + "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema Version: "4.0" Version: "1.3" Check: diff --git a/Unpublished/ADAMIG/AD0070/rule.yml b/Unpublished/ADAMIG/AD0070/rule.yml index 919119563..17c89d9e8 100644 --- a/Unpublished/ADAMIG/AD0070/rule.yml +++ b/Unpublished/ADAMIG/AD0070/rule.yml @@ -66,9 +66,10 @@ Check: value: AG - name: variable_name #in dataset operator: ends_with - value: N - #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails - # operator: not_exists + value: + N + #- name: Root_variable_name #substrings up to 'N' and checks fro presence, if returns false then fails + # operator: not_exists Core: Id: CDSIC.ADaMIG.AD0070 diff --git a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml index 7448f6a52..2325ed420 100644 --- a/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADAMIG.AD0061/rule.yml @@ -13,8 +13,9 @@ Authorities: Origin: ADaM Conformance Rules Rule Identifier: Id: AD0061 - Version: "1" - # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema + Version: + "1" + # Version 4.0 for ADaM/ADaMIG should be allowed according to yaml validation schema Version: "4.0" Version: "1.3" Check: diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml index ccf262416..177185d53 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml @@ -55,7 +55,7 @@ Check: operator: not_exists - name: VISITDY operator: "empty" - # TEST CONDITION. Remark that --MOMDY is "expected" + # TEST CONDITION. Remark that --MOMDY is "expected" - name: --NOMDY operator: "empty" Core: diff --git a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml index f504a7770..a11bf5a2b 100644 --- a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml +++ b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml @@ -110,9 +110,9 @@ Check: - name: TSPARMCD operator: does_not_contain value: RECSAC - # TSVAL empty for TSPARMCD=RECSAC - # REMARK: test at the record level - # OR: should we use a "filter" here? + # TSVAL empty for TSPARMCD=RECSAC + # REMARK: test at the record level + # OR: should we use a "filter" here? - all: - name: TSPARMCD operator: equal_to diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml index f16142132..f4bc3f4a6 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0097/rule.yml @@ -47,11 +47,12 @@ Check: all: - name: variable_name operator: equal_to - value: CMTRT - # skipping cases when CMTRT is not provided (though this should never be the case) - #- name: CMTRT - # operator: non_empty - # Generate an issue when CMTRT is not declared as "collected" in the define.xml + value: + CMTRT + # skipping cases when CMTRT is not provided (though this should never be the case) + #- name: CMTRT + # operator: non_empty + # Generate an issue when CMTRT is not declared as "collected" in the define.xml - name: define_variable_is_collected operator: equal_to value: false diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml index 402ce8751..b211bb9d7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml @@ -88,11 +88,12 @@ Operations: - id: $custom_domain operator: domain_is_custom - id: $dataset_variables - operator: get_column_order_from_dataset - # - id: $model_filtered_variables` - # key_name: "role" - # key_value: "Identifier" - # operation: get_model_filtered_variables` + operator: + get_column_order_from_dataset + # - id: $model_filtered_variables` + # key_name: "role" + # key_value: "Identifier" + # operation: get_model_filtered_variables` Outcome: Message: Custom domain is not based on one of the observation classes Output Variables: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml index b2cf4e152..d744579d0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml @@ -52,11 +52,12 @@ Check: all: - metadata: $valid_codes operator: equal_to - value: true - #- name: --BDSYCD - # operator: is_contained_by - # value: - # - MedDRA system organ class code + value: + true + #- name: --BDSYCD + # operator: is_contained_by + # value: + # - MedDRA system organ class code Core: Id: CDISC.SDTMIG.CG0386 Status: Draft diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml index c718df262..9ac983547 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml @@ -32,7 +32,7 @@ Check: - name: DOMAIN operator: not_matches_regex value: ^AP[A-Z][A-Z0-9]$ - # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character + # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character - all: - name: DOMAIN operator: prefix_matches_regex @@ -47,8 +47,9 @@ Check: - name: DOMAIN operator: suffix_is_not_contained_by suffix: 2 - value: $valid_domain_name - # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) + value: + $valid_domain_name + # Fire query if characters 5/6 refers to invalid SDTM domain (for APFA domains) - name: DOMAIN operator: matches_regex value: ^APFA(AD|AX|AP|SQ|SA)$ diff --git a/Unpublished/SDTMIG/CG0011/rule.yml b/Unpublished/SDTMIG/CG0011/rule.yml index b2cad8f7c..3b95d3896 100644 --- a/Unpublished/SDTMIG/CG0011/rule.yml +++ b/Unpublished/SDTMIG/CG0011/rule.yml @@ -52,7 +52,7 @@ Check: value: - STUDYID - DOMAIN # seems to give false positives when C66734 codelist is referenced for "DOMAIN" - # check whether variable has assigned CT in the CDISC Library + # check whether variable has assigned CT in the CDISC Library - name: library_variable_ccode operator: non_empty diff --git a/Unpublished/SDTMIG/CG0011A1/rule.yml b/Unpublished/SDTMIG/CG0011A1/rule.yml index a479344eb..ad536cf6c 100644 --- a/Unpublished/SDTMIG/CG0011A1/rule.yml +++ b/Unpublished/SDTMIG/CG0011A1/rule.yml @@ -52,13 +52,14 @@ Check: --DUR # negative: true means: allow negative durations negative: true - operator: invalid_duration - #- name: --DUR - # operator: not_matches_regex - # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ - #- name: --DUR - # operator: not_matches_regex - # value: ^-?P([0-9]+W)$ + operator: + invalid_duration + #- name: --DUR + # operator: not_matches_regex + # value: ^-?P([0-9]+Y)?([0-9]+M)?([0-9]+D)?(T([0-9]+H)?([0-9]+M)?([0-9]+(\.?[0-9]+)?S)?)?$ + #- name: --DUR + # operator: not_matches_regex + # value: ^-?P([0-9]+W)$ Core: Status: Draft diff --git a/Unpublished/SDTMIG/CG0011B1/rule.yml b/Unpublished/SDTMIG/CG0011B1/rule.yml index b75311763..479a98a82 100644 --- a/Unpublished/SDTMIG/CG0011B1/rule.yml +++ b/Unpublished/SDTMIG/CG0011B1/rule.yml @@ -61,7 +61,7 @@ Check: operator: non_empty - name: --ENDTC operator: invalid_date - # DM-specific date/time variables + # DM-specific date/time variables - all: - name: RFSTDTC operator: non_empty diff --git a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml index ba9603167..733b93ec6 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml @@ -83,19 +83,20 @@ Check: all: # DM: SPECIES variable does not exists - name: SPECIES - operator: not_exists - # There is no TSPARMCD=SPECIES in TS - #- name: $distinct_tsparmcd - # operator: does_not_contain - # value: SPECIES - # value_is_literal: true - #- all: - # #- name: TX - # # operator: non_empty - # - name: $distinct_txparmcd - # operator: is_not_contained_by - # value: SPECIES - # #value_is_literal: true + operator: + not_exists + # There is no TSPARMCD=SPECIES in TS + #- name: $distinct_tsparmcd + # operator: does_not_contain + # value: SPECIES + # value_is_literal: true + #- all: + # #- name: TX + # # operator: non_empty + # - name: $distinct_txparmcd + # operator: is_not_contained_by + # value: SPECIES + # #value_is_literal: true Core: Id: CDISC.SENDIG.105 Status: Draft diff --git a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml index 25841fe01..131965f45 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml @@ -32,10 +32,11 @@ Check: # value: true # Just trying an alternative 2024-06-04 - name: ARMCD - operator: empty - #- name: $TA_exists - # operator: equal_to - # value: true + operator: + empty + #- name: $TA_exists + # operator: equal_to + # value: true - name: $TA_present operator: equal_to value: true @@ -54,15 +55,17 @@ Operations: - domain: DM # necessary? id: $DM_ARMCD_null name: ARMCD - operator: variable_is_null - # Alternative approach 2024-06-04 - # BUT this fails when there is no TA dataset at all + operator: + variable_is_null + # Alternative approach 2024-06-04 + # BUT this fails when there is no TA dataset at all - domain: TA id: $TA_exists name: ARMCD - operator: variable_exists - # 2024-06-04: does this check whether TA is present in the study? - # NO: it doesn't like that it works as I was thinking + operator: + variable_exists + # 2024-06-04: does this check whether TA is present in the study? + # NO: it doesn't like that it works as I was thinking - id: $TA_present name: TA operator: study_domains diff --git a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml index 937100c73..a0874f247 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml @@ -95,19 +95,21 @@ Check: all: - name: variable_name operator: equal_to - value: AGE - # This may cause to be "overreporting", as there is no function define_variable_is_derived - # but essentially, AGE should not be "assigned" + value: + AGE + # This may cause to be "overreporting", as there is no function define_variable_is_derived + # but essentially, AGE should not be "assigned" - name: define_variable_is_collected operator: equal_to value: false - name: define_variable_has_comment operator: equal_to - value: false - # Commented out for the moment, as awaiting new function - #- name: define_variable_has_method - # operator: equal_to - # value: false + value: + false + # Commented out for the moment, as awaiting new function + #- name: define_variable_has_method + # operator: equal_to + # value: false Core: Id: CDISC.SENDIG.112 Status: Draft diff --git a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml index 791325559..65ee5fd7c 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml @@ -86,7 +86,7 @@ Check: - name: USUBJID operator: is_not_contained_by value: $ds_usubjid - # TODO: how do we express that for each record in DM, there must exactly be one record in DS? + # TODO: how do we express that for each record in DM, there must exactly be one record in DS? Core: Id: CDISC.SENDIG.140 diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml index e87bba749..e5466b17e 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml @@ -92,7 +92,7 @@ Check: - name: OMTESTCD operator: equal_to value: OWHT - # Part: Ratios and percentages should not be mixed. + # Part: Ratios and percentages should not be mixed. - all: - name: OMSTRESU operator: is_inconsistent_across_dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml index bc61341bb..ff6f9acc8 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml @@ -53,12 +53,12 @@ Check: - name: OMSTRESU operator: not_equal_to value: "%" - # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed - # 2026-03-03: we exclude OMSTAT='NOT DONE' - # "RATIO" is not considered here - # OMTESTCD=OWBR: Organ to Brain Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 + # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed + # 2026-03-03: we exclude OMSTAT='NOT DONE' + # "RATIO" is not considered here + # OMTESTCD=OWBR: Organ to Brain Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 - all: - name: OMTESTCD operator: equal_to @@ -72,10 +72,10 @@ Check: - name: $owbr_ratio_null_unit operator: greater_than value: 0 - # OMTESTCD=OWBW: Organ to BodyWeight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 - # 2026-03-03: we exclude OMSTAT='NOT DONE' + # OMTESTCD=OWBW: Organ to BodyWeight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 + # 2026-03-03: we exclude OMSTAT='NOT DONE' - all: - name: OMTESTCD operator: equal_to @@ -89,9 +89,9 @@ Check: - name: $owbw_ratio_null_unit operator: greater_than value: 0 - # OMTESTCD=OWHT: Organ to Heart Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU='RATIO'' rcords > 0 + # OMTESTCD=OWHT: Organ to Heart Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU='RATIO'' rcords > 0 - all: - name: OMTESTCD operator: equal_to @@ -129,8 +129,9 @@ Operations: # OMSTRESU: empty # 2026-02-10 id: $owbr_ratio_null_unit name: OMTESTCD # 2026-02-10 - operator: record_count - # OWBW: Organ to BodyWeight Ratio + operator: + record_count + # OWBW: Organ to BodyWeight Ratio - filter: OMSTRESU: "%" OMTESTCD: "OWBW" @@ -145,8 +146,9 @@ Operations: # OMSTRESU: empty # 2026-02-10 id: $owbw_ratio_null_unit name: OMTESTCD # 2026-02-10 - operator: record_count - # OWHT: Organ to Heart Weight Ratio + operator: + record_count + # OWHT: Organ to Heart Weight Ratio - filter: OMSTRESU: "%" OMTESTCD: "OWHT" @@ -161,12 +163,13 @@ Operations: # OMSTRESU: empty # 2026-02-10 id: $owht_ratio_null_unit name: OMTESTCD # 2026-02-10 - operator: record_count - # NOT USED FOR THE MOMENT - # - domain: OM - # id: $om_stresu_distinct - # name: OMSTRESU - # operator: distinct + operator: + record_count + # NOT USED FOR THE MOMENT + # - domain: OM + # id: $om_stresu_distinct + # name: OMSTRESU + # operator: distinct Outcome: Message: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml index 6f810ca0f..e8babb108 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml @@ -99,8 +99,9 @@ Check: all: # TA.ETCD non-empty. Required as otherwise the "blank" value is checked against TE - name: ETCD - operator: non_empty - # TA.ETCD is not in the list of distinct values of ETCD in TE + operator: + non_empty + # TA.ETCD is not in the list of distinct values of ETCD in TE - name: ETCD operator: is_not_contained_by value: $te_etcd diff --git a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml index 01b4875db..306abe072 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml @@ -148,13 +148,14 @@ Check: - name: $distinct_tsparmcd operator: does_not_contain value: GLPFL - value_is_literal: true - ## GLPTYP is only mandatory in SENDIG-3.0 - ## SO TODO? split off SENDIG-3.0 in separate file/rule - ##- name: $distinct_tsparmcd - ## operator: does_not_contain - ## value: GLPTYP - ## value_is_literal: true + value_is_literal: + true + ## GLPTYP is only mandatory in SENDIG-3.0 + ## SO TODO? split off SENDIG-3.0 in separate file/rule + ##- name: $distinct_tsparmcd + ## operator: does_not_contain + ## value: GLPTYP + ## value_is_literal: true - name: $distinct_tsparmcd operator: does_not_contain value: ROUTE diff --git a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml index 450eb5d5b..2846b793a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml @@ -54,10 +54,11 @@ Check: all: - name: define_variable_role operator: equal_to - value: "Identifier" - #- name: define_variable_role - # operator: equal_to - # value: 'Identifier' + value: + "Identifier" + #- name: define_variable_role + # operator: equal_to + # value: 'Identifier' - name: define_variable_name operator: is_not_contained_by value: $model_variables diff --git a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml index 5bedcaab7..c6beeb939 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.300/rule.yml @@ -61,10 +61,11 @@ Check: all: - name: $record_count operator: equal_to - value: 0 - # check whether there is an entry for the dataset in the define.xml - #- name: define_dataset_name - # operator: exists + value: + 0 + # check whether there is an entry for the dataset in the define.xml + #- name: define_dataset_name + # operator: exists - name: define_dataset_name operator: exists diff --git a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml index 61b1812d2..ebca0bfd6 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.359/rule.yml @@ -40,13 +40,14 @@ Check: value: ^[+-]?[0-9]+$ - name: --RPDY operator: not_matches_regex - value: ^[+-]?[0-9]+$ - #- name: --RPSTDY - # operator: not_matches_regex - # value: ^[+-]?[0-9]+$ - #- name: --RPENDY - # operator: not_matches_regex - # value: ^[+-]?[0-9]+$ + value: + ^[+-]?[0-9]+$ + #- name: --RPSTDY + # operator: not_matches_regex + # value: ^[+-]?[0-9]+$ + #- name: --RPENDY + # operator: not_matches_regex + # value: ^[+-]?[0-9]+$ Core: Id: CDISC.SENDIG.359 Status: Draft diff --git a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml index 2d03f2076..5267662e9 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml @@ -35,8 +35,9 @@ Check: all: - name: PYTESTCD operator: equal_to - value: PREGSTAT - # TODO: retrieve values from CDISC Library for codelist PYFINDRS + value: + PREGSTAT + # TODO: retrieve values from CDISC Library for codelist PYFINDRS - name: PYSTRESC operator: is_not_contained_by value: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml index 352ebc37a..2e19ae684 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml @@ -103,8 +103,9 @@ Check: # First part: check whether variable name is defined in the define.xml - name: variable_name operator: equal_to - value: define_variable_name - # Second part: check whether the data types match + value: + define_variable_name + # Second part: check whether the data types match - name: variable_data_type operator: not_equal_to value: define_variable_data_type diff --git a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml index 715f1bf3d..064fad0ae 100644 --- a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml +++ b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml @@ -189,8 +189,9 @@ Check: all: - name: LBTESTCD ## only for exploring operator: not_equal_to - value: "test variable" - # See DDF00110 (Richard Marshall) + value: + "test variable" + # See DDF00110 (Richard Marshall) - name: $codelist_extensible operator: equal_to value: @@ -227,35 +228,36 @@ Operations: ct_package_type: SDTM id: $codelist_extensible operator: codelist_extensible - version: category.codeSystemVersion - #- id: $column_order_from_library - # operator: get_column_order_from_library - # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist - # TODO: as we need to iterate over ALL variables that do have a codelist - # How do I pass the variable name and/or its codelist name as an argument to this? - # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked - # id: $codelist_extensible - # operator: codelist_extensible - # + version: + category.codeSystemVersion + #- id: $column_order_from_library + # operator: get_column_order_from_library + # P.S. it would be nice whem instead of the codelist name, one could also provide the NCI Code of the codelist + # TODO: as we need to iterate over ALL variables that do have a codelist + # How do I pass the variable name and/or its codelist name as an argument to this? + # - codelist: 'NOT DONE' # Can ignore schema warning - it IS required, and is name of the Codelist for which CT is checked + # id: $codelist_extensible + # operator: codelist_extensible + # - # - id: $codelist_terms - # operator: codelist_terms - # ct_packages: - # - sdtmct-2020-03-27 - # ct_version: LBVERSION - # id: $CODELISTEXTENSIBLE - # name: LBTESTCD - # operator: get_codelist_attributes - #- id: $column_order_from_library - # operator: get_column_order_from_library + # - id: $codelist_terms + # operator: codelist_terms + # ct_packages: + # - sdtmct-2020-03-27 + # ct_version: LBVERSION + # id: $CODELISTEXTENSIBLE + # name: LBTESTCD + # operator: get_codelist_attributes + #- id: $column_order_from_library + # operator: get_column_order_from_library - # - ct_attribute: extensible - # ct_packages: - # - sdtmct-2020-03-27 - # ct_version: 'LBVERSION' - # id: $CODELISTEXTENSIBLE - # name: LBTESTCD - # operator: get_codelist_attributes + # - ct_attribute: extensible + # ct_packages: + # - sdtmct-2020-03-27 + # ct_version: 'LBVERSION' + # id: $CODELISTEXTENSIBLE + # name: LBTESTCD + # operator: get_codelist_attributes Outcome: Message: A new term has been added to a non-extensible code list. diff --git a/Unpublished/SENDIG/SEND100/rule.yml b/Unpublished/SENDIG/SEND100/rule.yml index 78e5ac32a..4535b327b 100644 --- a/Unpublished/SENDIG/SEND100/rule.yml +++ b/Unpublished/SENDIG/SEND100/rule.yml @@ -88,8 +88,9 @@ Authorities: Check: all: - name: RFSTDTC - operator: non_empty - # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) + operator: + non_empty + # TODO: change into "has_method" (function requested: https://github.com/cdisc-org/cdisc-rules-engine/issues/1047) - name: define_variable_has_comment operator: equal_to value: false diff --git a/Unpublished/SENDIG/SEND106.1/rule.yml b/Unpublished/SENDIG/SEND106.1/rule.yml index 70b6fdc51..8b1e1a337 100644 --- a/Unpublished/SENDIG/SEND106.1/rule.yml +++ b/Unpublished/SENDIG/SEND106.1/rule.yml @@ -81,9 +81,9 @@ Check: operator: not_exists - name: STRAIN operator: empty - # Either TSPARMCD=STRAIN is missing from TS - # or TSVAL is null when TSPARMCD=STRAIN - # or TXVAL is null when TXPARMCD=STRAIN + # Either TSPARMCD=STRAIN is missing from TS + # or TSVAL is null when TSPARMCD=STRAIN + # or TXVAL is null when TXPARMCD=STRAIN - all: - any: - name: $distinct_tsparmcd @@ -127,8 +127,9 @@ Operations: - domain: TS id: $distinct_tsparmcd name: TSPARMCD - operator: distinct - # gets the distinct values of TXPARMCD + operator: + distinct + # gets the distinct values of TXPARMCD Outcome: Message: Missing STRAIN Trial Summary and Trial Sets Parameter when STRAIN is not present in DM Output Variables: diff --git a/Unpublished/SENDIG/SEND239/rule.yml b/Unpublished/SENDIG/SEND239/rule.yml index 3d2724ecd..c32b577ac 100644 --- a/Unpublished/SENDIG/SEND239/rule.yml +++ b/Unpublished/SENDIG/SEND239/rule.yml @@ -139,29 +139,33 @@ Operations: group: - SETCD id: $num_trtdos - operator: record_count - # count the number of records for TXOARMCD=TRTDOSU within each SETCD group + operator: + record_count + # count the number of records for TXOARMCD=TRTDOSU within each SETCD group - filter: TXPARMCD: TRTDOSU group: - SETCD id: $num_trtdosu - operator: record_count - # count the number of records for TXPARMCD=ARMCD within each SETCD group + operator: + record_count + # count the number of records for TXPARMCD=ARMCD within each SETCD group - filter: TXPARMCD: ARMCD group: - SETCD id: $num_armcd - operator: record_count - # count the number of records for TXPARMCD=SPGRPCD within each SETCD group + operator: + record_count + # count the number of records for TXPARMCD=SPGRPCD within each SETCD group - filter: TXPARMCD: SPGRPCD group: - SETCD id: $num_spgrpcd - operator: record_count - # count the number of records for TXPARMCD=GRPLBL within each SETCD group + operator: + record_count + # count the number of records for TXPARMCD=GRPLBL within each SETCD group - filter: TXPARMCD: GRPLBL group: diff --git a/Unpublished/SENDIG/SEND283/rule.yml b/Unpublished/SENDIG/SEND283/rule.yml index ee72cf180..188312095 100644 --- a/Unpublished/SENDIG/SEND283/rule.yml +++ b/Unpublished/SENDIG/SEND283/rule.yml @@ -94,8 +94,9 @@ Check: # As such, the rule is currently "partially executable". - name: "DSSTDTC" operator: "date_less_than" - value: "$max_seendtc" - # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction + value: + "$max_seendtc" + # TODO in FUTURE: part that states that DSSTDTC may not be larger than max(SEENDTC) + small fraction Core: Status: Draft Version: "1" diff --git a/Unpublished/SENDIG/SEND300/rule.yml b/Unpublished/SENDIG/SEND300/rule.yml index ecb853ed8..344708ab9 100644 --- a/Unpublished/SENDIG/SEND300/rule.yml +++ b/Unpublished/SENDIG/SEND300/rule.yml @@ -21,8 +21,9 @@ Check: all: - name: $records_in_dataset operator: equal_to - value: 0 - # check whether the dataset is described in the define.xml + value: + 0 + # check whether the dataset is described in the define.xml - name: define_dataset_name operator: not_equal_to value: "test" diff --git a/Unpublished/SENDIG/SEND310/rule.yml b/Unpublished/SENDIG/SEND310/rule.yml index 19ca707c0..7d7948075 100644 --- a/Unpublished/SENDIG/SEND310/rule.yml +++ b/Unpublished/SENDIG/SEND310/rule.yml @@ -82,7 +82,7 @@ Check: - name: STRAIN operator: is_inconsistent_across_dataset value: SETCD - # Second case: SPECIES + # Second case: SPECIES - all: # only apply when SPECIES is present, as it is "permissible" - name: SPECIES diff --git a/Unpublished/SENDIG/SEND313/rule.yml b/Unpublished/SENDIG/SEND313/rule.yml index d0f9edf37..63cc0e1cc 100644 --- a/Unpublished/SENDIG/SEND313/rule.yml +++ b/Unpublished/SENDIG/SEND313/rule.yml @@ -23,8 +23,9 @@ Check: value: COVAL - name: variable_name operator: longer_than - value: 5 - # check whether 6th and 7th character represent a digit + value: + 5 + # check whether 6th and 7th character represent a digit - any: # 6th character - name: variable_name @@ -38,12 +39,13 @@ Check: - name: variable_name operator: suffix_not_equal_to suffix: 1 - value: "1" # this need to be replaced by the last 1 or 2 charaters of the label - # Proposal Els - #- name: variable_label - # operator: does_not_equal_string_part - # regex: (\d+)$ - # value: variable_name + value: + "1" # this need to be replaced by the last 1 or 2 charaters of the label + # Proposal Els + #- name: variable_label + # operator: does_not_equal_string_part + # regex: (\d+)$ + # value: variable_name Core: Id: SEND313 Status: Draft diff --git a/Unpublished/SENDIG/SEND321/rule.yml b/Unpublished/SENDIG/SEND321/rule.yml index 75fa09fb9..1090dd59c 100644 --- a/Unpublished/SENDIG/SEND321/rule.yml +++ b/Unpublished/SENDIG/SEND321/rule.yml @@ -26,11 +26,12 @@ Check: operator: is_not_contained_by # REMARK: the NEOPLASM codelist is NOT the standard codelist for MISTRESC !!! - value: $NEOPASM_CODELIST - # The following does not seem to work => "invalid operator" - #- name: MISTRESC - # operator: does_not_use_valid_codelist_terms - # value: NEOPLASM + value: + $NEOPASM_CODELIST + # The following does not seem to work => "invalid operator" + #- name: MISTRESC + # operator: does_not_use_valid_codelist_terms + # value: NEOPLASM Core: Status: Draft Version: "1" diff --git a/Unpublished/SENDIG/SEND327/rule.yml b/Unpublished/SENDIG/SEND327/rule.yml index 47bde5904..73275a61c 100644 --- a/Unpublished/SENDIG/SEND327/rule.yml +++ b/Unpublished/SENDIG/SEND327/rule.yml @@ -53,16 +53,18 @@ Check: operator: is_contained_by value: $pp_ppcat - name: PCELTM - operator: non_empty - # value of PCELTM may not start with a dash (minus-character) + operator: + non_empty + # value of PCELTM may not start with a dash (minus-character) - name: PCELTM operator: starts_with - value: "-" - # Alternative test for first character being "-" - # - name: PCELTM - # operator: prefix_equal_to - # prefix: 1 - # value: '-' + value: + "-" + # Alternative test for first character being "-" + # - name: PCELTM + # operator: prefix_equal_to + # prefix: 1 + # value: '-' Core: Status: Draft Version: "1" diff --git a/Unpublished/SENDIG/SEND328-1/rule.yml b/Unpublished/SENDIG/SEND328-1/rule.yml index c7ee2c0ce..776805fef 100644 --- a/Unpublished/SENDIG/SEND328-1/rule.yml +++ b/Unpublished/SENDIG/SEND328-1/rule.yml @@ -52,30 +52,35 @@ Check: - name: USUBJID operator: exists - name: USUBJID - operator: non_empty - # case that PCSCAT is present + operator: + non_empty + # case that PCSCAT is present - name: PCSCAT - operator: exists - # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' + operator: + exists + # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - name: PCELTM operator: equal_to - value: "PT0H" - # 2025-07-09: PPCAT must correspond to PCTESTCD - # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) - # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' - #- name: PCTESTCD - # operator: is_contained_by - # value: $pp_cat - # reference of measurement in PC must be equal to reference of profile in PP - # TODO: This must be for the GIVEN SUBJECT! + value: + "PT0H" + # 2025-07-09: PPCAT must correspond to PCTESTCD + # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) + # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' + #- name: PCTESTCD + # operator: is_contained_by + # value: $pp_cat + # reference of measurement in PC must be equal to reference of profile in PP + # TODO: This must be for the GIVEN SUBJECT! - name: PCTPTREF operator: is_contained_by - value: $pp_tptref - # reference time (time point) must be equal to reference time of profile in PP + value: + $pp_tptref + # reference time (time point) must be equal to reference time of profile in PP - name: PCRFTDTC operator: is_contained_by - value: $pp_rftdtc - # Report a violation when the number of records for PCELTM=PT0H is not 1 + value: + $pp_rftdtc + # Report a violation when the number of records for PCELTM=PT0H is not 1 - name: $pc_group operator: not_equal_to value: 1 @@ -90,8 +95,9 @@ Operations: PC # we will count the number of records for which PCELTM = PT0H within each group filter: - PCELTM: PT0H - # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF + PCELTM: + PT0H + # The group consists of USUBJID, PCTESTCD, PCCAT, PCSCAT (must be present) and PCTPTREF group: - USUBJID - PCTESTCD @@ -100,8 +106,9 @@ Operations: - PCSPEC # added 2025-07-09 - PCTPTREF id: $pc_group - operator: record_count - # 2025-07-09: PPCAT and PCTESTCD must correspond + operator: + record_count + # 2025-07-09: PPCAT and PCTESTCD must correspond - domain: PP # we only want it for the current subject @@ -109,8 +116,9 @@ Operations: - USUBJID id: $pp_cat name: PPCAT - operator: distinct - # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") + operator: + distinct + # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") - domain: PP # we only want it for the current subject diff --git a/Unpublished/SENDIG/SEND328-2/rule.yml b/Unpublished/SENDIG/SEND328-2/rule.yml index 9ec411ccb..f646a4ac0 100644 --- a/Unpublished/SENDIG/SEND328-2/rule.yml +++ b/Unpublished/SENDIG/SEND328-2/rule.yml @@ -54,27 +54,31 @@ Check: - name: USUBJID operator: non_empty - name: PCSCAT - operator: not_exists - # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' + operator: + not_exists + # 2025-07-09: JUST TRYING: only check rows with PCELTM='PT0H' - name: PCELTM operator: equal_to - value: "PT0H" - # 2025-07-09: PPCAT must correspond to PCTESTCD - # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) - # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' - #- name: PCTESTCD - # operator: is_contained_by - # value: $pp_cat - # reference of measurement in PC must be equal to reference of profile in PP - # P.S. This must be for the GIVEN SUBJECT! + value: + "PT0H" + # 2025-07-09: PPCAT must correspond to PCTESTCD + # 2025-07-09: Somehow, this doesn't work as it always leads to "success" (i.e. no violation) + # and when commented out, causes a false positive for e.g. PCTESTCD='NOT FOR PROFILE' + #- name: PCTESTCD + # operator: is_contained_by + # value: $pp_cat + # reference of measurement in PC must be equal to reference of profile in PP + # P.S. This must be for the GIVEN SUBJECT! - name: PCTPTREF operator: is_contained_by - value: $pp_tptref - # reference time (time point) must be equal to reference time of profile in PP + value: + $pp_tptref + # reference time (time point) must be equal to reference time of profile in PP - name: PCRFTDTC operator: is_contained_by - value: $pp_rftdtc - # Report a violation when the number of records for PCELTM=PT0H is not 1 + value: + $pp_rftdtc + # Report a violation when the number of records for PCELTM=PT0H is not 1 - name: $pc_group_no_pcscat operator: not_equal_to value: 1 @@ -89,8 +93,9 @@ Operations: PC # we will count the number of records for which PCELTM = PT0H within each group filter: - PCELTM: PT0H - # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent + PCELTM: + PT0H + # The group consists of USUBJID, PCTESTCD, PCCAT, and PCTPTREF - PCSCAT is absent group: - USUBJID - PCTESTCD @@ -98,8 +103,9 @@ Operations: - PCSPEC # added 2025-07-09 - PCTPTREF id: $pc_group_no_pcscat - operator: record_count - # 2025-07-09: PPCAT and PCTESTCD must correspond + operator: + record_count + # 2025-07-09: PPCAT and PCTESTCD must correspond - domain: PP # we only want it for the current subject @@ -107,8 +113,9 @@ Operations: - USUBJID id: $pp_cat name: PPCAT - operator: distinct - # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") + operator: + distinct + # Value of PCTPTREF must be present in PPTPTREF (for the same USUBJID, so we need "group") - domain: PP # we only want it for the current subject diff --git a/Unpublished/SENDIG/SEND333/rule.yml b/Unpublished/SENDIG/SEND333/rule.yml index be1505afd..77f2d4b64 100644 --- a/Unpublished/SENDIG/SEND333/rule.yml +++ b/Unpublished/SENDIG/SEND333/rule.yml @@ -48,12 +48,13 @@ Check: all: - name: PCTESTCD operator: is_contained_by - value: $pp_ppcat - # TODO: count number of distinct values of PPCAT for this subject - #- name: $pp_cat - # operator: equal_to - # value: 'blabla' - # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF + value: + $pp_ppcat + # TODO: count number of distinct values of PPCAT for this subject + #- name: $pp_cat + # operator: equal_to + # value: 'blabla' + # TODO: when count = 1, check that PCNOMDY=PPNOMDY and PPCTPTREF=PPTPTREF - any: - name: PCNOMDY # old operator: empty @@ -76,14 +77,15 @@ Operations: - USUBJID id: $pp_ppcat name: PPCAT - operator: distinct - #- id: $countppcat - # name: $pp_ppcat - # operator: record_count + operator: + distinct + #- id: $countppcat + # name: $pp_ppcat + # operator: record_count - # just trying something else - #- group: - # - PCTESTCD + # just trying something else + #- group: + # - PCTESTCD - domain: PP filter: PPCAT: PCTESTCD # This would mean that the value of PPCAT must be the string 'PSTESTCD', not the value of the variable PCTESTCD diff --git a/Unpublished/SENDIG/SEND348/rule.yml b/Unpublished/SENDIG/SEND348/rule.yml index c482dc562..996b2c61a 100644 --- a/Unpublished/SENDIG/SEND348/rule.yml +++ b/Unpublished/SENDIG/SEND348/rule.yml @@ -59,7 +59,7 @@ Check: operator: empty - name: PCELTM operator: empty - # case that POOLID is populated. ATTENTION: POOLID is permissible! + # case that POOLID is populated. ATTENTION: POOLID is permissible! - all: # PC-POOLID column is present - name: POOLID diff --git a/Unpublished/SENDIG/SEND399/rule.yml b/Unpublished/SENDIG/SEND399/rule.yml index a6afbdff5..861037f57 100644 --- a/Unpublished/SENDIG/SEND399/rule.yml +++ b/Unpublished/SENDIG/SEND399/rule.yml @@ -40,9 +40,10 @@ Check: # check on whether there is a record with TSPARMCD=SNDIGVER - name: $distinct_tsparmcd operator: does_not_contain - value: SNDIGVER - # when there is a record with TSPARMCD=SNDIGVER, - # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2 + value: + SNDIGVER + # when there is a record with TSPARMCD=SNDIGVER, + # then TSVAL must be one from the SNDIGVER for DART-1.1 or DART-1.2 - all: - name: TSPARMCD operator: equal_to diff --git a/Unpublished/SENDIG/SEND57.1/rule.yml b/Unpublished/SENDIG/SEND57.1/rule.yml index 03f60380c..aa579631a 100644 --- a/Unpublished/SENDIG/SEND57.1/rule.yml +++ b/Unpublished/SENDIG/SEND57.1/rule.yml @@ -113,18 +113,19 @@ Check: operator: equal_to value: Char - name: variable_value - operator: non_empty - ## The following works for FB1502 test data - #- name: variable_value - # operator: equal_to - # value: '.' - # value_is_literal: true - ## The following DOES NOT work - #- name: variable_value - # operator: contains - # value: ';' - # value_is_literal: true - # Trying with a regex: does not return anything even when value has a semicolon + operator: + non_empty + ## The following works for FB1502 test data + #- name: variable_value + # operator: equal_to + # value: '.' + # value_is_literal: true + ## The following DOES NOT work + #- name: variable_value + # operator: contains + # value: ';' + # value_is_literal: true + # Trying with a regex: does not return anything even when value has a semicolon - name: variable_value operator: matches_regex value: ";" From b73b0d5876175f8861a4a41b6f032da652f9e9c4 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 14:46:55 -0400 Subject: [PATCH 10/18] permissions and logs --- .github/workflows/validate-yaml-format.yml | 77 +++++++++++++++------- 1 file changed, 53 insertions(+), 24 deletions(-) diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml index c4fce4feb..59846fdc1 100644 --- a/.github/workflows/validate-yaml-format.yml +++ b/.github/workflows/validate-yaml-format.yml @@ -11,6 +11,7 @@ jobs: runs-on: ubuntu-latest permissions: contents: read + issues: write pull-requests: write steps: - name: Checkout @@ -81,6 +82,24 @@ jobs: github-token: ${{ secrets.GITHUB_TOKEN }} script: | const fs = require('fs'); + + function truncatedList(path, maxChars = 3000) { + let raw = ''; + try { raw = fs.readFileSync(path, 'utf8'); } catch (e) { return ''; } + const lines = raw.split('\n').filter(l => l.trim().length > 0); + let out = []; + let total = 0; + for (const line of lines) { + if (total + line.length > maxChars) { + out.push(`...and ${lines.length - out.length} more`); + break; + } + out.push(line); + total += line.length + 1; + } + return out.join('\n'); + } + const sortOk = '${{ steps.sort-check.outcome }}' === 'success'; const prettierOk = '${{ steps.prettier-check.outputs.passed }}' === 'true'; const marker = ''; @@ -90,42 +109,52 @@ jobs: body += '## \u2705 YAML Format Check Passed\n\nAll changed `rule.yml` files are correctly sorted and formatted.'; } else { body += '## \u274c YAML Format Check Failed\n\n'; - if (!sortOk) { - let sortList = ''; - try { sortList = fs.readFileSync('/tmp/sort_stderr.txt', 'utf8'); } catch (e) {} + const sortList = truncatedList('/tmp/sort_stderr.txt'); body += '**Sorting issue** — one or more `rule.yml` files are not sorted alphabetically by key.\n\n'; body += 'Run the following command locally to fix them:\n\n```bash\npython scripts/sort_yaml.py\n```\n\n'; - if (sortList) { - body += '
Details\n\n```\n' + sortList + '\n```\n
\n\n'; - } + if (sortList) body += '
Details\n\n```\n' + sortList + '\n```\n
\n\n'; } - if (!prettierOk) { - let prettierList = ''; - try { prettierList = fs.readFileSync('/tmp/prettier_unformatted.txt', 'utf8'); } catch (e) {} + const prettierList = truncatedList('/tmp/prettier_unformatted.txt'); body += '**Formatting issue** — the following files are not formatted with Prettier:\n\n'; - body += '```\n' + prettierList + '```\n\n'; - body += 'Install the [Prettier VS Code extension](https://marketplace.visualstudio.com/items?itemName=esbenp.prettier-vscode) (recommended in `.vscode/extensions.json`) and make sure "Format On Save" is enabled, then re-save these files and push.\n\n'; + body += '```\n' + prettierList + '\n```\n\n'; + body += 'Install the [Prettier VS Code extension](https://marketplace.visualstudio.com/items?itemName=esbenp.prettier-vscode) and enable "Format On Save", then re-save these files and push.\n\n'; body += 'Alternatively, trigger the **Auto-format Rule YAML** workflow to fix them automatically.'; } } - const { data: comments } = await github.rest.issues.listComments({ - owner: context.repo.owner, repo: context.repo.repo, - issue_number: context.issue.number, - }); - const existing = comments.find(c => c.user.type === 'Bot' && c.body.includes(marker)); - if (existing) { - await github.rest.issues.updateComment({ - owner: context.repo.owner, repo: context.repo.repo, - comment_id: existing.id, body, - }); - } else { - await github.rest.issues.createComment({ + if (body.length > 60000) { + body = body.slice(0, 60000) + '\n\n...(comment truncated — see workflow run logs for full details)'; + } + + core.info(`Comment body length: ${body.length}`); + core.info(`Issue number: ${context.issue.number}`); + + try { + const { data: comments } = await github.rest.issues.listComments({ owner: context.repo.owner, repo: context.repo.repo, - issue_number: context.issue.number, body, + issue_number: context.issue.number, }); + core.info(`Found ${comments.length} existing comments on this PR.`); + const existing = comments.find(c => c.user.type === 'Bot' && c.body.includes(marker)); + if (existing) { + core.info(`Updating existing comment id ${existing.id}`); + const res = await github.rest.issues.updateComment({ + owner: context.repo.owner, repo: context.repo.repo, + comment_id: existing.id, body, + }); + core.info(`Updated comment: ${res.data.html_url}`); + } else { + core.info('No existing marker comment found — creating a new one.'); + const res = await github.rest.issues.createComment({ + owner: context.repo.owner, repo: context.repo.repo, + issue_number: context.issue.number, body, + }); + core.info(`Created comment: ${res.data.html_url}`); + } + } catch (err) { + core.setFailed(`Failed to post PR comment: ${err.message}`); } - name: Fail if any check failed From d64080d9991fded53d8eb064b9bf1af6e9d66552 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 15:03:30 -0400 Subject: [PATCH 11/18] update sort yaml --- .github/workflows/validate-yaml-format.yml | 4 ++-- .prettierrc | 16 ++++++++++++++++ 2 files changed, 18 insertions(+), 2 deletions(-) create mode 100644 .prettierrc diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml index 59846fdc1..502b9e170 100644 --- a/.github/workflows/validate-yaml-format.yml +++ b/.github/workflows/validate-yaml-format.yml @@ -54,8 +54,8 @@ jobs: id: sort-check if: steps.changed-files.outputs.has_files == 'true' run: | - FILES=$(cat /tmp/changed_rule_files.txt | tr '\n' ' ') - python scripts/sort_yaml.py --check $FILES 2> /tmp/sort_stderr.txt + mapfile -t FILES < /tmp/changed_rule_files.txt + python scripts/sort_yaml.py --check "${FILES[@]}" 2> /tmp/sort_stderr.txt continue-on-error: true - name: Check Prettier formatting diff --git a/.prettierrc b/.prettierrc new file mode 100644 index 000000000..70be3f0bc --- /dev/null +++ b/.prettierrc @@ -0,0 +1,16 @@ +{ + "printWidth": 100, + "tabWidth": 2, + "useTabs": false, + "singleQuote": false, + "endOfLine": "lf", + "overrides": [ + { + "files": ["*.yml", "*.yaml"], + "options": { + "printWidth": 100, + "tabWidth": 2 + } + } + ] +} \ No newline at end of file From 495663428af9a48fce0ecdbaff7dd94ac7f40eda Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 15:44:52 -0400 Subject: [PATCH 12/18] sort rework --- scripts/sort_yaml.py | 52 +++++++++++++++++++++++++++++++++++++++----- 1 file changed, 46 insertions(+), 6 deletions(-) diff --git a/scripts/sort_yaml.py b/scripts/sort_yaml.py index 987f679e1..bc5d5c04b 100644 --- a/scripts/sort_yaml.py +++ b/scripts/sort_yaml.py @@ -6,6 +6,10 @@ Prettier formatting is handled separately (via the VS Code extension locally, or in CI) — this script only handles key sorting. +Check mode (--check) verifies key order structurally, independent of exact +formatting bytes, so it agrees regardless of whether Prettier, ruamel, or an +editor last touched the file's whitespace/quotes/wrapping. + Usage: # Sort files in-place (default: all rule.yml under Published/ and Unpublished/) python scripts/sort_yaml.py @@ -13,7 +17,7 @@ # Sort specific files python scripts/sort_yaml.py path/to/rule.yml another/rule.yml - # Check mode: exit with code 1 if any file is not sorted correctly + # Check mode: exit with code 1 if any file's keys are not sorted python scripts/sort_yaml.py --check [files...] """ @@ -68,6 +72,25 @@ def sort_recursive(obj): return obj +def is_sorted_recursive(obj) -> bool: + """Check whether dict keys are already alphabetically sorted at every level. + + This is a structural check on key order only — it says nothing about + whitespace, quote style, or line wrapping, so it agrees with the file + regardless of which tool (Prettier, ruamel, an editor) last formatted it. + """ + if isinstance(obj, CommentedMap): + keys = list(obj.keys()) + if [str(k) for k in keys] != sorted(str(k) for k in keys): + return False + return all(is_sorted_recursive(v) for v in obj.values()) + + if isinstance(obj, CommentedSeq): + return all(is_sorted_recursive(item) for item in obj) + + return True + + def canonical(content: str) -> str: """Return the canonical (sorted) representation of a YAML string.""" data = _yaml.load(content) @@ -97,14 +120,31 @@ def process_files(files: list[Path], check_mode: bool) -> int: for path in files: try: original = path.read_text(encoding="utf-8") - formatted = canonical(original) except Exception as exc: errors.append(f" {path}: {exc}") continue - if original != formatted: - changed.append(path) - if not check_mode: + if check_mode: + try: + data = _yaml.load(original) + except Exception as exc: + errors.append(f" {path}: {exc}") + continue + + if data is None: + continue + + if not is_sorted_recursive(data): + changed.append(path) + else: + try: + formatted = canonical(original) + except Exception as exc: + errors.append(f" {path}: {exc}") + continue + + if original != formatted: + changed.append(path) path.write_text(formatted, encoding="utf-8") print(f" Sorted: {path}") @@ -145,7 +185,7 @@ def main(): parser.add_argument( "--check", action="store_true", - help="Check mode: exit 1 if any file needs sorting, without modifying files.", + help="Check mode: exit 1 if any file's keys are not sorted, without modifying files.", ) parser.add_argument( "files", From e9f918cced01cd780e56d7f40d3aee01b96559c1 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 15:53:41 -0400 Subject: [PATCH 13/18] new sort --- Published/CORE-000001/rule.yml | 6 +-- Published/CORE-000004/rule.yml | 9 ++-- Published/CORE-000007/rule.yml | 8 ++-- Published/CORE-000010/rule.yml | 3 +- Published/CORE-000011/rule.yml | 6 +-- Published/CORE-000012/rule.yml | 6 +-- Published/CORE-000014/rule.yml | 6 +-- Published/CORE-000015/rule.yml | 3 +- Published/CORE-000018/rule.yml | 6 +-- Published/CORE-000021/rule.yml | 3 +- Published/CORE-000022/rule.yml | 6 +-- Published/CORE-000027/rule.yml | 33 +++++---------- Published/CORE-000029/rule.yml | 3 +- Published/CORE-000030/rule.yml | 3 +- Published/CORE-000033/rule.yml | 6 +-- Published/CORE-000035/rule.yml | 3 +- Published/CORE-000041/rule.yml | 9 ++-- Published/CORE-000047/rule.yml | 6 +-- Published/CORE-000075/rule.yml | 6 +-- Published/CORE-000080/rule.yml | 3 +- Published/CORE-000081/rule.yml | 18 +++----- Published/CORE-000083/rule.yml | 6 +-- Published/CORE-000084/rule.yml | 3 +- Published/CORE-000085/rule.yml | 3 +- Published/CORE-000093/rule.yml | 3 +- Published/CORE-000097/rule.yml | 3 +- Published/CORE-000099/rule.yml | 6 +-- Published/CORE-000100/rule.yml | 3 +- Published/CORE-000103/rule.yml | 3 +- Published/CORE-000106/rule.yml | 3 +- Published/CORE-000107/rule.yml | 12 ++---- Published/CORE-000108/rule.yml | 8 ++-- Published/CORE-000116/rule.yml | 6 +-- Published/CORE-000117/rule.yml | 3 +- Published/CORE-000118/rule.yml | 6 +-- Published/CORE-000133/rule.yml | 3 +- Published/CORE-000134/rule.yml | 3 +- Published/CORE-000135/rule.yml | 3 +- Published/CORE-000136/rule.yml | 3 +- Published/CORE-000137/rule.yml | 15 +++---- Published/CORE-000138/rule.yml | 3 +- Published/CORE-000139/rule.yml | 6 +-- Published/CORE-000141/rule.yml | 3 +- Published/CORE-000142/rule.yml | 6 +-- Published/CORE-000151/rule.yml | 18 +++----- Published/CORE-000152/rule.yml | 3 +- Published/CORE-000154/rule.yml | 6 +-- Published/CORE-000165/rule.yml | 3 +- Published/CORE-000171/rule.yml | 3 +- Published/CORE-000172/rule.yml | 3 +- Published/CORE-000183/rule.yml | 3 +- Published/CORE-000200/rule.yml | 3 +- Published/CORE-000201/rule.yml | 9 ++-- Published/CORE-000203/rule.yml | 3 +- Published/CORE-000206/rule.yml | 3 +- Published/CORE-000208/rule.yml | 3 +- Published/CORE-000209/rule.yml | 6 +-- Published/CORE-000210/rule.yml | 3 +- Published/CORE-000212/rule.yml | 6 +-- Published/CORE-000214/rule.yml | 6 +-- Published/CORE-000217/rule.yml | 6 +-- Published/CORE-000218/rule.yml | 21 ++++------ Published/CORE-000220/rule.yml | 6 +-- Published/CORE-000221/rule.yml | 6 +-- Published/CORE-000225/rule.yml | 3 +- Published/CORE-000236/rule.yml | 3 +- Published/CORE-000238/rule.yml | 3 +- Published/CORE-000239/rule.yml | 3 +- Published/CORE-000248/rule.yml | 3 +- Published/CORE-000250/rule.yml | 3 +- Published/CORE-000252/rule.yml | 8 ++-- Published/CORE-000253/rule.yml | 8 ++-- Published/CORE-000254/rule.yml | 8 ++-- Published/CORE-000255/rule.yml | 3 +- Published/CORE-000257/rule.yml | 5 ++- Published/CORE-000258/rule.yml | 3 +- Published/CORE-000261/rule.yml | 6 +-- Published/CORE-000265/rule.yml | 8 ++-- Published/CORE-000266/rule.yml | 6 +-- Published/CORE-000268/rule.yml | 6 +-- Published/CORE-000269/rule.yml | 6 +-- Published/CORE-000270/rule.yml | 6 +-- Published/CORE-000271/rule.yml | 9 ++-- Published/CORE-000289/rule.yml | 3 +- Published/CORE-000290/rule.yml | 6 +-- Published/CORE-000293/rule.yml | 3 +- Published/CORE-000294/rule.yml | 3 +- Published/CORE-000298/rule.yml | 6 +-- Published/CORE-000299/rule.yml | 3 +- Published/CORE-000321/rule.yml | 6 +-- Published/CORE-000328/rule.yml | 6 +-- Published/CORE-000334/rule.yml | 3 +- Published/CORE-000342/rule.yml | 5 ++- Published/CORE-000353/rule.yml | 5 ++- Published/CORE-000354/rule.yml | 6 +-- Published/CORE-000357/rule.yml | 6 +-- Published/CORE-000358/rule.yml | 3 +- Published/CORE-000361/rule.yml | 3 +- Published/CORE-000363/rule.yml | 3 +- Published/CORE-000370/rule.yml | 6 +-- Published/CORE-000374/rule.yml | 3 +- Published/CORE-000376/rule.yml | 6 +-- Published/CORE-000386/rule.yml | 3 +- Published/CORE-000388/rule.yml | 24 ++++------- Published/CORE-000390/rule.yml | 3 +- Published/CORE-000398/rule.yml | 3 +- Published/CORE-000400/rule.yml | 3 +- Published/CORE-000413/rule.yml | 9 ++-- Published/CORE-000429/rule.yml | 3 +- Published/CORE-000432/rule.yml | 3 +- Published/CORE-000436/rule.yml | 6 +-- Published/CORE-000444/rule.yml | 6 +-- Published/CORE-000454/rule.yml | 6 +-- Published/CORE-000455/rule.yml | 3 +- Published/CORE-000458/rule.yml | 3 +- Published/CORE-000460/rule.yml | 21 ++++------ Published/CORE-000471/rule.yml | 7 ++-- Published/CORE-000472/rule.yml | 3 +- Published/CORE-000474/rule.yml | 3 +- Published/CORE-000475/rule.yml | 6 +-- Published/CORE-000476/rule.yml | 3 +- Published/CORE-000477/rule.yml | 3 +- Published/CORE-000480/rule.yml | 3 +- Published/CORE-000486/rule.yml | 3 +- Published/CORE-000490/rule.yml | 3 +- Published/CORE-000493/rule.yml | 3 +- Published/CORE-000494/rule.yml | 6 +-- Published/CORE-000495/rule.yml | 3 +- Published/CORE-000498/rule.yml | 3 +- Published/CORE-000499/rule.yml | 3 +- Published/CORE-000502/rule.yml | 3 +- Published/CORE-000503/rule.yml | 6 +-- Published/CORE-000505/rule.yml | 3 +- Published/CORE-000508/rule.yml | 3 +- Published/CORE-000509/rule.yml | 13 +++--- Published/CORE-000519/rule.yml | 3 +- Published/CORE-000523/rule.yml | 6 +-- Published/CORE-000526/rule.yml | 3 +- Published/CORE-000529/rule.yml | 6 +-- Published/CORE-000535/rule.yml | 3 +- Published/CORE-000538/rule.yml | 3 +- Published/CORE-000539/rule.yml | 3 +- Published/CORE-000540/rule.yml | 3 +- Published/CORE-000541/rule.yml | 6 +-- Published/CORE-000542/rule.yml | 3 +- Published/CORE-000545/rule.yml | 3 +- Published/CORE-000546/rule.yml | 3 +- Published/CORE-000547/rule.yml | 3 +- Published/CORE-000548/rule.yml | 3 +- Published/CORE-000550/rule.yml | 6 +-- Published/CORE-000551/rule.yml | 24 ++++------- Published/CORE-000555/rule.yml | 6 +-- Published/CORE-000557/rule.yml | 11 +++-- Published/CORE-000559/rule.yml | 3 +- Published/CORE-000561/rule.yml | 5 +-- Published/CORE-000567/rule.yml | 3 +- Published/CORE-000572/rule.yml | 3 +- Published/CORE-000575/rule.yml | 3 +- Published/CORE-000576/rule.yml | 6 +-- Published/CORE-000578/rule.yml | 6 +-- Published/CORE-000583/rule.yml | 3 +- Published/CORE-000584/rule.yml | 21 ++++------ Published/CORE-000590/rule.yml | 3 +- Published/CORE-000591/rule.yml | 3 +- Published/CORE-000595/rule.yml | 3 +- Published/CORE-000596/rule.yml | 3 +- Published/CORE-000599/rule.yml | 3 +- Published/CORE-000600/rule.yml | 3 +- Published/CORE-000601/rule.yml | 6 +-- Published/CORE-000602/rule.yml | 3 +- Published/CORE-000604/rule.yml | 6 +-- Published/CORE-000605/rule.yml | 9 ++-- Published/CORE-000606/rule.yml | 6 +-- Published/CORE-000607/rule.yml | 3 +- Published/CORE-000608/rule.yml | 6 +-- Published/CORE-000610/rule.yml | 3 +- Published/CORE-000611/rule.yml | 3 +- Published/CORE-000612/rule.yml | 3 +- Published/CORE-000618/rule.yml | 5 ++- Published/CORE-000619/rule.yml | 3 +- Published/CORE-000620/rule.yml | 5 ++- Published/CORE-000660/rule.yml | 3 +- Published/CORE-000672/rule.yml | 3 +- Published/CORE-000673/rule.yml | 3 +- Published/CORE-000674/rule.yml | 3 +- Published/CORE-000675/rule.yml | 3 +- Published/CORE-000676/rule.yml | 6 +-- Published/CORE-000678/rule.yml | 3 +- Published/CORE-000698/rule.yml | 3 +- Published/CORE-000699/rule.yml | 6 +-- Published/CORE-000700/rule.yml | 3 +- Published/CORE-000704/rule.yml | 3 +- Published/CORE-000707/rule.yml | 3 +- Published/CORE-000708/rule.yml | 3 +- Published/CORE-000710/rule.yml | 3 +- Published/CORE-000711/rule.yml | 3 +- Published/CORE-000712/rule.yml | 6 +-- Published/CORE-000714/rule.yml | 3 +- Published/CORE-000718/rule.yml | 3 +- Published/CORE-000721/rule.yml | 6 +-- Published/CORE-000722/rule.yml | 3 +- Published/CORE-000727/rule.yml | 6 +-- Published/CORE-000744/rule.yml | 9 ++-- Published/CORE-000750/rule.yml | 6 +-- Published/CORE-000751/rule.yml | 6 +-- Published/CORE-000752/rule.yml | 3 +- Published/CORE-000753/rule.yml | 3 +- Published/CORE-000754/rule.yml | 3 +- Published/CORE-000755/rule.yml | 3 +- Published/CORE-000756/rule.yml | 24 ++++------- Published/CORE-000757/rule.yml | 3 +- Published/CORE-000760/rule.yml | 3 +- Published/CORE-000763/rule.yml | 6 +-- Published/CORE-000764/rule.yml | 9 ++-- Published/CORE-000770/rule.yml | 23 ++++------- Published/CORE-000771/rule.yml | 3 +- Published/CORE-000774/rule.yml | 3 +- Published/CORE-000776/rule.yml | 6 +-- Published/CORE-000783/rule.yml | 6 +-- Published/CORE-000784/rule.yml | 6 +-- Published/CORE-000785/rule.yml | 3 +- Published/CORE-000852/rule.yml | 3 +- Published/CORE-000853/rule.yml | 6 +-- Published/CORE-000862/rule.yml | 6 +-- Published/CORE-000864/rule.yml | 6 +-- Published/CORE-000866/rule.yml | 3 +- Published/CORE-000869/rule.yml | 3 +- Published/CORE-000881/rule.yml | 3 +- Published/CORE-000882/rule.yml | 3 +- Published/CORE-000883/rule.yml | 3 +- Published/CORE-000884/rule.yml | 8 ++-- Published/CORE-000888/rule.yml | 3 +- Published/CORE-000891/rule.yml | 3 +- Published/CORE-000892/rule.yml | 3 +- Published/CORE-000893/rule.yml | 3 +- Published/CORE-000894/rule.yml | 3 +- Published/CORE-000895/rule.yml | 3 +- Published/CORE-000903/rule.yml | 3 +- Published/CORE-000914/rule.yml | 3 +- Published/CORE-000916/rule.yml | 6 +-- Published/CORE-000929/rule.yml | 3 +- Published/CORE-000934/rule.yml | 3 +- Published/CORE-000946/rule.yml | 8 ++-- Published/CORE-000953/rule.yml | 6 +-- Published/CORE-000993/rule.yml | 3 +- Published/CORE-001034/rule.yml | 3 +- Published/CORE-001044/rule.yml | 3 +- Unpublished/ADAMIG/AD0010/rule.yml | 3 +- Unpublished/ADAMIG/AD0014/rule.yml | 12 ++---- Unpublished/ADAMIG/AD0039/rule.yml | 3 +- Unpublished/ADAMIG/AD0070/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0860/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0861/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0862/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0863/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0865/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0866/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0867/rule.yml | 3 +- .../ADAMIG/CDISC.ADaMIG.AD0868/rule.yml | 3 +- .../FDA Business Rules/FB1113/rule.yml | 6 +-- .../FDA Business Rules/FB1901/rule.yml | 3 +- .../FDA.SDTMIG.CT2001/rule.yml | 3 +- .../FDA.SDTMIG.FB0801/rule.yml | 3 +- .../FDA.SDTMIG.FB0802/rule.yml | 3 +- .../FDA.SDTMIG.FB0803/rule.yml | 3 +- .../FDA.SDTMIG.FB1101/rule.yml | 3 +- .../FDA.SDTMIG.FB1801/rule.yml | 3 +- .../FDA.SDTMIG.FB2303/rule.yml | 6 +-- .../FDA.SDTMIG.FB3211/rule.yml | 3 +- .../FDA.SDTMIG.FB3405/rule.yml | 3 +- .../FDA.SENDIG.FB4702/rule.yml | 8 ++-- .../FDA.SENDIG.FB8202/rule.yml | 3 +- .../FFDA.SENDIG.FB1119/rule.yml | 9 ++-- .../SDTMIG/CDISC.SDTMIG.CG0015/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0019/rule.yml | 9 ++-- .../SDTMIG/CDISC.SDTMIG.CG0155/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0158/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0159/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0160/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0161/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0162/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0169/rule.yml | 9 ++-- .../SDTMIG/CDISC.SDTMIG.CG0173/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0184/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0188/rule.yml | 9 ++-- .../SDTMIG/CDISC.SDTMIG.CG0190/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0197/rule.yml | 12 ++---- .../SDTMIG/CDISC.SDTMIG.CG0236/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0237/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0249/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0250/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0252/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0253/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0254/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0295/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0296/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0321/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0322/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0323/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0324/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0347/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0378/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0386/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0400/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0425/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0431/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0524/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0525/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0527/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0532/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0546/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0555/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0556/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0557/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0558/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0559/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0560/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0563/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0607/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0608/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0609/rule.yml | 3 +- .../SDTMIG/CDISC.SDTMIG.CG0610/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0651/rule.yml | 6 +-- .../SDTMIG/CDISC.SDTMIG.CG0663/rule.yml | 11 +++-- Unpublished/SDTMIG/CG0011B1/rule.yml | 5 ++- Unpublished/SDTMIG/CORE-000343/rule.yml | 6 +-- Unpublished/SDTMIG/CORE-000344/rule.yml | 6 +-- Unpublished/SDTMIG/CORE-000345/rule.yml | 6 +-- Unpublished/SDTMIG/CORE-000347/rule.yml | 6 +-- Unpublished/SDTMIG/CORE-000348/rule.yml | 3 +- Unpublished/SDTMIG/CORE-000350/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml | 6 +-- Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml | 6 +-- Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml | 5 ++- Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml | 6 +-- .../SENDIG/CDISC.SENDIG.190.1B/rule.yml | 5 ++- Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml | 41 ++++++++++--------- Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml | 3 +- .../SENDIG/CDISC.SENDIG.265.1/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml | 9 ++-- Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml | 3 +- Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml | 3 +- .../SENDIG/CDISC.SENDIG.SEND142/rule.yml | 3 +- .../SENDIG/CDISC.SENDIG.SEND157/rule.yml | 3 +- Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml | 3 +- Unpublished/SENDIG/SEND100/rule.yml | 3 +- Unpublished/SENDIG/SEND106.1/rule.yml | 12 +++--- Unpublished/SENDIG/SEND310/rule.yml | 5 ++- Unpublished/SENDIG/SEND340/rule.yml | 3 +- Unpublished/SENDIG/SEND348/rule.yml | 5 ++- Unpublished/SENDIG/SEND41/rule.yml | 3 +- .../SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml | 3 +- Unpublished/TIG/TIG0031/rule.yml | 6 +-- Unpublished/TIG/TIG0044/rule.yml | 6 +-- 362 files changed, 664 insertions(+), 1195 deletions(-) diff --git a/Published/CORE-000001/rule.yml b/Published/CORE-000001/rule.yml index a536e43ed..ac5ae3363 100644 --- a/Published/CORE-000001/rule.yml +++ b/Published/CORE-000001/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The intent of the domain model is to collect responses to only those + - Cited Guidance: The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria. Document: SDTM v3.4 Section: 6.3.4 @@ -51,8 +50,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - The intent of the domain model is to collect responses to only those + - Cited Guidance: The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria. Document: TIG 1.0 Item: Assumption 1 diff --git a/Published/CORE-000004/rule.yml b/Published/CORE-000004/rule.yml index 16c58af95..773ce818f 100644 --- a/Published/CORE-000004/rule.yml +++ b/Published/CORE-000004/rule.yml @@ -16,8 +16,7 @@ Authorities: Document: IG v3.4 Item: Assumption 4a Section: 6.1.3.2 - - Cited Guidance: - Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary and/or appropriate to represent specific dose amounts not taken, not given, or missed. Document: IG v3.4 @@ -112,13 +111,11 @@ Core: Id: CORE-000004 Status: Published Version: "1" -Description: - When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used +Description: When ECOCCUR indicates no dose, then ECDOSE needs to be null or > 0; it cannot be used to indicate a dose wasn't taken. Executability: Fully Executable Outcome: - Message: - ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or + Message: ECOCCUR indicates dose was not given, but ECDOSE is not blank or has a value less than or equal to 0 Output Variables: - ECDOSE diff --git a/Published/CORE-000007/rule.yml b/Published/CORE-000007/rule.yml index 63ac979cc..2bbd10660 100644 --- a/Published/CORE-000007/rule.yml +++ b/Published/CORE-000007/rule.yml @@ -62,8 +62,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - #CG0435 is identical to rule FB0606. Added metadata for FB0606. + Version: + "1.0" + #CG0435 is identical to rule FB0606. Added metadata for FB0606. - Organization: FDA Standards: - Name: SDTMIG @@ -119,8 +120,7 @@ Core: Id: CORE-000007 Status: Published Version: "1" -Description: - When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL) +Description: When Date/Time of Death (DTHDTC) in the DM dataset is populated then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000010/rule.yml b/Published/CORE-000010/rule.yml index 0f1d60a45..652d007c7 100644 --- a/Published/CORE-000010/rule.yml +++ b/Published/CORE-000010/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - ARMCD is limited to 20 characters and does not have the character + - Cited Guidance: ARMCD is limited to 20 characters and does not have the character restrictions that apply to --TESTCD Document: SDTMIG v3.4 Section: 4.2.1 diff --git a/Published/CORE-000011/rule.yml b/Published/CORE-000011/rule.yml index 4404808c5..e77ff07e3 100644 --- a/Published/CORE-000011/rule.yml +++ b/Published/CORE-000011/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The intent of the domain model is to collect responses to only those + - Cited Guidance: The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria.  Document: SDTMIG v3.4 Item: Assumption 1 @@ -52,8 +51,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - The intent of the domain model is to collect responses to only those + - Cited Guidance: The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria. Document: TIG 1.0 Item: Assumption 1 diff --git a/Published/CORE-000012/rule.yml b/Published/CORE-000012/rule.yml index 3ec5a84a4..3728bdba0 100644 --- a/Published/CORE-000012/rule.yml +++ b/Published/CORE-000012/rule.yml @@ -24,8 +24,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The following Qualifiers would not be used in AE; --OCCUR, --STAT, + - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred. @@ -41,8 +40,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The following Qualifiers would not be used in AE; --OCCUR, --STAT, + - Cited Guidance: The following Qualifiers would not be used in AE; --OCCUR, --STAT, and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred. diff --git a/Published/CORE-000014/rule.yml b/Published/CORE-000014/rule.yml index c43d3e068..8c03eb9ae 100644 --- a/Published/CORE-000014/rule.yml +++ b/Published/CORE-000014/rule.yml @@ -87,8 +87,7 @@ Authorities: DONE".] Document: SDTM v2.1 Item: --PRESP|--OCCUR|--STAT - Section: - Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions Observation Class Origin: TIG Conformance Rules Rule Identifier: @@ -123,8 +122,7 @@ Core: Id: CORE-000014 Status: Published Version: "1" -Description: - Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or +Description: Raise an error when --PRESP is not equals to "Y" and --OCCUR is present in dataset or --STAT is equal to "NOT DONE" and --OCCUR is not blank Executability: Fully Executable Outcome: diff --git a/Published/CORE-000015/rule.yml b/Published/CORE-000015/rule.yml index 95daa9711..ebfe132ad 100644 --- a/Published/CORE-000015/rule.yml +++ b/Published/CORE-000015/rule.yml @@ -80,8 +80,7 @@ Authorities: DONE".] Document: SDTM v2.1 Item: --PRESP|--OCCUR|--STAT - Section: - Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions Observation Class Origin: TIG Conformance Rules Rule Identifier: diff --git a/Published/CORE-000018/rule.yml b/Published/CORE-000018/rule.yml index 041af2252..6195b831a 100644 --- a/Published/CORE-000018/rule.yml +++ b/Published/CORE-000018/rule.yml @@ -87,8 +87,7 @@ Authorities: DONE".] Document: SDTM v2.1 Item: --PRESP|--OCCUR|--STAT - Section: - Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions Observation Class Origin: TIG Conformance Rules Rule Identifier: @@ -112,8 +111,7 @@ Core: Id: CORE-000018 Status: Published Version: "1" -Description: - Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in +Description: Raise an error when --PRESP is equal to "Y", --STAT is blank, --OCCUR is present in dataset and --OCCUR is blank Executability: Fully Executable Outcome: diff --git a/Published/CORE-000021/rule.yml b/Published/CORE-000021/rule.yml index 3682a2ba5..b42afb7da 100644 --- a/Published/CORE-000021/rule.yml +++ b/Published/CORE-000021/rule.yml @@ -67,8 +67,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - The standardized result of the measurement, test, or examination in + - Cited Guidance: The standardized result of the measurement, test, or examination in character format. --STRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in --STRESN. If various tests have results "NONE", "NEG", and "NEGATIVE" in --ORRES and these results effectively diff --git a/Published/CORE-000022/rule.yml b/Published/CORE-000022/rule.yml index 3b2af74d2..d3a9f3188 100644 --- a/Published/CORE-000022/rule.yml +++ b/Published/CORE-000022/rule.yml @@ -120,13 +120,11 @@ Core: Id: CORE-000022 Status: Published Version: "1" -Description: - Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or +Description: Raise an error when AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE = 'Y' and AESER = 'N' or is empty. Executability: Fully Executable Outcome: - Message: - At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, + Message: At least one of the Seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD or AESMIE) = 'Y', but AESER = 'N' or empty. Output Variables: - AETERM diff --git a/Published/CORE-000027/rule.yml b/Published/CORE-000027/rule.yml index 49c854fca..b4342adb0 100644 --- a/Published/CORE-000027/rule.yml +++ b/Published/CORE-000027/rule.yml @@ -24,8 +24,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Either TEENRL or TEDUR must be present for each + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be populated.] Document: IG v3.2 @@ -40,8 +39,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Either TEENRL or TEDUR must be present for each + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be populated.] Document: IG v3.3 @@ -91,8 +89,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Either TEENRL or TEDUR must be present for each + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be populated.] Document: IG v3.2 @@ -107,8 +104,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Either TEENRL or TEDUR must be present for each + - Cited Guidance: Specification[Either TEENRL or TEDUR must be present for each Element.]|Assumption 12[At least one of TEENRL or TEDUR must be populated. Both may be populated.] Document: IG v3.3 @@ -145,8 +141,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.0 Item: Specification @@ -160,8 +155,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.1 Item: Specification @@ -175,8 +169,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.1.1 Item: Specification @@ -190,8 +183,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.1 Item: Specification @@ -205,8 +197,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.1.1 Item: Specification @@ -220,8 +211,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: IG v3.1.1 Item: Specification @@ -235,8 +225,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Either TEENRL or TEDUR must be present for each Element; both may be + - Cited Guidance: Either TEENRL or TEDUR must be present for each Element; both may be present. Document: TIG v1.0 Item: TEENRL CDISC Notes diff --git a/Published/CORE-000029/rule.yml b/Published/CORE-000029/rule.yml index 4078b9178..c4293b799 100644 --- a/Published/CORE-000029/rule.yml +++ b/Published/CORE-000029/rule.yml @@ -47,8 +47,7 @@ Core: Description: Raise an error when --TPTNUM exists in a dataset and --TPT does not exist. Executability: Fully Executable Outcome: - Message: - --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented + Message: --TPTNUM exists in a dataset, but --TPT does not exist. When time points are represented in SDTMIG domains, both --TPT and --TPTNUM must be used. Rule Type: Record Data Scope: diff --git a/Published/CORE-000030/rule.yml b/Published/CORE-000030/rule.yml index 859dae8c0..c7d0577ef 100644 --- a/Published/CORE-000030/rule.yml +++ b/Published/CORE-000030/rule.yml @@ -80,8 +80,7 @@ Core: Id: CORE-000030 Status: Published Version: "1" -Description: - Raise and error when --REASND is present in dataset and --PRESP is not present in +Description: Raise and error when --REASND is present in dataset and --PRESP is not present in dataset Executability: Fully Executable Outcome: diff --git a/Published/CORE-000033/rule.yml b/Published/CORE-000033/rule.yml index 55d8b2f5c..8b13f1473 100644 --- a/Published/CORE-000033/rule.yml +++ b/Published/CORE-000033/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the controlled terminology codelist NCOMPLT. Document: SDTMIG v3.4 Item: Assumption 3.b.i. @@ -48,8 +47,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the + - Cited Guidance: When DSTERM = "COMPLETED", DSDECOD is the term "COMPLETED" from the Controlled Terminology codelist NCOMPLT. Document: TIG 1.0 Item: Assumption 3.b.i. diff --git a/Published/CORE-000035/rule.yml b/Published/CORE-000035/rule.yml index 48301120a..afd6c141d 100644 --- a/Published/CORE-000035/rule.yml +++ b/Published/CORE-000035/rule.yml @@ -47,8 +47,7 @@ Core: Description: Raise an error when SVPRESP is null and VISITDY is not null. Executability: Fully Executable Outcome: - Message: - VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit. + Message: VISITDY is populated when SVPRESP is null. VISITDY is the Planned Study Day of a visit. It should not be populated for unplanned visits. Rule Type: Record Data Scope: diff --git a/Published/CORE-000041/rule.yml b/Published/CORE-000041/rule.yml index 7e3431d2a..029cde961 100644 --- a/Published/CORE-000041/rule.yml +++ b/Published/CORE-000041/rule.yml @@ -88,8 +88,7 @@ Check: operator: non_empty - name: TSVAL operator: not_matches_regex - value: - (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative + value: (?i:^(NI|No information|INV|Invalid|OTH|Other|PINF|Positive infinity|NINF|Negative infinity|UNC|Unencoded|DER|Derived|UNK|Unknown|ASKU|Asked but unknown|NAV|Temporarily unavailable|NASK|Not asked|TRC|Trace|MSK|Masked|QS|Sufficient Quantity)$) - name: TSVALNF @@ -98,14 +97,12 @@ Core: Id: CORE-000041 Status: Published Version: "1" -Description: - Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms +Description: Raise and error when TSVAL is not populated TSVAL is populated with values or synonyms of values in the ISO 21090 null flavor codelist (or other terms that can be represented as null flavors) but TSVALNF is completed. Executability: Fully Executable Outcome: - Message: - TSVAL is not populated with an ISO 21090 null flavor or null flavor description but + Message: TSVAL is not populated with an ISO 21090 null flavor or null flavor description but TSVALNF is populated. Rule Type: Record Data Scope: diff --git a/Published/CORE-000047/rule.yml b/Published/CORE-000047/rule.yml index a4808977d..67a407882 100644 --- a/Published/CORE-000047/rule.yml +++ b/Published/CORE-000047/rule.yml @@ -67,8 +67,7 @@ Core: Id: CORE-000047 Status: Published Version: "1" -Description: - When study does not use multi-stage arm assignments and ARM is populated, ARM must be +Description: When study does not use multi-stage arm assignments and ARM is populated, ARM must be present in TA.ARM. This rule has been executed to identify all cases when ARM is not present in TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. @@ -79,8 +78,7 @@ Operations: name: ARM operator: distinct Outcome: - Message: - ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is + Message: ARM value in DM dataset is not among the values of ARM variable in TA dataset. This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage assignment study Rule Type: Record Data diff --git a/Published/CORE-000075/rule.yml b/Published/CORE-000075/rule.yml index f70e59918..d43f0e48a 100644 --- a/Published/CORE-000075/rule.yml +++ b/Published/CORE-000075/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The following Qualifiers would not be used in AE, --OCCUR, --STAT, + - Cited Guidance: The following Qualifiers would not be used in AE, --OCCUR, --STAT, and--REASND. They are the only Qualifiers from the SDTM Events Class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred. @@ -55,8 +54,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - The following qualifiers would not be used in AE; --OCCUR, --STAT, + - Cited Guidance: The following qualifiers would not be used in AE; --OCCUR, --STAT, and--REASND. They are the only qualifiers from the SDTM Events class not in the AE domain. They are not permitted because the AE domain contains only records for adverse events that actually occurred diff --git a/Published/CORE-000080/rule.yml b/Published/CORE-000080/rule.yml index b82af1f5d..83a692e1d 100644 --- a/Published/CORE-000080/rule.yml +++ b/Published/CORE-000080/rule.yml @@ -81,8 +81,7 @@ Core: Id: CORE-000080 Status: Published Version: "1" -Description: - Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but +Description: Raise an error when --ELTM, --TPTNUM, and --TPT are not present in dataset, but --TPTREF is present. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000081/rule.yml b/Published/CORE-000081/rule.yml index 9ffa87db0..0904b5d4d 100644 --- a/Published/CORE-000081/rule.yml +++ b/Published/CORE-000081/rule.yml @@ -19,8 +19,7 @@ Authorities: prespecified intervention was not answered. Document: SDTM v2.0 Section: Interventions - - Cited Guidance: - Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.]| Document: SDTM v1.7 Section: Model v1.7[2.2.1 (Interventions )] @@ -32,8 +31,7 @@ Authorities: DONE] Document: SDTM v1.7 Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: - Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.] Document: SDTM v1.4 Section: Model v1.4[2.2.1 (Interventions) @@ -66,8 +64,7 @@ Authorities: prespecified intervention was not answered. Document: SDTM v2.0 Section: Interventions - - Cited Guidance: - Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.]| Document: SDTM v1.7 Section: Model v1.7[2.2.1 (Interventions )] @@ -79,8 +76,7 @@ Authorities: DONE] Document: SDTM v1.7 Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: - Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.] Document: SDTM v1.4 Section: Model v1.4[2.2.1 (Interventions) @@ -113,8 +109,7 @@ Authorities: prespecified intervention was not answered. Document: SDTM v2.0 Section: Interventions - - Cited Guidance: - Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.7[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.]| Document: SDTM v1.7 Section: Model v1.7[2.2.1 (Interventions )] @@ -126,8 +121,7 @@ Authorities: DONE] Document: SDTM v1.7 Section: Model v1.7[2.2.2 (Events)] - - Cited Guidance: - Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific + - Cited Guidance: Model v1.4[2.2.1 (Interventions )][ (--PRESP Used when a specific intervention is pre-specified on a CRF. Values should be "Y" or null.] Document: SDTM v1.4 Section: Model v1.4[2.2.1 (Interventions) diff --git a/Published/CORE-000083/rule.yml b/Published/CORE-000083/rule.yml index b72f3a030..793649c66 100644 --- a/Published/CORE-000083/rule.yml +++ b/Published/CORE-000083/rule.yml @@ -67,13 +67,11 @@ Core: Id: CORE-000083 Status: Published Version: "1" -Description: - Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not +Description: Verify that --ORRES is not null when --LOBXFL = Y and --DRVFL= null or --DRVFL is not present in the dataset Executability: Fully Executable Outcome: - Message: - --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset + Message: --ORRES is missing even though --LOBXFL= "Y" and either --DRVFL is not present in dataset or is not equal to "Y" Output Variables: - --ORRES diff --git a/Published/CORE-000084/rule.yml b/Published/CORE-000084/rule.yml index e9e31b654..fcfe64f68 100644 --- a/Published/CORE-000084/rule.yml +++ b/Published/CORE-000084/rule.yml @@ -22,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Identifies the end of the observation as being before or after the + - Cited Guidance: Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT. Document: Model v1.7 Item: Table 2.2.5.1 --ENRTPT diff --git a/Published/CORE-000085/rule.yml b/Published/CORE-000085/rule.yml index b73db6a30..141cdadf1 100644 --- a/Published/CORE-000085/rule.yml +++ b/Published/CORE-000085/rule.yml @@ -22,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Identifies the start of the observation as being before or after the + - Cited Guidance: Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT. Document: Model v1.7 Item: Table 2.2.5.1, --STRTPT diff --git a/Published/CORE-000093/rule.yml b/Published/CORE-000093/rule.yml index 16997dd89..5cb51bd6a 100644 --- a/Published/CORE-000093/rule.yml +++ b/Published/CORE-000093/rule.yml @@ -72,8 +72,7 @@ Core: Id: CORE-000093 Status: Published Version: "1" -Description: - Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT +Description: Raise an error when --DOSU = null and (--DOSE ^= null or --DOSTOT ^= null or --DOSTXT ^= null) Executability: Fully Executable Outcome: diff --git a/Published/CORE-000097/rule.yml b/Published/CORE-000097/rule.yml index 7ad197c4c..a6193ac69 100644 --- a/Published/CORE-000097/rule.yml +++ b/Published/CORE-000097/rule.yml @@ -86,8 +86,7 @@ Core: Id: CORE-000097 Status: Published Version: "1" -Description: - Raise an error when variable EPOCH values don't match between Subject Visits (SV) and +Description: Raise an error when variable EPOCH values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Partially Executable - Possible Overreporting Match Datasets: diff --git a/Published/CORE-000099/rule.yml b/Published/CORE-000099/rule.yml index 17882a27a..e8385f6ac 100644 --- a/Published/CORE-000099/rule.yml +++ b/Published/CORE-000099/rule.yml @@ -28,8 +28,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Used to indicate exam not done. Should be null if a result exists in + - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in LBORRES. Document: IG v3.2 Section: 6.3 LB @@ -42,8 +41,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Used to indicate exam not done. Should be null if a result exists in + - Cited Guidance: Used to indicate exam not done. Should be null if a result exists in LBORRES. Document: IG v3.3 Section: 6.3.6 LB diff --git a/Published/CORE-000100/rule.yml b/Published/CORE-000100/rule.yml index e83959c98..0e47c1c10 100644 --- a/Published/CORE-000100/rule.yml +++ b/Published/CORE-000100/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - A carrier or inert medium in which a medicinally active agent is + - Cited Guidance: A carrier or inert medium in which a medicinally active agent is administered. Document: Model v2.0 Item: --TRTV diff --git a/Published/CORE-000103/rule.yml b/Published/CORE-000103/rule.yml index 341f19145..14528c81a 100644 --- a/Published/CORE-000103/rule.yml +++ b/Published/CORE-000103/rule.yml @@ -71,8 +71,7 @@ Authorities: --CAT.] Document: SDTM v2.1 Item: Specifications --SCAT - Section: - Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation Class Origin: TIG Conformance Rules Rule Identifier: diff --git a/Published/CORE-000106/rule.yml b/Published/CORE-000106/rule.yml index 9b7cd2067..34a191c41 100644 --- a/Published/CORE-000106/rule.yml +++ b/Published/CORE-000106/rule.yml @@ -23,8 +23,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Identifies the end of the observation as being before or after the + - Cited Guidance: Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT. Document: Model v1.7 Item: Table 2.2.5.1 --ENTPT diff --git a/Published/CORE-000107/rule.yml b/Published/CORE-000107/rule.yml index 0173e6d72..1a72e1a17 100644 --- a/Published/CORE-000107/rule.yml +++ b/Published/CORE-000107/rule.yml @@ -13,8 +13,7 @@ Authorities: the following subject identifiers USUBJID, SPDEVID, or POOLID. Document: Model v2.0 Section: Identifiers - - Cited Guidance: - The Associated Persons Identifier (APID) will be required in all AP + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP datasets, and will identify records as AP data.' Document: Model v2.0 Section: Associated Persons Data @@ -48,8 +47,7 @@ Authorities: the following subject identifiers - SUBJID, SPDEVID, or POOLID. Document: SDTM v2.1 Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: - The Associated Persons Identifier (APID) will be required in all AP + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP datasets, and will identify records as AP data. Document: SDTM v2.1 Section: Section 4.0 Associated Persons Data @@ -94,14 +92,12 @@ Core: Id: CORE-000107 Status: Published Version: "1" -Description: - APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and +Description: APID is required in all Associated Persons Data. In addition to STUDYID, DOMAIN, and --SEQ being required for all domains based on one of the 3 general observation classes, one of USUBJID, APID, SPDEVID, or POOLID must also be present. Executability: Fully Executable Outcome: - Message: - An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID, + Message: An appropriate identifier is not present; USUBJID, APID, SPDEVID, SPTOBID, POOLID, SPTOBID, STOCONID should be present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000108/rule.yml b/Published/CORE-000108/rule.yml index b509ac700..4b7a56256 100644 --- a/Published/CORE-000108/rule.yml +++ b/Published/CORE-000108/rule.yml @@ -71,8 +71,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - #CG0133 is identical to rule FB0602. Added metadata for FB0602. + Version: + "1.0" + #CG0133 is identical to rule FB0602. Added metadata for FB0602. - Organization: FDA Standards: - Name: SDTMIG @@ -129,8 +130,7 @@ Core: Id: CORE-000108 Status: Published Version: "1" -Description: - When a record is present in the DD dataset then death flag (DTHFL) should be populated +Description: When a record is present in the DD dataset then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000116/rule.yml b/Published/CORE-000116/rule.yml index cddd15991..975b6e12d 100644 --- a/Published/CORE-000116/rule.yml +++ b/Published/CORE-000116/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The value will be "N" if the specimen is not usable, and null if the + - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the specimen is usable. Document: SDTM v2.0 Section: Findings @@ -21,8 +20,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - The value will be "N" if the specimen is not usable, and null if the + - Cited Guidance: The value will be "N" if the specimen is not usable, and null if the specimen is usable. Document: SDTM v2.1 Item: Specification diff --git a/Published/CORE-000117/rule.yml b/Published/CORE-000117/rule.yml index 9e451b004..627528f99 100644 --- a/Published/CORE-000117/rule.yml +++ b/Published/CORE-000117/rule.yml @@ -128,8 +128,7 @@ Core: Id: CORE-000117 Status: Published Version: "1" -Description: - Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is +Description: Raise an error when --STAT not equal to 'NOT DONE' when --PRESP = 'Y' and --OCCUR is null Executability: Fully Executable Outcome: diff --git a/Published/CORE-000118/rule.yml b/Published/CORE-000118/rule.yml index 5cfd842ea..3135e4af8 100644 --- a/Published/CORE-000118/rule.yml +++ b/Published/CORE-000118/rule.yml @@ -98,8 +98,7 @@ Authorities: Section: Section 3.1.1 The Interventions Observation Class | Section 3.1.3 The Findings Observation Class - - Cited Guidance: - An indication as to whether a prespecified event has occurred. | An + - Cited Guidance: An indication as to whether a prespecified event has occurred. | An indication as to whether a prespecified intervention has occurred Document: SDTM v2.1 Item: --OCCUR @@ -137,8 +136,7 @@ Core: Id: CORE-000118 Status: Published Version: "1" -Description: - Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not +Description: Raise an error when --PRESP is equal to 'Y' and --OCCUR is empty and --STAT is not present in dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000133/rule.yml b/Published/CORE-000133/rule.yml index c9cd9e7c1..188b1ffd7 100644 --- a/Published/CORE-000133/rule.yml +++ b/Published/CORE-000133/rule.yml @@ -72,8 +72,7 @@ Core: Id: CORE-000133 Status: Published Version: "1" -Description: - When --STRESU is populated, --STRESC must also be populated. Please note that this +Description: When --STRESU is populated, --STRESC must also be populated. Please note that this rule, as executed, cannot check if --STRESC is populated with the standardized unit. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000134/rule.yml b/Published/CORE-000134/rule.yml index f82d5f6a4..fdcc6a1b5 100644 --- a/Published/CORE-000134/rule.yml +++ b/Published/CORE-000134/rule.yml @@ -61,8 +61,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the exception of SUPPDM. IDVAR and IDVARVAL will not be populated in SUPPDM. Document: TIG 1.0 Section: 2.8.5.3 diff --git a/Published/CORE-000135/rule.yml b/Published/CORE-000135/rule.yml index cfb68ed49..1caa191fb 100644 --- a/Published/CORE-000135/rule.yml +++ b/Published/CORE-000135/rule.yml @@ -61,8 +61,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the + - Cited Guidance: IDVAR and IDVARVAL will be populated in all SUPP-- datasets with the exception of SUPPDM. Document: TIG 1.0 Section: 2.8.5.3 diff --git a/Published/CORE-000136/rule.yml b/Published/CORE-000136/rule.yml index e8d6d6f6b..5f0eb2c5a 100644 --- a/Published/CORE-000136/rule.yml +++ b/Published/CORE-000136/rule.yml @@ -57,8 +57,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Relationships between datasets are specified using the key variables + - Cited Guidance: Relationships between datasets are specified using the key variables STUDYID, RDOMAIN, and IDVAR only. The values of variables USUBJID and IDVARVAL will be null as relationships between specific subject records will not be identified. Document: TIG 1.0 diff --git a/Published/CORE-000137/rule.yml b/Published/CORE-000137/rule.yml index 25862d32a..37d9626a8 100644 --- a/Published/CORE-000137/rule.yml +++ b/Published/CORE-000137/rule.yml @@ -15,8 +15,7 @@ Authorities: Document: IG v3.4 Item: Assumption 4a Section: 6.1.3.2 - - Cited Guidance: - Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary and/or appropriate to represent specific dose amounts not taken, not given, or missed. Document: IG v3.4 @@ -39,8 +38,7 @@ Authorities: Document: IG v3.3 Item: Assumption 4a Section: 6.1.3.2 - - Cited Guidance: - Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary and/or appropriate to represent specific dose amounts not taken, not given, or missed. Document: IG v3.3 @@ -63,8 +61,7 @@ Authorities: Document: IG v3.2 Item: Assumption 4a Section: 6.1. - - Cited Guidance: - Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be + - Cited Guidance: Qualifiers that indicate dose amount (e.g., ECDOSE, ECDOSTXT) may be populated with positive (non-zero) values in cases where the sponsor feels it is necessary and/or appropriate to represent specific dose amounts not taken, not given, or missed. Document: IG v3.2 @@ -157,13 +154,11 @@ Core: Id: CORE-000137 Status: Published Version: "1" -Description: - Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but +Description: Raise an error when ECOCCUR is not equal to 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE less than or equal to 0. Executability: Fully Executable Outcome: - Message: - ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal + Message: ECOCCUR is not 'N', ECSTAT and ECDOSTXT are both empty but ECDOSE is less than or equal to 0. Output Variables: - ECOCCUR diff --git a/Published/CORE-000138/rule.yml b/Published/CORE-000138/rule.yml index 2437d14c9..19c12b443 100644 --- a/Published/CORE-000138/rule.yml +++ b/Published/CORE-000138/rule.yml @@ -113,8 +113,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in + Message: --STDY is not null when either --STDTC or DM.RFSTDTC do not contain complete values in their date portion Output Variables: - --STDY diff --git a/Published/CORE-000139/rule.yml b/Published/CORE-000139/rule.yml index 0125179f4..f58b07576 100644 --- a/Published/CORE-000139/rule.yml +++ b/Published/CORE-000139/rule.yml @@ -102,8 +102,7 @@ Core: Id: CORE-000139 Status: Published Version: "1" -Description: - Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date +Description: Trigger error if --ENDTC or DM.RFSTDTC does not contain complete values in their date portion, and --ENDY is not null. Executability: Fully Executable Match Datasets: @@ -111,8 +110,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in + Message: --ENDY is not null when either --ENDTC or DM.RFSTDTC do not contain complete values in their date portion Output Variables: - --ENDTC diff --git a/Published/CORE-000141/rule.yml b/Published/CORE-000141/rule.yml index 13d1ab8ca..32343ed33 100644 --- a/Published/CORE-000141/rule.yml +++ b/Published/CORE-000141/rule.yml @@ -134,8 +134,7 @@ Core: Id: CORE-000141 Status: Published Version: "1" -Description: - VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one +Description: VISITNUM and --TPTREF are not present then --TPT and --TPTNUM should have a one-to-one relationship. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000142/rule.yml b/Published/CORE-000142/rule.yml index 694edd647..be9c69f6d 100644 --- a/Published/CORE-000142/rule.yml +++ b/Published/CORE-000142/rule.yml @@ -100,14 +100,12 @@ Core: Id: CORE-000142 Status: Published Version: "1" -Description: - Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM +Description: Raise an error when --TPT ^= null and --TPTNUM ^= null and --ELTM ^= null and --ELTM does not have the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. Executability: Fully Executable Outcome: - Message: - --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM, + Message: --ELTM is not the same value across records with the same values of DOMAIN, VISITNUM, --TPTREF, and --TPTNUM. Output Variables: - --TPT diff --git a/Published/CORE-000151/rule.yml b/Published/CORE-000151/rule.yml index 347d6d9fa..27c76f79a 100644 --- a/Published/CORE-000151/rule.yml +++ b/Published/CORE-000151/rule.yml @@ -48,8 +48,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.0 Item: Specification @@ -63,8 +62,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.1 Item: Specification @@ -78,8 +76,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.1.1 Item: Specification @@ -93,8 +90,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.1 Item: Specification @@ -108,8 +104,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.1.1 Item: Specification @@ -123,8 +118,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Trial Summary allows for one TSVAL value to span multiple variables + - Cited Guidance: Trial Summary allows for one TSVAL value to span multiple variables (TSVAL-TSVALn), in order to accommodate values longer than 200 characters. Document: IG v3.1.1 Item: Specification diff --git a/Published/CORE-000152/rule.yml b/Published/CORE-000152/rule.yml index 7332d0931..cf8655a33 100644 --- a/Published/CORE-000152/rule.yml +++ b/Published/CORE-000152/rule.yml @@ -70,8 +70,7 @@ Core: Id: CORE-000152 Status: Published Version: "1" -Description: - When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between +Description: When TSVAL and TSVALCD are populated, there must be a one-to-one relationship between TSVALCD and TSVAL Executability: Fully Executable Outcome: diff --git a/Published/CORE-000154/rule.yml b/Published/CORE-000154/rule.yml index bf6bccf53..786c16ff4 100644 --- a/Published/CORE-000154/rule.yml +++ b/Published/CORE-000154/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Sequence number given to ensure uniqueness within a dataset. Allows + - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD. Document: IG v3.4 Item: Specification @@ -161,8 +160,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Sequence number given to ensure uniqueness within a dataset. Allows + - Cited Guidance: Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD. Document: TIG 1.0 Item: Specification diff --git a/Published/CORE-000165/rule.yml b/Published/CORE-000165/rule.yml index 6d0933e34..da0c7b8eb 100644 --- a/Published/CORE-000165/rule.yml +++ b/Published/CORE-000165/rule.yml @@ -197,8 +197,7 @@ Core: Id: CORE-000165 Status: Published Version: "1" -Description: - Time point reference (--TPTREF) should be present in the dataset, when reference time +Description: Time point reference (--TPTREF) should be present in the dataset, when reference time point (--RFTDTC) is also present in the dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000171/rule.yml b/Published/CORE-000171/rule.yml index bdca7bc04..bc0c99003 100644 --- a/Published/CORE-000171/rule.yml +++ b/Published/CORE-000171/rule.yml @@ -79,8 +79,7 @@ Core: Id: CORE-000171 Status: Published Version: "1" -Description: - Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in +Description: Raises an error when --ENRTPT is present in dataset but --ENTPT is not present in dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000172/rule.yml b/Published/CORE-000172/rule.yml index 2dd6bfef3..6625e9dc2 100644 --- a/Published/CORE-000172/rule.yml +++ b/Published/CORE-000172/rule.yml @@ -149,8 +149,7 @@ Core: Id: CORE-000172 Status: Published Version: "1" -Description: - Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must +Description: Raise an error when STUDYID is not equal to DM.STUDYID. The STUDYID in all domains must be the same in all records across the study. Executability: Fully Executable Operations: diff --git a/Published/CORE-000183/rule.yml b/Published/CORE-000183/rule.yml index f79c5409f..330c756cf 100644 --- a/Published/CORE-000183/rule.yml +++ b/Published/CORE-000183/rule.yml @@ -87,8 +87,7 @@ Core: Id: CORE-000183 Status: Published Version: "1" -Description: - Raise an error when a PP dataset is present in study, but a PC dataset is not present +Description: Raise an error when a PP dataset is present in study, but a PC dataset is not present in study. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000200/rule.yml b/Published/CORE-000200/rule.yml index 261fee582..575a4296f 100644 --- a/Published/CORE-000200/rule.yml +++ b/Published/CORE-000200/rule.yml @@ -101,8 +101,7 @@ Core: Id: CORE-000200 Status: Published Version: "1" -Description: - Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to +Description: Verify that --ORRES is not missing when either --STAT is null or --DRVFL not equal to 'Y' Executability: Fully Executable Outcome: diff --git a/Published/CORE-000201/rule.yml b/Published/CORE-000201/rule.yml index e37a2e28a..596a66221 100644 --- a/Published/CORE-000201/rule.yml +++ b/Published/CORE-000201/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The unique subject identifier (USUBJID) is required in all datasets + - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets containing subject-level data. USUBJID values must be unique for each trial participant (subject) across all trials in the submission. Document: IG v3.4 @@ -22,8 +21,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - The unique subject identifier (USUBJID) is required in all datasets + - Cited Guidance: The unique subject identifier (USUBJID) is required in all datasets containing subject-level data. USUBJID values must be unique for each trial participant (subject) across all trials in the submission. Document: IG v3.3 @@ -189,8 +187,7 @@ Core: Id: CORE-000201 Status: Published Version: "1" -Description: - Trigger error when domain is not an AP-- domain and USUBJID is not present in +Description: Trigger error when domain is not an AP-- domain and USUBJID is not present in DM.USUBJID Executability: Fully Executable Operations: diff --git a/Published/CORE-000203/rule.yml b/Published/CORE-000203/rule.yml index 840ffb0e3..74bdcbd44 100644 --- a/Published/CORE-000203/rule.yml +++ b/Published/CORE-000203/rule.yml @@ -90,8 +90,7 @@ Core: Id: CORE-000203 Status: Published Version: "1" -Description: - Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per +Description: Trigger error when the combination of IDVAR, IDVARVAL, and QNAM is not unique per parent subject record Executability: Fully Executable Outcome: diff --git a/Published/CORE-000206/rule.yml b/Published/CORE-000206/rule.yml index f6f6cb1bd..34044d82d 100644 --- a/Published/CORE-000206/rule.yml +++ b/Published/CORE-000206/rule.yml @@ -215,8 +215,7 @@ Core: Id: CORE-000206 Status: Published Version: "1" -Description: - When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by +Description: When IDVAR is populated, IDVARVAL must equal a value of the variable referenced by IDVAR within the domain referenced by RDOMAIN Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000208/rule.yml b/Published/CORE-000208/rule.yml index ffbde078b..9bc68212b 100644 --- a/Published/CORE-000208/rule.yml +++ b/Published/CORE-000208/rule.yml @@ -67,8 +67,7 @@ Core: Id: CORE-000208 Status: Published Version: "1" -Description: - Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null, +Description: Trigger error when study does not use multi-stage arm assignments and ACTARMCD ^= null, and ACTARMCD is not in TA.ARMCD Executability: Partially Executable - Possible Overreporting Operations: diff --git a/Published/CORE-000209/rule.yml b/Published/CORE-000209/rule.yml index fa970d831..99beb2582 100644 --- a/Published/CORE-000209/rule.yml +++ b/Published/CORE-000209/rule.yml @@ -67,8 +67,7 @@ Core: Id: CORE-000209 Status: Published Version: "1" -Description: - When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM +Description: When study does not use multi-stage arm assignments and ACTARM is populated, ACTARM must be present in TA.ARM. This rule has been executed to identify all cases when ACTARM is not present in TA.ARM and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. @@ -79,8 +78,7 @@ Operations: name: ARM operator: distinct Outcome: - Message: - ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset. + Message: ACTARM value in DM dataset is not among the values of ARM variable in the TA dataset. This is allowed only in a multistage study with incomplete ARM assignment. Please confirm if your study is a multistage assignment study. Output Variables: diff --git a/Published/CORE-000210/rule.yml b/Published/CORE-000210/rule.yml index 5ad375b41..626a7429f 100644 --- a/Published/CORE-000210/rule.yml +++ b/Published/CORE-000210/rule.yml @@ -65,8 +65,7 @@ Core: Id: CORE-000210 Status: Published Version: "1" -Description: - When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. diff --git a/Published/CORE-000212/rule.yml b/Published/CORE-000212/rule.yml index 490583df8..ff5426491 100644 --- a/Published/CORE-000212/rule.yml +++ b/Published/CORE-000212/rule.yml @@ -80,13 +80,11 @@ Core: Id: CORE-000212 Status: Published Version: "1" -Description: - When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT +Description: When subject has more than one record per Epoch with DSCAT = DISPOSITION EVENT, DSSCAT must be present. Executability: Fully Executable Outcome: - Message: - DSSCAT is not present when subject has more than one record per Epoch with DSCAT = + Message: DSSCAT is not present when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT'. Output Variables: - USUBJID diff --git a/Published/CORE-000214/rule.yml b/Published/CORE-000214/rule.yml index 27fd1f49b..95b36e7d7 100644 --- a/Published/CORE-000214/rule.yml +++ b/Published/CORE-000214/rule.yml @@ -68,8 +68,7 @@ Core: Id: CORE-000214 Status: Published Version: "1" -Description: - Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION +Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = 'STUDY PARTICIPATION' Executability: Fully Executable Operations: @@ -83,8 +82,7 @@ Operations: name: DSCAT operator: record_count Outcome: - Message: - More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'STUDY PARTICIPATION'. Output Variables: - DSSCAT diff --git a/Published/CORE-000217/rule.yml b/Published/CORE-000217/rule.yml index 1c4f24b36..1c27b96b6 100644 --- a/Published/CORE-000217/rule.yml +++ b/Published/CORE-000217/rule.yml @@ -135,13 +135,11 @@ Core: Id: CORE-000217 Status: Published Version: "1" -Description: - Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and +Description: Raise an error when ECDOSE is empty, ECOCCUR is not equal to 'N', ECSTAT is empty and ECDOSTXT is empty Executability: Fully Executable Outcome: - Message: - ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also + Message: ECDOSE is empty, ECOCCUR is not equal to 'N' and ECSTAT is empty, but ECDOSTXT is also empty. Output Variables: - ECDOSE diff --git a/Published/CORE-000218/rule.yml b/Published/CORE-000218/rule.yml index 53581e3ff..a9134fbdb 100644 --- a/Published/CORE-000218/rule.yml +++ b/Published/CORE-000218/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Comments[Value of identifying variable of the parent + - Cited Guidance: Comments[Value of identifying variable of the parent record(s).]|Supplemental Qualifiers[Value of identifying variable of the parent record(s).] Document: Model v2.0 @@ -59,8 +58,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.0 Item: Specification @@ -74,8 +72,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.1 Item: Specification @@ -89,8 +86,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.1.1 Item: Specification @@ -104,8 +100,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.1 Item: Specification @@ -119,8 +114,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.1.1 Item: Specification @@ -134,8 +128,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - IDVARVAL is used only when individual comments are related to domain + - Cited Guidance: IDVARVAL is used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. Document: IG v3.1 Item: Specification diff --git a/Published/CORE-000220/rule.yml b/Published/CORE-000220/rule.yml index 4f018fbff..8e275e55e 100644 --- a/Published/CORE-000220/rule.yml +++ b/Published/CORE-000220/rule.yml @@ -84,13 +84,11 @@ Core: Id: CORE-000220 Status: Published Version: "1" -Description: - Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters, +Description: Part A - Raise an error when --TESTCD > 8 chars or contains more than only letters, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: - --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + Message: --TESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts with a number. Output Variables: - --TESTCD diff --git a/Published/CORE-000221/rule.yml b/Published/CORE-000221/rule.yml index 9061a9ee0..7d1d43931 100644 --- a/Published/CORE-000221/rule.yml +++ b/Published/CORE-000221/rule.yml @@ -93,13 +93,11 @@ Core: Id: CORE-000221 Status: Published Version: "1" -Description: - Raise an error when QNAM > 8 chars or contains more than only letters in uppercase, +Description: Raise an error when QNAM > 8 chars or contains more than only letters in uppercase, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: - QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters, + Message: QNAM > 8 chars or contains letters that are in not in uppercase, more than only letters, numbers, underscores, or starts with a number. Output Variables: - IDVAR diff --git a/Published/CORE-000225/rule.yml b/Published/CORE-000225/rule.yml index 50fc7d0e1..12b6914c2 100644 --- a/Published/CORE-000225/rule.yml +++ b/Published/CORE-000225/rule.yml @@ -62,8 +62,7 @@ Authorities: Used in conjunction with --STAT when value is "NOT DONE".] Document: SDTM v2.1 Item: --REASND - Section: - Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions + Section: Section 3.1.2 The Events Observation Class|Section 3.1.1 The Interventions Observation Class|Section 3.1.3 The Findings Observation Class Origin: TIG Conformance Rules Rule Identifier: diff --git a/Published/CORE-000236/rule.yml b/Published/CORE-000236/rule.yml index 9faae4dbb..8354696b5 100644 --- a/Published/CORE-000236/rule.yml +++ b/Published/CORE-000236/rule.yml @@ -113,8 +113,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset + Message: MHSTDTC ^= null and MHSTDTC is on or after the DM.RFSTDTC. The medical history dataset should include the subject's prior history at the start of the trial. Output Variables: - MHSTDTC diff --git a/Published/CORE-000238/rule.yml b/Published/CORE-000238/rule.yml index a6248bdb4..621646b76 100644 --- a/Published/CORE-000238/rule.yml +++ b/Published/CORE-000238/rule.yml @@ -81,8 +81,7 @@ Core: Id: CORE-000238 Status: Published Version: "1" -Description: - Raise an error when EX records are present for subject but RFXENDTC does not equal the +Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the latest value of EX.EXSTDTC or EX.EXENDTC Executability: Fully Executable Operations: diff --git a/Published/CORE-000239/rule.yml b/Published/CORE-000239/rule.yml index 7b39ead43..67d5f9573 100644 --- a/Published/CORE-000239/rule.yml +++ b/Published/CORE-000239/rule.yml @@ -78,8 +78,7 @@ Core: Id: CORE-000239 Status: Published Version: "1" -Description: - Raise an error when EX records are present for subject but RFXSTDTC does not equal the +Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the earliest value of EX.EXSTDTC Executability: Fully Executable Operations: diff --git a/Published/CORE-000248/rule.yml b/Published/CORE-000248/rule.yml index 895453066..1f05459c9 100644 --- a/Published/CORE-000248/rule.yml +++ b/Published/CORE-000248/rule.yml @@ -299,8 +299,7 @@ Core: Id: CORE-000248 Status: Published Version: "1" -Description: - Time point reference (--TPTREF) should be populated when reference time point +Description: Time point reference (--TPTREF) should be populated when reference time point (--RFTDTC) is populated. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000250/rule.yml b/Published/CORE-000250/rule.yml index 938c40102..ecb9c12c8 100644 --- a/Published/CORE-000250/rule.yml +++ b/Published/CORE-000250/rule.yml @@ -252,8 +252,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset + Message: MHENDTC ^= null and MHENDTC is on or after the DM.RFSTDTC. The medical history dataset should include the subject's prior history at the start of the trial. Output Variables: - MHENDTC diff --git a/Published/CORE-000252/rule.yml b/Published/CORE-000252/rule.yml index fa1f32d4d..9e7a02f62 100644 --- a/Published/CORE-000252/rule.yml +++ b/Published/CORE-000252/rule.yml @@ -64,8 +64,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 + Version: + "1.0" + #CG0136 is identical to rule FB0605. Added metadata for FB0605 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG @@ -124,8 +125,7 @@ Core: Id: CORE-000252 Status: Published Version: "1" -Description: - When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag +Description: When a record is present in the DS dataset where DSDECOD = 'DEATH' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000253/rule.yml b/Published/CORE-000253/rule.yml index 3eb20f7cc..03d816da1 100644 --- a/Published/CORE-000253/rule.yml +++ b/Published/CORE-000253/rule.yml @@ -64,8 +64,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 + Version: + "1.0" + #CG0135 is identical to rule FB0604. Added metadata for FB0604 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG @@ -124,8 +125,7 @@ Core: Id: CORE-000253 Status: Published Version: "1" -Description: - When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL) +Description: When a record is present in the AE dataset where AESDTH = 'Y' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000254/rule.yml b/Published/CORE-000254/rule.yml index 3cd50202d..0fe4d8adb 100644 --- a/Published/CORE-000254/rule.yml +++ b/Published/CORE-000254/rule.yml @@ -64,8 +64,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 + Version: + "1.0" + #CG0134 is identical to rule FB0603. Added metadata for FB0603 by Malini Narreddy on 2025-03-05 - Organization: FDA Standards: - Name: SDTMIG @@ -124,8 +125,7 @@ Core: Id: CORE-000254 Status: Published Version: "1" -Description: - When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag +Description: When a record is present in the AE dataset where AEOUT = 'FATAL' then death flag (DTHFL) should be populated as 'Y' in the DM dataset for the corresponding subject. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000255/rule.yml b/Published/CORE-000255/rule.yml index a9151bbf3..d7b08bd26 100644 --- a/Published/CORE-000255/rule.yml +++ b/Published/CORE-000255/rule.yml @@ -96,8 +96,7 @@ Core: Id: CORE-000255 Status: Published Version: "1" -Description: - There should always be data presented in the --ORRES variable unless --STAT = "NOT +Description: There should always be data presented in the --ORRES variable unless --STAT = "NOT DONE". Executability: Fully Executable Outcome: diff --git a/Published/CORE-000257/rule.yml b/Published/CORE-000257/rule.yml index d3796e959..aa25d73d2 100644 --- a/Published/CORE-000257/rule.yml +++ b/Published/CORE-000257/rule.yml @@ -68,8 +68,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - # FDA rule FB4401 is identical - added Jozef 2024-12-19 + Version: + "1.0" + # FDA rule FB4401 is identical - added Jozef 2024-12-19 - Organization: "FDA" Standards: - Name: "SDTMIG" diff --git a/Published/CORE-000258/rule.yml b/Published/CORE-000258/rule.yml index d235a3e40..974b65693 100644 --- a/Published/CORE-000258/rule.yml +++ b/Published/CORE-000258/rule.yml @@ -79,8 +79,7 @@ Core: Id: CORE-000258 Status: Published Version: "1" -Description: - Raise an error when --STRTPT is present in dataset and --STTPT is not present in +Description: Raise an error when --STRTPT is present in dataset and --STTPT is not present in dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000261/rule.yml b/Published/CORE-000261/rule.yml index ef7657a27..800329184 100644 --- a/Published/CORE-000261/rule.yml +++ b/Published/CORE-000261/rule.yml @@ -22,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Identifies the start of the observation as being before or after the + - Cited Guidance: Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT. Document: Model v1.7 Item: Table 2.2.5.1 --STRTPT @@ -75,8 +74,7 @@ Core: Id: CORE-000261 Status: Published Version: "1" -Description: - Raise an error when --STTPT is present in dataset and --STRTPT is not present in +Description: Raise an error when --STTPT is present in dataset and --STRTPT is not present in dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000265/rule.yml b/Published/CORE-000265/rule.yml index e25f253a9..4e4b0332b 100644 --- a/Published/CORE-000265/rule.yml +++ b/Published/CORE-000265/rule.yml @@ -22,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Identifies the end of the observation as being before or after the + - Cited Guidance: Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable --ENTPT. Document: Model v1.7 Item: Table 2.2.5.1 --ENTPT @@ -64,8 +63,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SDTM - Version: "1.0" - # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 + Version: + "1.0" + # CG0046 is identical to rule FB4402. Added metadata for FB4402 Jozef Aerts 2024-12-19 - Organization: "FDA" Standards: - Name: "SDTMIG" diff --git a/Published/CORE-000266/rule.yml b/Published/CORE-000266/rule.yml index 30aaca605..7a99d1857 100644 --- a/Published/CORE-000266/rule.yml +++ b/Published/CORE-000266/rule.yml @@ -135,13 +135,11 @@ Core: Id: CORE-000266 Status: Published Version: "1" -Description: - Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE +Description: Select record where AESCAN and AESCONG and AESDISAB and AESDTH and AESHOSP and AESLIFE and AESOD and AESMIE ^= "Y" However, AESER ^= "N" Executability: Fully Executable Outcome: - Message: - If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, + Message: If AESER = "N" then none of the seriousness criteria (AESCAN, AESCONG, AESDISAB, AESDTH, AESHOSP, AESLIFE, AESOD, AESMIE) could be equal to "Y". Output Variables: - AESER diff --git a/Published/CORE-000268/rule.yml b/Published/CORE-000268/rule.yml index 203902fa9..d813222ec 100644 --- a/Published/CORE-000268/rule.yml +++ b/Published/CORE-000268/rule.yml @@ -26,8 +26,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Dictionary or sponsor-defined derived text description of the topic + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA). Document: Model v1.7 @@ -46,8 +45,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Dictionary or sponsor-defined derived text description of the topic + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic variable, --TERM, or the modified topic variable (--MODIFY), if applicable. Equivalent to the Preferred Term (PT in MedDRA). Document: Model v1.4 diff --git a/Published/CORE-000269/rule.yml b/Published/CORE-000269/rule.yml index 574d147d5..2fe651ede 100644 --- a/Published/CORE-000269/rule.yml +++ b/Published/CORE-000269/rule.yml @@ -88,8 +88,7 @@ Core: Id: CORE-000269 Status: Published Version: "1" -Description: - Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'), +Description: Verify when VISIT is not null in any given domain and VISIT is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISIT. Executability: Fully Executable Match Datasets: @@ -103,8 +102,7 @@ Operations: name: VISIT operator: distinct Outcome: - Message: - For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present + Message: For a planned visit (SVPRESP = 'Y'), non-missing VISIT value must be among those present in TV.VISIT. Output Variables: - VISIT diff --git a/Published/CORE-000270/rule.yml b/Published/CORE-000270/rule.yml index bf9a1b055..1a7c272b4 100644 --- a/Published/CORE-000270/rule.yml +++ b/Published/CORE-000270/rule.yml @@ -82,8 +82,7 @@ Core: Id: CORE-000270 Status: Published Version: "1" -Description: - Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP = +Description: Verify when VISITNUM is not null in any given domain and VISITNUM is planned (SVPRESP = 'Y'), then VISIT should be among TV.VISITNUM. Executability: Fully Executable Match Datasets: @@ -97,8 +96,7 @@ Operations: name: VISITNUM operator: distinct Outcome: - Message: - For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those + Message: For a planned visit (SVPRESP = 'Y'), non-missing VISITNUM value must be among those present in TV.VISITNUM. in TV.VISITNUM Output Variables: - VISITNUM diff --git a/Published/CORE-000271/rule.yml b/Published/CORE-000271/rule.yml index a97e6ce3b..4db6d977a 100644 --- a/Published/CORE-000271/rule.yml +++ b/Published/CORE-000271/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - EPOCH may be included as a timing variable as in other + - Cited Guidance: EPOCH may be included as a timing variable as in other general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn from the Trial Arms(TA) dataset (Section 7.2.1, Trial Arms). Document: SDTMIG v3.4 @@ -23,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - EPOCH may be included as a timing variable as in other + - Cited Guidance: EPOCH may be included as a timing variable as in other general-observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn from the Trial Arms (TA) dataset (Section 7.2.1, Trial Arms). Document: SDTMIG v3.3 @@ -55,8 +53,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - EPOCH may be included as a timing variable as in other general + - Cited Guidance: EPOCH may be included as a timing variable as in other general observation-class domains. In DS, EPOCH is based on DSSTDTC. The values of EPOCH are drawn from the Trial Arms (TA) dataset. Document: TIG 1.0 diff --git a/Published/CORE-000289/rule.yml b/Published/CORE-000289/rule.yml index e5063b039..772b05f74 100644 --- a/Published/CORE-000289/rule.yml +++ b/Published/CORE-000289/rule.yml @@ -86,8 +86,7 @@ Core: Id: CORE-000289 Status: Published Version: "1" -Description: - Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty. +Description: Raise an error when LBORRES is not a continuous measurement and LBORNRHI is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000290/rule.yml b/Published/CORE-000290/rule.yml index d74cbf849..aea94ad13 100644 --- a/Published/CORE-000290/rule.yml +++ b/Published/CORE-000290/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Lower end of reference range for continuous measurements for + - Cited Guidance: Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. Document: SDTMIG v3.4 Item: Specification @@ -82,8 +81,7 @@ Core: Id: CORE-000290 Status: Published Version: "1" -Description: - Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The +Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000293/rule.yml b/Published/CORE-000293/rule.yml index dfb618f1d..b17ec7918 100644 --- a/Published/CORE-000293/rule.yml +++ b/Published/CORE-000293/rule.yml @@ -61,8 +61,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Supplemental Qualifier datasets will be named using convention SUPP + - Cited Guidance: Supplemental Qualifier datasets will be named using convention SUPP concatenated with the two-character domain code or four-character code when a dataset is split (e.g., SUPPDM, SUPPFA, SUPPFACM). Document: TIG 1.0 diff --git a/Published/CORE-000294/rule.yml b/Published/CORE-000294/rule.yml index 174a5adbb..85c52b7bf 100644 --- a/Published/CORE-000294/rule.yml +++ b/Published/CORE-000294/rule.yml @@ -81,8 +81,7 @@ Core: Id: CORE-000294 Status: Published Version: "1" -Description: - Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to +Description: Trigger error when TSPARMCD = 'AGEMAX' and TSVAL ^= null and TSVAL does not conform to ISO 8601 Executability: Fully Executable Outcome: diff --git a/Published/CORE-000298/rule.yml b/Published/CORE-000298/rule.yml index 4d3bfd583..3ecc85812 100644 --- a/Published/CORE-000298/rule.yml +++ b/Published/CORE-000298/rule.yml @@ -52,8 +52,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Lower end of reference range for continuous measurements for + - Cited Guidance: Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results. Document: TIG 1.0 Item: Specification-LBSTNRLO @@ -82,8 +81,7 @@ Core: Id: CORE-000298 Status: Published Version: "1" -Description: - Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty. +Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRLO is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000299/rule.yml b/Published/CORE-000299/rule.yml index 5530a6b55..199af8e97 100644 --- a/Published/CORE-000299/rule.yml +++ b/Published/CORE-000299/rule.yml @@ -81,8 +81,7 @@ Core: Id: CORE-000299 Status: Published Version: "1" -Description: - Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty. +Description: Raise an error when LBORRES is not a continuous measurement and LBSTNRHI is not empty. The interpretation of the guidance is that LBORRES is populated (not null). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000321/rule.yml b/Published/CORE-000321/rule.yml index 9b46f9754..a962bb328 100644 --- a/Published/CORE-000321/rule.yml +++ b/Published/CORE-000321/rule.yml @@ -151,13 +151,11 @@ Core: Id: CORE-000321 Status: Published Version: "1" -Description: - When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of +Description: When Date/Time of Collection (--DTC) is present in the dataset, then the Study Day of Visit/Collection/Exam (--DY) should also present in the dataset. Executability: Fully Executable Outcome: - Message: - Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of + Message: Study Day of Visit/Collection/Exam (--DY) variable is missing when Date/Time of Collection (--DTC) is present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000328/rule.yml b/Published/CORE-000328/rule.yml index ffb53a6b8..b2f3e626b 100644 --- a/Published/CORE-000328/rule.yml +++ b/Published/CORE-000328/rule.yml @@ -151,13 +151,11 @@ Core: Id: CORE-000328 Status: Published Version: "1" -Description: - Study Day of Start (--STDY) variable should be included into dataset, when Start Study +Description: Study Day of Start (--STDY) variable should be included into dataset, when Start Study Date/Time (--STDTC) variable is present. Executability: Fully Executable Outcome: - Message: - The Study Day of Start of Observation (--STDY) is not present in the dataset when Start + Message: The Study Day of Start of Observation (--STDY) is not present in the dataset when Start Date/Time of Observation (--STDTC) is present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000334/rule.yml b/Published/CORE-000334/rule.yml index cdd5cb5c8..59efc38e9 100644 --- a/Published/CORE-000334/rule.yml +++ b/Published/CORE-000334/rule.yml @@ -168,8 +168,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Exp for variables which are Expected to be included in the resulting + - Cited Guidance: Exp for variables which are Expected to be included in the resulting dataset, even if all values are null. Such variables are considered necessary to make the data record useful in the context of the domain. Document: TIG v1.0 diff --git a/Published/CORE-000342/rule.yml b/Published/CORE-000342/rule.yml index 21980ac61..c55a16b6b 100644 --- a/Published/CORE-000342/rule.yml +++ b/Published/CORE-000342/rule.yml @@ -106,8 +106,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SEND - Version: "1.0" - # FDA BUsiness Rule metadata added as both have the same logic + Version: + "1.0" + # FDA BUsiness Rule metadata added as both have the same logic - Organization: FDA Standards: - Name: SENDIG diff --git a/Published/CORE-000353/rule.yml b/Published/CORE-000353/rule.yml index 3a23dc531..03867e58c 100644 --- a/Published/CORE-000353/rule.yml +++ b/Published/CORE-000353/rule.yml @@ -132,8 +132,9 @@ Check: operator: equal_to value: STENDTC - name: TSVAL - operator: invalid_date - # Duration parameter values - P.S. negative durations are allowed + operator: + invalid_date + # Duration parameter values - P.S. negative durations are allowed - all: - name: TSPARMCD operator: equal_to diff --git a/Published/CORE-000354/rule.yml b/Published/CORE-000354/rule.yml index e7574413c..3576385cf 100644 --- a/Published/CORE-000354/rule.yml +++ b/Published/CORE-000354/rule.yml @@ -83,8 +83,7 @@ Core: Id: CORE-000354 Status: Published Version: "1" -Description: - Raise an error when the date portion of --DTC is an incomplete date or the date portion +Description: Raise an error when the date portion of --DTC is an incomplete date or the date portion of DM.RFSTDTC is an incomplete date, but --DY is not empty Executability: Fully Executable Match Datasets: @@ -92,8 +91,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not + Message: The date portion of --DTC is not complete date or the date portion of DM.RFSTDTC is not complete date, but --DY is not empty Output Variables: - --DY diff --git a/Published/CORE-000357/rule.yml b/Published/CORE-000357/rule.yml index 464c1e722..7d08e6764 100644 --- a/Published/CORE-000357/rule.yml +++ b/Published/CORE-000357/rule.yml @@ -78,13 +78,11 @@ Core: Id: CORE-000357 Status: Published Version: "1" -Description: - When a supplemental qualifier dataset is associated with a split dataset, the dataset +Description: When a supplemental qualifier dataset is associated with a split dataset, the dataset name length must not be greater than 8 characters. Executability: Fully Executable Outcome: - Message: - Supplemental qualifier dataset associated with a split dataset is greater than 8 + Message: Supplemental qualifier dataset associated with a split dataset is greater than 8 characters in length Rule Type: Dataset Metadata Check Scope: diff --git a/Published/CORE-000358/rule.yml b/Published/CORE-000358/rule.yml index e73bae9ae..88c06c2ba 100644 --- a/Published/CORE-000358/rule.yml +++ b/Published/CORE-000358/rule.yml @@ -85,8 +85,7 @@ Core: Id: CORE-000358 Status: Published Version: "1" -Description: - Verify that when --LNKGRP is present in one domain it is also present in another +Description: Verify that when --LNKGRP is present in one domain it is also present in another domain. Executability: Fully Executable Operations: diff --git a/Published/CORE-000361/rule.yml b/Published/CORE-000361/rule.yml index 91185d08f..0d9a49ab6 100644 --- a/Published/CORE-000361/rule.yml +++ b/Published/CORE-000361/rule.yml @@ -127,8 +127,7 @@ Core: Id: CORE-000361 Status: Published Version: "1" -Description: - When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one +Description: When VISITNUM is present in TV, VISIT and VISITNUM should have a one-to-one relationship. Executability: Fully Executable Operations: diff --git a/Published/CORE-000363/rule.yml b/Published/CORE-000363/rule.yml index 22ab5f5e4..45e85b296 100644 --- a/Published/CORE-000363/rule.yml +++ b/Published/CORE-000363/rule.yml @@ -87,8 +87,7 @@ Core: Id: CORE-000363 Status: Published Version: "1" -Description: - When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT +Description: When there are multiple informed consents obtained and DSDECOD = 'INFORMED CONSENT OBTAINED', the earliest DSSTDTC for each subject should be equal to DM.RFICDTC. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000370/rule.yml b/Published/CORE-000370/rule.yml index 55d66767b..e953a8cba 100644 --- a/Published/CORE-000370/rule.yml +++ b/Published/CORE-000370/rule.yml @@ -98,8 +98,7 @@ Core: Id: CORE-000370 Status: Published Version: "1" -Description: - DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent +Description: DM.RFICDTC must equal the earliest DS.DSSTDTC when DSTERM indicates informed consent obtained. Executability: Fully Executable Match Datasets: @@ -114,8 +113,7 @@ Operations: name: DSSTDTC operator: min_date Outcome: - Message: - DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent + Message: DM.RFICDTC is not equal to the earliest DSSTDTC, when DSTERM indicates Informed consent obtained. Output Variables: - DSDECOD diff --git a/Published/CORE-000374/rule.yml b/Published/CORE-000374/rule.yml index 4922d8d9a..2f66d3907 100644 --- a/Published/CORE-000374/rule.yml +++ b/Published/CORE-000374/rule.yml @@ -52,8 +52,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY + - Cited Guidance: For records with DSCAT = ""DISPOSITION EVENT"", DSSCAT = ""STUDY PARTICIPATION"" is used to represent disposition of study participation. DSSCAT = ""PRODUCT EXPOSURE"" is used when a study has only a single product. If a study has multiple products, then DSSCAT should name the individual product." diff --git a/Published/CORE-000376/rule.yml b/Published/CORE-000376/rule.yml index 05fdcf710..a45491862 100644 --- a/Published/CORE-000376/rule.yml +++ b/Published/CORE-000376/rule.yml @@ -116,8 +116,7 @@ Core: Id: CORE-000376 Status: Published Version: "1" -Description: - Raise an error when the two first characters of a prefixed variable within a custom +Description: Raise an error when the two first characters of a prefixed variable within a custom domain do not match the DOMAIN value. Executability: Fully Executable Operations: @@ -127,8 +126,7 @@ Operations: - id: $domain_is_custom operator: domain_is_custom Outcome: - Message: - First 2 characters of prefixed variable within custom domain do not match the DOMAIN + Message: First 2 characters of prefixed variable within custom domain do not match the DOMAIN value. Output Variables: - $domain_list diff --git a/Published/CORE-000386/rule.yml b/Published/CORE-000386/rule.yml index 28bfd947f..b96e0e6e5 100644 --- a/Published/CORE-000386/rule.yml +++ b/Published/CORE-000386/rule.yml @@ -52,8 +52,7 @@ Core: Id: CORE-000386 Status: Published Version: "1" -Description: - Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within +Description: Trigger error when the order of SJSEQ is not chronologically (based on SJSTDTC) within USUBJID Executability: Fully Executable Outcome: diff --git a/Published/CORE-000388/rule.yml b/Published/CORE-000388/rule.yml index b7ad0e7c9..633ecd625 100644 --- a/Published/CORE-000388/rule.yml +++ b/Published/CORE-000388/rule.yml @@ -6,8 +6,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: SENDIG v3.1 Item: Assumption 3 @@ -21,8 +20,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: SENDIG v3.1.1 Item: Assumption 3 @@ -36,8 +34,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: SENDIG v3.1.1 Item: Assumption 3 @@ -51,8 +48,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: SENDIG v3.1 Item: Assumption 3 @@ -66,8 +62,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: SENDIG v3.1.1 Item: Assumption 3 @@ -81,8 +76,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are + - Cited Guidance: Record-to-record relationships (USUBJID or POOLID, and IDVARVAL are populated; RELTYPE is null) Document: TIG v1.0 Item: Assumption 3 @@ -114,13 +108,11 @@ Core: Id: CORE-000388 Status: Published Version: "1" -Description: - When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be +Description: When USUBJID or POOLID are populated, and IDVARVAL is populated, then RELTYPE must be null. Executability: Fully Executable Outcome: - Message: - RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is + Message: RELTYPE may not be populated when USUBJID or POOLID is populated, and IDVARVAL is populated Output Variables: - RDOMAIN diff --git a/Published/CORE-000390/rule.yml b/Published/CORE-000390/rule.yml index 189d897f1..b4ef81ca2 100644 --- a/Published/CORE-000390/rule.yml +++ b/Published/CORE-000390/rule.yml @@ -79,8 +79,7 @@ Core: Id: CORE-000390 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular +Description: Raise an error when there is more than one record present for any particular cardiovascular test for a subject and measurement date/time Executability: Fully Executable Outcome: diff --git a/Published/CORE-000398/rule.yml b/Published/CORE-000398/rule.yml index 04f065b2d..134dbcce7 100644 --- a/Published/CORE-000398/rule.yml +++ b/Published/CORE-000398/rule.yml @@ -116,8 +116,7 @@ Core: Id: CORE-000398 Status: Published Version: "1" -Description: - Raise an error when the variable label for an IG-variable does not correspond to the +Description: Raise an error when the variable label for an IG-variable does not correspond to the variable label in the Implementation Guide. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000400/rule.yml b/Published/CORE-000400/rule.yml index 5aab093a0..6faf21a7c 100644 --- a/Published/CORE-000400/rule.yml +++ b/Published/CORE-000400/rule.yml @@ -41,8 +41,7 @@ Description: must be given and vice versa." Executability: Fully Executable Outcome: - Message: - The administration duration will vary (durationWillVary is not 'false' or + Message: The administration duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing). Output Variables: diff --git a/Published/CORE-000413/rule.yml b/Published/CORE-000413/rule.yml index d04e4001a..cf6edfa2d 100644 --- a/Published/CORE-000413/rule.yml +++ b/Published/CORE-000413/rule.yml @@ -10,8 +10,7 @@ Authorities: Rule Identifier: Id: "DDF00020" Version: "1" - Validator Rule Message: - If the reason for a study amendment is 'Other' then this must be + Validator Rule Message: If the reason for a study amendment is 'Other' then this must be specified (attribute otherReason must be completed), and vice versa. Version: "1.0" Version: "4.0" @@ -38,13 +37,11 @@ Core: Id: "CORE-000413" Status: Published Version: "1" -Description: - If the reason for a study amendment is 'Other' then this must be specified (attribute +Description: If the reason for a study amendment is 'Other' then this must be specified (attribute otherReason must be completed), and vice versa. Executability: Fully Executable Outcome: - Message: - Population of otherReason is not consistent with code - code.code is C17649 ('Other') but + Message: Population of otherReason is not consistent with code - code.code is C17649 ('Other') but otherReason is blank, or otherReason is present but code.code is not C17649 ('Other'). Output Variables: - parent_entity diff --git a/Published/CORE-000429/rule.yml b/Published/CORE-000429/rule.yml index bc352ad82..4324e0c53 100644 --- a/Published/CORE-000429/rule.yml +++ b/Published/CORE-000429/rule.yml @@ -30,8 +30,7 @@ Core: Id: CORE-000429 Status: Published Version: "1" -Description: - If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null +Description: If the PCORRES result is outside the Limit of Quantification, a. PCSTRESN must be null and not populated with the value of zero (0). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000432/rule.yml b/Published/CORE-000432/rule.yml index c084714d5..98b6bce92 100644 --- a/Published/CORE-000432/rule.yml +++ b/Published/CORE-000432/rule.yml @@ -116,8 +116,7 @@ Core: Id: CORE-000432 Status: Published Version: "1" -Description: - TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum +Description: TXPARMCD Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000436/rule.yml b/Published/CORE-000436/rule.yml index ea0e1058c..260c9919a 100644 --- a/Published/CORE-000436/rule.yml +++ b/Published/CORE-000436/rule.yml @@ -116,8 +116,7 @@ Core: Id: CORE-000436 Status: Published Version: "1" -Description: - Raise an error when --DY is not calculated as per the study day algorithm as a non-zero +Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not empty Executability: Fully Executable @@ -130,8 +129,7 @@ Operations: name: --DTC operator: dy # does dy op take into acct +1? Outcome: - Message: - --DY is not calculated correctly even though the date portion of --DTC is complete, the + Message: --DY is not calculated correctly even though the date portion of --DTC is complete, the date portion of DM.RFSTDTC is a complete date, and --DY is not empty. Output Variables: - --DY diff --git a/Published/CORE-000444/rule.yml b/Published/CORE-000444/rule.yml index 7295d6459..91f9a672f 100644 --- a/Published/CORE-000444/rule.yml +++ b/Published/CORE-000444/rule.yml @@ -61,13 +61,11 @@ Core: Id: CORE-000444 Status: Published Version: "1" -Description: - When Result is outside the Limit of Quantification, i.e. it is not a number (e.g. +Description: When Result is outside the Limit of Quantification, i.e. it is not a number (e.g. <200), then PCSTRESC = "BLQ" or PCSTRESC = "ALQ" Executability: Fully Executable Outcome: - Message: - The value in PCORRES is not a number (so represents a value outside the Limit of + Message: The value in PCORRES is not a number (so represents a value outside the Limit of Quantification), in which case PCSTRESC must be either "BLQ" or "ALQ" Rule Type: Record Data Scope: diff --git a/Published/CORE-000454/rule.yml b/Published/CORE-000454/rule.yml index 19966d6a4..bab2e8519 100644 --- a/Published/CORE-000454/rule.yml +++ b/Published/CORE-000454/rule.yml @@ -96,8 +96,7 @@ Core: Id: CORE-000454 Status: Published Version: "1" -Description: - Raise an error when EX records are present for subject but RFXENDTC does not equal the +Description: Raise an error when EX records are present for subject but RFXENDTC does not equal the latest value of EX.EXENDTC Executability: Fully Executable Operations: @@ -118,8 +117,7 @@ Operations: name: EXENDTC operator: max_date Outcome: - Message: - RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC + Message: RFXSTDTC does not equal the latest value of EX.EXENDTC or the latest value of EX.EXSTDTC if EX.EXENDTC is not present or not populated. Output Variables: - RFXSTDTC diff --git a/Published/CORE-000455/rule.yml b/Published/CORE-000455/rule.yml index 45b6320a9..28967358e 100644 --- a/Published/CORE-000455/rule.yml +++ b/Published/CORE-000455/rule.yml @@ -88,8 +88,7 @@ Core: Id: CORE-000455 Status: Published Version: "1" -Description: - Raise an error when EX records are present for subject but RFXSTDTC does not equal the +Description: Raise an error when EX records are present for subject but RFXSTDTC does not equal the earliest value of EX.EXSTDTC Executability: Fully Executable Operations: diff --git a/Published/CORE-000458/rule.yml b/Published/CORE-000458/rule.yml index ee8c34d58..2c65d9286 100644 --- a/Published/CORE-000458/rule.yml +++ b/Published/CORE-000458/rule.yml @@ -123,8 +123,7 @@ Core: Id: CORE-000458 Status: Published Version: "1" -Description: - Sequence number given to ensure uniqueness of subject records within a domain. May be +Description: Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000460/rule.yml b/Published/CORE-000460/rule.yml index ae6561fe8..79e101381 100644 --- a/Published/CORE-000460/rule.yml +++ b/Published/CORE-000460/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.0 Item: Specification @@ -19,8 +18,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.1 Item: Specification @@ -34,8 +32,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.1.1 Item: Specification @@ -49,8 +46,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.1 Item: Specification @@ -64,8 +60,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.1.1 Item: Specification @@ -79,8 +74,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Trial Set Parameters that include dates are required to be presented + - Cited Guidance: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Document: IG v3.1.1 Item: Specification @@ -106,8 +100,7 @@ Core: Id: CORE-000460 Status: Published Version: "1" -Description: - Trial Set Parameters that include dates are required to be presented according to the +Description: Trial Set Parameters that include dates are required to be presented according to the international standard ISO 8601 Executability: Fully Executable Outcome: diff --git a/Published/CORE-000471/rule.yml b/Published/CORE-000471/rule.yml index 5a84ae8c9..4cffa9e61 100644 --- a/Published/CORE-000471/rule.yml +++ b/Published/CORE-000471/rule.yml @@ -86,9 +86,10 @@ Check: operator: equal_to_case_insensitive value: "MEASUREMENT" - name: EGEVAL - operator: non_empty - # report an error when EGORRESU is not null and EGEVAL is populated - # the idea is that evaluations do not have a unit + operator: + non_empty + # report an error when EGORRESU is not null and EGEVAL is populated + # the idea is that evaluations do not have a unit - all: - name: EGORRESU operator: non_empty diff --git a/Published/CORE-000472/rule.yml b/Published/CORE-000472/rule.yml index 0f3706739..d98dc78f9 100644 --- a/Published/CORE-000472/rule.yml +++ b/Published/CORE-000472/rule.yml @@ -86,8 +86,7 @@ Core: Id: CORE-000472 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular Body +Description: Raise an error when there is more than one record present for any particular Body Weight Gain test, in the BG Domain, for a subject on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where BGDTC is null diff --git a/Published/CORE-000474/rule.yml b/Published/CORE-000474/rule.yml index 869af77be..74e225b74 100644 --- a/Published/CORE-000474/rule.yml +++ b/Published/CORE-000474/rule.yml @@ -84,8 +84,7 @@ Core: Id: CORE-000474 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular ECG test +Description: Raise an error when there is more than one record present for any particular ECG test for a subject and measurement date/time. Executability: Partially Executable - Possible Underreporting Outcome: diff --git a/Published/CORE-000475/rule.yml b/Published/CORE-000475/rule.yml index 6dd4aa445..778c97bcf 100644 --- a/Published/CORE-000475/rule.yml +++ b/Published/CORE-000475/rule.yml @@ -101,13 +101,11 @@ Core: Id: CORE-000475 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular +Description: Raise an error when there is more than one record present for any particular Pharmacokinetics Concentration, in the PC Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: - Message: - The Pharmacokinetics Concentration test is not unique for this subject or pool and + Message: The Pharmacokinetics Concentration test is not unique for this subject or pool and specimen and date/time. Output Variables: - USUBJID diff --git a/Published/CORE-000476/rule.yml b/Published/CORE-000476/rule.yml index f95b18f12..8405c51ab 100644 --- a/Published/CORE-000476/rule.yml +++ b/Published/CORE-000476/rule.yml @@ -41,8 +41,7 @@ Core: Id: CORE-000476 Status: Published Version: "1" -Description: - When a domain belongs to the Findings General Observation Class, and the domain is one +Description: When a domain belongs to the Findings General Observation Class, and the domain is one in which data are usually collected at multiple study days, at least --DTC or --DY must be populated. Executability: Fully Executable diff --git a/Published/CORE-000477/rule.yml b/Published/CORE-000477/rule.yml index 36847e26d..8ec67d752 100644 --- a/Published/CORE-000477/rule.yml +++ b/Published/CORE-000477/rule.yml @@ -55,8 +55,7 @@ Core: Id: CORE-000477 Status: Published Version: "1" -Description: - When a domain belongs to the Findings General Observation Class, and the domain is one +Description: When a domain belongs to the Findings General Observation Class, and the domain is one in which data are usually collected at multiple study days, at least --DTC or --DY must be populated. Executability: Fully Executable diff --git a/Published/CORE-000480/rule.yml b/Published/CORE-000480/rule.yml index 4f0131b49..caa361754 100644 --- a/Published/CORE-000480/rule.yml +++ b/Published/CORE-000480/rule.yml @@ -84,8 +84,7 @@ Core: Id: CORE-000480 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular Vital +Description: Raise an error when there is more than one record present for any particular Vital Signs test for a subject and measurement date/time. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000486/rule.yml b/Published/CORE-000486/rule.yml index 01d09a749..07446adb8 100644 --- a/Published/CORE-000486/rule.yml +++ b/Published/CORE-000486/rule.yml @@ -83,8 +83,7 @@ Core: Id: CORE-000486 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular Subject +Description: Raise an error when there is more than one record present for any particular Subject Characteristics test for a subject. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000490/rule.yml b/Published/CORE-000490/rule.yml index 098ed6c53..ffc277d1f 100644 --- a/Published/CORE-000490/rule.yml +++ b/Published/CORE-000490/rule.yml @@ -122,8 +122,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - When extending a controlled terminology list, the case-sensitivity + - Cited Guidance: When extending a controlled terminology list, the case-sensitivity convention of that list should be followed. Document: TIG v1.0 Item: QNAM CDISC Notes diff --git a/Published/CORE-000493/rule.yml b/Published/CORE-000493/rule.yml index 485fabe28..57ae0bce0 100644 --- a/Published/CORE-000493/rule.yml +++ b/Published/CORE-000493/rule.yml @@ -149,8 +149,7 @@ Core: Id: CORE-000493 Status: Published Version: "1" -Description: - Age Range (AGETXT) should be populated with a number-number format when age range is +Description: Age Range (AGETXT) should be populated with a number-number format when age range is supplied. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000494/rule.yml b/Published/CORE-000494/rule.yml index 257d2c941..2deac5191 100644 --- a/Published/CORE-000494/rule.yml +++ b/Published/CORE-000494/rule.yml @@ -119,13 +119,11 @@ Core: Id: CORE-000494 Status: Published Version: "1" -Description: - Raise an error when the role provided in the define.xml does not correspond to the role +Description: Raise an error when the role provided in the define.xml does not correspond to the role in the IG Executability: Fully Executable Outcome: - Message: - The Role of the variable in the define.xml does not correspond to the Role given by the + Message: The Role of the variable in the define.xml does not correspond to the Role given by the Implementation Guide Output Variables: - define_variable_label diff --git a/Published/CORE-000495/rule.yml b/Published/CORE-000495/rule.yml index 9d543053c..ef5bee373 100644 --- a/Published/CORE-000495/rule.yml +++ b/Published/CORE-000495/rule.yml @@ -105,8 +105,7 @@ Core: Id: CORE-000495 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular +Description: Raise an error when there is more than one record present for any particular Macroscopic Finding test and result in the MA Domain, within a subject. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000498/rule.yml b/Published/CORE-000498/rule.yml index 54075af29..3b08cb0b4 100644 --- a/Published/CORE-000498/rule.yml +++ b/Published/CORE-000498/rule.yml @@ -110,8 +110,7 @@ Core: Id: CORE-000498 Status: Published Version: "1" -Description: - AGETXT is used to present the age range in situations where the exact birthdate is not +Description: AGETXT is used to present the age range in situations where the exact birthdate is not known. If AGETXT is included both BRTHDTC and AGE should not be populated. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000499/rule.yml b/Published/CORE-000499/rule.yml index 43ba227f9..9b8d2c89b 100644 --- a/Published/CORE-000499/rule.yml +++ b/Published/CORE-000499/rule.yml @@ -100,8 +100,7 @@ Core: Id: CORE-000499 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present per subject for any +Description: Raise an error when there is more than one record present per subject for any particular Organ Measurement test in the OM Domain Executability: Fully Executable Outcome: diff --git a/Published/CORE-000502/rule.yml b/Published/CORE-000502/rule.yml index 437657a93..212266c80 100644 --- a/Published/CORE-000502/rule.yml +++ b/Published/CORE-000502/rule.yml @@ -88,8 +88,7 @@ Core: Id: CORE-000502 Status: Published Version: "1" -Description: - Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a +Description: Raise an error when RDOMAIN is populated but the referenced RDOMAIN doesn't exist as a dataset in the present study Executability: Fully Executable Operations: diff --git a/Published/CORE-000503/rule.yml b/Published/CORE-000503/rule.yml index d22c6dc89..273cbb848 100644 --- a/Published/CORE-000503/rule.yml +++ b/Published/CORE-000503/rule.yml @@ -140,13 +140,11 @@ Core: Id: CORE-000503 Status: Published Version: "1" -Description: - QORIG is used to indicate the origin of the data. Possible values are COLLECTED, +Description: QORIG is used to indicate the origin of the data. Possible values are COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. Executability: Fully Executable Outcome: - Message: - When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER, + Message: When populated, the possible values for QORIG are limited to COLLECTED, DERIVED, OTHER, and NOT AVAILABLE. Rule Type: Record Data Scope: diff --git a/Published/CORE-000505/rule.yml b/Published/CORE-000505/rule.yml index 075cf18c2..202a8232e 100644 --- a/Published/CORE-000505/rule.yml +++ b/Published/CORE-000505/rule.yml @@ -201,8 +201,7 @@ Core: Id: CORE-000505 Status: Published Version: "1" -Description: - Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601 +Description: Study Start Date (SSTDTC) value in the TS dataset should be populated in ISO 8601 format. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000508/rule.yml b/Published/CORE-000508/rule.yml index 8ccd85d44..f5892ae7d 100644 --- a/Published/CORE-000508/rule.yml +++ b/Published/CORE-000508/rule.yml @@ -87,8 +87,7 @@ Core: Id: CORE-000508 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular Palpable +Description: Raise an error when there is more than one record present for any particular Palpable Mass test per Palpable Mass test in the PM Domain, for a subject on a particular date. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000509/rule.yml b/Published/CORE-000509/rule.yml index 4f3246ccf..b94a78ad8 100644 --- a/Published/CORE-000509/rule.yml +++ b/Published/CORE-000509/rule.yml @@ -84,9 +84,10 @@ Check: value: 1 - name: $record_count_AGE operator: greater_than_or_equal_to - value: 1 - # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present - # Both counts are 0 + value: + 1 + # NO TSPARMCD=AGE and no TSPARMCD=AGETXT is present + # Both counts are 0 - all: - name: $record_count_AGETXT operator: equal_to @@ -99,8 +100,7 @@ Core: Id: CORE-000509 Status: Published Version: "1" -Description: - Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not +Description: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Executability: Fully Executable Operations: @@ -116,8 +116,7 @@ Operations: id: $record_count_AGETXT operator: record_count Outcome: - Message: - Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not + Message: Either a record with TSPARMCD of AGE or TSPARMCD of AGETXT should be present, but not both. Output Variables: #- TSPARMCD diff --git a/Published/CORE-000519/rule.yml b/Published/CORE-000519/rule.yml index 97b2f609c..f4ad07911 100644 --- a/Published/CORE-000519/rule.yml +++ b/Published/CORE-000519/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000519 Status: Published Version: "1" -Description: - Raise an error when the value of DOMAIN has a character other than A-Z as the first +Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first character Executability: Fully Executable Outcome: diff --git a/Published/CORE-000523/rule.yml b/Published/CORE-000523/rule.yml index 82a3651ed..641617f6c 100644 --- a/Published/CORE-000523/rule.yml +++ b/Published/CORE-000523/rule.yml @@ -94,13 +94,11 @@ Core: Id: CORE-000523 Status: Published Version: "1" -Description: - Raise an error when the value of DOMAIN has a character other than A-Z as the first +Description: Raise an error when the value of DOMAIN has a character other than A-Z as the first character or a character A-Z, 0-9 for the second character Executability: Fully Executable Outcome: - Message: - First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9 + Message: First two characters of DOMAIN value must be in the range A-Z for the first, and A-Z,0-9 for the second Output Variables: - DOMAIN diff --git a/Published/CORE-000526/rule.yml b/Published/CORE-000526/rule.yml index 9e136bd1e..90005b05d 100644 --- a/Published/CORE-000526/rule.yml +++ b/Published/CORE-000526/rule.yml @@ -110,8 +110,7 @@ Core: Id: CORE-000526 Status: Published Version: "1" -Description: - The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be +Description: The combination of POOLID or USUBJID, PPTESTCD, PPCAT, PPSPEC, and PPTPTREF must be unique. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000529/rule.yml b/Published/CORE-000529/rule.yml index 689ab274b..427c33728 100644 --- a/Published/CORE-000529/rule.yml +++ b/Published/CORE-000529/rule.yml @@ -444,8 +444,7 @@ Core: Id: CORE-000529 Status: Published Version: "1" -Description: - Raise an error when --DY is not calculated as per the study day algorithm as a non-zero +Description: Raise an error when --DY is not calculated as per the study day algorithm as a non-zero integer value when the date portion of --DTC is complete and the date portion of DM.RFSTDTC is a complete date AND --DY is not empty Executability: Fully Executable @@ -458,8 +457,7 @@ Operations: name: --DTC operator: dy # does dy op take into acct +1? Outcome: - Message: - --DY is not correctly calculated even though the date portion of --DTC is complete, the + Message: --DY is not correctly calculated even though the date portion of --DTC is complete, the date portion of RFSTDTC is complete, and --DY is not empty. Output Variables: - $val_dy diff --git a/Published/CORE-000535/rule.yml b/Published/CORE-000535/rule.yml index bb03e2958..fdad975f0 100644 --- a/Published/CORE-000535/rule.yml +++ b/Published/CORE-000535/rule.yml @@ -188,8 +188,7 @@ Core: Id: CORE-000535 Status: Published Version: "1" -Description: - Trigger error when the order of --SEQ is not chronological (based on --STDTC) within +Description: Trigger error when the order of --SEQ is not chronological (based on --STDTC) within USUBJID Executability: Fully Executable Outcome: diff --git a/Published/CORE-000538/rule.yml b/Published/CORE-000538/rule.yml index fdd4c1905..b97aae66c 100644 --- a/Published/CORE-000538/rule.yml +++ b/Published/CORE-000538/rule.yml @@ -80,8 +80,7 @@ Core: Id: CORE-000538 Status: Published Version: "1" -Description: - Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary +Description: Trigger error when RDOMAIN does not match characters 5 and 6 of the Supplementary dataset name Executability: Fully Executable Operations: diff --git a/Published/CORE-000539/rule.yml b/Published/CORE-000539/rule.yml index 5a0cdc91a..6f7766e49 100644 --- a/Published/CORE-000539/rule.yml +++ b/Published/CORE-000539/rule.yml @@ -95,8 +95,7 @@ Core: Id: CORE-000539 Status: Published Version: "1" -Description: - Raise an error when split domains (i.e three/four-letter domain name) do not have a +Description: Raise an error when split domains (i.e three/four-letter domain name) do not have a two-letter parent domain present in the study. Executability: Fully Executable Operations: diff --git a/Published/CORE-000540/rule.yml b/Published/CORE-000540/rule.yml index 0de944473..523992b47 100644 --- a/Published/CORE-000540/rule.yml +++ b/Published/CORE-000540/rule.yml @@ -92,8 +92,7 @@ Core: Id: CORE-000540 Status: Published Version: "1" -Description: - Raise an error when parent domain referenced in Findings About dataset name is not +Description: Raise an error when parent domain referenced in Findings About dataset name is not present in the study. Executability: Fully Executable Operations: diff --git a/Published/CORE-000541/rule.yml b/Published/CORE-000541/rule.yml index 01cfdd88c..0545c526b 100644 --- a/Published/CORE-000541/rule.yml +++ b/Published/CORE-000541/rule.yml @@ -84,13 +84,11 @@ Core: Id: "CORE-000541" Status: Published Version: "1" -Description: - Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters, +Description: Part B - Raise an error when IETESTCD > 8 chars or contains more than only letters, numbers and underscores, or starts with a number. Executability: Fully Executable Outcome: - Message: - IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts + Message: IETESTCD > 8 chars or contains more than only letters, numbers, underscores, or starts with a number. Output Variables: - IETESTCD diff --git a/Published/CORE-000542/rule.yml b/Published/CORE-000542/rule.yml index 077bf55c6..88390a5df 100644 --- a/Published/CORE-000542/rule.yml +++ b/Published/CORE-000542/rule.yml @@ -244,8 +244,7 @@ Core: Id: CORE-000542 Status: Published Version: "1" -Description: - Raise an error when --STRESC is populated with a numeric value, but --STRESN is not +Description: Raise an error when --STRESC is populated with a numeric value, but --STRESN is not populated, or --STRESN is not equal to --STRESC. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000545/rule.yml b/Published/CORE-000545/rule.yml index bb794dec0..4f1e0d51b 100644 --- a/Published/CORE-000545/rule.yml +++ b/Published/CORE-000545/rule.yml @@ -110,8 +110,7 @@ Core: Id: CORE-000545 Status: Published Version: "1" -Description: - Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal +Description: Trigger error when --SCAT is not null and --SCAT is equal to --DECOD or --SCAT is equal to --BODSYS Executability: Fully Executable Outcome: diff --git a/Published/CORE-000546/rule.yml b/Published/CORE-000546/rule.yml index 5816d5e1e..37e151727 100644 --- a/Published/CORE-000546/rule.yml +++ b/Published/CORE-000546/rule.yml @@ -109,8 +109,7 @@ Core: Id: CORE-000546 Status: Published Version: "1" -Description: - Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to +Description: Trigger error when --CAT is not null and --CAT is equal to --DECOD or --CAT is equal to --BODSYS Executability: Fully Executable Outcome: diff --git a/Published/CORE-000547/rule.yml b/Published/CORE-000547/rule.yml index da3904ef8..6d396765a 100644 --- a/Published/CORE-000547/rule.yml +++ b/Published/CORE-000547/rule.yml @@ -355,8 +355,7 @@ Core: Id: CORE-000547 Status: Published Version: "1" -Description: - Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must +Description: Values of variables RFSTDTC, RFENDTC, BRTHDTC, --STDTC, --ENDTC, --DTC, --RFTDTC must be correct ISO-8601 dates / datetimes Executability: Fully Executable Outcome: diff --git a/Published/CORE-000548/rule.yml b/Published/CORE-000548/rule.yml index 5e0b4bdff..6e950a7bc 100644 --- a/Published/CORE-000548/rule.yml +++ b/Published/CORE-000548/rule.yml @@ -158,8 +158,7 @@ Core: Id: CORE-000548 Status: Published Version: "1" -Description: - --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional +Description: --EVLINT, --ELTM, --DUR must be in ISO 8601 duration format, including the additional format that allows the representation of "negative" intervals of time. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000550/rule.yml b/Published/CORE-000550/rule.yml index 329217d55..b36314a86 100644 --- a/Published/CORE-000550/rule.yml +++ b/Published/CORE-000550/rule.yml @@ -11,8 +11,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Sponsors may not add any variables other than those described in the + - Cited Guidance: Sponsors may not add any variables other than those described in the preceding three bullets. . . . Standard variables must not be renamed or modified for novel usage. Document: IG v3.4 @@ -145,8 +144,7 @@ Operations: - id: $allowed_variables operator: get_model_column_order Outcome: - Message: - Variables not listed in the Model List of Allowed Variables for Observation Class should + Message: Variables not listed in the Model List of Allowed Variables for Observation Class should be in SUPPQUAL. Rule Type: Variable Metadata Check Scope: diff --git a/Published/CORE-000551/rule.yml b/Published/CORE-000551/rule.yml index 1380ac6f4..6dac6f880 100644 --- a/Published/CORE-000551/rule.yml +++ b/Published/CORE-000551/rule.yml @@ -5,8 +5,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per IDVAR, IDVARVAL, and QNAM value per subject per related domain, Tabulation. Document: IG v3.0 @@ -23,8 +22,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per supplemental qualifier per related parent domain record(s), Tabulation. Document: IG v3.1 @@ -41,8 +39,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per supplemental qualifier per related parent domain record(s), Tabulation. Document: IG v3.1.1 @@ -59,8 +56,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per supplemental qualifier per related parent domain record(s), Tabulation. Document: IG v3.1 @@ -77,8 +73,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per supplemental qualifier per related parent domain record(s), Tabulation. Document: IG v3.1.1 @@ -95,8 +90,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship + - Cited Guidance: supp--.xpt, Supplemental Qualifiers for (domain name) - Relationship Datasets. One record per supplemental qualifier per related parent domain record(s), Tabulation. Document: IG v3.1.1 @@ -150,13 +144,11 @@ Core: Id: CORE-000551 Status: Published Version: "1" -Description: - There may be only be one record in a SUPP-- dataset with the same QNAM value within +Description: There may be only be one record in a SUPP-- dataset with the same QNAM value within USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL. Executability: Fully Executable Outcome: - Message: - Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with + Message: Duplicate value of the combination of USUBJID or POOLID, RDOMAIN, IDVAR, IDVARVAL with QNAM Output Variables: - RDOMAIN diff --git a/Published/CORE-000555/rule.yml b/Published/CORE-000555/rule.yml index f04782401..01e567d17 100644 --- a/Published/CORE-000555/rule.yml +++ b/Published/CORE-000555/rule.yml @@ -91,13 +91,11 @@ Core: Id: CORE-000555 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present the combination of USUBJID +Description: Raise an error when there is more than one record present the combination of USUBJID and DDORRES or for the combination of USUBJID and DDSTRESC. Executability: Fully Executable Outcome: - Message: - There is more than one for the combination of USUBJID and DDORRES or the combination of + Message: There is more than one for the combination of USUBJID and DDORRES or the combination of USUBJID and DDSTRESC Output Variables: - USUBJID diff --git a/Published/CORE-000557/rule.yml b/Published/CORE-000557/rule.yml index 820efa8b5..107627abd 100644 --- a/Published/CORE-000557/rule.yml +++ b/Published/CORE-000557/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - RELTYPE; Identifies the hierarchical level of the records in the + - Cited Guidance: RELTYPE; Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY, only when --SPID is used. However, values are only necessary when identifying a relationship between datasets. Document: SENDIG v3.0 @@ -126,8 +125,9 @@ Check: value: ONE - name: RELTYPE operator: not_equal_to - value: MANY - # Case that the POOLID column is present + value: + MANY + # Case that the POOLID column is present - all: - name: USUBJID operator: empty @@ -150,8 +150,7 @@ Core: Description: When USUBJID, POOLID, and IDVARVAL are empty, RELTYPE can only be "ONE" or "MANY" Executability: Fully Executable Outcome: - Message: - For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are + Message: For RELTYPE, only "ONE" and "MANY" are allowed when USUBJID, POOLID, and IDVARVAL are null Rule Type: Record Data Scope: diff --git a/Published/CORE-000559/rule.yml b/Published/CORE-000559/rule.yml index 27e1bfaf9..6a538cbfa 100644 --- a/Published/CORE-000559/rule.yml +++ b/Published/CORE-000559/rule.yml @@ -109,8 +109,7 @@ Core: Id: CORE-000559 Status: Published Version: "1" -Description: - When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. diff --git a/Published/CORE-000561/rule.yml b/Published/CORE-000561/rule.yml index 4a9c9aa2c..f860ea678 100644 --- a/Published/CORE-000561/rule.yml +++ b/Published/CORE-000561/rule.yml @@ -89,7 +89,7 @@ Check: - USUBJID - TFSPEC - TFANTREG - # case that TFANTREG is not present + # case that TFANTREG is not present - all: - name: TFANTREG operator: not_exists @@ -103,8 +103,7 @@ Core: Id: CORE-000561 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular tumor test +Description: Raise an error when there is more than one record present for any particular tumor test result for a subject and specimen. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000567/rule.yml b/Published/CORE-000567/rule.yml index 4d10c82fe..adc680e42 100644 --- a/Published/CORE-000567/rule.yml +++ b/Published/CORE-000567/rule.yml @@ -98,8 +98,7 @@ Core: Id: CORE-000567 Status: Published Version: "1" -Description: - Trigger error when --STAT is non-empty and does not contain a value from the ND +Description: Trigger error when --STAT is non-empty and does not contain a value from the ND codelist Executability: Fully Executable Outcome: diff --git a/Published/CORE-000572/rule.yml b/Published/CORE-000572/rule.yml index f4175b019..d70a78f71 100644 --- a/Published/CORE-000572/rule.yml +++ b/Published/CORE-000572/rule.yml @@ -101,8 +101,7 @@ Core: Id: CORE-000572 Status: Published Version: "1" -Description: - Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', +Description: Trigger error when --ENRTPT is not in ('BEFORE', 'COINCIDENT', 'ONGOING', 'AFTER', 'UNKNOWN') Executability: Partially Executable Outcome: diff --git a/Published/CORE-000575/rule.yml b/Published/CORE-000575/rule.yml index 6d164bb37..dc0394f4b 100644 --- a/Published/CORE-000575/rule.yml +++ b/Published/CORE-000575/rule.yml @@ -208,8 +208,7 @@ Core: Id: CORE-000575 Status: Published Version: "1" -Description: - There must be at least one timing variable for any of the domains based on the three +Description: There must be at least one timing variable for any of the domains based on the three general observation classes Executability: Partially Executable - Possible Underreporting Operations: diff --git a/Published/CORE-000576/rule.yml b/Published/CORE-000576/rule.yml index 226e2d054..d878db550 100644 --- a/Published/CORE-000576/rule.yml +++ b/Published/CORE-000576/rule.yml @@ -127,13 +127,11 @@ Core: Id: CORE-000576 Status: Published Version: "1" -Description: - The value of TRTDOS is either a number, a semicolon-delimited string containing numbers +Description: The value of TRTDOS is either a number, a semicolon-delimited string containing numbers without spaces, or "SEE PROTOCOL" for more complex dosing regimens. Executability: Fully Executable Outcome: - Message: - The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string + Message: The value of TXVAL for TXPARMCD=TRTDOS is neither a number, a semicolon-delimited string containing numbers without spaces, or "SEE PROTOCOL" Rule Type: Record Data Scope: diff --git a/Published/CORE-000578/rule.yml b/Published/CORE-000578/rule.yml index af44be4bf..8057e2a49 100644 --- a/Published/CORE-000578/rule.yml +++ b/Published/CORE-000578/rule.yml @@ -66,13 +66,11 @@ Core: Id: CORE-000578 Status: Published Version: "1" -Description: - If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in +Description: If the test result in PCORRES is below the Lower Limit of Quantitation as indicated in PCSTRESC, then the PCLLOQ must be populated and the PCSTRESU populated with the appropriate unit Executability: Fully Executable Outcome: - Message: - PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must + Message: PCSTRESC has value 'BLQ' (Below level of quantitation), so both PCLLOQ and PCSTRESU must be populated Rule Type: Record Data Scope: diff --git a/Published/CORE-000583/rule.yml b/Published/CORE-000583/rule.yml index 8fb6d1cfb..69f515673 100644 --- a/Published/CORE-000583/rule.yml +++ b/Published/CORE-000583/rule.yml @@ -112,8 +112,7 @@ Core: Id: CORE-000583 Status: Published Version: "1" -Description: - Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and +Description: Either TSVAL or TSVALNF is populated, but not both. Trigger error when TSVAL and TSVALNF are populated, or when both variables are empty. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000584/rule.yml b/Published/CORE-000584/rule.yml index 6abc09c5f..5a8063f71 100644 --- a/Published/CORE-000584/rule.yml +++ b/Published/CORE-000584/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.0 Item: Domain Table Header @@ -19,8 +18,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.1 Item: Domain Table Header @@ -34,8 +32,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.1.1 Item: Domain Table Header @@ -49,8 +46,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.1 Item: Domain Table Header @@ -64,8 +60,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.1.1 Item: Domain Table Header @@ -79,8 +74,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - lb.xpt, Laboratory - Findings. One record per test per specimen per + - Cited Guidance: lb.xpt, Laboratory - Findings. One record per test per specimen per observation time per subject or pool, Tabulation. Document: SENDIG v3.1.1 Item: Domain Table Header @@ -135,8 +129,7 @@ Core: Id: CORE-000584 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present per test per specimen, in the +Description: Raise an error when there is more than one record present per test per specimen, in the LB Domain, for a subject or pool on a particular date. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000590/rule.yml b/Published/CORE-000590/rule.yml index 9f56031a3..b3910a056 100644 --- a/Published/CORE-000590/rule.yml +++ b/Published/CORE-000590/rule.yml @@ -30,8 +30,7 @@ Core: Id: CORE-000590 Status: Published Version: "1" -Description: - Raise an error when the study is a study of tobacco product(s) but the TO dataset is +Description: Raise an error when the study is a study of tobacco product(s) but the TO dataset is not present. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000591/rule.yml b/Published/CORE-000591/rule.yml index 9faf5f3af..01c065c3e 100644 --- a/Published/CORE-000591/rule.yml +++ b/Published/CORE-000591/rule.yml @@ -28,8 +28,7 @@ Core: Id: CORE-000591 Status: Published Version: "1" -Description: - Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals +Description: Raise an error when there is no record present in TO per SPTOBID where TOPARMCD equals TBPRDCAT. Executability: Fully Executable Operations: diff --git a/Published/CORE-000595/rule.yml b/Published/CORE-000595/rule.yml index 7b1970976..ed91c03a1 100644 --- a/Published/CORE-000595/rule.yml +++ b/Published/CORE-000595/rule.yml @@ -67,8 +67,7 @@ Core: Description: Raise an error when UNII and CASNO are both not populated. Executability: Fully Executable Outcome: - Message: - At least one of the UNII and CASNO variables should be present and populated for each + Message: At least one of the UNII and CASNO variables should be present and populated for each ingredient if available. Output Variables: - UNII diff --git a/Published/CORE-000596/rule.yml b/Published/CORE-000596/rule.yml index 188a49f77..3c2c863af 100644 --- a/Published/CORE-000596/rule.yml +++ b/Published/CORE-000596/rule.yml @@ -39,8 +39,7 @@ Core: Description: Raise an error when INGRADE, INPURITY and TPMF are all not populated. Executability: Fully Executable Outcome: - Message: - At least one of INGRADE or INPURITY should be populated. If neither is available due to + Message: At least one of INGRADE or INPURITY should be populated. If neither is available due to the ingredient being proprietary and originating from a third-party supplier, populate TPMF with the Tobacco Product Master File number provided by the supplier. Output Variables: diff --git a/Published/CORE-000599/rule.yml b/Published/CORE-000599/rule.yml index bf03b778f..7e87e2d68 100644 --- a/Published/CORE-000599/rule.yml +++ b/Published/CORE-000599/rule.yml @@ -86,8 +86,7 @@ Core: Id: CORE-000599 Status: Published Version: "1" -Description: - If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT +Description: If no test article (as described in EXTRT) is administered (i.e., EXDOSE is 0), EXLOT is null. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000600/rule.yml b/Published/CORE-000600/rule.yml index 2022b0609..c8108d8ea 100644 --- a/Published/CORE-000600/rule.yml +++ b/Published/CORE-000600/rule.yml @@ -38,8 +38,7 @@ Core: Id: CORE-000600 Status: Published Version: "1" -Description: - Raise an error when a record has a PARENT value but no other record exists with REFID +Description: Raise an error when a record has a PARENT value but no other record exists with REFID value = PARENT value. Executability: Fully Executable Operations: diff --git a/Published/CORE-000601/rule.yml b/Published/CORE-000601/rule.yml index b9dcad422..a5cfc159c 100644 --- a/Published/CORE-000601/rule.yml +++ b/Published/CORE-000601/rule.yml @@ -36,8 +36,7 @@ Core: Id: CORE-000601 Status: Published Version: "1" -Description: - Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value +Description: Raise an error when per SPTOBID, the IQPARENT value does not match any IGDCMPID value of another record. Executability: Fully Executable Operations: @@ -48,8 +47,7 @@ Operations: name: IGDCMPID operator: distinct Outcome: - Message: - IQPARENT value does not match an ingredient represented in another records IGDCMPID + Message: IQPARENT value does not match an ingredient represented in another records IGDCMPID value. Output Variables: - SPTOBID diff --git a/Published/CORE-000602/rule.yml b/Published/CORE-000602/rule.yml index e2e0a3acd..f827d87da 100644 --- a/Published/CORE-000602/rule.yml +++ b/Published/CORE-000602/rule.yml @@ -31,8 +31,7 @@ Core: Id: CORE-000602 Status: Published Version: "1" -Description: - Raise an error when a record does not have associated PARENT records but the value for +Description: Raise an error when a record does not have associated PARENT records but the value for LEVEL does not equal '1'. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000604/rule.yml b/Published/CORE-000604/rule.yml index 3b465e91a..41740651b 100644 --- a/Published/CORE-000604/rule.yml +++ b/Published/CORE-000604/rule.yml @@ -38,8 +38,7 @@ Core: Id: CORE-000604 Status: Published Version: "1" -Description: - Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and +Description: Raise an error when a TOPARMCD in the TO dataset categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR does not have a matching PDPARMCD in the PD dataset. Executability: Fully Executable Operations: @@ -50,8 +49,7 @@ Operations: name: PDPARMCD operator: distinct Outcome: - Message: - TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but + Message: TOPARMCD in TO is categorized as TOCAT = NEW PRODUCT and TOSCAT = PRODUCT DESCRIPTOR but does not have a matching PDPARMCD per SPTOBID in PD. Output Variables: - SPTOBID diff --git a/Published/CORE-000605/rule.yml b/Published/CORE-000605/rule.yml index 112b268dd..0e674fa08 100644 --- a/Published/CORE-000605/rule.yml +++ b/Published/CORE-000605/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: "TIG" References: - Citations: - - Cited Guidance: - When quantifying ingredients in IQ, every ingredient (every value of + - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IT) must be accounted for in IQ (see IQ domain specification and assumptions for more information). Document: "TIG 1.0" @@ -26,8 +25,7 @@ Authorities: - Name: "TIG" References: - Citations: - - Cited Guidance: - When quantifying ingredients in IQ, every ingredient (every value of + - Cited Guidance: When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IN) must be accounted for in IQ (see IQ domain specification and assumptions for more information). Document: "TIG 1.0" @@ -50,8 +48,7 @@ Core: Id: CORE-000605 Status: Published Version: "1" -Description: - Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the +Description: Raise an error when a IGDCMPID in the dataset does not have a matching IGDCMPID in the IQ dataset per SPTOBID. Executability: Fully Executable Operations: diff --git a/Published/CORE-000606/rule.yml b/Published/CORE-000606/rule.yml index 381ecb59b..455286585 100644 --- a/Published/CORE-000606/rule.yml +++ b/Published/CORE-000606/rule.yml @@ -35,8 +35,7 @@ Core: Id: CORE-000606 Status: Published Version: "1" -Description: - Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT = +Description: Raise an error when IGDCMPID for a tobacco ingredient in the IQ dataset (IQCAT = TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IT dataset Executability: Fully Executable Operations: @@ -47,8 +46,7 @@ Operations: name: IGDCMPID operator: distinct Outcome: - Message: - IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching + Message: IGDCMPID in IQ categorized as IQCAT = TOBACCO INGREDIENT does not have a matching IGDCMPID per SPTOBID in IT. Output Variables: - SPTOBID diff --git a/Published/CORE-000607/rule.yml b/Published/CORE-000607/rule.yml index 37f9b941c..5a685b63d 100644 --- a/Published/CORE-000607/rule.yml +++ b/Published/CORE-000607/rule.yml @@ -28,8 +28,7 @@ Core: Id: CORE-000607 Status: Published Version: "1" -Description: - Raise an error when value for STOCONID in the PT dataset does not match a STOCONID +Description: Raise an error when value for STOCONID in the PT dataset does not match a STOCONID specified in the ES dataset. Executability: Fully Executable Operations: diff --git a/Published/CORE-000608/rule.yml b/Published/CORE-000608/rule.yml index e1739143f..aa47e7a5a 100644 --- a/Published/CORE-000608/rule.yml +++ b/Published/CORE-000608/rule.yml @@ -78,13 +78,11 @@ Core: Id: CORE-000608 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular +Description: Raise an error when there is more than one record present for any particular respiratory test for a subject and measurement date/time or evaluation interval. Executability: Fully Executable Outcome: - Message: - The respiratory test is not unique for this subject and measurement datetime and/or + Message: The respiratory test is not unique for this subject and measurement datetime and/or evaluation interval. Output Variables: - USUBJID diff --git a/Published/CORE-000610/rule.yml b/Published/CORE-000610/rule.yml index 4057cbadf..5887eeebb 100644 --- a/Published/CORE-000610/rule.yml +++ b/Published/CORE-000610/rule.yml @@ -27,8 +27,7 @@ Core: Id: CORE-000610 Status: Published Version: "1" -Description: - Raise an error when a REFID value in the GT dataset does not exist in the RELREF +Description: Raise an error when a REFID value in the GT dataset does not exist in the RELREF dataset. Executability: Fully Executable Operations: diff --git a/Published/CORE-000611/rule.yml b/Published/CORE-000611/rule.yml index 8a993c90b..366b183f1 100644 --- a/Published/CORE-000611/rule.yml +++ b/Published/CORE-000611/rule.yml @@ -27,8 +27,7 @@ Core: Id: CORE-000611 Status: Published Version: "1" -Description: - Raise an error when a REFID value in the RELREF dataset does not exist in the GT +Description: Raise an error when a REFID value in the RELREF dataset does not exist in the GT dataset. Executability: Fully Executable Operations: diff --git a/Published/CORE-000612/rule.yml b/Published/CORE-000612/rule.yml index 91f9e1d5a..ec356ff29 100644 --- a/Published/CORE-000612/rule.yml +++ b/Published/CORE-000612/rule.yml @@ -151,8 +151,7 @@ Core: Id: CORE-000612 Status: Published Version: "1" -Description: - Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug +Description: Standardized units (--STRESU) should be consistent per test (--TESTCD) for a given drug or metabolite across pharmacokinetic datasets within a submission. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000618/rule.yml b/Published/CORE-000618/rule.yml index 62285be30..ad9212214 100644 --- a/Published/CORE-000618/rule.yml +++ b/Published/CORE-000618/rule.yml @@ -109,8 +109,9 @@ Check: value: "BENIGN" - name: "MIRESCAT" operator: not_equal_to - value: "BENIGN" - # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN + value: + "BENIGN" + # Christy Kubin: METASTATIC is allowed for MALIGNANT but not for BENIGN - all: - name: "MISTRESC" operator: contains diff --git a/Published/CORE-000619/rule.yml b/Published/CORE-000619/rule.yml index a7f4f6fe6..99207066e 100644 --- a/Published/CORE-000619/rule.yml +++ b/Published/CORE-000619/rule.yml @@ -85,8 +85,7 @@ Core: Id: CORE-000619 Status: Published Version: "1" -Description: - Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a +Description: Value for Age Range (TXVAL when TXPARMCD = 'AGETXT') should be populated with a number-number format when age range is supplied. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000620/rule.yml b/Published/CORE-000620/rule.yml index 17cc63b5b..2b6cf76de 100644 --- a/Published/CORE-000620/rule.yml +++ b/Published/CORE-000620/rule.yml @@ -52,8 +52,9 @@ Authorities: Id: SEND113.1 Version: "1" Version: "5.0" - Version: "1.1" - # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here + Version: + "1.1" + # 2025-01-05: As identical to FDA business rule FB4901, FDA has been added here - Organization: FDA Standards: - Name: SENDIG diff --git a/Published/CORE-000660/rule.yml b/Published/CORE-000660/rule.yml index 420090108..9d4ec9259 100644 --- a/Published/CORE-000660/rule.yml +++ b/Published/CORE-000660/rule.yml @@ -31,8 +31,7 @@ Core: Id: CORE-000660 Status: Published Version: "1" -Description: - Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to +Description: Part A - Raise an error when the value of SPTOBID in the dataset does not correspond to a SPTOBID value present in TO. Executability: Fully Executable Operations: diff --git a/Published/CORE-000672/rule.yml b/Published/CORE-000672/rule.yml index 41e3e90ee..1ce232d5d 100644 --- a/Published/CORE-000672/rule.yml +++ b/Published/CORE-000672/rule.yml @@ -154,8 +154,7 @@ Core: Id: CORE-000672 Status: Published Version: "1" -Description: - Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal +Description: Normal Range Upper Limit-Standard Units (--STNRHI) should be greater than the Normal Range Lower Limit-Standard Units (--STNRLO). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000673/rule.yml b/Published/CORE-000673/rule.yml index 524e79d3e..08c46cdfa 100644 --- a/Published/CORE-000673/rule.yml +++ b/Published/CORE-000673/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000673 Status: Published Version: "1" -Description: - Part A - Raise an error when --VALTRG is a number and is less than the specified +Description: Part A - Raise an error when --VALTRG is a number and is less than the specified --VALMIN value. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000674/rule.yml b/Published/CORE-000674/rule.yml index f2948b0b2..2a70a2042 100644 --- a/Published/CORE-000674/rule.yml +++ b/Published/CORE-000674/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000674 Status: Published Version: "1" -Description: - Part B - Raise an error when --VALTRG is a number and is greater than the specified +Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified --VALMAX value. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000675/rule.yml b/Published/CORE-000675/rule.yml index bd9af453f..e764c947b 100644 --- a/Published/CORE-000675/rule.yml +++ b/Published/CORE-000675/rule.yml @@ -149,8 +149,7 @@ Core: Id: CORE-000675 Status: Published Version: "1" -Description: - When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and +Description: When a test is not done (--STAT = 'NOT DONE'), the result variables (--ORRES and --STRESC) should not be populated. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000676/rule.yml b/Published/CORE-000676/rule.yml index ce7c68d1f..8e2adb17a 100644 --- a/Published/CORE-000676/rule.yml +++ b/Published/CORE-000676/rule.yml @@ -35,8 +35,7 @@ Core: Id: CORE-000676 Status: Published Version: "1" -Description: - Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX +Description: Part B - Raise an error when the value of TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID value present in TO. Executability: Fully Executable Operations: @@ -45,8 +44,7 @@ Operations: name: SPTOBID operator: distinct Outcome: - Message: - Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID + Message: Value in TXVAL for TXPARMCD = SPTOBID in the TX dataset does not correspond to a SPTOBID value in TO. Output Variables: - TXVAL diff --git a/Published/CORE-000678/rule.yml b/Published/CORE-000678/rule.yml index 2cc6dc7f1..a6bc94625 100644 --- a/Published/CORE-000678/rule.yml +++ b/Published/CORE-000678/rule.yml @@ -118,8 +118,7 @@ Core: Id: CORE-000678 Status: Published Version: "1" -Description: - Part B - Raise error when value for POOLID in the dataset is not a POOLID value in +Description: Part B - Raise error when value for POOLID in the dataset is not a POOLID value in POOLDEF. Executability: Fully Executable Operations: diff --git a/Published/CORE-000698/rule.yml b/Published/CORE-000698/rule.yml index a4d7410c6..b266af95e 100644 --- a/Published/CORE-000698/rule.yml +++ b/Published/CORE-000698/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000698 Status: Published Version: "1" -Description: - Part A - Raise an error when --VALTRG is a number and is less than the specified +Description: Part A - Raise an error when --VALTRG is a number and is less than the specified --VALMIN value. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000699/rule.yml b/Published/CORE-000699/rule.yml index 0a9585dff..ec2d13c2b 100644 --- a/Published/CORE-000699/rule.yml +++ b/Published/CORE-000699/rule.yml @@ -156,13 +156,11 @@ Core: Id: CORE-000699 Status: Published Version: "1" -Description: - Standard units should be consistent within the same assessment (having the same +Description: Standard units should be consistent within the same assessment (having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values) Executability: Fully Executable Outcome: - Message: - Standards units are inconsistent within the same test (category, sub-category, specimen + Message: Standards units are inconsistent within the same test (category, sub-category, specimen and method) Output Variables: - --STRESU diff --git a/Published/CORE-000700/rule.yml b/Published/CORE-000700/rule.yml index 045c7ea3e..88e919f63 100644 --- a/Published/CORE-000700/rule.yml +++ b/Published/CORE-000700/rule.yml @@ -151,8 +151,7 @@ Core: Id: CORE-000700 Status: Published Version: "1" -Description: - When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the +Description: When Study Day of Visit/Collection/Exam (--DY) is present in the dataset, then the Date/Time of Collection (--DTC) should also be present in the dataset Executability: Fully Executable Outcome: diff --git a/Published/CORE-000704/rule.yml b/Published/CORE-000704/rule.yml index a97d2fecd..dc4a5d274 100644 --- a/Published/CORE-000704/rule.yml +++ b/Published/CORE-000704/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000704 Status: Published Version: "1" -Description: - Part B - Raise an error when --VALTRG is a number and is greater than the specified +Description: Part B - Raise an error when --VALTRG is a number and is greater than the specified --VALMAX value. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000707/rule.yml b/Published/CORE-000707/rule.yml index 50081628b..cb1d5e44e 100644 --- a/Published/CORE-000707/rule.yml +++ b/Published/CORE-000707/rule.yml @@ -161,8 +161,7 @@ Core: Id: CORE-000707 Status: Published Version: "1" -Description: - Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of +Description: Study Day of Visit/Collection/Exam (--DY) should be less than or equal to Study Day of End of Observation (--ENDY). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000708/rule.yml b/Published/CORE-000708/rule.yml index 2b4d1074c..b8a3eefa3 100644 --- a/Published/CORE-000708/rule.yml +++ b/Published/CORE-000708/rule.yml @@ -157,8 +157,7 @@ Core: Id: CORE-000708 Status: Published Version: "1" -Description: - When Study Day of End of Observation (--ENDY) is present in the dataset, then the End +Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End Date/Time of Observation (--ENDTC) should also be present in the dataset. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000710/rule.yml b/Published/CORE-000710/rule.yml index 840c6d449..e5e3a6359 100644 --- a/Published/CORE-000710/rule.yml +++ b/Published/CORE-000710/rule.yml @@ -99,8 +99,7 @@ Core: Status: Published Version: "1" -Description: - Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and +Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'AFTER', 'UNKNOWN') and --STTPT is prior to the date of collection or assessment. Executability: Partially Executable Outcome: diff --git a/Published/CORE-000711/rule.yml b/Published/CORE-000711/rule.yml index f92bb1d36..949d258ae 100644 --- a/Published/CORE-000711/rule.yml +++ b/Published/CORE-000711/rule.yml @@ -137,8 +137,7 @@ Core: Id: CORE-000711 Status: Published Version: "1" -Description: - Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject +Description: Subject Reference Start Date/Time (RFSTDTC) should be prior or equal to the Subject Reference End Date/Time (RFENDTC). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000712/rule.yml b/Published/CORE-000712/rule.yml index 6a120c303..5c6ec3bc1 100644 --- a/Published/CORE-000712/rule.yml +++ b/Published/CORE-000712/rule.yml @@ -100,8 +100,7 @@ Core: Id: CORE-000712 Status: Published Version: "1" -Description: - Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable +Description: Part A - Raise and error when IDVAR in SUPP-- is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: @@ -118,8 +117,7 @@ Operations: operator: distinct value_is_reference: true Outcome: - Message: - Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced + Message: Value for IDVAR in SUPP-- does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - IDVAR diff --git a/Published/CORE-000714/rule.yml b/Published/CORE-000714/rule.yml index d2592e777..3710f7420 100644 --- a/Published/CORE-000714/rule.yml +++ b/Published/CORE-000714/rule.yml @@ -125,8 +125,7 @@ Core: Id: CORE-000714 Status: Published Version: "1" -Description: - Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal +Description: Date/Time of First Study Treatment (RFXSTDTC) variable value should be prior or equal to the Date/Time of Last Study Treatment (RFXENDTC). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000718/rule.yml b/Published/CORE-000718/rule.yml index 066205567..57ce3c190 100644 --- a/Published/CORE-000718/rule.yml +++ b/Published/CORE-000718/rule.yml @@ -157,8 +157,7 @@ Core: Id: CORE-000718 Status: Published Version: "1" -Description: - Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time +Description: Start Date/Time of Observation (--STDTC) should be prior or equal to the End Date/Time of Observation (--ENDTC). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000721/rule.yml b/Published/CORE-000721/rule.yml index dbbb32446..3ca64d061 100644 --- a/Published/CORE-000721/rule.yml +++ b/Published/CORE-000721/rule.yml @@ -31,13 +31,11 @@ Core: Id: "CORE-000721" Status: Published Version: "1" -Description: - Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product +Description: Raise an error when ARM is 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure', or 'Not Exposed to Product' Executability: Fully Executable Outcome: - Message: - ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or + Message: ARM cannot be equal to 'Screen Failure', 'Not Assigned', 'Unplanned Product Exposure' or 'Not Exposed to Product'. Rule Type: Record Data Scope: diff --git a/Published/CORE-000722/rule.yml b/Published/CORE-000722/rule.yml index 18491896b..e51b54ca6 100644 --- a/Published/CORE-000722/rule.yml +++ b/Published/CORE-000722/rule.yml @@ -97,8 +97,7 @@ Core: Id: CORE-000722 Status: Published Version: "1" -Description: - If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN +Description: If the PCORRES result is less than the Lower Limit of Quantification, then PCSTRESN should be null and not populated with the value of zero (0). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000727/rule.yml b/Published/CORE-000727/rule.yml index cd2cfb644..34630e37c 100644 --- a/Published/CORE-000727/rule.yml +++ b/Published/CORE-000727/rule.yml @@ -35,8 +35,7 @@ Core: Id: CORE-000727 Status: Published Version: "1" -Description: - Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT = +Description: Raise an error when IGDCMPID for a non-tobacco ingredient in the IQ dataset (IQCAT = NON-TOBACCO INGREDIENT) does not have a matching IGDCMPID per SPTOBID in the IN dataset. Executability: Fully Executable Operations: @@ -47,8 +46,7 @@ Operations: name: IGDCMPID operator: distinct Outcome: - Message: - IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching + Message: IGDCMPID in IQ categorized as IQCAT = NON-TOBACCO INGREDIENT does not have a matching IGDCMPID per SPTOBID in IN. Output Variables: - SPTOBID diff --git a/Published/CORE-000744/rule.yml b/Published/CORE-000744/rule.yml index 792a4464b..3f641fd3e 100644 --- a/Published/CORE-000744/rule.yml +++ b/Published/CORE-000744/rule.yml @@ -52,8 +52,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - A record in FA may or may not have a parent record in an events or + - Cited Guidance: A record in FA may or may not have a parent record in an events or interventions domain. If an FA record does have a parent record, the value in FAOBJ should match the value in --TERM or --TRT, unless the parent domain is dictionary coded or subject to controlled terminology. In such cases, the value represented in FAOBJ will @@ -82,15 +81,13 @@ Core: Id: CORE-000744 Status: Published Version: "1" -Description: - Raise an error when a related record is present in the parent domain dataset but FAOBJ +Description: Raise an error when a related record is present in the parent domain dataset but FAOBJ is not equal to the --TERM, --TRT or --DECOD of the parent domain. Executability: Fully Executable Match Datasets: - Name: RELREC Outcome: - Message: - Related record is present in the parent domain dataset but FAOBJ is not equal to the + Message: Related record is present in the parent domain dataset but FAOBJ is not equal to the "TERM", "TRT" or "DECOD" of the parent domain. Output Variables: - FAOBJ diff --git a/Published/CORE-000750/rule.yml b/Published/CORE-000750/rule.yml index 5caf10407..32e247ce3 100644 --- a/Published/CORE-000750/rule.yml +++ b/Published/CORE-000750/rule.yml @@ -47,14 +47,12 @@ Core: Id: "CORE-000750" Status: Published Version: "1" -Description: - Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per +Description: Part A - Excluding TS.TSSEQ, raise an error when --SEQ is not a unique number per USUBJID per domain, or not a unique number per POOLID per domain, including when the domain is split into multiple files. Executability: Fully Executable Outcome: - Message: - --SEQ is not a unique number per one of the following identifier variables, per domain; + Message: --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID or POOLID. Rule Type: Record Data Scope: diff --git a/Published/CORE-000751/rule.yml b/Published/CORE-000751/rule.yml index 0ee460567..db0801fc4 100644 --- a/Published/CORE-000751/rule.yml +++ b/Published/CORE-000751/rule.yml @@ -54,13 +54,11 @@ Core: Id: CORE-000751 Status: Published Version: "1" -Description: - Part B - Raise an error when --SEQ is not a unique number per one of the following +Description: Part B - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID. Executability: Fully Executable Outcome: - Message: - --SEQ is not a unique number per one of the following identifier variables, per domain; + Message: --SEQ is not a unique number per one of the following identifier variables, per domain; USUBJID, POOLID or SPDEVID. Output Variables: - SPDEVID diff --git a/Published/CORE-000752/rule.yml b/Published/CORE-000752/rule.yml index 5319c1a2b..0819ecd1c 100644 --- a/Published/CORE-000752/rule.yml +++ b/Published/CORE-000752/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000752 Status: Published Version: "1" -Description: - Part C - Raise an error when --SEQ is not a unique number per one of the following +Description: Part C - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000753/rule.yml b/Published/CORE-000753/rule.yml index 490038516..7e13e2fb7 100644 --- a/Published/CORE-000753/rule.yml +++ b/Published/CORE-000753/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000753 Status: Published Version: "1" -Description: - Part D - Raise an error when --SEQ is not a unique number per one of the following +Description: Part D - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000754/rule.yml b/Published/CORE-000754/rule.yml index b15d09238..449a71f6c 100644 --- a/Published/CORE-000754/rule.yml +++ b/Published/CORE-000754/rule.yml @@ -33,8 +33,7 @@ Core: Id: CORE-000754 Status: Published Version: "1" -Description: - Part E - Raise an error when --SEQ is not a unique number per one of the following +Description: Part E - Raise an error when --SEQ is not a unique number per one of the following identifier variables, per domain; SPTOBID. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000755/rule.yml b/Published/CORE-000755/rule.yml index e627ca396..32ddc93d0 100644 --- a/Published/CORE-000755/rule.yml +++ b/Published/CORE-000755/rule.yml @@ -13,8 +13,7 @@ Authorities: the following subject identifiers - SUBJID, SPDEVID, or POOLID. Document: SDTM v2.1 Section: Section 3.1.4 Identifiers For All Classes - - Cited Guidance: - The Associated Persons Identifier (APID) will be required in all AP + - Cited Guidance: The Associated Persons Identifier (APID) will be required in all AP datasets, and will identify records as AP data. Document: SDTM v2.1 Section: Section 4.0 Associated Persons Data diff --git a/Published/CORE-000756/rule.yml b/Published/CORE-000756/rule.yml index 559025028..6cfbd4ddd 100644 --- a/Published/CORE-000756/rule.yml +++ b/Published/CORE-000756/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -21,8 +20,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -38,8 +36,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -55,8 +52,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -72,8 +68,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -89,8 +84,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -106,8 +100,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Occasionally data that are intended to be numeric are collected with + - Cited Guidance: Occasionally data that are intended to be numeric are collected with characters attached that cause the character-to numeric conversion to fail. For example, numeric cell counts in the source data may be specified with a greater than (>) or less than (<) sign attached (e.g., >10,000 or <1). These values should have a null result in @@ -133,8 +126,7 @@ Core: Id: CORE-000756 Status: Published Version: "1" -Description: - When --ORRES is representing numeric data with special characters like '<' and '>', , +Description: When --ORRES is representing numeric data with special characters like '<' and '>', , --STRESN may not be populated. Executability: Partially Executable # See JIRA Outcome: diff --git a/Published/CORE-000757/rule.yml b/Published/CORE-000757/rule.yml index 787cd0c41..5062a4735 100644 --- a/Published/CORE-000757/rule.yml +++ b/Published/CORE-000757/rule.yml @@ -47,8 +47,7 @@ Core: Id: CORE-000757 Status: Published Version: "1" -Description: - When findings are collected about an intervention, and the interventions parent record +Description: When findings are collected about an intervention, and the interventions parent record exists and --DECOD = null, FAOBJ should be equal to --TRT. Executability: Fully Executable Match Datasets: diff --git a/Published/CORE-000760/rule.yml b/Published/CORE-000760/rule.yml index 69be4d4b7..22bded515 100644 --- a/Published/CORE-000760/rule.yml +++ b/Published/CORE-000760/rule.yml @@ -41,8 +41,7 @@ Core: Id: CORE-000760 Status: Published Version: "1" -Description: - Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the +Description: Date/Time of First Challenge Agent Admin (RFCSTDTC) should be prior or equal to the Date/Time of Last Challenge Agent Admin (RFCENDTC). Executability: Fully Executable Outcome: diff --git a/Published/CORE-000763/rule.yml b/Published/CORE-000763/rule.yml index 5944c8fce..712adeb17 100644 --- a/Published/CORE-000763/rule.yml +++ b/Published/CORE-000763/rule.yml @@ -58,8 +58,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - If the reference time point corresponds to the date of collection or + - Cited Guidance: If the reference time point corresponds to the date of collection or assessment; Start values; an observation can start BEFORE that time point, can start COINCIDENT with that time point, or it is unknown (U) when it started. End values; an observation can end BEFORE that time point, can end COINCIDENT with that time point, can @@ -103,8 +102,7 @@ Core: Description: Trigger error when --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN') Executability: Partially Executable Outcome: - Message: - --STTPT is equal to the date of collection or assessment but --STRTPT is not in + Message: --STTPT is equal to the date of collection or assessment but --STRTPT is not in ('BEFORE', 'COINCIDENT', 'UNKNOWN'). Rule Type: Record Data Scope: diff --git a/Published/CORE-000764/rule.yml b/Published/CORE-000764/rule.yml index 70e74391b..05639e1e8 100644 --- a/Published/CORE-000764/rule.yml +++ b/Published/CORE-000764/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "TIG" References: - Citations: - - Cited Guidance: - DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single + - Cited Guidance: DSSCAT = "PRODUCT EXPOSURE" is used when a study has only a single product|2.b.iii If a study has multiple products, then DSSCAT should name the individual product. Document: TIG v1.0 @@ -36,8 +35,7 @@ Core: Id: CORE-000764 Status: Published Version: "1" -Description: - Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION +Description: Trigger error when subject has more than one record per Epoch with DSCAT = 'DISPOSITION EVENT' and more than one record where DSSCAT = PRODUCT EXPOSURE' Executability: Fully Executable Operations: @@ -51,8 +49,7 @@ Operations: name: DSCAT operator: record_count Outcome: - Message: - More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and + Message: More than 1 record exists per subject per EPOCH with DSCAT = 'DISPOSITION EVENT' and DSSCAT = 'PRODUCT EXPOSURE'. Output Variables: - USUBJID diff --git a/Published/CORE-000770/rule.yml b/Published/CORE-000770/rule.yml index eaf7e9954..f9e77b39f 100644 --- a/Published/CORE-000770/rule.yml +++ b/Published/CORE-000770/rule.yml @@ -16,8 +16,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: IG v3.1 Section: 7.2.1.1 @@ -30,8 +29,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: IG v3.1.1 Section: 7.2.1.1 @@ -44,8 +42,7 @@ Authorities: - Name: SENDIG-GENETOX References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: IG v3.1.1 Section: 7.2.1.1 @@ -58,8 +55,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: IG v3.1 Section: 7.2.1.1 @@ -72,8 +68,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: IG v3.1.1 Section: 7.2.1.1 @@ -86,8 +81,7 @@ Authorities: - Name: TIG References: - Citations: - - Cited Guidance: - Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding + - Cited Guidance: Each Trial Set should have a SPGRPCD in TXPARMCD with corresponding parameter value under TXVAL. Document: TIG v1.0 Item: Assumption 3 @@ -98,8 +92,9 @@ Authorities: Version: "1" Version: "1.0" Substandard: SEND - Version: "1.0" - # FDA rule FB4602 added (SEND-only) + Version: + "1.0" + # FDA rule FB4602 added (SEND-only) - Organization: FDA Standards: # Applicable to SENDIG as of version 3.1 diff --git a/Published/CORE-000771/rule.yml b/Published/CORE-000771/rule.yml index d11b43baf..e39a1e917 100644 --- a/Published/CORE-000771/rule.yml +++ b/Published/CORE-000771/rule.yml @@ -99,8 +99,7 @@ Core: Id: CORE-000771 Status: Published Version: "1" -Description: - Raise an error when there is more than one record present for any particular Result or +Description: Raise an error when there is more than one record present for any particular Result or Findings as Collected, in the CL Domain, for a subject or pool on a particular date. Executability: Fully Executable # The check for this rule was revised to NOT check the records where CLDTC is null diff --git a/Published/CORE-000774/rule.yml b/Published/CORE-000774/rule.yml index 5416d23af..cb2b9bcf7 100644 --- a/Published/CORE-000774/rule.yml +++ b/Published/CORE-000774/rule.yml @@ -156,8 +156,7 @@ Core: Id: CORE-000774 Status: Published Version: "1" -Description: - When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be +Description: When a test is not done (--STAT = NOT DONE), the Reason Not Done (--REASND) should be populated. Executability: Partially Executable - Possible Overreporting Outcome: diff --git a/Published/CORE-000776/rule.yml b/Published/CORE-000776/rule.yml index dd952ad00..a59c5c552 100644 --- a/Published/CORE-000776/rule.yml +++ b/Published/CORE-000776/rule.yml @@ -151,13 +151,11 @@ Core: Id: CORE-000776 Status: Published Version: "1" -Description: - When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study +Description: When End Date/Time of Observation (--ENDTC) is present in the dataset, then the Study Day of End of Observation (--ENDY) should also be present in the dataset Executability: Fully Executable Outcome: - Message: - Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of + Message: Study Day of End of Observation (--ENDY) variable is missing when End Date/Time of Observation (--ENDTC) is present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000783/rule.yml b/Published/CORE-000783/rule.yml index 4ea3e9b01..08b3b881c 100644 --- a/Published/CORE-000783/rule.yml +++ b/Published/CORE-000783/rule.yml @@ -153,16 +153,14 @@ Core: Id: CORE-000783 Status: Published Version: "1" -Description: - Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is +Description: Raise an error when SUPP--.QNAM is present in dataset, but value of SUPP--.QNAM is equal to a variable name defined in the corresponding SDTM version. Executability: Fully Executable Operations: - id: $model_variables operator: get_parent_model_column_order Outcome: - Message: - SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable + Message: SUPP--.QNAM is present in the dataset, but the value of SUPP--.QNAM equals a variable name defined in the corresponding SDTM version. Output Variables: - QNAM diff --git a/Published/CORE-000784/rule.yml b/Published/CORE-000784/rule.yml index 3980bf6a4..ce84bb0f2 100644 --- a/Published/CORE-000784/rule.yml +++ b/Published/CORE-000784/rule.yml @@ -86,8 +86,7 @@ Core: Id: CORE-000784 Status: Published Version: "1" -Description: - Raise an error when variable TAETORD values don't match between Subject Visits (SV) and +Description: Raise an error when variable TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Executability: Fully Executable Match Datasets: @@ -95,8 +94,7 @@ Match Datasets: - USUBJID Name: SE Outcome: - Message: - TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) + Message: TAETORD values don't match between Subject Visits (SV) and Subject Elements (SE) datasets. Output Variables: - SESTDTC diff --git a/Published/CORE-000785/rule.yml b/Published/CORE-000785/rule.yml index 63b65308a..54f9b3ad8 100644 --- a/Published/CORE-000785/rule.yml +++ b/Published/CORE-000785/rule.yml @@ -71,8 +71,7 @@ Authorities: --CAT.] Document: SDTM v2.1 Item: Specifications --SCAT - Section: - Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events + Section: Section 3.1.1 The Interventions Observation Class|Section 3.1.2 The Events Observation Class Section|3.1.3 The Findings Observation Class Origin: TIG Conformance Rules Rule Identifier: diff --git a/Published/CORE-000852/rule.yml b/Published/CORE-000852/rule.yml index 1ee924b76..8073c9984 100644 --- a/Published/CORE-000852/rule.yml +++ b/Published/CORE-000852/rule.yml @@ -37,8 +37,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Variables for the 3 general observation classes must be ordered with + - Cited Guidance: Variables for the 3 general observation classes must be ordered with Identifiers variables first, followed by Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM Sections 3.1.1, The Interventions Observation Class; 3.1.2, The Events Observation Class; 3.1.3, The Findings Observation diff --git a/Published/CORE-000853/rule.yml b/Published/CORE-000853/rule.yml index e1f47364f..496fa58ea 100644 --- a/Published/CORE-000853/rule.yml +++ b/Published/CORE-000853/rule.yml @@ -157,8 +157,7 @@ Core: Id: "CORE-000853" Status: Published Version: "1" -Description: - Collection study day (--DY) should be populated when date/time of collection (--DTC) is +Description: Collection study day (--DY) should be populated when date/time of collection (--DTC) is populated Executability: Fully Executable Match Datasets: @@ -166,8 +165,7 @@ Match Datasets: - USUBJID Name: DM Outcome: - Message: - Collection study day (--DY) is not populated when date/time of collection (--DTC) is + Message: Collection study day (--DY) is not populated when date/time of collection (--DTC) is populated. Rule Type: Record Data Scope: diff --git a/Published/CORE-000862/rule.yml b/Published/CORE-000862/rule.yml index f494b2eba..f715d5a84 100644 --- a/Published/CORE-000862/rule.yml +++ b/Published/CORE-000862/rule.yml @@ -151,13 +151,11 @@ Core: Id: CORE-000862 Status: Published Version: "1" -Description: - When Study Day of Start of Observation (--STDY) is present in the dataset, then the +Description: When Study Day of Start of Observation (--STDY) is present in the dataset, then the Start Date/Time of Observation (--STDTC) is also present in the dataset. Executability: Fully Executable Outcome: - Message: - Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of + Message: Start Date/Time of Observation (--STDTC) variable is missing when Study Day of Start of Observation (--STDY) is present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000864/rule.yml b/Published/CORE-000864/rule.yml index 436190794..3aaee0d30 100644 --- a/Published/CORE-000864/rule.yml +++ b/Published/CORE-000864/rule.yml @@ -151,13 +151,11 @@ Core: Id: CORE-000864 Status: Published Version: "1" -Description: - When Study Day of End of Observation (--ENDY) is present in the dataset, then the End +Description: When Study Day of End of Observation (--ENDY) is present in the dataset, then the End Date/Time of Observation (--ENDTC) is also present in the dataset Executability: Fully Executable Outcome: - Message: - End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of + Message: End Date/Time of Observation (--ENDTC) variable is missing when Study Day of End of Observation (--ENDY) is present. Rule Type: Record Data Scope: diff --git a/Published/CORE-000866/rule.yml b/Published/CORE-000866/rule.yml index 0f468d5fb..eb7ea9aec 100644 --- a/Published/CORE-000866/rule.yml +++ b/Published/CORE-000866/rule.yml @@ -161,8 +161,7 @@ Core: Id: CORE-000866 Status: Published Version: "1" -Description: - Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of +Description: Date/Time of Collection (--DTC) should be prior or equal to the End Date/Time of Observation (--ENDTC) Executability: Fully Executable Outcome: diff --git a/Published/CORE-000869/rule.yml b/Published/CORE-000869/rule.yml index b26f81425..791a7bb5f 100644 --- a/Published/CORE-000869/rule.yml +++ b/Published/CORE-000869/rule.yml @@ -45,8 +45,7 @@ Description: must be given and vice versa." Executability: Fully Executable Outcome: - Message: - The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is + Message: The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing). Output Variables: diff --git a/Published/CORE-000881/rule.yml b/Published/CORE-000881/rule.yml index 27a3d95b9..9d13e6e8d 100644 --- a/Published/CORE-000881/rule.yml +++ b/Published/CORE-000881/rule.yml @@ -48,8 +48,7 @@ Core: Id: CORE-000881 Status: Published Version: "1" -Description: - VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as +Description: VISITDY or DSNOMDY is populated in the DS dataset for scheduled disposition records as these are required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for post mortem data. Executability: Fully Executable diff --git a/Published/CORE-000882/rule.yml b/Published/CORE-000882/rule.yml index 9369b5672..d5a26c7c7 100644 --- a/Published/CORE-000882/rule.yml +++ b/Published/CORE-000882/rule.yml @@ -36,8 +36,7 @@ Core: Id: CORE-000882 Status: Published Version: "1" -Description: - VISITDY should be populated in the DS dataset for disposition records where DSTERM has +Description: VISITDY should be populated in the DS dataset for disposition records where DSTERM has been mapped to one of 'INTERIM SACRIFICE', 'RECOVERY SACRIFICE', 'REMOVED FROM STUDY ALIVE', or 'TERMINAL SACRIFICE', as these are required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated for post mortem data. diff --git a/Published/CORE-000883/rule.yml b/Published/CORE-000883/rule.yml index 4bf19f569..8fb20c0e1 100644 --- a/Published/CORE-000883/rule.yml +++ b/Published/CORE-000883/rule.yml @@ -95,8 +95,7 @@ Core: Id: CORE-000883 Status: Published Version: "1" -Description: - AGEU is the unit associated with AGE or AGETXT. If either of those variables is +Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as parameters) Executability: Fully Executable diff --git a/Published/CORE-000884/rule.yml b/Published/CORE-000884/rule.yml index 39e65bf03..ceede6457 100644 --- a/Published/CORE-000884/rule.yml +++ b/Published/CORE-000884/rule.yml @@ -89,8 +89,9 @@ Check: - name: AGETXT operator: non_empty - name: AGE - operator: non_empty - # for TS, they are parameters (values in TSPARMCD) + operator: + non_empty + # for TS, they are parameters (values in TSPARMCD) - all: - name: DOMAIN operator: equal_to @@ -103,8 +104,7 @@ Core: Id: CORE-000884 Status: Published Version: "1" -Description: - AGEU is the unit associated with AGE or AGETXT. If either of those variables is +Description: AGEU is the unit associated with AGE or AGETXT. If either of those variables is populated, AGEU should be populated. This applies to both DM (as variables) as to TS (as parameters) Executability: Fully Executable diff --git a/Published/CORE-000888/rule.yml b/Published/CORE-000888/rule.yml index 7d7714d57..59c79cb21 100644 --- a/Published/CORE-000888/rule.yml +++ b/Published/CORE-000888/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000888 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female +Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Female Subjects (PLANFSUB) record should be included. Executability: Fully Executable Grouping_Variables: diff --git a/Published/CORE-000891/rule.yml b/Published/CORE-000891/rule.yml index a9ef82850..ef4808812 100644 --- a/Published/CORE-000891/rule.yml +++ b/Published/CORE-000891/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000891 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be +Description: For each Trial Set (SETCD) in the TX dataset an Arm Code (ARMCD) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD Operations: diff --git a/Published/CORE-000892/rule.yml b/Published/CORE-000892/rule.yml index f70420983..587d66b28 100644 --- a/Published/CORE-000892/rule.yml +++ b/Published/CORE-000892/rule.yml @@ -228,8 +228,7 @@ Core: Id: CORE-000892 Status: Published Version: "1" -Description: - When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint +Description: When Eed timepoint (--ENDTC, --ENRF or --ENRTPT) is populated, related start timepoint (--STDTC, --STRF or --STRTPT should also be populated. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000893/rule.yml b/Published/CORE-000893/rule.yml index 14c1c28f4..def4469d2 100644 --- a/Published/CORE-000893/rule.yml +++ b/Published/CORE-000893/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000893 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record +Description: For each Trial Set (SETCD) in the TX dataset exactly one Group Label (GRPLBL) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD diff --git a/Published/CORE-000894/rule.yml b/Published/CORE-000894/rule.yml index 188c8014b..a388b989a 100644 --- a/Published/CORE-000894/rule.yml +++ b/Published/CORE-000894/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000894 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be +Description: For each Trial Set (SETCD) in the TX dataset a Dose Level (TRTDOS) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD diff --git a/Published/CORE-000895/rule.yml b/Published/CORE-000895/rule.yml index 896fd1982..cfcd2983b 100644 --- a/Published/CORE-000895/rule.yml +++ b/Published/CORE-000895/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000895 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be +Description: For each Trial Set (SETCD) in the TX dataset a Dose Units (TRTDOSU) record should be included. Executability: Fully Executable # We make a list of the distinct values of TXPARMCD within each group with same value for SETCD diff --git a/Published/CORE-000903/rule.yml b/Published/CORE-000903/rule.yml index 2babf4f62..fdb2e24f4 100644 --- a/Published/CORE-000903/rule.yml +++ b/Published/CORE-000903/rule.yml @@ -54,8 +54,7 @@ Description: the domain table and assumptions) may not be added to DM, CO, or SE" Executability: Fully Executable Outcome: - Message: - The variable is not allowed in this domain as it is not specified in the SENDIG for the + Message: The variable is not allowed in this domain as it is not specified in the SENDIG for the specific domain Output Variables: - variable_name diff --git a/Published/CORE-000914/rule.yml b/Published/CORE-000914/rule.yml index 27014b10b..e75c9b916 100644 --- a/Published/CORE-000914/rule.yml +++ b/Published/CORE-000914/rule.yml @@ -165,8 +165,7 @@ Core: Id: CORE-000914 Status: Published Version: "1" -Description: - There should be only one record with a baseline flag and non missing character standard +Description: There should be only one record with a baseline flag and non missing character standard result value having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values. Executability: Fully Executable Outcome: diff --git a/Published/CORE-000916/rule.yml b/Published/CORE-000916/rule.yml index 2ca87d419..d6009a04b 100644 --- a/Published/CORE-000916/rule.yml +++ b/Published/CORE-000916/rule.yml @@ -100,8 +100,7 @@ Core: Id: CORE-000916 Status: Published Version: "1" -Description: - Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable +Description: Part B - Raise and error when IDVAR in RELREC is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: @@ -118,8 +117,7 @@ Operations: operator: distinct value_is_reference: true Outcome: - Message: - Value for IDVAR in RELREC does not represent a variable present in the dataset referenced + Message: Value for IDVAR in RELREC does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - IDVAR diff --git a/Published/CORE-000929/rule.yml b/Published/CORE-000929/rule.yml index dd335d2dc..14e0d05a6 100644 --- a/Published/CORE-000929/rule.yml +++ b/Published/CORE-000929/rule.yml @@ -16,8 +16,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Check the CDISC Controlled Terminology [see Appendix C - Controlled + - Cited Guidance: Check the CDISC Controlled Terminology [see Appendix C - Controlled Terminology] for reserved two-character domain identifiers or abbreviations. If one has not been assigned by CDISC, then the sponsor may select the unique two-character domain code to be used consistently throughout the submission. diff --git a/Published/CORE-000934/rule.yml b/Published/CORE-000934/rule.yml index 7e0c23065..2d06cc512 100644 --- a/Published/CORE-000934/rule.yml +++ b/Published/CORE-000934/rule.yml @@ -113,8 +113,7 @@ Core: Id: CORE-000934 Status: Published Version: "1" -Description: - If multiple specimen types are used for a calculation (e.g., serum and urine for +Description: If multiple specimen types are used for a calculation (e.g., serum and urine for creatinine clearance), then this field should be populated with values from the (SPEC) Controlled Terminology codelist delimited by a semicolon. Executability: Fully Executable diff --git a/Published/CORE-000946/rule.yml b/Published/CORE-000946/rule.yml index 8af856afb..a33160d68 100644 --- a/Published/CORE-000946/rule.yml +++ b/Published/CORE-000946/rule.yml @@ -59,8 +59,9 @@ Check: - name: --RPENDY operator: exists - name: --RPENDY - operator: non_empty - # when one of the above is populated, RPHASE may not be empty + operator: + non_empty + # when one of the above is populated, RPHASE may not be empty - name: RPHASE operator: empty @@ -68,8 +69,7 @@ Core: Id: CORE-000946 Status: Published Version: "1" -Description: - Raise an error when one of the timing variables is populated and RPHASE is not +Description: Raise an error when one of the timing variables is populated and RPHASE is not populated Executability: Fully Executable Outcome: diff --git a/Published/CORE-000953/rule.yml b/Published/CORE-000953/rule.yml index df3858503..8592ec4b2 100644 --- a/Published/CORE-000953/rule.yml +++ b/Published/CORE-000953/rule.yml @@ -100,8 +100,7 @@ Core: Id: CORE-000953 Status: Published Version: "1" -Description: - Part C - Raise and error when IDVAR in CO is not populated with a valid variable from +Description: Part C - Raise and error when IDVAR in CO is not populated with a valid variable from the dataset referenced in RDOMAIN. Executability: Fully Executable Match Datasets: @@ -118,8 +117,7 @@ Operations: operator: distinct value_is_reference: true Outcome: - Message: - Value for IDVAR in CO does not represent a variable present in the dataset referenced in + Message: Value for IDVAR in CO does not represent a variable present in the dataset referenced in RDOMAIN. Output Variables: - IDVAR diff --git a/Published/CORE-000993/rule.yml b/Published/CORE-000993/rule.yml index c5b22883e..bd8c2e717 100644 --- a/Published/CORE-000993/rule.yml +++ b/Published/CORE-000993/rule.yml @@ -94,8 +94,7 @@ Core: Id: CORE-000993 Status: Published Version: "1" -Description: - For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male +Description: For each Trial Set (SETCD) in the TX dataset exactly one Planned Number of Male Subjects (PLANMSUB) record should be included. Executability: Fully Executable Grouping_Variables: diff --git a/Published/CORE-001034/rule.yml b/Published/CORE-001034/rule.yml index ba20a4daa..f45f5342d 100644 --- a/Published/CORE-001034/rule.yml +++ b/Published/CORE-001034/rule.yml @@ -75,8 +75,7 @@ Core: Id: CORE-001034 Status: Published Version: "1" -Description: - Raise an error when REPNUM is in the dataset and there are multiple records for a +Description: Raise an error when REPNUM is in the dataset and there are multiple records for a subject for a test within the timeframe identified by the timing variables on the record, and --REPNUM is null or not unique per subject per test per timing variables. Executability: Fully Executable diff --git a/Published/CORE-001044/rule.yml b/Published/CORE-001044/rule.yml index 1e19e2bfb..2a8e027e6 100644 --- a/Published/CORE-001044/rule.yml +++ b/Published/CORE-001044/rule.yml @@ -109,8 +109,7 @@ Core: Id: CORE-001044 Status: Published Version: "1" -Description: - Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start +Description: Subject Reference Start Date/Time (RFSTDTC) should be equal to the first Start Date/Time of Treatment (EXSDTC). Executability: Fully Executable Operations: diff --git a/Unpublished/ADAMIG/AD0010/rule.yml b/Unpublished/ADAMIG/AD0010/rule.yml index 4dbfcfc3b..1243397e5 100644 --- a/Unpublished/ADAMIG/AD0010/rule.yml +++ b/Unpublished/ADAMIG/AD0010/rule.yml @@ -136,8 +136,7 @@ Description: >- root and a suffix of FN is not equal to 1' Executability: Fully Executable Outcome: - Message: - A variable with a suffix of FL is equal to Y and a variable with the same root and a + Message: A variable with a suffix of FL is equal to Y and a variable with the same root and a suffix of FN is not equal to 1 Output Variables: - variable_name diff --git a/Unpublished/ADAMIG/AD0014/rule.yml b/Unpublished/ADAMIG/AD0014/rule.yml index 1f34418de..7014b5140 100644 --- a/Unpublished/ADAMIG/AD0014/rule.yml +++ b/Unpublished/ADAMIG/AD0014/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "Model v2.1" References: - Citations: - - Cited Guidance: - <- In developing naming conventions, sponsors should consider the + - Cited Guidance: <- In developing naming conventions, sponsors should consider the requirements noted in the eCTD guidance document as well as the need to conform to the SAS Transport format requirements (e.g., the total length of the name cannot exceed 8 characters). @@ -64,8 +63,7 @@ Authorities: - Name: "Model v2.1" References: - Citations: - - Cited Guidance: - <- In developing naming conventions, sponsors should consider the + - Cited Guidance: <- In developing naming conventions, sponsors should consider the requirements noted in the eCTD guidance document as well as the need to conform to the SAS Transport format requirements (e.g., the total length of the name cannot exceed 8 characters). @@ -124,8 +122,7 @@ Authorities: - Name: "Model v2.1" References: - Citations: - - Cited Guidance: - <- In developing naming conventions, sponsors should consider the + - Cited Guidance: <- In developing naming conventions, sponsors should consider the requirements noted in the eCTD guidance document as well as the need to conform to the SAS Transport format requirements (e.g., the total length of the name cannot exceed 8 characters). @@ -184,8 +181,7 @@ Authorities: - Name: "Model v2.1" References: - Citations: - - Cited Guidance: - <- In developing naming conventions, sponsors should consider the + - Cited Guidance: <- In developing naming conventions, sponsors should consider the requirements noted in the eCTD guidance document as well as the need to conform to the SAS Transport format requirements (e.g., the total length of the name cannot exceed 8 characters). diff --git a/Unpublished/ADAMIG/AD0039/rule.yml b/Unpublished/ADAMIG/AD0039/rule.yml index d4c21220e..6ea2e6ae5 100644 --- a/Unpublished/ADAMIG/AD0039/rule.yml +++ b/Unpublished/ADAMIG/AD0039/rule.yml @@ -46,8 +46,7 @@ Core: Id: CDISC.ADAMIG.AD0039 Status: Draft Version: "1" -Description: - Raise an error when a variable ends with DTF and values are not according to the DATEFL +Description: Raise an error when a variable ends with DTF and values are not according to the DATEFL controlled terminology codelist Outcome: Message: The values of ADTF are not following the DATEFL codelist diff --git a/Unpublished/ADAMIG/AD0070/rule.yml b/Unpublished/ADAMIG/AD0070/rule.yml index 17c89d9e8..c7863136c 100644 --- a/Unpublished/ADAMIG/AD0070/rule.yml +++ b/Unpublished/ADAMIG/AD0070/rule.yml @@ -80,8 +80,7 @@ Description: >- and a variable with the same root without a suffix of N is not present' Executability: Fully Executable Outcome: - Message: - A variable with a prefix of TR, containing AG with a suffix of N is present and a + Message: A variable with a prefix of TR, containing AG with a suffix of N is present and a variable with the same root without a suffix of N is not present Output Variables: - variable_name diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml index 41873a002..27e649d36 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0860/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "ADaMIG" References: - Citations: - - Cited Guidance: - <- Character representation of the COHORT variable. There must be a + - Cited Guidance: <- Character representation of the COHORT variable. There must be a one-to-one mapping to COHORT. The character versions of the primary/character variables can be assigned from its corresponding numeric pair variable. Document: ADPPKIG v1.0 diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml index c0218d009..74316f698 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0861/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "ADaMIG" References: - Citations: - - Cited Guidance: - <- Character representation of the COHORT variable. There must be a + - Cited Guidance: <- Character representation of the COHORT variable. There must be a one-to-one mapping to COHORT. The character versions of the primary/character variables can be assigned from its corresponding numeric pair variable. Document: ADPPKIG v1.0 diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml index 6b789b553..a9d794fec 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0862/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: - <- Character representation of the COHORT variable. There must be a + - Cited Guidance: <- Character representation of the COHORT variable. There must be a one-to-one mapping to COHORT. The character versions of the primary/character variables can be assigned from its corresponding numeric pair variable. Document: ADPPKIG v1.0 diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml index cc84f3573..aabcd3ebb 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0863/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: - <- Character representation of the COHORT variable. There must be a + - Cited Guidance: <- Character representation of the COHORT variable. There must be a one-to-one mapping to COHORT. The character versions of the primary/character variables can be assigned from its corresponding numeric pair variable. Document: ADPPKIG v1.0 diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml index e0704f62c..d2c4e4280 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0865/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "ADaMIG" References: - Citations: - - Cited Guidance: - <- Numeric version of RACE eg. Codes used as per the specification. + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use variables ARACE and ARACEN. diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml index 714773d3e..83e5b2349 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0866/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: "ADaMIG" References: - Citations: - - Cited Guidance: - <- Numeric version of RACE eg. Codes used as per the specification. + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian OR Other Pacific Islander, 5=White. If races need to be categorized differently, then use variables ARACE and ARACEN. diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml index 4727b2ce4..bf0c28e19 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0867/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: - <- Numeric version of RACE eg. Codes used as per the specification. + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use variables ARACE and ARACEN. diff --git a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml index 2ddfc21ea..399e9eae7 100644 --- a/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml +++ b/Unpublished/ADAMIG/CDISC.ADaMIG.AD0868/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: ADaMIG References: - Citations: - - Cited Guidance: - <- Numeric version of RACE eg. Codes used as per the specification. + - Cited Guidance: <- Numeric version of RACE eg. Codes used as per the specification. 1=American Indian OR Alaska Native, 2=Asian, 3=Black/African American, 4=Native Hawaiian OR Other Pacific Islander, 5=White. If RACEs need to be categorized differently, then use variables ARACE and ARACEN. diff --git a/Unpublished/FDA Business Rules/FB1113/rule.yml b/Unpublished/FDA Business Rules/FB1113/rule.yml index 09596f801..949944d14 100644 --- a/Unpublished/FDA Business Rules/FB1113/rule.yml +++ b/Unpublished/FDA Business Rules/FB1113/rule.yml @@ -74,8 +74,7 @@ Core: Id: Status: Draft Version: "1" -Description: - The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', +Description: The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is eq 1. Executability: Fully Executable @@ -85,8 +84,7 @@ Operations: name: TSPARMCD operator: distinct Outcome: - Message: - No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of + Message: No occurrence of TSPARAMCD='CURTRT' is included in TS or TSVAL is null.The count of occurrences of TSPARAMCD = not in the set ('FCNTRY', 'OBJPRIM', 'OBJSEC', 'OUTMSPRI', .'OUTMSSEC', 'RANDQT', 'REGID', 'TITLE', 'TTYPE') included in the list of TSPARAMCD with TSVAL populated is gt 1. diff --git a/Unpublished/FDA Business Rules/FB1901/rule.yml b/Unpublished/FDA Business Rules/FB1901/rule.yml index 18cb9c680..042ee8009 100644 --- a/Unpublished/FDA Business Rules/FB1901/rule.yml +++ b/Unpublished/FDA Business Rules/FB1901/rule.yml @@ -158,8 +158,7 @@ Check: Core: Status: Draft Version: "1" -Description: - All variables in each of the SUPPQUAL and RELREC datasets have a length that is not +Description: All variables in each of the SUPPQUAL and RELREC datasets have a length that is not longer than the length of the longest value for that variable. Executability: Partially Executable Outcome: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml index 8ac88b29d..0d848c3f5 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.CT2001/rule.yml @@ -23,8 +23,7 @@ Core: Id: FDA.SDTMIG.CT2001 Status: Draft Version: "1" -Description: - Variable must be populated with terms from its CDISC controlled terminology codelist. +Description: Variable must be populated with terms from its CDISC controlled terminology codelist. New terms cannot be added into non-extensible codelists. Operations: - domain: DS diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml index 9dd02953f..53e2dc10b 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0801/rule.yml @@ -147,8 +147,7 @@ Core: Id: FDA.SDTMIG.FB0801 Status: Draft Version: "1" -Description: - Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC) +Description: Treatment exposure start date/time (--STDTC) should fall on or between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml index 55aff97fe..2335763ca 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0802/rule.yml @@ -147,8 +147,7 @@ Core: Id: FDA.SDTMIG.FB0802 Status: Draft Version: "1" -Description: - Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC) +Description: Treatment exposure end date/time (--ENDTC) should fall on or between first (RFXSTDTC) and last (RFXENDTC) study treatment date/time in the DM dataset. Executability: Fully Executable Match Datasets: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml index 91b6da1a6..1d613228e 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB0803/rule.yml @@ -110,8 +110,7 @@ Core: Id: FDA.SDTMIG.FB0803 Status: Draft Version: "1" -Description: - Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time +Description: Treatment exposure start date/time (EXSTDTC) should fall on or between the date/time experimental start (EXPSTDTC) and end date (EXPENDTC) in the TS dataset. Executability: Fully Executable Operations: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml index 5ee0c03d0..760425b9f 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1101/rule.yml @@ -57,8 +57,7 @@ Core: Id: FDA.SDTMIG.FB1101 Status: Draft Version: "1" -Description: - All trial design datasets as listed in the corresponding IG should be present in the +Description: All trial design datasets as listed in the corresponding IG should be present in the submission. Executability: Fully Executable Outcome: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml index 7ff695eb4..18d66bce0 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB1801/rule.yml @@ -150,8 +150,7 @@ Core: Id: FDA.SDTMIG.FB1801 Status: Draft Version: "1" -Description: - The length of each variable cannot be different between datasets and should not be +Description: The length of each variable cannot be different between datasets and should not be longer than the maximum length of the data contained by the variable Executability: Partially Executable # Operations: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml index 41f264178..d088a0046 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB2303/rule.yml @@ -39,8 +39,7 @@ Core: Id: FDA.SDTMIG.FB2303 Status: Draft Version: "1" -Description: - All subjects in the Exposure domain who are participating in a study that includes an +Description: All subjects in the Exposure domain who are participating in a study that includes an interventional product must be assigned to a treatment. Executability: Fully Executable Match Datasets: @@ -53,8 +52,7 @@ Operations: name: USUBJID operator: distinct Outcome: - Message: - A subject has a record in EX but is not assigned to a treatment while participating in an + Message: A subject has a record in EX but is not assigned to a treatment while participating in an interventional study Output Variables: - ACTARMCD diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml index 669f85bc9..d6990e24a 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3211/rule.yml @@ -157,8 +157,7 @@ Core: Id: FDA.SDTMIG.FB3211 Status: Draft Version: "1" -Description: - Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection +Description: Start Date/Time of Observation (--STDTC) is prior or equal to Date/Time of Collection (--DTC) Executability: Fully Executable Outcome: diff --git a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml index 94d02a062..32ff92c72 100644 --- a/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SDTMIG.FB3405/rule.yml @@ -53,8 +53,7 @@ Core: Id: FDA.SDTMIG.FB3405 Status: Draft Version: "1" -Description: - Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of +Description: Start Date/Time (--STDTC) should be prior or equal to the Date/Time of End of Participation (RFPENDTC) Executability: Fully Executable Match Datasets: diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml index 177185d53..0376f779e 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB4702/rule.yml @@ -54,8 +54,9 @@ Check: - name: VISITDY operator: not_exists - name: VISITDY - operator: "empty" - # TEST CONDITION. Remark that --MOMDY is "expected" + operator: + "empty" + # TEST CONDITION. Remark that --MOMDY is "expected" - name: --NOMDY operator: "empty" Core: @@ -64,8 +65,7 @@ Core: Version: "1" # Description: 'Either VISITDY or --NOMDY must be populated when # --ORRES is # populated and --USCHFL is not populated' -Description: - VISITDY or --NOMDY should be populated for scheduled records as these are required +Description: VISITDY or --NOMDY should be populated for scheduled records as these are required timing variables for identification of the day on which group summaries (Group Means and Incidences) are calculated. Executability: Fully Executable diff --git a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml index 510405c06..e53d5bbca 100644 --- a/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml +++ b/Unpublished/FDA Business Rules/FDA.SENDIG.FB8202/rule.yml @@ -54,8 +54,7 @@ Core: Id: FDA.SENDIG.FB8202 Status: Draft Version: "1" -Description: - For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not +Description: For carcinogenicity studies, MIRESCAT value should be populated when MISTRESC does not have a value of UNREMARKABLE or MISTAT has a value of NOT DONE. Executability: Fully Executable Outcome: diff --git a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml index a11bf5a2b..fd20a6a8d 100644 --- a/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml +++ b/Unpublished/FDA Business Rules/FFDA.SENDIG.FB1119/rule.yml @@ -109,10 +109,11 @@ Check: - all: - name: TSPARMCD operator: does_not_contain - value: RECSAC - # TSVAL empty for TSPARMCD=RECSAC - # REMARK: test at the record level - # OR: should we use a "filter" here? + value: + RECSAC + # TSVAL empty for TSPARMCD=RECSAC + # REMARK: test at the record level + # OR: should we use a "filter" here? - all: - name: TSPARMCD operator: equal_to diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml index 26210fa04..7f21adcfe 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0015/rule.yml @@ -65,8 +65,7 @@ Core: Id: CDISC.SDTMIG.CG0015 Status: Draft Version: "1" -Description: - Raise an error when a variable is permissible, data is collected but variable has no +Description: Raise an error when a variable is permissible, data is collected but variable has no data. Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml index 238efdef1..fcd7c7301 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0019/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Note that the key variables shown in this table are examples only. A + - Cited Guidance: Note that the key variables shown in this table are examples only. A sponsor's actual key structure may be different. Document: IG v3.4 Section: Table 3.2.1 @@ -74,8 +73,7 @@ Core: Id: CDISC.SDTMIG.CG0019 Status: Draft Version: "1" -Description: - Trigger error if records are not unique as per sponsor defined key variables as +Description: Trigger error if records are not unique as per sponsor defined key variables as documented in the define.xml Executability: Fully Executable Match Datasets: @@ -83,8 +81,7 @@ Match Datasets: - USUBJID Name: SUPP-- Outcome: - Message: - Records are not unique as per sponsor defined key variables as documented in the + Message: Records are not unique as per sponsor defined key variables as documented in the define.xml Output Variables: - define_dataset_key_sequence diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml index 353c30ac9..0566783d1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0155/rule.yml @@ -50,8 +50,7 @@ Core: Id: CDISC.SDTMIG.CG0155 Status: Draft Version: "1" -Description: - Raise an error when DOMAIN value begins with AP and length of domain variable is not 4 +Description: Raise an error when DOMAIN value begins with AP and length of domain variable is not 4 or DOMAIN value doesn't end with a valid SDTM domain. Executability: Partially Executable - Possible Overreporting Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml index c27515198..2e1d3be20 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0158/rule.yml @@ -60,8 +60,7 @@ Core: Id: CDISC.SDTMIG.CG0158 Status: Draft Version: "1" -Description: - Trigger error if relationship described is to a pool and RSUBJID is not in +Description: Trigger error if relationship described is to a pool and RSUBJID is not in POOLDEF.POOLID Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml index 17774396e..2e5efd456 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0159/rule.yml @@ -59,13 +59,11 @@ Core: Id: CDISC.SDTMIG.CG0159 Status: Draft Version: "1" -Description: - Trigger error if relationship described is to a study (but not to individual study +Description: Trigger error if relationship described is to a study (but not to individual study subject) and RSUBJID is not null Executability: Fully Executable Outcome: - Message: - Relationship described is to a study (but not to individua study subject) and RSUBJID is + Message: Relationship described is to a study (but not to individua study subject) and RSUBJID is not null Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml index 4070316b1..2e7c1ce13 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0160/rule.yml @@ -71,13 +71,11 @@ Core: Id: CDISC.SDTMIG.CG0160 Status: Draft Version: "1" -Description: - Trigger error when RSUBJID ^= null and SREL does not describe the relationship of +Description: Trigger error when RSUBJID ^= null and SREL does not describe the relationship of associated person to study subject or pool Executability: Fully Executable Outcome: - Message: - SREL does not describe the relationship of associated person to study subject or pool + Message: SREL does not describe the relationship of associated person to study subject or pool when RSUBJID is not null Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml index 33fdc6253..85cf08818 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0161/rule.yml @@ -71,13 +71,11 @@ Core: Id: CDISC.SDTMIG.CG0161 Status: Draft Version: "1" -Description: - Trigger error when RDEVID ^= null and SREL does not describe relationship of associated +Description: Trigger error when RDEVID ^= null and SREL does not describe relationship of associated person to device identified in RDEVID Executability: Fully Executable Outcome: - Message: - SREL does not describe relationship of associated person to device identified in RDEVID + Message: SREL does not describe relationship of associated person to device identified in RDEVID when RDEVID ^= null Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml index f7a6255b2..4875d0c4f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0162/rule.yml @@ -66,13 +66,11 @@ Core: Id: CDISC.SDTMIG.CG0162 Status: Draft Version: "1" -Description: - Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the +Description: Trigger error when RSUBJID = null and RDEVID = null and SREL does not describe the relationship of associated person to study identified in STUDYID Executability: Not Executable Outcome: - Message: - SREL does not describe the relationship of associated person to study identified in + Message: SREL does not describe the relationship of associated person to study identified in STUDYID when RSUBJID = null and RDEVID = null Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml index 842e0602f..4c4cb3807 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0169/rule.yml @@ -23,8 +23,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - When the comment text is longer than 200 characters, the first 200 + - Cited Guidance: When the comment text is longer than 200 characters, the first 200 characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed to COVALn. See example, Rows 3-4. Document: IG v3.2 @@ -39,8 +38,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - When the comment text is longer than 200 characters, the first 200 + - Cited Guidance: When the comment text is longer than 200 characters, the first 200 characters of the comment will be in COVAL, the next 200 in COVAL1, and additional text stored as needed to COVALn. See example, Rows 3-4. Document: IG v3.3 @@ -62,8 +60,7 @@ Core: Id: CDISC.SDTMIG.CG0169 Status: Draft Version: "1" -Description: - Trigger error when there are no comments greater than 200 characters and COVALn is +Description: Trigger error when there are no comments greater than 200 characters and COVALn is present Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml index d9cc3bde4..9dc66078f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0173/rule.yml @@ -61,8 +61,7 @@ Core: Id: CDISC.SDTMIG.CG0173 Status: Draft Version: "1" -Description: - Trigger error when collected data fits a Qualifier variable listed in specified SDTM +Description: Trigger error when collected data fits a Qualifier variable listed in specified SDTM Sections and are represented in the Findings About domain, and the name of the variable is used as FATESTCD Executability: Partially Executable - Possible Underreporting @@ -71,8 +70,7 @@ Operations: name: FATESTCD operator: label_referenced_variable_metadata Outcome: - Message: - Collected data fits a Qualifier variable listed in specified SDTM Sections and are + Message: Collected data fits a Qualifier variable listed in specified SDTM Sections and are represented in the Findings About domain, and the name of the variable is used as FATESTCD Output Variables: - $label_referenced_variable_name diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml index 6aa9cfa2c..55734ac01 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0184/rule.yml @@ -23,8 +23,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - For normal range values that are character in ordinal scale or if + - Cited Guidance: For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). Document: IG v3.2 Item: Specification @@ -38,8 +37,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - For normal range values that are character in ordinal scale or if + - Cited Guidance: For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). Document: IG v3.3 Item: Specification diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml index a53883f43..af9162a76 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0188/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Lower end of reference range for continuous measurements for + - Cited Guidance: Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Document: IG v3.4 Item: Specification @@ -22,8 +21,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Lower end of reference range for continuous measurements for + - Cited Guidance: Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Document: IG v3.2 Item: Specification @@ -37,8 +35,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Lower end of reference range for continuous measurements for + - Cited Guidance: Lower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Document: IG v3.3 Item: Specification diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml index f4e6456d6..3a1345f5c 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0190/rule.yml @@ -54,8 +54,7 @@ Core: Id: CDISC.SDTMIG.CG0190 Status: Draft Version: "1" -Description: - Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in +Description: Trigger error if LBSTRESU is not null and LBSTNRC is not expressed using the units in LBSTRESU Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml index db5d03bc7..435f88005 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0197/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - If there are findings for a body system, then either the dictionary + - Cited Guidance: If there are findings for a body system, then either the dictionary preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not encoded) should appear here. Document: IG v3.4 @@ -23,8 +22,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - If there are findings for a body system, then either the dictionary + - Cited Guidance: If there are findings for a body system, then either the dictionary preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not coded) should appear here. Document: IG v3.2 @@ -38,8 +36,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - If there are findings for a body system, then either the dictionary + - Cited Guidance: If there are findings for a body system, then either the dictionary preferred term (if findings are coded using a dictionary) or PEORRES (if findings are not coded) should appear here. Document: IG v3.3 @@ -65,8 +62,7 @@ Core: Id: CDISC.SDTMIG.CG0197 Status: Draft Version: "1" -Description: - Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary +Description: Trigger error when PESTRESC ^= null but PESTRESC does not equal PEORRES OR a dictionary coded preferred term Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml index d54100ae3..102ea45e5 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0236/rule.yml @@ -66,13 +66,11 @@ Core: Id: CDISC.SDTMIG.CG0236 Status: Draft Version: "1" -Description: - Trigger error when --DTC is date/time of recording/acquisition, not date/time of +Description: Trigger error when --DTC is date/time of recording/acquisition, not date/time of specimen collection or observation Executability: Fully Executable Outcome: - Message: - --DTC is date/time of recording/acquisition, not date/time of specimen collection or + Message: --DTC is date/time of recording/acquisition, not date/time of specimen collection or observation Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml index 1353ab701..ea36c7b03 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0237/rule.yml @@ -68,13 +68,11 @@ Core: Id: CDISC.SDTMIG.CG0237 Status: Draft Version: "1" -Description: - Trigger error when --DTC is present and not populated with the date/time of +Description: Trigger error when --DTC is present and not populated with the date/time of recording/data acquisition Executability: Fully Executable Outcome: - Message: - --DTC is present in dataset and is not populated with the date/time of recording/data + Message: --DTC is present in dataset and is not populated with the date/time of recording/data acquisition Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml index bed794844..5af59ff9b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0249/rule.yml @@ -59,13 +59,11 @@ Core: Id: CDISC.SDTMIG.CG0249 Status: Draft Version: "1" -Description: - Trigger error when element does not end with a decision that could lead to a shortened +Description: Trigger error when element does not end with a decision that could lead to a shortened path within the Arm and TATRANS is not null Executability: Fully Executable Outcome: - Message: - TATRANS is populated when the element does not end with a decision that could lead to a + Message: TATRANS is populated when the element does not end with a decision that could lead to a shortened path within the Arm Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml index f36ba4677..1c9abba64 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0250/rule.yml @@ -53,8 +53,7 @@ Core: Id: CDISC.SDTMIG.CG0250 Status: Draft Version: "1" -Description: - Trigger error when at least one EPOCH is associated with more than one conceptual trial +Description: Trigger error when at least one EPOCH is associated with more than one conceptual trial period Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml index b2d51980c..1ea8ce869 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0252/rule.yml @@ -61,13 +61,11 @@ Core: Id: CDISC.SDTMIG.CG0252 Status: Draft Version: "1" -Description: - Trigger error when trial Design allows for a Subject to transition to an Element other +Description: Trigger error when trial Design allows for a Subject to transition to an Element other than the next Element in sequence, and TATRANS is null Executability: Not Executable Outcome: - Message: - TATRANS is null when trial Design allows for a Subject to transition to an Element other + Message: TATRANS is null when trial Design allows for a Subject to transition to an Element other than the next Element in sequence Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml index 0182b64ab..f8e014d05 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0253/rule.yml @@ -59,13 +59,11 @@ Core: Id: CDISC.SDTMIG.CG0253 Status: Draft Version: "1" -Description: - Trigger error when TIVERS is null and there is more than one version of the IE criteria +Description: Trigger error when TIVERS is null and there is more than one version of the IE criteria in study documentation Executability: Not Executable Outcome: - Message: - TIVERS is null when there is more than one version of the IE criteria in study + Message: TIVERS is null when there is more than one version of the IE criteria in study documentation Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml index b5027b9c0..0613f760b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0254/rule.yml @@ -59,8 +59,7 @@ Core: Id: CDISC.SDTMIG.CG0254 Status: Draft Version: "1" -Description: - Trigger error when TIVERS is not present in the data and there is more than one version +Description: Trigger error when TIVERS is not present in the data and there is more than one version of the IE criteria Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml index c4f24573a..750c80781 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0295/rule.yml @@ -59,13 +59,11 @@ Core: Id: CDISC.SDTMIG.CG0295 Status: Draft Version: "1" -Description: - Trigger error when ARMCD is populated and the timing and number of Visits for a trial +Description: Trigger error when ARMCD is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Executability: Fully Executable Outcome: - Message: - ARMCD is populated and the timing and number of Visits for a trial does not depend on + Message: ARMCD is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml index a85c2f2e0..ef0fa03d7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0296/rule.yml @@ -59,8 +59,7 @@ Core: Id: CDISC.SDTMIG.CG0296 Status: Draft Version: "1" -Description: - Trigger error when ARM is populated and the timing and number of Visits for a trial +Description: Trigger error when ARM is populated and the timing and number of Visits for a trial does not depend on which ARM a subject is in Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml index b211bb9d7..50618976a 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml @@ -80,8 +80,7 @@ Core: Id: CDISC.SDTMIG.CG0321 Status: Draft Version: "1" -Description: - Trigger error when a custom domain is present and is not based on one of the +Description: Trigger error when a custom domain is present and is not based on one of the observation classes Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml index 2bc225182..323fe51b4 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0322/rule.yml @@ -61,8 +61,7 @@ Core: Id: CDISC.SDTMIG.CG0322 Status: Draft Version: "1" -Description: - When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a +Description: When ELEMENT is associated with more than 1 arm, the ELEMENT value must not refer to a specific ARM Executability: Fully Executable Match Datasets: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml index 9640d884c..3dd5dc4f9 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0323/rule.yml @@ -64,8 +64,7 @@ Core: Id: CDISC.SDTMIG.CG0323 Status: Draft Version: "1" -Description: - When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a +Description: When ELEMENT is associated with more than 1 EPOCH, ELEMENT should not refer to a specific EPOCH. Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml index 1109c207f..a4fdf3b21 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0324/rule.yml @@ -58,8 +58,7 @@ Core: Id: CDISC.SDTMIG.CG0324 Status: Draft Version: "1" -Description: - TEENRL should not reference a specific ARM. This rule has only been partially executed +Description: TEENRL should not reference a specific ARM. This rule has only been partially executed to identify explicit references to ARM. Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml index a364a9b56..e280b7c1d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0347/rule.yml @@ -67,13 +67,11 @@ Core: Id: CDISC.SDTMIG.CG0347 Status: Draft Version: "1" -Description: - Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the +Description: Trigger error when --ORRES is equal to MULTIPLE when it is not a valid response in the context of the finding (e.g., Questionnaire CT) Executability: Fully Executable Outcome: - Message: - --ORRES is equal to MULTIPLE when it is not a valid response in the context of the + Message: --ORRES is equal to MULTIPLE when it is not a valid response in the context of the finding (e.g., Questionnaire CT) Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml index 0cf0f020c..04fe86199 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0378/rule.yml @@ -20,8 +20,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Dictionary or sponsor-defined derived text description of the topic + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to the Preferred Term (PT in MedDRA). Document: Model v1.7 @@ -35,8 +34,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Dictionary or sponsor-defined derived text description of the topic + - Cited Guidance: Dictionary or sponsor-defined derived text description of the topic variable; --TERM; or the modified topic variable (--MODIFY); if applicable. Equivalent to the Preferred Term (PT in MedDRA). Document: Model v1.4 diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml index d744579d0..03e60b80b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0386/rule.yml @@ -23,8 +23,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - MedDRA System Organ Class code corresponding to -BODSYS assigned for + - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for analysis. Document: Model v1.4 Section: 2.2.2 @@ -37,8 +36,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - MedDRA System Organ Class code corresponding to -BODSYS assigned for + - Cited Guidance: MedDRA System Organ Class code corresponding to -BODSYS assigned for analysis. Document: Model v1.7 Section: 2.2.2 diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml index 27e748909..cfa133326 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0400/rule.yml @@ -57,13 +57,11 @@ Core: Id: CDISC.SDTMIG.CG0400 Status: Draft Version: "1" -Description: - Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary +Description: Trigger error when --LOINC is not a valid code in the version of the LOINC dictionary specified in define.xml Executability: Fully Executable Outcome: - Message: - --LOINC is not a valid code in the version of the LOINC dictionary specified in + Message: --LOINC is not a valid code in the version of the LOINC dictionary specified in define.xml Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml index b92293dc2..be9f01778 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0425/rule.yml @@ -51,8 +51,7 @@ Core: Id: CDISC.SDTMIG.CG0425 Status: Draft Version: "1" -Description: - Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for +Description: Trigger error if --STRESU is null when --STRESC ^= null and units are applicable for the result Executability: Not Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml index f5ac49041..0ab552b56 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0431/rule.yml @@ -66,8 +66,7 @@ Core: Id: CDISC.SDTMIG.CG0431 Status: Draft Version: "1" -Description: - Raise an error when the variable Core Status = Expected, data is collected, but the +Description: Raise an error when the variable Core Status = Expected, data is collected, but the variable has no data. Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml index ebc862ceb..d15ad7341 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0524/rule.yml @@ -44,8 +44,7 @@ Core: Id: CDISC.SDTMIG.CG0524 Status: Draft Version: "1" -Description: - Trigger error when ACTARMCD is populated for a subject who was not assigned to +Description: Trigger error when ACTARMCD is populated for a subject who was not assigned to treatment Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml index a577712ab..26379d8d0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0525/rule.yml @@ -47,8 +47,7 @@ Core: Id: CDISC.SDTMIG.CG0525 Status: Draft Version: "1" -Description: - Trigger error when Sponsor collects Other, specify and chooses to map the value to +Description: Trigger error when Sponsor collects Other, specify and chooses to map the value to SUPPDM, and NOT - RACE = 'OTHER' or RACE = 'MULTIPLE' Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml index 59543965b..477cadd69 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0527/rule.yml @@ -45,13 +45,11 @@ Core: Id: CDISC.SDTMIG.CG0527 Status: Draft Version: "1" -Description: - Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and +Description: Trigger error when RACE does not equal "MULTIPLE" when multiple races collected and primary race not specified Executability: Fully Executable Outcome: - Message: - RACE does not equal "MULTIPLE" when multiple races collected and primary race not + Message: RACE does not equal "MULTIPLE" when multiple races collected and primary race not specified Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml index 10454071c..c5c029564 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0532/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Reference Start Date/time for the subject in ISO 8601 + - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.]|Assumption 9[As described in Section 4.1.4, Order of the Variables, RFSTDTC is used to calculate @@ -36,8 +35,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Specification[Reference Start Date/time for the subject in ISO 8601 + - Cited Guidance: Specification[Reference Start Date/time for the subject in ISO 8601 character format. Usually equivalent to date/time when subject was first exposed to study treatment. See Assumption 9 for additional detail on when RFSTDTC may be null.| Assumption 9 [RFSTDTC is used to calculate study day variables. RFSTDTC is usually defined as the diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml index 78ba6d08d..962c0f630 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0546/rule.yml @@ -66,8 +66,7 @@ Core: Id: CDISC.SDTMIG.CG0546 Status: Draft Version: "1" -Description: - Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a +Description: Trigger error when MIDSTYPE=TM.MIDSTYPE and TM.TMRPT=Y and MIDS is not suffixed with a sequence number in consistent chronological order Executability: Fully Executable Match Datasets: @@ -81,8 +80,7 @@ Operations: id: $records_per_usubjid_per_midstype operator: record_count Outcome: - Message: - MIDS is not suffixed with a sequence number in consistent chronological order with + Message: MIDS is not suffixed with a sequence number in consistent chronological order with SMSTDTC. Output Variables: - MIDSTYPE diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml index 19c871280..1dfdedd39 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0555/rule.yml @@ -62,8 +62,7 @@ Core: Id: CDISC.SDTMIG.CG0555 Status: Draft Version: "1" -Description: - Trigger error when parameter is non-normalized and value in PPORRESU is not for a +Description: Trigger error when parameter is non-normalized and value in PPORRESU is not for a non-normalized parameter. Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml index cdf3c6332..8637853e1 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0556/rule.yml @@ -65,8 +65,7 @@ Core: Id: CDISC.SDTMIG.CG0556 Status: Draft Version: "1" -Description: - Trigger error when parameter is normalized by dose and value in PPORRESU is not for a +Description: Trigger error when parameter is normalized by dose and value in PPORRESU is not for a parameter normalized by dose. Executability: Fully Executable Operations: @@ -83,8 +82,7 @@ Operations: operator: codelist_terms returntype: value Outcome: - Message: - Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor + Message: Parameter is normalized by dose, and the value in PPORRESU is not in codelist PKUDMG nor in codelist PKUDUG. Output Variables: - PPTESTCD diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml index 110e3f657..c46cd8f72 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0557/rule.yml @@ -65,8 +65,7 @@ Core: Id: CDISC.SDTMIG.CG0557 Status: Draft Version: "1" -Description: - Trigger error when parameter is normalized by weight and value in PPORRESU is not for a +Description: Trigger error when parameter is normalized by weight and value in PPORRESU is not for a parameter normalized by weight. Executability: Fully Executable Operations: @@ -83,8 +82,7 @@ Operations: operator: codelist_terms returntype: value Outcome: - Message: - Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor + Message: Parameter is normalized by weight, and the value in PPORRESU is not in codelist PKUWG nor in codelist PKUWKG. Output Variables: - PPTESTCD diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml index 6a79b4edc..2bf5f978f 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0558/rule.yml @@ -62,8 +62,7 @@ Core: Id: CDISC.SDTMIG.CG0558 Status: Draft Version: "1" -Description: - Trigger error when parameter is non-normalized and value in PPSTRESU is not for a +Description: Trigger error when parameter is non-normalized and value in PPSTRESU is not for a non-normalized parameter. Executability: Fully Executable Operations: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml index 4f0b64b95..db69012b7 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0559/rule.yml @@ -65,8 +65,7 @@ Core: Id: CDISC.SDTMIG.CG0559 Status: Draft Version: "1" -Description: - Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a +Description: Trigger error when parameter is normalized by dose and value in PPSTRESU is not for a parameter normalized by dose. Executability: Fully Executable Operations: @@ -83,8 +82,7 @@ Operations: operator: codelist_terms returntype: value Outcome: - Message: - Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor + Message: Parameter is normalized by dose, and the value in PPSTRESU is not in codelist PKUDMG nor in codelist PKUDUG. Output Variables: - PPTESTCD diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml index 7effbeaa1..c4802d8a0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0560/rule.yml @@ -65,8 +65,7 @@ Core: Id: CDISC.SDTMIG.CG0560 Status: Draft Version: "1" -Description: - Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a +Description: Trigger error when parameter is normalized by weight and value in PPSTRESU is not for a parameter not normalized by weight. Executability: Fully Executable Operations: @@ -83,8 +82,7 @@ Operations: operator: codelist_terms returntype: value Outcome: - Message: - Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor + Message: Parameter is normalized by weight, and the value in PPSTRESU is not in codelist PKUWG nor in codelist PKUWKG. Output Variables: - PPTESTCD diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml index 031484b30..f3f55a6eb 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0563/rule.yml @@ -50,8 +50,7 @@ Core: Id: CDISC.SDTMIG.CG0563 Status: Draft Version: "1" -Description: - Raise an error when record is derived in a data collection tool and RSDRVFL is not +Description: Raise an error when record is derived in a data collection tool and RSDRVFL is not equal to "Y" Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml index 9b635fdbb..c9f2799ec 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0607/rule.yml @@ -29,13 +29,11 @@ Core: Id: CDISC.SDTMIG.CG0607 Status: Draft Version: "1" -Description: - Verify MBTEST equals the name of the organism/antigen targeted by the identification +Description: Verify MBTEST equals the name of the organism/antigen targeted by the identification assay. Executability: Fully Executable Outcome: - Message: - Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of + Message: Test targets an organism, group of organisms, or antigen, but MBTEST is not the name of the organism/antigen. Rule Type: Range and limit Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml index 273102318..f7ff8702d 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0608/rule.yml @@ -29,8 +29,7 @@ Core: Id: CDISC.SDTMIG.CG0608 Status: Draft Version: "1" -Description: - Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or +Description: Verify MBTSTDTL is "DETECTION" if the tests targets an organism, group of organisms, or antigen. Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml index 851a601fe..49ee46109 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0609/rule.yml @@ -30,8 +30,7 @@ Core: Id: CDISC.SDTMIG.CG0609 Status: Draft Version: "1" -Description: - Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of +Description: Verify MBTESTCD is "MCORGIDN" if the test is for a non-targeted identification of organisms. Executability: Fully Executable Outcome: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml index a71f8cbd7..f2e8c3b85 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0610/rule.yml @@ -29,13 +29,11 @@ Core: Id: CDISC.SDTMIG.CG0610 Status: Draft Version: "1" -Description: - If the test is for culture characteristics, verify that MBTEST equals the name of the +Description: If the test is for culture characteristics, verify that MBTEST equals the name of the organism/antigen being characterized. Executability: Fully Executable Outcome: - Message: - Test is for culture characteristics, but MBTEST is not the name of the organism or group + Message: Test is for culture characteristics, but MBTEST is not the name of the organism or group of organisms. Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml index 4c8eef5cc..4ba06266b 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0651/rule.yml @@ -53,8 +53,7 @@ Core: Id: CDISC.SDTMIG.CG0651 Status: Draft Version: "1" -Description: - Raise an error when variable Core Status = Permissible and data is planned to be +Description: Raise an error when variable Core Status = Permissible and data is planned to be collected, but variable is not present Executability: Partially Executable - Possible Underreporting Operations: @@ -63,8 +62,7 @@ Operations: - id: $get_column_order_from_dataset operator: get_column_order_from_dataset Outcome: - Message: - Variable is missing, where variable core status is permissible and data is planned to be + Message: Variable is missing, where variable core status is permissible and data is planned to be collected. Output Variables: - define_variable_name diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml index 9ac983547..650e465a0 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0663/rule.yml @@ -31,8 +31,9 @@ Check: value: ^APFA$ - name: DOMAIN operator: not_matches_regex - value: ^AP[A-Z][A-Z0-9]$ - # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character + value: + ^AP[A-Z][A-Z0-9]$ + # Fire query if domain name starts with APFA and is not followed by an alpha character, then an alphanum character - all: - name: DOMAIN operator: prefix_matches_regex @@ -57,8 +58,7 @@ Core: Id: CDISC.SDTMIG.CG0663 Status: Draft Version: "1" -Description: - Raise an error when an AP Core Domain does not have a value length of 4 characters +Description: Raise an error when an AP Core Domain does not have a value length of 4 characters beginning with 'AP' and ending with 2 character SDTM domain Executability: Fully Executable Operations: @@ -66,8 +66,7 @@ Operations: name: domain_suffix operator: extract_metadata Outcome: - Message: - AP Core Domain does not have a value length of 4 characters beginning with 'AP' and + Message: AP Core Domain does not have a value length of 4 characters beginning with 'AP' and ending with 2 character SDTM domain Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CG0011B1/rule.yml b/Unpublished/SDTMIG/CG0011B1/rule.yml index 479a98a82..d8c9ede42 100644 --- a/Unpublished/SDTMIG/CG0011B1/rule.yml +++ b/Unpublished/SDTMIG/CG0011B1/rule.yml @@ -60,8 +60,9 @@ Check: - name: --ENDTC operator: non_empty - name: --ENDTC - operator: invalid_date - # DM-specific date/time variables + operator: + invalid_date + # DM-specific date/time variables - all: - name: RFSTDTC operator: non_empty diff --git a/Unpublished/SDTMIG/CORE-000343/rule.yml b/Unpublished/SDTMIG/CORE-000343/rule.yml index 879063250..a2b5c227f 100644 --- a/Unpublished/SDTMIG/CORE-000343/rule.yml +++ b/Unpublished/SDTMIG/CORE-000343/rule.yml @@ -50,13 +50,11 @@ Core: Id: CORE-000343 Status: Draft Version: "1" -Description: - Trigger error when variable format does not match SDTM-specified controlled terminology +Description: Trigger error when variable format does not match SDTM-specified controlled terminology or format guidelines for variables (when provided) Executability: Not Executable Outcome: - Message: - Variable format does not match SDTM-specified controlled terminology or format guidelines + Message: Variable format does not match SDTM-specified controlled terminology or format guidelines for variables (when provided) Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CORE-000344/rule.yml b/Unpublished/SDTMIG/CORE-000344/rule.yml index ebac9d39b..47bae367a 100644 --- a/Unpublished/SDTMIG/CORE-000344/rule.yml +++ b/Unpublished/SDTMIG/CORE-000344/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Conformance with the SDTMIG Domain Models is minimally indicated by + - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by following SDTM-specified controlled terminology and format guidelines for variables, when provided Document: IG v3.4 @@ -66,8 +65,7 @@ Core: Id: CORE-000344 Status: Draft Version: "1" -Description: - Trigger error if the value of a variable, which is associated with an extensible +Description: Trigger error if the value of a variable, which is associated with an extensible codelist, is in the associated codelist or equal to 'MULTIPLE' Executability: Not Executable Outcome: diff --git a/Unpublished/SDTMIG/CORE-000345/rule.yml b/Unpublished/SDTMIG/CORE-000345/rule.yml index 102e152e3..b5c2d95e6 100644 --- a/Unpublished/SDTMIG/CORE-000345/rule.yml +++ b/Unpublished/SDTMIG/CORE-000345/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SDTMIG References: - Citations: - - Cited Guidance: - Conformance with the SDTMIG Domain Models is minimally indicated by + - Cited Guidance: Conformance with the SDTMIG Domain Models is minimally indicated by following SDTM-specified controlled terminology and format guidelines for variables, when provided Document: IG v3.4 @@ -60,8 +59,7 @@ Core: Id: CORE-000345 Status: Draft Version: "1" -Description: - Trigger error if the value of a variable, which is associated with an extensible +Description: Trigger error if the value of a variable, which is associated with an extensible codelist, is in the associated codelist or equal to 'OTHER' Executability: Not Executable Outcome: diff --git a/Unpublished/SDTMIG/CORE-000347/rule.yml b/Unpublished/SDTMIG/CORE-000347/rule.yml index 3fb62f845..e16a5a405 100644 --- a/Unpublished/SDTMIG/CORE-000347/rule.yml +++ b/Unpublished/SDTMIG/CORE-000347/rule.yml @@ -72,13 +72,11 @@ Core: Id: CORE-000347 Status: Draft Version: "1" -Description: - Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or +Description: Trigger error when DSCAT = 'DISPOSITION EVENT' and DSTERM does not equal 'COMPLETED' or the reason for discontinuation Executability: Not Executable Outcome: - Message: - DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT = + Message: DSTERM does not equal 'COMPLETED' or the reason for discontinuation when DSCAT = 'DISPOSITION EVENT' Rule Type: Record Data Scope: diff --git a/Unpublished/SDTMIG/CORE-000348/rule.yml b/Unpublished/SDTMIG/CORE-000348/rule.yml index 8a436af28..0539746b8 100644 --- a/Unpublished/SDTMIG/CORE-000348/rule.yml +++ b/Unpublished/SDTMIG/CORE-000348/rule.yml @@ -53,8 +53,7 @@ Core: Id: CORE-000348 Status: Draft Version: "1" -Description: - Trigger error if deviation record is a derived variable, not a deviation that was +Description: Trigger error if deviation record is a derived variable, not a deviation that was collected Executability: Not Executable Outcome: diff --git a/Unpublished/SDTMIG/CORE-000350/rule.yml b/Unpublished/SDTMIG/CORE-000350/rule.yml index cbd157e38..74b7174e6 100644 --- a/Unpublished/SDTMIG/CORE-000350/rule.yml +++ b/Unpublished/SDTMIG/CORE-000350/rule.yml @@ -51,8 +51,7 @@ Core: Id: CORE-000350 Status: Draft Version: "1" -Description: - Trigger error if --TRT represents an alteration to the collected value for coding +Description: Trigger error if --TRT represents an alteration to the collected value for coding purposes and --MODIFY is null Executability: Not Executable Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml index 2eb350f4f..fe19d66ee 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.101/rule.yml @@ -103,8 +103,7 @@ Core: Id: CDISC.SENDIG.101 Status: Draft Version: "1" -Description: - Raise a message when the define.xml does not explain how DM.RFENDTC was populated, +Description: Raise a message when the define.xml does not explain how DM.RFENDTC was populated, using either def:CommentOID (on ItemDef) or MethodOID (on ItemRef) Executability: Partially Executable - Possible Underreporting Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml index 733b93ec6..7cf879a49 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.105/rule.yml @@ -101,8 +101,7 @@ Core: Id: CDISC.SENDIG.105 Status: Draft Version: "1" -Description: - Raise an error when the variable SPECIES is not present in DM, and there is no record +Description: Raise an error when the variable SPECIES is not present in DM, and there is no record TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX Executability: Fully Executable #Operations: @@ -121,8 +120,7 @@ Executability: Fully Executable # name: TXPARMCD # operator: distinct Outcome: - Message: - SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is + Message: SPECIES in not present in DM and there is no record TSPARMCD=SPECIES in TS and there is no record TXPARMCD=SPECIES in TX #Output Variables: # - $distinct_tsparmcd diff --git a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml index 131965f45..6edd4cd61 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.107/rule.yml @@ -45,8 +45,7 @@ Core: Id: CDISC.SENDIG.107 Status: Draft Version: "1" -Description: - When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. diff --git a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml index a0874f247..509da38d8 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.112/rule.yml @@ -114,8 +114,7 @@ Core: Id: CDISC.SENDIG.112 Status: Draft Version: "1" -Description: - When AGE is described as "derived" in the define.xml, check whether either a Method or +Description: When AGE is described as "derived" in the define.xml, check whether either a Method or a Comment is assigned to the variable AGE in the define.xml Executability: Partially Executable - Possible Overreporting Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml index 5d7acdb6b..20eed8d57 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.127/rule.yml @@ -28,8 +28,7 @@ Core: Id: CDISC.SENDIG.127 Status: Draft Version: "1" -Description: - Because there are no time gaps between Elements, the SEENDTC value for the last Element +Description: Because there are no time gaps between Elements, the SEENDTC value for the last Element is the date of subject disposition. Executability: Fully Executable Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml index cf4fe560c..66280d53f 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.137/rule.yml @@ -28,13 +28,11 @@ Core: Id: CDISC.SENDIG.137 Status: Draft Version: "1" -Description: - Raise a message when the define.xml does not contain an explanation of EXDOSE values +Description: Raise a message when the define.xml does not contain an explanation of EXDOSE values with respect for intended or actual dose levels, using a reference to a def:CommentDef Executability: Partially Executable - Possible Underreporting Outcome: - Message: - The define.xml does not contain an explanation of EXDOSE values with respect for intended + Message: The define.xml does not contain an explanation of EXDOSE values with respect for intended or actual dose levels # Rule Type: Value Check against Define XML Variable Rule Type: Variable Metadata Check against Define XML diff --git a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml index 65ee5fd7c..cd53c5738 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.140/rule.yml @@ -85,8 +85,9 @@ Check: operator: non_empty - name: USUBJID operator: is_not_contained_by - value: $ds_usubjid - # TODO: how do we express that for each record in DM, there must exactly be one record in DS? + value: + $ds_usubjid + # TODO: how do we express that for each record in DM, there must exactly be one record in DS? Core: Id: CDISC.SENDIG.140 diff --git a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml index cd7a1e757..a63c70466 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.180/rule.yml @@ -68,14 +68,12 @@ Core: Id: CDISC.SENDIG.180 Status: Draft Version: "1" -Description: - Raise an error when there is more than one record present for any particular +Description: Raise an error when there is more than one record present for any particular Microscopic Finding in the MI Domain, for a specific subject, test code, specimen, laterality, directionality, anatomical region and standardized resulz Executability: Fully Executable Outcome: - Message: - The Microscopic Finding record is not unique for this subject, test code, specimen, + Message: The Microscopic Finding record is not unique for this subject, test code, specimen, standardized result and laterality (when present and populated), directionality (when present and populated) and anatomical region (when present and populated) Output Variables: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml index e5466b17e..0650a2c40 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190.1B/rule.yml @@ -91,8 +91,9 @@ Check: value: OWBW - name: OMTESTCD operator: equal_to - value: OWHT - # Part: Ratios and percentages should not be mixed. + value: + OWHT + # Part: Ratios and percentages should not be mixed. - all: - name: OMSTRESU operator: is_inconsistent_across_dataset diff --git a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml index ff6f9acc8..619f34ca7 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.190B/rule.yml @@ -52,13 +52,14 @@ Check: value: "" - name: OMSTRESU operator: not_equal_to - value: "%" - # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed - # 2026-03-03: we exclude OMSTAT='NOT DONE' - # "RATIO" is not considered here - # OMTESTCD=OWBR: Organ to Brain Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 + value: + "%" + # Part B of the rule: i.e. that within OMTESTCD, OMSTRESU=% and OMSTRESU=null may not be mixed + # 2026-03-03: we exclude OMSTAT='NOT DONE' + # "RATIO" is not considered here + # OMTESTCD=OWBR: Organ to Brain Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 - all: - name: OMTESTCD operator: equal_to @@ -71,11 +72,12 @@ Check: value: 0 - name: $owbr_ratio_null_unit operator: greater_than - value: 0 - # OMTESTCD=OWBW: Organ to BodyWeight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU=null rcords > 0 - # 2026-03-03: we exclude OMSTAT='NOT DONE' + value: + 0 + # OMTESTCD=OWBW: Organ to BodyWeight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU=null rcords > 0 + # 2026-03-03: we exclude OMSTAT='NOT DONE' - all: - name: OMTESTCD operator: equal_to @@ -88,10 +90,11 @@ Check: value: 0 - name: $owbw_ratio_null_unit operator: greater_than - value: 0 - # OMTESTCD=OWHT: Organ to Heart Weight Ratio - # Raise a violation when the number of OMSTRESU='%'' rcords > 0 - # AND the number of OMSTRESU='RATIO'' rcords > 0 + value: + 0 + # OMTESTCD=OWHT: Organ to Heart Weight Ratio + # Raise a violation when the number of OMSTRESU='%'' rcords > 0 + # AND the number of OMSTRESU='RATIO'' rcords > 0 - all: - name: OMTESTCD operator: equal_to @@ -109,8 +112,7 @@ Core: Id: CDISC.SENDIG.190B Status: Draft Version: "1" -Description: - Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the +Description: Trigger error when, for the given test, the value of OMSTRESU is inconsistent in the dataset when OMTESTCD is either OWBR, OWBW or OWHT Executability: Fully Executable Operations: @@ -172,8 +174,7 @@ Operations: # operator: distinct Outcome: - Message: - The organ weight standardized measurement unit must be consistent for the given + Message: The organ weight standardized measurement unit must be consistent for the given OMTESTCD'. Output Variables: - OMTESTCD diff --git a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml index e8babb108..41ec4586d 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.222/rule.yml @@ -109,8 +109,7 @@ Core: Id: CDISC.SENDIG.222 Status: Draft Version: "1" -Description: - The values of ETCD used in the Trial Arms dataset must match values for the same +Description: The values of ETCD used in the Trial Arms dataset must match values for the same Element in the Trial Elements dataset. Executability: Fully Executable Operations: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml index e78fc4583..699c3d562 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.223/rule.yml @@ -102,8 +102,7 @@ Core: Id: CDISC.SENDIG.223 Status: Draft Version: "1" -Description: - When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. diff --git a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml index 84e275af9..953b233cf 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.225/rule.yml @@ -102,8 +102,7 @@ Core: Id: CDISC.SENDIG.225 Status: Draft Version: "1" -Description: - When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must +Description: When study does not use multi-stage arm assignments and ARMCD is populated, ARMCD must be present in TA.ARMCD. This rule has been executed to identify all cases when ARMCD is not present in TA.ARMCD and therefore acknowledges that false positives may be recorded when multi-stage arm assignments are in use. diff --git a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml index 306abe072..77fd375f0 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.247/rule.yml @@ -240,8 +240,7 @@ Core: Id: CDISC.SENDIG.247 Status: Draft Version: "1" -Description: - For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, +Description: For each TSPARMCD = AGEU, SDESIGN, DOSDUR, EXPENDTC, EXPSTDTC, GLPTYP, ROUTE, SNDIGVER, SNDCTVER, SPECIES, SPLRNAM, SPREFID, SSPONSOR, STCAT, STDIR, STRAIN, STSTDTC, STITLE, SSTYP, TRT, TFCNTRY, TSTFLOC, TSTFNAM, TRMSAC, TRTCAS, TRTV, a record must be present in TS Executability: Fully Executable diff --git a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml index 2846b793a..55499619c 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.265.1/rule.yml @@ -66,8 +66,7 @@ Core: Id: CDISC.SENDIG.265.1 Status: Draft Version: "1" -Description: - Raise an error when variable role is 'Identifier', but the variable is not found in the +Description: Raise an error when variable role is 'Identifier', but the variable is not found in the SDTM model correspond to the role in the IG Executability: Fully Executable Operations: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml index 5e677bfc0..70747ee01 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.309/rule.yml @@ -7,8 +7,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Sets (TX) can have multiple species and/or strains if they are + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are different by set. DM records with different values for SPECIES cannot have the same SETCD value. Document: IG v3.1 @@ -22,8 +21,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - Trial Sets (TX) can have multiple species and/or strains if they are + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are different by set. DM records with different values for SPECIES cannot have the same SETCD value. Document: IG v3.1.1 @@ -37,8 +35,7 @@ Authorities: - Name: SENDIG-DART References: - Citations: - - Cited Guidance: - Trial Sets (TX) can have multiple species and/or strains if they are + - Cited Guidance: Trial Sets (TX) can have multiple species and/or strains if they are different by set. DM records with different values for SPECIES cannot have the same SETCD value. Document: IG v3.1 diff --git a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml index 5267662e9..f3bf0804d 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.362/rule.yml @@ -51,8 +51,7 @@ Core: Id: CDISC.SENDIG.362 Status: Draft Version: "1" -Description: - Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not +Description: Raise an error when the value of PYTESTCD = PREGSTAT and the value of PYSTRESC is not one of the codelist PYFINDRS Executability: Fully Executable Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml index 2e19ae684..510220f1a 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.4/rule.yml @@ -113,8 +113,7 @@ Core: Id: CDISC.SENDIG.4 Status: Draft Version: "1" -Description: - Raise an error when the data type in the define.xml does not correspond to the data +Description: Raise an error when the data type in the define.xml does not correspond to the data type in the dataset Executability: Fully Executable Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml index 969885480..d14246301 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.71/rule.yml @@ -100,8 +100,7 @@ Core: Id: CDISC.SENDIG.71 Status: Draft Version: "1" -Description: - --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after +Description: --DY = (date portion of --DTC) - (date portion of RFSTDTC) + 1 if --DTC is on or after RFSTDTC; --DY = (date portion of --DTC) - (date portion of RFSTDTC) if --DTC precedes RFSTDTC Executability: Fully Executable Match Datasets: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml index 7396369bd..6c6cb391d 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND142/rule.yml @@ -89,8 +89,7 @@ Core: Id: CDISC.SENDIG.SEND142 Status: Draft Version: "1" -Description: - Raise an error when there is more than one record present for any particular Body +Description: Raise an error when there is more than one record present for any particular Body Weight test, in the BW Domain, for a subject on a particular date. #The check for this rule was revised to NOT check the records where BWDTC is null Outcome: diff --git a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml index ce11b77fb..43b6ef1ee 100644 --- a/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml +++ b/Unpublished/SENDIG/CDISC.SENDIG.SEND157/rule.yml @@ -130,8 +130,7 @@ Core: Id: CDISC.SENDIG.SEND157 Status: Draft Version: "1" -Description: - Raise an error when the mass identification is not unique within the subject, +Description: Raise an error when the mass identification is not unique within the subject, regardless of the mass location. Outcome: Message: The mass identification is not unique within the subject regardless of the mass location. diff --git a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml index 064fad0ae..72af22b1e 100644 --- a/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml +++ b/Unpublished/SENDIG/FDA.SDTMIG.FB1901/rule.yml @@ -218,8 +218,7 @@ Core: Id: FDA.SDTMIG.FB1901 Status: Draft Version: "1" -Description: - When CDISC published Controlled Terminology indicates that a codelist is non-extensible +Description: When CDISC published Controlled Terminology indicates that a codelist is non-extensible then only terms from the codelist should be used. Executability: Fully Executable Operations: diff --git a/Unpublished/SENDIG/SEND100/rule.yml b/Unpublished/SENDIG/SEND100/rule.yml index 4535b327b..0b33578ea 100644 --- a/Unpublished/SENDIG/SEND100/rule.yml +++ b/Unpublished/SENDIG/SEND100/rule.yml @@ -98,8 +98,7 @@ Core: Id: SEND100 Status: Draft Version: "1" -Description: - Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to +Description: Check in the define.xml whether there is a "Method" (@MethodOID/MethodDef) attached to the DM variable DM Executability: Fully Executable Outcome: diff --git a/Unpublished/SENDIG/SEND106.1/rule.yml b/Unpublished/SENDIG/SEND106.1/rule.yml index 8b1e1a337..51d2780c1 100644 --- a/Unpublished/SENDIG/SEND106.1/rule.yml +++ b/Unpublished/SENDIG/SEND106.1/rule.yml @@ -80,10 +80,11 @@ Check: - name: STRAIN operator: not_exists - name: STRAIN - operator: empty - # Either TSPARMCD=STRAIN is missing from TS - # or TSVAL is null when TSPARMCD=STRAIN - # or TXVAL is null when TXPARMCD=STRAIN + operator: + empty + # Either TSPARMCD=STRAIN is missing from TS + # or TSVAL is null when TSPARMCD=STRAIN + # or TXVAL is null when TXPARMCD=STRAIN - all: - any: - name: $distinct_tsparmcd @@ -113,8 +114,7 @@ Core: Id: SEND106.1 Status: Draft Version: "1" -Description: - When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an +Description: When "STRAIN" is absent in DM, and also absent as a parameter in TS and TX, report an error Executability: Fully Executable # 2025-02-25: Jozef: what is this doing? diff --git a/Unpublished/SENDIG/SEND310/rule.yml b/Unpublished/SENDIG/SEND310/rule.yml index 7d7948075..30fea40a2 100644 --- a/Unpublished/SENDIG/SEND310/rule.yml +++ b/Unpublished/SENDIG/SEND310/rule.yml @@ -81,8 +81,9 @@ Check: operator: exists - name: STRAIN operator: is_inconsistent_across_dataset - value: SETCD - # Second case: SPECIES + value: + SETCD + # Second case: SPECIES - all: # only apply when SPECIES is present, as it is "permissible" - name: SPECIES diff --git a/Unpublished/SENDIG/SEND340/rule.yml b/Unpublished/SENDIG/SEND340/rule.yml index dbc5a0a77..958b34540 100644 --- a/Unpublished/SENDIG/SEND340/rule.yml +++ b/Unpublished/SENDIG/SEND340/rule.yml @@ -42,8 +42,7 @@ Core: Id: SEND340 Status: Draft Version: "1" -Description: - If expected variables in a domain are all null, a comment should be included in the +Description: If expected variables in a domain are all null, a comment should be included in the Define-XML document to explain why all records are null. Executability: Fully Executable Operations: diff --git a/Unpublished/SENDIG/SEND348/rule.yml b/Unpublished/SENDIG/SEND348/rule.yml index 996b2c61a..8860275fa 100644 --- a/Unpublished/SENDIG/SEND348/rule.yml +++ b/Unpublished/SENDIG/SEND348/rule.yml @@ -58,8 +58,9 @@ Check: - name: PCTPTREF operator: empty - name: PCELTM - operator: empty - # case that POOLID is populated. ATTENTION: POOLID is permissible! + operator: + empty + # case that POOLID is populated. ATTENTION: POOLID is permissible! - all: # PC-POOLID column is present - name: POOLID diff --git a/Unpublished/SENDIG/SEND41/rule.yml b/Unpublished/SENDIG/SEND41/rule.yml index 524d4123b..cdf820084 100644 --- a/Unpublished/SENDIG/SEND41/rule.yml +++ b/Unpublished/SENDIG/SEND41/rule.yml @@ -4,8 +4,7 @@ Authorities: - Name: SENDIG References: - Citations: - - Cited Guidance: - When extending a controlled terminology list, the case-sensitivity + - Cited Guidance: When extending a controlled terminology list, the case-sensitivity convention of that list should be followed. Document: IG v3.0 Item: Specification diff --git a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml index 0d75b9a94..5cbc3dfc6 100644 --- a/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml +++ b/Unpublished/SENDIG/SEND_AUTHORING_TEMPLATE/rule.yml @@ -12,8 +12,7 @@ Authorities: Logical Expression: Condition: "" Rule: "" - Plain Language Expression: - This is where you describe the rule in human readable + Plain Language Expression: This is where you describe the rule in human readable sentence(s). Type: Success Origin: SEND Conformance Rules diff --git a/Unpublished/TIG/TIG0031/rule.yml b/Unpublished/TIG/TIG0031/rule.yml index dcc2b7de1..75062fe53 100644 --- a/Unpublished/TIG/TIG0031/rule.yml +++ b/Unpublished/TIG/TIG0031/rule.yml @@ -30,8 +30,7 @@ Check: Core: Status: Draft Version: "1" -Description: - Raise an error when a record has a PARENT record but the value for LEVEL does not equal +Description: Raise an error when a record has a PARENT record but the value for LEVEL does not equal the level of the PARENT LEVEL + 1. Executability: Fully Executable Match Datasets: @@ -41,8 +40,7 @@ Match Datasets: Right: REFID Name: RELREF Outcome: - Message: - Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT + Message: Record has a PARENT record but the value for LEVEL does not equal the level of the PARENT LEVEL + 1. Output Variables: - LEVEL diff --git a/Unpublished/TIG/TIG0044/rule.yml b/Unpublished/TIG/TIG0044/rule.yml index d112bcb1c..e48722fd4 100644 --- a/Unpublished/TIG/TIG0044/rule.yml +++ b/Unpublished/TIG/TIG0044/rule.yml @@ -31,8 +31,7 @@ Core: Id: Status: Draft Version: "1" -Description: - Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS +Description: Part A - Raise an error when there is no record with TSPARMCD = "STRAIN" present in TS or TSVAL is not completed and no record with TXPARMCD = "STRAIN" present in TX or TXVAL is not completed. Executability: Fully Executable @@ -52,8 +51,7 @@ Operations: name: TSPARMCD operator: record_count Outcome: - Message: - There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record + Message: There should be a record in TS with TSPARMCD = "STRAIN" and completed TSVAL or a record in TX with TXPARMCD = "STRAIN" and completed TXVAL. Output Variables: - $txparmcdstrain_count From 185938463f409761bc823cf542ea5ca9af874c5b Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 16:17:09 -0400 Subject: [PATCH 14/18] chore: normalize line endings to LF --- .gitattributes | 6 ++++++ Published/CORE-000011/rule.yml | 2 +- 2 files changed, 7 insertions(+), 1 deletion(-) diff --git a/.gitattributes b/.gitattributes index 2c695418b..2f2247c5c 100644 --- a/.gitattributes +++ b/.gitattributes @@ -1,2 +1,8 @@ # Explicitly force LF for files *.csv text eol=lf + +# Force LF line endings for text files, regardless of local core.autocrlf +* text=auto eol=lf + +*.yml text eol=lf +*.yaml text eol=lf \ No newline at end of file diff --git a/Published/CORE-000011/rule.yml b/Published/CORE-000011/rule.yml index e77ff07e3..8b7c2a34f 100644 --- a/Published/CORE-000011/rule.yml +++ b/Published/CORE-000011/rule.yml @@ -8,7 +8,7 @@ Authorities: References: - Citations: - Cited Guidance: The intent of the domain model is to collect responses to only those - criteria that the subject did not meet, and not the responses to all criteria.  + criteria that the subject did not meet, and not the responses to all criteria. Document: SDTMIG v3.4 Item: Assumption 1 Section: 6.3.4 From d70d063775b367ad25be217eacf36bdbcd9df572 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 20 Jul 2026 16:23:03 -0400 Subject: [PATCH 15/18] formatting --- Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml | 1 - Unpublished/SENDIG/SEND340/rule.yml | 1 - 2 files changed, 2 deletions(-) diff --git a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml index 50618976a..287f9f750 100644 --- a/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml +++ b/Unpublished/SDTMIG/CDISC.SDTMIG.CG0321/rule.yml @@ -111,5 +111,4 @@ Scope: Include: - ALL Sensitivity: Dataset - # Document End diff --git a/Unpublished/SENDIG/SEND340/rule.yml b/Unpublished/SENDIG/SEND340/rule.yml index 958b34540..b38529561 100644 --- a/Unpublished/SENDIG/SEND340/rule.yml +++ b/Unpublished/SENDIG/SEND340/rule.yml @@ -70,5 +70,4 @@ Scope: Include: - ALL Sensitivity: Record - #Sensitivity: Dataset From 653173b7dd83be0e0954efeb24a09e7041146fe8 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Fri, 24 Jul 2026 10:22:57 -0400 Subject: [PATCH 16/18] data, schema, sorting --- .github/workflows/validate-yaml-format.yml | 2 +- .vscode/settings.json | 5 +++-- Published/CORE-000117/rule.yml | 2 +- Published/CORE-000770/negative/01/data/tx.csv | 3 ++- Published/CORE-000786/negative/01/data/_datasets.csv | 1 + Published/CORE-000786/negative/01/data/_variables.csv | 6 ++++++ Published/CORE-000786/negative/01/data/ti.csv | 9 +++++++++ .../negative/01/data/ScheduledDecisionInstance.csv | 6 +++--- .../positive/01/data/ScheduledDecisionInstance.csv | 6 +++--- 9 files changed, 29 insertions(+), 11 deletions(-) create mode 100644 Published/CORE-000786/negative/01/data/ti.csv diff --git a/.github/workflows/validate-yaml-format.yml b/.github/workflows/validate-yaml-format.yml index 502b9e170..74e5012e6 100644 --- a/.github/workflows/validate-yaml-format.yml +++ b/.github/workflows/validate-yaml-format.yml @@ -30,7 +30,7 @@ jobs: with: node-version: "20" - name: Install Prettier - run: npm install -g prettier@3.3.3 + run: npm install -g prettier - name: Detect changed rule.yml files id: changed-files diff --git a/.vscode/settings.json b/.vscode/settings.json index b8e8225a6..42dc1cbf1 100644 --- a/.vscode/settings.json +++ b/.vscode/settings.json @@ -1,4 +1,5 @@ { + "extensions.autoUpdate": true, "yaml.schemas": { "https://raw.githubusercontent.com/cdisc-org/cdisc-rules-engine/refs/heads/main/resources/schema/rule-merged/CORE-base.json": "rule.yml" }, @@ -7,7 +8,7 @@ { "match": "rule\\.yml$", "isAsync": false, - "cmd": "${workspaceFolder}/venv/bin/python ${workspaceFolder}/scripts/sort_yaml.py --no-format ${file}" + "cmd": "${workspaceFolder}/venv/bin/python ${workspaceFolder}/scripts/sort_yaml.py ${file}" } ] }, @@ -16,4 +17,4 @@ "editor.formatOnSave": true }, "yaml.format.enable": false -} +} \ No newline at end of file diff --git a/Published/CORE-000117/rule.yml b/Published/CORE-000117/rule.yml index 627528f99..fca18d2e5 100644 --- a/Published/CORE-000117/rule.yml +++ b/Published/CORE-000117/rule.yml @@ -42,7 +42,7 @@ Authorities: Origin: SDTM and SDTMIG Conformance Rules Rule Identifier: Id: CG0081 - Version: "1.0" + Version: "1" Version: "2.0" Version: "3.4" - Name: SDTMIG diff --git a/Published/CORE-000770/negative/01/data/tx.csv b/Published/CORE-000770/negative/01/data/tx.csv index 5b6d0f3e7..c50dd4d6c 100644 --- a/Published/CORE-000770/negative/01/data/tx.csv +++ b/Published/CORE-000770/negative/01/data/tx.csv @@ -5,4 +5,5 @@ CDISCPILOT01,TX,SET1,"Control Group, Vehicle Control once daily ",3,TCNTRL,Contr CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",4,ARMCD,Arm Code,ARM2 CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",5,XXSPGRPCD,Sponsor-defined Group Code,GRP2 CDISCPILOT01,TX,SET2,"Low-Dose Group, 100 mg/kg Drug a once daily ",6,GRPLBL,Group Label,Label 2 -CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",6,ARMCD,Arm Code,ARM3 +CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",7,ARMCD,Arm Code,ARM3 +CDISCPILOT01,TX,SET3,"Low-Dose Group, 100 mg/kg Drug a once daily ",8,TCNTRL,Control Type,Vehicle Control diff --git a/Published/CORE-000786/negative/01/data/_datasets.csv b/Published/CORE-000786/negative/01/data/_datasets.csv index 87639a89d..18280d3ae 100644 --- a/Published/CORE-000786/negative/01/data/_datasets.csv +++ b/Published/CORE-000786/negative/01/data/_datasets.csv @@ -14,3 +14,4 @@ mh,Medical History da,Product Accountability eg,ECG Test Results fa,Findings About Events or Interventions +ti,Trial Inclusion/Exclusion Criteria \ No newline at end of file diff --git a/Published/CORE-000786/negative/01/data/_variables.csv b/Published/CORE-000786/negative/01/data/_variables.csv index d5bd786ee..1c9c2fe22 100644 --- a/Published/CORE-000786/negative/01/data/_variables.csv +++ b/Published/CORE-000786/negative/01/data/_variables.csv @@ -104,3 +104,9 @@ fa,FATESTCD,Findings About Test Short Name,Char,8 fa,FATEST,Findings About Test Name,Char,40 fa,FAOBJ,Object of the Observation,Char,50 fa,FASCAT,Subcategory for Findings About,Char,50 +ti,STUDYID,Study Identifier,Char,12 +ti,DOMAIN,Domain Abbreviation,Char,2 +ti,IETESTCD,Incl/Excl Criterion Short Name,Char,7 +ti,IETEST,Inclusion/Exclusion Criterion,Char,196 +ti,IESCAT,Inclusion/Exclusion Subcategory,Char,9 +ti,TIVERS,Protocol Criteria Versions,Char,200 diff --git a/Published/CORE-000786/negative/01/data/ti.csv b/Published/CORE-000786/negative/01/data/ti.csv new file mode 100644 index 000000000..0d64f6420 --- /dev/null +++ b/Published/CORE-000786/negative/01/data/ti.csv @@ -0,0 +1,9 @@ +STUDYID,DOMAIN,IETESTCD,IETEST,IESCAT,TIVERS +CDISCPILOT01,TI,INCL01,Males and postmenopausal females at least 50 years of age.,INCLUSION,ORIGINAL +CDISCPILOT01,TI,INCL02,Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines.,INCLUSION,ORIGINAL +CDISCPILOT01,TI,INCL03,MMSE score of 10 to 23.,,ORIGINAL +CDISCPILOT01,TI,EXCL11,Serious illness which required hospitalization within 3 months of screening.,EXCLUSION,ORIGINAL +CDISCPILOT01,TI,EXCL14,"A history within the last 5 years of the following: a) Schizophrenia b) Bipolar Disease c) Ethanol or psychoactive drug abuse or dependence.",EXCLUSION,AMENDMENT 1 +CDISCPILOT01,TI,EXCL15,A history of syncope within the last 5 years.,,AMENDMENT 1 +CDISCPILOT01,TI,EXCL16,"Evidence from ECG recording at screening of any of the following conditions: a) Left bundle branch block b) Bradycardia <50 beats per minute c) Sinus pauses >2 seconds (See Protocol for Remainder)",EXCLUSION,AMENDMENT 1 +CDISCPILOT01,TI,EXCL17,"A history within the last 5 years of a serious cardiovascular disorder, including a) Clinically significant arrhythmia (See Protocol for Remainder)",EXCLUSION,AMENDMENT 1 diff --git a/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv b/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv index b31f894d6..75d4ed31f 100644 --- a/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv +++ b/Published/CORE-000804/negative/01/data/ScheduledDecisionInstance.csv @@ -1,4 +1,4 @@ parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,defaultConditionId,epochId,timelineId,timelineExitId,instanceType,conditionAssignments -ScheduleTimeline,ScheduleTimeline_4,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 -ScheduleTimeline,ScheduleTimeline_4,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 -Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 +ScheduleTimeline,ScheduleTimeline_4,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True +ScheduleTimeline,ScheduleTimeline_4,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True +Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True diff --git a/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv b/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv index 50efb5ea1..bb5f2ac0a 100644 --- a/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv +++ b/Published/CORE-000804/positive/01/data/ScheduledDecisionInstance.csv @@ -1,4 +1,4 @@ parent_entity,parent_id,parent_rel,rel_type,id,name,description,label,defaultConditionId,epochId,timelineId,timelineExitId,instanceType,conditionAssignments -ScheduleTimeline,ScheduleTimeline_1,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 -ScheduleTimeline,ScheduleTimeline_1,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 -Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,ConditionAssignment_1 +ScheduleTimeline,ScheduleTimeline_1,instances,definition,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True +ScheduleTimeline,ScheduleTimeline_1,entryId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True +Timing,Timing_6,relativeToScheduledInstanceId,reference,ScheduledDecisionInstance_1,Meet requirements for WK6 or end,,,ScheduledActivityInstance_27,,,,ScheduledDecisionInstance,True From fc919f2e66fd0a94d870121f2f6dd5a1d4d4131c Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Mon, 3 Aug 2026 17:15:02 -0400 Subject: [PATCH 17/18] current progress --- .../negative/01/results/results.csv | 2 - Published/CORE-000660/negative/01/data/.env | 3 +- Published/CORE-000673/negative/01/data/iq.csv | 4 +- .../negative/01/results/results.csv | 9 +++ .../negative/01/data/_datasets.csv | 2 +- .../negative/01/data/_variables.csv | 21 +++---- Published/CORE-000674/negative/01/data/pd.csv | 12 ++++ .../negative/01/results/results.csv | 56 ++++++++++++------- Published/CORE-000674/negative/02/data/.env | 4 ++ .../negative/02/data/_datasets.csv | 2 + .../negative/02/data/_variables.csv | 9 +++ Published/CORE-000674/negative/02/data/pd.csv | 12 ++++ .../negative/02/results/results.csv | 13 +++++ Published/CORE-000674/negative/03/data/.env | 4 ++ .../negative/03/data/_datasets.csv | 2 + .../negative/03/data/_variables.csv | 13 +++++ .../negative/{01 => 03}/data/iq.csv | 0 .../negative/03/results/results.csv | 21 +++++++ .../negative/01/data/_datasets.csv | 1 - .../negative/01/data/_variables.csv | 3 - .../CORE-000677/negative/01/data/pooldef.csv | 7 --- .../negative/02/data/_datasets.csv | 3 +- .../negative/02/data/_variables.csv | 3 - .../positive/02/data/_datasets.csv | 1 + .../positive/02/data/_variables.csv | 3 + .../02/data/pooldef.csv | 0 .../negative/01/results/results.csv | 34 +++++------ .../negative/02/data/_datasets.csv | 2 + .../CORE-000698/negative/02/data/results.csv | 2 - .../negative/02/results/results.csv | 32 +++++++---- 30 files changed, 194 insertions(+), 86 deletions(-) create mode 100644 Published/CORE-000673/negative/01/results/results.csv create mode 100644 Published/CORE-000674/negative/01/data/pd.csv create mode 100644 Published/CORE-000674/negative/02/data/.env create mode 100644 Published/CORE-000674/negative/02/data/_datasets.csv create mode 100644 Published/CORE-000674/negative/02/data/_variables.csv create mode 100644 Published/CORE-000674/negative/02/data/pd.csv create mode 100644 Published/CORE-000674/negative/02/results/results.csv create mode 100644 Published/CORE-000674/negative/03/data/.env create mode 100644 Published/CORE-000674/negative/03/data/_datasets.csv create mode 100644 Published/CORE-000674/negative/03/data/_variables.csv rename Published/CORE-000674/negative/{01 => 03}/data/iq.csv (100%) create mode 100644 Published/CORE-000674/negative/03/results/results.csv delete mode 100644 Published/CORE-000677/negative/01/data/pooldef.csv rename Published/CORE-000677/{negative => positive}/02/data/pooldef.csv (100%) create mode 100644 Published/CORE-000698/negative/02/data/_datasets.csv delete mode 100644 Published/CORE-000698/negative/02/data/results.csv diff --git a/Published/CORE-000653/negative/01/results/results.csv b/Published/CORE-000653/negative/01/results/results.csv index 72c2cb74f..5e2636035 100644 --- a/Published/CORE-000653/negative/01/results/results.csv +++ b/Published/CORE-000653/negative/01/results/results.csv @@ -7,5 +7,3 @@ DS,5,DSDTC,2018-05-08T09:13 DS,5,DSENDTC,2018-05-08T08:00 DS,6,DSDTC,2018-09-21 DS,6,DSENDTC,2018-09-04 -DS,8,DSDTC,2018-09-21T09:21 -DS,8,DSENDTC,2018-09-21 diff --git a/Published/CORE-000660/negative/01/data/.env b/Published/CORE-000660/negative/01/data/.env index 3eef46d54..2d7f67aab 100644 --- a/Published/CORE-000660/negative/01/data/.env +++ b/Published/CORE-000660/negative/01/data/.env @@ -1,4 +1,3 @@ PRODUCT=TIG VERSION=1-0 -SUBSTANDARD=SEND -USE_CASE=NONCLIN +SUBSTANDARD=sdtm diff --git a/Published/CORE-000673/negative/01/data/iq.csv b/Published/CORE-000673/negative/01/data/iq.csv index 255de2f14..4bb16ceee 100644 --- a/Published/CORE-000673/negative/01/data/iq.csv +++ b/Published/CORE-000673/negative/01/data/iq.csv @@ -1,6 +1,6 @@ STUDYID,DOMAIN,SPTOBID,IGDCMPID,IQCAT,IQPARENT,IQLEVEL,IQFUNCT,IQVALTRG,IQVALMIN,IQVALMAX,IQVALU -TOB07,IQ,CIG01A,Tobacco Filler,TOBACCO INGREDIENT,,1,,683.71,661.3,683.7,mg/cigarette +TOB07,IQ,CIG01A,Tobacco Filler,TOBACCO INGREDIENT,,1,,603.71,661.3,683.7,mg/cigarette TOB07,IQ,CIG01A,Bright Tobacco,TOBACCO INGREDIENT,Tobacco Filler,2,,306,295,305,mg/cigarette TOB07,IQ,CIG01A,Oriental Tobacco,TOBACCO INGREDIENT,Tobacco Filler,2,,118,,117,mg/cigarette TOB07,IQ,CIG01A,Cationic Starch,NON-TOBACCO INGREDIENT,FSC Paper B,2,Binder,0.46,,0.45,mg/cigarette -TOB07,IQ,CIG01A,Seam Adhesive,NON-TOBACCO INGREDIENT,FSC Paper B,2,Adhesive,-0.24,-1.75,-0.25,mg/cigarette +TOB07,IQ,CIG01A,Seam Adhesive,NON-TOBACCO INGREDIENT,FSC Paper B,2,Adhesive,-2.24,-1.75,-0.25,mg/cigarette diff --git a/Published/CORE-000673/negative/01/results/results.csv b/Published/CORE-000673/negative/01/results/results.csv new file mode 100644 index 000000000..590c8919c --- /dev/null +++ b/Published/CORE-000673/negative/01/results/results.csv @@ -0,0 +1,9 @@ +Dataset,Record,Variable,Value +IQ,1,IGDCMPID,Tobacco Filler +IQ,1,IQVALMIN,661.3 +IQ,1,IQVALTRG,603.71 +IQ,1,SPTOBID,CIG01A +IQ,5,IGDCMPID,Seam Adhesive +IQ,5,IQVALMIN,-1.75 +IQ,5,IQVALTRG,-2.24 +IQ,5,SPTOBID,CIG01A diff --git a/Published/CORE-000674/negative/01/data/_datasets.csv b/Published/CORE-000674/negative/01/data/_datasets.csv index 2f28eb4c1..8829a8a4b 100644 --- a/Published/CORE-000674/negative/01/data/_datasets.csv +++ b/Published/CORE-000674/negative/01/data/_datasets.csv @@ -1,2 +1,2 @@ Filename,Label -iq,Ingredient Quantities by Component +pd,Product Design Parameters diff --git a/Published/CORE-000674/negative/01/data/_variables.csv b/Published/CORE-000674/negative/01/data/_variables.csv index 4d51d0d4d..be4a7a9e2 100644 --- a/Published/CORE-000674/negative/01/data/_variables.csv +++ b/Published/CORE-000674/negative/01/data/_variables.csv @@ -1,13 +1,10 @@ dataset,variable,label,type,length -iq,STUDYID,Study Identifier,Char,50 -iq,DOMAIN,Domain Abbreviation,Char,50 -iq,SPTOBID,Applicant-Defined Tobacco Product ID,Char,50 -iq,IGDCMPID,Ingredient or Component Identifier,Char,50 -iq,IQCAT,Category of Ingredient or Component,Char,50 -iq,IQPARENT,Parent of Ingredient or Component,Char,50 -iq,IQLEVEL,Ingredient Level in Hierarchy,Num,50 -iq,IQFUNCT,Ingredient Function,Char,50 -iq,IQVALTRG,Ingredient Target Value,Num,50 -iq,IQVALMIN,Ingredient Minimum Value,Num,50 -iq,IQVALMAX,Ingredient Maximum Value,Num,50 -iq,IQVALU,Ingredient Value Unit,Char,50 +pd,STUDYID,Study Identifier,Char,200 +pd,DOMAIN,Domain Abbreviation,Char,200 +pd,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40 +pd,PDSEQ,Sequence Number,Num,10 +pd,PDPARMCD,Design Parameter Element Short Name,Char,8 +pd,PDPARM,Design Parameter Element Name,Char,40 +pd,PDVALTRG,Design Parameter Element Target Value,Char,50 +pd,PDVALMAX,Design Parameter Element Maximum Value,Char,50 +pd,PDVALU,Design Parameter Element Value Unit,Char,50 diff --git a/Published/CORE-000674/negative/01/data/pd.csv b/Published/CORE-000674/negative/01/data/pd.csv new file mode 100644 index 000000000..1ebb0b6fa --- /dev/null +++ b/Published/CORE-000674/negative/01/data/pd.csv @@ -0,0 +1,12 @@ +STUDYID,DOMAIN,SPTOBID,PDSEQ,PDPARMCD,PDPARM,PDVALTRG,PDVALMAX,PDVALU +TOB09,PD,VAPE-Z27,2,PUFCNT,Puff Count,311,310, +TOB09,PD,VAPE-Z27,3,CRTVOL,Cartridge Volume,3,2.9,mL +TOB09,PD,VAPE-Z27,4,HTELNUM,Number of Heating Elements,-1.1,-2.1, +TOB09,PD,VAPE-Z27,5,HTELGTH,Heating Element Length,3.4,3.3,mm +TOB09,PD,VAPE-Z27,9,HTELCFG,Heating Element Configuration,SPIRAL,SPIRAL, +TOB09,PD,VAPE-Z27,10,BTVLTORG,Battery Voltage Operating Range,4.5,4,V +TOB09,PD,VAPE-Z27,11,BTCRTORG,Battery Current Operating Range,1601,1600.99,mAh +TOB09,PD,VAPE-Z27,21,PDUVOR,PDU Voltage Operating Range,4.3,4.2,V +TOB09,PD,VAPE-Z27,22,PDUCOR,PDU Current Operating Range,YES,NO, +TOB09,PD,VAPE-Z27,23,PDUTCTOF,PDU Temperature Cut-off,70,69,C +TOB09,PD,VAPE-Z27,24,AIRFLRT,Airflow Rate,800,740,L/min diff --git a/Published/CORE-000674/negative/01/results/results.csv b/Published/CORE-000674/negative/01/results/results.csv index 243a5867d..5a36682f3 100644 --- a/Published/CORE-000674/negative/01/results/results.csv +++ b/Published/CORE-000674/negative/01/results/results.csv @@ -1,21 +1,37 @@ Dataset,Record,Variable,Value -IQ,1,IGDCMPID,Tobacco Filler -IQ,1,IQVALMAX,683.7 -IQ,1,IQVALTRG,683.71 -IQ,1,SPTOBID,CIG01A -IQ,2,IGDCMPID,Bright Tobacco -IQ,2,IQVALMAX,305.0 -IQ,2,IQVALTRG,306.0 -IQ,2,SPTOBID,CIG01A -IQ,3,IGDCMPID,Oriental Tobacco -IQ,3,IQVALMAX,117.0 -IQ,3,IQVALTRG,118.0 -IQ,3,SPTOBID,CIG01A -IQ,4,IGDCMPID,Cationic Starch -IQ,4,IQVALMAX,0.45 -IQ,4,IQVALTRG,0.46 -IQ,4,SPTOBID,CIG01A -IQ,5,IGDCMPID,Seam Adhesive -IQ,5,IQVALMAX,-0.25 -IQ,5,IQVALTRG,-0.24 -IQ,5,SPTOBID,CIG01A +PD,1,PDPARMCD,PUFCNT +PD,1,PDVALMAX,310 +PD,1,PDVALTRG,311 +PD,1,SPTOBID,VAPE-Z27 +PD,2,PDPARMCD,CRTVOL +PD,2,PDVALMAX,2.9 +PD,2,PDVALTRG,3 +PD,2,SPTOBID,VAPE-Z27 +PD,3,PDPARMCD,HTELNUM +PD,3,PDVALMAX,-2.1 +PD,3,PDVALTRG,-1.1 +PD,3,SPTOBID,VAPE-Z27 +PD,4,PDPARMCD,HTELGTH +PD,4,PDVALMAX,3.3 +PD,4,PDVALTRG,3.4 +PD,4,SPTOBID,VAPE-Z27 +PD,6,PDPARMCD,BTVLTORG +PD,6,PDVALMAX,4 +PD,6,PDVALTRG,4.5 +PD,6,SPTOBID,VAPE-Z27 +PD,7,PDPARMCD,BTCRTORG +PD,7,PDVALMAX,1600.99 +PD,7,PDVALTRG,1601 +PD,7,SPTOBID,VAPE-Z27 +PD,8,PDPARMCD,PDUVOR +PD,8,PDVALMAX,4.2 +PD,8,PDVALTRG,4.3 +PD,8,SPTOBID,VAPE-Z27 +PD,10,PDPARMCD,PDUTCTOF +PD,10,PDVALMAX,69 +PD,10,PDVALTRG,70 +PD,10,SPTOBID,VAPE-Z27 +PD,11,PDPARMCD,AIRFLRT +PD,11,PDVALMAX,740 +PD,11,PDVALTRG,800 +PD,11,SPTOBID,VAPE-Z27 diff --git a/Published/CORE-000674/negative/02/data/.env b/Published/CORE-000674/negative/02/data/.env new file mode 100644 index 000000000..0ce633d09 --- /dev/null +++ b/Published/CORE-000674/negative/02/data/.env @@ -0,0 +1,4 @@ +PRODUCT=TIG +VERSION=1-0 +SUBSTANDARD=SDTM +USE_CASE=PROD diff --git a/Published/CORE-000674/negative/02/data/_datasets.csv b/Published/CORE-000674/negative/02/data/_datasets.csv new file mode 100644 index 000000000..8829a8a4b --- /dev/null +++ b/Published/CORE-000674/negative/02/data/_datasets.csv @@ -0,0 +1,2 @@ +Filename,Label +pd,Product Design Parameters diff --git a/Published/CORE-000674/negative/02/data/_variables.csv b/Published/CORE-000674/negative/02/data/_variables.csv new file mode 100644 index 000000000..948838ab0 --- /dev/null +++ b/Published/CORE-000674/negative/02/data/_variables.csv @@ -0,0 +1,9 @@ +dataset,variable,label,type,length +pd,STUDYID,Study Identifier,Char,200 +pd,DOMAIN,Domain Abbreviation,Char,200 +pd,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40 +pd,PDSEQ,Sequence Number,Num,10 +pd,PDPARM,Design Parameter Element Name,Char,40 +pd,PDVALTRG,Design Parameter Element Target Value,Char,50 +pd,PDVALMAX,Design Parameter Element Maximum Value,Char,50 +pd,PDVALU,Design Parameter Element Value Unit,Char,50 diff --git a/Published/CORE-000674/negative/02/data/pd.csv b/Published/CORE-000674/negative/02/data/pd.csv new file mode 100644 index 000000000..9e02de392 --- /dev/null +++ b/Published/CORE-000674/negative/02/data/pd.csv @@ -0,0 +1,12 @@ +STUDYID,DOMAIN,SPTOBID,PDSEQ,PDPARM,PDVALTRG,PDVALMAX,PDVALU +TOB09,PD,VAPE-Z27,2,Puff Count,300,310, +TOB09,PD,VAPE-Z27,3,Cartridge Volume,3,2.9,mL +TOB09,PD,VAPE-Z27,4,Number of Heating Elements,,, +TOB09,PD,VAPE-Z27,5,Heating Element Length,,3.3,mm +TOB09,PD,VAPE-Z27,9,Heating Element Configuration,SPIRAL,SPIRAL, +TOB09,PD,VAPE-Z27,10,Battery Voltage Operating Range,4.5,4,V +TOB09,PD,VAPE-Z27,11,Battery Current Operating Range,1601,,mAh +TOB09,PD,VAPE-Z27,21,PDU Voltage Operating Range,3,4.2,V +TOB09,PD,VAPE-Z27,22,PDU Current Operating Range,YES,NO, +TOB09,PD,VAPE-Z27,23,PDU Temperature Cut-off,70,69,C +TOB09,PD,VAPE-Z27,24,Airflow Rate,699,740,L/min diff --git a/Published/CORE-000674/negative/02/results/results.csv b/Published/CORE-000674/negative/02/results/results.csv new file mode 100644 index 000000000..18a66d21d --- /dev/null +++ b/Published/CORE-000674/negative/02/results/results.csv @@ -0,0 +1,13 @@ +Dataset,Record,Variable,Value +PD,2,PDPARMCD,Not in dataset +PD,2,PDVALMAX,2.9 +PD,2,PDVALTRG,3 +PD,2,SPTOBID,VAPE-Z27 +PD,6,PDPARMCD,Not in dataset +PD,6,PDVALMAX,4 +PD,6,PDVALTRG,4.5 +PD,6,SPTOBID,VAPE-Z27 +PD,10,PDPARMCD,Not in dataset +PD,10,PDVALMAX,69 +PD,10,PDVALTRG,70 +PD,10,SPTOBID,VAPE-Z27 diff --git a/Published/CORE-000674/negative/03/data/.env b/Published/CORE-000674/negative/03/data/.env new file mode 100644 index 000000000..0ce633d09 --- /dev/null +++ b/Published/CORE-000674/negative/03/data/.env @@ -0,0 +1,4 @@ +PRODUCT=TIG +VERSION=1-0 +SUBSTANDARD=SDTM +USE_CASE=PROD diff --git a/Published/CORE-000674/negative/03/data/_datasets.csv b/Published/CORE-000674/negative/03/data/_datasets.csv new file mode 100644 index 000000000..2f28eb4c1 --- /dev/null +++ b/Published/CORE-000674/negative/03/data/_datasets.csv @@ -0,0 +1,2 @@ +Filename,Label +iq,Ingredient Quantities by Component diff --git a/Published/CORE-000674/negative/03/data/_variables.csv b/Published/CORE-000674/negative/03/data/_variables.csv new file mode 100644 index 000000000..4d51d0d4d --- /dev/null +++ b/Published/CORE-000674/negative/03/data/_variables.csv @@ -0,0 +1,13 @@ +dataset,variable,label,type,length +iq,STUDYID,Study Identifier,Char,50 +iq,DOMAIN,Domain Abbreviation,Char,50 +iq,SPTOBID,Applicant-Defined Tobacco Product ID,Char,50 +iq,IGDCMPID,Ingredient or Component Identifier,Char,50 +iq,IQCAT,Category of Ingredient or Component,Char,50 +iq,IQPARENT,Parent of Ingredient or Component,Char,50 +iq,IQLEVEL,Ingredient Level in Hierarchy,Num,50 +iq,IQFUNCT,Ingredient Function,Char,50 +iq,IQVALTRG,Ingredient Target Value,Num,50 +iq,IQVALMIN,Ingredient Minimum Value,Num,50 +iq,IQVALMAX,Ingredient Maximum Value,Num,50 +iq,IQVALU,Ingredient Value Unit,Char,50 diff --git a/Published/CORE-000674/negative/01/data/iq.csv b/Published/CORE-000674/negative/03/data/iq.csv similarity index 100% rename from Published/CORE-000674/negative/01/data/iq.csv rename to Published/CORE-000674/negative/03/data/iq.csv diff --git a/Published/CORE-000674/negative/03/results/results.csv b/Published/CORE-000674/negative/03/results/results.csv new file mode 100644 index 000000000..243a5867d --- /dev/null +++ b/Published/CORE-000674/negative/03/results/results.csv @@ -0,0 +1,21 @@ +Dataset,Record,Variable,Value +IQ,1,IGDCMPID,Tobacco Filler +IQ,1,IQVALMAX,683.7 +IQ,1,IQVALTRG,683.71 +IQ,1,SPTOBID,CIG01A +IQ,2,IGDCMPID,Bright Tobacco +IQ,2,IQVALMAX,305.0 +IQ,2,IQVALTRG,306.0 +IQ,2,SPTOBID,CIG01A +IQ,3,IGDCMPID,Oriental Tobacco +IQ,3,IQVALMAX,117.0 +IQ,3,IQVALTRG,118.0 +IQ,3,SPTOBID,CIG01A +IQ,4,IGDCMPID,Cationic Starch +IQ,4,IQVALMAX,0.45 +IQ,4,IQVALTRG,0.46 +IQ,4,SPTOBID,CIG01A +IQ,5,IGDCMPID,Seam Adhesive +IQ,5,IQVALMAX,-0.25 +IQ,5,IQVALTRG,-0.24 +IQ,5,SPTOBID,CIG01A diff --git a/Published/CORE-000677/negative/01/data/_datasets.csv b/Published/CORE-000677/negative/01/data/_datasets.csv index 71f47d966..17424bac4 100644 --- a/Published/CORE-000677/negative/01/data/_datasets.csv +++ b/Published/CORE-000677/negative/01/data/_datasets.csv @@ -1,3 +1,2 @@ Filename,Label vs,Vital Signs -pooldef,Pool Definition diff --git a/Published/CORE-000677/negative/01/data/_variables.csv b/Published/CORE-000677/negative/01/data/_variables.csv index d4eebc7a9..1ddac9181 100644 --- a/Published/CORE-000677/negative/01/data/_variables.csv +++ b/Published/CORE-000677/negative/01/data/_variables.csv @@ -4,6 +4,3 @@ vs,DOMAIN,Domain Abbreviation,Char,2 vs,USUBJID,Unique Subject Identifier,Char,8 vs,POOLID,Pool Identfier,Char,8 vs,VSSEQ,Sequence Number,Num,8 -pooldef,STUDYID,Study Identifier,Char,12 -pooldef,POOLID,Pool Identfier,Char,8 -pooldef,USUBJID,Unique Subject Identifier,Char,8 diff --git a/Published/CORE-000677/negative/01/data/pooldef.csv b/Published/CORE-000677/negative/01/data/pooldef.csv deleted file mode 100644 index b20d93d12..000000000 --- a/Published/CORE-000677/negative/01/data/pooldef.csv +++ /dev/null @@ -1,7 +0,0 @@ -STUDYID,POOLID,USUBJID -CDISCPILOT01,POOL1, -CDISCPILOT01,POOL1, -CDISCPILOT01,POOL1, -CDISCPILOT01,POOL2, -CDISCPILOT01,POOL2, -CDISCPILOT01,POOL2, diff --git a/Published/CORE-000677/negative/02/data/_datasets.csv b/Published/CORE-000677/negative/02/data/_datasets.csv index 71f47d966..996df63ae 100644 --- a/Published/CORE-000677/negative/02/data/_datasets.csv +++ b/Published/CORE-000677/negative/02/data/_datasets.csv @@ -1,3 +1,2 @@ Filename,Label -vs,Vital Signs -pooldef,Pool Definition +vs,Vital Signs \ No newline at end of file diff --git a/Published/CORE-000677/negative/02/data/_variables.csv b/Published/CORE-000677/negative/02/data/_variables.csv index d4eebc7a9..1ddac9181 100644 --- a/Published/CORE-000677/negative/02/data/_variables.csv +++ b/Published/CORE-000677/negative/02/data/_variables.csv @@ -4,6 +4,3 @@ vs,DOMAIN,Domain Abbreviation,Char,2 vs,USUBJID,Unique Subject Identifier,Char,8 vs,POOLID,Pool Identfier,Char,8 vs,VSSEQ,Sequence Number,Num,8 -pooldef,STUDYID,Study Identifier,Char,12 -pooldef,POOLID,Pool Identfier,Char,8 -pooldef,USUBJID,Unique Subject Identifier,Char,8 diff --git a/Published/CORE-000677/positive/02/data/_datasets.csv b/Published/CORE-000677/positive/02/data/_datasets.csv index 17424bac4..71f47d966 100644 --- a/Published/CORE-000677/positive/02/data/_datasets.csv +++ b/Published/CORE-000677/positive/02/data/_datasets.csv @@ -1,2 +1,3 @@ Filename,Label vs,Vital Signs +pooldef,Pool Definition diff --git a/Published/CORE-000677/positive/02/data/_variables.csv b/Published/CORE-000677/positive/02/data/_variables.csv index ec37b34c8..c8529fb82 100644 --- a/Published/CORE-000677/positive/02/data/_variables.csv +++ b/Published/CORE-000677/positive/02/data/_variables.csv @@ -23,3 +23,6 @@ vs,VSDTC,Date/Time of Measurements,Char,10 vs,VSDY,Study Day of Vital Signs,Num,8 vs,VSTPT,Planned Time Point Name,Char,200 vs,VSTPTNUM,Planned Time Point Number,Num,8 +pooldef,STUDYID,Study Identifier,Char,12 +pooldef,POOLID,Pool Identfier,Char,8 +pooldef,USUBJID,Unique Subject Identifier,Char,8 \ No newline at end of file diff --git a/Published/CORE-000677/negative/02/data/pooldef.csv b/Published/CORE-000677/positive/02/data/pooldef.csv similarity index 100% rename from Published/CORE-000677/negative/02/data/pooldef.csv rename to Published/CORE-000677/positive/02/data/pooldef.csv diff --git a/Published/CORE-000698/negative/01/results/results.csv b/Published/CORE-000698/negative/01/results/results.csv index 5a36682f3..b81404c1c 100644 --- a/Published/CORE-000698/negative/01/results/results.csv +++ b/Published/CORE-000698/negative/01/results/results.csv @@ -1,37 +1,37 @@ Dataset,Record,Variable,Value PD,1,PDPARMCD,PUFCNT -PD,1,PDVALMAX,310 -PD,1,PDVALTRG,311 +PD,1,PDVALMIN,300.01 +PD,1,PDVALTRG,300 PD,1,SPTOBID,VAPE-Z27 PD,2,PDPARMCD,CRTVOL -PD,2,PDVALMAX,2.9 -PD,2,PDVALTRG,3 +PD,2,PDVALMIN,1 +PD,2,PDVALTRG,0 PD,2,SPTOBID,VAPE-Z27 PD,3,PDPARMCD,HTELNUM -PD,3,PDVALMAX,-2.1 -PD,3,PDVALTRG,-1.1 +PD,3,PDVALMIN,0 +PD,3,PDVALTRG,-1 PD,3,SPTOBID,VAPE-Z27 PD,4,PDPARMCD,HTELGTH -PD,4,PDVALMAX,3.3 -PD,4,PDVALTRG,3.4 +PD,4,PDVALMIN,3 +PD,4,PDVALTRG,2 PD,4,SPTOBID,VAPE-Z27 PD,6,PDPARMCD,BTVLTORG -PD,6,PDVALMAX,4 -PD,6,PDVALTRG,4.5 +PD,6,PDVALMIN,-4.5 +PD,6,PDVALTRG,-4.6 PD,6,SPTOBID,VAPE-Z27 PD,7,PDPARMCD,BTCRTORG -PD,7,PDVALMAX,1600.99 +PD,7,PDVALMIN,1602 PD,7,PDVALTRG,1601 PD,7,SPTOBID,VAPE-Z27 PD,8,PDPARMCD,PDUVOR -PD,8,PDVALMAX,4.2 -PD,8,PDVALTRG,4.3 +PD,8,PDVALMIN,3.2 +PD,8,PDVALTRG,3 PD,8,SPTOBID,VAPE-Z27 PD,10,PDPARMCD,PDUTCTOF -PD,10,PDVALMAX,69 -PD,10,PDVALTRG,70 +PD,10,PDVALMIN,55 +PD,10,PDVALTRG,54.99 PD,10,SPTOBID,VAPE-Z27 PD,11,PDPARMCD,AIRFLRT -PD,11,PDVALMAX,740 -PD,11,PDVALTRG,800 +PD,11,PDVALMIN,700 +PD,11,PDVALTRG,699 PD,11,SPTOBID,VAPE-Z27 diff --git a/Published/CORE-000698/negative/02/data/_datasets.csv b/Published/CORE-000698/negative/02/data/_datasets.csv new file mode 100644 index 000000000..8829a8a4b --- /dev/null +++ b/Published/CORE-000698/negative/02/data/_datasets.csv @@ -0,0 +1,2 @@ +Filename,Label +pd,Product Design Parameters diff --git a/Published/CORE-000698/negative/02/data/results.csv b/Published/CORE-000698/negative/02/data/results.csv deleted file mode 100644 index 7a371d5e3..000000000 --- a/Published/CORE-000698/negative/02/data/results.csv +++ /dev/null @@ -1,2 +0,0 @@ -Filename,Label -pd.csv,Product Design Parameters diff --git a/Published/CORE-000698/negative/02/results/results.csv b/Published/CORE-000698/negative/02/results/results.csv index 18a66d21d..4592b8c22 100644 --- a/Published/CORE-000698/negative/02/results/results.csv +++ b/Published/CORE-000698/negative/02/results/results.csv @@ -1,13 +1,21 @@ Dataset,Record,Variable,Value -PD,2,PDPARMCD,Not in dataset -PD,2,PDVALMAX,2.9 -PD,2,PDVALTRG,3 -PD,2,SPTOBID,VAPE-Z27 -PD,6,PDPARMCD,Not in dataset -PD,6,PDVALMAX,4 -PD,6,PDVALTRG,4.5 -PD,6,SPTOBID,VAPE-Z27 -PD,10,PDPARMCD,Not in dataset -PD,10,PDVALMAX,69 -PD,10,PDVALTRG,70 -PD,10,SPTOBID,VAPE-Z27 +PD,1,PDPARMCD,Not in dataset +PD,1,PDVALMIN,310 +PD,1,PDVALTRG,300 +PD,1,SPTOBID,VAPE-Z27 +PD,3,PDPARMCD,Not in dataset +PD,3,PDVALMIN,5 +PD,3,PDVALTRG,-1 +PD,3,SPTOBID,VAPE-Z27 +PD,4,PDPARMCD,Not in dataset +PD,4,PDVALMIN,3.3 +PD,4,PDVALTRG,2 +PD,4,SPTOBID,VAPE-Z27 +PD,8,PDPARMCD,Not in dataset +PD,8,PDVALMIN,4.2 +PD,8,PDVALTRG,3 +PD,8,SPTOBID,VAPE-Z27 +PD,11,PDPARMCD,Not in dataset +PD,11,PDVALMIN,740 +PD,11,PDVALTRG,699 +PD,11,SPTOBID,VAPE-Z27 From 944314ab7093b801535af8f4dc3c0d19a4e50136 Mon Sep 17 00:00:00 2001 From: Samuel Johnson Date: Thu, 13 Aug 2026 13:19:40 -0400 Subject: [PATCH 18/18] update --- Deprecated/CORE-000178/rule.yml | 9 +-- .../negative/01/data/_variables.csv | 34 +++++----- Published/CORE-000238/negative/01/data/ex.csv | 3 +- .../negative/01/results/results.csv | 17 +++-- .../negative/02/results/results.csv | 7 ++ .../negative/01/data/_datasets.csv | 1 - .../negative/01/data/_variables.csv | 17 +++++ Published/CORE-000457/negative/01/data/ec.csv | 5 +- .../negative/01/results/results.csv | 2 + .../negative/02/results/results.csv | 41 +++++------- .../negative/01/data/_datasets.csv | 2 + .../positive/01/data/_datasets.csv | 2 + .../CORE-000484/negative/01/data/relrec.csv | 12 ++-- .../negative/01/results/results.csv | 10 --- .../negative/01/results/results.csv | 2 + .../negative/01/results/results.csv | 8 +-- .../negative/01/results/results.csv | 1 + Published/CORE-000534/negative/02/data/ta.csv | 8 +-- .../negative/02/results/results.csv | 1 + .../negative/01/results/results.csv | 14 ++-- .../negative/02/results/results.csv | 7 +- .../negative/02/results/results.csv | 6 +- .../negative/01/results/results.csv | 7 ++ Published/CORE-000542/negative/01/data/fa.csv | 2 +- .../negative/01/results/results.csv | 35 +++++++--- .../negative/02/results/results.csv | 30 +++++++++ Published/CORE-000558/negative/01/data/ds.csv | 4 +- .../negative/01/results/results.csv | 12 +++- .../negative/01/results/results.csv | 1 - .../negative/02/results/results.csv | 3 + .../negative/01/results/results.csv | 2 + .../negative/02/results/results.csv | 2 + .../negative/01/results/results.csv | 2 + .../negative/01/results/results.csv | 2 + .../negative/01/results/results.csv | 9 +++ Published/CORE-000593/negative/01/data/pt.csv | 2 +- .../negative/01/results/results.csv | 22 +++++++ .../negative/01/results/results.csv | 8 +-- Published/CORE-000597/rule.yml | 8 +-- .../negative/01/results/results.csv | 33 ++++++++++ .../negative/01/results/results.csv | 65 +++++++++++++++++++ .../negative/01/results/results.csv | 13 ++++ .../negative/01/results/results.csv | 19 ++++++ .../negative/01/results/results.csv | 22 +++++++ Published/CORE-000605/negative/01/data/it.csv | 4 +- .../negative/01/results/results.csv | 13 ++++ .../negative/01/results/results.csv | 33 ++++++++++ .../negative/01/results/results.csv | 19 ++++++ .../negative/01/results/results.csv | 29 +++++++++ .../negative/01/results/results.csv | 15 +++++ .../negative/01/results/results.csv | 17 +++++ 51 files changed, 512 insertions(+), 130 deletions(-) create mode 100644 Published/CORE-000376/negative/02/results/results.csv create mode 100644 Published/CORE-000457/negative/01/results/results.csv create mode 100644 Published/CORE-000463/negative/01/data/_datasets.csv create mode 100644 Published/CORE-000463/positive/01/data/_datasets.csv create mode 100644 Published/CORE-000541/negative/01/results/results.csv create mode 100644 Published/CORE-000571/negative/02/results/results.csv create mode 100644 Published/CORE-000581/negative/01/results/results.csv create mode 100644 Published/CORE-000581/negative/02/results/results.csv create mode 100644 Published/CORE-000590/negative/01/results/results.csv create mode 100644 Published/CORE-000592/negative/01/results/results.csv create mode 100644 Published/CORE-000593/negative/01/results/results.csv create mode 100644 Published/CORE-000600/negative/01/results/results.csv create mode 100644 Published/CORE-000601/negative/01/results/results.csv create mode 100644 Published/CORE-000602/negative/01/results/results.csv create mode 100644 Published/CORE-000603/negative/01/results/results.csv create mode 100644 Published/CORE-000604/negative/01/results/results.csv create mode 100644 Published/CORE-000605/negative/01/results/results.csv create mode 100644 Published/CORE-000606/negative/01/results/results.csv create mode 100644 Published/CORE-000607/negative/01/results/results.csv create mode 100644 Published/CORE-000609/negative/01/results/results.csv create mode 100644 Published/CORE-000610/negative/01/results/results.csv create mode 100644 Published/CORE-000611/negative/01/results/results.csv diff --git a/Deprecated/CORE-000178/rule.yml b/Deprecated/CORE-000178/rule.yml index 62b694505..b90565581 100644 --- a/Deprecated/CORE-000178/rule.yml +++ b/Deprecated/CORE-000178/rule.yml @@ -13,8 +13,7 @@ Authorities: Version: "2" Version: "2.0" Citations: - - Cited Guidance: - Subject Status does not contain details about the circumstances + - Cited Guidance: Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details, but those details are to be stored in appropriate separate domains. For @@ -34,8 +33,7 @@ Authorities: Version: "2" Version: "2.0" Citations: - - Cited Guidance: - Subject Status does not contain details about the circumstances + - Cited Guidance: Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, @@ -55,8 +53,7 @@ Authorities: Version: "2" Version: "2.0" Citations: - - Cited Guidance: - Subject Status does not contain details about the circumstances + - Cited Guidance: Subject Status does not contain details about the circumstances of a subject's status. The response to the status assessment may trigger collection of additional details but those details are to be stored in appropriate separate domains. For example, diff --git a/Published/CORE-000238/negative/01/data/_variables.csv b/Published/CORE-000238/negative/01/data/_variables.csv index 61eca95ed..fb64f0c3a 100644 --- a/Published/CORE-000238/negative/01/data/_variables.csv +++ b/Published/CORE-000238/negative/01/data/_variables.csv @@ -25,20 +25,20 @@ dm,ACTARM,Description of Actual Arm,Char,50 dm,ARMNRS,Reason Arm and/or Actual Arm is Null,Char,50 dm,ACTARMUD,Description of Unplanned Actual Arm,Char,50 dm,COUNTRY,Country,Char,50 -ex,STUDYID,50,CDISCPILOT01,CDISCPILOT01 -ex,DOMAIN,50,EX,EX -ex,USUBJID,50,CDISC001,CDISC001 -ex,SPDEVID,200,DEV0001,DEV0001 -ex,EXSEQ,8,1,2 -ex,EXTRT,50,ZANOMALINE,ZANOMALINE -ex,EXDOSE,8,54,54 -ex,EXDOSU,50,mg,mg -ex,EXDOSFRM,50,INJECTION,INJECTION -ex,EXDOSFRQ,50,QD,QD -ex,EXROUTE,50,SUBCUTANEOUS,SUBCUTANEOUS -ex,EXLOT,50,SDS580-359,SDS580-359 -ex,EPOCH,50,TREATMENT,TREATMENT -ex,EXSTDTC,50,2012-11-30,2012-12-01 -ex,EXENDTC,50,2012-11-30,2012-12-01 -ex,EXSTDY,8,1,2 -ex,EXENDY,8,1,2 +ex,STUDYID,Study Identifier,Char,50 +ex,DOMAIN,Domain Abbreviation,Char,50 +ex,USUBJID,Unique Subject Identifier,Char,50 +ex,SPDEVID,Sponsor Device Identifier,Char,200 +ex,EXSEQ,Sequence Number,Num,8 +ex,EXTRT,Name of Treatment,Char,50 +ex,EXDOSE,Dose,Num,8 +ex,EXDOSU,Dose Units,Char,50 +ex,EXDOSFRM,Dose Form,Char,50 +ex,EXDOSFRQ,Dosing Frequency per Interval,Char,50 +ex,EXROUTE,Route of Administration,Char,50 +ex,EXLOT,Lot Number,Char,50 +ex,EPOCH,Epoch,Char,50 +ex,EXSTDTC,Start Date/Time of Treatment,Char,50 +ex,EXENDTC,End Date/Time of Treatment,Char,50 +ex,EXSTDY,Study Day of Start of Treatment,Num,8 +ex,EXENDY,Study Day of End of Treatment,Num,8 diff --git a/Published/CORE-000238/negative/01/data/ex.csv b/Published/CORE-000238/negative/01/data/ex.csv index 2f9c6dab0..da4f3aca2 100644 --- a/Published/CORE-000238/negative/01/data/ex.csv +++ b/Published/CORE-000238/negative/01/data/ex.csv @@ -52,5 +52,4 @@ CDISCPILOT01,EX,CDISC001,DEV0001,52,ZANOMALINE,54,mg,INJECTION,QD,SUBCUTANEOUS,S CDISCPILOT01,EX,CDISC001,DEV0001,53,ZANOMALINE,54,mg,INJECTION,QD,SUBCUTANEOUS,SDS580-359,TREATMENT,2013-01-21,2013-01-21,53,53 CDISCPILOT01,EX,CDISC001,DEV0001,54,ZANOMALINE,54,mg,INJECTION,QD,SUBCUTANEOUS,SDS580-359,TREATMENT,2013-01-22,2013-01-22,54,54 CDISCPILOT01,EX,CDISC001,DEV0001,55,ZANOMALINE,54,mg,INJECTION,QD,SUBCUTANEOUS,SDS580-359,TREATMENT,2013-01-23,2013-01-23,55,55 -Char,Char,Char,Char,Num,Char,Num,Char,Char,Char,Char,Char,Char,Char,Char,Num,Num -Study Identifier,Domain Abbreviation,Unique Subject Identifier,Sponsor Device Identifier,Sequence Number,Name of Treatment,Dose,Dose Units,Dose Form,Dosing Frequency per Interval,Route of Administration,Lot Number,Epoch,Start Date/Time of Treatment,End Date/Time of Treatment,Study Day of Start of Treatment,Study Day of End of Treatment + diff --git a/Published/CORE-000370/negative/01/results/results.csv b/Published/CORE-000370/negative/01/results/results.csv index 39fe02e53..6ab8e09a6 100644 --- a/Published/CORE-000370/negative/01/results/results.csv +++ b/Published/CORE-000370/negative/01/results/results.csv @@ -1,10 +1,9 @@ Dataset,Record,Variable,Value -DS,7,DSDECOD,DEATH -DS,7,DSSTDTC,2022-02-20 -DS,7,DTHDTC,2021-02-18 -DS,21,DSDECOD,DEATH -DS,21,DSSTDTC,2019-01-10 -DS,21,DTHDTC, -DS,26,DSDECOD,DEATH -DS,26,DSSTDTC,2021-01-10 -DS,26,DTHDTC,2021-01 +DS,1,$min_ds_dsstdtc,2018-03-06 +DS,1,DSDECOD,INFORMED CONSENT OBTAINED +DS,1,DSSTDTC,2018-03-06 +DS,1,RFICDTC,2018-05-20 +DS,18,$min_ds_dsstdtc,2018-04-06 +DS,18,DSDECOD,INFORMED CONSENT OBTAINED +DS,18,DSSTDTC,2018-04-06 +DS,18,RFICDTC,2019-08-15 diff --git a/Published/CORE-000376/negative/02/results/results.csv b/Published/CORE-000376/negative/02/results/results.csv new file mode 100644 index 000000000..8bffb7e5c --- /dev/null +++ b/Published/CORE-000376/negative/02/results/results.csv @@ -0,0 +1,7 @@ +Dataset,Record,Variable,Value +XA,13,$domain_list,['XA'] +XA,13,variable_name,CMOUT +XM,12,$domain_list,['XM'] +XM,12,variable_name,PRSTDTC +XM,13,$domain_list,['XM'] +XM,13,variable_name,PRENDTC diff --git a/Published/CORE-000457/negative/01/data/_datasets.csv b/Published/CORE-000457/negative/01/data/_datasets.csv index 0b5a4a1c4..d2ec28c30 100644 --- a/Published/CORE-000457/negative/01/data/_datasets.csv +++ b/Published/CORE-000457/negative/01/data/_datasets.csv @@ -1,5 +1,4 @@ Filename,Label -, ec,Exposure as Collected suppec,Supplemental Qualifiers for Exposure suppdm,Supplemental Qualifiers for Demographics diff --git a/Published/CORE-000457/negative/01/data/_variables.csv b/Published/CORE-000457/negative/01/data/_variables.csv index 3efdc3d2b..ac720c6b5 100644 --- a/Published/CORE-000457/negative/01/data/_variables.csv +++ b/Published/CORE-000457/negative/01/data/_variables.csv @@ -19,3 +19,20 @@ suppec,QLABEL,Qualifier Variable Label,Char,40 suppec,QVAL,Data Value,Char,200 suppec,QORIG,Origin,Char,13 suppec,QEVAL,Evaluator,Char,200 +ec,STUDYID,Study Identifier,Char,50 +ec,DOMAIN,Domain Abbreviation,Char,50 +ec,USUBJID,Unique Subject Identifier,Char,50 +ec,ECSEQ,Sequence Number,Num,8 +ec,ECLNKID,Link ID,Char,50 +ec,ECTRT,Name of Treatment,Char,50 +ec,ECPRESP,Pre-Specified,Char,50 +ec,ECOCCUR,Occurrence,Char,50 +ec,ECREASOC,Reason for Occur Value,Char,50 +ec,ECDOSE,Dose,Num,8 +ec,ECDOSTXT,Dose Description,Char,50 +ec,ECDOSU,Dose Units,Char,50 +ec,ECDOSFRM,Dose Form,Char,50 +ec,ECSTDTC,Start Date/Time of Treatment,Char,50 +ec,ECENDTC,End Date/Time of Treatment,Char,50 +ec,ECSTDY,Study Day of Start of Treatment,Num,8 +ec,ECENDY,Study Day of End of Treatment,Num,8 \ No newline at end of file diff --git a/Published/CORE-000457/negative/01/data/ec.csv b/Published/CORE-000457/negative/01/data/ec.csv index a254912c9..c22e1844e 100644 --- a/Published/CORE-000457/negative/01/data/ec.csv +++ b/Published/CORE-000457/negative/01/data/ec.csv @@ -1,7 +1,4 @@ -,,,,,,,,,,,,,,,, -Study Identifier,Domain Abbreviation,Unique Subject Identifier,Sequence Number,Link ID,Name of Treatment,Pre-Specified,Occurrence,Reason for Occur Value,Dose,Dose Description,Dose Units,Dose Form,Start Date/Time of Treatment,End Date/Time of Treatment,Study Day of Start of Treatment,Study Day of End of Treatment -Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Char,Char,Char,Char,Char,Num,Num -50,50,50,8,50,50,50,50,50,8,50,50,50,50,50,8,8 +STUDYID,DOMAIN,USUBJID,ECSEQ,ECLNKID,ECTRT,ECPRESP,ECOCCUR,ECREASOC,ECDOSE,ECDOSTXT,ECDOSU,ECDOSFRM,ECSTDTC,ECENDTC,ECSTDY,ECENDY ABC,EC,ABC1001,1,A2-20110114,BOTTLE A,Y,Y,,2,,TABLET,QD,2011-01-14 00:00:00,2011-01-28 00:00:00,1,15 ABC,EC,ABC2001,1,A2-20110114,BOTTLE A,Y,Y,,2,,,QD,2011-01-14 00:00:00,2011-01-23 00:00:00,1,10 ABC,EC,ABC2001,2,A0-20110124,BOTTLE A,Y,N,PATIENT MISTAKE,,,TABLET,QD,2011-01-24 00:00:00,2011-01-24 00:00:00,11,11 diff --git a/Published/CORE-000457/negative/01/results/results.csv b/Published/CORE-000457/negative/01/results/results.csv new file mode 100644 index 000000000..1544d0532 --- /dev/null +++ b/Published/CORE-000457/negative/01/results/results.csv @@ -0,0 +1,2 @@ +Dataset,Record,Variable,Value +SUPPDM,,RDOMAIN,DM diff --git a/Published/CORE-000458/negative/02/results/results.csv b/Published/CORE-000458/negative/02/results/results.csv index 1e72a8c2e..160721cfc 100644 --- a/Published/CORE-000458/negative/02/results/results.csv +++ b/Published/CORE-000458/negative/02/results/results.csv @@ -1,34 +1,25 @@ Dataset,Record,Variable,Value -VS,1,POOLID, +VS,1,POOLID,Not in dataset VS,1,USUBJID,CDISC001 -VS,1,VSSEQ,1 -VS,3,POOLID, +VS,1,VSSEQ,1.0 +VS,3,POOLID,Not in dataset VS,3,USUBJID,CDISC001 -VS,3,VSSEQ,1 -VS,4,POOLID,POOL1 -VS,4,USUBJID, -VS,4,VSSEQ,4 -VS,5,POOLID, +VS,3,VSSEQ,1.0 +VS,5,POOLID,Not in dataset VS,5,USUBJID,CDISC001 -VS,5,VSSEQ,5 -VS,6,POOLID, +VS,5,VSSEQ,5.0 +VS,6,POOLID,Not in dataset VS,6,USUBJID,CDISC001 -VS,6,VSSEQ,5 -VS,8,POOLID, +VS,6,VSSEQ,5.0 +VS,8,POOLID,Not in dataset VS,8,USUBJID,CDISC002 -VS,8,VSSEQ,3 -VS,9,POOLID, +VS,8,VSSEQ,3.0 +VS,9,POOLID,Not in dataset VS,9,USUBJID,CDISC002 -VS,9,VSSEQ,3 -VS,10,POOLID,POOL1 -VS,10,USUBJID, -VS,10,VSSEQ,4 -VS,11,POOLID, +VS,9,VSSEQ,3.0 +VS,11,POOLID,Not in dataset VS,11,USUBJID,CDISC002 -VS,11,VSSEQ,6 -VS,12,POOLID, +VS,11,VSSEQ,6.0 +VS,12,POOLID,Not in dataset VS,12,USUBJID,CDISC002 -VS,12,VSSEQ,6 -VS,14,POOLID,POOL1 -VS,14,USUBJID, -VS,14,VSSEQ,4 +VS,12,VSSEQ,6.0 diff --git a/Published/CORE-000463/negative/01/data/_datasets.csv b/Published/CORE-000463/negative/01/data/_datasets.csv new file mode 100644 index 000000000..a764663d8 --- /dev/null +++ b/Published/CORE-000463/negative/01/data/_datasets.csv @@ -0,0 +1,2 @@ +Filename,Label +lb,Laboratory Test Results diff --git a/Published/CORE-000463/positive/01/data/_datasets.csv b/Published/CORE-000463/positive/01/data/_datasets.csv new file mode 100644 index 000000000..a764663d8 --- /dev/null +++ b/Published/CORE-000463/positive/01/data/_datasets.csv @@ -0,0 +1,2 @@ +Filename,Label +lb,Laboratory Test Results diff --git a/Published/CORE-000484/negative/01/data/relrec.csv b/Published/CORE-000484/negative/01/data/relrec.csv index 69ca9bfef..46871656b 100644 --- a/Published/CORE-000484/negative/01/data/relrec.csv +++ b/Published/CORE-000484/negative/01/data/relrec.csv @@ -1,10 +1,10 @@ STUDYID,RDOMAIN,USUBJID,IDVAR,IDVARVAL,RELTYPE,RELID -CDISCPILOT01,AE,,AELNKID,,ONE,AEDS1 -CDISCPILOT01,DS,,DSLNKID,,ONE,AEDS2 -CDISCPILOT01,AE,,AELNKID,,ONE,AEDD3 -CDISCPILOT01,DD,,DDLNKID,,ONE,AEDD4 -CDISCPILOT01,AE,,AELNKID,,ONE,AEFA5 -CDISCPILOT01,FA,,FALNKGRP,,MANY,AEFA6 +CDISCPILOT01,AE,CDISC002,AELNKID,,ONE,AEDS1 +CDISCPILOT01,DS,CDISC002,DSLNKID,,ONE,AEDS2 +CDISCPILOT01,AE,CDISC002,AELNKID,,ONE,AEDD3 +CDISCPILOT01,DD,CDISC002,DDLNKID,,ONE,AEDD4 +CDISCPILOT01,AE,CDISC002,AELNKID,,ONE,AEFA5 +CDISCPILOT01,FA,CDISC002,FALNKGRP,,MANY,AEFA6 CDISCPILOT01,AE,CDISC001,AESEQ,1,ONE,AECM1 CDISCPILOT01,CM,CDISC001,CMSEQ,2,ONE,AECM2 CDISCPILOT01,AE,CDISC001,AESEQ,2,ONE,AECM3 diff --git a/Published/CORE-000484/negative/01/results/results.csv b/Published/CORE-000484/negative/01/results/results.csv index 00569ddfd..925f117fd 100644 --- a/Published/CORE-000484/negative/01/results/results.csv +++ b/Published/CORE-000484/negative/01/results/results.csv @@ -1,21 +1,11 @@ Dataset,Record,Variable,Value RELREC,1,RELID,AEDS1 -RELREC,1,USUBJID, RELREC,2,RELID,AEDS2 -RELREC,2,USUBJID, RELREC,3,RELID,AEDD3 -RELREC,3,USUBJID, RELREC,4,RELID,AEDD4 -RELREC,4,USUBJID, RELREC,5,RELID,AEFA5 -RELREC,5,USUBJID, RELREC,6,RELID,AEFA6 -RELREC,6,USUBJID, RELREC,7,RELID,AECM1 -RELREC,7,USUBJID,CDISC001 RELREC,8,RELID,AECM2 -RELREC,8,USUBJID,CDISC001 RELREC,9,RELID,AECM3 -RELREC,9,USUBJID,CDISC001 RELREC,10,RELID,AECM4 -RELREC,10,USUBJID,CDISC001 diff --git a/Published/CORE-000495/negative/01/results/results.csv b/Published/CORE-000495/negative/01/results/results.csv index 0a24ae66f..318e6815f 100644 --- a/Published/CORE-000495/negative/01/results/results.csv +++ b/Published/CORE-000495/negative/01/results/results.csv @@ -2,6 +2,8 @@ Dataset,Record,Variable,Value MA,1,MAORRES,"Discoloration dark, mucosal" MA,1,MASPEC,SKIN MA,1,MATESTCD,GROSPATH +MA,1,USUBJID,CDISC-TEST-001 MA,2,MAORRES,"Discoloration dark, mucosal" MA,2,MASPEC,SKIN MA,2,MATESTCD,GROSPATH +MA,2,USUBJID,CDISC-TEST-001 diff --git a/Published/CORE-000502/negative/01/results/results.csv b/Published/CORE-000502/negative/01/results/results.csv index 24696a347..64585c44d 100644 --- a/Published/CORE-000502/negative/01/results/results.csv +++ b/Published/CORE-000502/negative/01/results/results.csv @@ -1,7 +1,7 @@ Dataset,Record,Variable,Value -CO,,$study_domains,"['CO', 'SUPPLB', 'RELREC']" +CO,,$study_domains,"['CO', None]" CO,,RDOMAIN,IS -RELREC,,$study_domains,"['CO', 'SUPPLB', 'RELREC']" +RELREC,,$study_domains,"['CO', None]" RELREC,,RDOMAIN,LB -SUPPLB,,$study_domains,"['CO', 'SUPPLB', 'RELREC']" -SUPPLB,,RDOMAIN,LB +SUPPLB,,$study_domains,"['CO', None]" +SUPPLB,,RDOMAIN,LB \ No newline at end of file diff --git a/Published/CORE-000527/negative/01/results/results.csv b/Published/CORE-000527/negative/01/results/results.csv index 31938a20b..ee7daeb04 100644 --- a/Published/CORE-000527/negative/01/results/results.csv +++ b/Published/CORE-000527/negative/01/results/results.csv @@ -1,2 +1,3 @@ Dataset,Record,Variable,Value SE,12,SEENDTC, +SE,12,SESTDTC,2013-02-19 diff --git a/Published/CORE-000534/negative/02/data/ta.csv b/Published/CORE-000534/negative/02/data/ta.csv index ad861bcf9..b26f72890 100644 --- a/Published/CORE-000534/negative/02/data/ta.csv +++ b/Published/CORE-000534/negative/02/data/ta.csv @@ -1,5 +1,5 @@ STUDYID,DOMAIN,ARMCD,ARM,TAETORD,ETCD,ELEMENT,TABRANCH,TATRANS,EPOCH -CDISC-TEST,TA,A,DRUG A,A,SCR,SCREENING,,,SCREENING -CDISC-TEST,TA,A,DRUG A,B,DRUGA,DRUG A,,,TREATMENT -CDISC-TEST,TA,B,DRUG B,A,SCR,SCREENING,,,SCREENING -CDISC-TEST,TA,B,DRUG B,B,DRUGB,DRUG B,,,TREATMENT +CDISC-TEST,TA,A,DRUG A,1,SCR,SCREENING,,,SCREENING +CDISC-TEST,TA,A,DRUG A,2.1,DRUGA,DRUG A,,,TREATMENT +CDISC-TEST,TA,B,DRUG B,1,SCR,SCREENING,,,SCREENING +CDISC-TEST,TA,B,DRUG B,2,DRUGB,DRUG B,,,TREATMENT diff --git a/Published/CORE-000534/negative/02/results/results.csv b/Published/CORE-000534/negative/02/results/results.csv index a13018c5f..afc34ee05 100644 --- a/Published/CORE-000534/negative/02/results/results.csv +++ b/Published/CORE-000534/negative/02/results/results.csv @@ -1 +1,2 @@ Dataset,Record,Variable,Value +TA,2,TAETORD,2.1 diff --git a/Published/CORE-000535/negative/01/results/results.csv b/Published/CORE-000535/negative/01/results/results.csv index 2b401aa49..8d3019fe0 100644 --- a/Published/CORE-000535/negative/01/results/results.csv +++ b/Published/CORE-000535/negative/01/results/results.csv @@ -1,13 +1,7 @@ Dataset,Record,Variable,Value -SM,1,SMSEQ,1 +SM,1,SMSEQ,1.0 SM,1,SMSTDTC,2005-10 -SM,1,USUBJID,001 -SM,2,SMSEQ,2 +SM,2,SMSEQ,2.0 SM,2,SMSTDTC,2005-10-08 -SM,2,USUBJID,001 -SM,3,SMSEQ,3 -SM,3,SMSTDTC,2005-10-06 -SM,3,USUBJID,001 -SM,4,SMSEQ,4 -SM,4,SMSTDTC,2005-11 -SM,4,USUBJID,001 +SM,3,SMSEQ,3.0 +SM,3,SMSTDTC,2005-10-06 \ No newline at end of file diff --git a/Published/CORE-000535/negative/02/results/results.csv b/Published/CORE-000535/negative/02/results/results.csv index 068797ffa..244dd87dc 100644 --- a/Published/CORE-000535/negative/02/results/results.csv +++ b/Published/CORE-000535/negative/02/results/results.csv @@ -1,4 +1,5 @@ Dataset,Record,Variable,Value -SE,,SESEQ,4 -SE,,SESTDTC,2006-05-31 -SE,,USUBJID,456 +SE,5,SESEQ,4.0 +SE,5,SESTDTC,2006-05-31 +SE,6,SESEQ,3.0 +SE,6,SESTDTC,2006-06-13 \ No newline at end of file diff --git a/Published/CORE-000540/negative/02/results/results.csv b/Published/CORE-000540/negative/02/results/results.csv index 7530b84b6..0015a2d4f 100644 --- a/Published/CORE-000540/negative/02/results/results.csv +++ b/Published/CORE-000540/negative/02/results/results.csv @@ -1,5 +1,3 @@ Dataset,Record,Variable,Value -FA,2,$list_dataset_names,"['FACM', 'FA1', 'FA']" -FA,2,dataset_name,FACM -FA,3,$list_dataset_names,"['FACM', 'FA1', 'FA']" -FA,3,dataset_name,FA1 +FACM,,$list_dataset_names,"['FACM', 'FA1', 'FA']" +FACM,,dataset_name,FACM diff --git a/Published/CORE-000541/negative/01/results/results.csv b/Published/CORE-000541/negative/01/results/results.csv new file mode 100644 index 000000000..5f773bc9a --- /dev/null +++ b/Published/CORE-000541/negative/01/results/results.csv @@ -0,0 +1,7 @@ +Dataset,Record,Variable,Value +TI,2,IETESTCD,INCL0201A +TI,6,IETESTCD,1INCL06 +TI,7,IETESTCD,INCL070001 +TI,8,IETESTCD,INCL082121212 +TI,12,IETESTCD,EXCL12& +TI,15,IETESTCD,EXCL15123145 diff --git a/Published/CORE-000542/negative/01/data/fa.csv b/Published/CORE-000542/negative/01/data/fa.csv index a90929d64..e442630b1 100644 --- a/Published/CORE-000542/negative/01/data/fa.csv +++ b/Published/CORE-000542/negative/01/data/fa.csv @@ -2,5 +2,5 @@ STUDYID,DOMAIN,USUBJID,FASEQ,FATESTCD,FATEST,FAOBJ,FAORRES,FAORRESU,FASTRESC,FAS 1234,FA,123101,1,SEV,Severity/Intensity,Migraine,SEVERE,,SEVERE,,, 1234,FA,123101,2,OCCUR,Occurrence Indicator,Sensitivity To Light,,,,,,NOT DONE 1234,FA,123101,3,TSTRES,Test Result,Sensitivity To Light,-1.234,,-1.234,1,, -1235,FA,123101,4,TSTRES,Test Result,Sensitivity To Light,-1.235,,-1.235,YES,, +1235,FA,123101,4,TSTRES,Test Result,Sensitivity To Light,-1.235,,-1.235,0,, 1236,FA,123101,5,TSTRES,Test Result,Sensitivity To Light,1.236,,1.236,1.235,, diff --git a/Published/CORE-000542/negative/01/results/results.csv b/Published/CORE-000542/negative/01/results/results.csv index 2545ac45c..334751645 100644 --- a/Published/CORE-000542/negative/01/results/results.csv +++ b/Published/CORE-000542/negative/01/results/results.csv @@ -1,15 +1,34 @@ Dataset,Record,Variable,Value +EG,1,EGSTRESC,72 +EG,1,EGSTRESN,62.0 +EG,1,EGTESTCD,EGHRMN EG,2,EGSTRESC,150 -EG,2,EGSTRESN,null +EG,2,EGSTRESN,150.2 +EG,2,EGTESTCD,PRAG EG,4,EGSTRESC,149.876 -EG,4,EGSTRESN,null +EG,4,EGSTRESN,150.0 +EG,4,EGTESTCD,PRAG FA,3,FASTRESC,-1.234 -FA,3,FASTRESN,null +FA,3,FASTRESN,1.0 +FA,3,FATESTCD,TSTRES +FA,4,FASTRESC,-1.235 +FA,4,FASTRESN,0.0 +FA,4,FATESTCD,TSTRES FA,5,FASTRESC,1.236 -FA,5,FASTRESN,null +FA,5,FASTRESN,1.235 +FA,5,FATESTCD,TSTRES LB,2,LBSTRESC,200 -LB,2,LBSTRESN,null +LB,2,LBSTRESN,210.0 +LB,2,LBTESTCD,Prot +LB,3,LBSTRESC,200.01 +LB,3,LBSTRESN,200.0 +LB,3,LBTESTCD,Prot MI,1,MISTRESC,0 -MI,1,MISTRESN,null -VS,2,VSSTRESC,44 -VS,2,VSSTRESN,null +MI,1,MISTRESN, +MI,1,MITESTCD,HER2 +VS,1,VSSTRESC,154 +VS,1,VSSTRESN,Not in dataset +VS,1,VSTESTCD,SYSBP +VS,2,VSSTRESC,44.0 +VS,2,VSSTRESN,Not in dataset +VS,2,VSTESTCD,DIABP diff --git a/Published/CORE-000547/negative/02/results/results.csv b/Published/CORE-000547/negative/02/results/results.csv index 43cbcf16c..6e352726f 100644 --- a/Published/CORE-000547/negative/02/results/results.csv +++ b/Published/CORE-000547/negative/02/results/results.csv @@ -1,6 +1,36 @@ Dataset,Record,Variable,Value +DS,3,BRTHDTC,Not in dataset DS,3,DSDTC,2018-06-31 +DS,3,DSENDTC,2018-05-08 +DS,3,DSRFTDTC,Not in dataset +DS,3,DSSTDTC,2018-05-06 +DS,3,RFENDTC,Not in dataset +DS,3,RFSTDTC,Not in dataset +DS,4,BRTHDTC,Not in dataset DS,4,DSDTC,2018-05-a +DS,4,DSENDTC,2018-05-08 +DS,4,DSRFTDTC,Not in dataset +DS,4,DSSTDTC,2018-05-06 +DS,4,RFENDTC,Not in dataset +DS,4,RFSTDTC,Not in dataset +DS,6,BRTHDTC,Not in dataset DS,6,DSDTC,hallo +DS,6,DSENDTC,2018-09-21 +DS,6,DSRFTDTC,Not in dataset +DS,6,DSSTDTC,2018-09-04 +DS,6,RFENDTC,Not in dataset +DS,6,RFSTDTC,Not in dataset +DS,8,BRTHDTC,Not in dataset DS,8,DSDTC,2022-05-08T13:44:66 +DS,8,DSENDTC,2018-09-21 +DS,8,DSRFTDTC,Not in dataset +DS,8,DSSTDTC,2018-09-04 +DS,8,RFENDTC,Not in dataset +DS,8,RFSTDTC,Not in dataset +DS,11,BRTHDTC,Not in dataset DS,11,DSDTC,20220921 +DS,11,DSENDTC,2018-09-21 +DS,11,DSRFTDTC,Not in dataset +DS,11,DSSTDTC,2018-09-04 +DS,11,RFENDTC,Not in dataset +DS,11,RFSTDTC,Not in dataset diff --git a/Published/CORE-000558/negative/01/data/ds.csv b/Published/CORE-000558/negative/01/data/ds.csv index 285efa057..5f5b27b07 100644 --- a/Published/CORE-000558/negative/01/data/ds.csv +++ b/Published/CORE-000558/negative/01/data/ds.csv @@ -3,5 +3,5 @@ CDISCCORE01,DS,015246-300-0004-00002,5,ADVERSE EVENT,LAST CONTACT,DISPOSITION EV CDISCCORE01,DS,015246-300-0004-00002,3,RANDOMIZED,RANDOMIZED,PROTOCOL MILESTONE,,,-5,, CDISCCORE01,DS,015246-300-0004-00002,3,RANDOMIZED,RANDOMIZED,PROTOCOL MILESTONE,,,0,44, CDISCCORE01,DS,015246-300-0004-00002,3,RANDOMIZED,RANDOMIZED,PROTOCOL MILESTONE,,,3.2,,65 -CDISCCORE01,DS,015246-300-0004-00002,3,RANDOMIZED,RANDOMIZED,PROTOCOL MILESTONE,,,NaN,, -CDISCCORE01,DS,015246-300-0004-00002,5,ADVERSE EVENT,LAST CONTACT,DISPOSITION EVENT,,TREATMENT,invalid,, +CDISCCORE01,DS,015246-300-0004-00002,3,RANDOMIZED,RANDOMIZED,PROTOCOL MILESTONE,,,-4.5,, +CDISCCORE01,DS,015246-300-0004-00002,5,ADVERSE EVENT,LAST CONTACT,DISPOSITION EVENT,,TREATMENT,,, diff --git a/Published/CORE-000558/negative/01/results/results.csv b/Published/CORE-000558/negative/01/results/results.csv index f2e8bb312..385832ae7 100644 --- a/Published/CORE-000558/negative/01/results/results.csv +++ b/Published/CORE-000558/negative/01/results/results.csv @@ -1,3 +1,13 @@ Dataset,Record,Variable,Value -DS,3,DSDY,0 +DS,3,DSDY,0.0 +DS,3,DSENDY, +DS,3,DSSTDY,44.0 +DS,3,VISITDY,Not in dataset DS,4,DSDY,3.2 +DS,4,DSENDY,65.0 +DS,4,DSSTDY, +DS,4,VISITDY,Not in dataset +DS,5,DSDY,-4.5 +DS,5,DSENDY, +DS,5,DSSTDY, +DS,5,VISITDY,Not in dataset diff --git a/Published/CORE-000569/negative/01/results/results.csv b/Published/CORE-000569/negative/01/results/results.csv index 8cd76b7d6..e20cfcc24 100644 --- a/Published/CORE-000569/negative/01/results/results.csv +++ b/Published/CORE-000569/negative/01/results/results.csv @@ -1,4 +1,3 @@ Dataset,Record,Variable,Value DM,2,variable_name,aDOMAIN -DM,5,variable_name,ARM1 DM,8,variable_name,ARM_NRS diff --git a/Published/CORE-000571/negative/02/results/results.csv b/Published/CORE-000571/negative/02/results/results.csv new file mode 100644 index 000000000..70f10cab7 --- /dev/null +++ b/Published/CORE-000571/negative/02/results/results.csv @@ -0,0 +1,3 @@ +Dataset,Record,Variable,Value +FA,,$VARIABLE_COUNT,1 +FA,,FALNKID,CDISC001 - 1 diff --git a/Published/CORE-000581/negative/01/results/results.csv b/Published/CORE-000581/negative/01/results/results.csv new file mode 100644 index 000000000..a2f4e031d --- /dev/null +++ b/Published/CORE-000581/negative/01/results/results.csv @@ -0,0 +1,2 @@ +Dataset,Record,Variable,Value +STUDY,,DM,Not in dataset diff --git a/Published/CORE-000581/negative/02/results/results.csv b/Published/CORE-000581/negative/02/results/results.csv new file mode 100644 index 000000000..a2f4e031d --- /dev/null +++ b/Published/CORE-000581/negative/02/results/results.csv @@ -0,0 +1,2 @@ +Dataset,Record,Variable,Value +STUDY,,DM,Not in dataset diff --git a/Published/CORE-000583/negative/01/results/results.csv b/Published/CORE-000583/negative/01/results/results.csv index b58a9262b..cc77e3a3c 100644 --- a/Published/CORE-000583/negative/01/results/results.csv +++ b/Published/CORE-000583/negative/01/results/results.csv @@ -5,3 +5,5 @@ TS,6,TSVAL,METFORMIN TS,6,TSVALNF,UNK TS,21,TSVAL,2 TS,21,TSVALNF,INF +TS,37,TSVAL, +TS,37,TSVALNF, diff --git a/Published/CORE-000590/negative/01/results/results.csv b/Published/CORE-000590/negative/01/results/results.csv new file mode 100644 index 000000000..de17efe7b --- /dev/null +++ b/Published/CORE-000590/negative/01/results/results.csv @@ -0,0 +1,2 @@ +Dataset,Record,Variable,Value +STUDY,,TO,Not in dataset diff --git a/Published/CORE-000592/negative/01/results/results.csv b/Published/CORE-000592/negative/01/results/results.csv new file mode 100644 index 000000000..aab56dcc3 --- /dev/null +++ b/Published/CORE-000592/negative/01/results/results.csv @@ -0,0 +1,9 @@ +Dataset,Record,Variable,Value +TO,1,TOPARMCD,TBPRDCAT +TO,1,TOVAL, +TO,6,TOPARMCD,TBPRDCAT +TO,6,TOVAL, +TO,7,TOPARMCD,TBPRDCAT +TO,7,TOVAL, +TO,10,TOPARMCD,TBPRDCAT +TO,10,TOVAL, diff --git a/Published/CORE-000593/negative/01/data/pt.csv b/Published/CORE-000593/negative/01/data/pt.csv index 7dd5f13d8..da12ce44d 100644 --- a/Published/CORE-000593/negative/01/data/pt.csv +++ b/Published/CORE-000593/negative/01/data/pt.csv @@ -4,6 +4,6 @@ TOB07,PT,111,Condition 1,2,NON-INTENSE REGIMEN,NICOTINE,Nicotine,STABILITY TESTI TOB07,PT,111,Condition 1,3,,NORNCTN,Nornicotine,STABILITY TESTING,Nicotine Degradant,25.76,ug/g,,25.76,25.76,ug/g,,,,TPT LABCO,E-LIQUID,,0.001,1,2023-01-02 00:00:00,Week 0 TOB07,PT,111,Condition 1,4,NON-INTENSE REGIMEN,NORNCTN,Nornicotine,STABILITY TESTING,Nicotine Degradant,0.0392,ug/PUFF,,0.0392,0.0392,ug/PUFF,,,,TPT LABCO,AEROSOL,,0.001,1,2023-01-02 00:00:00,Week 0 TOB07,PT,112,Condition 1,5,,GLYCRL,Glycerol,STABILITY TESTING,Primary Ingredient,615.68,mg/g,,615.68,615.68,mg/g,,,,TPT LABCO,E-LIQUID,,0.001,1,2023-01-02 00:00:00,Week 0 -TOB07,PT,112,Condition 1,6,NON-INTENSE REGIMEN,GLYCRL,Glycerol,STABILITY TESTING,Primary Ingredient,1.81,mg/PUFF,0.00144,1.81,1.81,mg/PUFF,,,,TPT LABCO,AEROSOL,,0.001,1,2023-01-02 00:00:00,Week 0 +TOB07,PT,112,Condition 1,6,NON-INTENSE REGIMEN,GLYCRL,Glycerol,STABILITY TESTING,Primary Ingredient,1.81,mg/PUFF,0.00144,1.81,1.81,mg/PUFF,,,,TPT LABCO,AEROSOL,METHOD 5,0.001,1,2023-01-02 00:00:00,Week 0 TOB07,PT,112,Condition 1,7,,PRPYLGLY,Propylene Glycol,STABILITY TESTING,Primary Ingredient,218.21,mg/g,,218.21,218.21,mg/g,,,,TPT LABCO,E-LIQUID,,0.001,1,2023-01-02 00:00:00,Week 0 TOB07,PT,112,Condition 1,8,NON-INTENSE REGIMEN,PRPYLGLY,Propylene Glycol,STABILITY TESTING,Primary Ingredient,0.8565,mg/PUFF,0.00024,0.8565,0.8565,mg/PUFF,,,,TPT LABCO,AEROSOL,,0.001,1,2023-01-02 00:00:00,Week 0 diff --git a/Published/CORE-000593/negative/01/results/results.csv b/Published/CORE-000593/negative/01/results/results.csv new file mode 100644 index 000000000..4cc043e67 --- /dev/null +++ b/Published/CORE-000593/negative/01/results/results.csv @@ -0,0 +1,22 @@ +Dataset,Record,Variable,Value +PT,1,PTMETHOD, +PT,1,PTXFN, +PT,1,SPTOBID,111 +PT,2,PTMETHOD, +PT,2,PTXFN, +PT,2,SPTOBID,111 +PT,3,PTMETHOD, +PT,3,PTXFN, +PT,3,SPTOBID,111 +PT,4,PTMETHOD, +PT,4,PTXFN, +PT,4,SPTOBID,111 +PT,5,PTMETHOD, +PT,5,PTXFN, +PT,5,SPTOBID,112 +PT,7,PTMETHOD, +PT,7,PTXFN, +PT,7,SPTOBID,112 +PT,8,PTMETHOD, +PT,8,PTXFN, +PT,8,SPTOBID,112 diff --git a/Published/CORE-000597/negative/01/results/results.csv b/Published/CORE-000597/negative/01/results/results.csv index a951a81f7..3ec095d19 100644 --- a/Published/CORE-000597/negative/01/results/results.csv +++ b/Published/CORE-000597/negative/01/results/results.csv @@ -1,5 +1,5 @@ Dataset,Record,Variable,Value -AE,6,AESMIE, -AE,6,QNAM,AESOSP -AE,73,AESMIE,N -AE,73,QNAM,AESOSP +AE,1,AESMIE, +AE,1,AESOSP,SPONTANEOUS ABORTION +AE,8,AESMIE,N +AE,8,AESOSP,HIGH RISK FOR ADDITIONAL THROMBOSIS diff --git a/Published/CORE-000597/rule.yml b/Published/CORE-000597/rule.yml index 82b5ac047..e68a1aad0 100644 --- a/Published/CORE-000597/rule.yml +++ b/Published/CORE-000597/rule.yml @@ -71,10 +71,8 @@ Authorities: Version: "1.0" Check: all: - - name: QNAM - operator: equal_to - value: AESOSP - value_is_literal: true + - name: AESOSP + operator: non_empty - name: AESMIE operator: not_equal_to value: Y @@ -91,7 +89,7 @@ Match Datasets: Outcome: Message: Missing AESMIE=Y where SUPPAE.QNAM=AESOSP Output Variables: - - QNAM + - AESOSP - AESMIE Rule Type: Record Data Scope: diff --git a/Published/CORE-000600/negative/01/results/results.csv b/Published/CORE-000600/negative/01/results/results.csv new file mode 100644 index 000000000..026c9b36f --- /dev/null +++ b/Published/CORE-000600/negative/01/results/results.csv @@ -0,0 +1,33 @@ +Dataset,Record,Variable,Value +RELREF,2,$relref_refid,"['C01', 'C0-Count1', 'C0-Count2', 'C0-Count3', 'C0-Count4']" +RELREF,2,LEVEL,2.0 +RELREF,2,PARENT,C0 +RELREF,2,SETCD,A1 +RELREF,3,$relref_refid,"['C01', 'C0-Count1', 'C0-Count2', 'C0-Count3', 'C0-Count4']" +RELREF,3,LEVEL,2.0 +RELREF,3,PARENT,C0 +RELREF,3,SETCD,A1 +RELREF,4,$relref_refid,"['C01', 'C0-Count1', 'C0-Count2', 'C0-Count3', 'C0-Count4']" +RELREF,4,LEVEL,2.0 +RELREF,4,PARENT,C0 +RELREF,4,SETCD,A1 +RELREF,5,$relref_refid,"['C01', 'C0-Count1', 'C0-Count2', 'C0-Count3', 'C0-Count4']" +RELREF,5,LEVEL,2.0 +RELREF,5,PARENT,C0-Count5 +RELREF,5,SETCD,A1 +RELREF,7,$relref_refid,"['C0', 'C1250', 'C1250-Count2', 'C1250-Count3', 'C1250-Count4']" +RELREF,7,LEVEL,2.0 +RELREF,7,PARENT,C1250 +RELREF,7,SETCD,A2 +RELREF,8,$relref_refid,"['C0', 'C1250', 'C1250-Count2', 'C1250-Count3', 'C1250-Count4']" +RELREF,8,LEVEL,2.0 +RELREF,8,PARENT,C12501 +RELREF,8,SETCD,A2 +RELREF,9,$relref_refid,"['C0', 'C1250', 'C1250-Count2', 'C1250-Count3', 'C1250-Count4']" +RELREF,9,LEVEL,2.0 +RELREF,9,PARENT,C12502 +RELREF,9,SETCD,A2 +RELREF,10,$relref_refid,"['C0', 'C1250', 'C1250-Count2', 'C1250-Count3', 'C1250-Count4']" +RELREF,10,LEVEL,2.0 +RELREF,10,PARENT,C12503 +RELREF,10,SETCD,A2 diff --git a/Published/CORE-000601/negative/01/results/results.csv b/Published/CORE-000601/negative/01/results/results.csv new file mode 100644 index 000000000..380dc992b --- /dev/null +++ b/Published/CORE-000601/negative/01/results/results.csv @@ -0,0 +1,65 @@ +Dataset,Record,Variable,Value +IQ,2,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,2,IGDCMPID,Burley Tobacco +IQ,2,IQPARENT,Tobacco Filler +IQ,2,SPTOBID,CIG01A +IQ,3,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,3,IGDCMPID,Bright Tobacco +IQ,3,IQPARENT,Tobacco Filler +IQ,3,SPTOBID,CIG01A +IQ,4,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,4,IGDCMPID,Oriental Tobacco +IQ,4,IQPARENT,Tobacco Filler +IQ,4,SPTOBID,CIG01A +IQ,5,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,5,IGDCMPID,Oriental Tobacco +IQ,5,IQPARENT,Tobacco Filler +IQ,5,SPTOBID,CIG01A +IQ,8,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,8,IGDCMPID,Reconstituted Tobacco +IQ,8,IQPARENT,Reconstituted Tobacco +IQ,8,SPTOBID,CIG01A +IQ,10,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,10,IGDCMPID,"1,3-Butanediol" +IQ,10,IQPARENT,Triacetin +IQ,10,SPTOBID,CIG01A +IQ,11,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,11,IGDCMPID,Cocoa Extract +IQ,11,IQPARENT,Tobacco Filler +IQ,11,SPTOBID,CIG01A +IQ,12,$iq_igdcmpid,"['Tobacco Fillers', 'Burley Tobacco', 'Bright Tobacco', 'Oriental Tobacco', 'Burley Tobacco 2', 'Reconstituted Tobacco', 'Methylcellulose', '1,3-Butanediol', 'Cocoa Extract', 'Butyric Acid']" +IQ,12,IGDCMPID,Butyric Acid +IQ,12,IQPARENT,Tobacco Filler +IQ,12,SPTOBID,CIG01A +IQ,13,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,13,IGDCMPID,Cellulose Acetate +IQ,13,IQPARENT,Cellulose Filter A +IQ,13,SPTOBID,CIG02A +IQ,14,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,14,IGDCMPID,Triacetin +IQ,14,IQPARENT,Cellulose Filter A +IQ,14,SPTOBID,CIG02A +IQ,16,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,16,IGDCMPID,Cellulose Pulp +IQ,16,IQPARENT,FSC Paper B +IQ,16,SPTOBID,CIG02A +IQ,17,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,17,IGDCMPID,Calcium Carbonate +IQ,17,IQPARENT,FSC Paper B +IQ,17,SPTOBID,CIG02A +IQ,18,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,18,IGDCMPID,Sodium Alginate +IQ,18,IQPARENT,FSC Paper B +IQ,18,SPTOBID,CIG02A +IQ,19,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,19,IGDCMPID,Trisodium Citrate +IQ,19,IQPARENT,FSC Paper B +IQ,19,SPTOBID,CIG02A +IQ,20,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,20,IGDCMPID,Cationic Starch +IQ,20,IQPARENT,FSC Paper B +IQ,20,SPTOBID,CIG02A +IQ,21,$iq_igdcmpid,"['Cellulose Acetate', 'Triacetin', 'FSC Paper A', 'Cellulose Pulp', 'Calcium Carbonate', 'Sodium Alginate', 'Trisodium Citrate', 'Cationic Starch', 'Seam Adhesive']" +IQ,21,IGDCMPID,Seam Adhesive +IQ,21,IQPARENT,FSC Paper B +IQ,21,SPTOBID,CIG02A diff --git a/Published/CORE-000602/negative/01/results/results.csv b/Published/CORE-000602/negative/01/results/results.csv new file mode 100644 index 000000000..02d58a0db --- /dev/null +++ b/Published/CORE-000602/negative/01/results/results.csv @@ -0,0 +1,13 @@ +Dataset,Record,Variable,Value +RELREF,1,LEVEL,2.0 +RELREF,1,PARENT, +RELREF,1,SETCD,A1 +RELREF,6,LEVEL,0.0 +RELREF,6,PARENT, +RELREF,6,SETCD,A2 +RELREF,11,LEVEL, +RELREF,11,PARENT, +RELREF,11,SETCD,A3 +RELREF,16,LEVEL,-1.0 +RELREF,16,PARENT, +RELREF,16,SETCD,A4 diff --git a/Published/CORE-000603/negative/01/results/results.csv b/Published/CORE-000603/negative/01/results/results.csv new file mode 100644 index 000000000..1cb2898bb --- /dev/null +++ b/Published/CORE-000603/negative/01/results/results.csv @@ -0,0 +1,19 @@ +Dataset,Record,Variable,Value +RELREF,1,REFID,C0 +RELREF,1,STUDYID,123 +RELREF,2,REFID,C0 +RELREF,2,STUDYID,123 +RELREF,3,REFID,C0-Count2 +RELREF,3,STUDYID,123 +RELREF,4,REFID,C0-Count2 +RELREF,4,STUDYID,123 +RELREF,5,REFID,C0-Count2 +RELREF,5,STUDYID,123 +RELREF,6,REFID,C0-Count2 +RELREF,6,STUDYID,123 +RELREF,7,REFID,C0-Count2 +RELREF,7,STUDYID,123 +RELREF,8,REFID, +RELREF,8,STUDYID,123 +RELREF,9,REFID, +RELREF,9,STUDYID,123 diff --git a/Published/CORE-000604/negative/01/results/results.csv b/Published/CORE-000604/negative/01/results/results.csv new file mode 100644 index 000000000..f10d058b7 --- /dev/null +++ b/Published/CORE-000604/negative/01/results/results.csv @@ -0,0 +1,22 @@ +Dataset,Record,Variable,Value +TO,3,$distinct_pdparmcd,"['LENGTHS', 'TBFLMASS', 'MOISTURE', 'TOCUTSIZ', 'VENTLTOT', 'TPNPLGTH', 'CPBPOR', 'FLTRLGTH', 'FLTPRDRP', 'CIGPLGTH']" +TO,3,SPTOBID,CIG01a +TO,3,TOPARMCD,TRADENAM +TO,4,$distinct_pdparmcd,"['LENGTHS', 'TBFLMASS', 'MOISTURE', 'TOCUTSIZ', 'VENTLTOT', 'TPNPLGTH', 'CPBPOR', 'FLTRLGTH', 'FLTPRDRP', 'CIGPLGTH']" +TO,4,SPTOBID,CIG01a +TO,4,TOPARMCD,PACKTYP +TO,5,$distinct_pdparmcd,"['LENGTHS', 'TBFLMASS', 'MOISTURE', 'TOCUTSIZ', 'VENTLTOT', 'TPNPLGTH', 'CPBPOR', 'FLTRLGTH', 'FLTPRDRP', 'CIGPLGTH']" +TO,5,SPTOBID,CIG01a +TO,5,TOPARMCD,PRDQUAN +TO,6,$distinct_pdparmcd,"['LENGTHS', 'TBFLMASS', 'MOISTURE', 'TOCUTSIZ', 'VENTLTOT', 'TPNPLGTH', 'CPBPOR', 'FLTRLGTH', 'FLTPRDRP', 'CIGPLGTH']" +TO,6,SPTOBID,CIG01a +TO,6,TOPARMCD,LENGTH +TO,7,$distinct_pdparmcd,['CIRCUM'] +TO,7,SPTOBID,CIG02a +TO,7,TOPARMCD,CIRCUMF +TO,8,$distinct_pdparmcd,['CIRCUM'] +TO,8,SPTOBID,CIG02a +TO,8,TOPARMCD,VENTLTOT +TO,9,$distinct_pdparmcd,['CIRCUM'] +TO,9,SPTOBID,CIG02a +TO,9,TOPARMCD,CHARFLAV diff --git a/Published/CORE-000605/negative/01/data/it.csv b/Published/CORE-000605/negative/01/data/it.csv index 221cac033..61d034057 100644 --- a/Published/CORE-000605/negative/01/data/it.csv +++ b/Published/CORE-000605/negative/01/data/it.csv @@ -1,7 +1,7 @@ STUDYID,DOMAIN,SPTOBID,IGDCMPID,TPMF,ITSPECIF,ITIGDPLX,ITCIGIND,ITCURMTH TOB07,IT,CIG01A,Tobacco Filler,,,COMPLEX INGREDIENT,, -TOB07,IT,CIG01A,Burley Tobacco,MF5555555,NC 7LC,SINGLE INGREDIENT,Air, +TOB07,IT,CIG01A,Burley Tobacco 2,MF5555555,NC 7LC,SINGLE INGREDIENT,Air, TOB07,IT,CIG01A,Bright Tobacco,,CC 1063,SINGLE INGREDIENT,Flue, TOB07,IT,CIG01A,Oriental Tobacco,,USDA Nicotiana Collection PI 552747,SINGLE INGREDIENT,Sun, TOB07,IT,CIG02A,Reconstituted Tobacco,,,COMPLEX INGREDIENT,,N -TOB07,IT,CIG02A,Burley Tobacco 2,,KT215LC,SINGLE INGREDIENT,Air, +TOB07,IT,CIG02A,Methylcellulose,,KT215LC,SINGLE INGREDIENT,Air, diff --git a/Published/CORE-000605/negative/01/results/results.csv b/Published/CORE-000605/negative/01/results/results.csv new file mode 100644 index 000000000..f6b3879c0 --- /dev/null +++ b/Published/CORE-000605/negative/01/results/results.csv @@ -0,0 +1,13 @@ +Dataset,Record,Variable,Value +IT,1,$iq_igdcmpid,"['Reconstituted Tobacco', 'Burley Tobacco 2', 'Cocoa Extract', 'Butyric Acid']" +IT,1,IGDCMPID,Tobacco Filler +IT,1,SPTOBID,CIG01A +IT,3,$iq_igdcmpid,"['Reconstituted Tobacco', 'Burley Tobacco 2', 'Cocoa Extract', 'Butyric Acid']" +IT,3,IGDCMPID,Bright Tobacco +IT,3,SPTOBID,CIG01A +IT,4,$iq_igdcmpid,"['Reconstituted Tobacco', 'Burley Tobacco 2', 'Cocoa Extract', 'Butyric Acid']" +IT,4,IGDCMPID,Oriental Tobacco +IT,4,SPTOBID,CIG01A +IT,5,$iq_igdcmpid,"['Oriental Tobacco', 'Methylcellulose', '1,3-Butanediol']" +IT,5,IGDCMPID,Reconstituted Tobacco +IT,5,SPTOBID,CIG02A diff --git a/Published/CORE-000606/negative/01/results/results.csv b/Published/CORE-000606/negative/01/results/results.csv new file mode 100644 index 000000000..df2f51bef --- /dev/null +++ b/Published/CORE-000606/negative/01/results/results.csv @@ -0,0 +1,33 @@ +Dataset,Record,Variable,Value +IQ,1,$it_igdcmpid,['Tobacco Filler'] +IQ,1,IGDCMPID,Tobacco Fillers +IQ,1,IQCAT,TOBACCO INGREDIENT +IQ,1,SPTOBID,CIG01A +IQ,2,$it_igdcmpid,['Tobacco Filler'] +IQ,2,IGDCMPID,Burley Tobacco +IQ,2,IQCAT,TOBACCO INGREDIENT +IQ,2,SPTOBID,CIG01A +IQ,3,$it_igdcmpid,['Tobacco Filler'] +IQ,3,IGDCMPID,Bright Tobacco +IQ,3,IQCAT,TOBACCO INGREDIENT +IQ,3,SPTOBID,CIG01A +IQ,4,$it_igdcmpid,['Tobacco Filler'] +IQ,4,IGDCMPID,Oriental Tobacco +IQ,4,IQCAT,TOBACCO INGREDIENT +IQ,4,SPTOBID,CIG01A +IQ,5,$it_igdcmpid,"['Bright Tobacco', 'Bright Tobaccos', 'BURLEY TOBACCO 2']" +IQ,5,IGDCMPID,Reconstituted Tobacco +IQ,5,IQCAT,TOBACCO INGREDIENT +IQ,5,SPTOBID,CIG02A +IQ,6,$it_igdcmpid,['Tobacco Filler'] +IQ,6,IGDCMPID,Burley Tobacco 2 +IQ,6,IQCAT,TOBACCO INGREDIENT +IQ,6,SPTOBID,CIG01A +IQ,7,$it_igdcmpid,"['Bright Tobacco', 'Bright Tobaccos', 'BURLEY TOBACCO 2']" +IQ,7,IGDCMPID,Burley Tobacco 2 +IQ,7,IQCAT,TOBACCO INGREDIENT +IQ,7,SPTOBID,CIG02A +IQ,8,$it_igdcmpid,['Tobacco Filler'] +IQ,8,IGDCMPID,Oriental Tobacco +IQ,8,IQCAT,TOBACCO INGREDIENT +IQ,8,SPTOBID,CIG01A diff --git a/Published/CORE-000607/negative/01/results/results.csv b/Published/CORE-000607/negative/01/results/results.csv new file mode 100644 index 000000000..4d60fbb9f --- /dev/null +++ b/Published/CORE-000607/negative/01/results/results.csv @@ -0,0 +1,19 @@ +Dataset,Record,Variable,Value +PT,1,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,1,SPTOBID,111 +PT,1,STOCONID,Conditions 1 +PT,2,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,2,SPTOBID,111 +PT,2,STOCONID,Conditioning 1 +PT,3,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,3,SPTOBID,111 +PT,3,STOCONID,Condition 2 +PT,4,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,4,SPTOBID,111 +PT,4,STOCONID,Condition 2 +PT,5,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,5,SPTOBID,111 +PT,5,STOCONID,Condition +PT,6,$es_stoconid,"['Condition 1', 'Condition 3', 'Condition 4']" +PT,6,SPTOBID,111 +PT,6,STOCONID,Condition 5 diff --git a/Published/CORE-000609/negative/01/results/results.csv b/Published/CORE-000609/negative/01/results/results.csv new file mode 100644 index 000000000..2801ea0d8 --- /dev/null +++ b/Published/CORE-000609/negative/01/results/results.csv @@ -0,0 +1,29 @@ +Dataset,Record,Variable,Value +DM,1,$tx_setcd,"['A1', 'A2', 'A-1']" +DM,1,SETCD,a1 +DM,2,$tx_setcd,"['A1', 'A2', 'A-1']" +DM,2,SETCD,a2 +DM,3,$tx_setcd,"['A1', 'A2', 'A-1']" +DM,3,SETCD,A16 +RELREF,1,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,1,SETCD,A_1 +RELREF,2,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,2,SETCD,A4 +RELREF,3,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,3,SETCD,A5 +RELREF,4,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,4,SETCD,A6 +RELREF,5,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,5,SETCD,A7 +RELREF,6,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,6,SETCD,A8 +RELREF,7,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,7,SETCD,A9 +RELREF,8,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,8,SETCD,A10 +RELREF,9,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,9,SETCD,A11 +RELREF,10,$tx_setcd,"['A1', 'A2', 'A-1']" +RELREF,10,SETCD,A12 +TX,41,$tx_setcd,"['A1', 'A2', 'A-1']" +TX,41,SETCD, diff --git a/Published/CORE-000610/negative/01/results/results.csv b/Published/CORE-000610/negative/01/results/results.csv new file mode 100644 index 000000000..9da2e3122 --- /dev/null +++ b/Published/CORE-000610/negative/01/results/results.csv @@ -0,0 +1,15 @@ +Dataset,Record,Variable,Value +GT,1,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,1,GTREFID,2_1 +GT,2,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,2,GTREFID,2_2 +GT,3,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,3,GTREFID,2_3 +GT,4,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,4,GTREFID,B +GT,5,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,5,GTREFID,6.1 +GT,6,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,6,GTREFID,6.2 +GT,7,$relref_refid,"['A', '1_1', '1_2', '1_3', '1_4', '1_5', 'F', '6_1', '6_2', '6_3', 'G', '7_1', '7_2', '7_3', 'R', '18_1', '18_2', '18_3']" +GT,7,GTREFID, diff --git a/Published/CORE-000611/negative/01/results/results.csv b/Published/CORE-000611/negative/01/results/results.csv new file mode 100644 index 000000000..53c0081d5 --- /dev/null +++ b/Published/CORE-000611/negative/01/results/results.csv @@ -0,0 +1,17 @@ +Dataset,Record,Variable,Value +RELREF,1,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,1,REFID,A +RELREF,2,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,2,REFID,1_1 +RELREF,3,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,3,REFID,1_2 +RELREF,4,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,4,REFID,1_3 +RELREF,5,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,5,REFID,1_4 +RELREF,6,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,6,REFID,1_5 +RELREF,7,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,7,REFID,F +RELREF,8,$gt_refid,"['2_1', '2_2', '2_3', 'B', '6.1', '6.2']" +RELREF,8,REFID,6_1